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Ibuprofen 400 Mg Soft Capsules

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PACKAGE LEAFLET: INFORMATION FOR THE USER Ibuprofen 400 mg Soft Capsules

Ibuprofen

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. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days in adolescents, after 4 days for pain or 3 days for fever and migraine headaches in adults.

In this leaflet:

1.    What Ibuprofen 400 mg soft capsules are and what they are used for

2.    What you need to know before you take Ibuprofen 400 mg soft capsules

3.    How to take Ibuprofen 400 mg soft capsules

4.    Possible side effects

5.    How to store Ibuprofen 400 mg soft capsules

6.    Contents of the pack and other information

1.    What Ibuprofen 400 mg soft capsules are and what they are used for

Ibuprofen 400 mg soft capsules contain ibuprofen which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) that work by relieving pain and fever.

Ibuprofen 400mg soft capsules are indicated in adults and adolescents from 40 kg and above (12 years of age and above) for the relief of mild to moderate pain such as headache, acute migraine headaches with or without aura, muscular pain, period pain, feverishness and pain associated with a common cold.

2.    What you need to know before you take Ibuprofen 400 mg soft capsules

Do NOT take Ibuprofen 400 mg soft capsules if you:

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

o ever suffered shortness of breath, asthma, runny nose, swelling or itching rash after you have used acetylsalicylic acid (aspirin) or other related painkillers (NSAIDs)

o have a history of stomach or intestinal bleeding or perforation related to previous NSAID therapy

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

o suffer from a blood coagulation disorder or have another bleeding disorder

o suffer from severe liver, kidney or heart failure

o suffer from cerebrovascular bleeding or other active bleeding

o suffer from unclarified blood-formation disturbances e.g. thrombocytopenia

o suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

o are in the last 3 months of pregnancy

Do NOT use Ibuprofen 400 mg soft capsules in adolescents under 40 kg body weight or in

children under 12 years.

This medicinal product contains soya lecithin. If you are allergic to peanuts or soya do not

use this medicinal product.

Warnings and precautions

Talk to a pharmacist or your doctor before taking this medicine if you:

o suffer from Systemic Lupus Erythematosus (SLE) - a condition of the immune system affecting connective tissue resulting in joint pain, skin changes and disorders of other organs, or a mixed connective tissue disease

o suffer from serious skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome or toxic epidermal necrolysis. These capsules should be stopped immediately at the first appearance of skin rash, lesions, or any other signs of allergic reactions

o have hereditary blood formation disorder (acute intermittent porphyria)

o have or have ever had bowel problems or disease (ulcerative colitis, Crohn's disease)

o have or have had asthma or allergic disease, as shortness of breath may occur

o suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk of allergic reactions exists. The allergic reactions may show as asthma attacks (so called analgesic asthma), Quincke’s oedema or rash with raised, itchy bumps

o are elderly, as you may be more likely to suffer from side effects o suffer from kidney or liver disease o have just had major surgery

o have swelling (oedema), high blood pressure (hypertension) or heart disease

o are trying to become pregnant (ibuprofen belongs to a group of medicines, NSAIDs that may impair fertility in women. The effect is reversible upon stopping the medicine)

o are in the first 6 months of pregnancy o are taking low dose aspirin (up to 75 mg/day)

o have chicken pox (varicella); it is advisable not to take these capsules.

Side effects can be reduced by using the lowest effective dose for the shortest period of time.

There is a risk of renal impairment in dehydrated adolescents.

Medicines such as Ibuprofen 400 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 (in adults 4 days for pain or 3 days for fever or migraine headaches and in adolescents 3days). 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, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

For prolonged use of Ibuprofen 400 mg soft capsules, regular checking of:

• your liver values, kidney function and blood count is required.

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.

In general, the frequent use of painkillers can lead to lasting severe kidney problems. This risk may be increased under physical strain associated with dehydration. Do not take this medicine if you feel dehydrated.

Taking NSAIDs may mask the symptoms of an infection. Speak to your doctor if you feel unwell.

Other medicines and Ibuprofen 400mg soft capsules What should you avoid when you are taking this medicine?

Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid/aspirin, 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 affect or be affected by the treatment of ibuprofen. Therefore, always seek the advice of doctor before you use ibuprofen with other medicines’.

