TRITACE TABLET TITRATION PACK

Active substance: RAMIPRIL

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5. ow to store Tritace
H
• Keep out of the reach and sight of children.
• Do not use Tritace after the expiry date which is
stated on the carton and blister pack. The expiry
date refers to the last day of that month.
• This medicinal product does not require any
special storage conditions.
• 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.

30/04/2014
IST. TRITACE GB I02

Istruzione

89026138

62C0006

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PACK. ITEM:
167 x 304,8 DP
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Tritace can be used:
• To treat high blood pressure (hypertension)
• To reduce the risk of you having a heart attack
or stroke
• To reduce the risk or delay the worsening of
kidney problems (whether or not you have
diabetes)
• To treat your heart when it cannot pump
enough blood to the rest of your body (heart
failure)
• As treatment following heart attack (myocardial
infarction) complicated with heart failure.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

Tritace works by:
• Decreasing your body’s production of substances
that could raise your blood pressure
• Making your blood vessels relax and widen
• Making it easier for your heart to pump blood
around your body.

101011010

Tritace contains a medicine called ramipril. This
belongs to a group of medicines called ACE
inhibitors (Angiotensin Converting Enzyme
inhibitors).

Take special care with Tritace
Check with your doctor or pharmacist before
taking your medicine:
SSIf you have heart, liver or kidney problems
SSIf you have lost a lot of body salts or fluids
(through being sick (vomiting), having
diarrhoea, sweating more than usual, being on
a low salt diet, taking diuretics (water tablets)
for a long time or having had dialysis)
SSIf you are going to have treatment to reduce
your allergy to bee or wasp stings
(desensitization)
SSIf you are going to receive an anesthestic. This
may be given for an operation or any dental
work. You may need to stop your Tritace
treatment one day beforehand; ask your doctor
for advice
SSIf you have high amounts of potassium in your
blood (shown in blood test results)
SSYou are taking medicines or have conditions
which may decrease sodium levels in your
blood. Your doctor may carry out regular blood
tests, particularly for checking the levels of
sodium in your blood especially if you are
elderly.
SSIf you have a collagen vascular disease such as
scleroderma or systemic lupus erythematosus.
SSYou must tell your doctor if you think that you
are (or might become) pregnant. Tritace is not
recommended in early pregnancy and must not
be taken if you are more than 3 months
pregnant, as it may cause serious harm to
your baby if used at that stage (see
section “Pregnancy and breast-feeding”).

GB: GREAT BRITAIN

1. hat Tritace is and what
W
it is used for

Do not take Tritace if any of the above apply to
you. If you are not sure, talk to your doctor before
taking Tritace.

 Reflex Blue

In this leaflet:
1. What Tritace is and what it is used for
2. Before you take Tritace
3. How to take Tritace
4. Possible side effects
5. How to store Tritace
6. Further information

Arkhé S.a.s.

Your Titration Pack is available in packs containing
a total of 35 tablets.

Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do
not pass it on to others. It may harm them even
if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Tel. 0862.404140
fax 0862.404140

Your Tritace Tablets Titration Pack contains 3
different strengths of Tritace Tablets in 3 different
cartons.
• 7 x 2.5mg ramipril (yellowish to yellow white
oblong tablets with a score-line. The upper face
is marked with 2.5 and a logo ( ) and the lower
face is marked with HMR and 2.5
• 21 x 5mg ramipril (pale red oblong tablets with
a score-line. The upper face is marked with 5
and a logo ( ) and the lower face is marked
with HMP and 5
• 7 x 10mg ramipril (white to almost white
oblong tablets with a score-line. The upper face
is marked with HMO/HMO and the lower face is
unmarked

This leaflet was last revised in 01/2014
© Sanofi 2003 - 2014

Is this leaflet hard to see
or read?
Phone 0845 372 7101
for help

3 - Estrapolazione testo e reimpaginazione + modifiche

All strengths are supplied in PVC/aluminium
blisters in packs of 28 tablets.

This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.

