Defrinol forte 60 mg/400 mg film-coated tablets – pseudoephedrine and ibuprofen for colds and flu with a blocked nose

Defrinol forte is a combination medicine with two active substances: pseudoephedrine hydrochloride, a nasal decongestant that relieves blocked nose and sinuses, and ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) that relieves pain and headache, lowers fever and reduces signs of inflammation.

In Serbia it is authorised as a film-coated tablet containing 60 mg pseudoephedrine hydrochloride and 400 mg ibuprofen, in a pack of 10 tablets, manufactured by Galenika AD Beograd. It is a non-prescription medicine intended for adults and children over 12 years.

What is Defrinol forte used for and how should it be taken?

Key facts about the medicine

What is Defrinol forte used for?

According to the patient leaflet, Defrinol forte is used to relieve the following symptoms of colds and flu:

• blocked nose and sinuses,
• headache and pain,
• inflammation,
• fever and other symptoms of colds and flu.

The combination should be used when both relief of nasal congestion and an effect against pain/fever are needed. If only one symptom dominates, the leaflet recommends a single-ingredient product.

How is it taken and dosed?

• Adults and children over 12 years: one film-coated tablet as needed, at intervals of at least 8 hours.
• Do not take more than 3 tablets in 24 hours.
• Use the lowest effective dose for the shortest possible time; do not take for more than 3 days without medical advice.
• For oral use – swallow the tablet.

This is the general dosage from the leaflet – if unsure, ask your doctor or pharmacist.

Special patient groups

• Children under 12: the medicine must not be used.
• Elderly patients: more prone to NSAID side effects, especially stomach bleeding and perforation.
• Kidney or liver disease: caution is needed; severe kidney disease is a contraindication. Particular caution is needed in dehydrated children and adolescents.

Contraindications – when the medicine must not be used

• allergy to ibuprofen, pseudoephedrine or any of the excipients
• shortness of breath, worsening of asthma, rash, runny nose or facial swelling after taking ibuprofen, acetylsalicylic acid or similar medicines
• taking MAO inhibitors (antidepressants) now or within the last 14 days
• stomach bleeding or perforation after NSAIDs, or a history of ulcer, perforation or bleeding of the digestive tract (two or more episodes)
• severe heart or kidney disease (acute or chronic), heart or blood vessel disease
• high blood pressure, including blood pressure not controlled by medicines
• diabetes
• angle-closure glaucoma
• thyroid or prostate problems
• phaeochromocytoma (adrenal gland tumour)
• pregnancy
• age under 12 years

Warnings and precautions

• Asthma (now or in the past), systemic lupus and other connective tissue diseases, kidney or liver disease, high cholesterol, previous heart attack or stroke, smoking – talk to your doctor before use.
• The medicine can mask signs of infection (fever and pain); if signs of infection persist or worsen, see a doctor at once. This has been observed in bacterial pneumonia and bacterial skin infections with chickenpox.
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, AGEP) have been reported with ibuprofen – stop at the first sign of rash, blisters or mucosal lesions.
• Rare cases of PRES and RCVS (reduced blood supply to the brain) have been reported with pseudoephedrine – sudden severe headache, nausea, vomiting, confusion or visual disturbances require emergency care.
• Sudden loss of vision (reduced blood flow to the optic nerve) and sudden abdominal pain with rectal bleeding (ischaemic colitis) require stopping the medicine and urgent examination.
• NSAIDs may be associated with a small increase in the risk of heart attack or stroke, especially at high doses; higher doses over a longer time increase the risk of stomach and kidney damage and low blood potassium.
• The medicine may temporarily affect female fertility; it contains the colouring Ponceau 4R (E124), which may cause allergic reactions.

Interactions with other medicines, food and drink

• Other NSAIDs and acetylsalicylic acid, corticosteroids, antiplatelet medicines, SSRI antidepressants, anticoagulants (warfarin, ticlopidine) – higher risk of bleeding and ulcers.
• Blood pressure medicines (ACE inhibitors, beta blockers, sartans, diuretics, guanethidine, reserpine, methyldopa) – weaker effect of the blood pressure medicine; pseudoephedrine may block their effect.
• MAO inhibitors and moclobemide – risk of very high blood pressure (hypertensive crisis); do not take within 14 days after MAO inhibitors.
• Other decongestants and appetite suppressants – increased effect; tricyclic antidepressants and anticholinergics – altered or increased effect.
• Digoxin and other cardiac glycosides, quinidine – risk of rhythm disorders; ergot alkaloids (ergotamine, methysergide) – risk of ergotism; oxytocin – risk of hypertension.
• Lithium and methotrexate (increased levels), ciclosporin and tacrolimus (kidney risk), zidovudine, mifepristone (within 8–12 days), probenecid, aminoglycosides, oral diabetes medicines, quinolone antibiotics (risk of convulsions).

