Capozide 50mg/25mg Tablets
5. How to store Capozide
■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C. Store in the original package.
■ Do not take the tablets after the date shown on the carton over label or blister strip.
■ If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
■ If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
■ 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. Contents of the pack and other information
What Capozide contains
■ Each tablet contains 50mg of captopril and 25mg of hydrochlorothiazide, as the active ingredients.
■ The tablets also contain microcrystalline cellulose, pregelatinised starch, stearic acid, magnesium stearate and lactose.
What Capozide looks like and contents of the pack
Capozide is white to off-white, oval, biconvex tablet; with a breakbar on one side and engraved with "C H" on the other side. The tablet can divided into equal halves.
Capozide is available in blister packs containing 30 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HAO 1 DX.
Manufacturer
This product is manufactured by Bristol-Myers Squibb, S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy.
|POM| PL 19488/0553
Leaflet revision date: 28 May 2016
Capozide® Tablets is a registered trade mark ofER Squibb & Sons LLC, USA.
S553 LEAFLET Capozide 20160528
S553 LEAFLET Capozide 20160528
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CAPOZIDE® 50mg/25mg TABLETS (captopril/hydrochlorothiazide)
Your medicine is known as Capozide 50mg/25mg Tablets but will be referred to as Capozide throughout the following patient information leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Capozide is and what it is used for
2. What you need to know before you take Capozide
3. How to take Capozide
4. Possible side effects
5. How to store Capozide
6. Contents of the pack and other information
1. What Capozide is and what it is used for
Capozide is a combination of two active substances, captopril and hydrochlorothiazide.
Captopril belongs to a group of medicinal products called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors cause blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicinal products called thiazide diuretics (also known as water tablets). They increase urine output and hence decrease blood pressure.
The two active substances in Capozide work together to decrease blood pressure further than if either was given alone.
Capozide is used in the treatment of high blood pressure (essential hypertension), if treatment with captopril or hydrochlorothiazide alone has not led to a sufficient decrease in blood pressure.
2. What you need to know before you take Capozide
Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Capozide.
Do not take Capozide
■ if you are allergic to captopril or to any other ACE inhibitors or to any of the other ingredients of this medicine (listed in section 6).
■ if you are allergic to hydrochlorothiazide or to any other sulphonamide derivatives.
■ if you have previously been treated with a medicine in the same group as Capozide (ACE inhibitors) and have had an allergic reaction which caused swelling of the arms, legs, ankles, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema) or if a member of your family has had a similar reaction.
■ if you have severe liver or kidney problems (ask your doctor if you have any doubt).
■ if you are more than 3 months pregnant. (It is also better to avoid Capozide in early pregnancy - see pregnancy section.).
■ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Capozide and if any of the following applies to you:
■ if you suffer from excessive vomiting or diarrhoea.
■ if you are on a low-salt diet and you use salt substitutes or supplements containing potassium.
■ if you have any liver or kidney problems (ask your doctor if you have any doubt).
■ if you know that you have reduced blood circulation in the heart muscle or a narrowing of the aorta (aortic stenosis) or the renal artery (renal artery stenosis).
■ if you have had shock following heart failure (cardiogenic shock).
■ if you suffer from diabetes.
Capozide may influence the effect of insulin or other antidiabetic medicines. Please ask your doctor for advice.
■ if you are using dialysis.
There have been some reports of allergic-type reactions when people using medicinal products such as Capozide undergo dialysis with certain dialysis membranes [so called High-flux-Haemodialysis-Membranes or low-density lipoprotein (LDL)-apheresis with dextran sulphate absorption]. Tell your doctor before your next dialysis treatment.
■ if you are to have desensitisation treatment for wasp or bee stings.
There have been some reports of allergic-type reactions when people using medicinal products such as Capozide have such desensitisation treatment. Tell your doctor before your treatment.
■ if you suffer from lupus or lupus-like disorders.
