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Climaval
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The patient information leaflet for Climaval is in the form of a small booklet. The text below is the information that it contains.
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What you should know about CLIMAVAL tablets
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This leaflet contains information on your medication. You should read it before you start to take the tablets. This information given is not designed to replace your doctor's instructions, but to reinforce them.
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If you are unsure about anything or have any questions, please ask your doctor or pharmacist.
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What is in your tablets?
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CLIMAVAL tablets contain the active ingredient oestradiol valerate USP, which is a natural oestrogen made from plant sources. It is available in two strengths, CLIMAVAL 1 mg tablets and CLIMAVAL 2mg tablets.
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The tablets contain the following inactive ingredients: lactose, maize starch, povidone, talc (sterilised), magnesium stearate, methylhydroxypropylcellulose, propylene glycol.
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The colouring in the tablets contains E132, E171 and E464.
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CLIMAVAL 1 mg packs contain: 28 grey-blue tablets each containing 1 mg oestradiol valerate which are marked E1 on one side.
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CLIMAVAL 2 mg packs contain: 28 blue tablets each containing 2 mg oestradiol valerate which are marked E2 on one side.
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Both strengths are available as one or three month calendar packs, with each calendar pack containing 28 tablets.
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How does CLIMAVAL work?
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CLIMAVAL tablets contain the hormone oestradiol valerate. The hormone is designed to replace the oestrogen which is lost during the decline in the function of the ovaries after the menopause. Tablets of this kind are often known as Hormone Replacement Therapy or HRT.
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Who makes CLIMAVAL?
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The licence for CLIMAVAL is held by Sandoz Pharmaceuticals (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 5SG.
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CLIMAVAL tablets are made in the United Kingdom by: Medevale Pharmaservices Ltd. Ashton-Under-Lyne, England.
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What is CLIMAVAL for?
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CLIMAVAL is designed for use by women who have had a hysterectomy. It will relieve the symptoms associated with the menopause, by replacing the hormones lost during the decline in the function of the ovaries.
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In middle age, typically between the ages of 45 and 55, a natural process occurs in women, during which the levels of female hormones found in the body decline. These hormones are produced by the ovaries and at the end of this process, which is often called the 'change of life', climacteric or menopause, the ovaries cease to function.
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After a hysterectomy, even when the ovaries are left behind, women usually experience a loss of the function of ovaries earlier than they would normally. Again, this can result in symptoms of the menopause being experienced.
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In some women, the drop in hormone levels causes certain symptoms, the best known of which are hot flushes, sweating, tiredness, sleeplessness and depression. Other symptoms include dizziness, headache, palpitations (flutterings in the chest), tingling in the hands and feet, and discomfort during sexual intercourse.
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Few women will have all of these symptoms and the number, frequency, severity and duration of them varies from one woman to another.
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Before taking your tablets
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You should read this section carefully because there are some conditions your doctor should know about before you start your treatment. Ask yourself the following questions before you start taking CLIMAVAL. If you have ever suffered or currently suffer from:
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Liver problems, for example jaundice, heart or kidney disease, clotting in blood vessels (the medical term for this is thromboembolism) e.g. in the legs or lungs, heart attack or stroke, persistent irregular bleeding from the vagina, any condition affected by hormones e.g. tumours of the breast or womb
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Remember, tell your doctor or pharmacist, if the answer is 'yes' to any of these questions.
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You should not take CLIMAVAL if you are pregnant or if you think you are pregnant and you should not breast feed while taking it.
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If you are unsure about anything, ask for advice from your doctor or pharmacist.
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Are you taking any other medicines?
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The hormone in CLIMAVAL is to supplement your own natural hormones and it is unlikely to react with other medicines. However, you should always tell your doctor about any other medicines you are taking, including ones you have bought yourself.
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Accidents, illnesses and operations
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CLIMAVAL can affect your circulation and therefore your doctor may stop your CLIMAVAL tablets if you are about to have an operation or if you suffer an injury or illness where there may be an increased risk of blood clotting or if your blood pressure rises significantly for the first time.
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Check ups whilst taking CLIMAVAL
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While you are taking CLIMAVAL you should see your doctor regularly, at least every 6 to 12 months. You should have a thorough internal (vaginal) and physical examination before and at regular times during your treatment.
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If you have mild chronic liver disease, your liver function will be checked every 8-12 weeks. Your doctor will also keep a closer eye on you if you suffer from gallstones or some diseases, including multiple sclerosis, epilepsy, migraine, diabetes, high blood pressure, hearing impairment due to bone deposits in the ear, tetany, uterine fibroids, and porphyria.
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You will also be monitored and receive regular checks from your doctor if you have any significant kidney or heart impairment.
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If a member of your family has had or is suffering from breast cancer you should tell your doctor because he or she may want to keep a careful check on you.
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It is generally recommended that all women regularly check their breasts - if you do not know how to do this, ask your doctor or practice nurse.
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How do you take CLIMAVAL?
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Whether you are taking CLIMAVAL 1 mg or CLIMAVAL 2 mg tablets, you should take one tablet each day.
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The pack has been designed specifically to help you take the tablets correctly.
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You should take one tablet each day by following the sequence of numbers and arrows below each tablet.
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Remove the tablets from the foil as shown in the picture.
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Swallow your tablets whole with a glass of water. The tablets are best taken at the same time every day, try to get into a routine. You should start your next pack of CLIMAVAL IMMEDIATELY after you have finished this one. Do not take a break between packs.
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You should follow your doctor's instructions as to how and when you should take CLIMAVAL tablets <PB n=1>
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Other effects of taking CLIMAVAL can be: dyspepsia or indigestion, wind, vomiting, abdominal or stomach pain, bloating, weight gain, palpitations (fluttering in the chest), increased libido, dizziness, vertigo, nose
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