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TIOTROPIUM 2.5 MICROGRAM INHALATION SOLUTION

Active substance(s): TIOTROPIUM / TIOTROPIUM BROMIDE

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Transcript
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Evaluation of the side effects is based on the following frequencies:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
The side effects described below have been experienced by people
taking this medicine and they are listed according to frequency as either
common, uncommon, rare or not known
Frequency
Frequency
Side effect
COPD
Asthma
Dry mouth: this is usually mild
Common
Common
Dizziness

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of
the mouth and face or sudden difficulties in breathing (angioneurotic
oedema) or other hypersensitivity reactions (such as sudden reduction of
your blood pressure or dizziness) may occur individually or as part of severe
allergic reaction (anaphylactic reaction) after administration of Spiriva
Respimat. If any of these occur, please consult your doctor
immediately
In addition, in common with all inhaled medicines, some patients may
experience an unexpected tightness of the chest, coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm).
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist.This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.
5

How to store Spiriva Respimat

Uncommon
Uncommon

Uncommon
Uncommon

Keep out of the sight and reach of children.

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Do not use Spiriva Respimat after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Spiriva Respimat inhaler should be discarded at the latest 3 months
after first use (see Instructions for Use overleaf).

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon
Rare

Uncommon
Not Known

Inflammation of the throat
(pharyngitis)

Uncommon

Uncommon

Hoarseness (dysphonia)

Uncommon

Uncommon

Tightness of the chest, associated
with coughing, wheezing or
breathlessness immediately after
inhalation (bronchospasm)

Rare

Uncommon

Constipation

Uncommon

Rare

Fungal infections of the oral cavity
and throat (oropharyngeal
candidiasis)

Uncommon

Uncommon

Difficulties swallowing (dysphagia)

Rare

Not known

Rash

Uncommon

Rare

Itching (pruritus)

Uncommon

Rare

Difficulties passing urine (urinary
retention)
Painful urination (dysuria)

Uncommon

Not known

Uncommon

Not known

Seeing halos around lights or
coloured images in association
with red eyes (glaucoma)

Rare

Not known

Increase of the measured eye
pressure

Rare

Not known

Blurred vision

Rare

Not know

Inflammation of the larynx
(laryngitis)
Heart burn (gastrooesophageal
reflux disease)

Rare

Not known

Rare

Not Known

Dental caries
Inflammation of the gums
(gingivitis)

Rare
Rare

Not known
Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)

Rare

Nettle rash (urticaria)

Rare

Rare

Infections or ulcerations of the
skin

Rare

Not known

Dryness of the skin
Hypersensitivity,
including immediate reactions

Rare
Not known

Not known
Rare

Infections of the urinary tract

Rare

Not known

Depletion of body water
(dehydration)

Not known

Not known

Inflammation in sinuses (sinusitis)

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including ileus
paralytic)

Not known

Not known

Feeling sick (nausea)
Severe allergic reaction
(anaphylactic reaction)

Not known
Not known

Not known
Not known

Headache

Nosebleed (epistaxis)

Swelling of joint
Page 2

Not known

Not known

Rare

Rare

Not known

Spiriva® Respimat ® 2.5 mcg, inhalation solution
(tiotropium bromide)

Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Spiriva Respimat 2.5 mcg inhalation solution and will
be referred to as Spiriva Respimat throughout the rest of this leaflet.
What is in this leaflet
1 What Spiriva Respimat is and what it is used for
2

Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.
6

Contents of the pack and other information

What Spiriva Respimat contains:
The active substance is tiotropium. The delivered dose is 2.5 micrograms
tiotropium (as bromide monohydrate) per puff (2 puffs comprise one
medicinal dose).
The other ingredients are: Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Spiriva Respimat looks like and contents of the pack
The Cardboard carton contains one inhaler and one aluminium cylindrical
cartridge containing a clear colourless solution for inhalation. A plastic cap is
present on both ends of the inhaler: a green cap covering the mouth piece;
and a transparent cap where the cartridge is to be inserted. The inhaler has
an indicator on the side showing the number of doses left.
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer and Licence Holder
This medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG, Binger Strasse 173, D-55216 Ingelhein am Rhein, Germany and is
procured from within the EU. Product Licence Holder: Lexon UK Limited, Unit
18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.
Spiriva ® Respimat ® is a registered trademark of Boehringer ingelheim
Pharma GmbH & Co. KG.

POM

PL 15184/1619 - Spiriva Respimat 250 microgram,
Inhalation solution

Leaflet revision date: 04/04/16

Blind or partially sighted? Is this leaflet hard to see
or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Ref:1619/040416/1/F

3
4
5
6

1

What you need to know before you take Spiriva Respimat
How to take Spiriva Respimat
Possible side effects
How to store Spiriva Respimat
Contents of the pack and other information

What Spiriva Respimat is and what it is used for

Spiriva Respimat helps people who have chronic obstructive pulmonary
disease (COPD) or asthma to breathe more easily. COPD is a long-term lung
disease that causes shortness of breath and coughing. The term COPD
is associated with the conditions chronic bronchitis and emphysema. Asthma
is a long-term disease characterised by airway inflammation and narrowing of
the airways. As COPD and asthma are long-term diseases you should take
Spiriva Respimat every day and not only when you have breathing problems
or other symptoms. When used to treat asthma you should use Spiriva
Respimat in addition to so-called inhaled corticosteroids and long-acting ß2
agonists.
Spiriva Respimat is a long-acting bronchodilator that helps to open your
airways and makes it easier to get air in and out of the lungs. Regular use of
Spiriva Respimat can also help you when you have on-going shortness of
breath related to your disease, and will help to minimise the effects of the
disease on your everyday life. Daily use of Spiriva Respimat will also help to
prevent any sudden, short-term worsening of your COPD symptoms which
may last for several days.
For correct dosing of Spiriva Respimat please see section 3. How to take
Spiriva Respimat and the instructions for use provided on the other side of
the leaflet.

2

What you need to know before you take Spiriva Respimat

Please read the following questions carefully. If you can answer any of
these questions with ‘Yes’ please discuss this with your doctor before taking
Spiriva Respimat








are you allergic (hypersensitive) to tiotropium, atropine or similar drugs
such as ipratropium or oxitropium?
are you taking any other medicinal products containing ipratropium or
oxitropium?
are you pregnant, do you think you are pregnant, or are you
breast-feeding?
are you suffering from blurred vision, eye pain and/or red eyes, prostate
problems or have difficulty passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during the last 6 months or
from any unstable or life threatening irregular heart beat or severe heart
failure within the past year?

Do not use Spiriva Respimat
• if you are allergic (hypersensitive) to tiotropium, its active ingredient or any
of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to atropine or substances related to it,
e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor before taking Spiriva Respimat.
When taking Spiriva Respimat take care not to let any spray enter your eyes.
This may result in eye pain or discomfort, blurred vision, seeing halos around
lights or coloured images in association with red eyes (i.e. narrow angle
glaucoma). Eye symptoms may be accompanied by headache, nausea or
vomiting. Wash your eyes in warm water, stop using tiotropium bromide and
immediately consult your doctor for further advice.
If your breathing has got worse or if you experience rash, swelling or itching
directly after using your inhaler, stop using it and tell your doctor immediately.
Dry mouth which has been observed with anti-cholinergic treatment may in
the long term be associated with dental caries. Therefore, please remember
to pay attention to oral hygiene.