■ if you have changes in your vision or pain in one or both of your eyes while taking Capozide. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Capozide treatment and seek medical attention.
■ if you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems.
aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e. g. potassium) in your blood at regular intervals. See also information under the heading “Do not take CAPOZIDE”.
You must tell your doctor if you think you are for might become') pregnant. Capozide 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).
Medicinal products containing lithium should not be taken with Capozide without close monitoring by your doctor.
If you develop one of the following, contact your doctor immediately:
■ swelling of the arms, legs, ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing,
■ any sign of infection (such as sore throat or fever) not readily responding to the usual treatment,
■ severe dizziness or fainting,
■ severe abdominal pain,
■ unusually fast or irregular heart beat,
■ jaundice (yellow skin/eyes),
■ any sudden, unexplained rash or burning, red or peeling skin.
• the medical staff, especially the anaesthetist (if you are having an operation) if you are hospitalised.
• your dentist before you have an anaesthetic for a dental procedure.
If you are taking Capozide for the first time you may feel lightheaded or dizzy for a short time and it may help to sit or lie down. This is unlikely to happen when you are taking the tablets regularly. If you are worried, contact your doctor.
The hydrochlorothiazide contained in this medicine could produce a positive result in a doping test.
Children and adolescents
Capozide should not be given to children and adolescents (< 18 years).
Other medicines and Capozide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicinal products obtained without a prescription.
These include medicines for a cold, cough, hay fever or sinus problems as these may increase your blood pressure.
This applies in particular if you are also taking
■ some pain-killers which are also called ‘anti-inflammatories’
(e.g. indomethacin, ibuprofen),
■ lithium (for the treatment of mental disorders),
■ carbenoxolone (for the treatment of gastrointestinal ulcers),
■ corticosteroids, corticotrophin (ACTH),
■ some laxatives,
■ injections of an antifungal (amphotericin),
■ muscle relaxants (given at the time of surgery),
■ cholestyramine resin, colestipol (for lowering blood cholesterol),
■ allopurinol (for the treatment of gout)
■ procainamide and digoxin or other cardiac glycosides (treatment for irregular pulse),
■ cytostatic or immunosuppressive agents (e.g. azathioprine and cyclophosphamide),
■ calcium salts,
■ potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in particular those so called potassium sparing), other drugs which can increase potassium in your body (such as heparin),
■ drugs that reduce blood pressure by widening of the blood vessels (e.g. minoxidil),
■ carbamazepine (for the treatment of epilepsy)
■ drugs used in diabetes (insulin and oral antidiabetics such as sulphonyl ureas),
■ drugs used to treat psychotic conditions and some antidepressants,
■ or any other treatment for high blood pressure.
Your doctor may need to change your dose and/or take other precautions:
If you are taking:
■ an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take CAPOZIDE” and “Warnings and precautions”).
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are for might becomel pregnant. Your doctor will normally advise you to stop taking Capozide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Capozide. Capozide is not recommended during 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Capozide is not recommended for mothers who are breastfeeding.
Driving and using machines
Caution is necessary when driving or operating machinery if side effects occur such as light-headedness, dizziness or tiredness. This applies in particular at the start of the treatment, when the dosage is changed or if you have had any alcohol.
Capozide contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
3. How to take Capozide
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor has prescribed Capozide since previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will inform you how to switch from the previous treatment to Capozide.
Dosage:
The usual dose is 1 tablet Capozide a day (corresponding to 50 mg captopril and 25 mg hydrochlorothiazide). The maximum daily dose of 1 tablet Capozide should not be exceeded.
Method of administration
Capozide tablets are for oral use only.
The tablets should be swallowed with a sufficient amount of fluid (e.g. one glass of water). You can take Capozide with or without food. You should try to take your daily dose at about the same time each day, preferably in the morning.
It is important that you continue to take Capozide until your doctor tells you otherwise.