Ramipril

Do not take Tritace:
±±If you are allergic (hypersensitive) to ramipril,
any other ACE inhibitor medicine or any of the
other ingredients of Tritace listed in section 6
Signs of an allergic reaction may include: a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
±±If you have ever had a serious allergic reaction
called “angioedema”. The signs include itching,
hives (urticaria), red marks on the hands, feet
and throat, swelling of the throat and tongue,
swelling around the eyes and lips, difficulty
breathing and swallowing
±±If you are having dialysis or any other type of
blood filtration. Depending on the machine
that is used, Tritace may not be suitable for you
±±If you have kidney problems where the blood
supply to your kidneys is reduced (renal artery
stenosis)
±±If you are more than 3 months pregnant. It is
also better to avoid Tritace in early pregnancy
(see section “Pregnancy and breast-feeding”)
±±If your blood pressure is abnormally low or
unstable. Your doctor will need to make this
assessment
±±If you are taking a blood pressure medicine
containing aliskiren and you have diabetes
mellitus
±±If you are taking a blood pressure medicine
containing aliskiren and you have kidney
problems.
89026138 1/4

What Tritace Tablets look like and contents of
the pack
• Tritace® 1.25mg Tablets are white to almost
white oblong tablets with score-line. The upper
face is marked with 1.25 and a logo ( ) and the
lower face is marked with HMN and 1.25. The
score line is only to facilitate breaking for ease
of swallowing and not to divide into equal
doses.
• Tritace® 2.5mg Tablets are yellowish to yellow
oblong tablets with a score-line. The upper face
is marked with 2.5 and a logo ( ) and the lower
face is marked with HMR and 2.5. The tablet can
be divided into equal halves.
• Tritace® 5mg Tablets are pale red oblong tablets
with a score-line. The upper face is marked with
5 and a logo ( ) and the lower face is marked
with HMP and 5. The tablet can be divided into
equal halves.
• Tritace® 10mg Tablets are white to almost white
oblong tablets with a score-line. The upper face
is marked with HMO/HMO and the lower face is
unmarked. The tablet can be divided into equal
halves.

This medicinal product is authorised in the
Member States of the EEA under the following
names:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets,
Tritace 5 mg tablets, Tritace 10 mg tablets,
Tritace Titration Pack tablets.

Tritace® 1.25mg - 2.5mg
5mg - 10mg Tablets
Tritace® Tablets Titration Pack

2. efore you take Tritace
B

2 - Modifica versione PDF

What Tritace Tablets contain.
• The active substance is ramipril.
• The other ingredients are Hypromellose,
pregelatinised maize starch, microcrystalline
cellulose, sodium stearyl fumarate.
• The 2.5mg tablets also contain yellow ferric
oxide (E172).
• The 5mg tablets also contain red ferric oxide
(E172).

Manufacturer Sanofi-aventis S.p.A.
SS 17 Km 22, Scoppito (AQ), Italy

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1 - Prima realizzazione

6. urther information
F

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder Sanofi, One
Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

Children
Tritace is not recommended for use in children
and adolescents below 18 years of age because the
safety and efficacy of Tritace in children has not
yet been established.
If any of the above apply to you (or you are not
sure), talk to your doctor before taking Tritace.

89026138

62C0006

89024082

89026138 2/4

30/04/2014
IST. TRITACE GB I02

Istruzione

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3
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If you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

10pt su 10pt

Treatment after you have had a heart attack
• The usual starting dose is 1.25 mg once daily to
2.5 mg twice daily.
• Your doctor will adjust the amount you take.

Common (affects less than 1 in 10 people):
• Headache or feeling tired
• Feeling dizzy. This is more likely to happen when
you start taking Tritace or start taking a higher
dose
• Fainting, hypotension (abnormally low blood
pressure), especially when you stand or sit up
quickly
• Dry tickly cough, inflammation of your sinuses
(sinusitis) or bronchitis, shortness of breath
• Stomach or gut pain, diarrhoea, indigestion,
feeling or being sick

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Treatment of heart failure
• The usual starting dose is 1.25 mg once daily.
• Your doctor will adjust the amount you take.
• The maximum dose is 10 mg daily. Two
administrations per day are preferable.

Other side effects include:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.

Other side effects reported:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.
• Difficulty concentrating
• Swollen mouth
• Blood tests showing too few blood cells in your
blood
• Blood tests showing less sodium than usual in
your blood
• Fingers and toes changing colour when you are
cold and then tingling or feeling painful when
you warm up (Raynaud’s phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Change in the way things smell
• Hair loss.

