RESTANDOL TESTOCAPS 40MG CAPSULE SOFT
Active substance: TESTOSTERONE UNDECANOATE
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Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or your pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effect gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist. In this leaflet: 1. What Restandol Testocaps are and what are they used for 2. Before you take Restandol Testocaps 3. How to take Restandol Testocaps 4. Possible side effects 5. How to store Restandol Testocaps 6. Further information 1. What Restandol Testocaps are and what are they used for Restandol Testocaps are soft oval glossy capsules which contain 40mg of testosterone undecanoate. The active substance, testosterone undecanoate is turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen. It is produced in the body by both men and women. Restandol Testocaps are used if your body does not make enough testosterone of its own, for example: impotence caused by hormonal disorders after castration or a similar problem called eunuchoidism decreased sex drive and decreased mental and physical activity certain types of infertility because you dont make enough sperm It may also be used to treat a type of bone disease (osteoporosis) caused by having too little testosterone. 2. Before you take Restandol Testocaps Do not take Restandol Testocaps If you are allergic (hypersensitive) to testosterone undecanoate or any of the ingredients of Restandol Testocaps If you have prostate cancer If you have breast cancer If you have ever had liver cancer
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Take special care with Restandol Testocaps: Extra supervision by your doctor may sometimes benecessary; particularly if you are elderly. In men over the age of45,the prostate gland will be investigated by digital rectal examination(DRE) of the prostate and by determination of the serum prostate-specific antigen (PSA) via blood tests. Tell your doctor if you have ever had: heart disease kidney disease liver disease high blood pressure epilepsy migraine prostatic complaints, such as problems passing urine cancer of the lungs, kidney, breast or bones Also tell your doctor if you are diabetic or if you are taking anticoagulants (drugs to treat blood clots) Your medication may need to be monitored more closely. Children and adolescents Safety and efficacy have not been adequately determined in children and adolescents. Extra supervision by the doctor is necessary in the treatment of young boys since male hormones may cause early sexual development and delay growth. Extra supervision by a doctor is also necessary in elderly men since male hormones may increase the size of the prostate gland. Furthermore, at regular intervals, blood tests will be doneto check the oxygen-carrying substance in your red bloodcells (hemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications. Taking other medicines Other medicines may affect how Restandol Testocaps worksor Restandol Testocaps may affect how they work. The following medicines may decrease the effect of Restandol Testocaps: antibiotics such as rifampicin anti-epileptic drugs such as barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin and primidone.
RESTANDOL TESTOCAPS
40MG CAPSULES, SOFT
Testosterone undecanoate
RA 1410 GB P4 (ref 4.0)
XXXXX/XXXXXX-X
For Position Only
Restandol Testocaps may also affect how drugs used to treat diabetes and blood clots work. Please tell your doctor or pharmacist if you are using (or intend to use anti-diabetic, anti-clotting medicines, the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): Restandol Testocaps may increase the risk of water retention, especially if your heart and liver are not working properly. Restandol testocaps may also affect the results of some laboratory tests (e.g. thyroid gland). Tell your doctor or laboratory staff that you are using Restandol Testocaps. Please tell your doctor or pharmacist if you are taking orhave recently taken any other medicines, including medicines obtained without a prescription. Taking Restandol Testocaps with food and drink Food allows testosterone undecanoate to be absorbed by your body. Therefore, Restandol Testocaps must be taken with a normalmeal. Pregnancy and breast-feeding Restandol Testocaps must not be taken during pregnancy or when you are breast feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines As far as is known Restandol Testocaps have no adverse effecton alertness or concentration. Important information about some of the ingredients of Restandol Testocaps The capsules also contain: Glycerin which is harmful in high doses and may cause headache, stomach upset or diarrhoea. Sunset yellow (E110) which can cause allergic type reactions including asthma. Allergy is more common in those people whoare allergic to aspirin. 3. How to take Restandol Testocaps Always take Restandol Testocaps exactly as your doctor has told you. You should check with your doctor or pharmacist if youare not sure.
