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1. Ibuprofen Perrigo 400 Mg Film-Coated Tablets
2. Ibuprofen Perrigo 400 Mg Film-Coated Tablets

1.3.1 PRODUCT INFORMATION.

Ibuprofen Perrigo 400mg Film-coated Tablets

For adults and adolescents weighing from 40 kg body weight (12 years of age and above)

Ibuprofen Lysine

Patient Information Leaflet

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

■    Keep this leaflet. You may need to read it again.

■    Ask your pharmacist if you need more information or advice.

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

■    You must talk to a doctor if your symptoms worsen or do not improve after 3 days when you are suffering from a fever or 4 days when you are suffering from pain.

In this leaflet:

1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

1.    WHAT THIS MEDICINE IS FOR

This medicine contains ibuprofen lysine which is the lysine salt of ibuprofen. Ibuprofen is one of a group of non-steroidal anti-inflammatory drugs (known as NSAIDS) which work to reduce pain and fever.

This medicine is used for the symptomatic treatment of:

•    mild to moderate pain, such as headache, period pain and dental pain

•    fever and pain associated with common cold.

2.    BEFORE YOU TAKE THE MEDICINE Do not take this medicine if you:

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

■    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)

■    have (or have had two or more episodes of) a stomach ulcer, or bleeding of the stomach

■    have a history of gastro-intestinal bleeding or perforation related to previous NSAID therapy

■    have severe kidney or severe heart failure or severe liver failure

■    are bleeding, including any bleeding within the brain (cerebrovascular bleeding)

■    are suffering from blood clotting disorders

■    suffer from a currently undiagnosed problem with your body’s ability to form blood

■    are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake)

■    are in the last 3 months of pregnancy

■    LOW DOSE ASPIRIN: 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 Ibuprofen Perrigo 400mg Film-coated Tablets.

Talk to your doctor or pharmacist before taking Ibuprofen Perrigo 400mg Film-coated

Tablets:

■    if you suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. The use of Ibuprofen Tablets should be stopped immediately at the first appearance of skin rash, mucosal lesions, or any other signs of allergic reactions

■    if you have hereditary blood formation disorder (acute intermittent porphyria)

■    if you are elderly because you may be at more risk of having side effects, particularly stomach problems

■    if you have or have suffered from asthma or have allergies 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 urticaria

■    during chickenpox (varicella) it is advisable to avoid use of Ibuprofen Perrigo 400mg Film-coated Tablets

■    if you have reduced liver or kidney function

■    directly after major surgery

■    if you have stomach or bowel disorders including Crohn’s disease or a condition known as ulcerative colitis

■    if you have Systemic Lupus Erythematosus (SLE) or mixed connective tissue disease -illnesses which affects your immune system. They cause joint pains, skin changes and problems with other parts of your body.

■    if you have, have previously had, or are at risk of heart problems, high blood pressure or stroke. Medicines such as Ibuprofen Perrigo 400mg Film-coated Tablets 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 in the treatment of fever and 4 days in the treatment of pain). 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

■    In prolonged administration of Ibuprofen Perrigo 400mg Film-coated Tablets 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 “If you are taking other medicines” below) and should be avoided.

Undesirable effects are minimised by using the minimum effective dose for the shortest period of time.

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.

Consult a doctor before using Ibuprofen Perrigo 400mg Film-coated Tablets if any above mentioned conditions concerns you.

If you are taking other medicines

What should you avoid when you are taking other medicines?

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 or have recently taken any other medicines, including medicines obtained without a prescription. In particular, tell them if you are taking:

Taking Ibuprofen Perrigo 400mg Film-coated Tablets with food and drink

It is recommended that patients with sensitive stomachs take Ibuprofen Perrigo 400mg Film-coated Tablets 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 Ibuprofen Perrigo 400mg Film-coated Tablets.

Driving and using machines

For short-term use and at normal dosage this medicine has no or negligible influence on the ability to drive and use machines.

Pregnancy, breast feeding and fertility

Tell your doctor if you become pregnant during intake of this medicine. Do not take this medicine if you are in the last 3 months of pregnancy. Talk to your doctor before taking Ibuprofen Perrigo 400mg Film-coated Tablets if you are in the first 6 months of pregnancy.

This medicine may be used during breast feeding for a maximum of 3 days (when you are treating a fever) or 4 days (for the treatment of pain), as only small amounts of this medicine pass into breast milk.

