TRANDOLAPRIL 2MG CAPSULES
Active substance: TRANDOLAPRIL
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The number of capsules that you will need to take will depend on what you are treated for. If you are already taking diuretics your doctor may tell you to reduce the dose of the diuretic or even tell you to stop taking them, before you start to take Trandolapril capsules. Adults: High blood pressure (hypertension): The usual starting dose is 0.5mg once a day. Your doctor will probably increase this dose to 1-2mg daily. The maximum dose is 4mg a day. Patients with heart failure: The hospital will initiate your treatment. The usual starting dose is 0.5mg once a day. Treatment following a heart attack: Treatment will normally be started quite as early as the third day after a heart attack, usually at a low dose of 0.5mg each day. Your doctor will probably increase this dose gradually to a maximum of 4mg each day. Dose for adults treated earlier with diuretics (water tablets): The diuretic treatment (water tablets) should be discontinued at least 72 hours (3 days) before beginning treatment with Trandolapril capsules, and/or treatment may be started with 0.5mg once daily. Afterwards the dose will be adjusted when your doctor sees the effect of the treatment. The elderly: It is not necessary to reduce the dose if you have normal kidney function. You must start with a low dose, and your doctor will watch your blood pressure and measure your kidney function during treatment. However, caution is needed if at the same time you are being treated with diuretics (water tablets) or you have reduced heart, liver or kidney function. Children: Trandolapril should not be given to children. Patients with kidney problems: Your doctor will adjust your dose depending on the results of your laboratory tests (0.5-1mg daily). Patients in kidney dialysis: 0.5mg daily. Patients with liver problems: The initial dose is 0.5mg daily. Afterwards your doctor may adjust your dose as needed. If you take more Trandolapril capsules than you should Contact your doctor, hospital or pharmacy, if you have taken too much of this medicine and you feel uncomfortable. The symptoms of overdose are severely reduced blood pressure, shock (swelling in the mouth and throat which causes difficulty breathing contact your doctor), slowing down of thought processes (lethargy), slow pulse, disturbances in the salt balance and reduced kidney function. If you forget to take Trandolapril capsules Do not take a double dose to make up for a forgotten dose. If you stop using Trandolapril capsules It is important that you keep taking the capsules until your doctor tells you to stop. Do not stop just because you feel better. If you stop taking the capsules, your condition may get worse. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Trandolapril capsules can cause side effects, although not everybody gets them. Stop taking Trandolapril and contact your doctor immediately if you experience any of the following: allergic reactions such as sudden wheeziness, tightness in the chest, difficulty swallowing, swelling of eyelids, face or lips, a skin rash such as red spots or hives (skin lumps) or itching. kidney problems, severe drops in blood pressure with symptoms such as fainting, chest pain or stroke. Tell your doctor or pharmacist if you notice any of the following effects: Very common side effects (occur in more than 1 out of 10 treated) and common side effects (occur in between 1 and 10 out of 100 treated): Reduced blood pressure. Common side effects (occur in between 1 and 10 out of 100 treated): Dizziness, headache, weakness and cough. Uncommon side effects (occur in between 1 and 10 out of 1,000 treated): Noticeable heartbeats. Nausea. Itching and skin rash, feeling sick and/or being sick. Rare side effects (occur in between 1 and 10 out of 10,000 treated) and very rare side effects (occur in fewer than 1 out of 10,000 treated): Nervousness, difficulties sleeping, sleepiness moving towards loss of consciousness. Throat irritation, nosebleed. Vomiting, stomach pain,
AAAE1470