Spiriva Respimat is indicated for the maintenance treatment of your chronic
obstructive pulmonary disease or asthma. Do not use this medicine to treat a
sudden attack of breathlessness or wheezing. Your doctor should have
given you another inhaler (“rescue medication”) for this.
Please follow the instructions your doctor has given you.
If you have been prescribed Spiriva Respimat for your asthma it should be
added on to inhaled corticosteroids and long-acting ß2 agonists. Continue
taking the inhaled corticosteroids as prescribed by your doctor, even if you
feel better.
In case you have suffered from a myocardial infarction during the last 6
months or from any unstable or life threatening irregular heart beat or severe
heart failure within the past year, please, inform your doctor. This is
important to decide if Spiriva is the right medicine for you to take.
Do not take Spiriva Respimat more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.
If you have cystic fibrosis, tell your doctor because Spiriva Respimat could
make your cystic fibrosis symptoms worse.
Children and adolescents
Spiriva Respimat is not recommended for children and adolescents under 18
years.
Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription.
In particular, please tell your doctor or pharmacist if you are taking/have
taken anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Spiriva Respimat has
been taken with other products used to treat COPD such as reliever inhalers
(e.g. salbutamol), methylxanthines (e.g. theophylline), antihistamines,
mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast),
cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. You should not use this medicine unless specifically recommended
by your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use machines have
been performed. In case dizziness or blurred vision occurs the ability to drive
and use machinery may be influenced.

3

How to take Spiriva Respimat

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Spiriva Respimat is for inhalation use only.
The recommended dose for adults is:
Spiriva Respimat is effective for 24 hours so you will need to use Spiriva
Respimat only ONCE A DAY, if possible at the same time of the day. Each
time you use it take TWO PUFFS.
As COPD and asthma are long-term diseases take Spiriva Respimat every
day and not only when you experience breathing problems. Do not take more
than the recommended dose.
Spiriva Respimat is not recommended for use in children and adolescents
below 18 years due to lack of data on safety and efficacy.
Make sure that you know how to use your Spiriva Respimat inhaler properly.
The instructions for use of the Spiriva Respimat inhaler are provided on the
other side of this leaflet.
If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one day talk to your
doctor immediately. You may be at a higher risk of experiencing a side effect
such as dry mouth, constipation, difficulties passing urine, increased heart
beat or blurred vision.
If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it as soon as you remember but do not take two doses at the
same time or on the same day. Then take your next dose as usual.
If you stop taking Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk to your doctor or
your pharmacist. If you stop taking Spiriva Respimat the signs and symptoms
of COPD may worsen.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
Page 1

Instructions For Use

Prepare for first use

Introduction

Remove clear base

Spiriva Respimat (tiotropium bromide). Read these Instructions for Use
before you start using Spiriva Respimat.

1. • Keep the cap closed.
• Press the safety catch while firmly pulling off the clear base with your
other hand

Daily use
TURN




Keep the cap closed.
TURN the clear base in the direction of the arrows on the label until it
clicks (half a turn).

You will need to use this inhaler only ONCE A DAY. Each time you use it take
TWO PUFFS.

Answers to Common Questions
It is difficult to insert the cartridge deep enough.
Did you accidentally turn the clear base before inserting the cartridge?
Open the cap, press the dose-release button, then insert the cartridge.
Did you insert the cartridge with the wide end first?
Insert the cartridge with the narrow end first.

The dose indicator on the Spiriva Respimat reaches zero too soon.
Did you use Spiriva Respimat as indicated (two puffs/Once daily)?
Spiriva Respimat will last 30 days if used at two puffs once daily.
Did you turn the clear base before you inserted the cartridge?
The dose indicator counts each turn of the clear base regardless whether a
cartridge has been inserted or not.

Insert cartridge
2. • Insert the narrow end of the cartridge into the inhaler.
• Place the inhaler on a firm surface and push down firmly until it clicks
into place.

Did you spray in the air often to check whether the Spiriva Respimat is
working?
Once you have prepared Spiriva Respimat, no test-spraying is
required if used daily.
Did you insert the cartridge into a used Spiriva Respimat?
Always insert a new cartridge into a NEW Spiriva Respimat

OPEN





If Spiriva Respimat has not been used for more than 7 days release one
puff towards the ground.
If Spiriva Respimat has not been used for more than 21 days repeat steps
4 to 6 under ‘Prepare for first Use’ until a cloud is visible. Then repeat
steps 4 to 6 three more times.
Do not touch the piercing element inside the clear base.



.

OPEN the cap until it snaps fully open.
I cannot press the dose-release button.
Did you turn the clear base?
If not, turn the clear base in a continuous movement until it clicks
(half a turn).

Replace clear base
3. • Put the clear base back into place until it clicks.

Is the dose indicator on the Spiriva Respimat pointing to zero?
The Spiriva Respimat inhaler is locked after 60 puffs (30 medicinal doses).
Prepare and use your new Spiriva Respimat inhaler.

How to care for your Spiriva Respimat
Clean the mouthpiece including the metal part inside the mouthpiece with a
damp cloth or tissue only, at least once a week.
Any minor discoloration in the mouthpiece does not affect your Spiriva
Respimat inhaler performance. If necessary, wipe the outside of your Spiriva
Respimat inhaler with a damp cloth.

My Spiriva Respimat sprays automatically.
Was the cap open when you turned the clear base?
Close the cap, then turn the clear base.
Turn

Did you press the dose-release button when turning the clear
base?
Close the cap, so the dose-release button is covered, then turn the clear
base.

4. • Keep the cap closed.
• Turn the clear base in the direction of the arrows on the label until it
clicks (half a turn).

PRESS








Breathe out slowly and fully.
Close your lips around the mouthpiece without covering the air vents.
Point your Inhaler to the back of your throat.
While taking a slow, deep breath through your mouth, PRESS the
dose-release button and continue to breathe in slowly for as long as
comfortable.
Hold your breath for 10 seconds or for as long as comfortable.
Repeat TURN, OPEN, PRESS for a total of 2 puffs.
Close the cap until you use your inhaler again.

Did you stop when turning the clear base before it clicked?
Turn the clear base in a continuous movement until it clicks (half a turn).

I cannot turn the clear base.
Did you turn the clear base already?
If the clear base has already been turned, follow steps “OPEN” and “PRESS”
under “Daily Use” to get your medicine.

Open







Your Spiriva Respimat inhaler contains 60 puffs (30 doses) if used as
indicated (two puffs/once daily).
The dose indicator shows approximately how much medication is left.
When the dose indicator enters the red area of the scale you need to get a
new prescription; there is approximately medication for 7 days left
(14 puffs).
Once the dose indicator reaches the end of the red scale, your Spiriva
Respimat locks automatically – no more doses can be released.
At this point, the clear base cannot be turned any further.
Spiriva Respimat should be discarded three months after you have
prepared it for first use, even if it has not been fully used or used at all.