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

3. HOW TO TAKE THE MEDICINE

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

Age	Dose and how often to take
Adults, and adolescents weighing from 40 kg (12 years old and above)	Take 1 tablet with water, every 6 hours, as required. Do not take more often than every 6 hours. Do not take more than 3 tablets in any 24 hour period.
The tablets are intended for short-term use only. Use them for the shortest time needed to relieve symptoms. Always use the lowest dose that relieves your symptoms. Talk to your doctor if symptoms worsen or you need to take these tablets for more than 3 days when you have a fever or 4 days when you are suffering from pain.
Do not give to adolescents weighing under 40 kg or children under 12 years.

For oral use.

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

If you take too many tablets: Talk to a doctor straight away, or go to your nearest hospital casualty department. Take the carton and this leaflet with you. The following signs may occur: nausea, vomiting, stomach pain, diarrhoea, ringing in the ear, headache, gastrointestinal bleeding, dizziness, drowsiness, confusion, disorientation. Rarely: loss of consciousness.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ibuprofen Perrigo 400mg Film-coated Tablets 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 (see below). 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	affects more than 1 user in 10
common	affects 1 to 10 users in 100
uncommon	affects 1 to 10 users in 1,000
rare	affects 1 to 10 users in 10,000
very rare	affects less than1 user in 10,000
not know	frequency cannot be estimated from the available data.

STOP TAKING this medicine and seek immediate medical help if you develop:

•    signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools, vomiting blood or dark particles that look like coffee grounds.

•    signs of very rare but serious allergic reaction such as worsening of asthma or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.

•    severe skin reactions such as rashes covering the whole body, peeling, blistering or flaking skin.

Tell your doctor if you have any of the following side effects, they become worse or you

notice any effects not listed.

Common

•    gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick and indigestion, vomiting, wind (flatulence), diarrhoea, constipation, and slight blood losses in stomach and/or bowel that may cause anaemia in exceptional cases.

Uncommon

•    stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease

•    central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness

•    visual disturbances

•    allergic reactions , such as skin rashes, itching and asthma attacks. You must stop taking Ibuprofen Perrigo 400mg Film-coated Tablets and inform your doctor at once.

Rare

•    tinnitus (ringing in the ears)

•    kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood

Very rare

•    swelling (oedema), high blood pressure (hypertension) and cardiac failure have been reported in association with NSAID treatment.

•    inflammation of the oesophagus or pancreas, formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures)

•    serious infections of the skin and soft-tissue complications have occurred during chicken pox (varicella) infection.

•    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 or if you have a general miserable feeling, stop taking Ibuprofen Perrigo 400mg Film-coated Tablets and consult your doctor immediately as these could be first signs of a kidney damage or kidney failure.

•    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.

•    psychotic reactions and depression

•    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 Ibuprofen Tablets, you must go to a doctor without delay. It is to be investigated whether there is an indication for an antiinfective/antibiotic therapy.

•    high blood pressure, palpitations, heart failure, heart attack.

•    liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)

•    the symptoms of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or consciousness clouding have been observed when using ibuprofen. Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected. Contact a doctor at once, if these occur.

•    severe forms of skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).

•    severe general hypersensitivity reactions.

•    worsening of asthma, bronchospasm, dyspnoea.

Medicines such as Ibuprofen Perrigo 400mg Film-coated Tablets may be associated with a small

increased risk of heart attack ("myocardial infarction") or stroke.

5. STORING THE MEDICINE

Do not use after the expiry date shown on the pack.

Store in the original container.

Keep all medicines out of the reach and sight of children.

6. FURTHER INFORMATION What is in this medicine:

The active ingredient is: Ibuprofen 400 mg (as ibuprofen lysine 684mg) per coated tablet. The other ingredients are: Crospovidone, copovidone, microcrystalline cellulose and magnesium stearate. The tablet coating ingredient is: Opadry II White (contains polyvinyl alcohol, titanium dioxide E171, macrogol and talc).

What this medicine looks like and contents of the pack

Each tablet is a film-coated white tablet, embossed with ‘L684’ on one side.

This product is available in a pack size of 8, 12, 16 or 24 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder: Wrafton Laboratories Limited, Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.

Manufacturer: Wrafton Laboratories Limited (Trading as Perrigo), Braunton, Devon, EX33 2DL, United Kingdom.

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

Czech Republic : Ibuprofen Perrigo 400mg Germany : Ibuprofen Perrigo 400mg Filmtabletten Hungary : Ibuprofen APC 400 mg film-coated tablet Italy: Dolipro

The Netherlands : Ibuprofen Wrafton 400mg, filmomhulde tabletten Poland : Ibuprofen Lysine Perrigo

The leaflet was revised in: Jan 2013

Ibuprofen Lysine 684mg Film-coated Tablets / Module 1.3.1 / January 2013