Progynova TS general information

What is Progynova TS used for?

Progynova TS 50 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries that happens during menopause or following surgical removal of the ovaries. Progynova TS 50 patches are for postmenopausal women of more than one year post menopause, to help relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Progynova TS 50 is also used to help prevent postmenopausal bone loss (osteoporosis) and reduce risk of fracture. Progynova TS 50 stimulates the development of female sexual characteristics, and can be used as part of a transgender hormone therapy for male to female transsexuals.

How does Progynova TS work?

Progynova TS 50 is a transdermal skin patch containing the active ingredient oestradiol hemihydrate, a naturally occurring form of the major and most active form of the female hormone oestrogen. When you apply the patch to your skin, the oestradiol diffuses out of the patch through your skin and into your blood, delivering a dose of 50mcg oestradiol per day. Oestrogen is a steroid hormone produced by the ovaries that binds to specific receptors inside oestrogen-responsive cells and stimulates them to make proteins involved in producing secondary sexual characteristics, such as breast development and in regulating the menstrual cycle. Oestrogen also has several other actions in various metabolic processes including maintaining bone mass and lipid (fat) metabolism. Because the oestadiol in Progynova TS 50 enters your blood directly and continuously, it is not metabolised (broken down) by the liver, as happens when you take oral oestrogen tablets, which means that Progynova TS 50 patches are effective at a lower dose and provide more even blood levels similar to the natural release of oestrogen by the ovaries.

What does Progynova TS contain?

Progynova TS 50 contains the active ingredient oestradiol hemihydrate, the most active form of the female hormone oestrogen that is used in hormone replacement therapy (HRT). Progynova TS 50 is a transdermal delivery system (skin patch) that comprises a translucent homogenous matrix on a transparent carrier film and contains 3.9mg oestradiol in each patch, delivered at 50mcg over a 24 hour period. The patch also contains isooctyl acrylate/acrylamide/vinyl acetate copolymer, ethyl oleate, isopropyl myristate, glycerol monolaurate mounted on a polyester release liner and protected with a polyethylene backing film.

Treating symptoms of menopause with Progynova TS

Progynova TS 50 is used to substitute for the loss of oestrogen production by the ovaries that occurs during menopause and is the cause of symptoms such as hot flushes, night sweats, sleeplessness, dry vagina, headaches, mood swings, lack of concentration loss of energy and bone loss (osteoporosis). Progynova TS 50 is a transdermal delivery system (skin patch) that contains oestradiol, an active form of the female hormone oestrogen that alleviates moderate to severe menopausal symptoms.

Progynova TS for hormone replacement therapy (HRT)

Progynova TS 50 is a transdermal delivery system (skin patch) containing oestrogen that is used as a short-term hormone replacement therapy (HRT) to substitute for a lack of oestrogen production by the ovaries during the menopause. Progynova TS 50 is used to relieve symptoms of menopause caused by oestrogen deficiency, such as hot flushes, night sweats, sleeplessness, vaginal dryness, headaches, mood swings, lack of concentration and loss of energy. Progynova TS 50 is also used to help prevent postmenopausal bone loss (osteoporosis), which is also caused by lack of oestrogen, and reduce risk of fracture.

Progynova TS for transgender treatment

Progynova TS 50 can be used as part of a gender reassignment program for male to female transsexuals, by providing a source of oestradiol, the most active form of the female hormone oestrogen. Progynova TS 50 is a transdermal delivery system (skin patch) for oestrogen that stimulates the development of female secondary sexual characteristics, such as breast development and also induces metabolic changes such as fat distribution to redefine the general body shape.

What are the side effects of Progynova TS?

The most commonly reported side effects when taking Progynova TS include: itching under the patch, reddening of the skin after the patch has been removed (but this usually disappears within a few days), breast tenderness, breast pain, abdominal pain, nausea, oedema, and headache, skin rash and itching, insomnia and depression.

What are the health risks of Progynova TS?

Long-term HRT with Progynova TS 50 does have associated health risks, including an increased risk of breast cancer, endometrial cancer, stroke and deep vein thrombosis. For women with an intact uterus adding a progestogen to an oestrogen replacement regimen like Progynova TS 50 patches is recommended to reduce the risk of endometrial cancer.

When should Progynova TS not be used?

You should not use Progynova TS 50 if you:

• are allergic to oestradiol hemihydrate or any ingredients in Progynova TS
• have a past or family history of carcinoma of the breast, endometrial carcinoma or liver disease
• have deep venous thrombosis, thromboembolic disorders, cerebral vascular accident associated with oestrogen use
• abnormal genital bleeding of unknown cause
• are pregnant or planning to become pregnant
• are taking other medications that may interact with Progynova, such as anticonvulsants like phenytoin and carbamazepin, anti-infectives like rifampicin, rifabutin, nevirapine, efavirenz, some medicines to help you sleep like barbiturates or preparations containing St John's Wort

How should Progynova TS be used?

Progynova TS 50 patches can be used continually (which means you will usually have a patch on all the time) or in cycles (interrupted for one week after every 3 weeks) as recommended by your doctor. You should apply a new patch once weekly.

1. Before you apply your patch, make sure your skin is clean and dry and is not oily, broken or irritated.
2. Remove the protective liner from the adhesive side of the patch and apply the patch to your skin either on your lower abdomen, hips or buttocks (areas that remain covered) but never on your breasts. Do not put the patch on your waistline where tight clothes may rub it and avoid areas where the skin is hairy or folded or the patch may not stick.
3. Press the patch firmly in place with the palm of the hand for about 10 seconds and make sure the patch sticks well, especially around the edges.
4. Leave the patch in place for 7 days and then remove it and replace with a new patch straight away or as advised by your doctor.
5. Apply the next patch to a different part of your body as you should not use the same area of skin twice running.
6. If your patch accidentally falls off, dry your skin and reapply it or apply a new patch for the remainder of the 7 days dosing period.

How long should you use Progynova TS?

You can use your Progynova TS 50 patches continually or in cycles (interrupted for one week after every 3 weeks) for as long as recommended by your doctor.

Missed dose of Progynova TS

Progynova TS 50 patches are intended to last for 7 days. If your patch accidentally falls off, reapply it or apply a new patch for the remainder of the 7 day dosing period. If you lose a patch or forget to replace it for several days, irregular bleeding may occur. Replace the patch as soon as possible.

How should Progynova TS be stored?

You should store your Progynova TS in their protective pouch until you are about to use one. Store below 25°C in a cool dry place.