diarrhoea, constipation, indigestion. Fluid retention (oedema), tendency to sweat, nettle rash. Muscle pain. Hot flashes. Side effects with unknown frequency: Changes to blood test parameters such as liver enzymes, creatinine and urea. Increased levels of potassium in the blood. Bleeding in the brain, muscular paralysis, temporary loss of consciousness. Shortness of breath, bronchitis. Dry mouth, inflammation in the pancreas. Hair loss. Severe skin diseases (including Erythema multiforme and Stevens-Johnsons syndrome). Fever. Blood disorders such as agranulocytosis (a condition in which there is an insufficient number of white blood cells and therefore infections can occur), leucopenia (reduction in the number of white blood cells), pancytopenia (a reduction of all types of blood cells, including red and white blood cells as well as platelets) and decreased amount of oxygen-carrying protein in the blood (haemoglobin) and haematocrit (the proportion of space red blood cells take up in the blood). If you suffer from any of these side effects or any other side effects not mentioned in this leaflet, please talk to your doctor or pharmacist. 5. HOW TO STORE TRANDOLAPRIL CAPSULES Keep out of the reach and sight of children. Store in the original package in order to protect from light and moisture. Store below 30oC. Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. 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. 6. FURTHER INFORMATION What Trandolapril capsules contain The active substance is trandolapril 0.5mg, 1mg, 2mg or 4mg. The other ingredients are: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, dimeticone, magnesium stearate, colloidal anhydrous silica, gelatin, titanium dioxide (E171) and erythrosine (E127). In addition, each strength also contains the following: 0.5mg: sunset yellow (E110), quinoline yellow (E104) 1mg: sunset yellow (E110) 2mg: sunset yellow (E110) 4mg: red iron oxide (E172) and yellow iron oxide (E172) What Trandolapril capsules look like and contents of the pack 0.5mg: light scarlet rich yellow, size 2 oblong capsules 1mg: light scarlet light orange, size 2 oblong capsules 2mg: light scarlet light scarlet, size 2 oblong capsules 4mg: swedish orange swedish orange, size 2 oblong capsules Contents: 0.5mg, 1mg, 2mg and 4mg: 14, and 28 capsules. Marketing Authorisation Holder Actavis Group PTC ehf Reykjavkurvegi 76-78 IS-220 Hafnarfjrur Iceland Manufacturer Pharmathen S.A., 6, Dervenakion str. Pallini Attikis 153 51 Greece Pharmathen International S.A. Sapes Industrial Park Block 5 69300 Rodopi Greece For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Actavis, Barnstaple, EX32 8NS, UK Telephone: 01271 311257 This leaflet was last revised in August 2012
Trandolapril 0.5mg, 1mg, 2mg and 4mg Capsules
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. 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. 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 effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Trandolapril capsules are and what they are used for 2. Before you use Trandolapril capsules 3. How to use Trandolapril capsules 4. Possible side effects 5. How to store Trandolapril capsules 6. Further information 1. WHAT TRANDOLAPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR Trandolapril, the active ingredient in Trandolapril capsules belongs to a group of medicines called angiotensin-converting enzyme inhibitors (sometimes called ACE inhibitors). ACE inhibitors work by relaxing the blood vessels which makes it easier for the heart to pump blood around the body. This helps to lower the blood pressure. Trandolapril capsules are used to treat high blood pressure.They may also be used to protect the heart after a heart attack. 2. BEFORE YOU USE TRANDOLAPRIL CAPSULES Do not use Trandolapril capsules if: You are allergic to trandolapril, other ACE inhibitors (e.g. perindopril or ramipril) or any of the other ingredients listed in section 6 You have ever had the condition known as angioedema (an itchy rash such as nettle rash or hives) or Quinkes oedema (this is a severe allergic skin condition) associated with administration of an ACE inhibitor You are more than 3 months pregnant. (It is also better to avoid Trandolapril in early pregnancy see pregnancy section.) Take special care with Trandolapril capsules if: It is possible that you may develop problems with low blood pressure and reduced kidney function if you are a patient at risk being treated with Trandolapril capsules. This may cause you to faint. You must be placed in a side position and someone in your surroundings must call an ambulance or the emergency services. Tell your doctor if You have been taking diuretics (water tablets) for a long time or you have been on a low salt diet You recently had severe or prolonged vomiting or diarrhoea You ever had an allergic reaction (named Quinckes oedema or angioedema) to any other ACE inhibitors (e.g. perindopril or ramipril including swelling in the face, lips, tongue or throat with difficulty in swallowing or breathing) You suffer from a condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma) You suffer from diabetes mellitus You suffer from heart failure You are on kidney dialysis (some kinds of dialysis membrane may not be suitable) You have liver or kidney problems including transplantation You are going to be anaesthetised before an operation You have a narrowing of one of the valves in the heart (aorta stenosis) or in the outflow from the left chamber of the heart You are being treated with medicine that lowers your immune response You develop a cough. Your doctor may choose another medicine for you You are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine) You are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings You think you are (or might become) pregnant. Trandolapril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
