Flarin 200 Mg Soft Capsules
Out of date information, search another1.3.1 - package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flarin 200 mg Soft Capsules Ibuprofen
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 Flarin 200 mg Soft Capsules are and what they are used for
2. What you need to know before you take Flarin 200 mg Soft Capsules
3. How to take Flarin 200 mg Soft Capsules
4. Possible side effects
5. How to store Flarin 200 mg Soft Capsules
6. Contents of the pack and other information
1. What Flarin 200 mg Soft Capsules are and what they are used for
This medicine contains ibuprofen, which belongs to a group of medicines known as non-steroidal antiinflammatory drugs (NSAIDs).
Your capsules are used for the relief from rheumatic or muscular pain, also for the relief of pain of nonserious arthritic conditions (caused by swelling, stiffness and inflammation of joints), joint pain, back pain, 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. What you need to know before you take Flarin 200 mg Soft 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.
Warnings and precautions
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 symptoms persist or worsen, consult your doctor.
Medicines such as Flarin 200 mg Soft 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.
Other medicines and Flarin 200 mg Soft Capsules
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 75 mg daily. If you are on low-dose aspirin (up to 75 mg daily) speak to your doctor or pharmacist before you take Flarin 200 mg Soft 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)
• serotonin 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)
Other medicines and Flarin 200 mg Soft Capsules
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
Flarin 200 mg Soft 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 Flarin 200 mg Soft 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
Flarin 200 mg Soft Capsules are unlikely to cause any effect on your ability to drive or use machines.
Important information about some of the ingredients of Flarin 200 mg Soft Capsules.
• Contains sorbitol. If you have an intolerance to some sugars, contact your doctor before taking this product.
• Brilliant blue (E133) and Allura Red (E129) may cause allergic reactions.
3. How to take Flarin 200 mg Soft Capsules
Swallow the capsules whole with water. Do not chew.
Adults, the elderly and children over 12 years:
For the treatment of rheumatic pain or muscular pain, back pain, neuralgia, migraine, headache, dental pain, period pain, feverishness and symptoms of colds and flu:
Take one or two capsules (200 mg - 400 mg), up to three times a day as required (maximum dose 400 mg).
For the treatment of joint pain, swelling and stiffness associated with the pain of non-serious arthritic conditions:
Take two capsules (400 mg), up to three times a day.
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 Flarin 200 mg Soft 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 Flarin 200 mg Soft 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.
September
CONFIDENTIAL
4. Possible side effects
Like all medicines, Flarin 200 mg Soft 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 Flarin 200 mg Soft Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
5. How to store Flarin 200 mg Soft Capsules
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or carton after EXP.. 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. Contents of the pack and other information What Flarin 200 mg Soft Capsules contain:
The active ingredient is: ibuprofen 200 mg.
The other ingredients are: Hard fat, glycerol monolinoleate, macrogol 400, gelatin, sorbitol, purified water, brilliant blue (E133) and allura red (E129). Hard fat and glycerol monolinoleate are lipids.
Lipids are long chain fatty acids from a vegetable source.
Ink ingredients: Titanium dioxide, isopropyl alcohol, propylene glycol, hypromellose.
(see also end of Section 2 "Important information about some of the ingredients of "Flarin 200 mg Soft Capsules").
What Flarin 200 mg Soft Capsules look like and contents of the pack
Each Flarin 200 mg Soft Capsules is an oval red and blue capsule printed in white with 'Flarin'.
This product is available in packs of 4, 10, 16 and 30 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
infirst HEALTHCARE Ltd.
Central Point 45 Beech Street London EC2Y8AD
Manufacturer
Patheon Softgels B.V.
P.O. Box 5037 5004 EA Tilburg The Netherlands
PL 42459/0002
This leaflet was last revised in September 2014.
September
CONFIDENTIAL
5
Flarin 200 mg Soft Capsules - PL 42459/0002
2014
Version 2.0