Ibuprofen 400 mg film-coated tablets (Ibuprofen UNION) – pain, fever and cold and flu symptoms

Ibuprofen UNION is a film-coated tablet containing 400 mg ibuprofen, an active substance from the group of non-steroidal anti-inflammatory drugs (NSAIDs). Ibuprofen relieves pain, lowers fever and reduces inflammation. The marketing authorisation holder and manufacturer is UNION-MEDIC d.o.o. Novi Sad.

The medicine is intended for short-term symptomatic treatment of mild to moderate pain and fever in adults and adolescents aged 12 and over weighing at least 40 kg. In Serbia it is available without a prescription, but it must be used exactly as described in the leaflet – at the lowest effective dose for the shortest time.

What is Ibuprofen 400 mg used for and how should it be taken?

Key facts about the medicine

What is Ibuprofen 400 mg used for?

According to the leaflet, Ibuprofen UNION is used for short-term symptomatic treatment of mild to moderate pain, such as:

• headache and migraine;
• toothache;
• period pain (dysmenorrhoea);
• muscle and back pain, rheumatic pain;
• fever and symptoms such as raised temperature and aches in common colds and flu.

The medicine is intended for adults and adolescents aged 12 and over weighing at least 40 kg.

How is it used and dosed?

• Swallow the tablet whole with at least half a glass of water to avoid a temporary burning sensation in the throat or mouth.
• For a faster onset the medicine can be taken on an empty stomach; with a sensitive stomach take it with food.
• The score line on the tablet is not intended for breaking.
• Adults: if the medicine is needed for more than 3 days for migraine or fever, or more than 5 days for pain, or symptoms get worse – see a doctor.
• Adolescents 12–18 years: if the medicine is needed for more than 3 days or symptoms get worse – see a doctor.

Always use the lowest effective dose for the shortest time needed to relieve symptoms.

Special patient groups

• Children under 12 and adolescents under 40 kg: must not be used; more suitable forms of ibuprofen exist for children.
• Dehydrated children and adolescents: there is a risk of kidney damage.
• Elderly: higher risk of side effects, especially bleeding and perforation in the digestive tract; the dose is set by the doctor (lowest possible).
• Severe liver or kidney disease: contraindicated; in milder impairment the dose is set by the doctor.

Contraindications – when the medicine must not be used

Do not take Ibuprofen UNION:

• if you are allergic to ibuprofen or any of the excipients;
• if you have a stomach or duodenal ulcer, recurrent ulcer or bleeding in the stomach or intestines;
• if you have previously had bleeding or perforation in the stomach or intestines when taking ibuprofen or other NSAIDs;
• if you have severe liver or kidney disease or severe heart failure;
• if you have an increased tendency to bleed;
• in the third trimester of pregnancy;
• if you have had allergic reactions (difficulty breathing, blocked nose, rash) after acetylsalicylic acid or other NSAIDs;
• if you are under 12 or an adolescent weighing less than 40 kg.

Precautions and warnings

• Asthma, chronic rhinitis or allergies – possible breathing difficulties, hives or serious allergic reaction.
• Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis.
• Heart disease (heart failure, angina, previous heart attack, bypass), peripheral arterial disease, stroke or TIA; high blood pressure, diabetes, high cholesterol, smoking – small increase in risk of heart attack or stroke, especially at high doses.
• Inflammatory bowel disease or previous ulcer – elderly people and those with previous problems should report any stomach symptoms, especially bleeding.
• Dehydration – risk of kidney damage.
• Serious skin reactions (exfoliative dermatitis, SJS, TEN, DRESS, AGEP) – stop immediately in case of rash, blisters or peeling.
• Ibuprofen may mask signs of infection (fever, pain); it should be avoided during chickenpox.
• Long-term use of painkillers can cause headache that should not be treated with these medicines.
• NSAIDs may reversibly affect female fertility; not recommended when trying to conceive.

Interactions with other medicines, alcohol and food

• Do not use several different painkillers at the same time unless recommended by a doctor.
• Methotrexate, lithium, digoxin.
• Acetylsalicylic acid and other medicines that prevent blood clotting (warfarin, dicoumarol, ticlopidine).
• SSRI antidepressants.
• Blood pressure medicines: ACE inhibitors (e.g. captopril), beta blockers (e.g. atenolol), angiotensin II receptor antagonists (e.g. losartan), diuretics.
• Ciclosporin, tacrolimus, corticosteroids, aminoglycoside antibiotics, voriconazole, fluconazole, sulfonylureas, cholestyramine, zidovudine, mifepristone.
• Alcohol may increase side effects; the medicine can be taken with food and drinks.