5. • Open the cap until it snaps fully open.

Is the dose indicator on the Spiriva Respimat pointing to zero?
The Spiriva Respimat inhaler is locked after 60 puffs (30 medicinal doses).
Prepare and use your new Spiriva Respimat inhaler.

My Spiriva Respimat doesn’t spray.
Did you insert a cartridge?
If not, insert a cartridge.
Press
6. • Point the inhaler toward the ground.
• Press the dose-release button
• Close the cap
• Repeat steps 4-6 until a cloud is visible.
• After a cloud is visible, repeat steps 4-6 three more times.

Did you repeat TURN, OPEN, PRESS less than three times after
inserting the cartridge?
Repeat TURN, OPEN, PRESS three times after inserting the cartridge as
shown in the steps 4 to 6 under “Prepare for first Use”.
Is the dose indicator on the Spiriva Respimat pointing to 0?
If the dose indicator points to 0, you have used up all your medication and
the inhaler is locked.

Your inhaler is now ready to use. These steps will not affect the number of
doses available.After preparation your inhaler will be able todeliver 60 puffs
(30 doses).

Once your Spiriva Respimat is assembled, do not remove the clear base or
the cartridge. Always insert a new cartridge into a NEW Spiriva Respimat.

Page 2

Ref:1619/040416/1/B

Page 3

4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Evaluation of the side effects is based on the following frequencies:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
The side effects described below have been experienced by people
taking this medicine and they are listed according to frequency as either
common, uncommon, rare or not known
Frequency
Frequency
Side effect
COPD
Asthma
Dry mouth: this is usually mild
Common
Common
Dizziness

Immediate allergic reactions such as rash, nettle rash (urticaria), swelling of
the mouth and face or sudden difficulties in breathing (angioneurotic
oedema) or other hypersensitivity reactions (such as sudden reduction of
your blood pressure or dizziness) may occur individually or as part of severe
allergic reaction (anaphylactic reaction) after administration of Tiotropium. If
any of these occur, please consult your doctor
immediately
In addition, in common with all inhaled medicines, some patients may
experience an unexpected tightness of the chest, coughing, wheezing or
breathlessness immediately after inhalation (bronchospasm).
Reporting of side effects:
If you get any side effects, talk to your doctor or pharmacist.This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme (Tel: Freephone 0808 100
3352 or Website: www.mhra.gov.uk/yellowcard). By reporting side effects you
can help provide more information on the safety of this medicine.
5

How to store Tiotropium

Uncommon
Uncommon

Uncommon
Uncommon

Keep out of the sight and reach of children.

Difficulty in sleeping
(insomnia)

Rare

Uncommon

Irregular heart beat (atrial
fibrillation, supraventricular
tachycardia)

Rare

Not known

Do not use Tiotropium after the expiry date which is stated on the
carton and on the inhaler label. The expiry date refers to the last day of the
month. Tiotropium inhaler should be discarded at the latest 3 months after
first use (see Instructions for Use overleaf).

Feeling your heartbeat
(palpitations)

Rare

Uncommon

Faster heart beat (tachycardia)

Rare

Not known

Cough

Uncommon
Rare

Uncommon
Not Known

Inflammation of the throat
(pharyngitis)

Uncommon

Uncommon

Hoarseness (dysphonia)

Uncommon

Uncommon

Tightness of the chest, associated
with coughing, wheezing or
breathlessness immediately after
inhalation (bronchospasm)

Rare

Uncommon

Constipation

Uncommon

Rare

Fungal infections of the oral cavity
and throat (oropharyngeal
candidiasis)

Uncommon

Uncommon

Difficulties swallowing (dysphagia)

Rare

Not known

Rash

Uncommon

Rare

Itching (pruritus)

Uncommon

Rare

Difficulties passing urine (urinary
retention)
Painful urination (dysuria)

Uncommon

Not known

Uncommon

Not known

Seeing halos around lights or
coloured images in association
with red eyes (glaucoma)

Rare

Not known

Increase of the measured eye
pressure

Rare

Not known

Blurred vision

Rare

Not know

Inflammation of the larynx
(laryngitis)
Heart burn (gastrooesophageal
reflux disease)
Dental caries

Rare

Not known

Rare

Not Known

Rare

Not known

Inflammation of the gums
(gingivitis)

Rare

Rare

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

Rare

Serious allergic reaction which
causes swelling of the mouth and
face or throat (angloneurotic
oedema)

Rare

Nettle rash (urticaria)

Rare

Rare

Infections or ulcerations of the
skin

Rare

Not known

Dryness of the skin
Hypersensitivity,
including immediate reactions

Rare
Not known

Not known
Rare

Infections of the urinary tract

Rare

Not known

Depletion of body water
(dehydration)

Not known

Not known

Inflammation in sinuses (sinusitis)

Not known

Not known

Blockage of intestines or absence
of bowel movements (intestinal
obstruction, including ileus
paralytic)

Not known

Not known

Feeling sick (nausea)
Severe allergic reaction
(anaphylactic reaction)

Not known
Not known

Not known
Not known

Headache

Nosebleed (epistaxis)

Swelling of joint
Page 2

Not known

Rare

Not known

Tiotropium 2.5 mcg, inhalation solution

Ref:1619/040416/2/F

Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Tiotropium 2.5 mcg, inhalation solution and will be
referred to as Tiotropium throughout the rest of this leaflet..
What is in this leaflet
1 What Tiotropium is and what it is used for

What you need to know before you take Tiotropium
How to take Tiotropium
4 Possible side effects
5 How to store Tiotropium
6 Contents of the pack and other information

Tiotropium is indicated for the maintenance treatment of your chronic
obstructive pulmonary disease or asthma. Do not use this medicine to treat a
sudden attack of breathlessness or wheezing. Your doctor should have
given you another inhaler (“rescue medication”) for this.
Please follow the instructions your doctor has given you.
If you have been prescribed Tiotropium for your asthma it should be added
on to inhaled corticosteroids and long-acting ß2 agonists. Continue taking the
inhaled corticosteroids as prescribed by your doctor, even if you
feel better.
In case you have suffered from a myocardial infarction during the last 6
months or from any unstable or life threatening irregular heart beat or severe
heart failure within the past year, please, inform your doctor. This is
important to decide if Spiriva is the right medicine for you to take.

2

Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
If your medicine becomes discoloured or show any other signs of
deterioration, ask your pharmacist who will advise you what to do.

