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ADVIL 400 MG EFFERVESCENT TABLETS

Active substance(s): IBUPROFEN

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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.

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Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic
acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACEinhibitors 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.

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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:
Uncommon
(occur in 1 to 10 users in 1,000)

- Allergic reactions such as hives, skin rashes and

Rare
(occur in 1 to 10 users in 10,000)

- Diarrhoea, wind, constipation or being sick.

Very rare
(occur in less than 1 user in 10,000)

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

itching (or SLE).
- Abdominal pain, indigestion, heartburn and feeling
sick.
- Headache

- 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.

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- 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 30ºC.
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

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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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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