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Package leaflet: information for the user Remifemin 2.5 mg tablets for use in menopausal women dry extract from Cimicifuga rhizome Read all of this leaflet carefully before you start taking this medicine because it contains important information. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects talk to your doctor or pharmacist. This include any possible side effects not listed in the leaflet. See section 4. • You must talk to a doctors if you do not feel better or if you feel worse after 4 to 6 weeks. What is in this leaflet 1. What Remifemin is and what it is used for 2. What you need to know before you take Remifemin 3. How to take Remifemin 4. Possible side effects 5. How to store Remifemin 6. Contents of the pack and other information 1. What Remifemin is and what it is used for Remifemin is an herbal medicine used to relieve menopausal complaints. Remifemin is used for relief of psychological and neurovegetative complaints due to menopause such as hot flushes, sweating, and sleeping disorders. 2. What you need to know before you take Remifemin Do not take Remifemin if you are hypersensitive (allergic) to Cimicifuga rhizome (Black Cohosh rootstock) or any of the other ingredients of this medicine listed in section 6. Warnings and precautions Be careful when using Remifemin: - if you experience any unusual menstrual problems or your menstruation reappears. Also, if unclear symptoms persist or new symptoms appear, you should consult a doctor. In these cases, there may be an illness that needs to be investigated by a doctor. - if you take estrogens at the same time. This should only take place under medical supervision. Remifemin may intensify the effect of the estrogens. Consult your doctor. - if you already have liver injury. Then Remifemin should only be taken after consultation with your doctor. This is the English translation of the German patient information. - if symptoms suggesting a liver injury (yellowing of the skin or eyes, dark urine, upper stomach pain, nausea, loss of appetite, tiredness) occur. You should immediately stop taking Remifemin and consult a doctor. - if you have been treated or you are undergoing treatment for breast cancer or other hormone-dependent tumors, you should not use Remifemin without medical advice. - if the symptoms worsen during the use of Remifemin, you should consult a doctor or a pharmacist. Taking Remifemin with other medicines: There are no known interactions. Please, however, tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines. Pregnancy and breast-feeding: Safety during pregnancy and breast-feeding cannot be assessed due to insufficient data. Therefore, the use during pregnancy and breast-feeding is not recommended. Women of childbearing potential should consider an effective method of contraception during treatment. Driving and using machines: No studies have been conducted on the ability to drive and use machines. No negative effects are known. Remifemin contains milk sugar (lactose). Therefore, contact your doctor before taking Remifemin if you know that you have an intolerance of certain sugars. 3. How to take Remifemin Always take this medicine exactly as described in this package leaflet or as your doctor or pharmacist have told you. Please check with your doctor or pharmacist if you are not sure. The recommended dose is: Twice daily (morning and evening) 1 tablet to be taken unchewed with a small amount of liquid. (Do not suck on the tablet.) The tablets do not need to be taken with a meal. The score-line is not to be used to split the tablet. Due to the therapeutic indication, the use in children, adolescents, and men is not intended. There is insufficient data available for specific dosage recommendations for impaired kidney/liver function. Duration of treatment: Remifemin does not reveal its effect immediately. The first therapeutic effects are apparent after two weeks of treatment. It is advisable to take Remifemin for several months but not longer than six months without medical advice. If you take more Remifemin than you should: An overdose of Remifemin could worsen the possible side effects. If this happens, you should stop taking the medicine and consult a doctor. If none of these side effects occur, continue taking the usual dose at the usual time.