PFIZER CONSUMER HEALTHCARE

LEAFLET: USER INFORMATION

Advil 400 mg Effervescent Tablets Ibuprofen

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take your medicine carefully to get the best results.

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

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

-    You must contact a doctor if your symptoms worsen or do not improve after 5 days for pain or 3 days for fever.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Advil Effervescent Tablets are and what they are used for

2.    Before you take Advil Effervescent Tablets

3.    How to take Advil Effervescent Tablets

4.    Possible side effects

5.    How to store Advil Effervescent Tablets

6.    Further information

1. WHAT ADVIL EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR

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

This medicinal product is suitable for adults and children over 30 kg (around 12 years old) for relief of mild to moderate pain such as: headache, previously diagnosed migraine (and related symptoms such as light and noise sensitivity, and nausea), muscular pain, period pain, dental pain, feverishness and pain associated with a common cold.

2. BEFORE YOU TAKE ADVIL EFFERVESCENT TABLETS Do not take Advil Effervescent Tablets if you:

• are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicinal product (see section 6), aspirin or other related painkillers

Taking other medicines

Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not use this medicine if you are taking:

• Other NSAID painkillers (including COX-2 inhibitors), or acetylsalicylic acid.

•    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. Always seek advice of a doctor before you use ibuprofen with other medicines.

Talk to your doctor or pharmacist if you are:

•    taking a certain type of anti-depressant called SSRIs (e.g. fluoxetine, sertraline, paroxetine), corticosteroids, lithium, methotrexate, cyclosporin or zidovudine as the effect of these medicines can be influenced by ibuprofen.

Taking Advil Effervescent Tablets with food and drink

Advil Effervescent Tablets may be taken on an empty stomach. However, a small number of people might experience mild indigestion with this medicinal product. If you experience mild indigestion, it is recommended to take this medicine with food or milk, to avoid gastrointestinal problems.

If you are using ibuprofen and usually consume three or more units of alcohol per day (e.g. from wine, beer and spirits) you may increase the chance of gastrointestinal bleeding.

Pregnancy and breast feeding

If you are in the first six months of pregnancy or breast-feeding talk to your doctor or a pharmacist before using Advil Effervescent Tablets. If you are in the last three months of pregnancy do not use this medicine because it might cause problems to the unborn child or complications during delivery.

This product 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 ibuprofen, used occasionally, will affect your chances of becoming pregnant however, tell your doctor before taking this medicine if you have problems becoming pregnant.

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

Driving and using machines

Do not drive or use machines if you start to experience dizziness, drowsiness, vertigo or visual disturbance.

Important information about some of the ingredients of Advil Effervescent Tablets

•    Each effervescent tablet contains 170 mg potassium, which should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

•    Each effervescent tablet also contains 407 mg sodium, which should be taken into consideration by patients on a controlled sodium diet and by patients suffering from high blood pressure.

The medicinal product contains sucrose. 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 ADVIL EFFERVESCENT TABLETS

Always take Advil Effervescent Tablets exactly as stated in this package leaflet. You should check with your doctor or pharmacist if you are not sure.

For oral use.

For short term use only.

The minimum effective dose should be used for the shortest time necessary to relieve symptoms. The elderly and patients with renal and hepatic impairment should always start treatment with the lowest effective dose.

If symptoms persist for more than 5 days for pain and 3 days for fever or worsen, consult your doctor or pharmacist.

Dosage: Adults, the elderly and adolescents over 30 kg in weight (around 12 years old):

Take one to two effervescent tablets (400 mg ibuprofen) up to 3 times a day, as required. The effervescent tablet should be dissolved in a glass of water and the solution drunk immediately. Do not swallow effervescent tablets whole. Take only as much as you need to relieve your symptoms and leave at least 4-6 hours between each dose.

Do not take more than three effervescent tablets (1200 mg ibuprofen) in any 24 hour period.

If you take more tablets than you should:

If you accidentally take too many tablets, contact your doctor or hospital immediately. Bring the remaining tablets with you to show the doctor. The symptoms of taking a lot more tablets than the stated dose (an overdose) include: nausea, stomach pain, vomiting containing either 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, your medicine can cause side effects, although not everybody gets them. The following are side effects that may be experienced:

-    Allergic reactions such as hives, skin rashes and itching (or SLE).

-    Abdominal pain, indigestion, heartburn and feeling sick.

-    Headache

-    Diarrhoea, wind, constipation or being sick.

If you experience any of the following serious effects then STOP taking the medicine immediately and contact your doctor or pharmacist:

- Peptic ulceration or perforation. Symptoms could include abdominal pain, vomiting blood (or liquid with what looks like coffee grounds), blood in the faeces (stools/motions) or passing black tarry stools.

-    Inflammation of the brain lining. Symptoms could include stiff neck, headache, feeling or being sick, fever or feeling disoriented.

-    Severe allergic reactions. Symptoms could include fainting, faster heart rate, swelling of the face, tongue and throat.

-    Worsening of asthma and wheezing or difficult breathing.

Other very rare side effects:

-    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.

-    High blood pressure.

-    Heart failure.

-    Nervousness, visual disturbance, ringing in the ears and dizziness.

-    Liver problems. Symptoms could include yellowing of the skin or the whites of the eyes.

-    Kidney problems. Symptoms could include swelling of the ankles.

-    Severe skin reactions. Symptoms could include blistering.

Medicines such as this product 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 (5 days for pain and 3 days for fever).

If any of the side effects get serious, or if you notice any side effect not listed in the leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ADVIL EFFERVESCENT TABLETS

•    Keep out of the reach and sight of children.

•    Do not use Advil Effervescent Tablets after the expiry date which is stated on the strip and the carton. The expiry date refers to the last day of the month.

•    Do not store above 30°C.

•    Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Advil Effervescent Tablets contains

The active substance is ibuprofen.

Each effervescent tablet contains 400 mg of ibuprofen.

The other ingredients are: potassium carbonate (E501); sodium carbonate, anhydrous (E500); citric acid, anhydrous (E330); monosodium citrate (E331); sodium hydrogen carbonate (E500); hypromellose (E464); saccharin sodium (E954); saccharose palmitate (contains sucrose); menthol flavour; grapefruit flavour and magnesium stearate (E470b).

What Advil Effervescent Tablets look like and contents of the pack

Advil 400 mg Effervescent Tablets are round, white tablets, flat-faced on both sides. They are available in packs containing 2, 4, 8, 10, 12, 16, 20, 32 and 40 effervescent tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Pfizer Consumer Healthcare Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom Your medicine is manufactured by:

Losan Pharma GmbH, Otto-Hahn-Stasse 13, 79395 Neuenburg, Germany This leaflet was last approved in May 2010.

Advil 400mg Effervescent PL 00165/0368