Oestrogel

• Female sex hormone
• Hormone Replacement Therapy (HRT)
• Apply to skin

Oestrogel is a Hormone Replacement Therapy (HRT). HRT is prescribed to relieve menopause symptoms by replenishing lost hormones.

Oestrogel works by replacing the oestrogen in your body. When the gel is applied to the skin, the active ingredient is absorbed through the skin and enters into the bloodstream.

Oestrogel is used in women who have not had a menstrual period for at least six months.

The medicine is used for:

• Relief of symptoms occurring after menopause

During the menopause the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as a hot face, neck and chest (hot flashes). Oestrogel alleviates these symptoms.

• Prevention of osteoporosis

After the menopause some women may develop fragile bones (osteoporosis). If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Oestrogel to prevent osteoporosis after menopause.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will aim to prescribe the lowest dose to treat your symptoms for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough.

Oestrogel contains the female hormone estradiol. When applied, the gel will dry within 5 minutes. The active ingredient is absorbed through the skin and enters into the bloodstream.

Instructions for applying the gel:

• Using your hand, spread the gel as thinly as possible on a large area of skin, either the inside and outside of your arm from your wrist to your shoulder and/or the midinner thigh of both legs. Spread out evenly. If the skin is still sticky after 5 minutes, the gel has not been spread out thinly enough.
• Do NOT apply on or near the breasts, or near the genital area.
• Do not allow other people to apply Oestrogel to your skin for you. Wash hands with soap and water after applying the gel.
• Apply the gel once a day, either in the morning or evening. Try to use the gel at about the same time each day.
• Do not allow others to make contact with the area of skin where you applied Oestrogel for at least one hour after application.

Dosage

• The usual daily dose is one measure (i.e., one pump of 1.25 g) of gel. Use the gel daily for 21 days (three weeks) consecutively, then stop using the gel for seven days (one week).

The doctor will prescribe a progestogen separately if you still have your womb. This will protect you from the risk of excessive thickening of the lining of the womb (endometrial hyperplasia). You will have a bleed once a month (withdrawal bleed) while using this medicine.

For more information on usage and dosage, please see the package leaflet.

Alcohol/driving

This medicine does not affect your ability to drive safely.

There are no dietary restrictions with Oestrogel.

If you use more Oestrogel than you should/stop using Oestrogel

Have you used more Oestrogel than you should? The effects of overdosing are generally breast tenderness, nervousness and vaginal bleeding. These symptoms disappear when treatment is stopped or the dose is reduced. In case of the accidental use of an excessive dose of the medicine consult your doctor or pharmacist.

If you forget to use Oestrogel:

• If it is less than 12 hours until your next dose, skip the missed dose and apply the next dose at the normal time.
• If it is more than 12 hours until your next dose, apply the gel as soon as you remember and apply the next dose at the normal time.

Want to stop using Oestrogel? The doctor will tell you how long you need to use it. It is important to follow the doctor's instructions. Do not stop using Oestrogel early without consulting a doctor first.

Oestrogel is not suitable for every female. Do not use this medicine if:

• • You have, or have had, breast cancer, or if you are suspected of having it.
  • You have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it.
  • You have any unexplained vaginal bleeding.
  • You have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated.
  • You have, or have had, a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism).
  • You have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency).
  • You have, or recently have had, a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
  • You have, or have had, a liver disease and your liver function tests have not returned to
  • normal.
  • You have a rare blood problem called porphyria which is passed down in families (inherited).
  • You are allergic (hypersensitive) to any ingredient of this medicine (see section ‘What Oestrogel contains').

If you are going to have surgery, tell the surgeon that you are using Oestrogel. You may need to stop using Oestrogel about four to six weeks before the operation to reduce the risk of a blood clot.

When should Oestrogel be used with caution?

The package leaflet tells you when you need to take special care with Oestrogel. Always consult a doctor if you are unsure if this medicine is suitable for you.

Pregnancy and breastfeeding

Oestrogel is for use in postmenopausal women only.

If you become pregnant, stop using Oestrogel and contact your doctor.

Other medicines and Oestrogel

Some medicines may interfere with the effect of Oestrogel. This might lead to irregular bleeding. This applies to the following medicines:

• • Other skin medications which change how skin is made, e.g. anticancer products.
  • Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine).
  • Medicines for tuberculosis (e.g., rifampicin, rifabutin).
  • Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir).
  • Herbal products containing St John’s wort (Hypericum perforatum).

It is important to tell your doctor if you are taking any of these medicines. You can find more information on this topic in the package leaflet.

Oestrogel may cause side effects. The most commonly reported side effects include:

• • Menstrual problems.
  • Vaginal discharge.
  • Problems affecting the stomach and intestines.
  • Headache.
  • Muscle problems.
  • Depression.
  • Nervousness.

For a list of less common or rare side effects, please see the package leaflet. The use of Oestrogel has been associated with a slightly increased risk of thrombosis and certain types of cancer. Side effects should be reported to a doctor or pharmacist.

The active substance in this medicine is estradiol. The other ingredients are: carbomer, trolamine, ethanol and purified water.

The manufacturer of Oestrogel is:

Delpharm Drogenbos SA Groot-Bijgaardenstraat 128
B-1620 Drogenbos
Belgium

Or:

Laboratoires Besins International 13 Rue Perrier
92120 Montrouge
France

Read the package leaflet before use.