Special populations: If you suffer from moderate kidney disease, diabetes, or if you have less salt or water in your body, your doctor may prescribe a lower dose of Capozide for you, such as % tablet Capozide (corresponding to 25mg captopril and 12.5mg hydrochlorothiazide).
Elderly patients: your doctor may prescribe a lower dose of Capozide for you, such as % tablet Capozide (corresponding to 25mg captopril and 12.5mg hydrochlorothiazide).
If you have the impression that the effect of Capozide is too strong or too weak, talk to your doctor or pharmacist.
If you take more Capozide than you should
If you have accidentally taken too many tablets, or a child has swallowed some, contact your doctor or pharmacist immediately. Take the empty container and any remaining tablets with you.
If you take more than you should you may experience the following: passing water more frequently, a change in the levels of some components in your blood, a large drop in your blood pressure, a reduced awareness of yourself or your surrounding (which includes coma), fits, a weakness in the muscles, an irregular or slower heartbeat or reduced kidney function.
If another person has taken too many tablets and has fainted, lay the person down and rest the person’s feet higher than the person’s head.
If you forget to take Capozide
If you accidentally miss a daily dose, just take the next dose as prescribed. Do not take a double dose to make up for the missed tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Capozide and seek medical attention immediately if you experience any of the following:
■ swelling ofthe arms, legs, ankles, face, lips, tongue and/or throat with difficulty in swallowing or breathing, sore throat or fever,
■ severe dizziness or fainting,
■ severe abdominal pain,
■ unusually fast or irregular heart beat,
■ jaundice (yellow skin/eyes),
■ sudden unexplained skin reactions such as rash, burning, red or peeling skin.
Below you will find separated side effects presented in order of decreasing seriousness that were observed with captopril and/or other ACE inhibitors and side effects that were observed with hydrochlorothiazide.
Following side effects were commonly observed (occurring in more than 1 in 100 but fewer than 1 in 10 patients) that may occur with captopril and other ACE inhibitors:
■ sleep disorders,
■ taste impairment, dizziness, dry, irritating (non-productive) cough, breathing problems,
■ nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth, peptic ulcer
■ skin problems such as itchiness and rash, hair loss.
Following uncommon side effects were observed (occurring in more than 1 in 1000 but fewer than 1 in 100 patients) that may occur with captopril and other ACE inhibitors:
■ decreased appetite (anorexia),
■ headache, an abnormal sensation on your skin (burning or prickle),
■ heart problems such as an unusually fast or irregular heart beat, chest pain (angina), feeling your heartbeat,
■ low blood pressure, impaired circulation in the fingers (Raynaud’s syndrome), flushing or pale skin,
■ swellings of the hands, face, lips or tongue,
■ chest pain, tiredness, feeling unwell.
Following rare side effects were observed (occurring in less than 1 in 1000 but more than 1 in 10,000 patients) that may occur with captopril and other ACE inhibitors:
■ drowsiness,
■ mouth problems such as sore mouth and mouth ulcers,
■ allergic reaction in the gut causing severe abdominal pain (intestinal angioedema),
■ kidney problems, increased or decreased urination.
Following very rare side effects were observed (occurring in 1 or less in 10,000 patients including isolated reports) that may occur with captopril and other ACE inhibitors:
■ side effects affecting the blood and its components such as:
■ anaemia (reduced red blood cell count that may cause decrease in performance and tiredness),
■ lack of certain types of white blood cells which may cause infection, sore throat, fever or bleeding (neutropenia, agranulocytosis, pancytopenia),
■ a reduced ability of the blood to clot (thrombocytopenia) which may cause bleeding or bruising
■ confusion, depression,
■ stroke, fainting,
■ blurred vision,
■ heart attack,
■ chest problems (including:
■ difficulty in breathing or wheezing,
■ a blocked or runny nose, a type of pneumonia, caused by changes in the blood or a condition which causes cough, fever, shortness of breath and wheezing),
■ swollen tongue, pancreatitis (inflammation of the pancreas which may cause a stomach ache),
■ impaired liver function, including jaundice which causes the skin and eyes to turn yellow, and inflammation of the liver (hepatitis),
■ severe skin reactions such as:
■ allergic reactions which cause the skin to itch and turn red (urticaria),
■ a severe rash all over the body (Stevens-Johnson-syndrome),
■ an allergic rash which causes pink-red patches which may have clear centres (erythema multiforme),
■ sensitivity of the skin to light,
■ a reddening of the skin (erythroderma),
■ a series of skin reactions which can cause fluid-filled patches to form (pemphigoid reactions),
■ a condition causing the skin to scale or peel (exfoliative dermatitis),
■ pains in the muscles and joints,
■ kidney problems,
■ impotence, swelling of the breasts in men,
■ fever,
■ changes in laboratory test values.
