Ibuprofen 200 Mg Liquid Capsules
Ibuprofen 200mg Liquid 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 . Possible side effects
. Storing the medicine 6. Further information
Q WHAT THIS MEDICINE IS FOR
This medicine contains ibuprofen. Ibuprofen is one of a group of non-steroidal antiinflammatory drugs (known as NSAIDs) which 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), dental pain, period pain
• headache, migraine
• fever (high temperature)
• the symptoms of colds and flu.
£3 BEFORE YOU TAKE THE MEDICINE
Do not take this medicine if you:
• have (or have had two or more episodes of) 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 aspirin with a daily dose above 75mg
• are in the last 3 months of pregnancy. Warnings and precautions Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment. You should discuss your treatment with your doctor or pharmacist before taking this medicine if you:
• have heart problems including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke' or transient ischaemic attack “TIA”).
• have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.
• 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 an intolerance to some sugars (these capsules contain sorbitol)
• 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.
There is a risk of renal impairment in dehydrated adolescents.
Other medicines and this medicine You must not take these capsules if you are taking certain other medicines - see section 2 ‘Do not take this medicine if you'.
This medicine may affect or be affected by some other medicines. For example:
• medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/ acetylsalicylic acid, warfarin, ticlopidine)
• 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 (anti-coagulants)
• other NSAID painkillers, including cyclooxygenase-2 selective inhibitors
• medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blocker such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• antidepressants called selective-serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine
• corticosteroids (for skin problems and allergies e.g. cortisol)
• methotrexate (a medicine for cancer)
• cardiac glycosides (medicines used to treat heart failure e.g. digoxin)
• ciclosporin 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 infection e.g. ciprofloxacin).
Some other medicines may also affect or be affected by the treatment of this medicine. You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines.
Pregnancy and Breastfeeding Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking Ibuprofen Capsules if you are in the first 6 months of pregnancy or are breastfeeding. These capsules belongs to a group of medicines which may affect fertility in women. Fertility goes back to normal when you stop taking the medicine.
Further information overleaf ^
It is unlikely that if you only take these capsules occasionally it will affect your chances of becoming pregnant. If you have problems becoming pregnant talk to your doctor before taking this medicine.
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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.
Q POSSIBLE SIDE EFFECTS
Most people take these capsules without any problems, but they 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 or perforation, mouth ulcers
• 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 ibuprofen capsules may be associated with a small increased risk of heart attack (myocardial infarction), high blood pressure, heart failure, swelling due to fluid build-up (oedema) or stroke. Other side effects that may occur include those listed below. If you experience any of these symptoms, or have any other unusual symptoms or concerns with your medicine, stop taking the capsules and see your doctor. 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.
0 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 out of the sight and reach of children. FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Ibuprofen 200 mg per liquid capsule.
The other ingredients are: macrogol 600, potassium hydroxide, gelatine, sorbitol, purified water, titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose. Also contains Ponceau 4R (E124), which may cause allergic reactions. What this medicine looks like and contents of the pack Each oval, red capsule is printed in white with ‘I200'. This pack contains 16 capsules. Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Banner Pharmacaps Europe P.O. Box 5037, 5004 EA Tilburg, The Netherlands. Manufacturer: Patheon Softgels B.V. P.O. Box 5037, 5004 EA Tilburg, The Netherlands.
Text revised: October 2015.
PL 14338/0001 2752851
HOW TO TAKE THE MEDICINE
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Age |
Dose and how often to take |
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Adults, the elderly and adolescents |
Initial dose 1 or 2 capsules to be swallowed whole with water, preferably with or after food. Do not chew. Then if necessary 1 or 2 capsules every 4 hours. Do not take more often than every 4 hours. Do not take more than 6 capsules in any 24 hour period. |
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Do not give to children under 12 years. | |
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• This medicine is for short-term use only. • Take the lowest dose for the shortest time necessary. • Do not take these capsules for longer than 10 days. • If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. 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 the medicine. | |
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Perrigo Quality Affordable Healthcare Products™ T: +44(0)1226 779911 |
PRODUCT Generic Ibuprofen 200mg Liquid Capsules |
PROJECT Art 31 & MA Name |
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VERSION 2 HUB 9986 PROFILE L111 DATE 09/10/15 COMPONENT 2752851 DIMENSIONS 139.7x209.55mm AMENDED BY DH SUPPLIER Wrafton | ||
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BLACKS | ||