PROVIRON Tablet Ref.[51091] Active ingredients: Mesterolone

Source: Web Search  Revision Year: 2020  Publisher: Bayer Israel Ltd., 36 Hacharash St.,Hod Hasharon 45240 Manufacturer: Bayer Weimar GmbH und CO. KG., Germany

4.3. Contraindications

Carcinoma of the prostate, previous or existing liver tumors.

4.4. Special warnings and precautions for use

Androgens are not suitable for enhancing mascular development in healthy individuals or for increasing physical performance.

Proviron is for use in male patients only.

Regular examinations of the prostate should be carried out prophylactically.

In rare cases benign and in even rarer cases malignant liver tumours leading in isolated cases to lifethreatening intraabdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Proviron. If severe upper abdominal complaints, liver enlargement or signs of intraabdominal haemorrhage occur, a liver tumour should be included in the differential-diagnostic considerations.

Proviron contains lactose. Patients with rare genetic conditions such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption must not use this medication.

4.5. Interaction with other medicinal products and other forms of interaction

Not applicable.

4.6. Fertility, pregnancy and lactation

Not applicable.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

If, in individual cases, frequent or persisting erections occur, the dose must be reduced or treatment discontinued in order to avoid injury to the penis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il

6.2. Incompatibilities

Not applicable.

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