Following side effects that were observed with hydrochlorothiazide, the second active substance contained in Capozide include:
■ swollen salivary glands,
■ side effects affecting the blood and its components which may cause:
■ decrease in performance,
■ tiredness,
■ infection,
■ sore throat or fever due to a lack of white blood cells,
■ a reduced ability for the blood to clot which may cause bleeding or bruising
■ loss of appetite (anorexia), sugar in the urine, abnormal changes in your blood components such as sugar, uric acid (gout), sodium, potassium, high levels of cholesterol and other lipids in the blood,
■ restlessness, depression, sleep disturbances,
• abnormal sensation on your skin (pins and needles), lightheadedness,
■ problems with the eyes and vision such as ‘yellow vision’ and blurred vision, decrease in vision and eye pain (possible signs of acute-angle closure glaucoma),
■ dizziness,
■ low blood pressure, heart problems such as an irregular heart beat,
■ circulation problems such as inflammed blood vessels including those in the skin and other organs (necrotising angiitis),
■ lung and breathing problems such as respiratory distress,
■ gastric irritation, diarrhoea, constipation, pancreatitis,
■ jaundice which causes the skin and eyes to turn yellow,
■ severe skin reactions such as:
■ sensitivity of the skin to light,
■ rash,
■ a condition that causes a characteristic red, blotchy, butterfly-shaped rash over the cheeks and nose (lupus and lupus-like reactions),
■ allergic reactions which cause the skin to itch and turn red (urticaria),
■ an over-reaction of the body’s natural defence system (hypersensitivity reactions),
■ muscle spasm,
■ kidney problems,
■ fever, weakness.
Reporting of side effects
you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.
S553 LEAFLET Capozide 20160528
■ an over-reaction of the body’s natural defence system (hypersensitivity reactions),
■ muscle spasm,
■ kidney problems,
■ fever, weakness.
Reporting of side effects
you get any side effects, talk to your doctor or pharmacist. This includes any possible 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.
5. How to store Captopril and Hydrochlorothiazide Tablets
■ KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not store above 25°C. Store in the original package.
■ Do not take the tablets after the date shown on the carton over label or blister strip.
■ If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
■ If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
■ 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. Contents of the pack and other information
What Captopril and Hydrochlorothiazide Tablets contains
■ Each tablet contains 50mg of captopril and 25mg of hydrochlorothiazide, as the active ingredients.
■ The tablets also contain microcrystalline cellulose, pregelatinised starch, stearic acid, magnesium stearate and lactose.
What Captopril and Hydrochlorothiazide Tablets look like and contents of the pack
Captopril and Hydrochlorothiazide Tablets are white to off-white, oval, biconvex tablet; with a breakbar on one side and engraved with "C H" on the other side. The tablet can divided into equal halves.
Captopril and Hydrochlorothiazide Tablets are available in blister packs containing 30 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HAO 1 DX.