For Position Only
Adults Usually, the dosage is 34capsules daily during the first 23weeks, followed by a gradual decrease to 13capsules daily. Look at the label on the pack to see how many capsules your doctor would like you to take each day. You must take Restandol Testocaps with a normal meal. Swallow the capsules whole without chewing, using some water or other fluid. Depending on the dose prescribed for you, take the capsules asshown in the table below. Prescribed daily dose 1 2 3 4 No. of capsules to take Morning Evening 1 0 1 1 2 1 2 2
Elderly Smaller doses, taken less often, may be given if you are elderly. Your doctor will have chosen the correct dose for you. Children Restandol Testocaps should not be given to children who have not reached puberty. If you take more Restandol Testocaps than you should: If you have taken several capsules at once, there is no need forgreat concern, however you should tell your doctor. Thecastor oil in the capsule may cause diarrhoea. If you forgot to take Restandol Testocaps: Dont worry. If you miss the morning dose and it is more than 2hoursafter breakfast, wait until lunch-time and then take the dose. Ifyoumiss the evening dose, and its more than 2hours after dinner, dont take the missed dose. Take the next morning doseas normal. Remember to always take Restandol Testocaps with food. If you have any further questions on the use of the product, askyour doctor or pharmacist. 4. Possible side effects Like all medicines, Restandol Testocaps can have side effects, although not everybody gets them.
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Mild side effects include: headache dizziness diarrhoea Other side effects that may occur during testosterone therapy are: rash nausea (feeling sick) yellowing of the skin or eyes increased or decreased sex drive depression nervousness mood disturbances muscle pain high blood pressure changes in the way your body processes fats increase in the number of red blood cells problems with your liver including liver tumours, though this is rare. allergy to sunset yellow, a colour used in the capsules. In men, enlargement of the breasts, growth of the prostate gland, worsening of the early stage of prostate cancer, difficultypassing urine, prolonged painful erection, decreased amounts of ejaculation fluid and sperm. In women, increase in facial or body hair, acne, no or lighter periods and voice changes which may not return to normal. In children, early sexual development and delayed bone growth. In a few patients stomach pain or discomfort have been reported during the use of Restandol Testocaps. If any of the side effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Restandol Testocaps Keep out of the reach and sight of children. Do not use Restandol Testocaps after the expiry date stated on the package, sachet and blister. Do not store above 30C. Do not refrigerate or freeze. Keep the blister in the outer carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
For Position Only
XXXXX/XXXXXX-X
6. Further information What Restandol Testocaps contains The active substance is testosterone undecanoate, 40mg per capsule. The other ingredients are: - castor oil, - propylene glycol laurate (E477), - gelatin, - medium-chain triglycerides, - lecithin and - printing ink Opacode WB white. - glycerin, - Sunset Yellow (E110) What Restandol Testocaps looks like and contents of the pack The capsules are transparent and orange in colour. They are oval in shape with a glossy, transparent, orange appearance. They are filled with a yellow oil. A box of Restandol Testocaps contains either 3or 6sachets. Each sachet contains a blister strip with 10capsules. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Organon Laboratories Ltd, Cambridge Science Park, Milton Road, Cambridge, CB40FL, UK Manufacturer: N.V. Organon, Kloosterstraat 6 5349AB Oss, The Netherlands Other formats: To listen to or request a copy of this leaflet in Braille, large printor audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Restandol Testocaps, 40mg Capsules, Soft Reference number 00065/0059 This is a service provided by the Royal National Institute of BlindPeople. This leaflet was last updated in April 2012
o
For Position Only
Take special care with Restandol Testocaps: Extra supervision by your doctor may sometimes benecessary; particularly if you are elderly. In men over the age of45,the prostate gland will be investigated by digital rectal examination(DRE) of the prostate and by determination of the serum prostate-specific antigen (PSA) via blood tests. Tell your doctor if you have ever had: heart disease kidney disease liver disease high blood pressure epilepsy migraine prostatic complaints, such as problems passing urine cancer of the lungs, kidney, breast or bones Also tell your doctor if you are diabetic or if you are taking anticoagulants (drugs to treat blood clots) Your medication may need to be monitored more closely. Children and adolescents Safety and efficacy have not been adequately determined in children and adolescents. Extra supervision by the doctor is necessary in the treatment of young boys since male hormones may cause early sexual development and delay growth. Extra supervision by a doctor is also necessary in elderly men since male hormones may increase the size of the prostate gland. Furthermore, at regular intervals, blood tests will be doneto check the oxygen-carrying substance in your red bloodcells (hemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications. Taking other medicines Other medicines may affect how Restandol Testocaps worksor Restandol Testocaps may affect how they work. The following medicines may decrease the effect of Restandol Testocaps: antibiotics such as rifampicin anti-epileptic drugs such as barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin and primidone.
