SANDRENA 0.5MG GEL

Sandrena 0.5 mg gel Sandrena 1 mg gel
Estradiol
Package leaet: Information for the user
Read all of this leaet carefully before you start using this medicine because it contains important information for you. - Keep this leaet.You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaet. Note: Sandrena is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice. HRT and cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) Taking oestrogen-only HRT will increase the risk of excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer). Taking a progestogen in addition to oestrogen for at least 12 days of each 28 day cycle protects you from this extra risk. So your doctor will prescribe a progestogen separately if you still have your womb. If you have had your womb removed (a hysterectomy), discuss with your doctor whether you can safely take this product without a progestogen. In women who still have a womb and who are not taking HRT, on average, 5 in 1,000 will be diagnosed with endometrial cancer between the ages of 50 and 65. For women aged 50 to 65 who still have a womb and who take oestrogen-only HRT, between 10 and 60 women in 1,000 will be diagnosed with endometrial cancer (i.e. between 5 and 55 extra cases), depending on the dose and for how long it is taken. Unexpected bleeding If your doctor has prescribed you progestogen tablets in addition to Sandrena, you will usually have a bleed once a month (so-called withdrawal bleed). But, if you have unexpected bleeding or drops of blood (spotting) besides your monthly bleeding, which: carries on for more than the rst 6 months starts after you have been taking Sandrena more than 6 months carries on after you have stopped using Sandrena see your doctor as soon as possible. Breast cancer Evidence suggests that taking combined oestrogenprogestogen and possibly also oestrogen-only HRT increases the risk of breast cancer. The extra risk depends on how long you take HRT. The additional risk becomes clear within a few years. However, it returns to normal within a few years (at most 5) after stopping treatment. For women who have had their womb removed and who are using oestrogen-only HRT for 5 years, little or no increase in breast cancer risk is shown. Compare Women aged 50 to 79 who are not taking HRT, on average, 9 to 14 in 1,000 will be diagnosed with breast cancer over a 5-year period. For women aged 50 to 79 who are taking oestrogenprogestogen HRT over 5 years, there will be 13 to 20 cases in 1,000 users (i.e. an extra 4 to 6 cases). Regularly check your breasts. See your doctor if you notice any changes such as: - dimpling of the skin - changes in the nipple - any lumps you can see or feel Ovarian cancer Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years. Women aged 50 to 69 who are not taking HRT, on average about 2 women in 1,000 will be diagnosed with ovarian cancer over a 5-year period. For women who have been taking HRT for 5 years, there will be between 2 and 3 cases per 1,000 users (i.e. up to 1 extra case). Effects of HRT on heart and circulation Blood clots in a vein (thrombosis) The risk of blood clots in the veins is about 1.3 to 3 times higher in HRT users than in nonusers, especially during the rst year of taking it. Blood clots can be serious, and if one travels to the lungs, it can cause chest pain, breathlessness, fainting or even death. You are more likely to get a blood clot in your veins as you get older and if any of the following applies to you. Inform your doctor if any of these situations applies to you: you are unable to walk for a long time because of major surgery, injury or illness (see also section 3, If you need to have surgery) you are seriously overweight (BMI > 30 kg/m2) you have any blood clotting problem that needs long-term treatment with a medicine used to prevent blood clots if any of your close relatives has ever had a blood clot in the leg, lung or another organ you have systemic lupus erythematosus (SLE) you have cancer. For signs of a blood clot, see Stop using Sandrena and see a doctor immediately. Compare Looking at women in their 50s who are not taking HRT, on average, over a 5-year period, 4 to 7 in 1,000 would be expected to get a blood clot in a vein. For women in their 50s who have been taking oestrogen-progestogen HRT for over 5 years, there will be 9 to 12 cases in 1,000 users (i.e. an extra 5 cases). For women in their 50s who have had their womb removed and have been taking oestrogen-only HRT for over 5 years, there will be 5 to 8 cases in 1,000 users (i.e. 1 extra case). Heart disease (heart attack) There is no evidence that HRT will prevent a heart attack. Women over the age of 60 years who use oestrogen-progestogen HRT are slightly more likely to develop heart disease than those not taking any HRT. For women who have had their womb removed and are taking oestrogen-only therapy there is no increased risk of developing a heart disease. Stroke The risk of getting a stroke is about 1.5-times higher in HRT users than in non-users.The number of extra cases of stroke due to use of HRT will increase with age. Compare Looking at women in their 50s who are not taking HRT, on average, 8 in 1,000 would be expected to have a stroke over a 5-year period. For women in their 50s who are taking HRT, there will be 11 cases in 1,000 users, over 5 years (i.e. an extra 3 cases). Other conditions HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice. Women with a tendency to discoloration of the skin (chloasma) should minimise exposure to the sun or ultraviolet radiation whilst using Sandrena.

