RANTUDIL FORTE Hard capsule Ref.[51125] Active ingredients: Acemetacin

Source: Medicines Authority (MT)  Revision Year: 2023  Publisher: Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

4.1. Therapeutic indications

Symptomatic treatment of pain and inflammation in

  • acute arthritis (including attacks of gout)
  • chronic arthritis, in particular in cases of rheumatoid arthritis (chronic polyarthritis)
  • ankylosing spondylitis (Bechterew’s disease) and other inflammatory rheumatic conditions of the spinal column
  • irritation caused by osteoarthritis and spondylosis
  • inflammatory soft-tissue rheumatism syndrome
  • painful swelling or inflammation following injuries.

4.2. Posology and method of administration

Posology with single and daily doses

The dose of acemetacin depends on the severity of the disorder being treated. The recommended dose range for adults is between 60 and 180 mg of acemetacin per day, spread over 1-3 individual doses.

Age Single dose
(Capsules)
Total daily dose
(Capsules)
Adults 1
(equivalent to 60 mg of
acemetacin)
1-3
(equivalent to 60-180 mg
of acemetacin)

Dosage in acute attacks of gout

The dose for acute attacks of gout is 180 mg of acemetacin a day until the symptoms subside. Higher doses may be indicated if specifically prescribed by the doctor. Patients without preexisting gastrointestinal damage can take 120 mg of acemetacin at the start of treatment followed by a further 60 mg of acemetacin every 6 hours; a maximum dose range of 300 mg of acemetacin per 24 hours is permitted. On the second day of treatment, the same dose may be taken if necessary; otherwise, the dose should be reduced.

Method and duration of application

Rantudil forte should be swallowed whole with sufficient liquid and not on an empty stomach. If you suffer from a sensitive stomach, it is recommended to take Rantudil forte during meals.

The treating physician shall decide on the duration of treatment; however, treatment with a dose of 180 mg acemetacin daily should not exceed a maximum period of 7 days.

Patients with rheumatic disorders may have to take Rantudil forte over an extended period of time.

Side effects can be reduced by administering the lowest effective dose over the shortest period of time necessary for symptom control (see section 4.4.).

Specific patient groups

Elderly patients

Due to the possible side effect profile (see section 4.4) elderly patients should be monitored with particular care.

Children and adolescents

Rantudil forte is not recommended for use in children and adolescents, as there is insufficient data on its efficacy and safety for this age group.

4.9. Overdose

a) Symptoms of overdose

Symptoms of overdose include central nervous disturbances such as headache, dizziness, drowsiness, disorientation, lethargy, increased spasmophilia and loss of consciousness ranging up to coma, as well as abdominal pain, nausea and vomiting. In addition, bleeding in the gastrointestinal tract, perspiration, electrolyte shifts, hypertension, ankle oedema, oliguria, haematuria, respiratory depression as well as impaired hepatic and renal function can occur.

b) Therapeutic measures in case of overdose

No specific antidote is known. In case of suspected overdose, supportive and symptomatic treatment is recommended. Depending on the patient’s current state, supervision and treatment in an intensive care unit may be required. Absorption-reducing measures and substitution of serum electrolytes, if appropriate, may be indicated.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 30°C.

6.5. Nature and contents of container

Package with 20 hard capsules.

Package with 50 hard capsules.

Package with 100 hard capsules.

Not all package sizes may be placed on the market.

6.6. Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.