RESTANDOL TESTOCAPS
40MG CAPSULES, SOFT
Testosterone undecanoate
RA 1410 GB P4 (ref 4.0)
XXXXX/XXXXXX-X
For Position Only
Restandol Testocaps may also affect how drugs used to treat diabetes and blood clots work. Please tell your doctor or pharmacist if you are using (or intend to use anti-diabetic, anti-clotting medicines, the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma): Restandol Testocaps may increase the risk of water retention, especially if your heart and liver are not working properly. Restandol testocaps may also affect the results of some laboratory tests (e.g. thyroid gland). Tell your doctor or laboratory staff that you are using Restandol Testocaps. Please tell your doctor or pharmacist if you are taking orhave recently taken any other medicines, including medicines obtained without a prescription. Taking Restandol Testocaps with food and drink Food allows testosterone undecanoate to be absorbed by your body. Therefore, Restandol Testocaps must be taken with a normalmeal. Pregnancy and breast-feeding Restandol Testocaps must not be taken during pregnancy or when you are breast feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines As far as is known Restandol Testocaps have no adverse effecton alertness or concentration. Important information about some of the ingredients of Restandol Testocaps The capsules also contain: Glycerin which is harmful in high doses and may cause headache, stomach upset or diarrhoea. Sunset yellow (E110) which can cause allergic type reactions including asthma. Allergy is more common in those people whoare allergic to aspirin. 3. How to take Restandol Testocaps Always take Restandol Testocaps exactly as your doctor has told you. You should check with your doctor or pharmacist if youare not sure.
For Position Only
Adults Usually, the dosage is 34capsules daily during the first 23weeks, followed by a gradual decrease to 13capsules daily. Look at the label on the pack to see how many capsules your doctor would like you to take each day. You must take Restandol Testocaps with a normal meal. Swallow the capsules whole without chewing, using some water or other fluid. Depending on the dose prescribed for you, take the capsules asshown in the table below. Prescribed daily dose 1 2 3 4 No. of capsules to take Morning Evening 1 0 1 1 2 1 2 2
Elderly Smaller doses, taken less often, may be given if you are elderly. Your doctor will have chosen the correct dose for you. Children Restandol Testocaps should not be given to children who have not reached puberty. If you take more Restandol Testocaps than you should: If you have taken several capsules at once, there is no need forgreat concern, however you should tell your doctor. Thecastor oil in the capsule may cause diarrhoea. If you forgot to take Restandol Testocaps: Dont worry. If you miss the morning dose and it is more than 2hoursafter breakfast, wait until lunch-time and then take the dose. Ifyoumiss the evening dose, and its more than 2hours after dinner, dont take the missed dose. Take the next morning doseas normal. Remember to always take Restandol Testocaps with food. If you have any further questions on the use of the product, askyour doctor or pharmacist. 4. Possible side effects Like all medicines, Restandol Testocaps can have side effects, although not everybody gets them.
For Position Only
Mild side effects include: headache dizziness diarrhoea Other side effects that may occur during testosterone therapy are: rash nausea (feeling sick) yellowing of the skin or eyes increased or decreased sex drive depression nervousness mood disturbances muscle pain high blood pressure changes in the way your body processes fats increase in the number of red blood cells problems with your liver including liver tumours, though this is rare. allergy to sunset yellow, a colour used in the capsules. In men, enlargement of the breasts, growth of the prostate gland, worsening of the early stage of prostate cancer, difficultypassing urine, prolonged painful erection, decreased amounts of ejaculation fluid and sperm. In women, increase in facial or body hair, acne, no or lighter periods and voice changes which may not return to normal. In children, early sexual development and delayed bone growth. In a few patients stomach pain or discomfort have been reported during the use of Restandol Testocaps. If any of the side effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Restandol Testocaps Keep out of the reach and sight of children. Do not use Restandol Testocaps after the expiry date stated on the package, sachet and blister. Do not store above 30C. Do not refrigerate or freeze. Keep the blister in the outer carton. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
For Position Only
XXXXX/XXXXXX-X
6. Further information What Restandol Testocaps contains The active substance is testosterone undecanoate, 40mg per capsule. The other ingredients are: - castor oil, - propylene glycol laurate (E477), - gelatin, - medium-chain triglycerides, - lecithin and - printing ink Opacode WB white. - glycerin, - Sunset Yellow (E110) What Restandol Testocaps looks like and contents of the pack The capsules are transparent and orange in colour. They are oval in shape with a glossy, transparent, orange appearance. They are filled with a yellow oil. A box of Restandol Testocaps contains either 3or 6sachets. Each sachet contains a blister strip with 10capsules. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Organon Laboratories Ltd, Cambridge Science Park, Milton Road, Cambridge, CB40FL, UK Manufacturer: N.V. Organon, Kloosterstraat 6 5349AB Oss, The Netherlands Other formats: To listen to or request a copy of this leaflet in Braille, large printor audio please call, free of charge: 08001985000(UK only) Please be ready to give the following information: Product name Restandol Testocaps, 40mg Capsules, Soft Reference number 00065/0059 This is a service provided by the Royal National Institute of BlindPeople. This leaflet was last updated in April 2012
o
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