2, 3 / 4

Treatment to reduce or delay the worsening of
kidney problems
• You may be started on a dose of 1.25 mg or
2.5 mg once daily.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once daily.

Very rare (affects less than 1 in 10,000 people)
• Being more sensitive to the sun than usual.

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To reduce the risk of you having a heart attack or
stroke
• The usual starting dose is 2.5 mg once daily.
• Your doctor may then decide to increase the
amount you take.
• The usual dose is 10 mg once daily.

Rare (affects less than 1 in 1,000 people)
• Feeling shaky or confused
• Red and swollen tongue
• Severe flaking or peeling skin, itchy, lumpy rash
• Nail problems (e.g. loosening or separation of a
nail from its bed)
• Skin rash or bruising
• Blotches on your skin and cold extremities
• Red, itchy, swollen or watery eyes
• Disturbed hearing or ringing in your ears
• Feeling weak
• Blood tests showing a decrease in the number of
red blood cells, white blood cells or platelets or
in the amount of haemoglobin.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

How much to take
Treatment of high blood pressure
• The usual starting dose is 1.25 mg or 2.5 mg
once daily.
• Your doctor will adjust the amount you take
until your blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are already taking diuretics (water tablets),
your doctor may stop or reduce the amount of
the diuretic you take before beginning
treatment with Tritace.

Tell your doctor immediately if you experience:
• Faster heart rate, uneven or forceful heartbeat
(palpitations), chest pain, tightness in your chest or
more serious problems including heart attack and
stroke
• Shortness of breath or a cough. These could be
signs of lung problems
• Bruising more easily, bleeding for longer than
normal, any sign of bleeding (e.g. bleeding from
the gums), purple spots, blotching on the skin or
getting infections more easily than usual, sore
throat and fever, feeling tired, faint, dizzy or
having pale skin. These can be signs of blood or
bone marrow problems
• Severe stomach pain which may reach through to
your back. This could be a sign of pancreatitis
(inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach
pain, feeling sick, yellowing of your skin or eyes
(jaundice). These can be signs of liver problems
such as hepatitis (inflammation of the liver) or
liver damage.

167 x 304,8 DP

Taking this medicine
• Take this medicine by mouth at the same time
of the day each day.
• Swallow the tablets/capsules whole with liquid.
• Do not crush or chew the tablets/capsules.

PACK. ITEM:

Always take Tritace exactly as your doctor has told
you. You should check with your doctor or
pharmacist if you are not sure.

Stop taking Tritace and see a doctor straight away,
if you notice any of the following serious side
effects – you may need urgent medical treatment:
• Swelling of the face, lips or throat which make it
difficult to swallow or breathe, as well as itching
and rashes. This could be a sign of a severe
allergic reaction to Tritace
• Severe skin reactions including rash, ulcers in your
mouth, worsening of a pre-existing skin disease,
reddening, blistering or detachment of skin (such
as Stevens-Johnson syndrome, toxic epidermal
necrolysis or erythema multiform).

101011010

3. ow to take Tritace
H

Like all medicines, Tritace can cause side effects,
although not everybody gets them.

GB: GREAT BRITAIN

Driving and using machines
You may feel dizzy, while taking Tritace. This is more
likely to happen when you start taking Tritace or
start taking a higher dose. If this happens, do not
drive or use any tools or machines.

 Reflex Blue

4. ossible side effects
P

Arkhé S.a.s.

Taking Tritace with food and alcohol
• Drinking alcohol with Tritace may make you feel
dizzy or light-headed. If you are concerned
about how much you can drink while you are
taking Tritace, discuss this with your doctor as
medicines used to reduce blood pressure and
alcohol can have additive effects.
• Tritace may be taken with or without food.

If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

Tel. 0862.404140
fax 0862.404140

If any of the above apply to you (or you are not
sure), talk to your doctor before taking Tritace.

If you forget to take Tritace
• If you miss a dose, take your normal dose when
it is next due.
• Do not take a double dose to make up for a
forgotten tablet/capsule.

