1. WHAT A PROGESTOGEL IS AND WHAT IT IS USED FOR
Progestogel is a gel for topical application to the skin containing 1% progesterone. Progestogel is a hormonal medicinal product and is used to treat benign diseases of the mammary gland:
- mastodynia (chest pain and tension);
- additional treatment of benign mastopathy in case of progesterone deficiency.
Progestogel is not intended for use by men.
2. BEFORE YOU USE PROGESTOGEL
Do not use Progestogel:
- if you are allergic (hypersensitive) to the active substance progesterone or to any of the other ingredients of Progestogel.
Take special care with Progestogel
Care must be taken to ensure that the chest and arms are thoroughly cleaned before applying the product. If your menstrual cycle is irregular, oral progesterone or progestants are recommended.
This medicinal product is for external use only and should not be swallowed.
Progestogel is not a contraceptive
In some cases, there may be a shift in the menstrual cycle from 1 to 2 days ahead. In these cases, the use of Progestogel should be between the 10th and 25th day after the onset of menstruation.
Use of other medicines
No interactions with other medicines are known.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Use of Progestogel with food and drink
Progestogel is not known to interact with any type of food or drink.
Pregnancy and lactation
There are no data from the use of the product during pregnancy and lactation, therefore the use of Progestogel during pregnancy and lactation is not recommended.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no evidence that Progestogel affects the ability to drive and use machines.
Important information about any of the ingredients of Progestogel This
medicine contains castor oil, polyethoxylated, hydrogenated, which may cause skin reactions.
3. HOW TO USE PROGESTOGEL
Always use Progestogel exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
The usual dose is one to two units of the measuring line, ie. 2.5 g - 5 g gel on each breast per day. A dose of 5 g gel contains 50 mg progesterone.
Apply after daily use until the product is completely absorbed. The treatment is desirable to be long - every day of the month, including during menstruation.
Progestogel leaves no stains.
If you use more Progestogel than you should
There are no data on cases of overdose after taking Progestogel.
It has been found that there may be a shift in the menstrual cycle by a maximum of 1 to 2 days ahead. In this case, the use of Progestogel should be between the 10th and 25th day after the onset of menstruation.
If you have used more Progestogel, contact your doctor, pharmacist or the nearest hospital.
If you forget to use Progestogel
Do not take a double dose to make up for a forgotten dose. Continue treatment as prescribed.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Progestogel can cause side effects, although not everybody gets them.
Adverse reactions may occur with a frequency determined as follows.
• very common: affects more than 1 user in 10;
• common: affects 1 to 10 users in 100
• uncommon: affects 1 to 10 users in 1,000
• rare: affects 1 to 10 users in 10,000
• very rare: affects less than 1 user in 10,000 treated;
• Not known: cannot be estimated from the available data.
The most common side effect is a shift in the menstrual cycle from 1 to 2 days ahead, but without a change in the intensity of menstrual bleeding.
In isolated cases, hypersensitivity or redness of the skin is observed.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Str., 1303 Sofia, tel .: +359 2 8903417, website: www.bda.be. By reporting side effects, you can help to get more information about the safety of this medicine.
5. HOW TO STORE PROGESTOGEL
Store below 25 ° C.
Do not swallow.
Keep out of reach of children.
Do not use after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container, as they may be harmful to the environment. Ask your pharmacist how to dispose of medicines no longer required.
6. ADDITIONAL INFORMATION
Active substance: 100 g of gel contain 1 g of progesterone. Each ruler measurement delivers a 2.5 g gel corresponding to 25 mg progesterone.
One tube of Progestogel contains 32 doses (ruler measurements).
The other ingredients are: octyldecanol, carbomer, castor hydrogenated, trolamine, ethanol, purified water.
What Progestogel looks like and contents of the pack
Each pack contains one tube of 80 g gel and applicator.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ECOPHARM GROUP AD
14 Cherni Vrah Blvd., bl. 3,
1421 Sofia, Bulgaria
tel: (02) 963 15 96; 950 44 10
fax: (02) 963 15 61