AAAE1470
Using other medicines Other medication can affect the efficacy and safety of this medication. On the other hand, Trandolapril capsules can affect the efficacy and safety of other medication. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal products or natural products. Remember to tell your doctor about Trandolapril capsules if you receive another medication during your treatment or shortly after your treatment with Trandolapril capsules. It is especially important to inform your doctor if you use: Other medicines for high blood pressure including water tablets such as bendroflumethiazide Diuretics (water tablets) that retain potassium such as spironolactone, amiloride and triamterene or potassium canrenoate and potassium supplements Anti-inflammatory pain killers (NSAIDs e.g. ibuprofen, diclofenac, indometacin, acetylsalicylic acid and COX-2 inhibitors) Lithium or tricyclic antidepressant (e.g. amitriptyline, dosulepin) Medicines for diabetes (such as insulin, glibenclamide or gliclazide) Antacids Allopurinol (for gout) or procainamide (for abnormal heart rhythms) Immunosuppressants (e.g. ciclosporin), steroid medication (e.g. prednisolone, hydrocortisone) or anticancer medication Antipsychotic drugs such as chlorpromazine, thioridazine, flupentixol If you need to have an operation, it is important that you tell the surgeon or dentist that you are taking Trandolapril capsules. It may affect the anaesthetic or other treatments used. Contact your doctor and inform him if you are taking any of the above medications. It may be necessary to adjust the dose. Using Trandolapril capsules with food and drink You may take Trandolapril capsules with or after food and with drink. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Trandolapril capsules before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Trandolapril capsules. Trandolapril capsules is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Trandolapril capsules is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines Trandolapril capsules can make some people feel dizzy or faint especially when they first start to take the capsules. Do not drive, operate machinery or do anything that requires you to be alert for several hours after your first dose or any increase in the dose. Wait and see how the capsules affect you. Important information about some of the ingredients of Trandolapril capsules This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine (in capsules of 0.5mg, 1mg and 2mg) contains sunset yellow (E110). May cause allergic reactions. 3. HOW TO USE TRANDOLAPRIL CAPSULES Always take Trandolapril capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow your capsules whole without chewing them and take them with a glass of water. Always take them at the same time of day.
If you would like a leaflet with larger text, please contact 01271 311257.
Actavis, Barnstaple, EX32 8NS, UK
Trandolapril Capsules 0.5mg, 1mg, 2mg & 4mg PIL - UK
item no: AAAE1470 print proof no: 2 origination date: 07.08.12 originated by: SA approved for print/date revision date: 12.09.12 revised by: sa supplier: Pharmathen
Technical Approval
colours/plates 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. Prole 2. Varnish Free
Trandolapril Capsules 0.5mg, 1mg, 2mg & 4mg PIL - UK
item no: AAAE1470 print proof no: 2 origination date: 07.08.12 originated by: SA approved for print/date revision date: 12.09.12 revised by: sa supplier: Pharmathen
Technical Approval
colours/plates 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. Prole 2. Varnish Free
dimensions: 170 x 250 pharmacode: min pt size:
dimensions: 170 x 250 pharmacode: min pt size:
date sent: 07.08.12 technically app. date: 03.09.12
date sent: 07.08.12 technically app. date: 03.09.12
3. Braille
3. Braille
AAAE1470
