Ibufen Junior 200 mg, 10 soft capsules

Ibufen Junior 200 mg capsules are a nonsteroidal anti-inflammatory drug (NSAID) designed for children from 6 years of age. They provide analgesic, antipyretic, and anti-inflammatory effects, relieving mild to moderate pain and reducing fever. Capsules should be swallowed whole with water and not chewed, sucked, or crushed.

Indications

• Mild to moderate pain: headaches (including migraines), toothache, muscle, joint, and bone pain, post-injury pain, neuralgia, pain associated with colds or flu, painful menstruation, earache due to middle ear inflammation
• Fever of various origins (including influenza and infections)

Composition

• Active substance: ibuprofen 200 mg per capsule
• Excipients: macrogol 600, potassium hydroxide, purified water; capsule coating: gelatin, liquid non-crystallising sorbitol, liquid maltitol, patent blue (E131), purified water

Action

Analgesic, antipyretic, and anti-inflammatory.

Dosage

• Children 6–9 years (20–29 kg): 1 capsule initially, then 1 capsule every 8 hours if needed (max 3 capsules/day, 600 mg)
• Children 10–12 years (30–39 kg): 1 capsule initially, then 1 capsule every 6 hours if needed (max 4 capsules/day, 800 mg)
• Adults and adolescents over 12 years (>40 kg): 1–2 capsules initially, then 1–2 capsules every 4–6 hours if needed (max 6 capsules/day, 1200 mg)

Minimum interval between doses: 4–6 hours. Take with water. Do not exceed the recommended dose.

Contraindications

• Allergy to ibuprofen, NSAIDs, or excipients
• History of asthma, hives, angioedema, gastrointestinal bleeding, peptic ulcer, liver, kidney, or heart failure
• Active bleeding, blood clotting disorders, severe dehydration
• Pregnancy (last trimester) and infants <5 kg

Side Effects

Common: diarrhea due to maltitol and glycerol.
Uncommon: indigestion, abdominal pain, nausea, flatulence, headaches, skin rashes, hives.
Rare: constipation, vomiting, dizziness, insomnia, agitation, fatigue.
Very rare: aseptic meningitis, hematopoietic disorders, severe hypersensitivity, asthma exacerbation, visual disturbances, tinnitus, heart failure, gastrointestinal bleeding, liver disorders, severe skin reactions (Stevens-Johnson syndrome, Lyell’s syndrome), acute renal failure, DRESS syndrome, depression, psychotic reactions.

Warnings and Precautions

• Do not exceed the recommended dose or duration
• May increase risk of heart attack or stroke at high doses
• Use caution in children with heart, kidney, liver problems, asthma, allergies, digestive disorders, or who have recently undergone surgery
• Avoid concomitant use with other NSAIDs or COX-2 inhibitors
• Use at the lowest effective dose for the shortest duration

Interactions

May interact with anticoagulants, antihypertensives, corticosteroids, cardiac glycosides, SSRIs, lithium, diuretics, methotrexate, immunosuppressants, zidovudine, quinolone and aminoglycoside antibiotics, voriconazole, fluconazole, baclofen, mifepristone, oral antidiabetics, cholestyramine, and other drugs. Consult your doctor or pharmacist before use.

Pregnancy, Breastfeeding, and Fertility

• First 6 months of pregnancy: only if doctor advises
• Last trimester: avoid completely
• Breastfeeding: small amounts pass into milk; unlikely to affect infant
• May temporarily affect female fertility (reversible after treatment)

Storage

Store below 25°C, out of reach of children.

Important Ingredient Information

• Contains liquid maltitol and sodium benzoate
• Essentially sodium-free (<1 mmol per 5 ml)

Keywords

Ibufen Junior, ibuprofen, children pain relief, fever reduction, NSAID, soft capsules, 200 mg, headache, toothache, muscle pain, joint pain, cold, flu, 6 years+