Manufacturer
This product is manufactured by Bristol-Myers Squibb, S.r.l., Contrada Fontana del Ceraso, 03012 Anagni (FR), Italy.
|POM| PL 19488/0553
Leaflet revision date: 28 May 2016
S553 LEAFLET Captopril 20160528
S553 LEAFLET Captopril 20160528
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CAPTOPRIL AND HYDROCHLOROTHIAZIDE 50mg/25mg TABLETS
Your medicine is known as Captopril and Hydrochlorothiazide 50mg/25mg Tablets but will be referred to as Captopril and Hydrochlorothiazide Tablets throughout the following patient information leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
■ 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
■ If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Captopril and Hydrochlorothiazide Tablets are and what they are used for
2. What you need to know before you take Captopril and Hydrochlorothiazide Tablets
3. How to take Captopril and Hydrochlorothiazide Tablets
4. Possible side effects
5. How to store Captopril and Hydrochlorothiazide Tablets
6. Contents of the pack and other information
1. What Captopril and Hydrochlorothiazide Tablets are and what they are used for
Captopril and Hydrochlorothiazide Tablet is a combination of two active substances, captopril and hydrochlorothiazide.
Captopril belongs to a group of medicinal products called Angiotensin Converting Enzyme (ACE) Inhibitors. ACE inhibitors cause blood vessels to relax and the blood pressure to lower. Hydrochlorothiazide is one of a group of medicinal products called thiazide diuretics (also known as water tablets). They increase urine output and hence decrease blood pressure.
The two active substances in Captopril and Hydrochlorothiazide Tablets work together to decrease blood pressure further than if either was given alone.
Captopril and Hydrochlorothiazide Tablet is used in the treatment of high blood pressure (essential hypertension), if treatment with captopril or hydrochlorothiazide alone has not led to a sufficient decrease in blood pressure.
2. What you need to know before you take Captopril and Hydrochlorothiazide Tablets
Please read the following section attentively. It contains important
information which you and your doctor should observe prior to
taking of Captopril and Hydrochlorothiazide Tablets.
Do not take Captopril and Hydrochlorothiazide Tablets
■ if you are allergic to captopril or to any other ACE inhibitors or to any of the other ingredients of this medicine (listed in section 6).
■ if you are allergic to hydrochlorothiazide or to any other sulphonamide derivatives.
■ if you have previously been treated with a medicine in the same group as Captopril and Hydrochlorothiazide Tablets (ACE inhibitors) and have had an allergic reaction which caused swelling of the arms, legs, ankles, lips, tongue and/or throat with difficulty in swallowing or breathing (angioedema) or if a member of your family has had a similar reaction.
■ if you have severe liver or kidney problems (ask your doctor if you have any doubt).
■ if you are more than 3 months pregnant. (It is also better to avoid Captopril and Hydrochlorothiazide Tablets in early pregnancy - see pregnancy section.).
■ if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor before taking Captopril and Hydrochlorothiazide Tablets and if any of the following applies to you:
■ if you suffer from excessive vomiting or diarrhoea.
■ if you are on a low-salt diet and you use salt substitutes or supplements containing potassium.
■ if you have any liver or kidney problems (ask your doctor if you have any doubt).
■ if you know that you have reduced blood circulation in the heart muscle or a narrowing of the aorta (aortic stenosis) or the renal artery (renal artery stenosis).
■ if you have had shock following heart failure (cardiogenic shock).
■ if you suffer from diabetes.
Captopril and Hydrochlorothiazide Tablets may influence the effect of insulin or other anti-diabetic medicines. Please ask your doctor for advice.
■ if you are using dialysis.
There have been some reports of allergic-type reactions when people using medicinal products such as Captopril and Hydrochlorothiazide Tablets undergo dialysis with certain dialysis membranes [so called High-flux-Haemodialysis-Membranes or low-density lipoprotein (LDL)-apheresis with dextran sulphate absorption]. Tell your doctor before your next dialysis treatment.
■ if you are to have desensitisation treatment for wasp or bee stings.
There have been some reports of allergic-type reactions when people using medicinal products such as Captopril and Hydrochlorothiazide Tablets have such desensitisation treatment. Tell your doctor before your treatment.
■ if you suffer from lupus or lupus-like disorders.
