PROGESTOGEL® (Progesterone) 1%, 80 g

Common/Other brand names: PROGESTOGEL® (Europe), Crinone Gel (USA, Canada), Prometrium Gel (USA), Utrogestan Gel (France, Belgium), Progestogel (Germany, Switzerland), Progestogel (Russia, Ukraine), Gesterol (Latin America), Agolutin (Biotika, Slovakia), Cyclogest (Actavis, UK), Gesterol (Latin America), Gestone (Nordic Pharma, UK), Progestasert (Global), Progestogel (Besins, Europe), Qi Ning (Aisheng Pharmaceutical, China), Relantan (Aversi, Georgia), Susten (Sun Pharma, India), Utrogestran (Faran Laboratories, Iran), Utrovin (Bestochem, India), Vasclor (Verisfield, South Africa)

What is PROGESTOGEL®?

PROGESTOGEL® (Progesterone) 1% is a topical gel containing the hormone progesterone.

It is designed for external use to help manage benign breast conditions caused by hormonal imbalances, such as mastodynia (breast pain) and diffuse fibrocystic mastopathy.

This gel provides a local effect of progesterone directly to the breast tissue, helping alleviate symptoms without systemic absorption.

What are the uses of PROGESTOGEL®?

PROGESTOGEL® is primarily used to treat benign breast diseases associated with an absolute or relative deficiency of progesterone, including:

• Mastodynia (breast pain or tenderness)
• Diffuse fibrocystic mastopathy, a condition characterized by the presence of fibrous tissue and cysts in the breast.

Who should avoid using PROGESTOGEL®?

You should not use PROGESTOGEL® if you:

• Are hypersensitive to progesterone or any other ingredients in the gel
• Have nodular forms of fibrocystic mastopathy
• Have been diagnosed with breast cancer

How should PROGESTOGEL® be applied?

PROGESTOGEL® is for external use only. It should be applied once daily on clean, dry skin using the provided applicator-dispenser. For each breast, apply a 2.5 g dose of gel, evenly distributing it across the entire surface, avoiding the areola. The gel should be absorbed naturally without rubbing or massaging. After application, hands should be washed thoroughly.

Key instructions:

• Do not apply the gel to damaged skin, as this increases the risk of systemic progesterone absorption.
• Avoid direct sunlight on the treated area after applying the gel.
• PROGESTOGEL® is flammable until fully dry.

Can PROGESTOGEL® interact with other medications?

There have been no studies specifically examining interactions between PROGESTOGEL® and other drugs.

Currently, no drug interactions have been reported.

Is PROGESTOGEL® safe to use during pregnancy or breastfeeding?

While there is limited data on the use of PROGESTOGEL® during pregnancy, it is generally not recommended for pregnant women.

Additionally, the gel should not be used while breastfeeding, as small amounts of progesterone may pass into breast milk, although no harmful effects have been documented.

How long should PROGESTOGEL® treatment last?

The typical treatment duration is 3 to 6 months. PROGESTOGEL® is usually applied continuously throughout the menstrual cycle, including during menstruation. Treatment duration and the need for continued therapy should be discussed with your healthcare provider.

What should I do if I miss a dose?

If you forget to apply a dose of PROGESTOGEL®, simply continue with your regular dosing schedule.

Do not double the dose to make up for the missed one.

What are the potential side effects of PROGESTOGEL®?

When used as directed, systemic side effects are unlikely due to the transdermal method of administration. However, some rare side effects include:

• Skin reactions like redness at the application site or hypersensitivity reactions
• Menstrual cycle changes, such as a shortened period or intermenstrual bleeding
• Headaches

If the skin barrier is damaged, there is an increased risk of systemic side effects.

How should PROGESTOGEL® be stored?

Store PROGESTOGEL® at a temperature not exceeding 25°C (77°F).

Ensure it is kept out of reach of children and do not use it after the expiration date indicated on the packaging.

Can men use PROGESTOGEL®?

No, PROGESTOGEL® is not intended for use by men.

It is specifically designed for conditions related to female breast health and hormonal imbalances.