Flarin 400 mg capsules, zacht

Flarin belongs to a group of medicinal products called NSAIDs (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever.

Flarin 200 mg and 400 mg soft capsules are used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain, back-, muscle- and joint pain and fever.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days in fever and 5 days in pain.

Do not use Flarin

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6)

• if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin)

or other drugs for pain and inflammation (NSAIDs).

• if you have suffered from an ulcer or bleeding in the stomach or small intestine (duodenum) related to previous use of drugs for pain and inflammation (NSAIDs)

• if you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past

- if you suffer from severe liver, kidney or heart problems (including coronary heart disease)

• if you are in the last three months of pregnancy

• if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

• if you have any active bleeding (including bleeding in the brain)

- if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells

• do not give Flarin to children younger than 6 years.

Warnings and precautions

• if you have Systemic lupus erythematosus (SLE) or other autoimmune disease

• if you have inherited a disorder of the red blood pigment haemoglobin (porphyria)

• if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers

(ulcerative colitis), inflammation affecting the digestive tract (Crohn’s disease) or other stomach or intestinal diseases

• if you have disturbances in the formation of blood cells

• if you have problems with the normal blood clotting mechanism

• if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or

chronic obstructive affections of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater

- if you suffer from circulation problems in the arteries of your arms or legs - if you have liver, kidney, heart problems or high blood pressure

• if you have just had major surgery

- if you are in the first six months of pregnancy

• if you are breast-feeding

Elderly

If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal.

Ulcers, perforation and bleeding in the stomach or intestines

If you have had an ulcer in the stomach or intestines before, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment. This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped.

Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal.

The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see Taking other medicines, below).

Skin reactions

You should stop taking Flarin with the first sign of skin rash, lesions of the mucous membranes or other signs of allergy since this can be the first sign of serious skin reactions (exfoliative dermatitis, erythema multiforme, Steven-Johnson’s syndrome, Lyell’s syndrome), sometimes with fatal outcome. The highest risk of these reactions is in the first month of treatment.

Effects on the heart and brain

Medicines such as Flarin 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.

If you have heart problems, previous stroke or think that you might be at a 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.

Effects on the kidneys

Ibuprofen may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals.

Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery.

Other precautions

During long-term, high-dose use of pain killers headache may occur. This should not be treated with high doses of this medicine. The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure.

Ibuprofen may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time.

Flarin may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Other medicines and Flarin

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

The side effects of Flarin may be increased if certain medicines are taken at the same time. On the other hand, Flarin may increase or decrease the effect of other medicines or increase their side effects when taken at the same time.

Please tell your doctor or pharmacist if you are taking:

• other NSAIDs

• acetylsalicylic acid

• anticoagulants (against clotting) such as warfarin or heparin

• platelet aggregation inhibitors (against clotting) such as ticlopidine or clopidogrel
• methotrexate (used to treat cancer and auto-immune diseases)

• digoxin (for treatment of various heart conditions)

- phenytoin (used in prevention of the occurrence of epileptic seizures)

• lithium (used to treat depression and mania)

- diuretics (water tablets), including potassium-sparing diuretics - antihypertensives (for treating high blood pressure) such as:

o ACE-inhibitors, e.g. captopril

o beta-receptor blocking medicines o angiotensin II-antagonists

• cholestyramine (used in the treatment of high cholesterol)

• aminoglycosides (medicines against certain types of bacteria)

- SSRIs (medicines against depression) such as paroxetine, sertraline, citalopram - moclobemide (RIMA – a medicine to treat depressive illness or social phobia) - ciclosporin, tacrolimus (for immuno-suppression after organ transplant)

• zidovudine or ritanovir (used to treat patients with HIV)

• mifepristone

- probenecid or sulfinpyrazone (for treating gout)

• quinolone antibiotics

• sulphonylureas (to treat type 2 diabetes)

• corticosteroids (e.g. anti-inflammatory drugs).

• bisphosphonates (used in osteoporosis, Paget’s disease and to reduce high blood calcium levels)

• oxpentifylline (pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms)

• baclofen (a muscle relaxant)

Flarin with food, drink and alcohol

You should swallow Flarin with a glass of water during or after a meal.

Avoid alcohol since it may enhance the side effects of Flarin, especially those affecting the stomach, intestines or brain.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ibuprofen must not be taken in the last three months of pregnancy since it may cause major heart, lung and kidney disorders in the unborn child. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions delaying the onset of delivery. Treatment during the first six months of pregnancy will only be prescribed by your doctor if clearly necessary.

The product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

Ibuprofen appears in breast milk in very small amounts and breastfeeding will not usually need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered.

Driving and using machines

Ibuprofen generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced the ability to drive a car or operate machinery may be impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol.

Flarin soft capsules contain sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

The ibuprofen dose depends on the patient’s age and body weight.

The recommended dose is:

Mild to moderate pain and fever

Adults and adolescents older than 12 years (over 40 kg):

200 mg-400 mg given as a single dose or 3- 4 times a day with an interval of 4 to 6 hours. The dosage in migraine headache should be: 400 mg given as a single dose. If necessary, continue taking 400 mg with intervals of 4 to 6 hours. The maximum daily dose should not exceed 1200 mg.

Children 6-12 years (over 20 kg):

Children 6-9 years (20-29 kg): 200 mg 1-3 times a day with an interval of 4 to 6 hours as required. The maximum daily dose should not be more than 600 mg.