■ if you have changes in your vision or pain in one or both of your eyes while taking Captopril and Hydrochlorothiazide Tablets. This could be a sign that you are developing glaucoma, increased pressure in your eye(s). You should discontinue Captopril and Hydrochlorothiazide Tablets treatment and seek medical attention.
■ if you are taking any of the following medicines used to treat high blood pressure:
an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems, aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e. g. potassium) in your blood at regular intervals. See also information under the heading “Do not take CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS”.
You must tell your doctor if you think you are for might become') pregnant. Captopril and Hydrochlorothiazide Tablet 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).
Medicinal products containing lithium should not be taken with Captopril and Hydrochlorothiazide Tablets without close monitoring by your doctor.
If you develop one of the following, contact your doctor immediately:
■ swelling of the arms, legs, ankles, face, lips, tongue and/or throat with difficulty swallowing or breathing,
■ any sign of infection (such as sore throat or fever) not readily responding to the usual treatment,
■ severe dizziness or fainting,
■ severe abdominal pain,
■ unusually fast or irregular heart beat,
■ jaundice (yellow skin/eyes),
■ any sudden, unexplained rash or burning, red or peeling skin.
• the medical staff, especially the anaesthetist (if you are having an operation) if you are hospitalised.
• your dentist before you have an anaesthetic for a dental procedure.
If you are taking Captopril and Hydrochlorothiazide Tablets for the first time you may feel light-headed or dizzy for a short time and it may help to sit or lie down. This is unlikely to happen when you are taking the tablets regularly. If you are worried, contact your doctor.
The hydrochlorothiazide contained in this medicine could produce a positive result in a doping test.
Children and adolescents
Captopril and Hydrochlorothiazide Tablets should not be given to children and adolescents (< 18 years).
Other medicines and Captopril and Hydrochlorothiazide Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicinal products obtained without a prescription.
These include medicines for a cold, cough, hay fever or sinus problems as these may increase your blood pressure.
This applies in particular if you are also taking
■ some pain-killers which are also called ‘anti-inflammatories’ (e.g. indomethacin, ibuprofen),
■ lithium (for the treatment of mental disorders),
■ carbenoxolone (for the treatment of gastrointestinal ulcers),
■ corticosteroids, corticotrophin (ACTH),
■ some laxatives,
■ injections of an antifungal (amphotericin),
■ muscle relaxants (given at the time of surgery),
■ cholestyramine resin, colestipol (for lowering blood cholesterol),
■ allopurinol (for the treatment of gout)
■ procainamide and digoxin or other cardiac glycosides (treatment for irregular pulse),
■ cytostatic or immunosuppressive agents (e.g. azathioprine and cyclophosphamide),
■ calcium salts,
■ potassium supplements or salt substitutes containing potassium, diuretics (water tablets, in particular those so called potassium sparing), other drugs which can increase potassium in your body (such as heparin),
■ drugs that reduce blood pressure by widening of the blood vessels (e.g. minoxidil),
■ carbamazepine (for the treatment of epilepsy)
■ drugs used in diabetes (insulin and oral antidiabetics such as sulphonyl ureas),
■ drugs used to treat psychotic conditions and some antidepressants,
■ or any other treatment for high blood pressure.
Your doctor may need to change your dose and/or take other precautions:
If you are taking:
■ an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take CAPTOPRIL AND HYDROCHLOROTHIAZIDE TABLETS” and “Warnings and precautions”).
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are for might becomel pregnant. Your doctor will normally advise you to stop taking Captopril and Hydrochlorothiazide Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Captopril and Hydrochlorothiazide Tablets. Captopril and Hydrochlorothiazide Tablet is not recommended during 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Captopril and Hydrochlorothiazide Tablet is not recommended for mothers who are breast-feeding.
Driving and using machines
Caution is necessary when driving or operating machinery if side effects occur such as light-headedness, dizziness or tiredness. This applies in particular at the start of the treatment, when the dosage is changed or if you have had any alcohol.
