Evorel® Conti Patch Patch

EVOREL CONTI patches contain estradiol and norethisterone. EVOREL CONTI is used for hormone replacement therapy (HRT) in the treatment of symptoms of the menopause, such as hot flushes and vaginal dryness in women who still have a womb.

In women who still have a womb, using estrogen regularly without using a progestogen may cause the lining of the womb to build up and thicken, which may lead to cancer of the womb. Adding a progestogen hormone to the estrogen treatment prevents this build-up of the lining of the womb. That is why the EVOREL CONTI patches also contain the progestogen, norethisterone acetate. EVOREL CONTI does not cause a regular monthly period in the majority of women. EVOREL CONTI should not be used by children. EVOREL CONTI should not be used for contraception.

Do not use EVOREL CONTI if

• You are allergic (hypersensitive) to any of the ingredients in EVOREL CONTI patches (see section 6: “What EVOREL CONTI contains” below).
• You had, have or suspect that you have breast cancer.
• You have a family history of breast cancer.
• You have genital tract cancer or other cancers known to be sensitive to estrogens.
• You have undiagnosed vaginal bleeding.
• You are pregnant or breastfeeding.
• You have liver disease or a history of liver disease as long as liver function tests have not returned to normal.
• You have or have had blood clots (thrombosis) or inflammation of veins (thrombophlebitis) or have, a family history thereof.
• You have active or previous arterial thrombotic disease (e.g. stroke, heart attack).
• You have porphyria.
• You have depression, which is not well controlled with treatment.
• You have had depression with previous use of estrogen and/or progesterone/progestogen containing medicines.

Warnings and precautions

Medical check-ups

• It is important that you have a full and thorough physical and gynaecological examination and that your own family’s medical histories regarding thrombosis (blood clots) are taken before you start EVOREL CONTI.
• You should receive regular full medical examinations whilst using EVOREL CONTI.

Before you use EVOREL CONTI, tell you doctor if:

• You are known to have inherited genetic changes called “BRCA1 and/or BRCA2 genes”.
• You started your menstrual periods before the age of 12 years.
• You have a history of non-cancerous breast diseases such as atypical hyperplasia or lobular carcinoma in situ.
• You had any previous treatment using radiation therapy to the chest or breast.
• You have been treated or exposed while in your mother’s womb to a medicine called diethylstilboestrol (DES).
• You are on treatment for depression.
• You have had depression with previous use of estrogen and/or progesterone/progestogen containing medicines.
• You have a substance abuse problem.
• You have underlying psychiatric disorder such as post-traumatic stress disorder or bipolar disorder.
• You have a family history of mental disorders.
• You have a history of physical or sexual abuse.

If you have any of the following, you may still be able to use EVOREL CONTI, but you should discuss this with your doctor first. He/she may need to see you more regularly for monitoring purposes whilst you are using EVOREL CONTI.

Do not share medicines prescribed for you with any other person. Always use EVOREL CONTI exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. EVOREL CONTI treatment should not be continued for longer than 5 years.

When to use the patch

There are enough hormones in each patch to last for several days but to ensure a steady supply to the body, the patches must be changed at 3 or 4-day intervals. To make it easy to remember when this should be done, keep to the same two days every week. This will mean that one patch is on for three and the other for four days. For example, if you use your first patch on a Monday, it should be changed on Thursday and again on the following Monday.

You can work out the two days of your own schedule from the following table, starting from the first day of use:

To help you to remember your “two patch change” days, mark them as shown:

Mon Tues Wed Thur Fri Sat Sun
Thur Fri Sat Sun Mon Tues Wed

How to put the patch on

The patch should be applied to clean, dry skin but not on top of cuts, spots or other skin blemishes or on an area where you have just applied cream, moisturiser or talc. The EVOREL CONTI patch should be applied to the skin as soon as it is removed from the wrapper and applied as described below:

1. Tear open the wrapper, first between the “V’s” along one edge and then along the other edge. Take out the patch.
2. With the backing foil facing you, bend the patch and peel off one half of the foil. Do not touch the sticky side of the patch otherwise it may not stick properly.
3. Apply the open half of the patch to your skin, remove the other half of the foil and press down the rest of the patch.
4. Press the patch with the palm of your hand to ensure it is firmly stuck to the skin.
5. To remove, peel away an edge of the patch and pull smoothly away from the skin.
6. You may use soap and water to help remove any gum/glue, which may remain on your skin after patch removal.