Children 10-12 years (30-40 kg): 200 mg 1-4 times a day with an interval of 4 to 6 hours as required. The maximum daily dose should not be more than 800 mg.

Period pain

Adults and adolescents over 12 years of age:

200-400 mg 1-3 times a day with an interval of 4 to 6 hours. The maximum daily dose should not be more than 1200 mg.

Capsule(s) should be taken with adequate amount of liquid (e.g. a glass of water).

Elderly

If you are elderly you should always consult your doctor before using Flarin since you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal. Your doctor will advise you accordingly.

Reduced kidney or liver function

If you suffer from reduced kidney or liver function, always consult your doctor before using Flarin. Your doctor will advise you accordingly.

If you take more Flarin than you should

If you take more Flarin than you should, contact a doctor, emergency room or pharmacy. The symptoms of overdose may be: nausea, vomiting and stomach pain or diarrhoea. A buzzing in the ears, headache, dizziness, vertigo and bleeding from the stomach or intestines may also occur. In more serious cases of overdose, drowsiness, excitation, disorientation, coma, convulsions, cramps (especially in children), blurred vision and eye problems, kidney failure, liver damage, low blood pressure, reduced respiration, bluish discolouration of lips, tongue and fingers, and increased bleeding tendency may all occur. Worsening of asthma in asthmatics can also occur.

If you forget to take Flarin

If you forget to take a dose, take it as soon as you can, except if there are less than four hours remaining until the time for the next dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Undesirable effects are more likely with higher doses and longer duration of treatment.

Medicines such as Flarin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs.

The side effects are stated according to the frequency they occur. The following convention has been used: Very common: affects more than 1 in 10 users

Common: affects 1 to 10 in 100 users Uncommon: affects 1 to 10 in 1,000 users Rare: affects 1 to 10 in 10,000 users

Very rare: affects less than 1 user in 10,000 users

Not known: frequency cannot be estimated from the available data

Depression, confusion, hallucinations Lupus erythematosus syndrome

The following side effects can be serious and will require immediate action if you experience them. You should stop taking Flarin and see your doctor immediately if the following symptoms occur:

Common:

- black tarry stools or blood-stained vomit (digestive tract ulcer with bleeding). Very rare:

• swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing (angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock

• a sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure

• severe rash with blisters on the skin especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson´s syndrome). This can get even more severe, the blisters get larger and spread out and parts of the skin may slough off (Lyell´s syndrome). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle.

You should stop taking the medicine and contact your doctor as soon as possible if you develop the following side effects:

Very common:

- heartburn, abdominal pain, indigestion Uncommon:

• blurred vision or other eye problems such as sensitivity to light

• hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low blood

pressure)

Rare:

- vision loss Very rare:

• sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain

Other possible side effects with Flarin are:

Very common:

- Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation. Common:

• Digestive tract ulcer with or without perforation

• Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn's

disease) and complications of diverticula of the large bowel (perforation or fistula) - Microscopic bleeding from the intestine which may result in anemia

• Mouth ulcers and inflammation

- Headache, sleepiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability. Uncommon:

• Inflammation of the stomach lining

- Kidney problems including development of oedema, inflammation of the kidneys and kidney failure

• Runny nose

- Difficulties in breathing (bronchospasm) Rare:

-

-

• Increase of blood urea nitrogen and other liver enzymes, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease of serum calcium and increase in serum uric acid values

Very rare:

• Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure

• Disorders of blood cell formation (with symptoms like: fever, sore throat, surface mouth ulcers, flu- like symptoms, severe fatigue, nasal and skin bleeding)

• Ringing or buzzing in the ears

- Inflammation of the oesophagus or pancreas

• Narrowing of the bowel

• Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction, damage or failure

- Inflammation of the brain membrane (without bacterial infection) - Damage of the kidney tissue

• Hair loss

Flarin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

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 carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Flarin contains

• The active substance is ibuprofen. The capsules contain 200 mg or 400 mg ibuprofen, respectively.
• The ingredients in the capsule core of 200 mg and 400 mg capsules are macrogols, potassium hydroxide and purified water.
• The ingredients in the capsule shell are gelatine, sorbitol (liquid, partially dehydrated) and purified water.
• The ingredients in the printing ink for capsules of 200 mg are titanium dioxide (E 171), propylene glycol, isopropyl alcohol, hypromellose and purified water.
• The ingredients in the printing ink for capsules of 400 mg are black iron oxide (E 172), propylene glycol, isopropyl alcohol, hypromellose and purified water.

What Flarin looks like and contents of the pack

Capsule, soft

Capsule 200 mg: A pale yellow, oval-shaped transparent soft gelatine capsule with a print in white ink. Capsule 400 mg: A pale yellow, oval-shaped transparent soft gelatine capsule with a print in black ink.

Pack sizes:

PVC/PE/PVdC/Al blisters: 10, 20, 30, 50 and 100 capsules.

Not all pack sizes may be marketed.

Nummers van de vergunning voor het in de handel brengen:

Flarin 200 mg capsules, zacht: RVG 109413

Flarin 400 mg capsules, zacht: RVG 109414

Houder van de vergunning voor het in de handel brengen

Infirst Healthcare Limited

265 Strand

London, WC2R 1BH

Verenigd Koninkrijk

Fabrikant

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Dit geneesmiddel is in de lidstaten van de EEA onder de volgende namen geregistreerd:

Denemarken, Nederland, Noorwegen, Zweden: Flarin

Deze bijsluiter is voor de laatste keer goedgekeurd in oktober 2013.