Mastopan (Granules) Instructions for Use

Marketing Authorization Holder

Homeopathic Pharmacy, LLC (Russia)

Dosage Form

Mastopan

Homeopathic granules: 8 g tubes or jars

Dosage Form, Packaging, and Composition

Homeopathic granules uniform in appearance, of regular spherical shape, white with a gray or cream tint.

Excipients: sucrose pellets 100 g.

8 g – polymer tubes (1) – cardboard packs.
8 g – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

Homeopathic preparation used for menstrual cycle disorders, mastopathy and premenstrual syndrome

Pharmacotherapeutic Group

Homeopathic agent

Pharmacological Action

Homeopathic preparation.

Indications

Use as a symptomatic agent exclusively within a complex therapy regimen.

Employ for the management of the following conditions:

• Fibrocystic mastopathy and mastodynia (breast pain).
• Premenstrual syndrome, specifically addressing symptoms such as breast tension and engorgement, mental lability with mood swings, and associated headaches.

ICD codes

Dosage Regimen

Administer by dissolving 5 granules in the mouth.

Take this dose 3 to 4 times daily, maintaining a consistent schedule.

Ensure administration occurs either 20 minutes before a meal or 1 hour after a meal to optimize absorption.

Continue the treatment course for a minimum of 3 months to achieve the desired therapeutic effect.

Do not repeat the course without prior consultation with a physician for re-evaluation and approval.

Adverse Reactions

Monitor for the development of allergic reactions, which may include skin rash, itching, or urticaria.

Discontinue use immediately upon the first appearance of any hypersensitivity symptoms.

Report any suspected adverse reactions to a healthcare professional for further assessment and management guidance.

Contraindications

Do not use under any circumstances in the presence of the following conditions:

• Established hypersensitivity or known allergy to any of the active or inactive components of the granules.
• Confirmed or suspected pregnancy at any trimester due to potential risks.
• Throughout the entire period of breastfeeding (lactation).
• In patients under 18 years of age, as safety and efficacy have not been established in this pediatric population.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated for children under 18 years of age.

Special Precautions

The drug is not used in the treatment of malignant diseases of the mammary glands.

The use of the drug as a symptomatic agent in the complex therapy of fibrocystic mastopathy and mastodynia is carried out strictly as prescribed and under the supervision of a mammologist.

When using homeopathic medicines, a temporary exacerbation of symptoms may be observed. In this case, you should stop taking the drug and consult a doctor.

If there is no therapeutic effect within 1 month, as well as if side effects appear, you should consult a doctor.

Information for patients with diabetes: the maximum daily dose of the drug corresponds to 0.06 XE (Bread Units).

Effect on the ability to drive vehicles and operate machinery

No effect.

Overdose

No confirmed cases of overdose have been reported in the post-marketing surveillance period.

In the event of accidental ingestion of a significantly larger than prescribed quantity, immediately seek medical advice or contact a Poison Control Center.

Provide symptomatic and supportive care as no specific antidote is known for the homeopathic components.

Drug Interactions

The use of this homeopathic preparation does not preclude or prohibit concurrent therapy with other conventional medicines.

No specific pharmacokinetic or pharmacodynamic interactions with other pharmaceutical agents have been documented or are currently anticipated.

Always inform your healthcare provider about all other medications you are taking to ensure comprehensive therapy management.

Storage Conditions

At a temperature not exceeding 25°C (77°F) in a place protected from light. Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

Over-the-counter.

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.