Uncommon (affects less than 1 in 100 people):
• Balance problems (vertigo)
• Itching and unusual skin sensations such as
numbness, tingling, pricking, burning or
creeping on your skin (paraesthesia)
• Loss or change in the way things taste
• Sleep problems
• Feeling depressed, anxious, more nervous than
usual or restless
• Blocked nose, difficulty breathing or worsening
of asthma
• A swelling in your gut called “intestinal
angioedema” presenting with symptoms like
abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Passing more water (urine) than usual over the
day
• Sweating more than usual
• Loss or decrease of appetite (anorexia)
• Increased or irregular heart beats
• Swollen arms and legs. This may be a sign of
your body holding onto more water than usual
• Flushing
• Blurred vision
• Pain in your joints
• Fever
• Sexual inability in men, reduced sexual desire in
men or women
• An increased number of certain white blood
cells (eosinophilia) found during a blood test
• Blood tests showing changes in the way your
liver, pancreas or kidneys are working.

3 - Estrapolazione testo e reimpaginazione + modifiche

Please tell your doctor if you are taking any of the
following medicines. They may be affected by
Tritace:
• Medicines for diabetes such as oral glucose
lowering medicines and insulin. Tritace may lower
your blood sugar amounts. Check your blood sugar
amounts closely while taking Tritace
• Lithium (for mental health problems). Tritace
may increase the amount of lithium in your
blood. Your lithium amount will need to be
closely checked by your doctor.

If you take more Tritace than you should
Tell a doctor or go to the nearest hospital casualty
department straight away. Do not drive to the
hospital, get somebody else to take you or call for
an ambulance. Take the medicine pack with you.
This is so the doctor knows what you have taken.

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Please tell your doctor if you are taking any of the
following medicines. They can increase the chance
of getting side effects if you take them with Tritace:
• Medicines used to relieve pain and inflammation
(e.g. Non-Steroidal Anti- Inflammatory Drugs
(NSAIDs) such as ibuprofen or indomethacin and
aspirin)
• Medicines for cancer (chemotherapy)
• Medicines to stop the rejection of organs after a
transplant such as ciclosporin
• Diuretics (water tablets) such as furosemide
• Medicines which can increase the amount of
potassium in your blood such as spironolactone,
triamterene, amiloride, potassium salts and
heparin (for thinning blood)
• Steroid medicines for inflammation such as
prednisolone
• Allopurinol (used to lower the uric acid in your
blood)
• Procainamide (for heart rhythm problems)
• Aliskiren (for high blood pressure).

Elderly
Your doctor will reduce the initial dose and adjust
your treatment more slowly.

• Skin rash with or without raised area
• Chest pain
• Cramps or pain in your muscles
• Blood tests showing more potassium than usual
in your blood.

2 - Modifica versione PDF

Please tell your doctor if you are taking any of the
following medicines. They can make Tritace work
less well:
• Medicines used to relieve pain and inflammation
(e.g. Non-Steroidal Anti- Inflammatory Drugs
(NSAIDs) such as ibuprofen or indomethacin and
aspirin)
• Medicines used for the treatment of low blood
pressure, shock, cardiac failure, asthma or allergies
such as ephedrine, noradrenaline or adrenaline.
Your doctor will need to check your blood pressure.

Breast-feeding
Tell your doctor if you are breast-feeding or about
to start breast-feeding. Tritace is not
recommended for mothers who are breastfeeding, and your doctor may choose another
treatment for you if you wish to breast-feed,
especially if your baby is newborn, or was born
prematurely.
Ask your doctor or pharmacist for advise before
taking any medicine.

• The usual dose is 10 mg daily. Two
administrations per day are preferable.

1 - Prima realizzazione

Taking Tritace with other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a
prescription (including herbal medicines). This is
because Tritace can affect the way some other
medicines work. Also some medicines can affect
the way Tritace works.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think that you are
(or might become) pregnant.
Your doctor will normally advise you to stop taking
Tritace before you become pregnant or as soon as
you know you are pregnant and will advise you to
take another medicine instead of Tritace. Tritace is
not recommended in early pregnancy, and must
not be taken when more than 3 months pregnant,
as it may cause serious harm to your baby if used
after the third month of pregnancy.

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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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