diarrhoea, constipation, indigestion. Fluid retention (oedema), tendency to sweat, nettle rash. Muscle pain. Hot flashes. Side effects with unknown frequency: Changes to blood test parameters such as liver enzymes, creatinine and urea. Increased levels of potassium in the blood. Bleeding in the brain, muscular paralysis, temporary loss of consciousness. Shortness of breath, bronchitis. Dry mouth, inflammation in the pancreas. Hair loss. Severe skin diseases (including Erythema multiforme and Stevens-Johnsons syndrome). Fever. Blood disorders such as agranulocytosis (a condition in which there is an insufficient number of white blood cells and therefore infections can occur), leucopenia (reduction in the number of white blood cells), pancytopenia (a reduction of all types of blood cells, including red and white blood cells as well as platelets) and decreased amount of oxygen-carrying protein in the blood (haemoglobin) and haematocrit (the proportion of space red blood cells take up in the blood). If you suffer from any of these side effects or any other side effects not mentioned in this leaflet, please talk to your doctor or pharmacist. 5. HOW TO STORE TRANDOLAPRIL CAPSULES Keep out of the reach and sight of children. Store in the original package in order to protect from light and moisture. Store below 30oC. Do not use after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. 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. 6. FURTHER INFORMATION What Trandolapril capsules contain The active substance is trandolapril 0.5mg, 1mg, 2mg or 4mg. The other ingredients are: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose, dimeticone, magnesium stearate, colloidal anhydrous silica, gelatin, titanium dioxide (E171) and erythrosine (E127). In addition, each strength also contains the following: 0.5mg: sunset yellow (E110), quinoline yellow (E104) 1mg: sunset yellow (E110) 2mg: sunset yellow (E110) 4mg: red iron oxide (E172) and yellow iron oxide (E172) What Trandolapril capsules look like and contents of the pack 0.5mg: light scarlet rich yellow, size 2 oblong capsules 1mg: light scarlet light orange, size 2 oblong capsules 2mg: light scarlet light scarlet, size 2 oblong capsules 4mg: swedish orange swedish orange, size 2 oblong capsules Contents: 0.5mg, 1mg, 2mg and 4mg: 14, and 28 capsules. Marketing Authorisation Holder Actavis Group PTC ehf Reykjavkurvegi 76-78 IS-220 Hafnarfjrur Iceland Manufacturer Pharmathen S.A., 6, Dervenakion str. Pallini Attikis 153 51 Greece Pharmathen International S.A. Sapes Industrial Park Block 5 69300 Rodopi Greece For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Actavis, Barnstaple, EX32 8NS, UK Telephone: 01271 311257 This leaflet was last revised in August 2012
Trandolapril 0.5mg, 1mg, 2mg and 4mg Capsules
Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. 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. 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 effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Trandolapril capsules are and what they are used for 2. Before you use Trandolapril capsules 3. How to use Trandolapril capsules 4. Possible side effects 5. How to store Trandolapril capsules 6. Further information 1. WHAT TRANDOLAPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR Trandolapril, the active ingredient in Trandolapril capsules belongs to a group of medicines called angiotensin-converting enzyme inhibitors (sometimes called ACE inhibitors). ACE inhibitors work by relaxing the blood vessels which makes it easier for the heart to pump blood around the body. This helps to lower the blood pressure. Trandolapril capsules are used to treat high blood pressure.They may also be used to protect the heart after a heart attack. 2. BEFORE YOU USE TRANDOLAPRIL CAPSULES Do not use Trandolapril capsules if: You are allergic to trandolapril, other ACE inhibitors (e.g. perindopril or ramipril) or any of the other ingredients listed in section 6 You have ever had the condition known as angioedema (an itchy rash such as nettle rash or hives) or Quinkes oedema (this is a severe allergic skin condition) associated with administration of an ACE inhibitor You are more than 3 months pregnant. (It is also better to avoid Trandolapril in early pregnancy see pregnancy section.) Take special care with Trandolapril capsules if: It is possible that you may develop problems with low blood pressure and reduced kidney function if you are a patient at risk being treated with Trandolapril capsules. This may cause you to faint. You must be placed in a side position and someone in your surroundings must call an ambulance or the emergency services. Tell your doctor if You have been taking diuretics (water tablets) for a long time or you have been on a low salt diet You recently had severe or prolonged vomiting or diarrhoea You ever had an allergic reaction (named Quinckes oedema or angioedema) to any other ACE inhibitors (e.g. perindopril or ramipril including swelling in the face, lips, tongue or throat with difficulty in swallowing or breathing) You suffer from a condition known as collagen vascular disease (this is sometimes called connective