6

Contents of the pack and other information

What Tiotropium contains:
The active substance is tiotropium. The delivered dose is 2.5 micrograms
tiotropium (as bromide monohydrate) per puff (2 puffs comprise one
medicinal dose).
The other ingredients are: Benzalkonium chloride, disodium edetate, purified
water, and hydrochloric acid 3.6% for pH adjustment.
What Tiotropium looks like and contents of the pack
The Cardboard carton contains one inhaler and one aluminium cylindrical
cartridge containing a clear colourless solution for inhalation. A plastic cap is
present on both ends of the inhaler: a green cap covering the mouth piece;
and a transparent cap where the cartridge is to be inserted. The inhaler has
an indicator on the side showing the number of doses left.
Single pack: 1 Respimat inhaler and 1 cartridge, providing 60 puffs
(30 medicinal doses)
Manufacturer and Licence Holder
This medicine is manufactured by Boehringer Ingelheim Pharma GmbH &
Co. KG, Binger Strasse 173, D-55216 Ingelhein am Rhein, Germany and is
procured from within the EU. Product Licence Holder: Lexon UK Limited, Unit
18 Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and will
be able to advise you.

3

1

Tiotropium helps people who have chronic obstructive pulmonary
disease (COPD) or asthma to breathe more easily. COPD is a long-term lung
disease that causes shortness of breath and coughing. The term COPD
is associated with the conditions chronic bronchitis and emphysema. Asthma
is a long-term disease characterised by airway inflammation and narrowing of
the airways. As COPD and asthma are long-term diseases you should take
Tiotropium every day and not only when you have breathing problems or
other symptoms. When used to treat asthma you should use Tiotropium in
addition to so-called inhaled corticosteroids and long-acting ß2
agonists.
Tiotropium is a long-acting bronchodilator that helps to open your
airways and makes it easier to get air in and out of the lungs. Regular use of
Tiotropium can also help you when you have on-going shortness of breath
related to your disease, and will help to minimise the effects of the
disease on your everyday life. Daily use of Tiotropium will also help to prevent any sudden, short-term worsening of your COPD symptoms which may
last for several days.
For correct dosing of Tiotropium please see section 3. How to take
Tiotropium and the instructions for use provided on the other side of the
leaflet.

2

PL 15184/1619 - Tiotropium 250 microgram,
Inhalation solution

Leaflet revision date: 04/04/16

Blind or partially sighted? Is this leaflet hard to see
or read? Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

What you need to know before you take Tiotropium

Please read the following questions carefully. If you can answer any of
these questions with ‘Yes’ please discuss this with your doctor before taking
Tiotropium




POM

What Tiotropium is and what it is used for






are you allergic (hypersensitive) to tiotropium, atropine or similar drugs
such as ipratropium or oxitropium?
are you taking any other medicinal products containing ipratropium or
oxitropium?
are you pregnant, do you think you are pregnant, or are you
breast-feeding?
are you suffering from blurred vision, eye pain and/or red eyes, prostate
problems or have difficulty passing urine?
do you have any kidney problems?
have you suffered from a myocardial infarction during the last 6 months or
from any unstable or life threatening irregular heart beat or severe heart
failure within the past year?

Do not use Tiotropium
• if you are allergic (hypersensitive) to tiotropium, its active ingredient or any
of the other ingredients of this medicine (listed in section 6)
• if you are allergic (hypersensitive) to atropine or substances related to it,
e.g. ipratropium or oxitropium
Warnings and precautions
Talk to your doctor before taking Tiotropium.
When taking Tiotropium take care not to let any spray enter your eyes. This
may result in eye pain or discomfort, blurred vision, seeing halos around
lights or coloured images in association with red eyes (i.e. narrow angle
glaucoma). Eye symptoms may be accompanied by headache, nausea or
vomiting. Wash your eyes in warm water, stop using tiotropium bromide and
immediately consult your doctor for further advice.
If your breathing has got worse or if you experience rash, swelling or itching
directly after using your inhaler, stop using it and tell your doctor immediately.
Dry mouth which has been observed with anti-cholinergic treatment may in
the long term be associated with dental caries. Therefore, please remember
to pay attention to oral hygiene.

Do not take Tiotropium more frequently than once daily.
You should also contact your doctor if you feel that your breathing is
worsening.
If you have cystic fibrosis, tell your doctor because Tiotropium could make
your cystic fibrosis symptoms worse.
Children and adolescents
Tiotropium is not recommended for children and adolescents under 18 years.
Other medicines and Tiotropium
Please tell your doctor or pharmacist if you are taking, or have recently
taken, any other medicines, including medicines obtained without a
prescription.
In particular, please tell your doctor or pharmacist if you are taking/have
taken anticholinergic drugs, e.g. ipratropium or oxitropium.
No interaction side effects have been reported when Tiotropium has been
taken with other products used to treat COPD such as reliever inhalers (e.g.
salbutamol), methylxanthines (e.g. theophylline), antihistamines,
mucolytics (e.g. ambroxol), leukotriene modifiers (e.g. montelukast),
cromones, anti-IgE treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this
medicine. You should not use this medicine unless specifically recommended
by your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use machines have
been performed. In case dizziness or blurred vision occurs the ability to drive
and use machinery may be influenced.
3

How to take Tiotropium

Always take this medicine exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
Tiotropium is for inhalation use only.
The recommended dose for adults is:
Tiotropium is effective for 24 hours so you will need to use Tiotropium only
ONCE A DAY, if possible at the same time of the day. Each time you use it
take TWO PUFFS.
As COPD and asthma are long-term diseases take Tiotropium every day and
not only when you experience breathing problems. Do not take more
than the recommended dose.
Tiotropium is not recommended for use in children and adolescents below 18
years due to lack of data on safety and efficacy.
Make sure that you know how to use your Tiotropium inhaler properly.
The instructions for use of the Tiotropium inhaler are provided on the other
side of this leaflet.
If you take more Tiotropium than you should
If you take more Tiotropium than two puffs in one day talk to your
doctor immediately. You may be at a higher risk of experiencing a side effect
such as dry mouth, constipation, difficulties passing urine, increased heart
beat or blurred vision.
If you forget to take Tiotropium
If you forget to take your daily dose (TWO PUFFS ONCE A DAY), don’t
worry. Take it as soon as you remember but do not take two doses at the
same time or on the same day. Then take your next dose as usual.
If you stop taking Tiotropium
Before you stop taking Tiotropium, you should talk to your doctor or your
pharmacist. If you stop taking Tiotropium the signs and symptoms of COPD
may worsen.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
Page 1

Instructions For Use
Introduction
Tiotropium (tiotropium bromide). Read these Instructions for Use before you
start using Tiotropium.

Prepare for first use
Remove clear base
1.

• Your Tiotropium inhaler contains 60 puffs (30 doses) if used as


indicated (two puffs/once daily).
The dose indicator shows approximately how much medication is left.

Daily use
TURN

• Keep the cap closed.
• TURN the clear base in the direction of the arrows on the label until it
clicks (half a turn).

You will need to use this inhaler only ONCE A DAY. Each time you use it take
TWO PUFFS.

Answers to Common Questions
It is difficult to insert the cartridge deep enough.
Did you accidentally turn the clear base before inserting the cartridge?
Open the cap, press the dose-release button, then insert the cartridge.
Did you insert the cartridge with the wide end first?
Insert the cartridge with the narrow end first.
The dose indicator on the Tiotropium reaches zero too soon.
Did you use Tiotropium as indicated (two puffs/Once daily)? Tiotropium
will last 30 days if used at two puffs once daily.
Did you turn the clear base before you inserted the cartridge?
The dose indicator counts each turn of the clear base regardless whether a
cartridge has been inserted or not.
Did you spray in the air often to check whether the Tiotropium is working?
Once you have prepared Tiotropium, no test-spraying is
required if used daily.

