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Document: leaflet MAH GENERIC_PL 21880-0176 change

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• leaflet MAH GENERIC_PL 20075-0436
• leaflet MAH GENERIC_PL 21880-0176
• leaflet MAH GENERIC_PL 34088-0039

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Other possible side effects

Uncommon side effects (may affect up to 1 in 100 people)

•    Allergic reactions such as hives, skin rashes and itching

•    Feeling sick

•    Headache

Rare side effects (may affect up to 1 in 1000 people)

•    Diarrhoea, wind, constipation and being sick

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

•    Reduction in blood cells, which can make the skin pale or yellow, cause fever, sore throat, mild mouth ulcers, flu-like symptoms, exhaustion or weakness, easy bruising, or bleeding from the skin or nose

•    Nervousness, visual disturbance, ringing in the ears and vertigo

•    Ibuprofen 400 mg tablets have also been shown to sometimes worsen the symptoms of Crohn’s disease or colitis.

•    Yellowing of the skin or the whites of the eyes

•    Kidney problems: Symptoms could include swelling of the ankles

•    Mouth ulcer

Medicines such as ibuprofen 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, pharmacist or nurse. 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 Ibuprofen 400 mg tablets

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 and the blister strip. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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.

6.    Contents of the pack and other information What Ibuprofen tablets contain

The active substance is Ibuprofen available as 400 mg tablets. The other ingredients are Sodium lauryl sulphate, Cross-Carmellose sodium, Lactose monohydrate, Microcrystalline cellulose, Povidone, Colloidal Anhydrous silica, Stearic acid, Hypromellose, Macrogols 6000, Purified Talc, Titanium dioxide (E171).

What Ibuprofen tablet looks like and content of the pack

Ibuprofen 400 mg tablets are white to off-white, pillow-shaped film coated tablet, plain on both sides.

Ibuprofen 400 mg tablets are supplied in blister packs of 12, 24, 48, 84, 96 tablets and HDPE container of 100 tablets.

Not all pack size may be marketed.

This leaflet was last revised in 08/2015

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0176/O/PIL/001/XXX

Marketing Authorisation Holder and Manufacturer: MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

O) 121XXXX -

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ibuprofen 400 mg Film-coated tablets

Read all of these leaflet carefully before you start taking this medicine because it contains important information for 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 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, particularly if symptoms worsen or do not improve after 10 days

What is in this leaflet

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

2.    What you need to know before taking Ibuprofen 400 mg tablets

3.    How to take Ibuprofen 400 mg tablets

4.    Possible side effects

5.    How to store Ibuprofen 400 mg tablets

6.    Contents of the pack and other information.

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

Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-inflammatory Drugs (NSAIDs) that work by relieving pain, reducing inflammation, swelling and fever.

Ibuprofen 400mg Tablets are effective for relief of mild to moderate pain including rheumatic and muscular pain, pain of some arthritic conditions, backache, neuralgia, migraine, headache, dental pain, period pains, feverishness and the symptoms of cold and flu.

You must talk to a doctor if you do not feel better or if you feel worse particularly if symptoms worsen or do not improve after 10 days

2.    What you need to know before taking Ibuprofen 400 mg tablets

Do not take Ibuprofen 400 mg tablets if you:

•    are allergic to ibuprofen 400 mg tablets, any of the other ingredients of the medicine (listed in section 6), aspirin or other related painkillers. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal damage, or any other sign of allergic reactions

•    have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines.

•    have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding or other gastric complaint due to NSAIDs. Do not take Ibuprofen 400 mg tablets if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past. There is an increased risk of the elderly having these side effects.

•    are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg

•    suffer from liver or kidney disease

•    suffer from heart disease, high blood pressure

•    are in the last 3 months of pregnancy Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

•    If you have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems

•    If you are a smoker

•    If you are pregnant

•    If you are suffering from gastrointestinal disorders or long term inflammation of the intestines (for example, ulcerative colitis or Crohn’s disease). See “Do not take Ibuprofen 400 mg Tablets" section

•    are suffering from Systemic Lupus Erythematosus (SLE) a condition of the immune system affecting connective tissue resulting in joint pain, skin change and disorders of other organs

•    Medicines such as ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Do not exceed the recommended dose or duration of treatment. Any risk is more likely with high doses and

This section is continued overleaf —>

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Specification: Colours:	Title: Art Work Approval Form Printed on 56 - 60 GSM Maplitho Paper 2 - Red 032 C & Black
Dimensions:	190 x 285 mm (Open Size) 190 x 48 mm (Folded Size)
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(only for PIL)	4	Artwork made to	80%

prolonged treatment. If you have had heart problems, have had a previous stroke or think that you may 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.

•    There is a risk of renal impairment in dehydrated children and adolescents. Therefore ask a doctor before use if you have not been drinking fluids or have lost fluid due to continuous vomiting or diarrhea.