tissue disease, for example lupus or scleroderma) You suffer from diabetes mellitus You suffer from heart failure You are on kidney dialysis (some kinds of dialysis membrane may not be suitable) You have liver or kidney problems including transplantation You are going to be anaesthetised before an operation You have a narrowing of one of the valves in the heart (aorta stenosis) or in the outflow from the left chamber of the heart You are being treated with medicine that lowers your immune response You develop a cough. Your doctor may choose another medicine for you You are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine) You are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings You think you are (or might become) pregnant. Trandolapril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
AAAE1470
Using other medicines Other medication can affect the efficacy and safety of this medication. On the other hand, Trandolapril capsules can affect the efficacy and safety of other medication. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, herbal products or natural products. Remember to tell your doctor about Trandolapril capsules if you receive another medication during your treatment or shortly after your treatment with Trandolapril capsules. It is especially important to inform your doctor if you use: Other medicines for high blood pressure including water tablets such as bendroflumethiazide Diuretics (water tablets) that retain potassium such as spironolactone, amiloride and triamterene or potassium canrenoate and potassium supplements Anti-inflammatory pain killers (NSAIDs e.g. ibuprofen, diclofenac, indometacin, acetylsalicylic acid and COX-2 inhibitors) Lithium or tricyclic antidepressant (e.g. amitriptyline, dosulepin) Medicines for diabetes (such as insulin, glibenclamide or gliclazide) Antacids Allopurinol (for gout) or procainamide (for abnormal heart rhythms) Immunosuppressants (e.g. ciclosporin), steroid medication (e.g. prednisolone, hydrocortisone) or anticancer medication Antipsychotic drugs such as chlorpromazine, thioridazine, flupentixol If you need to have an operation, it is important that you tell the surgeon or dentist that you are taking Trandolapril capsules. It may affect the anaesthetic or other treatments used. Contact your doctor and inform him if you are taking any of the above medications. It may be necessary to adjust the dose. Using Trandolapril capsules with food and drink You may take Trandolapril capsules with or after food and with drink. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Trandolapril capsules before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Trandolapril capsules. Trandolapril capsules is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breastfeeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Trandolapril capsules is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. Driving and using machines Trandolapril capsules can make some people feel dizzy or faint especially when they first start to take the capsules. Do not drive, operate machinery or do anything that requires you to be alert for several hours after your first dose or any increase in the dose. Wait and see how the capsules affect you. Important information about some of the ingredients of Trandolapril capsules This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine (in capsules of 0.5mg, 1mg and 2mg) contains sunset yellow (E110). May cause allergic reactions. 3. HOW TO USE TRANDOLAPRIL CAPSULES Always take Trandolapril capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow your capsules whole without chewing them and take them with a glass of water. Always take them at the same time of day.
If you would like a leaflet with larger text, please contact 01271 311257.
Actavis, Barnstaple, EX32 8NS, UK
Trandolapril Capsules 0.5mg, 1mg, 2mg & 4mg PIL - UK
item no: AAAE1470 print proof no: 2 origination date: 07.08.12 originated by: SA approved for print/date revision date: 12.09.12 revised by: sa supplier: Pharmathen
Technical Approval
colours/plates 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. Prole 2. Varnish Free
Trandolapril Capsules 0.5mg, 1mg, 2mg & 4mg PIL - UK
item no: AAAE1470 print proof no: 2 origination date: 07.08.12 originated by: SA approved for print/date revision date: 12.09.12 revised by: sa supplier: Pharmathen
Technical Approval
colours/plates 1. Black 2. 3. 4. 5. 6. Non Printing Colours 1. Prole 2. Varnish Free
dimensions: 170 x 250 pharmacode: min pt size:
dimensions: 170 x 250 pharmacode: min pt size:
date sent: 07.08.12 technically app. date: 03.09.12
date sent: 07.08.12 technically app. date: 03.09.12
3. Braille
3. Braille
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.