Captopril and Hydrochlorothiazide Tablet contains lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine.
3. How to take Captopril and Hydrochlorothiazide Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor has prescribed Captopril and Hydrochlorothiazide Tablet since previous treatment for high blood pressure did not provide appropriate blood pressure reduction. Your doctor will inform you how to switch from the previous treatment to Captopril and Hydrochlorothiazide Tablets.
Dosage:
The usual dose is 1 tablet Captopril and Hydrochlorothiazide Tablet a day (corresponding to 50 mg captopril and 25 mg hydrochlorothiazide). The maximum daily dose of 1 tablet Captopril and Hydrochlorothiazide Tablet should not be exceeded.
Method of administration
Captopril and Hydrochlorothiazide tablets are for oral use only.
The tablets should be swallowed with a sufficient amount of fluid (e.g. one glass of water). You can take Captopril and Hydrochlorothiazide Tablets with or without food. You should try to take your daily dose at about the same time each day, preferably in the morning.
It is important that you continue to take Captopril and Hydrochlorothiazide Tablets until your doctor tells you otherwise.
Special populations: If you suffer from moderate kidney disease, diabetes, or if you have less salt or water in your body, your doctor may prescribe a lower dose of Captopril and Hydrochlorothiazide Tablets for you, such as % tablet Captopril and Hydrochlorothiazide Tablets (corresponding to 25mg captopril and 12.5mg hydrochlorothiazide).
Elderly patients: your doctor may prescribe a lower dose of Captopril and Hydrochlorothiazide Tablets for you, such as % tablet Captopril and Hydrochlorothiazide Tablets (corresponding to 25mg captopril and 12.5mg hydrochlorothiazide).
If you have the impression that the effect of Captopril and Hydrochlorothiazide Tablet is too strong or too weak, talk to your doctor or pharmacist.
If you take more Captopril and Hydrochlorothiazide Tablets than you should
If you have accidentally taken too many tablets, or a child has swallowed some, contact your doctor or pharmacist immediately. Take the empty container and any remaining tablets with you.
If you take more than you should you may experience the following: passing water more frequently, a change in the levels of some components in your blood, a large drop in your blood pressure, a reduced awareness of yourself or your surrounding (which includes coma), fits, a weakness in the muscles, an irregular or slower heartbeat or reduced kidney function.
If another person has taken too many tablets and has fainted, lay the person down and rest the person’s feet higher than the person’s head.
If you forget to take Captopril and Hydrochlorothiazide Tablets
If you accidentally miss a daily dose, just take the next dose as prescribed. Do not take a double dose to make up for the missed tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Captopril and Hydrochlorothiazide Tablets and seek medical attention immediately if you experience any of the following:
■ swelling of the arms, legs, ankles, face, lips, tongue and/or throat with difficulty in swallowing or breathing, sore throat or fever,
■ severe dizziness or fainting,
■ severe abdominal pain,
■ unusually fast or irregular heart beat,
■ jaundice (yellow skin/eyes),
■ sudden unexplained skin reactions such as rash, burning, red or peeling skin.
Below you will find separated side effects presented in order of decreasing seriousness that were observed with captopril and/or other ACE inhibitors and side effects that were observed with hydrochlorothiazide.
Following side effects were commonly observed (occurring in more than 1 in 100 but fewer than 1 in 10 patients) that may occur with captopril and other ACE inhibitors:
■ sleep disorders,
■ taste impairment, dizziness, dry, irritating (non-productive) cough, breathing problems,
■ nausea, vomiting, gastric irritations, abdominal pain, diarrhoea, constipation, dry mouth, peptic ulcer
■ skin problems such as itchiness and rash, hair loss.
