SPEDIFEN 200 mg

Spedifen 200 mg was supplied as granules for preparing an oral solution. Each sachet contained 200 mg of ibuprofen in the form of an L-arginine salt.

Ibuprofen is a non-steroidal anti-inflammatory drug – NSAID – with analgesic, anti-inflammatory and fever-reducing effects.

Spedifen 200 mg – previously approved use and safety information

What was it used for?

According to the last approved Serbian patient leaflet, Spedifen 200 was used for short-term symptomatic treatment of mild to moderate:

• headache;
• toothache;
• menstrual pain;
• neuralgia;
• bone and joint pain;
• muscle pain.

It was also used as supportive symptomatic treatment for fever and influenza.

Ibuprofen reduces pain and fever but does not treat the underlying cause of an infection. Medical advice is required when symptoms persist or become worse.

Previously approved dosage

Adults and adolescents over 12 years could take one or two sachets per dose, two or three times daily when required.

At least 4–6 hours had to pass between doses. The maximum was six sachets or 1200 mg of ibuprofen during 24 hours.

The medicine was not intended for children under 12 years.

Preparing the solution

1. Empty one or two sachets into 50–100 mL of still water.
2. Stir thoroughly.
3. Drink the prepared solution immediately.
4. People with a sensitive stomach were advised to take it after food.

A double amount was not taken after a missed dose.

Duration of treatment

• Pain: no longer than four days without medical review.
• Fever: no longer than three days without medical review.
• Adolescents aged 12–18 years: medical advice if treatment was needed for more than three days.

When was Spedifen contraindicated?

• allergy to ibuprofen or an excipient;
• a previous asthma attack, bronchospasm, rhinitis, hives or angioedema caused by aspirin or another NSAID;
• active or recurrent stomach or duodenal ulcer;
• previous NSAID-related gastrointestinal bleeding or perforation;
• active gastrointestinal, cerebrovascular or other bleeding;
• ulcerative colitis or Crohn’s disease;
• severe kidney or liver impairment;
• severe heart failure;
• an increased bleeding tendency;
• systemic lupus erythematosus or selected connective-tissue disorders;
• phenylketonuria because the product contained aspartame;
• the final three months of pregnancy;
• children under 12 years.

Stomach, heart and kidney risks

Ibuprofen may cause gastrointestinal ulceration, bleeding or perforation, sometimes without warning symptoms.

The risk is greater in older people, patients with a previous ulcer and those using anticoagulants, antiplatelet medicines, corticosteroids, another NSAID or selected antidepressants.

NSAIDs may also cause fluid retention, swelling, increased blood pressure and worsening heart or kidney function.

Important interactions

Relevant interactions include:

• low-dose acetylsalicylic acid and other antiplatelet medicines;
• warfarin and other anticoagulants;
• other NSAIDs;
• corticosteroids and SSRI antidepressants;
• ACE inhibitors, angiotensin-receptor blockers, beta-blockers and diuretics;
• lithium, digoxin and phenytoin;
• methotrexate;
• ciclosporin and tacrolimus;
• selected antibiotics and antifungal medicines;
• diabetes medicines;
• ginkgo-containing products.

Ibuprofen may interfere with the cardiovascular antiplatelet effect of low-dose acetylsalicylic acid.

Pregnancy, breastfeeding and fertility

According to the last approved leaflet, use during the first six months of pregnancy was permitted only when considered necessary by a doctor, at the lowest effective dose for the shortest period.

The medicine was contraindicated during the final three months of pregnancy, and use during breastfeeding was to be avoided.

Ibuprofen may temporarily affect ovulation and female fertility.

Possible side effects

• indigestion, diarrhoea, nausea and abdominal pain;
• wind, heartburn and vomiting;
• headache, dizziness or drowsiness;
• rash, itching and hives;
• gastrointestinal ulceration or bleeding;
• bronchospasm and allergic reactions;
• swelling and increased blood pressure;
• kidney, liver or blood-cell abnormalities.

Composition and historical pack

• Active ingredient: 200 mg ibuprofen per sachet as an L-arginine salt.
• Form: granules for oral solution.
• Appearance: white granules with a characteristic peppermint odour.
• Pack: 20 sachets containing 3 g of granules each.
• Other ingredients: L-arginine, sodium hydrogen carbonate, saccharin sodium, aspartame, sucrose and peppermint flavour.
• ATC code: M01AE01.
• EAN: 8606103110060.
• JKL: 3162145.
• Manufacturer: Zambon Switzerland Ltd., Cadempino, Switzerland.
• Former authorisation holder: Bonifar d.o.o. Novi Beograd, Serbia.
• Former supply status: without a prescription.

Related educational content

Serbian-language guide: Which pain medicine is the safest?

Sources: the last approved Spedifen 200 patient leaflet and packaging text, together with the official ALIMS list of authorisations that ceased to be valid.
Last approved Spedifen 200 leaflet | Packaging text
Last leaflet approval: September 2019. Authorisation ended: 10 December 2024. Sources checked: 3 August 2026.