1. What Sandrena is and what it is used for 2. What you need to know before you use Sandrena 3. How to use Sandrena 4. Possible side effects 5. How to store Sandrena 6. Contents of the pack and other information 1. What Sandrena is and what it is used for
Sandrena is a Hormone Replacement Therapy (HRT). It contains the female hormone oestrogen. Sandrena is used for: Relief of symptoms occurring after menopause During the menopause, the amount of the oestrogen produced by a womans body drops. This can cause symptoms such as hot face, neck and chest (hot ushes). Sandrena alleviates these symptoms after menopause. You will only be prescribed Sandrena if your symptoms seriously hinder your daily life. You must talk to your doctor if you do not feel better or if you feel worse.

What is in this leaet

2. What you need to know before you use Sandrena
Medical history and regular check-ups The use of HRT carries risks which need to be considered when deciding whether to start taking it, or whether to carry on taking it. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT may be different. Please talk to your doctor. Before you start (or restart) HRT, your doctor will ask about your own and your familys medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary. Once you have started on Sandrena you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benets and risks of continuing with Sandrena. Regularly check your breasts for any changes (see Breast cancer below). Go for regular breast screening, as recommended by your doctor. Do not use Sandrena: If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before using Sandrena. Do not use Sandrena: - if you have or have ever had breast cancer, or if you are suspected of having it - if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it - if you have any unexplained vaginal bleeding - if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated - if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) - if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deciency) - if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina - if you have or have ever had a liver disease and your liver function tests have not returned to normal - if you have a rare blood problem called porphyria which is passed down in families (inherited) - if you are allergic to estradiol or any of the other ingredients of this medicine Sandrena (listed in section 6). If any of the above conditions appear for the rst time while using Sandrena, stop using it at once and consult your doctor immediately. Warnings and precautions Talk to your doctor or pharmacist before using Sandrena.Tell your doctor if you have ever had any of the following problems, before you start the treatment, as these may return or become worse during treatment with Sandrena. If so, you should see your doctor more often for check-ups: - broids inside your womb - growth of womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) - increased risk of developing blood clots (see Blood clots in a vein (thrombosis)) - increased risk of getting a oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer) - high blood pressure - a liver disorder, such as a benign liver tumour - diabetes - gallstones - migraine or severe headaches - a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) - epilepsy - asthma - a disease affecting the eardrum and hearing (otosclerosis) - a very high level of fat in your blood (triglycerides) - uid retention due to cardiac or kidney problems - hereditary angioedema. Stop using Sandrena and see a doctor immediately If you notice any of the following when taking HRT: - any of the conditions mentioned in the Do not use Sandrena section - yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease - a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) - migraine-like headaches which happen for the rst time - if you become pregnant - if you notice signs of a blood clot, such as: - painful swelling and redness of the legs - sudden chest pain - difculty in breathing For more information, see Blood clots in a vein (thrombosis).

