Essential Waitrose Ibuprofen 200 Mg Liquid Capsules
Out of date information, search anotherPL 14338/0001 Ibucaps 200mg PIL
PACKAGE LEAFLET: INFORMATION FOR THE USER Ibucaps Ibuprofen 200mg Soft Gelatin Capsules
Read all of this leaflet carefully before you start taking this product.
This medicine is available without prescription. However, you still need to take this product 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.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ibucaps Ibuprofen 200mg Soft Gelatin Capsules are and what they are used for?
2. Before you take Ibucaps Ibuprofen 200mg Soft Gelatin Capsules
3. How to take Ibucaps Ibuprofen 200mg Soft Gelatin Capsules?
4. Possible side effects
5. How to store Ibucaps Ibuprofen 200mg Soft Gelatin Capsules?
6. Further information
1. What Ibucaps Ibuprofen 200mg Soft Gelatin Capsules are and what are they used for?
This medicine contains ibuprofen, which belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs).
Your capsules are used for the relief from rheumatic or muscular pain, backache, neuralgia (sharp pain along nerves), migraine, headache, dental pain, period pain, feverishness, cold and flu symptoms. They are designed to provide effective relief from pain.
2. Before you take Ibucaps Ibuprofen 200mg Soft Gelatin Capsules Do not take these capsules if you:
• are allergic to ibuprofen or any of the other ingredients of this product, aspirin or other related painkillers (see end of section 2 and section 6)
• have had a worsening of asthma, allergic rash or itchy, runny nose when taking similar medicines
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• ever had stomach bleeding or a perforation due to NSAIDs
• are already taking other drugs that belong to the NSAIDs group
• are taking aspirin at doses of above 75 mg daily
• are in the last 3 months of pregnancy
• suffer from severe heart, liver or kidney disease.
Please see your doctor or pharmacist before taking this medicine if you:
• are elderly, as you may be more likely to suffer from side effects
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
• are allergic to any other painkiller
• suffer from systemic lupus erythematosus (a chronic rheumatic disease)
• suffer from an allergy
• suffer from inflammation of the intestines (ulcerative colitis, Crohn’s disease)
• are on low-dose aspirin (up to 75 mg daily)
• are a smoker
• are in the first 6 months of pregnancy
• if in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted
If symptoms persist or worsen, consult your doctor.
There is a risk of renal impairment in dehydrated adolescents.
Medicines such as Ibucaps Ibuprofen 200mg Soft Gelatin 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 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 any of the following medicines, please see your doctor before taking the capsules:
• any other painkillers (aspirin or other NSAIDs). Do not take this medicine if you are taking aspirin at doses of above 75mg daily. If you are on low-dose aspirin (up to 75mg daily) speak to your doctor or pharmacist before you take Ibucaps Ibuprofen 200mg soft gelatin capsules.
• regular medication for high blood pressure (antihypertensives or diuretics)
• blood thinner medicines (anti-coagulants)
• corticosteroids (anti-inflammatory) which can increase the risk of side effects in the stomach including bleeding
• anti-platelet agents (prevention of thrombotic cerebrovascular and cardiovascular diseases)
• serotonine reuptake inhibitors and lithium (for treatment of depression - bipolar disease and mania)
• cardiac glycosides (treatment of heart failure and cardiac arrhythmia)
• methotrexate (anti-cancer and psoriasis)
• zidovudine (HIV/AIDS infection)
• cyclosporine (prevent rejection after organ transplant)
• mifepristone (emergency contraceptive)
• tacrolimus (prevent rejection after organ transplant, treatment of skin diseases)
• quinolone (antibiotics)
Can you take Ibucaps Ibuprofen 200mg Soft Gelatine Capsules with other medicines?
Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan), and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek advice of your doctor or pharmacist before you take ibuprofen with other medicines.
Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking this medicine if you are in the first 6 months of pregnancy. DO NOT TAKE the capsules if you are in the last 3 months of pregnancy.
Ask your doctor or pharmacist for advice before taking any medicine if you are breast-feeding.
Female fertility
Ibucaps Ibuprofen 200mg soft gelatin capsules belong to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Ibucaps Ibuprofen 200mg soft gelatin capsules used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.
Driving and using machines
Ibucaps Ibuprofen 200mg Soft Gelatin Capsules are unlikely to cause any effect on your ability to drive or use machines.