Insert cartridge
2.

• Insert the narrow end of the cartridge into the inhaler.
• Place the inhaler on a firm surface and push down firmly until it clicks
into place.

Did you insert the cartridge into a used Tiotropium?
Always insert a new cartridge into a NEW Tiotropium.
I cannot press the dose-release button.
Did you turn the clear base?
If not, turn the clear base in a continuous movement until it clicks
(half a turn).

OPEN





If Tiotropium has not been used for more than 7 days release one
puff towards the ground.
If Tiotropium has not been used for more than 21 days repeat steps
4 to 6 under ‘Prepare for first Use’ until a cloud is visible. Then repeat
steps 4 to 6 three more times.
Do not touch the piercing element inside the clear base.

• OPEN the cap until it snaps fully open.

Is the dose indicator on the Tiotropium pointing to zero?
The Tiotropium inhaler is locked after 60 puffs (30 medicinal doses). Prepare
and use your new Tiotropium inhaler.
My Tiotropium sprays automatically.

Replace clear base
3.

Was the cap open when you turned the clear base?
Close the cap, then turn the clear base.

• Put the clear base back into place until it clicks.

Did you press the dose-release button when turning the clear
base?
Close the cap, so the dose-release button is covered, then turn the clear
base.

How to care for your Tiotropium
Clean the mouthpiece including the metal part inside the mouthpiece with a
damp cloth or tissue only, at least once a week.
Any minor discoloration in the mouthpiece does not affect your Tiotropium
inhaler performance. If necessary, wipe the outside of your Tiotropium inhaler
with a damp cloth.

Did you stop when turning the clear base before it clicked?
Turn the clear base in a continuous movement until it clicks (half a turn).
I cannot turn the clear base.
Did you turn the clear base already?
If the clear base has already been turned, follow steps “OPEN” and “PRESS”
under “Daily Use” to get your medicine.

Turn
4.

• Keep the cap closed.
• Turn the clear base in the direction of the arrows on the label until it

Is the dose indicator on the Tiotropium pointing to zero?
The Tiotropium inhaler is locked after 60 puffs (30 medicinal doses). Prepare
and use your new Tiotropium inhaler.

clicks (half a turn).

PRESS

• Breathe out slowly and fully.
• Close your lips around the mouthpiece without covering the air vents.
Point your Inhaler to the back of your throat.

• While taking a slow, deep breath through your mouth, PRESS the



Open

• Your Tiotropium inhaler contains 60 puffs (30 doses) if used as





5.

indicated (two puffs/once daily).
The dose indicator shows approximately how much medication is left.
When the dose indicator enters the red area of the scale you need to get a
new prescription; there is approximately medication for 7 days left
(14 puffs).
Once the dose indicator reaches the end of the red scale, your Spiriva
Respimat locks automatically – no more doses can be released.
At this point, the clear base cannot be turned any further.
Tiotropium should be discarded three months after you have
prepared it for first use, even if it has not been fully used or used at all.

• Open the cap until it snaps fully open.

dose-release button and continue to breathe in slowly for as long as
comfortable.
Hold your breath for 10 seconds or for as long as comfortable.
Repeat TURN, OPEN, PRESS for a total of 2 puffs.
Close the cap until you use your inhaler again.

My Tiotropium doesn’t spray.
Did you insert a cartridge?
If not, insert a cartridge.
Did you repeat TURN, OPEN, PRESS less than three times after
inserting the cartridge?
Repeat TURN, OPEN, PRESS three times after inserting the cartridge as
shown in the steps 4 to 6 under “Prepare for first Use”.
Is the dose indicator on the Tiotropium pointing to 0?
If the dose indicator points to 0, you have used up all your medication and
the inhaler is locked.
Once your Tiotropium is assembled, do not remove the clear base or the cartridge. Always insert a new cartridge into a NEW Tiotropium.

Press
6.

• Point the inhaler toward the ground.
• Press the dose-release button
• Close the cap
• Repeat steps 4-6 until a cloud is visible.
• After a cloud is visible, repeat steps 4-6 three more times.

Your inhaler is now ready to use. These steps will not affect the number of
doses available.After preparation your inhaler will be able todeliver 60 puffs
(30 doses).

Page 2

Ref:1619/040416/1/B

Page 3

Other useful information
• Bathing, swimming, showering or exercising should not affect the patch if it
has been correctly applied. You may wear the patch under your swimming
costume.
• If the patch does come off in the bath or shower it may be reapplied.
Shake it to remove any water, dry the skin thoroughly, allow the area to
cool and put it on again in the usual way.
• Never apply a patch on a sweaty area or after a hot bath or shower. Wait
until the skin is completely cool and dry.
• Sunbathing: always make sure your patch is covered by clothing.
• Using a sunbed: cover up the patch
• The drug in your patch is a gel which is colourless. This does not mean
that the patch does not contain any medication.
How long to use Estracombi TTS
Estracombi TTS should be used only as long as needed, possibly for several
months or more. This will help to control your symptoms.
While you are using Estracombi TTS you should go to the doctor regularly to
discuss the possible risks and benefits associated with HRT, and whether
you still need the treatment. Your doctor will aim to give you the lowest
possible dose for the shortest possible length of time to treat your symptoms.
If you forget to use Estracombi TTS
If you forget to apply a patch, apply a new patch as soon as you remember.
No matter what day that happens, go back to changing this patch on the
same day as you usually do. There is an increased chance of breakthrough
bleeding or spotting if there is a break in treatment.

4

Possible side effects

Estracombi TTS is suitable for most people, but, like all medicines, there are
sometimes side effects.
Stop using Estracombi TTS immediately and tell your doctor if you
develop any of the following:
• Signs of an allergic reaction (difficulty in breathing, tight chest, itching all
over, generalised swelling or itching)
• Signs of a blood clot (swollen legs, breathlessness, chest pain)
• Migraine or unusually severe headaches, or other signs of a stroke
• You become pregnant
• Signs of jaundice (yellowing of your skin or eyes).
The side effects listed below have also been reported:
More than 10 % of people have experienced:
• Headache
• Redness and itching where the patch has been applied
• Tender or painful breasts
• Painful periods and other menstrual problems.
Up to 1 in 10 people have experienced:
Dizziness, depression, nervousness, sleeplessness, mood changes
Feeling sick, stomach ache, indigestion, wind, diarrhoea
Acne, rash, dry skin and itching
A condition called endometrial hyperplasia (thickening of the lining of the
womb)
Enlarged breasts, cramps
Heavy periods, vaginal discharge, bleeding or irritation
Pain, back pain, restlessness
Abnormal weight gain
Fluid retention (swelling or accumulation of fluid in the lower legs or ankles).
Up to 1 in 100 people have experienced:
Migraine
Breast cancer
Rise in blood pressure
Being sick or feeling bloated,
Abnormal liver function test results
Peeling and blistered skin where the patch is applied
Changes in the pigmentation in your skin (lightening or darkening of your skin
colour)
Up to 1 in 1,000 people have experienced:
Blood clots in the veins
Gallstones, other disease of the gall bladder, jaundice
Fibroids, cysts or polyps of the ovarian, uterine or cervical regions which
might cause pain or bleeding
Allergic reactions
Changes in libido
Tingling of the hands and feet.

