Ibuprofen FAIR-MED 400 mg filmomhulde tabletten

1. What is and what it is used for

<Product Name>belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).These medicines provide relief by changing how the body responds to pain and high temperature.

<Product Name> is used for the symptomatic treatment of: mild to moderate pain such as headache, acute migraine headache with or without aura, toothache, period pains, fever and pain associated with common cold.

You must contact a doctor if your symptoms worsen or do not improve after 3 days if you have fever or migraine headache and after 4 days for the treatment of pain.

2. What you need to know before you take

Do not take <Product Name>

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if you have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid (known as aspirin) or other similar painkillers (NSAIDs)

• if you have (or have had two or more episodes of ) a stomach ulcer or bleeding of the stomach
• if you have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy
• if you have severe liver, kidney, coronary heart disease or heart failure
• if you suffer from cerebrovascular or other active bleeding
• if you suffer from unclarified blood-formation disturbances
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• during the last three months of pregnancy (see below)
• if the patient is a child under 20 kg bodyweight

[<Product Name> 400mg film-coated tablets]:

- Adolescents under 40 kg bodyweight and children

Warnings and precautions

Talk to your doctor before taking <Product Name>

• if you have certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed connective tissue disease). If you suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The use of <Product Name>should be stopped immediately at the first appearance of skin rash, mucosal lesions, or any other sings of allergic reactions
• if you have hereditary blood formation disorder (acute intermittent porphyria)
• if you have or have ever had bowel disease (ulcerative colitis or Crohn’s disease)
• if you have ever had a high blood pressure and/or heart failure
• if you have reduced renal function
• if you have liver disorders
• directly after major surgery
• if you have or have had asthma or allergic disease as shortness of breath may occur
• if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma). Quincke’s oedema or hives.
• During chicken pox (varicella) it is advisable to avoid use of <Product Name>
• medicines such as <Product Name> 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 (3 days if you have fever and 4 days for pain relief)
• 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 suffer from coagulation disturbances
• In prolonged administration of <Product Name> regular checking of your liver values, the kidney function, as well as of the blood count, is required
• The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases risk of adverse reactions (see section “Taking other medicines” below) and should be avoided

Undesirable effects are minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.

In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore it should be avoided.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications. NSAIDs may mask symptoms of infection and fever.

Other medicines and <Product name>

Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may effect or be effected by the treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other medicines.

Please tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking:

acetylsalicylic acid, or other NSAIDs (anti- inflammatories and analgesics)

digoxin (for heart insufficiency)

glucocorticoids (medicinal products containing cortisone or cortisone-like substances)

anti-platelet agents acetylsalicylic acid (low dose)

medicines for thinning the blood (such as warfarin)

phenytoin (for epilepsy)

selective serotonin reuptake inhibitors (medicines used for depression)

lithium (a medicine for manic depressive illness and depression)

probenecid and sulfinpyrazones (medicines for gout)

medicines for high blood pressure and water tablets

potassium sparing diuretics

methotrexate (a medicine for cancer or rheumatism)

tacrolimus and cyclosporine

since this may increase the risk of gastrointestinal ulcers or bleeding

since the effect of digoxin may be enhanced

since this may increase the risk of gastrointestinal ulcers or bleeding

since this may increase the risk of bleeding

since the blood-thinning effect may be impaired

since ibuprofen may enhance the effects of these medicines

since the effect of phenytoin may be enhanced

as these may increase the risk of gastrointestinal bleeding

since the effect of lithium may be enhanced

since the excretion of ibuprofen may be delayed

since ibuprofens may diminish the effects of these medicines and there could be a possible increased risk for the kidney

since this may lead to hyperkalaemia

since the effect of methotrexate may be enhanced

since kidney damage may occur

(immunosuppressive medicines)
zidovudine: (a medicine for treating Aids)	since the use of <Product Name> may result
	in an increased risk of bleeding into a joint
	or a bleeding that leads to swelling in HIV
	(+) haemophiliacs
sulfonylureas (antidiabetic medicines)	interactions may be possible
quinolone antibiotics	since the risk for convulsions may be
	increased

<Product Name>with food, drink and alcohol

Swallow the tablets with water. It is recommended that patients with sensitive stomachs take <Product Name> with food. Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is taken at the same time as <Product Name>.

