Brufen Analgesic 400mg Ibuprofen 12 Coated Tablets

Film-coated tablets with ibuprofen (as lysine salt).

Therapeutic indications

Brufen Analgesic Tablets are used for the symptomatic treatment of mild to moderate pain, such as headache (headache), acute migraine, with or without aura, dental pain, menstrual pain, and pain and fever associated with colds.

Dosage and posology

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

This product is intended for short-term use only. You should use the lowest effective dose for the shortest period of time to relieve your symptoms.

You should not take Brufen Analgesic for more than 3 days for migraine or fever, or for 4 days for pain treatment, unless your doctor tells you to. If symptoms persist or worsen, consult your doctor.

Adults and adolescents over 40 kg in weight (12 years of age or older): the recommended dose is 400 mg (1 tablet) up to three times a day, as needed. Leave at least six hours between 400 mg (1 tablet) doses.

Do not take more than 1200 mg (3 tablets) in 24 hours. If this medicine is required for more than 3 days in children over 12 years of age and adolescents or if symptoms worsen you should seek medical attention.

For the treatment of migraine, the recommended dose is 1 tablet of 400 mg as a single dose. If necessary, take a dose of 400 mg (1 tablet) with intervals of 4 to 6 hours. Do not take more than 1200 mg (3 tablets) in 24 hours.

Use in adolescents weighing less than 40 kg or in children under 12 years of age: Brufen Analgesic is contraindicated for use in adolescents weighing less than 40 kg or in children under 12 years of age.

Method of administration

Brufen Analgesic tablets should be swallowed whole with plenty of water. Do not chew the tablets. Patients with a sensitive stomach should take the tablets with a meal. Taking the tablets after a meal may delay the onset of pain or fever effect. Do not exceed the recommended dose or take the tablets more frequently than recommended.

Overdose

Nausea, stomach pain, headache, vomiting, diarrhea, ringing in the ears, blood in vomit and stool may occur. More serious poisonings can lead to dizziness, sleepiness, excitement, disorientation, hypotension, reduced breathing (respiratory depression), bluish discoloration of the skin and mucous membranes (cyanosis), loss of consciousness, seizures and coma. In case of overdose you should seek medical advice immediately, even if you feel well.

Contraindications

Do not take Brufen Analgesic:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine
• if you have suffered from an allergic reaction, such as asthma, difficulty in breathing, swelling of the face, tongue or throat, hives, runny and itchy nose, caused by acetylsalicylic acid (ASA) or other NSAIDs
• if you have (or have had two or more episodes) of stomach ulcer or bleeding
• if you have had gastrointestinal perforation or bleeding while using NSAIDs
• if you suffer from cerebrovascular or other active bleeding
• if you suffer from unclear disorders of blood formation
• if you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake)
• if you have severe liver, kidney or heart failure
• if you are in the last 3 months of pregnancy
• it is contraindicated in adolescents below 40 kg body weight or in children under 12 years of age.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can be minimized by taking the lowest dose for the shortest period of time necessary to relieve symptoms. Elderly people who use this product have a higher risk of developing problems associated with side effects. Medicines such as Brufen Analgesic may be associated with a small increased risk of a heart attack (myocardial infarction) or stroke. Some of the undesirable effects listed below are less frequent when the maximum daily dose is 1200 mg compared to high dose therapy in rheumatic patients.

Pregnancy and breastfeeding

Do not take Brufen Analgesic during the last 3 months of pregnancy. If you are in the first 6 months of pregnancy, think you may be pregnant or are planning to have a baby, or if you are breast-feeding ask your doctor or pharmacist for advice before using this medicine.

Brufen Analgesic belongs to a group of medicines which can impair fertility in women. This effect is reversible after stopping treatment. Occasionally used Ibuprofen Mylan is unlikely to affect the likelihood of becoming pregnant, however tell your doctor before taking this medicine if you have problems getting pregnant.

Special warnings

Talk to your doctor or pharmacist before taking Brufen Analgesic:

• if you have recently had major surgery
• if you have or have had asthma or an allergic disease, as breathing difficulties may occur
• if you suffer from hay fever, nasal polyps or chronic obstructive respiratory disease, because there is an increased risk of allergic reactions. Allergic reactions can present as asthma attacks (so-called analgesic asthma), Quincke's edema or hives
• if you suffer from heart problems
• if you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease)
• if you suffer from systemic lupus erythematosus or mixed connective tissue disease (a disease affecting the skin, joints and kidneys)
• if you suffer from certain inherited blood formation disorders (e.g. acute intermittent porphyria)
• if you suffer from blood clotting disorders
• if you are taking other NSAIDs. Concomitant use with other NSAIDs, including specific cyclo-oxygenase-2 inhibitors, increases the risk of adverse reactions and should be avoided.
• if you have chickenpox it is advisable to avoid using Brufen Analgesic
• if you are elderly
• Patients with kidney or liver problems should consult a doctor before taking Ibuprofen tablets.
• Anti-inflammatories such as ibuprofen may be associated with a small increased risk of heart attack (myocardial infarction) or stroke, particularly when given in high doses. Do not exceed the recommended dose or duration of treatment.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

Each 400 mg tablet of Brufen Analgesic contains:

Active principle

400 mg of ibuprofen (as lysine).

Excipients

Microcrystalline cellulose, anhydrous colloidal silica, crospovidone, povidone, magnesium stearate, talc (E553b). The tablet coating contains: polyvinyl alcohol hydrolyzed, titanium dioxide (E171), macrogol (E1521), talc (E553b). The printing ink contains: shellac, black iron oxide (E172), ammonium hydroxide (E527).