Following uncommon side effects were observed (occurring in more than 1 in 1000 but fewer than 1 in 100 patients) that may occur with captopril and other ACE inhibitors:
■ decreased appetite (anorexia),
■ headache, an abnormal sensation on your skin (burning or prickle),
■ heart problems such as an unusually fast or irregular heart beat, chest pain (angina), feeling your heartbeat,
■ low blood pressure, impaired circulation in the fingers (Raynaud’s syndrome), flushing or pale skin,
■ swellings of the hands, face, lips or tongue,
■ chest pain, tiredness, feeling unwell.
Following rare side effects were observed (occurring in less than 1 in 1000 but more than 1 in 10,000 patients) that may occur with captopril and other ACE inhibitors:
■ drowsiness,
■ mouth problems such as sore mouth and mouth ulcers,
■ allergic reaction in the gut causing severe abdominal pain (intestinal angioedema),
■ kidney problems, increased or decreased urination.
Following very rare side effects were observed (occurring in 1 or less in 10,000 patients including isolated reports) that may occur with captopril and other ACE inhibitors:
■ side effects affecting the blood and its components such as:
■ anaemia (reduced red blood cell count that may cause decrease in performance and tiredness),
■ lack of certain types of white blood cells which may cause infection, sore throat, fever or bleeding (neutropenia, agranulocytosis, pancytopenia),
■ a reduced ability of the blood to clot (thrombocytopenia) which may cause bleeding or bruising
■ confusion, depression,
■ stroke, fainting,
■ blurred vision,
■ heart attack,
■ chest problems (including:
■ difficulty in breathing or wheezing,
■ a blocked or runny nose, a type of pneumonia, caused by changes in the blood or a condition which causes cough, fever, shortness of breath and wheezing),
■ swollen tongue, pancreatitis (inflammation of the pancreas which may cause a stomach ache),
■ impaired liver function, including jaundice which causes the skin and eyes to turn yellow, and inflammation of the liver (hepatitis),
■ severe skin reactions such as:
■ allergic reactions which cause the skin to itch and turn red (urticaria),
■ a severe rash all over the body (Stevens-Johnson-syndrome),
■ an allergic rash which causes pink-red patches which may have clear centres (erythema multiforme),
■ sensitivity of the skin to light,
■ a reddening of the skin (erythroderma),
■ a series of skin reactions which can cause fluid-filled patches to form (pemphigoid reactions),
■ a condition causing the skin to scale or peel (exfoliative dermatitis),
■ pains in the muscles and joints,
■ kidney problems,
■ impotence, swelling of the breasts in men,
■ fever,
■ changes in laboratory test values.
Following side effects that were observed with hydrochlorothiazide, the second active substance contained in Captopril and Flydrochlorothiazide Tablets include:
■ swollen salivary glands,
■ side effects affecting the blood and its components which may cause:
■ decrease in performance,
■ tiredness,
■ infection,
■ sore throat or fever due to a lack of white blood cells,
■ a reduced ability for the blood to clot which may cause bleeding or bruising
■ loss of appetite (anorexia), sugar in the urine, abnormal changes in your blood components such as sugar, uric acid (gout), sodium, potassium, high levels of cholesterol and other lipids in the blood,
■ restlessness, depression, sleep disturbances,
■ abnormal sensation on your skin (pins and needles), lightheadedness,
■ problems with the eyes and vision such as ‘yellow vision’ and blurred vision, decrease in vision and eye pain (possible signs of acute-angle closure glaucoma),
■ dizziness,
■ low blood pressure, heart problems such as an irregular heart beat,
■ circulation problems such as inflammed blood vessels including those in the skin and other organs (necrotising angiitis),
■ lung and breathing problems such as respiratory distress,
■ gastric irritation, diarrhoea, constipation, pancreatitis,
■ jaundice which causes the skin and eyes to turn yellow,
■ severe skin reactions such as:
■ sensitivity of the skin to light,
■ rash,
■ a condition that causes a characteristic red, blotchy, butterfly-shaped rash over the cheeks and nose (lupus and lupus-like reactions),
■ allergic reactions which cause the skin to itch and turn red (urticaria),
S553 LEAFLET Captopril 20160528