Page 4

Other side effects include:
Estrogen-dependent conditions such as blood clots, worsening varicose
veins, tumours including breast cancer, cancer of the endometrium, heart
attack, stroke, dementia (these are discussed in Section 2) and gall bladder
disease.
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are using Estracombi TTS. Ask your doctor or
pharmacist to answer any questions you may have.

5





How to store the patches
KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF
CHILDREN
Do not store above 25°C.
Store in the original packaging. Do not refrigerate.

Do not use this medicine after the expiry date shown on the carton label. If
your doctor tells you to stop using the patches, take them back to the
pharmacist for safe disposal. Only keep the patches if your doctor tells you to
do so.
If the patches become brittle, discoloured or show any signs of deterioration,
ask your pharmacist who will advise you what to do.

6 Further information
Your medicine
Your medicine is called Estracombi TTS patches. They are available as a
calendar pack which contains 4 patches, marked (A) and 4 patches marked
(B). The patches are individually sealed in foil pouches in strips of 2 pouches.
The name and strength are printed on the labels.
What is in your medicine
Each patch marked (A) contains 4mg of the active ingredient, estradiol. While
you are wearing an Estracombi TTS patch (marked A) your body will absorb
approximately 50 micrograms of estradiol per day.
Each patch marked (B) contains 10mg of the active ingredient estradiol, and
30mg of the active ingredient norethisterone acetate. While you are wearing
an Estracombi TTS patch (marked B) your body will absorb approximately 50
micrograms of estradiol per day and 250 micrograms of norethisterone
acetate per day.
Estracombi TTS patches also contain the following inactive ingredients:
Ethanol, hydroxypropylcellulose, light liquid paraffin, polyethylene
terephthalate, ethylene vinyl acetate co-polymer and poly-isobutylene.
Manufacturer and Licence Holder
The patches are manufactured by Novarits Pharma, S.A. Basle, Switzerland,
and are procured from within the EU and repackaged by the Product Licence
Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.

POM

PL Number:

15184/0131

Estracombi TTS is a registered trademark of Novartis AG.
Leaflet revision date: 21/01/09

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

Estracombi ® TTS Patches

Ref:0131/210109/1/F

(estradiol & norethisterone acetate)

Patient Information Leaflet
Your medicine is called Estracombi TTS Patches, and will be referred to as
Estracombi TTS throughout this leaflet.
What you need to know about Estracombi TTS
Your doctor has decided that you need this medicine to help treat your
condition.
Please read this leaflet carefully before you start to use the patches. It
contains important information. Keep the leaflet in a safe place because
you may want to read it again.
If you have any other questions, or if there is something you don’t
understand, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Never give it to someone else. It
may not be the right medicine for them even if their symptoms seem to be
the same as yours.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1 What Estracombi TTS is, and what it’s used for
2 Things to consider before you start to use Estracombi TTS
3 How to use Estracombi TTS
4 Possible side effects
5 How to store the patches
6 Further information

1

What Estracombi TTS is and what it’s used for

Estracombi TTS is known as a combined HRT product. The pack contains
two different patches which you stick on your skin, Estracombi TTS (A) and
Estracombi TTS (B). Estracombi TTS (A) is a round patch which contains a
supply of estradiol. Estracombi TTS (B) is a goggle-shaped patch which
contains two active ingredients, estradiol and norethisterone acetate.

Estracombi TTS (A)

Estracombi TTS (B)

The active ingredients are released from the patch and absorbed through the
skin into your blood stream. This is why the patches are called transdermal
patches.
Estradiol is one of a group of hormones called estrogens which are the
natural female sex hormone produced in large amounts by the ovaries before
the menopause. After the menopause the ovaries produce less estrogen.
Norethisterone acetate is a different sort of hormone called a progestogen. It
is similar to another female hormone, progesterone. It helps to protect the
lining of the womb in women who have not had a hysterectomy (see the
section below on endometrial cancer).
Estracombi TTS is used as hormone replacement therapy (HRT) to relieve
the symptoms of the menopause. The menopause can occur naturally or as
the result of surgery.
Estracombi TTS can also be used to prevent osteoporosis (thinning of the
bones), when you have a high risk of future fractures, and if you are unable
to take other medicines for this purpose.

• To relieve the symptoms of the menopause:
Estracombi TTS is used to help relieve the uncomfortable symptoms which
you sometimes get during and after the menopause (the time when
menstrual periods stop). Menopause occurs naturally in all women, usually
between the ages of 45 and 55. It also occurs in younger women who have
had their ovaries removed by surgery. The reduced levels of estrogen can
cause unpleasant symptoms such as hot face, neck and chest, hot flushes
(sudden waves of heat and sweating all over), sleep problems, irritability and
depression. Some women also have problems with urine control, or with a
dry vagina which may cause discomfort during or after sexual intercourse.
Taking estrogens can reduce or eliminate these symptoms.


To prevent osteoporosis:
After the age of 40, and especially after the menopause, some women are at
risk of developing osteoporosis. This is when the bones become thinner and
weaker and more likely to break, especially the bones of the spine, hip and

wrist. Lack of estrogens increases the risk of osteoporosis. Taking estrogens
after the menopause slows down bone loss and can help to prevent it. The
protective effects on the bone cease once treatment is stopped. You should
discuss the benefits and risks of Estracombi TTS and other therapies with
your doctor.