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.

Do not take <Product Name> in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.

This medicine passes into breast milk but may be used during breast-feeding if it is used at the recommended dose and for the shortest possible time.

This product belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This product is not recommended in women trying to conceive. This effect is reversible on stopping the medicine.

Driving and using machines

Ibuprofen has no or negligible influence on the ability to drive and use machines. 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.

<Product name> contains lactose.

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist when you are not sure.

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have 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.

200 mg strength: Suitable for adult and children from 20kg (around 6 years old) 400 mg strength: Suitable for adults and adolescents from 40 kg (12 years and older)

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults and adolescents from 40 kg bodyweight:

Initial dose: Take 200 mg to 400 mg ibuprofen with water. If necessary take additional doses of 200 mg to 400 mg ibuprofen but do not exceed a total dose of 1200 mg in any 24 hour period. The dosing interval should not be below 4 hours for the 200 mg dose and not below 6 hours for the 400 mg dose.

The dosage in migraine headache should be 400 mg given as a single dose, if necessary 400 mg with intervals of 4 to 6 hours. The maximum daily dose should not exceed 1200 mg ibuprofen. Intake should be restricted to no more than two to three days a week.

Use in children

Children from 20 kg (around 6 years old) to 39 kg bodyweight:

<Product Name> 200mg should only to be used for children with at least 20 kg bodyweight. The maximum total daily dose of ibuprofen is 20-30 mg per kg of body weight, divided into 3 to 4 single doses of 200mg each. The dosing interval should not be below 6 hours. Do not exceed the maximum recommended daily dose. A total dose of 30 mg/kg ibuprofen should not be exceeded in any 24-hour period. For <Product Name> for children you can use the following dosing instruction:

Body weight	Dose	How often?
Children 20 kg – 29	200 mg	If necessary take
kg	Ibuprofen)	another tablet
		after at least 8
		hours.
		No more than 3
		tablets (up to 600
		mg Ibuprofen) in
		any 24 hour
		period
Children 30 kg – 39	200 mg	If necessary take
kg	Ibuprofen)	another tablet
		after at least 6 to 8
		hours.
		No more than 4
		tablets (up to 800
		mg Ibuprofen) in
		any 24 hour
		period
Method of administration

For oral use. Do not chew.

The tablet should be swallowed with a glass of water during or after a meal. It is recommended that patients with sensitive stomachs take <Product name> with food.

Please speak to the doctor or pharmacist if you feel that the effect of this medicine is greater or less than you expected.

Intake should be restricted to no more than two to three days a week.

If you take more <Product Name> than you should

Consult a doctor immediately. Central nervous disturbances such as headache, dizziness, light-headedness and unconsciousness (also myoclonic convulsions in children), as well as abdominal pain, nausea and vomiting, may occur as symptoms of an overdose. In addition, gastrointestinal bleeding, as well of functional disturbances of the liver and kidneys, is possible. There may furthermore be hypotension, reduced breathing (respiratory depression) and blue discolouring of the skin and mucosa (cyanosis).

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

If you forget to take <Product Name>

Do not take a double dose to make up for a forgotten dose.

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

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

Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. You may suffer one of the known side effects of NSAIDs. If you do, or if you have concerns, stop taking this medicine and talk to your doctor as soon as possible. Elderly people using this product are at increased risk of developing problems associated with side effects.

The following frequencies are taken as a basis when evaluating side effects:

very common may affect more than 1 in 10 people common may affect up to 1 in 10 people uncommon may affect up to 1 in 100 people rare may affect up to 1 in 1000 people very rare may affect up to 1 in 10,000 people

not know frequency cannot be estimated from the available data.

Side effects may include:

Infections

Very rare: Exceptionally, severe skin infections and soft-tissue complications during chicken pox. Exacerbation of infection-related inflammations (e.g. necrotising fasciitis) associated with use of certain painkillers (NSAIDs) has been described.

If signs of an infection occur or get worse during use of <Product Name>, you must go to a doctor without delay. It is to be investigated whether there is an indication for an anti- infective/antibiotic therapy. The symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or consciousness clouding have been observed under ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed.

Blood disorders

Very rare: Problems in the blood cell production - first signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding. In these cases you must stop the therapy immediately and consult a doctor. Any self-treatment with pain

killers or medicinal products that reduce fever (antipyretic medicinal products) mustn’t be done.