The use of ibuprofen 400 mg capsule, soft with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided

Avoid the use of this medicine if you are taking:

o other NSAID painkillers (including cyclooxygenase-2 selective inhibitors (COX-2 inhibitors)).

o aspirin above 75 mg daily.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially any of the following medicines:

o low-dose aspirin (up to 75 mg a day)

o diuretics (drug to help you pass water)

o anticoagulants e.g. warfarin and heparin and anti-platelet drugs such as clopidogrel and ticlopidine (drugs that thin the blood)

o antihypertensives (drugs used to treat high blood pressure e.g. captopril or propranolol)

o lithium, digoxin, phenytoin or selective serotonin reuptake inhibitors (SSRIs e.g. fluoxetine - used to treat mood disorders)

o methotrexate (used to treat rheumatoid arthritis, psoriasis and some cancers)

o zidovudine (used to treat HIV)

o corticosteroids (anti-inflammatory drugs, such as prednisone) o cyclosporin or tacrolimus (used to suppress the body’s immune system) o quinolone antibiotics (used to treat a wide range of infections e.g. ciprofloxacin) o probenecid and sulfinpyrazole (used to treat gout) o aminoglycosides (an antibiotic) o cholestyramine (used to reduce cholesterol) o sulphonylureas (used to treat diabetes)

o Any other ibuprofen preparations or NSAID painkillers, including those you can buy without a prescription.

Ibuprofen 400 mg soft capsules with food and drink

Ibuprofen 400 mg soft capsules may be taken on an empty stomach. However, a small number of people might experience mild indigestion with this medicine. If you experience mild indigestion, it is recommended to take this medicine with food or milk to avoid gastrointestinal (digestive) problems.

Some side effects, such as those affecting the digestive system can be more likely when alcohol is taken at the same time as Ibuprofen 400 mg soft capsules.

Pregnancy, breast-feeding and fertility

Tell your doctor if you become pregnant whilst taking Ibuprofen 400 mg soft capsules.

If you are in the first 6 months of pregnancy talk to your doctor or a pharmacist before taking these capsules.

If you are in the last 3 months of pregnancy do NOT take this medicine because it might cause problems to the unborn child or complications during delivery.

Ibuprofen passes into breast milk, but may be taken during breast-feeding at the recommended doses, for the shortest time possible.

Ibuprofen belongs to a group of medicines (NSAIDs) which might impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that this medicine, when taken occasionally, will affect your chances of becoming pregnant; however, talk to your doctor before using it if you have problems becoming pregnant.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you start to experience dizziness, drowsiness, vertigo or visual disturbances do not drive or use machines.

Ibuprofen 400 mg 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 these capsules.

3. How to take Ibuprofen 400 mg soft capsules

Always take 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.

For oral use.

For short term use only.

Adolescents (age range: > 12years to < 18 years):

If you feel worseor this medicinal product is required for more than 3 days, talk to your doctor.

Adults:

If you feel worse-or you do not feel better after 4 days for pain or 3 days for fever and migraine headaches talk to a doctor.

Adults and adolescents over 40 kg in weight (12 years and above):

One capsule (400 mg ibuprofen) up to 3 times a day, as required. Take only as much as you need to relieve your symptoms and leave at least 6 hours between each dose. Swallow the capsule with plenty of liquid. Do not chew.

Do NOT take more than 3 capsules (1200 mg ibuprofen) in any 24 hour period.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms.

If you feel worse-or you do not feel better after 4 days for pain or 3 days for fever and migraine headaches talk to a doctor.

Elderly: take care, as you may be more likely to suffer from side effects.

Children: Ibuprofen 400 mg soft capsules are NOT to be given to adolescents under 40 kg body weight or children under 12 years.

If you take more Ibuprofen 400 mg soft capsules than you should

If you accidentally take too many capsules, contact your doctor or hospital immediately. Take the remaining capsules with you to show to the doctor.

The symptoms of an overdose include: nausea, stomach pain, vomiting containing blood or brown grit (like ground coffee), diarrhoea, ringing in the ears, headache, dizziness, drowsiness, confusion, disorientation and 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, this medicine can cause side effects, although not everybody gets them.