Important information about some of the ingredients of Ibucaps Ibuprofen 200mg Soft Gelatin Capsules.
• Contains sorbitol. If you have an intolerance to some sugars, contact your doctor before taking this product.
• Ponceau 4R (E124) may cause allergic reactions.
3. How to take Ibucaps Ibuprofen 200mg Soft Gelatin Capsules?
Swallow the capsules whole with water. Do not chew.
Adults, the elderly and adolescents:
Take one or two capsules (200mg - 400mg), up to three times a day as required (maximum dose 400mg).
Leave at least 4 hours between doses and do not take more than 6 capsules in 24 hours.
This medicine is intended for short-term use only. You should take the lowest dose for the shortest time necessary to relieve your symptoms. Do not take this medicine for longer than 10 days unless your doctor tells you to.
If symptoms persist or worsen consult your doctor, who may instruct you to continue taking the medicine.
Not suitable for children under 12 years.
If you take more Ibucaps Ibuprofen 200mg Soft Gelatin Capsules than you should:
Problems in overdose are rare, but if you accidentally take more than the recommended dose contact your doctor immediately.
If you forget to take Ibucaps Ibuprofen 200mg Soft Gelatin Capsules:
Do not take a double dose to make up for a forgotten dose.
If you have any question on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ibucaps Ibuprofen 200mg Soft Gelatin Capsules can cause side effects, although not everybody gets them.
If you experience any of the following side effects, or anything unusual happens, stop taking the medicine immediately, and see your doctor or pharmacist.
Rare side effects are:
• oedema, high blood pressure (hypertension) and cardiac failure
• worsening of asthma (difficulty in breathing) unexplained wheezing or shortness of breath
• itchy skin or rashes, urticaria (hives)
• facial or tongue or larynx swelling
• anaphylaxis (life threatening allergy)
• tachycardia (fast heart rate)
• low blood pressure (hypotension)
• abdominal pain, nausea (feeling sick), gastrointestinal disorders, stomach ulcer
• headache
• skin peeling.
Very rarely, the following side effects can happen:
• kidney failure, liver problems, blood disorders:
the first signs can be fever, sore throat, mouth ulcers, flu like symptoms, severe exhaustion, unexplained bleeding and bruising,
• meningitis symptoms such as fever and chills, severe headache, nausea and vomiting and stiff neck (in patients with inflammatory disease of connective tissue in the skin or joints [systemic lupus erythematosus] and worsening of colitis or Crohn’s disease [inflammation of the bowel]),
• peptic ulcer, perforation or gastrointestinal haemorrhage, black tarry stools, vomit of blood or dark particles, ulcerative stomatitis (inflammation of the mouth), gastritis.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you suffer from any of the following, at any time, during your treatment STOP TAKING the medicine and seek immediate medical help:
• pass blood in your faeces (stools/motions)
• pass black tarry stools
• vomit any blood or dark particles that look like coffee grounds
STOP taking the medicine and tell your doctor if you experience:
• indigestion or heartburn
• abdominal pain (pains in your stomach) or other abnormal stomach symptoms.
Medicines such as Ibucaps Ibuprofen 200mg Soft Gelatin Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
5. How to store Ibucaps Ibuprofen 200mg Soft Gelatin Capsules?
Keep all medicines out of the reach and sight of children.
Do not use these capsules after the expiry date printed on the blister or carton. The expiry date refers to the last day of that month.
Keep the capsules in the original pack.
Do not store above 25°C.
6. Further Information
What Ibucaps Ibuprofen 200mg Soft Gelatin Capsules Ibuprofen contain:
The active ingredient is: ibuprofen 200mg.
The other ingredients are: macrogol 600, potassium hydroxide, gelatin, sorbitol, purified water, Ponceau 4R (E124).
Ink ingredients: titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose.
(see also end of Section 2 “Important information about some of the ingredients of “Ibucaps Ibuprofen 200mg Soft Gelatin Capsules”).
What Ibucaps Ibuprofen 200mg Soft Gelatin Capsules look like and contents of the pack?
Each Ibucaps Ibuprofen 200mg Soft Gelatin Capsule is an oval pink capsule printed in white with ‘I200’.
This product is available in packs of 4, 10 and 16 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Banner Pharmacaps Europe B.V.
P.O. Box 5037 5004 EA Tilburg The Netherlands
PL 14338/0001
Text revised: September 2014
August 2014 5 / 5 Rev: 2.0