Brufen Analgesic 200mg Ibuprofen 12 Coated Tablets

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

Therapeutic indications

Ibuprofen Mylan 200 mg tablets are used for the symptomatic treatment of mild to moderate pain, such as headache (headache), dental pain, menstrual pain, and pain and fever associated with colds.

Dosage and posology

Ibuprofen Mylan 200 mg is indicated for adults and adolescents over 40 kg (12 years of age or older).

The recommended dose ranges from 200 mg to 400 mg (1 or 2 tablets) up to three times a day, as needed. Leave at least four hours between doses of 200 mg (1 tablet) and at least six hours between doses of 400 mg (2 tablets). Do not take more than 1200 mg (6 tablets) in 24 hours.

For the treatment of migraine, the recommended dose is 2 tablets of 200 mg as a single dose. If necessary, take a dose of 400 mg (2 tablets) with intervals of 4 to 6 hours. Do not take more than 1200 mg (6 tablets) in 24 hours.

Use in children over 6 years of age (20 kg - 40 kg body weight) The recommended daily dose ranges from 20 mg to 30 mg of ibuprofen per kg of weight, divided into three or four divided doses, as shown in the table below. Leave at least six to eight hours between doses.

If this medicine is required for more than 3 days in children over 6 years of age and adolescents or if symptoms worsen you should seek medical attention. Use in children under 6 years (less than 20 kg in weight) Ibuprofen Mylan is contraindicated for use in children under 6 years (less than 20 kg in weight).

How to use

Ibuprofen Mylan 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 Ibuprofen Mylan:

• 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
• in children under 6 years (less than 20 kg of body weight).

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 Ibuprofen Mylan 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 Ibuprofen Mylan 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.

Ibuprofen Mylan 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 Ibuprofen Mylan:

• 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 the use of Ibuprofen Mylan
• 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 200 mg tablet of Ibuprofen Mylan contains:

Active principle

200 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).