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Other medicines and Sandrena Some medicines may interfere with the effect of Sandrena.This might lead to irregular bleeding.This applies to the following medicines: - Medicines for epilepsy (such as phenobarbital, phenytoin and carbamazepine) - Medicines for tuberculosis (such as rifampicin, rifabutin) - Medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelnavir) - Herbal remedies containing St Johns Wort (Hypericum perforatum). Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription, herbal medicines or other natural products. Laboratory tests If you need a blood test, tell your doctor or the laboratory staff that you are using Sandrena, because this medicine can affect the results of some tests. Pregnancy, breast-feeding and fertility Sandrena is for use in postmenopausal women only. If you become pregnant, stop using Sandrena and contact your doctor. Driving and using machines Sandrena has no effect on the ability to drive or use machines. Sandrena contains propylene glycol and ethanol (alcohol) Sandrena contains propylene glycol, which may cause skin irritation. Sandrena contains ethanol (alcohol): - Sandrena 0.5 mg gel contains 58.5 vol% ethanol (alcohol), i.e. up to 293 mg per dose. This is equivalent to 6 ml beer, or 3 ml wine per dose. (A teaspoon contains 5 ml). - Sandrena 1.0 mg gel contains 58.5 vol% ethanol (alcohol), i.e. up to 585 mg per dose. This is equivalent to 12 ml beer, or 5 ml wine per dose. (A teaspoon contains 5 ml). This may be harmful for those suffering from alcoholism. This should also be taken into account in HRT users with liver disease or epilepsy.

- heart disease - stroke - probable memory loss if HRT is started over the age of 65. For more information about these side effects, see section 2. During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment. Other side effects Common (affects up to 1 in 10 people): - itching of the skin, pain, increased sweating - breasts become tender or painful - increase in your weight - swollen feet and lower legs - headache, dizziness - tummy pains, feeling sick or being sick, atulence - bleeding or spotting, menstrual disorder - depression, nervousness, lethargy - hot ushes. Uncommon (affects up to 1 in 100 people): - changes to sex drive and mood, anxiety, sleeplessness, apathy, emotional instability, impaired concentration - migraine, delusion - benign breast or endometrial tumour - increased appetite - increased heart rate - constipation - acne, alopecia, dry skin - joint disorders, muscle cramps - increased urinary frequency/urgency - tender or swollen breast, abnormal growth of the lining of the womb - tiredness. Rare (affects up to 1 in 1,000 people): - hypertension - venous thromboembolism - alterations in liver function and biliary ow - rash Not known (cannot be estimated from the available data): - uterine broids - hereditary angioedema - high level of cholesterol in the blood - euphoria, agitation - trembling - abnormal vision, dry eye - cerebral circulatory disorder, supercial phlebitis, purpura - shortness of breath, rhinitis - stomach ache, bloating, digestive disturbance, diarrhoea, rectal disorder - liver disease causing yellowing of the skin - contact rash, eczema, nail disorder, skin nodule, excessive growth of hair - loss of bladder control, urinary tract infection, urine discoloration, haematuria - uterine disorder - abnormal laboratory test, weakness, fever, u syndrome, general feeling of ill health. If you have any of these side effects tell your doctor. The doctor may decide to stop your treatment for a while. Dementia HRT will not prevent memory loss. There is some evidence of a higher risk of memory loss in women who start using HRT after the age of 65. Speak to your doctor for advice. The following side effects have been reported with other HRTs: - gall bladder disease - various skin disorders: - discolouration 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). If you get any side effects, talk to your doctor or pharmacist.This includes any side effects not listed in this leaet.

