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RINATEC 21 MICROGRAMS NASAL SPRAY

Active substance(s): IPRATROPIUM BROMIDE

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Assessed against UK PIL dated September 2014
Package leaflet: Information for the user

Rinatec® 21 micrograms
nasal spray
(ipratropium bromide)

By addisonf at 3:15 pm, May 27, 2016
Your medicine is known by the above name but will be
referred to as Rinatec throughout this leaflet.
Read all of this leaflet carefully before you start using
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 gets troublesome or
serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What RINATEC is and what it is used for
2. Before you use RINATEC
3. How to use RINATEC
4. Possible side effects
5. How to store RINATEC
6. Further information
1. WHAT RINATEC IS AND WHAT IT IS USED FOR
The name of your medicine is RINATEC 21
micrograms per metered dose Nasal Spray Solution.
It is a solution that you spray into your nose.
RINATEC contains a medicine called ipratropium
bromide. This belongs to a group of medicines called
‘anticholinergics’. It is used to help stop a runny nose
caused by Rhinitis. Rhinitis is an inflammation of the
nose which could be because of an allergy (such as
hay fever) or other reasons.
2. BEFORE YOU USE RINATEC
Do not use RINATEC if:
• You are allergic (hypersensitive) to ipratropium
bromide or any of the other ingredients in RINATEC
(listed in Section 6 below)
• You are allergic (hypersensitive) to medicines that are
similar to RINATEC, such as atropine
Do not use this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or
pharmacist before using RINATEC.
Take special care with RINATEC
Check with your doctor or pharmacist before using
your medicine if:
• You have cystic fibrosis
• You have glaucoma or any other eye problems
• You are a man who has prostate problems
• You have problems passing water (urine)
• You are pregnant, likely to get pregnant or you are
breast-feeding
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before using RINATEC.
Taking other medicines
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines. This
includes medicines obtained without a prescription
and herbal medicines. This is because RINATEC can
affect the way some other medicines work. Also some
other medicines can affect the way RINATEC works.
Pregnancy and breast-feeding
Talk to your doctor or pharmacist before using this
medicine if you are pregnant, likely to get pregnant or
are breast-feeding.
Driving and using machines
You may feel dizzy, or have difficulty in focusing, or
blurred vision while taking RINATEC. If this happens do
not drive or use any tools or machines.
Important information about some of the
ingredients of RINATEC
RINATEC contains benzalkonium chloride which is an
irritant to the skin and may cause skin reactions.

HOW TO USE RINATEC
Always use RINATEC as your doctor has told you. You
should check with your doctor or pharmacist if you
are not sure.
How many sprays
Adults
• Two sprays in each nostril
• Two to three times each day
Children under 12 years of age
RINATEC is not recommended for children under
12 years
Using this medicine
1. Remove the cap
2. • The nasal spray pump must be
primed before RINATEC is used for
the first time
• To prime the pump, hold the bottle
with your thumb at the base and
your first and middle fingers on the
white shoulder area. Point the bottle
upright and away from your eyes.
Press your thumb firmly and quickly
against the bottle seven times. The
pump is now primed and ready to
use.
• If it has been more than 24 hours
since you used your spray, you will
need to prime the pump again before
using it. Reprime the pump as before,
but this time you will only need to
pump the bottle twice
• If you have not used your spray for
more than seven days you will need
to reprime the pump using the
normal seven sprays
3. Blow your nose to clear your nostrils, if necessary.
4. • Close one nostril by gently placing
your finger against the side of your
nose
• Tilt your head slightly forward and,
keeping the bottle upright, insert the
bottle tip into the other nostril. Point
the tip toward the back and outer
side of your nose
• Press firmly and quickly upwards
with the thumb at the base while
holding the white shoulder area
between your first and middle fingers
• Following each spray, sniff deeply
and breathe out through your
mouth. After you have finished
spraying, remove the bottle and tilt
your head backwards for a few
seconds to let the spray spread over
the back of the nose
5. Repeat step 4 in the other nostril
6. Replace the cap
7. • If the bottle tip becomes clogged, remove cap.
Hold the bottle tip under warm running water for
about a minute
• Dry the bottle tip, reprime the pump and replace
the cap
If any of the spray accidentally gets into your eyes,
wash it out with cold tap water for several minutes.
You may get painful, stinging or red eyes, dilated
pupils, blurred vision, see colours or lights. If this
happens, talk to your doctor for advice. If affected,
do not drive or use any tools or machines. If you get
problems with your eyes at any other time, talk to
your doctor for advice

