Brand Name Choices
No generic medication is available for Divigel (Estradiol)
What Divigel 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 woman’s body drops. This can cause symptoms such as hot face, neck and chest (“hot flushes”). 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.
How to take Divigel
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 progestagen. This is normally a tablet taken for 12 to 14 days in each monthly cycle. After each course of progestagen 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 progestagen tablets, take them as your doctor has told you. You will normally have a withdrawal bleed after each course of progestagen. 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 1–2 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. Nausea, vomiting and withdrawal bleeding may also occur in some women. Overdosage is unlikely with transdermal application. Treatment is symptomatic. The gel should be washed. The symptoms disappear when the treatment is stopped or when the dose is reduced. 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.
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:
•abnormal growth or cancer of the lining of the womb (endometrial hyperplasia or cancer)
•blood clots in the veins of the legs or lungs (venous thromboembolism)
•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, rash, pain, increased sweating, swollen feet and lower legs
•breasts become tender or painful
•increase or decrease in your weight
•tummy pains, feeling sick or being sick, flatulence
•bleeding or spotting, menstrual disorder
•depression, nervousness, lethargy
Uncommon (affects up to 1 in 100 people):
•changes to sex drive and mood, anxiety, sleeplessness, apathy, emotional instability, impaired concentration,euphoria, agitation
•migraine, delusion, trembling
•visual impairment, dry eye
•hypertension, superficial phlebitis, purpura
•shortness of breath, rhinitis
•benign breast or endometrial tumour
•increased appetite, high level of cholesterol in the blood
•increased heart rate
•constipation, digestive disturbance, diarrhoea, rectal disorder
•acne, alopecia, dry skin, nail disorder, skin nodule, excessive growth of hair, urticaria (a raised, itchy rash that appears on the skin), painful reddish skin nodules (erythema nodosum)
•joint disorders, muscle cramps
•increased urinary frequency/urgency, loss of bladder control, urinary tract infection, urine discoloration, haematuria
•tender or swollen breast, abnormal growth of the lining of the womb, uterine disorder
•tiredness, abnormal laboratory test, weakness, fever, flu syndrome, general feeling of ill health
•allergic (hypersensitivity) reaction.
Rare (affects up to 1 in 1,000 people):
•alterations in liver function and biliary flow
•contact lense intolerance
•pre-menstrual like syndrome. Adverse events reported post marketing with frequency not known (cannot be estimated from the available data):
•cerebral circulatory disorder
•liver disease causing yellowing of the skin
•contact rash, eczema 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
•probable dementia over the age of 65
•various skin disorders:
•discolouration of the skin especially of the face or neck known as “pregnancy patches” (chloasma)
•rash with target-shaped reddening or sores (erythema multiforme)
•purpura due to loss of integrity or function of the vessels (vascular purpura)
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Divigel
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 25°C). 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.
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