Leaflet ARTHROTEC 75mg / 0.2mg gastro-resistant tablets

Indicated for: pain and inflammation; prevention of gastric ulcer

Route of administration: oral

Substance: diclofenac + misoprostol (nonsteroidal anti-inflammatory drug + vasodilator)

ATC: M01AB55 (Musculo-skeletal system | Antiinflammatory and antirheumatic products, non-steroids | Acetic acid derivatives and related substances)

Precautions:
Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Hypotension / fall risk
Hypotension / fall risk

May lower blood pressure and increase the risk of falls.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Nephrotoxicity
Nephrotoxicity

This medicine may affect the kidneys.

Bleeding risk
Bleeding risk

This medicine may increase the risk of bleeding.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Ulcer / gastrointestinal bleeding
Ulcer / gastrointestinal bleeding

This medicine may increase the risk of ulcer or gastrointestinal bleeding.

The combination of diclofenac and misoprostol is used to treat pain and inflammation associated with musculoskeletal conditions such as osteoarthritis and rheumatoid arthritis in patients at high risk of developing gastric or duodenal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs).

- Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that reduces pain and inflammation by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), decreasing prostaglandin production.
- Misoprostol is a prostaglandin analog that protects the gastric mucosa, reducing the risk of ulcers and gastrointestinal complications associated with NSAID use.

This combination is taken orally, usually 2-3 times daily, as directed by a doctor. It is particularly indicated for patients with a history of ulcers or other gastrointestinal conditions.

Common side effects include nausea, diarrhea, abdominal pain, and flatulence. Rarely, more serious reactions such as gastrointestinal bleeding, kidney dysfunction, or allergic reactions may occur. Misoprostol can cause uterine contractions and is contraindicated in pregnancy.

The treatment should be administered under medical supervision, and patients must strictly follow the prescribed dosage to minimize risks.

General data about ARTHROTEC 75mg / 0.2mg

  • Substance: diclofenac + misoprostol
  • Date of latest medicines list: 01-06-2026
  • Product code: W02034002
  • Concentration: 75mg / 0.2mg
  • Pharmaceutical form: gastro-resistant tablets
  • Quantity: 20
  • Product type: Original
  • Price: 41.07 RON
  • Prescription status: P-6L - Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

  • Manufacturer: PIRAMAL PHARMA SOLUTIONS (DUTCH) B.V. - OLANDA
  • Holder: PFIZER EUROPE MA EEIG - BELGIA
  • Number: 12398/2019/01
  • Shelf life: 3 years

Compensation lists for ARTHROTEC 75mg / 0.2mg Pfizer

C3 - Sublist C - section C3 (children, pregnant women and postpartum women) with 100% discount from the reference price

Price

Copayment

Patient

41.07 RON

41.07 RON

0.00 RON