If you suffer from any of the following at any time whilst taking these capsules STOP TAKING the medicine and seek immediate medical help:

o blood in your faeces (stools/motions)

o black tarry stools

o vomit any blood or dark particles that look like coffee grounds

o unexplained wheezing, shortness of breath, skin rash (which may be severe and include blistering or peeling of the skin), itching or bruising, light-headedness, racing of the heart or fluid retention e.g. swollen ankles, not passing enough water

o aseptic meningitis with stiff neck, headache, nausea, vomiting, fever and consciousness clouding. Patients with autoimmune disorders (lupus, mixed connective-tissue disease) appear to be predisposed.

o problems in the blood cell production - first signs are: severe sore throat with high fever or unexplained bleeding, bruising and tiredness, superficial mouth ulcers, flulike symptoms, severe exhaustion, nose and skin bleeding

o allergic reactions with hives and itching, as well as asthma attacks

o severe allergic reactions: swelling of face, tongue and throat, shortness of breath, palpitations, severe shock.

STOP TAKING the medicine and tell your doctor if you experience:

o indigestion or heartburn

o abdominal pain (pains in your stomach) or other abnormal stomach symptoms

o yellowing of the eyes and/or skin.

The following are other side effects that may be experienced.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

•    headache, dizziness, sleeplessness, agitation, irritability and tiredness

•    visual disturbances

•    various skin rashes.

•    Gastrointestinal ulcers, potentially with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis.

Rare (may affect up to 1 in 1,000 people)

•    tinnitus (ringing in the ears)

•    pain in the sides and/or abdomen, blood in the urine and a fever may be signs of damage to the kidneys. Raised urea concentration in the blood shown in blood test.

Very rare (may affect up to 1 in 10,000 people)

•    psychotic reactions, depression, nervousness

•    heart palpitations, heart failure, heart attack

•    high blood pressure

•    asthma, shortness of breath and wheezing

•    inflammation of the gullet (oesophagus), inflammation of the pancreas, lesions (diaphragm-like strictures) in the bowel resulting in abdominal pain, nausea, vomiting and constipation

•    passing less urine than normal, swelling (oedema) and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that may lead to acute kidney failure

•    anaemia, shown in a blood test.

•    Exacerbation of infection-related inflammations (e.g. necrotising fasciitis)

•    Damage to the liver, acute hepatitis

•    Severe forms of skin reactions including rash with redness and blistering, Stevens-Johnson syndrome and dead-tissue. Exceptionally, severe skin infection and soft tissue complications during chicken pox (varicella) infections.

Medicines such as Ibuprofen 400 mg soft capsules 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. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Ibuprofen 400 mg soft capsules

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

Do not store above 30°C.

Do not use Ibuprofen 400 mg soft capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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

6.    Contents of the pack and other information What Ibuprofen 400 mg soft capsules contain

The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen

The other ingredients are: macrogol 600, potassium hydroxide, purified water

Capsule shell: gelatin, sorbitol liquid partially dehydrated (E420) (see end of Section 2 for further information on sorbitol)

Processing Aids

Medium chain triglycerides, Lecithin.

Capsule printing: Purified water, Black iron oxide, Propylene glycol, Isopropyl alcohol, HPMC 2910/hypromellose 6cP

What Ibuprofen 400 mg soft capsules look like and contents of the pack

Ibuprofen 400 mg soft capsules are clear oval transparent soft gelatin capsules available in PVC/PE/PVdC/Al or PVC/PE/PVdC/Paper/PET/Al blisters of pack sizes: 4, 6, 10, 12, 15, 16, 20, 24, 30 and 50 capsules. Not all packs may be marketed.

Marketing Authorisation Holder and Manufacturer

MA Holder:

McNeil Products Limited,

Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, UK. Manufacturer:

Patheon Softgels B.V.

De Posthoornstraat 7, 5048 AS Tilburg, The Netherlands.

Or

Janssen-Cilag

Domaine de Maigremont, 27 100 Val-de-Reuil, France Or

Johnson & Johnson Consumer NV/SA Antwerpseweg 15-17, B-2340 Beerse

This leaflet was last revised in May 2016.