Ibuprofen And Phenylephrine Hydrochloride 200 Mg/6.1 Mg Tablets
Read this leaflet carefully because it contains important information for you.
k Keep this leaflet. You may need to read it again, k Ask your pharmacist if you need more information or advice.
k You must contact a doctor or pharmacist if your symptoms worsen or do not improve.
1. What this medicine is for 4. Possible side effects
2. Before you take the medicine 5. How to store this medicine
3. How to take the medicine 6. Further information
fel WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen and phenylephrine hydrochloride. Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) which work by changing how the (body responds to pain, swelling and high temperature. Phenylephrine hydrochloride is a decongestant which shrinks the blood vessels in the nose and pinuses which opens the airways helping you to breathe more easily. This medicine is used to relieve the symptoms of cold and 'flu with associated (congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses.
H BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
• are allergic to ibuprofen, phenylephrine hydrochloride, to any of the ingredients (listed in section 6), or to aspirin or other painkillers (an allergic reaction may be recognised as shortness of breath, runny nose, skin rash or itching)
k have or have had a stomach ulcer, perforation or bleeding
k have kidney or heart failure or severe liver failure k have heart problems or high blood pressure (particularly due to a tumour near the kidney)
|» have diabetes k have prostate problems
• have glaucoma (increased pressure in the eye) p have an overactive thyroid gland
k are taking more than 75mg of aspirin a day
• are taking Monoamine Oxidase inhibitor medicines (used for depression) or have taken them within the last 14 days
• are pregnant or breast feeding.
Talk to your doctor or pharmacist before taking this medicine if you:
• are elderly because you may be at more risk of having serious side effects, particularly stomach problems k have or have suffered from asthma, diabetes, high cholesterol or have allergies p have liver or kidney problems k have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis p_ have Systemic Lupus Erythematosus (SLE) - an
illness which affects your immune system/TT causes joint pains, skin changes and problems with other parts of your body.
• have problems with your blood circulation (including Raynaud's Phenomenon, which might appear as paleness or a blue tinge to the skin and/or pain of the fingers, toes, ears and nose in response to cold)
• have, have previously had, or are at risk of heart, problems or stroke. Medicines containing ibuprofenl may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any, risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (10 days). If you have previously had a stroke or think that you might be at risk of heart problems or stroke (for example if you have high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist
If you are taking other medicines You must not take these tablets if you are taking certain other medicines - see section 2 ‘Do not take this medicine if. Talk to your pharmacist or doctor before you take the tablets if you are taking any regular medication, especially:
• low-dose aspirin (up to 75mg daily)
• other medicines for thinning the blood (anticoagulants (against clotting) and anti-platelet agents such as warfarin and ticlopidin)
• medicines for high blood pressure (ACE-inhibitors| such as captopril, beta-blockers and angiotensin II antagonists) and water tablets (diuretics)
• corticosteroids
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure)
• cyclosporin and tacrolimus (immunosuppressant! medicines often used following organ transplants)
• mifepristone (a medicine used to terminate pregnancy - NSAIDs should not be used for 12 days after mifepristone)
• lithium (for depression or mental problems)
• zidovudine (a medicine to treat viruses)
• quinolone antibiotics (medicines used to treat bacterial infections)
• tricyclic antidepressants (e.g. amitriptyline)
• some antibiotics and epilepsy treatments
• other nasal decongestants (e.g. pseudoephedrine).. Pregnancy and Breast feeding
Do not take this medicine if you are pregnant or breast feeding. Ibuprofen belongs to a group of medicines which may affect fertility in women. Fertility goes bacH to normal when you stop taking the medicine. It is unlikely that if you only take this medicine occasionally it will affect your chances of becoming pregnant. If you| have problems becoming pregnant talk to your doctor before taking this medicine.
Important information about some of the ingredients of this medicine.
This product contains 31,66mg sucrose per tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This product contains tartrazine (E102) which may cause allergic reactions.