2

Things to consider before you start to use Estracombi TTS

Read this section carefully because, there are some conditions your doctor
should know about before you start your treatment.
Medical check-ups
Before you start using HRT, your doctor should ask you about your own, and
your family’s, medical history. Your doctor may decide to examine your
breasts and/or your abdomen and may do an internal examination - but only
if these examinations are necessary for you, or you have any special
concerns. Once you have started HRT, you should see your doctor for
regular check-ups (at least once a year). At these check-ups your doctor may
discuss with you the benefits and risks of continuing with HRT.
While you are using HRT make sure that you:
• Go for regular breast screening and cervical smear tests.
• Regularly check your breasts for any changes such as dimpling of the
skin, changes in the nipple, a discharge from the nipple, or any lumps you
can see or feel.
Some people MUST NOT use Estracombi TTS. Talk to your doctor if:
• you have ever had any unusual or allergic reaction to estrogens,
progestogens or to any other components of the patch, (These are listed
at the end of the leaflet.)
• you have, or have ever had, breast cancer, (See the section below on
breast cancer.)
• you have, or have ever had, cancer of the endometrium (lining of the
womb) or any other cancer which is sensitive to estrogens, (See the
sections below on endometrial and ovarian cancer.)
• you have a blood disease called porphyria,
• you have, or have ever had, a blood clot in a vein in your leg or anywhere
else (a ‘deep vein thrombosis’) or a clot that has travelled to your lung or
another part of your body (an ‘embolus’), (See the section below on blood
clots.)
• you have ever had a heart attack, stroke or angina, (See the sections
below on heart disease and stroke.)
• you have had any unexpected bleeding or very heavy bleeding from the
vagina,
• you have a history of severe liver, kidney or heart disease,
• you have the genetic disorders Dubin-Johnson syndrome or Rotor
syndrome which affect the blood and cause hyperbilirubinaemia,
• you are pregnant or breastfeeding.
Estracombi TTS should not be used in children.
You should also ask yourself these questions before using the patch. If
the answer to any of these questions is YES, tell your doctor or
pharmacist because Estracombi TTS might not be the right medicine
for you.
• Has anyone in your immediate family had breast cancer?
• Do you have fibroids or any other growths in your womb?
• Do you have endometriosis (a condition which causes painful periods)?
• Do you have high blood pressure?
• Do you have any problems with your liver including jaundice or a
widespread rash?
• Do you have diabetes, epilepsy or asthma?
• Do you get migraine or other bad headaches?
• Do you have a condition called lupus (SLE)?
• Do you have problems with your hearing?
• Do you have any of the conditions which put you at increased risk of blood
clots (see below)?
• Do you have a high level of cholesterol or other fats in your blood?
• Do you have heart or kidney problems?
• Have you ever had problems with your gall bladder, such as gallstones?
• Are you over 65?
Are you taking other medicines?
Some medicines can interfere with your treatment. Tell your doctor or
pharmacist if you are taking any of the following:
• medicines to treat epilepsy such as phenobarbital, phenytoin and
carbamazepine,

Page 1




antibiotics and other medicines to treat infections (e.g. rifampicin, rifabutin,
nevirapine, efavirenz, ritonavir, nelfinavir),
the herbal medicine St John’s Wort (also known as Hypericum
perforatum).

Always tell your doctor or pharmacist about all the medicines you are taking.
This means medicines you have bought yourself as well as medicines on
prescription from your doctor.

If you get:
Painful swelling in your leg
Sudden chest pain
Difficulty breathing
See a doctor as soon as possible and do not use any more HRT until
your doctor says you can. These may be signs of a blood clot.





Before you have a blood test remind your doctor that you are using
Estracombi TTS as it may affect the result.

If you’re going to have surgery, make sure your doctor knows about it. You
may need to stop using HRT about 4 to 6 weeks before the operation, to
reduce the risk of a blood clot. Your doctor will tell you when you can start
using HRT again.

Will there be any problems with driving or using machinery?
No problems have been reported.

A comparison – the approximate risk of stroke or blood clots in women not
using, or using, HRT over a 5 year period.

Using contraception whilst taking Estracombi TTS
Estracombi TTS is not a contraceptive, nor a fertility treatment.
If you are using an oral or other hormone contraceptive, e.g. the pill or depot
injection, you must change to a non-hormone contraceptive, for example, a
diaphragm or condom, BEFORE starting Estracombi TTS.
If you have been told that you don’t need to use a contraceptive any longer,
you won’t need one while you are using Estracombi TTS even if you have a
monthly bleed.

Women in their 50s
Not using
HRT
Stroke
Blood clot

Women in their 60s

Using HRT

Not using
HRT

Using HRT

3 in 1,000

4 in 1,000

11 in 1,000

15 in 1,000

3 in 1,000

7 in 1,000

8 in 1,000

17 in 1,000

Other special warnings
HRT will not help to prevent heart disease.
As well as benefits, HRT has some risks which you need to consider when
you are deciding whether to use it, or whether to carry on using it. These are:

Effects on your risk of developing cancer
i. Breast cancer
Women who have breast cancer, or have had breast cancer in the past,
should not use HRT.

Effects on your heart or circulation
i. Heart disease
HRT is not recommended for women who have heart disease, or have
had heart disease recently. If you have ever had heart disease, talk to your
doctor to see if you should be using HRT.
Studies with one type of HRT (containing conjugated estrogen plus a
progestogen) have shown that women may be slightly more likely to get
heart disease during the first year of taking the medication. For other types of
HRT, the risk is likely to be similar, although this is not yet certain.

Using HRT slightly increases the risk of breast cancer; so does having a late
menopause. The risk for a post-menopausal woman using estrogen-only
HRT for 5 years is about the same as for a woman of the same age who’s
still having periods over that time and not using HRT. The risk for a woman
who is using combined HRT (estrogen plus progestogen) is higher than for
estrogen-only HRT (but combined HRT is beneficial for the endometrium, see
Endometrial cancer, below).

If you get:
A pain in your chest that spreads to your arm or neck,
See a doctor as soon as possible and do not use any more HRT until
your doctor says you can. This pain could be a sign of heart disease.
ii. Stroke
Recent research suggests that HRT slightly increases the risk of having a
stroke. Other things that can increase the risk of stroke include:
• Getting older
• High blood pressure
• Smoking
• Drinking too much alcohol
• An irregular heartbeat
If you are worried about any of these things, or if you have had a stroke
in the past, talk to your doctor to see if you ought to be using HRT.
If you get:
• Unexplained migraine-type headaches, with or without disturbed vision,
See a doctor as soon as possible and do not use any more HRT until
your doctor says you can. These headaches may be an early warning sign of
a stroke.
iii. Blood clots
Using HRT may increase the risk of blood clots in the veins (also called deep
vein thrombosis, or DVT), especially during the first year. These blood clots
are not always serious, but if one travels to the lungs, it can cause chest
pain, breathlessness, collapse or even death. This condition is called
pulmonary embolism, or PE.
DVT and PE are examples of a condition called venous thromboembolism, or
VTE.
You are more likely to get a blood clot if:
• You are seriously overweight
• You have had a blood clot before
• Any of your close family have had blood clots
• You have had one or more miscarriages
• You have any blood clotting problem that needs treatment with a medicine
such as warfarin
• You’re off your feet for a long time because of major surgery, injury or
illness
• You are going on a long journey and will be immobile for some time
• You have a rare condition called systemic lupus erythematosus (SLE – a
connective tissue disease).
If any of these things apply to you, talk to your doctor to see if you should
be using HRT.
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For all kinds of HRT, the extra risk of breast cancer goes up the longer you
use it, but returns to normal within about 5 years of stopping HRT.
Your risk of breast cancer is also higher if:
• You have a close relative (mother, sister or grandmother) who has had
breast cancer
• You are seriously overweight.
If you notice any changes in your breast, such as:
• Dimpling of the skin
• Changes in the nipple or a discharge from the nipple
• Any lumps you can see or feel
Make an appointment to see your doctor as soon as possible.
A comparison – the risk of developing breast cancer: the number of women
aged 50 who will get breast cancer by the time they are 65.
Not using
HRT

32 in 1,000

Using estrogen-only HRT

Using combined HRT

For 5 years

For 10 years

For 5 years

For 10 years

33.5 in 1,000

37 in 1,000

38 in 1,000

51 in 1,000

(1-2 cases extra) (5 cases extra)

(6 cases extra) (19 cases extra)

ii. Endometrial cancer (cancer of the lining of the womb)
Estracombi TTS is a combined HRT product containing an estrogen and a
progestogen.
Using estrogen-only HRT for a long time can increase the risk of cancer
of the lining of the womb. Taking a progestogen as well as the estrogen
helps to lower the extra risk.
If you still have your womb, your doctor may prescribe a progestogen as well
as estrogen. They can be prescribed separately, or as a combined HRT
product.
If you have had your womb removed (a hysterectomy), your doctor will
discuss with you whether you can safely take estrogen without a
progestogen.
If you’ve had your womb removed because of endometriosis, any
endometrium left in your body may be at risk. So your doctor may prescribe
HRT that includes a progestogen as well as an estrogen.

