Posology : מינונים

4.2 Posology and method of administration

- Profenid 50 mg hard capsules
Method of administration:
Oral use.
The hard capsules are to be swallowed whole with a large glass of water.
Dosage:
Unwanted side effects may be reduced by using the lowest possible dose for the shortest time necessary to alleviate symptoms (see Section 4.4).
The maximum daily dose is 200 mg. The benefit/risk ratio should be carefully assessed before initiating treatment at a daily dose of 200 mg; the use of higher doses is not recommended (also see Section 4.4).
• Long-term symptomatic treatment: three 50 mg hard capsules per day, i.e. 150 mg per day.
• Short-term symptomatic treatment of acute episodes: four 50 mg hard capsules per day, i.e.
200 mg per day.

Frequency of administration:
The hard capsules are to be taken with meals.
The daily dose is to be taken as two or three divided doses.
Populations at risk:
• Patients with renal insufficiency and elderly subjects: the initial dose should be reduced then adjusted if necessary based on renal tolerance.
• Patients with hypovolemia: see Section 4.4.

• Patients with impaired heptic function : These patients should be carefully monitored and kept at the minimal effective daily dosage

• Children : The safety and effectivness of ketoprofen have not been established. It is restricted for adults and children above 15 years of age
•
• Elderly: The elderly are at increased risk of serious adverse reactions from NSAIDs. If an NSAID is considered necessary, it is generally advisable to begin ketoprofen therapy at the lower end of the dose range and to maintain such patients on the lowest effective dosage, for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

- Profenid 100 mg suppositories

Method of administration:
Rectal use.
Dosage:
Unwanted side effects may be reduced by using the lowest possible dose for the shortest time necessary to alleviate symptoms (see Section 4.4).


The maximum daily dose is 200 mg. The benefit/risk ratio should be carefully assessed before initiating treatment at a daily dose of 200 mg; the use of higher doses is not recommended (also see Section 4.4).
• Long-term symptomatic treatment: one to two 100 mg suppositories per day, i.e. 100 mg to 200 mg per day.
• Short-term symptomatic treatment of acute episodes: two 100 mg suppositories per day, i.e.
200 mg per day.

Frequency of administration:
The daily dose is to be taken as 1 dose or 2 divided doses.

Duration of treatment:
Use of the rectal route should be as short as possible due to the risk of local adverse effects which occur in addition to those observed with oral administration.

Populations at risk:

• Patients with renal insufficiency and elderly subjects: the initial dose should be reduced then adjusted if necessary based on renal tolerance.
• Patients with hypovolemia: see Section 4.4.

• Patients with impaired heptic function : These patients should be carefully monitored and kept at the minimal effective daily dosage

• Children : The safety and effectivness of ketoprofen have not been established. It is restricted for adults and children above 15 years of age
•
• Elderly: The elderly are at increased risk of serious adverse reactions from NSAIDs. If an NSAID is considered necessary, it is generally advisable to begin ketoprofen therapy at the lower end of the dose range and to maintain such patients on the lowest effective dosage, for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.