Evorel® Sequi Patch Patch

Each pack of EVOREL SEQUI contains two types of patches: • EVOREL 50 • EVOREL CONTI

EVOREL 50 patches contain an estrogen called estradiol. EVOREL CONTI patches contain estradiol and norethisterone. EVOREL SEQUI 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. The EVOREL 50 and the EVOREL CONTI patches replace the natural estrogen that is normally released by the ovaries. In women who still have a womb, using estrogen without using a progestogen regularly may cause the lining of the womb to build up and thicken, which may lead to cancer of the womb. It is necessary to shed this lining regularly to prevent any problems occurring. Adding a progestogen hormone to the estrogen treatment for approximately 2 weeks of a 4-week cycle will cause the lining to be shed to protect the womb. The shedding of the lining of the womb will produce a withdrawal bleed, so you will probably have a “period” each month starting during week 4, shortly before you finish an EVOREL SEQUI pack. EVOREL SEQUI should not be used by children. EVOREL SEQUI should not be used for contraception.

Do not use EVOREL SEQUI if:
• You are allergic (hypersensitive) to any of the ingredients in EVOREL 50 and EVOREL CONTI patches (see section 6: “ What EVOREL SEQUI contains ” below).
• You had, have or suspect that you have breast cancer.
• You have a family history of breast cancer.
• You suspect or have estrogens-dependent malignant tumours (e.g. cancer of womb lining) or pre-malignant tumours (e.g. untreated atypical womb lining overgrowth).
• 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 had or have venous thromboembolism (deep venous blood clots, blood clots in the lungs).
• You have known conditions that promote blood clotting.
• You have active or recent past stroke or 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 full and thorough physical and gynaecological examination and that your own family’s medical histories regarding thrombosis (blood clots) are taken before you start any Hormone Replacement Therapy (HRT).
• You should receive regular full medical examinations whilst using EVOREL SEQUI. A careful appraisal of the risk/benefit ratio should be undertaken before the initiation of long-term treatment. Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

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

When to use the patch
You MUST use the patches in the correct order as directed by your doctor.
• For weeks 1 and 2 you should use the EVOREL 50 patches
• As soon as you remove your last EVOREL 50 patch, replace it with one EVOREL CONTI patch
• For weeks 3 and 4 you should use the EVOREL CONTI patches. Start a new pack on EVOREL SEQUI as soon as you finish the current one. Do not leave a break between packs.

The instructions below apply to both EVOREL 50 and EVOREL CONTI patches:
• 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.

EVOREL SEQUI can cause side effects. The side effects include the following: Data from clinical trials:
Frequent:
• Depression
• Sleeplessness
• Nervousness
• Emotional incontinence (involuntary emotions)
• Headache
• High blood pressure
• Abdominal pain
• Digestive tract Disorder
• Feeling sick
• Itching
• Red skin rash
• Joint pain
• Breast pain
• Abnormal menstrual period (heavy and or prolonged)
• Painful menstruation
• Menstrual disorder (Irregular, heavy or prolonged bleeding from the vagina)
• 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
• Generalised feeling of discomfort
• Increased weight

Less frequent:
• Female breast cancer, noncancerous (benign) tumour of breast
• Low sex drive, increased sex drive.
• Disturbance in attention, dizziness
• Excessive growth of womb lining, breakthrough bleeding or spotting
• Fatigue
• Suicidal thoughts/behaviour and suicide

Store all medicines out of reach of children. EVOREL SEQUI should be stored at room temperature (i.e., at or below 25 °C). Do not freeze. Keep used and unused patches out of reach of children and pets. Put used patches in the bin you use for household rubbish. Do not flush down the toilet.

Other important information: Do not use the patches:
 After the expiry date shown on the label
 If the protective sachet/pouch is open
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).