If you use more RINATEC than you should
Do not use more sprays than the doctor has told you.
If you use more sprays than you should, talk to a doctor
or go to a hospital straight away. Take the medicine
pack with you, even if there is no medicine left.
If you forget to use RINATEC
• If you forget a dose, use the spray as soon as you
remember
• However, if it is nearly time for the next dose, skip
the missed dose
• Do not use a double dose to make up for a
forgotten dose
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, RINATEC can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine:
Stop taking and see a doctor straight away, if you
notice any of the following serious side effects – you
may need urgent medical treatment.
• Allergic reactions – the signs may include itching or
nettle rash (affects less than 1 in 1000 people). In
severe cases the signs include swelling of your mouth
and face, skin rash, sudden difficulties in breathing
and reduction of your blood pressure. Tightening of
your throat (affects less than 1 in 100 people)
• Increased heart rate, irregular heart rhythm such as
atrial fibrillation or quickening of the heart rate
(affects less than 1 in 100 people)
• Palpitations (fast or uneven heart beats) (affects
less than 1 in 1000 people)
Stop using this medicine and see your doctor straight
away if you have any of these side effects.
Other side effects include:
Common (affects less than 1 in 10 people)
• Headache or stuffy nose
• Nasal drying, nasal irritation such as itching or a
burning sensation or nosebleeds
• Throat irritation
Uncommon (affects less than 1 in 100 people)
• Skin rash
• Dizziness
• Unexpected tightness of the chest, swelling of the
throat, dry throat
• Blurred vision, difficulty focusing, dilated pupils,
glaucoma, painful, stinging, red or swelling of the
eyes, see colours or lights
• Mouth or lip sores
• Problems passing water (urine), especially if you
already have problems passing urine
• Feeling sick (nausea), stomach upset or discomfort
• Dry mouth
Rare (affects less than 1 in 1000 people)
• Itching or nettle rash (urticaria)
If any of the spray accidentally gets into your eyes, wash
it out with cold tap water for several minutes. You may
get painful, stinging or red eyes, dilated pupils, blurred
vision, see colours or lights. If this happens, talk to
your doctor for advice. If you get problems with your
eyes at any other time, talk to your doctor for advice.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at: 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 RINATEC
Keep out of the sight and reach of children.
Use this spray within six weeks of first priming the
nasal spray pump. Do not use this medicine after the
expiry date which is stated on the carton and label
after EXP. The expiry date refers to the last day of the
month.
Do not store above 25°C. Do not freeze. Protect from heat.
If your spray shows signs of deterioration or discoluration
seek the advice of your pharmacist who will tell you what
to do.
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.
6. FURTHER INFORMATION
What RINATEC contains
Each metered dose contains 21 micrograms of
ipratropium bromide (as monohydrate).
Also includes sodium chloride, benzalkonium chloride,
disodium edetate, purified water, sodium hydroxide
and hydrochloric acid (for pH adjustment).
What RINATEC looks like and contents of the pack
Clear aqueous solution in an amber glass bottle with a
white nasal pump, and plastic cover.
Available as a 15 ml spray, which gives 180 individual
sprays.
Who manufactured your medicine
Manufactured by Istituto De Angeli S.R.L, Localita
Prulli, Reggello (FI), Italy. Procured from within the EU
and repackaged by Product Licence Holder Ennogen
Healthcare Ltd, Unit G4 Riverside Industrial Estate,
Riverside Way, Dartford, Kent DA1 5BS.
PL 40739/0066

POM

Leaflet date: 26 May 2016

Ref: Rin15/v2

Rinatec is a registered trademark of Boehringer Ingelheim
KG

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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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