Problems of the immune system

Uncommon: Hypersensitivity reactions with hives and itch, as well as asthma attacks. You must stop taking <Product Name> and inform your doctor at once.

Very rare: Severe hypersensitivity reactions – signs could be: swelling of face, tongue and throat, shortness of breath, accelerated heartbeat, low blood pressure, severe shock. If one of these symptoms occurs, which can happen even on first use, the immediate assistance of a doctor is required.

Psychiatric disorders

Very rare: Psychotic reactions, depression, hallucinations

Nervous system disorders

Uncommon: Headache, dizziness, sleeplessness, agitation, irritability and tiredness

Eye disorders

Uncommon: visual disturbances

Ear and balance disorders

Rare: Tinnitus

Cardiac disorders

Very rare: palpitations, heart failure, myocardial infarction, oedema, hypertension and cardiac failure have been reported in association with NSAID treatment at high doses

Vascular disorders

Very rare: arterial hypertension

Stomach and bowel disorders

Common: Stomach complaints, such as acid burn, stomach pain and nausea, diarrhoea, vomiting, flatulence (wind) and constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.

Uncommon: Perforation or gastrointestinal bleeding, black stools and vomiting of blood, worsening of existing bowel disease (ulcerative colitis or Crohn’s disease), gastritis Very rare: Oesophagitis, pancreatitis, formation of intestinal diaphragm-like strictures

In case of strong pain in the upper abdomen, vomiting of blood or black stools you must stop the treatment and consult a doctor.

Liver disorders

Very rare: Damage to the liver (first signs could be discoloration of the skin), hepatic damage especially in long-term therapy, hepatic failure, acute hepatitis, jaundice.

Skin disorders

Very rare: Severe forms of skin reactions including rash with redness and blistering, Stevens- Johnson syndrome and mortification of tissue, alopecia.

Kidney disorders

Rare: Medicines such as <Product Name> may very rarely lead to kidney disease. Pain in the flanks and/or abdomen, blood in the urine, and a fever may be signs of damage to the kidneys (papillary necrosis). Elevated urea concentration in blood may also occur rarely.

Very rare: Passing less urine than normal and swelling (especially in patients with high blood pressure or reduced kidney function); swelling (oedema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) that my lead to acute kidney

failure. If one of the above mentioned symptoms occur of if you have a general miserable feeling, stop taking <Product Name> and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.

Medicines such as <Product Name> may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

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

5. HOW TO STORE

Keep this medicine out of the sight and the reach of children.

Do not use this medicine after the expiry date which is stated on the pack EXP. The expiry date refers to the last day of that month.

Store below 25°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 <Product Name> contains

-The active substance is ibuprofen.

Each film-coated tablet contains 200 mg ibuprofen.

Each film-coated tablet contains 400 mg ibuprofen.

The other ingredients are:

Tablet core:

Lactose monohydrate

Maize starch (Corn Starch (400L))

Hypromellose 6 CPS (Pharmacoat 606) (E464)

Colloidal Anhydrous Silica (E551)

Microcrystalline Cellulose (E460)

Croscarmellose Sodium (E468)

Magnesium Stearate (E572)

Film coating:

Hydroxy Propyl Methyl Cellulose

Polyethylene Glycol 400

Propyethylene Glycol 6000

Titanium dioxide (E171)

What <Product Name>looks like and contents of the pack

Film-coated tablets.

200mg

White coloured, film coated pillow shaped tablets debossed with ‘235’ on one side and plain on the other.

400mg

White coloured, film coated pillow shaped tablets debossed with ‘236’ on one side and plain on the other.

Pack sizes:

200mg

2, 4, 6, 10, 12, 20, 24, 30, 40, 48, 50, 60, 96, 100, 250 tablets 400mg

6, 10, 12, 20, 24, 30, 40, 48, 50, 60, 100, 250, 500, 1000 tablets

Not all pack sizes may be marketed.

In het register ingeschreven onder nummer:

200 mg: RVG 107994

400 mg: RVG 107995

Marketing Authorisation Holder and Manufacturer

FAIR-MED HEALTHCARE GmbH

Planckstr. 13

22765 Hamburg

Duitsland

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last approved in January 2013.