Brand Name Choices
No generic medication is available for Climara (Estradiol Hemihydrate)
What Climara is and what it is used for
Progynova TS 100 is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Progynova TS 100 is used in postmenopausal women with at least 12 months (1 year) since their last natural period. Progynova TS 100 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”). Progynova TS 100 alleviates these symptoms after menopause. You will only be prescribed Progynova TS 100 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 Progynova TS 100 to prevent osteoporosis after menopause.
How to take Climara
Always apply Progynova TS 100 exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how long you should apply Progynova TS 100 for and whether you should have a gap week (no patch for 7 days). Do not start using Progynova TS 100 until at least twelve months after your last natural period. Applying the patch Remove the protective liner from 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 100 patches to the breasts. Apply the patch to a different site every time. Never apply the patch to the same place twice in a row. Do not choose an area that is oily, damaged or irritated. Avoid the waistline since tight clothing may rub the patch off. Apply the patch immediately after opening the pouch and removing the protective liner. Press the patch firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. Change the patch v019_0 once a week. If the patch is applied correctly, you can bath or shower as usual. However, the patch might come off in very hot bath water or in the sauna. If you have been taking other HRT preparations: carry on until you have finished your current pack and have taken all the treatment for that month. Start with the first Progynova TS 100 patch the next day. Do not leave a break between your old tablets and Progynova TS 100. If you have been using HRT treatment with a gap week: start Progynova TS 100 immediately after the gap days. If this is your first HRT treatment: you can start using Progynova TS 100 any day. Continuous use: Apply 1 patch per week. Remove this patch after 7 days and apply a fresh patch to a different site on your body. Cyclical use (includes a gap week): Apply 1 patch per week for 3 weeks. Take a 7-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 100. If you apply more Progynova TS 100 than you should Only apply one patch at a time. If you apply more by mistake you may feel sick, throw up or have some menstruation-like bleeding. If this happens remove the patches. No specific treatment is necessary but you should consult your doctor or pharmacist if you are concerned. If a patch falls off or if you forget to apply Progynova TS 100 If a patch falls off before 7 days are up, it may be reapplied. If necessary, you can apply a new patch for the rest of the 7 days. If you forget to replace the patch for several days you might have breakthrough bleeding and spotting. If you stop using Progynova TS 100 You may begin to feel the usual symptoms of the menopause again, which may include hot flushes, trouble sleeping, nervousness, dizziness or vaginal dryness. Consult your doctor or pharmacist if you are considering stopping your Progynova TS 100 treatment. If you need to have surgery If you are going to have surgery, tell the surgeon that you are using Progynova TS 100. You may need to stop using Progynova TS 100 about 4 to 6 weeks before the operation to reduce the risk of a blood clot (see section 2, ‘Blood clots in a vein’). Ask your doctor when you can start using Progynova TS 100 again. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine 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 v019_0
• probable loss of memory if HRT is started over the age of 65 For more information about these side effects see Section 2. The following is a list of side effects that have been linked to the use of Progynova TS 100: Most frequent side effects:
• breakthrough bleeding at unexpected times (see also section 2 ’HRT and cancer’)
• breast tenderness
• breast pain These side effects occur during the first few months of treatment with Progynova TS 100. They are usually temporary and normally disappear with continued treatment. If they do not, contact your doctor.
Common side effects (may affect up to 1 in 10 people):
• depression, dizziness, nervousness, lack of energy, increased sweating, hot flushes
• wind, nausea
• itching or rash at the site of application
• fluid retention, weight gain
• irregularities in your menstrual period, changes in vaginal discharge
• generalized pain
Uncommon side effects (may affect up to 1 in 100 people):
• increase in blood cholesterol
• anxiety, inability to sleep, apathy, mood swings, poor concentration, extreme feelings of euphoria, tremor, agitation, altered sex drive
• pins and needles
• visual disturbance, dry eye
• superficial inflammation of the veins (phlebitis), high blood pressure
• breathlessness, runny or blocked nose
• increased appetite, constipation, indigestion, diarrhoea, rectal disorder
• unusual bleeding or bruising under the skin (purpura)
• acne, hair loss, dry skin, nail problems, small skin swellings, excessive hair growth
• joint pain, muscle cramps
• increased and frequent urge to pass urine, urinary incontinence, bladder infections (cystitis), discoloured urine, blood in the urine
• benign growths in the lining of the womb, thickening of the lining of the womb, problems with the womb, swollen breasts, tender breasts
• tiredness, irregular blood tests, high temperature, lack of energy, feeling generally unwell Additional side effects reported by healthcare professionals:
• reduced oxygen flow to the brain or to a section of the brain (see Section 2 ‘Stroke’)
• abdominal pain, bloating, yellowing of the skin or eyes (jaundice)
• contact dermatitis
• fibroids v019_0
The following side effects have been reported with other HRTs:
• gall bladder disease
• a variety of skin disorders: o discoloration of the skin especially of the face and neck known as “Pregnancy patches” (chloasma) o painful reddish skin nodules (erythema nodosum) o rash with target-shaped reddening or sores (erythema multiforme) If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Climara
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after "EXP". The expiry date refers to the last day of that month. Store your patches in the original packaging to protect from moisture. Store below 30°C. After use the patch still contains the active ingredient, which may have harmful effects on the environment. Therefore, the used patch should be discarded carefully. Fold any used or unused patches in half, sticky side together, and dispose of them in household rubbish. 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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