Progynova Transdermal (TS) Patch

Progynova TS 50 is a hormone replacement therapy (HRT). It contains the female hormone oestrogen. Progynova TS 50 is used in postmenopausal women with at least 12 months (one year) since their last natural period.

Progynova TS 50 is used for:

Relief of symptoms occurring after menopause. You will only be prescribed Progynova TS 50 if your symptoms seriously hinder your daily life.

If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Progynova TS 50 to prevent osteoporosis after menopause.

Always apply Progynova TS 50 exactly as your doctor has told you.

Progynova TS 50 has two methods of administration:

• Continuous use: Apply one patch per week. Remove this patch after seven days and apply a fresh patch to a different site on your body.
• Cyclical use (includes a gap week): Apply one patch for three weeks. Take a seven-day break and then start again with the next patch.

You will have a bleed once a month (so-called withdrawal bleed) while using Progynova TS 50.

Your doctor will tell you how long you should apply Progynova TS 50 for and whether you should have a gap week (no patch for seven days). Do not start using Progynova TS 50 until at least 12 months after your last natural period.

Progynova TS 100 patches are also available. Your doctor will tell you which strength you need to use.

Applying the patch

Place the patch, sticky side down, on a clean, dry area of the skin of your lower abdomen or buttocks. Do not apply Progynova TS 50 patches to the breasts.

See the package leaflet for more information on dosage and use. Follow these instructions closely.

Do not use Progynova TS 50 if:

• You have or have ever had breast cancer, or if you are suspected of having it.
• You have a 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 has not been treated.
• You have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep vein thrombosis) or in the 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.
• If you have or have ever had a liver disease and your liver function tests have not yet returned to normal.
• You have a rare blood problem called ‘porphyria' which is passed down in families (inherited).
• You are allergic (hypersensitive) to oestrogens or any of the other ingredients in Progynova TS 50.

If any of the above conditions appear for the first time while using Progynova TS 50, stop

using it at once and consult your doctor immediately.

When to take special care with Progynova TS 50

In some cases, special care should be taken when using Progynova hormone patches. More frequent health checks may be required. For example, if you have:

• Fibroids inside your womb.
• Growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia).
• Increased risk of developing blood clots (see the package leaflet for more information).
• Increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer).
• High blood pressure.
• A liver disorder, such as benign liver tumour.
• Diabetes.
• Gallstones.
• Migraine or severe headaches.

This list is not exhaustive. For a complete list of precautions, see the package leaflet.

Note: there are more warnings and precautions associated with HRT and the use of Progynova TS. All risks and precautions are listed in the package leaflet. Always consult a doctor if you are unsure if Progynova TS is suitable for you.

Other medicines and Progynova TS 50

Some medicines may interfere with the effect of Progynova TS 50. This might lead to irregular bleeding. For a list of these medicines, please see the package leaflet.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products.

• If you are going to have surgery, tell the surgeon that you are using Progynova TS 50. You may need to stop using Progynova TS 50 about four to six weeks before the operation to reduce the risk of a blood clot.
• Progynova TS 50 is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy.

Hormone patches are not suitable for everyone. Therefore, Progynova TS is available on prescription only. A doctor can write a prescription for Progynova TS 50 after an online consultation.

What do Progynova TS 50 patches cost? The current price of Progynova TS is listed on our order page. The price includes the cost of the online consultation and a service fee.

Like all medicines, Progynova TS 50 can cause side effects, although not everybody gets them. The following diseases have been reported more often in women using HRT compared to women not using HRT:

• Breast cancer.
• Abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer).
• Ovarian cancer.
• Blood clots in the veins of the legs or lungs (venous thromboembolism).
• Heart disease.
• Stroke.
• Probable loss of memory if HRT is started over the age of 65.

For more information about these side effects see the package leaflet.

Other side effects:

Most frequent side effects:

• Breakthrough bleeding at unexpected times (see the package leaflet for more information).
• Breast tenderness.
• Breast pain.

These side effects occur during the first few months of treatment with Progynova TS 50. They are usually temporary and normally disappear with continued treatment. If they do not, contact your doctor.

Common side effects (may affect between 1 and 10 in every 100 patients):

• Depression, dizziness, nervousness, lack of energy, increased sweating, hot flashes.
• Headache.
• Wind, nausea.
• Itching or rash at the site of application.
• Fluid retention, weight gain.
• Irregularities in your menstrual period, changes in vaginal discharge.
• Generalised pain.

This list is not exhaustive. For a complete list of side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in the leaflet.

What Progynova TS 50 contains

The active substance is estradiol hemihydrate. Each 12.5 cm2 patch contains 3.8 mg estradiol (from 3.9 mg estradiol hemihydrate), releasing 50 micrograms of estradiol per 24 hours.

What Progynova TS 100 contains

The active substance is estradiol hemihydrate. Each 25 cm2 patch contains 7.6 mg estradiol (from 7.8 mg estradiol hemihydrate), releasing 100 micrograms of estradiol per 24 hours.

Other ingredients in Progynova TS 50/Progynova TS 100:

The other ingredients are: isooctyl acrylate, acrylamide, vinyl acetate copolymer, ethyl

oleate, isopropyl myristate and glycerol monolaurate on a polyester release liner protected by a backing film.