PONSTEL Capsule / Tablet / Suspension Ref.[50221] Active ingredients: Mefenamic acid

Posology

Use the lowest effective dose for the shortest possible duration of treatment. Therapy should not be continued for longer than 7 days.

Adults: 500 mg three times per day.

In menorrhagia the dosage is 500 mg three times a day beginning with the onset of menstrual flow and continuing for five days or until cessation of flow, whichever is less.

In primary dysmenorrhoea the dosage is 500 mg three times a day commencing at the onset of period pain and continued for up to three days while the symptoms persist.

The doses may be repeated as necessary, up to three times daily.

Gastric irritation may be reduced by taking medication during meals.

Special populations

No information available.

Paediatric population

Children (6 months and older): 25 mg/kg of body weight daily, in divided doses, or:

• 6 months to 1 year: One medicine measureful (5 mL)
• 2 to 4 years: Two medicine measuresful (10 mL)
• 5 to 8 years: Three medicine measuresful (15 mL)
• 9 to 12 years: Four medicine measuresful (20 mL)

The doses may be repeated as necessary, up to three times daily.

Gastric irritation may be reduced by taking medication during meals.

Method of administration

For oral administration.

Mefenamic acid has a marked tendency to induce tonic-clonic (grand mal) convulsions in overdosage. Dyskinesia, acute renal failure and coma have been reported. Overdose has led to fatalities.

Treatment is symptomatic and supportive. Following accidental overdosage, the stomach should be emptied by inducing emesis or gastric lavage followed by administration of activated charcoal. Vital functions should be monitored and supported. Haemodialysis is of little value since mefenamic acid and its metabolites are firmly bound to plasma proteins.

PONSTEL 250: 36 months.
PONSTEL 250: 24 months packed in HDPE screw type containers with screw cap.
PONSTEL FORTE: 24 months.
PONSTEL S: 24 months.

Store in a cool (at or below 25ºC), dry place.

Keep the blisters in outer carton until required for use.

Keep bottle tightly closed.

PONSTEL FORTE to be protected from direct sunlight.

PONSTEL 250:

250 mg capsules in containers of 100’s and 250’s, and blister packs of 20’s.

• 100’s pack: White cylindrically shaped polypropylene securitainer (49 × 75 mm) with a round white LDPE closure.
• 250’s pack: White cylindrically shaped polypropylene securitainer (62 × 152 mm) with a round white LDPE Closure.
• 250’s pack: White cylindrical shaped high-density polyethylene (HDPE) container (475 mL, 53 × 450 cc) with screw cap with an inside wad seal.
• 20’s pack: Clear, transparent, non-toxic well thermo formable, food grade PVC film on printed aluminium foil with VMCH coating (dull side printing).

PONSTEL FORTE:

500 mg tablets in containers of 50’s.

50’s Blister pack: Clear, transparent, non-toxic, well thermo formable, food grade PVC film on aluminium foil with VMCH coating on bright side (dull side printing).

• 50’s Securitainer pack: White or grey polypropylene securitainer (0205), 49 mm LDPE closure and cotton wool balls as wadding.
• 50’s HDPE container: 160mL (35 × 150) white colour cylindrical screw type high density polyethylene (HDPE) container with a white colour HDPE screw cap with induction seal Wad.

PONSTEL S:

Suspension in bottles of 100 ml, 200 ml and 2,5 L.

PONSTEL S, is packed using the following packaging materials:

• 100 mL or 200 mL amber glass bottles with a 28 mm white polypropylene cap with liner.
• 2,5 L rectangular amber HDPE bottle with a utility thread finish with a 3,15 mm white polypropylene cap with liner.

Not all pack sizes may be marketed.

No special requirements.