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Active substance(s): PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE / PARACETAMOL / PSEUDOEPHEDRINE HYDROCHLORIDE
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Information for the user
Paracetamol, Pseudoephedrine Hydrochloride
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription to treat minor conditions. However, you still need to take
it carefully to get the best results from it.
Keep this leaflet, you may need to read it again
Ask your pharmacist if you need more information or advice
What this medicine is for
This medicine contains pseudoephedrine hydrochloride, a decongestant, which acts to relieve a
blocked nose, and also paracetemol, a painkiller which also reduces fever.
It can be used to relieve the symptoms of colds and flu, including aches and pains, headache, blocked
nose and sinuses and to reduce fever.
For children, simple treatments should be tried first before you give this medicine. Further information
on “Treating coughs and colds in children” is provided at the end of this leaflet.
Before you take this medicine
This medicine can be taken by adults and children of 6 years and over. However, some people should
not take this medicine or should seek the advice of their pharmacist or doctor first.
Do not take:
If you are allergic (hypersensitive) to any of the ingredients in this medicine (see What is in
If you are allergic to other decongestants
If you have high blood pressure (including that due to a tumour near your kidney)
If you suffer from severe liver or kidney disease
If you have diabetes
If you have an overactive thyroid
If you have glaucoma or you have been told you have high blood pressure in the eye
If you have phaeochromocytoma, a tumour in the adrenal gland
If you are taking any of these medicines
- Monoamine oxidase inhibitors or moclobemide (for depression), or have taken them within the
last 14 days
- Medicines called beta-blockers (normally for heart problems)
- Other decongestants
If you are pregnant
Talk to your pharmacist or doctor before taking this medicine:
If you have liver problems (including disease caused by drinking alcohol) or alcohol
If you have other kidney or liver problems
If you have problems with your prostate problems
If you are breastfeeding
Other important information
Do not drink alcohol (wine, beer, spirits) while taking this medicine.
If you take other medicines
This medicine contains paracetamol, do not take with any other paracetamol containing
Before you take these tablets, make sure that you tell your pharmacist about ANY other medicines you
might be using at the same time, particularly the following:
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Medicines to treat high blood pressure (e.g. beta-blockers)
Medicines for heart problems (e.g. digoxin)
Medicines which may cause a dry mouth (e.g. tri-cyclic anti-depressants)
Appetite suppressants, amphetamines (stimulants)
Ergot alkaloids (for migraine)
Medicines for epilepsy (anticonvulsants)
Oxytocin (to induce labour and stop excessive bleeding after the birth)
Non-steroidal anti-inflammatory drugs (for pain and swelling, e.g. ibuprofen, aspirin)
Warfarin or other blood thinners – if you take warfarin you can take occasional doses of this
medicine, but talk to your doctor first before you take it on a regular basis
If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes
medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and
How to take this medicine
Check the foil is not broken before use. If it is, do not take that tablet.
Adults and children of 12 years
How many to take
Children of 6 to 11 years
Half a tablet
3 or 4 times in 24 hours.
Don’t take more than 4 tablets
in any 24 hours.
4 times in 24 hours
Don’t take more than 4 half
tablets in any 24 hours.
Don’t take more often than every four hours.
Swallow the tablet with water.
Do not give to children under 6 years.
If you are treating a child and their symptoms worsen at any time, talk to a pharmacist or doctor.
Do not take this medicine for more than 5 days, unless your doctor tells you to.
Do not take more than the amount recommended above.
If symptoms do not go away talk to your doctor.
If you take too many tablets: Immediate medical advice should be sought in the event of an
overdose, even if you feel well, because of the risk of delayed, serious liver damage. Go to your
nearest hospital casualty department. Take your medicine and this leaflet with you.
Possible side effects
Most people will not have problems, but some may get some.
If you get any of these serious side effects, stop taking the tablets. See a doctor at once:
Difficulty breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)
Very rare cases of serious skin reactions have been reported. This may include peeling,
blistering and lesions of the skin.
If you get any of these side effects, stop taking the tablets:
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The following possible side-effects are less serious, however, talk to your doctor or pharmacist
if you experience any of the effects listed:
Other allergic reactions including skin rash
Feeling sick, being sick, headache
Fast or irregular heartbeat, high blood pressure, palpitations (awareness of your heartbeat)
Anxiety, feelings of paranoia, irritability, feeling excited, difficulty sleeping, tremors
Difficulty in passing urine
Unusual bruising or infections such as sore throats – this may be a sign of very rare changes in
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.
How to store this medicine
Do not store above 30°C. Store in the original package.
Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked
Use by the date on the end flap of the carton.
If you still have tablets left return them to your nearest pharmacy for disposal.
What is in this medicine
Each tablet contains Paracetamol 500 mg, Pseudoephedrine Hydrochloride 60 mg, which are the
As well as the active ingredients, the tablets also contain microcrystalline cellulose, pregelatinised
maize starch, croscarmellose sodium, sodium lauryl sulphate, magnesium stearate, quinoline yellow
The pack contains 12 yellow capsule shaped tablets.
Who makes this medicine
Marketing Authorisation Holder
Manufactured for Novartis Consumer Health UK Limited,
Camberley, GU15 3YL, UK, by
Famar SA, Anthoussa Attiki 15344, Greece
Leaflet prepared May 2015
If you would like any further information about this medicine, please contact Novartis Consumer Health,
Camberley, GU15 3YL, UK.
Treating coughs and colds in children
It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and
get fewer colds. Most colds will get better within a few days and you may not need to do more than
keep your child comfortable until they get over it.
Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.
Follow these simple steps, which may help your child overcome their cough or cold:
1. If your child is hot or has a fever: Increase the amount of fluid your child normally drinks. Lower
their temperature with a paracetamol or ibuprofen medicine, which is suitable for children.
(Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3
Your pharmacist will be able to help you find a suitable product if in doubt.
2. For coughs: Although it may be distressing to hear your child cough, the coughing itself serves an
important purpose. It helps to clear phlegm on the chest or mucus from the nose. Give your child plenty
of lukewarm clear fluids to drink, which may help loosen the phlegm and relax the airways.
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3. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies
with blocked noses who are having trouble feeding.
PACK MOCK UP BOX
Product Name: Otrivine MU-CRON
Product Licence No: 00014/0594
Wording Ref: PROPOSED A4 LEAFLET TEXT
Status: INTERNAL DRAFT
Pack details: Leaflet
Pack size: 12 Tab. 12s UK
Version No: 1
Reason for change: Proposed A4 Wording to include the ADR reporting statement and the PRAC
paracetamol sIde effect statement.
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.