Pregnancy and breastfeeding

The medicine must not be used in the third trimester of pregnancy, as it may harm the baby (heart and kidney problems), affect the tendency to bleed and prolong labour. In the first 6 months of pregnancy it is used only if absolutely necessary and on medical advice, at the lowest dose for the shortest time. After week 20, if taken for more than a few days, it can reduce amniotic fluid (oligohydramnios) or narrow the ductus arteriosus in the baby.

Ibuprofen passes into breast milk, but the risk to the infant with short-term use of therapeutic doses is unlikely; medical advice is needed for more frequent use while breastfeeding.

Driving and using machines

In some people the medicine may reduce reaction ability due to visual disturbances, dizziness or drowsiness – keep this in mind when driving, especially in combination with alcohol.

Possible side effects

• Common (up to 1 in 10): headache, dizziness; indigestion, diarrhoea, nausea, vomiting, abdominal pain, bloating, constipation, black stools, bleeding in the stomach and intestines, vomiting blood; rash; tiredness.
• Uncommon (up to 1 in 100): rhinitis, hypersensitivity, insomnia, anxiety, visual and hearing disturbances, bronchospasm, asthma, mouth ulcers, stomach or duodenal ulcer (sometimes with perforation), gastritis, hepatitis, jaundice, itching, small bruises, sensitivity to light, kidney impairment, blood count changes and anaemia, drowsiness, angioedema, agranulocytosis.
• Rare (up to 1 in 1,000): non-bacterial meningitis, allergic reactions, depression, confusion, ringing in the ears, fainting, liver impairment, fluid retention.
• Very rare: inflammation of the pancreas, liver failure; severe skin reactions (SJS, TEN, erythema multiforme).
• Not known: worsening of ulcerative colitis or Crohn’s disease, heart failure, heart attack, high blood pressure, DRESS, AGEP, Kounis syndrome (chest pain as a sign of an allergic reaction).

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose (or if a child has taken the medicine by accident): contact a doctor or the nearest healthcare facility immediately. Symptoms may include nausea, abdominal pain, vomiting (possibly with blood), headache, ringing in the ears, confusion, rapid eye movements, and at high doses drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), blood in the urine and difficulty breathing.
• Missed dose: do not take a double dose to make up for a missed one.
• Stopping: the medicine is taken only while symptoms last; if they do not improve within the stated time, see a doctor.

Related information

• What is the safest pain reliever?

For additional care and support with colds and flu, see also the Colds and flu category – products in this category do not replace the medicine you have been prescribed.

Composition, packaging and manufacturer

• Active substance: ibuprofen 400 mg per film-coated tablet.
• Core: colloidal anhydrous silica, povidone K25, croscarmellose sodium, maize starch, microcrystalline cellulose, talc.
• Coating: hypromellose, talc, titanium dioxide (E171), macrogol 8000, erythrosine (E127).
• Appearance: oblong, biconvex reddish-pink film-coated tablets with a score line on one side.
• Pack: 1 Al/PVC blister with 10 film-coated tablets in a carton with leaflet.
• Marketing authorisation holder and manufacturer: UNION-MEDIC D.O.O. NOVI SAD, Arhimandrita Jovana Rajića 2, Novi Sad.
• Authorisation number: 001964455 2025 of 08.12.2025.

Storage

• Store below 25 °C in the original package to protect from light and moisture.
• Keep out of the sight and reach of children; do not use after the expiry date.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

How many Ibuprofen 400 mg tablets can I take a day?

According to the leaflet, adults and adolescents (≥ 40 kg) take one 400 mg tablet one to three times daily, at least 4–6 hours apart. In total no more than 1,200 mg (3 tablets) in 24 hours.

Should Ibuprofen 400 mg be taken before or after food?

For a faster onset it can be taken on an empty stomach, while people with a sensitive stomach should take it with food. The tablet should be swallowed whole with at least half a glass of water.

Can I combine ibuprofen with paracetamol or aspirin?

The leaflet says different painkillers should not be used at the same time unless recommended by a doctor, and acetylsalicylic acid is listed among medicines that interact with ibuprofen. Ask your doctor or pharmacist.

Can children take Ibuprofen 400 mg tablets?

No. The medicine must not be given to children under 12 or to adolescents weighing less than 40 kg; more suitable forms of ibuprofen (e.g. syrups) available in Serbia are used for them.

Can ibuprofen mask an infection?

Yes. Ibuprofen lowers fever and relieves pain, so it may delay recognition and treatment of an infection. If signs of infection persist or worsen, see a doctor without delay.

Sources

• ALIMS – Patient leaflet Ibuprofen UNION, 400 mg film-coated tablets (December 2025, Serbian)
• ALIMS – Summary of product characteristics Ibuprofen UNION, 400 mg film-coated tablets (Serbian)

Sources checked on: 24 October 2026.