A comparison – the risk of developing endometrial cancer
Women who still have their uterus and who do not use HRT
About 5 in 1,000 women aged 50 will get endometrial cancer by the time they
are 65.
Women who have used estrogen-only HRT
The number will be 2-12 times higher depending on the dose and length of
use.

The progestogen, norethisterone acetate, causes a monthly bleed in most
women. This bleeding usually starts at the end of the Estracombi TTS (B)
treatment phase. The duration and the amount of bleeding are usually similar
to that of a normal period. Tell your doctor if you have heavy or irregular
bleeding after a few months of treatment.
You should apply the first Estracombi TTS (A) patch of the next cycle
immediately, even if the bleeding has not stopped.
About the patch

Women who are using estrogen plus progestogen HRT
The risk of endometrial cancer is substantially reduced.
If you get breakthrough bleeding or spotting, it’s usually nothing to worry
about, especially during the first few months of taking HRT.
But if the bleeding or spotting:
Carries on for more than the first few months
Starts after you’ve been on HRT for a while
Carries on even after you’ve stopped using HRT
Make an appointment to see your doctor. It could be a sign that your
endometrium has become thicker.





iii. Ovarian cancer (cancer of the ovaries)
Cancer of the ovaries is very rare, but it is serious. It can be difficult to
diagnose, because there are often no obvious signs of the disease.
Some studies have indicated that using estrogen-only HRT for more than 5
years may increase the risk of ovarian cancer. It is not yet known whether
other kinds of HRT increase the risk in the same way.
Effects on your risk of developing dementia
HRT will not prevent memory loss. In one study of women who started using
combined HRT after the age of 65, a small increase in risk of dementia was
observed.

3

Where to apply the patch
Stick the patch on to a hairless area of skin below the waist. Most women
find that the buttock is the best place. Choose an area of the buttock where
the skin is not inflamed, broken, or irritated. You could also try the lower
back, hip or abdomen. Avoid the waistline since the patch might get rubbed
off.
Never put a patch on or near the breasts.
Choose a clean, dry area of skin. To help the patch stick, the skin should be
clean, dry, and free of creams, lotions, oil, or powder. You should use a
different area of skin each time. Wait a week before using the same area
again. Avoid skin which is red or irritated.
Do not expose the patch to direct sunlight.
Opening the sachets
Each patch is sealed in an airtight sachet. A double-pack for one week's
treatment consists of two sachets joined by a perforated seam. Tear open
one of the sachets at the notch (do not use scissors) and take out the patch.
Make sure that the second sachet is undamaged, because the patch
becomes ineffective when exposed to the air before use. If you happen to
tear open both sachets at the same time, throw one of them away.

How to use Estracombi TTS patches

The doctor will tell you how to use Estracombi TTS. Always follow his/her
instructions carefully. The information will be on the pharmacist’s label. Check
the label carefully. If you are not sure, ask your doctor or pharmacist. Do not
change or stop the treatment without talking to your doctor.
Starting to use the patches
Estracombi TTS patches are applied to the skin. You wear a patch all the
time. For one treatment cycle you need 4 patches of Estracombi TTS (A) and
4 patches of Estracombi TTS (B).
If you are still having fairly regular periods, start using Estracombi TTS no
more than 5 days after the beginning of your period. If your periods have
stopped, you can start using Estracombi TTS at any convenient time.
If you have been using a continuous combined HRT product (where estrogen
and progestogen are given every day without interruption) you can start
Estracombi TTS on any convenient day.

Removing the lining
A stiff, transparent protective lining covers the sticky side of the patch, i.e. the
side that will be placed against your skin. Loosen this lining by rubbing the
edge of the patch between your thumb and forefinger. Holding the patch at
the edge, peel off the protective lining and throw it away. Try to avoid
touching the adhesive. Now apply the patch.
1

2

Applying the patch
Press the sticky side of the patch firmly onto the spot you have chosen with
the palm of your hand. Hold it there for about 10-20 seconds. Make sure that
it sticks well, especially around the edges. Do not test the patch by pulling it
once it is on your skin.

If you are changing from a sequential HRT treatment (where the progestogen
is added for 12-14 days of the cycle) you should finish your current cycle of
treatment before starting Estracombi TTS. Menstrual type bleeding often
occurs at the end of sequential HRT treatment cycles, try to start Estracombi
TTS on the first day of bleeding.
It is very important that you use all the Estracombi TTS (A) patches followed
by all the Estracombi TTS (B) patches in the correct order each month. If for
any reason a patch becomes unusable or you lose it, apply a fresh patch of
the same type, preferably taken from a spare pack. You should then keep
this pack as a spare until its expiry date.
Consult your doctor if this is not possible or leaves you short of patches.

When and how to remove the patch
The patch should be changed twice each week i.e. every 3-4 days, always
on the same two days, e.g. Mondays and Thursdays. You may find it helpful
to tick the box on the packaging for the day of the week when you apply your
first Estracombi TTS patch. This then shows the two days each week when
you should change your patch. When you finish an Estracombi TTS pack,
start the next pack straightaway. Do not have a break between packs.

The treatment cycle starts with an Estracombi TTS (A) patch.
During weeks 1 and 2 you apply the Estracombi TTS (A) patches, changing
the patch every 3 to 4 days. During weeks 3 and 4 you use the Estracombi
TTS (B) (0.25/50) patches, also changing the patch every 3 to 4 days.

When the time comes to change the patch, peel it off and fold it in half with
the sticky side inside. Dispose of the patch carefully with normal household
waste, making sure that it is out of the reach of children because it will still
contain some medication. Stick a new patch onto a different area of skin.

Week
Patches

1
1

2
2

3

3
4

Estracombi TTS (A)

1

4
2

3

4

= 1 cycle

Estracombi TTS (B)

What to do if a patch comes off
If a patch falls off the same patch may be put on a different area (see Where
to apply the patch). Make sure you choose a clean, dry, lotion-free area of
the skin. No matter what day this happens, go back to changing the patch on
the same days as usual.

When you finish an Estracombi TTS pack, i.e. after one cycle, start the next
pack straight away. Do not have a break between packs.
Ref:0131/210109/1/B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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