Brand Name Choices
No generic medication is available for Activella (Estradiol/Norethindrone Acetate)
What Activella is and what it is used for
Kliovance® is a continuous combined Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen and a progestagen. Kliovance® is used in postmenopausal women with at least 1 year since their last natural period. Kliovance® is used for: Relief of symptoms occurring after menopause During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Kliovance® alleviates these symptoms after menopause. You will only be prescribed Kliovance® if your symptoms seriously hinder your daily life Prevention of osteoporosis After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Kliovance® to prevent osteoporosis after menopause. Kliovance® is prescribed for women who have not had their womb removed, and whose periods stopped more than a year ago. There is only limited experience of treating women older than 65 years with Kliovance®.
How to take Activella
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are unsure. Take one tablet once a day, at about the same time each day. Once you have finished all the 28 tablets in the pack, start a new pack continuing the treatment without interruption. For further information on the use of the calendar pack, see ‘User Instructions’ at the end of the package leaflet. You may start treatment with Kliovance® on any convenient day. However, if you are switching from an HRT product when you have monthly bleeding, start your treatment straight after the bleeding has ended. Your doctor should aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough. 6 If you take more Kliovance® than you should If you have taken more Kliovance® than you should, talk to a doctor or pharmacist. An overdose of Kliovance® could make you feel sick or vomit. If you forget to take Kliovance® If you forget to take your tablet at the usual time, take it within the next 12 hours. If more than 12 hours have gone by, skip the missed dose and start again as normal the next day. Do not take a double dose to make up for a forgotten tablet. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting if you still have your womb. If you stop taking Kliovance® If you would like to stop taking Kliovance®, talk to your doctor first. Your doctor will explain the effects of stopping treatment and discuss other possibilities with you. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you need to have surgery If you are going to have surgery, tell the surgeon that you are taking Kliovance®. You may need to stop taking Kliovance® about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein (thrombosis)’). Ask your doctor when you can start taking Kliovance® again.
Possible side effects
Like all medicines, this medicine can have side effects, although not everybody gets them.
The following diseases are 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
• probable memory loss if HRT is started over the age of 65. For more information about these side effects, see section 2, ‘What you need to know before you take Kliovance®’. Hypersensitivity/allergy (uncommon side effect – affects 1 to 10 users in 1,000) Though it is an uncommon event, hypersensitivity/allergy may occur. Signs of hypersensitivity/allergy may include one or more of the following symptoms: hives, itching, swelling, difficulty in breathing, low blood pressure (paleness and coldness of skin, rapid heart beat), feeling dizzy, sweating, which could be signs of anaphylactic reaction/shock. If one of the mentioned symptoms appears, stop taking Kliovance® and seek immediate medical help.
Very common side effects (affects more than 1 user in 10)
• Breast pain or breast tenderness
• Vaginal bleeding.
Common side effects (affects 1 to 10 users in 100)
• Weight gain caused by fluid retention
• Vaginal inflammation
• Migraine, new or worse than before
• Vaginal infection with a fungus
• Depression, new or worse than before 7
• Enlargement or swelling of the breasts (breast oedema)
• Back pain
• Uterine fibroid (benign tumour), aggravation, occurrence or reoccurrence
• Swelling of arms and legs (peripheral oedema)
• Weight increase.
Uncommon side effects (affects 1 to 10 users in 1,000)
• Bloating, abdominal pain, swelling, discomfort or flatulence
• Hair loss (alopecia)
• Abnormal (male pattern) hair growth
• Itching or hives (urticaria)
• Inflammation of a vein (superficial thrombophlebitis)
• Leg cramps
• Drug ineffective
• Allergic reaction
Rare side effects (affects 1 to 10 users in 10,000)
• Blood clots in the blood vessels of the legs or the lungs (deep vein thrombosis, lung embolism).
Very rare side effects (affects less than 1 user in 10,000)
• Cancer of the lining of the womb (endometrial cancer)
• Excessive thickening of the lining of the womb (endometrial hyperplasia)
• Increase in blood pressure or worsening of high blood pressure
• Gall bladder disease, gall stones occurrence/reoccurrence or aggravated
• Excessive secretion of sebum, skin eruption
• Acute or recurring attack of oedema (angioneurotic oedema)
• Insomnia, dizziness, anxiety
• Change in sexual desire
• Visual disturbances
• Weight decreased
• Vaginal and genital itching
• Heart attack and stroke.
Other side effects of combined HRT
• gall bladder disease
• various skin disorders: – discoloration of the skin especially of the face or neck known as ‘pregnancy patches’ (chloasma) – painful reddish skin nodules (erythema nodosum) – rash with target-shaped reddening or sores (erythema multiforme) – red or purple discolorations of the skin and/or mucous membranes (vascular purpura)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Activella
Keep this medicine out of the sight and reach of children. 8 Do not use this medicine after the expiry date, which is stated on the label and outer carton after ‘EXP’. The expiry date refers to the last day of that month. Do not store above 25°C Do not refrigerate. Keep the container in the outer carton in order to protect it from light. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
2 to 3 weeks on average
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