3. How to use Sandrena
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. When to start using Sandrena You can start using Sandrena straight away if: - You have never used HRT before - You are changing over from a period-free HRT. Wait for your period to end if: - You are changing over from another type of HRT where you have a period. If you have not had your womb removed, your doctor will normally also prescribe another medicine containing the hormone progestogen. This is normally a tablet taken for 12 to 14 days in each monthly cycle. After each course of progestogen you will usually have a withdrawal bleed, like a period. How much to use Sandrena comes in sachets of 0.5 mg estradiol in 0.5 g of gel, or in sachets of 1 mg estradiol in 1g of gel. Each pack of Sandrena 0.5 mg gel contains only 0.5 g sachets. Each pack of Sandrena 1 mg gel contains only 1 g sachets. Use the amount of Sandrena gel that your doctor has prescribed. Your doctor will 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. The recommended dose is between 0.5 mg and 1.5 mg of estradiol a day. - Use the following number of 0.5 g or 1 g sachets depending on the dose, and the pack size prescribed by your doctor: For a 0.5 mg daily dose: Use one 0.5 g sachet. For a 1 mg daily dose: There are two options. Use one 1 g sachet or use two 0.5 g sachets. For a 1.5 mg daily dose: There are two options. Use three 0.5 g sachets or use one 0.5 g sachet with one 1 g sachet. If you are also taking progestogen tablets, take them as your doctor has told you. You will normally have a withdrawal bleed after each course of progestogen. How to apply the gel Sandrena should be rubbed gently on dry and clean skin. It should not be swallowed. Where to apply the gel - Do not apply the gel to your breasts, face or on irritated skin. - Apply the gel to your lower body or thighs. - Apply the gel to a different side of your body each day. Follow these instructions: 1. Apply the gel once a day to the skin on your lower body or thighs. 2. Spread the gel over an area 12 times the size of your hand. 3. Allow the gel to dry for a few minutes. 4. Wash your hands after applying the gel. Avoid contact of the gel with your eyes. The gel may irritate your eyes. 5. Do not wash the area where you have applied the gel for at least one hour. If you need to have surgery If you are going to have surgery, tell the surgeon that you are using Sandrena.You may need to stop using Sandrena 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 Sandrena again. If you use more Sandrena gel than you should If you use more gel than you should, talk to your doctor or pharmacist.You may feel bloated, anxious or irritable, or your breasts may feel tender. If you swallow Sandrena If you swallow Sandrena there is no need to worry. However, you should talk to your doctor. If you forget to use Sandrena - Apply the missed dose when you remember, unless you are more than 12 hours late. - If you are more than 12 hours late just skip the missed dose. - Missed doses may cause some bleeding between your periods. This is called breakthrough bleeding. If you stop using Sandrena Keep using this medicine as prescribed by your doctor. Keep using Sandrena, even if you seem to be better. If you stop too early or too suddenly your problem may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

5. How to store Sandrena
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 carton and sachet after use by. Store the gel at room temperature (below 25C). 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.

6. Contents of the pack and other information
What Sandrena 0.5 mg gel and Sandrena 1 mg gel contain - The active substance is estradiol.There is 0.5 mg (milligrams) or 1.0 mg of estradiol in each sachet. - The other ingredients are Carbopol 974P, trolamine, propylene glycol, alcohol and puried water. What Sandrena 0.5 mg gel and Sandrena 1 mg gel look like and the contents of the packs Sandrena gel is a smooth alcohol-based gel. Pack sizes: Sandrena 0.5 mg gel comes in packs of 28 or 91 sachets. Sandrena 1 mg gel comes in packs of 28 or 91 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Orion Corporation PO Box 65 FIN-02101 Espoo Finland The manufacturer is: Orion Corporation PO Box 425 FIN-02101 Turku Finland This medicinal product is authorised in the Member States of the EEA under the following names: Denmark Ercostrol France Dlidose Italy, the United Kingdom Sandrena Germany GynPolar Gel Sweden Divigel This leaet was last revised in November 2011.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using the gel and see your doctor straight away, if you notice any of the following serious side effects: - your blood pressure rises - your skin or the whites of your eyes go yellow (jaundice) - you suddenly have migraine-type headaches (see section 2) - you have signs of a blood clot (see section 2) - you get any of the problems listed in section 2. 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)