_ _ _ _Further information overleaf
El HOW TO TAKE THE MEDICINE
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Age |
Dose and how often to take |
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Adults, the elderly and children over 12 years |
Take 2 tablets every 8 hours, as required. Swallow tablets with a glass of water preferably with or after food. Leave at least 4 hours between doses and do not exceed six tablets in any 24 hour period. |
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• This medicine is for short-term use only. • Take the lowest dose for the shortest time necessary. • Do not take this medicine for longer than 10 days. If you do not get better, or get worse, talk to your doctor. They will tell you if it is safe to carry on taking this medicine . | |
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Do not give to children under 12 years. | |
If you take more of this medicine than you Ishould: Talk to a doctor straight away, or go to your nearest hospital casualty department. Take (the carton and this leaflet with you.
[] POSSIBLE SIDE EFFECTS
Most people take this medicine without any problems, but it can have side effects, like all medicines.
To reduce the chance of side effects, especially if bou are elderly, use the lowest effective dose for the shortest possible time.
If you get any of the following at any time during your treatment STOP TAKING, and get medical help straight away:
Allergic reactions:
The following reactions may mean you are having an allergic reaction to this medicine:
(• asthma, worsening of asthma, unexplained wheezing or shortness of breath
• swelling of the face, lips, tongue and throat (causing difficulty in swallowing or breathing)
|» rapid heart rate, low blood pressure, collapse.
• also, there may be skin reaction (including hives, rash and itching) - very rarely these can be severe with blistering and peeling skin
Stomach and bowel problems including:
(• indigestion or heartburn !• pains in your stomach (abdomen) or other abnormal stomach problems (• pass blood in your stools or motions |» pass black tarry stools or motions
• vomit any blood or dark particles that look like coffee grounds
|» worsening of bowel problems (ulcerative colitis or Crohn's disease)
Blood disorders which can cause:
!• unexplained or unusual bruising or bleeding
• sore throat or mouth ulcers (• fever (high temperature)
!• extreme paleness or weakness and exhaustion Heart and circulation effects: llbuprofen may be associated with a small Increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, Iswelling due to fluid build-up (oedema) or stroke._
Either side effects That may occur include:
Other stomach and intestine effects including:
• diarrhoea, flatulence, constipation and vomiting. Other heart and circulation effects including:
• fast heart rate, changes in heart rhythm, palpitations, high blood pressure.
Liver problems that might be indicated by yellowing of the skin and eyes (jaundice) and/or pale coloured stools and dark urine.
Kidney problems that might be indicated by passing less or more urine than normal, cloudy urine, blood in the urine, pain in the back and/or swelling (particularly of the legs) - very rarely kidney failure.
Nervous system problems including headache and aseptic meningitis (which can have symptoms such as severe headache, stiff neck, disorientation, fever and eye sensitivity to light in those with existing auto-immune disorders such as lupus).
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.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
El HOW TO STORE THIS MEDICINE
Do not use after the expiry date (EXP) shown on the pack. Do not store above 25°C. Store in the original container.
Keep out of the sight and reach of children.
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.
El FURTHER INFORMATION
What this medicine contains:
The active ingredients are: Ibuprofen 200mg and Phenylephrine Hydrochloride 6.1 mg per coated tablet.
The other ingredients are: Calcium Hydrogen Phosphate Dihydrate, Croscarmellose Sodium, Cellulose Powdered, Talc, Simeticone, Silica Colloidal Anhydrous. The sugar coating contains: Talc, Sucrose, Povidone K90, Calcium Carbonate, Macrogol 6000, Macrogol 4000, Green Spruce Food Colourant 83270-DO (Containing Sodium Sulphate (E514), Tartrazine (E102) and Brilliant Blue (E133)), Titanium Dioxide, Shellac and Theobroma Oil.
What this medicine looks like and contents of the pack. The tablets are circular, green sugar coated tablets. This pack contains 16 tablets.
Marketing Authorisation Holder:
Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer: Galpharm International Ltd.,
Elmhirst Park, Middle Field Road, Barnsley,
South Yorkshire, S75 4LS, United Kingdom.
Text revised: June 2015. _ _ 4005319|