Download Company name Manufactured by: International Drug Agency for

Company name
Manufactured by: International Drug Agency for Pharmaceutical industry (IDI)
For: Haya Pharm.
Trade name
Womankit film-coated tablet
Generic name
Pamabrom and Paracetamol
Composition
Each film coated tablet contains:
Active ingredients:
Pamabrom
20 mg
Paracetamol
500 mg
Inactive ingredients:
Povidone K30
30 mg
Magnesium stearate
5 mg
Croscarmellose sodium
50 mg
Lactose monohydrate
280 mg
Microcrystalline cellulose
90 mg
Talc purified
10 mg
Pharmaceutical form
Film-Coated tablet
Pharmacological actions
Womankit Menstrual Relief tablets contain a clinically proven analgesic-antipyretic and a diuretic.
Maximum allowable non-prescription levels of acetaminophen and Pamabrom provide temporary
relief of miser aches and pains due to cramps, headache, and backache and water retention,
weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual
periods.
Pharmacokinetics
Paracetamol is almost completely absorbed from the gastrointestinal tract with peak plasma
concentrations occurring is 30-60 minutes. The bioavailability is around 80%.
Paracetamol is uniformly distributed throughout the body. The binding to plasma proteins is
variable; the volume of distribution is 0.9 L/Kg.
Paracetamol undergoes hepatic metabolism. There are no active metabolites produced.
Paracetamol is excreted in the urine approximately 90-100% after 24 hours, mostly as the
metabolites of paracetamol. Less than 5% of Paracetamol is excreted as unmetabolized
Paracetamol in urine.
Pamabrom peak Plasma concentrations (Cmax) following administrations of single dose ranging
from 1481.1 to 3598 ng/ml with mean value of 2539.5 599.0 ng/ml.
Pamabrom median time to peak concentrations (tmax) is 2.0 hours.
Pamabrom area under the plasma concentrations time curve AUC0-? from 6345.27 to 23540.5
ng.hr/ml, with a mean of 11118.5 4191.5 ng.hr/ml.
Pamabrom AUC0-? following administrations of single dose 4788.8 to 8630.4 ng.hr/ml, with a
mean of 6919.8 972.7 ng.hr/ml.
Pamabrom elimination half-life (t) from: 1.72 to 15.99 hours, with mean value 4.52 3.48 hours.
Pamabrom Elimination rats constant (K) from 0.0434 to 0.4041 hours-1, with a mean value of
0.2187 0.1098 hours-1.
Indications
Relieves minor aches and pains due to:
Cramps - headaches - backache
Premenstrual and menstrual cramps
Relieves water-weight gain, bloating, swelling and/or full feeling associated with the premenstrual
and menstrual periods.
Dosage & administration
Adults and children 12 years and over:
take 2 tablets every 4 to 6 hours
do not take more than 8 tablets in 24 hours
Children under 12 years
Do not use this adult product in children under 12 years of age; this will provide more than the
recommended dose (overdose) and may cause liver damage.
Do not take more than directed (see overdose warning).
Contraindications
Hypersensitivity to drug, severe hepatic and/or renal insufficiency, glaucoma, urine retention.
Side-effects
Anemia, agranulocytosis, thrombocytopenia, Hepatitis, Renal Colic and allergic reaction.
Tell your doctor about any unusual side effects.
Drug-interaction
Paracetamol increases the hepatotoxic effect of barbiturates, anti-epileptics, rifampicin, alcohol,
and indirect anticoagulants.
High doses of Vitamin C (1000-3000mg/day) may increase the level of Paracetamol is the body.
Ask your doctor before taking Womankit if you also take any other diuretic (often used as blood
pressure medication).
Precautions & warnings
Alcohol warning: If you consume alcoholic drinks, ask your doctor whether you should take
Paracetamol or other pain relievers /fever reducers. Paracetamol may cause liver damage.
Stop use and ask a doctor if:
New symptoms occur.
Redness or swelling is present.
Pain gets worse or lasts for more than 10 days.
Pregnancy and lactation
- In Pregnancy:
Used Only When Necessary: safe in therapeutic dose with short term, avoid chronic high doses.
- Nursing:
No Knows Risk: it is considered to be compatible is breast feeding.
Patient Information
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) way cause liver damage.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick
medical attention is critical for adults as well as for children even if you do not notice any signs or
symptoms.
Package & Storage
Carton box containing two strips of 10 tablets + insert leaflet.
Keep at a temperature not exceeding 30?C in a dry place.