Pregnancy and breast-feeding

Defrinol forte is contraindicated during pregnancy. Its use should also be avoided during breast-feeding. The medicine may make it harder to become pregnant – tell your doctor if you are planning a pregnancy or have problems conceiving; this effect disappears after stopping the medicine.

Driving and using machines

No effect on the ability to drive or use machines is expected when the medicine is used at the recommended dose and for the recommended period.

Possible side effects

• Uncommon: allergic reactions (hives, itching, peeling skin), headache, tremor.
• Very rare: blood disorders (unexplained bleeding and bruising, fever, sore throat, mouth ulcers), drop in blood pressure and heart rhythm disorder, stomach or bowel ulcer with bleeding or perforation, gastritis, liver and kidney problems, swelling, worsening of skin infections in chickenpox.
• Not known: worsening of asthma, swelling, raised blood pressure, heart failure or heart attack, Kounis syndrome, worsening of colitis and Crohn's disease, dry mouth, reduced appetite, irritability, sweating, difficulty passing urine, thirst, ischaemic optic neuropathy, sensitivity of the skin to light, ischaemic colitis.
• Stop taking the medicine and tell your doctor in case of indigestion, heartburn, nausea, abdominal pain, hallucinations, restlessness, sleep disturbance or difficulty passing urine.

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

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor at once and take the pack with you. Nausea, vomiting, abdominal pain, ringing in the ears, headache, gastrointestinal bleeding, restlessness, fast or irregular heartbeat, high blood pressure and convulsions may occur, and in severe overdose impaired consciousness and kidney failure.
• Missed dose: do not take a double dose – continue with your usual schedule.
• Stopping: the medicine is taken as needed, for as short a time as possible; see a doctor if there is no improvement after 3 days.

Related information

For additional care of a blocked nose, see also the Clogged nose category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substances: 60 mg pseudoephedrine hydrochloride and 400 mg ibuprofen per film-coated tablet.
• Excipients – core: calcium phosphate; maize starch; sodium starch glycolate type A; hypromellose E-5; magnesium stearate. Coating: hypromellose E-5; macrogol 6000; talc; titanium dioxide; Ponceau 4R lake 22% (E124).
• The medicine is essentially "sodium-free" (less than 23 mg per dose).
• Pack: carton with 1 ALU/PVC-PVC blister of 10 film-coated tablets.
• Marketing authorisation holder and manufacturer: GALENIKA AD BEOGRAD, Batajnički drum b.b., Belgrade.

Storage

• Store below 25 °C in the original package.
• Keep out of the sight and reach of children. Do not use after the expiry date (shelf life 3 years).

Frequently asked questions

How many Defrinol forte tablets may I take per day?

Adults and children over 12 take one tablet as needed, at least 8 hours apart, and no more than 3 tablets in 24 hours. Without medical advice the medicine should not be taken for more than 3 days.

Can people with high blood pressure take Defrinol forte?

No. High blood pressure, including blood pressure not controlled by medicines, as well as heart and blood vessel disease, are contraindications.

Can I take another painkiller or nasal drops with Defrinol forte?

Not without the advice of a doctor or pharmacist. The medicine contains ibuprofen and pseudoephedrine, so taking other NSAIDs, acetylsalicylic acid or decongestants at the same time increases the risk of side effects.

How does Defrinol forte differ from Defrinol?

Defrinol forte contains 60 mg pseudoephedrine hydrochloride and 400 mg ibuprofen per tablet, twice the amount in Defrinol film-coated tablets (30 mg + 200 mg), so the dosage must not be transferred from one medicine to the other.

Sources

• ALIMS – Summary of Product Characteristics Defrinol® forte, 60 mg + 400 mg, film-coated tablets (Serbian)
• ALIMS – Patient leaflet Defrinol® forte, 60 mg + 400 mg, film-coated tablets (July 2024, Serbian)

Sources checked on: 25 October 2026.