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IPRATROPIUM BROMIDE 21 MICROGRAMS PER METERED DOSE NASAL SPRAY SOLUTION

Active substance(s): IPRATROPIUM BROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Rinatec® 21 micrograms per metered dose Nasal Spray Solution /
Ipratropium Bromide 21 micrograms per metered dose Nasal Spray Solution
(ipratropium bromide)
This product is available using one of the above names but it will be referred as Rinatec throughout
the following 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
Rinatec 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.
3. 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. Do not expose to excessive heat.
• If your inhaler fails to work properly you should ask your doctor or pharmacist for advice.
• 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).
The other ingredients are: sodium chloride, benzalkonium chloride, disodium edetate, sodium
hydroxide, hydrochloric acid and purified water (for pH adjustment).
What Rinatec looks like and contents of the pack
Rinatec is a clear colourless aqueous solution in an amber coloured glass bottle fitted with a white
manually activated nasal pump/closure covered with a plastic cap.
Rinatec is available as a 15 ml spray, which gives 180 individual sprays.
PL 15814/1115

POM

Manufactured by Istituto De Angeli S.r.l., Italy.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd.,
Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 21.11.2014.
Rinatec is a registered trademark of Boehringer Ingelheim KG.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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