• If you are 65 years and older. The elderly have an increased frequency of side effects to NSAIDs, especially stomach bleeding and perforation, which may be fatal. Inform your doctor if you have unusual abdominal symptoms particularly in the initial stages of treatment

Take special care with Ibuprofen 400 mg Tablets

•    • The use of Ibuprofen simultaneously with other NSAIDs, including celecoxib, rofecoxib, etoricoxib (cyclooxygenase-2 selective inhibitors), should be avoided due to the increased risk of ulceration or bleeding (see section “Other medicines and Ibuprofen 400 mg tablets”)

•    When using concomitantly with certain medications (see section “Other medicines and Ibuprofen 400 mg tablets”)

Use in children and adolescents:

Take special care and talk to a pharmacist or your doctor before taking this medicine if you are 12-18 years old as there is a risk of renal impairment. Therefore ask a doctor before use if you have not been drinking fluid or have lost fluids due to continuous vomiting or diarrhea.

This medicine is not to be used in children under 12 years of age. Other medicines and Ibuprofen 400 mg tablets

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/ acetyl salicylic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, B-blockers such as atenolol, or angiotensin-II receptor antagonists such as losartan) and any other ibuprofen preparations, such as those you can buy without a prescription may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines.

In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above that are prescribed:

•    to help you passing water (water tablets)

•    for the treatment of inflammatory conditions (steroids)

•    for mania or depression (e.g. lithium or selective serotonin reuptake inhibitors)

•    to treat heart conditions (cardiac glycosides, such as digoxin)

•    to treat certain cancers (methotrexate)

•    for the temporary suppression of immune system (e.g. ciclosporin and tacrolimus)

•    for pregnancy termination (mifepristone)

•    for HIV treatment (zidovudine)

•    antibiotics called quinolones such as ciprofloxacin

Do not use this medicine if you are taking other NSAID painkillers, or aspirin with a daily dose above 75mg.

Fertility, pregnancy and breast-feeding:

Fertility

Ibuprofen 400 mg tablets belong to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine. It is unlikely that Ibuprofen 400 mg tablets, used occasionally, will affect your chances of becoming pregnant, however, tell your doctor before taking this medicine if you have problems becoming pregnant.

Pregnancy

The use of Ibuprofen 400 mg tablets whilst pregnant should be avoided Ibuprofen 400 mg tablets should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

O) 121XXXX -

Breast-feeding

The use of Ibuprofen 400 mg tablets whilst pregnant should be avoided.

Ibuprofen 400 mg tablets should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and using machines:

Ibuprofen 400 mg tablets may make you feel dizzy or drowsy. If the tablets affect you in this way do not drive, operate machinery or do anything that requires you to be alert.

Ibuprofen 400 mg tablets contain lactose

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

3. How to take Ibuprofen 400 mg tablets?

Always take Ibuprofen 400 mg tablets exactly as described in the leaflet or as your pharmacist has told you. Check with your pharmacist if you are not sure.

This medicine is for oral administrationonly.

Take your Ibuprofen 400 mg tablets with or after food, with a glass of water. Ibuprofen 400 mg tablets should be swallowed whole and not chewed, broken, crushed or sucked to help prevent discomfort in the mouth or irritation in the throat.

This product is intended for short term use only. Take the lowest dose for the shortest time necessary to relieve your symptoms. You should not take Ibuprofen 400 mg tablets for longer than 10 days unless your doctor tells you to. If symptoms persist or worsen consult your doctor.

Dosage:

Dosage in adults, the elderly and children over 12 years:

Take 1 tablet upto three times a day as required. Leave at least four hours between doses. Do not take more than 3 tablets in any 24 hour period.

Do not give these tablets to children under 12 years old except on the advice of a doctor.

If you take more ibuprofen 400 mg tablets than you should

Contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your tablets with you.

You may feel faint, drowsy or nauseous, experience stomach pain, headache, ringing in the ears, dizziness, fits, disorientation, excitation and loss of consciousness. You may also have decreased or increased heart beats, drop in blood pressure.

If you forget to take your Ibuprofen 400 mg tablet

Take them as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. Possible side effects

Like all medicines, Ibuprofen 400 mg tablets may cause side effects, although not everybody gets them .

The following effects are very rare (may affect upto 1 in 10, 000 people), but if you suffer from any of the following at any time during your treatment

STOP TAKING Ibuprofen 400 mg tablets and seek immediate medical help:

•    Signs of serious allergic reaction such as difficulties in breathing or unexplained wheezing, dizziness or faster heartbeat, severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g.: Steven-Johnson syndrome), swelling of your face, tongue and/or throat or shock

•    Signs of intestinal bleeding such as passing blood in your faeces (stools/motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds.

•    Indigestion or heartburn

•    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms

•    Signs of aseptic meningitis (swelling of the protective membrane surrounding the brain) such as severe headache, high temperature, stiffness of the neck, nausea, vomiting, disorientation or intolerance to light. Patients with autoimmune disorders (lupus, mixed connective-tissue disease) may be more likely to be affected

•    High blood pressure, heart failure or chest pain

•    Worsening of asthma and wheezing or difficulty breathing

This section is continued overleaf —>

COLOURS B Red 032 C | Black

Specification: Colours:	Title: Art Work Approval Form Printed on 56 - 60 GSM Maplitho Paper 2 - Red 032 C & Black
Dimensions:	190 x 285 mm (Open Size) 190 x 48 mm (Folded Size)
No. of Folds
(only for PIL)	4	Artwork made to	80%