Teva Ibuprofen 200mg Long Lasting Capsules
Out of date information, search anotherG ALFROFEN'TBU PR0FEN LONG LASTING CAPSULES
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor or pharmacist if your symptoms worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
[] WHAT THIS MEDICINE IS FOR
Galprofen® Ibuprofen Long Lasting Capsules contain ibuprofen, which belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These medicines work by changing how the body responds to pain, swelling and high temperature.
This medicine is used to relieve:
• rheumatic and muscular pain, backache
• neuralgia (nerve pain)
• headache, migraine
• dental pain, period pain
• fever (high temperature)
p the symptoms of colds and flu.
Q BEFORE YOU TAKE THE MEDICINE
Do not take Galprofen® Ibuprofen Long Lasting Capsules if you:
• have or have had a stomach ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, 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)
• have kidney or heart failure or severe liver failure
• are taking other NSAID painkillers, or aspirin with a daily dose above 75mg
• are in the last 3 months of pregnancy Talk to your doctor or pharmacist before taking Galprofen® Ibuprofen Long Lasting Capsules if you:
• are elderly because you may be at more risk of having serious side effects, particularly stomach problems
• have or have suffered from asthma, diabetes, high cholesterol or have allergies
• have liver or kidney problems
• have stomach or bowel disorders including Crohn's disease or a condition known as ulcerative colitis
• have Systemic Lupus Erythematosus (SLE) -an illness which affects your immune system. It causes joint pains, skin changes and
|_problems with other parts of your body
• have, have previously had, or are at risk of I heart problems, high blood pressure or stroke.1 Medicines such as Galprofen® Ibuprofen Long Lasting Capsules 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 heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or 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 capsules if you are taking certain other medicines - see section 2 ‘Do not take Galprofen® Ibuprofen Long Lasting Capsules if.
Talk to your pharmacist or doctor before you take the capsules if you are taking any regular medication, especially:
• aspirin at low dose as an anti-platelet medicine (i.e. 75mg or below daily) as taking ibuprofen may reduce the effectiveness of the aspirin or cause stomach problems
• 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)
• guinolone antibiotics (medicines used to treat bacterial infections)
Pregnancy and Breast feeding Do not take Galprofen® Ibuprofen Long Lasting Capsules if you are in the last 3 months of pregnancy. Talk to your doctor before taking Galprofen® Ibuprofen Long Lasting Capsules if you are in the first 6 months of pregnancy or are breastfeeding. Galprofen® Ibuprofen Long Lasting Capsules belong to a group of medicines, which may impair fertility in women. This is reversible on stopping the medicine. It is unlikely that the capsules, used occasionally, will affect your chances of becoming pregnant. However, tell your doctor before taking this medicine if you have problems becoming pregnant.
Important information about some of the ingredients of this medicine.
This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
_ Further information overleaf W\
El HOW TO TAKE THE MEDICINE
|
Age |
Dose and how often to take |
|
Adults, the elderly and children over 12 years |
Take 2 capsules (400mg) each morning and evening, as reguired. Swallow capsules whole (do not chew) with a glass of water preferably with or after food. Do not exceed 4 capsules in 24 hours. |
|
The capsules are intended for short-term use only. Use them for the shortest time needed to relieve symptoms. Always use the lowest dose that relieves your symptoms. Do not take Galprofen® Ibuprofen Long Lasting Capsules for longer than 10 days unless your doctor tells you to. | |
|
Do not give to children under 12 years. | |
Talk to a doctor or pharmacist if you do not get better or get worse, or if new symptoms occur.
If you take too many capsules: 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 Galprofen® Ibuprofen Long Lasting Capsules without any problems, but it can have side effects, like all medicines.
To reduce the chance of side effects, especially if you are elderly, use the lowest effective dose for the shortest possible time.
STOP TAKING the capsules and contact your doctor immediately if you develop any of the following symptoms at any time while taking your medicine:
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:
• stomach discomfort or pain, nausea, indigestion or heartburn, stomach ulcer
• stomach bleeding which can result in vomit with blood or dark particles (like coffee grounds), black tarry stools or blood passed in your stools
• 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: Medicines such! as Galprofen® Ibuprofen Long Lasting Capsules may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid buildup (oedema) or stroke.
Other side effects that may occur include:
Other stomach and intestine effects including: • diarrhoea, flatulence, constipation and vomiting. 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.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
El STORING THE MEDICINE
Do not use after the expiry date shown on the pack. Do not store above 25°C. Store in the original container.
Keep all medicines out of the reach and sight of children.
El FURTHER INFORMATION
What is in this medicine:
The active ingredient is: 200mg of Ibuprofen in each prolonged release capsule.
The other ingredients are: Microcrystalline Cellulose, Eudragit NE30D, Hypromellose,
Talc, Collodial Silicon Dioxide. The capsule shell contains Gelatin, Titanium Dioxide (E171), Patent Blue V (E131), Erythrosine (E127).
What this medicine looks like and contents of the pack
Galprofen® Ibuprofen Long Lasting Capsules are blue and clear capsules containing white coated beads, available in pack sizes of 6, 8, 12 or 16 capsules (not all pack sizes may be marketed).
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: September 2013 . 57683-e 400431^