Femizol (Tablets) Instructions for Use

Marketing Authorization Holder

Sagmel Inc. (USA)

ATC Code

N02BE51 (Paracetamol in combination with other drugs, excluding psycholeptics)

Active Substances

Paracetamol (Rec.INN registered by WHO)

Pamabrom (USAN adopted for use in the USA)

Mepyramine (Rec.INN registered by WHO)

Dosage Form

Femizol

Coated tablets, 500 mg+25 mg+15 mg: 24 pcs.

Dosage Form, Packaging, and Composition

Coated tablets white, biconvex, oval, with the imprint “CPC 2444” on one side, the other side is smooth; the cross-section is white.

Excipients: calcium sulfate, croscarmellose sodium, lactose, magnesium oxide, magnesium silicate, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, potassium gluconate, sodium lauryl sulfate, sodium starch glycolate, sorbitol, starch, stearic acid.

Shell composition: hypromellose, titanium dioxide.

24 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug used for premenstrual syndrome

Pharmacotherapeutic Group

Analgesic agent (non-narcotic analgesic agent + spasmolytic agent + H1-histamine receptor blocker)

Pharmacological Action

A combined drug whose action is due to the effects of its ingredients (Pamabrom is a diuretic that promotes the removal of fluid from the body, Paracetamol is an analgesic that relieves pain, pyrilamine maleate is an H₁-histamine receptor antagonist).

The drug Femizol is intended to relieve such symptoms of premenstrual syndrome as: abdominal bloating, weight gain due to fluid retention in the body, headaches and back pain.

Indications

• Treatment of premenstrual syndrome.

ICD codes

Dosage Regimen

Take 1-2 tablets with a full glass of water.

Repeat the dose every 4-6 hours as needed for symptom relief.

Do not exceed 8 tablets in any 24-hour period.

Space doses evenly to maintain consistent therapeutic levels.

Use the lowest effective dose for the shortest duration necessary.

Do not use for more than 10 consecutive days unless directed by a physician.

Consult a doctor if symptoms persist beyond 10 days or worsen.

Avoid concurrent use with other products containing paracetamol.

Do not consume alcoholic beverages during treatment.

Refrain from driving or operating machinery due to potential drowsiness.

Adverse Reactions

Drowsiness, dizziness.

Rarely: allergic reactions (skin rash, urticaria, angioedema).

With long-term use in high doses hepatotoxic effects are possible.

In isolated cases thrombocytopenia, hemolytic anemia.

Contraindications

• Children under 15 years of age;
• Pregnancy;
• Increased individual sensitivity to the ingredients of the drug;
• Severe forms of liver and/or kidney dysfunction.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy.

During breastfeeding, it should be prescribed only in case of clear necessity.

Use in Hepatic Impairment

Contraindicated: severe forms of liver dysfunction.

Use in Renal Impairment

Contraindicated: severe forms of kidney dysfunction

Pediatric Use

Contraindicated: children under 15 years of age.

Special Precautions

Femizol should not be taken for more than 10 days in a row unless prescribed by a doctor. If pain persists for more than 10 days, consult a doctor immediately.

Do not take this drug without a doctor’s prescription if you have respiratory diseases, or if you have glaucoma.

During the use of this drug, the consumption of alcoholic beverages should be avoided.

Effect on the ability to drive vehicles and operate machinery

When taking Femizol, you should refrain from driving vehicles and working with machinery.

Overdose

Stimulating effect on the CNS (hallucinations, impaired coordination of movements, convulsions).

Treatment symptomatic.

Storage Conditions

In a dry place, out of the reach of children, at a temperature of 15-30°C (59-86°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.