Where to place the patch

Stick the patch onto a hairless area of skin below the waist. Most women prefer to wear the patch on the thigh or bottom. It should never be worn on or near the breasts. Although it can be worn underneath clothing, it should not be placed under elasticized waistbands. The patch should not be placed on the same area of skin twice in a row.

What if the patch falls off?

Just apply a new patch and keep to your original “patch change” days.

Can I wash, bath or shower as normal?

YES, but do not scrub too hard in case you loosen the edges of the patch.

Can I go swimming with the patch on?

YES, the patch will not be affected.

Can I exercise or play sports?

YES, but try to avoid wearing it under tight clothing or waistband.

Can I sunbathe with the patch on?

YES, but keep the patch covered to avoid direct sunlight.

What if I am allergic to the patch?

As with normal sticking plaster, allergic reactions to the patch are unlikely. However, should you have such a reaction, please consult your doctor.

Does the patch work as a contraceptive?

NO, the levels of hormone supplied by the EVOREL CONTI patch are too low for it to do this. Although menopausal women face an ever-decreasing risk of pregnancy, normal precautions should be taken during intercourse. If in doubt, talk to your doctor.

EVOREL CONTI can cause side effects. Side effects include the following:

Frequent:

• Sudden swelling of the face or throat which may cause difficulty in swallowing or breathing. This may be a sign of an allergic reaction
• Depression
• Nervousness
• Anxiety
• Sleeplessness
• Headache
• Sensation of tingling, burning, pricking or numbness of the body
• Abnormal heart beat
• High blood pressure
• Widening of blood vessels
• Varicose veins
• Stomach pain
• Feeling sick
• Red rash
• Joint pain
• Back pain
• Menstrual disorder (Irregular, heavy or prolonged bleeding from the vagina)
• Breast pain
• Bleeding at irregular intervals
• Genital discharge
• Small, fingerlike growths of opening of vagina (cervical polyps)
• Painful periods
• Excessive proliferation of the cells of the inner lining of the womb
• Abnormally heavy and prolonged menstrual period at regular intervals
• Application site reaction – this includes sensitivity, redness, swelling and/or itchiness on the skin where the patch was placed
• Swelling may occur on the skin where the patch was placed
• Tiredness
• Pain
• Weight gain

Less frequent:

• Decreased sex drive
• Suicidal thoughts/behaviour and suicide
• Itching
• Swelling may occur on the skin where the patch is placed
• Genital/ vaginal fungal thrush
• Breast cancer
• Dizziness; epilepsy
• Formation of a blood clot inside a blood vessel
• Frequent and loose watery stools with excessive gas in stomach or intestines
• Muscle pain
• Vaginal thrush
• Abnormal growth of breast tissue, endometrial cancer
• Mood swings
• Stroke, dizziness, migraine
• Deep vein blood clots
• Clots in the lungs
• Abdominal enlargement
• Gall stones
• Severe skin and mucous membrane rash (Stevens-Johnson Syndrome)
• Breast enlargement

If you develop skin rashes or irritation where you applied the patch, remove the patch and ask your doctor for advice. Not all side effects reported for EVOREL CONTI are included in this leaflet. Should your general health worsen or if you experience any other untoward effects while using this medicine, please consult your health care provider for advice. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of EVOREL CONTI.

Store all medicines out of reach of children. Store at or below 25 °C. Do not freeze. Return all unused medicine to your pharmacist. Do not dispose unused medicine in drains or sewerage systems (e.g. toilets).

Other important information: Do not use the patches:

• After the expiry date shown on the label
• If the protective sachet/pouch is open