Perindopril / Indapamide 2mg/0.625mg Tablets
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Perindopril tert-butylamine and Indapamide
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 Perindopril / Indapamide Tablets are and what they are used for
2 What you need to know before you take Perindopril / Indapamide Tablets
3 How to take Perindopril / Indapamide Tablets
4 Possible side effects
5 How to store Perindopril / Indapamide Tablets
6 Contents of the pack and other information
1. What Perindopril / Indapamide Tablets are and what they are used for
Perindopril / Indapamide Tablets are a combination of two active ingredients, Perindopril and Indapamide. This medicine is an anti-hypertensive and is used in the treatment of high blood pressure (hypertension).
Perindopril belongs to a class of medicines called ACE inhibitors. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys and are sometimes called water tablets. However, Indapamide is different from other diuretics, as it only causes a slight increase in the amount of urine produced. Each of the active ingredients reduces blood pressure and they work together to control your blood pressure.
2. What you need to know before you take Perindopril /Indapamide Tablets Do not take Perindopril / Indapamide Tablets if you
• are allergic to Perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any other ingredients of this medicine listed in section 6.
• have experienced symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes with previous ACE inhibitor treatment or if you or a member of your family have had these symptoms in any other circumstances (a condition called angioedema)
• have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease of the brain)
• have a severe kidney disease or if you are receiving dialysis
• have low or high blood potassium
• are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing)
• are more than 3 months pregnant. (It is also better to avoid Perindopril / Indapamide Tablets in early pregnancy - see pregnancy section.)
• are breastfeeding.
• 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 or pharmacist before taking these tablets, if you
• have aortic stenosis (narrowing of the main blood vessel leading from the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood)
• have any other heart problems or problems with your kidneys
• have liver problems
• suffer from a collagen disease such as systemic lupus erythematosus (allergic condition which causes joint pain, skin rashes and fever) or scleroderma
• have atherosclerosis (hardening of the arteries)
• suffer from hyperparathyroidism (overactive parathyroid gland)
• suffer from gout
• have diabetes
• are on a salt restricted diet or use salt substitutes which contain potassium
• take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with these tablets should be avoided (see “Taking other medicines”)
• think you are (or might become) pregnant. Perindopril / Indapamide Tablets 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)
• are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (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 underthe heading ‘Do not take Perindopril/Indapamide Tablets'.
You should also inform your doctor or the medical staff that you are taking Perindopril / Indapamide Tablets if you:
• are to undergo anaesthesia and/or surgery
• have recently suffered from diarrhoea or vomiting
• are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine)
• are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings
• are to undergo a medical test that requires injection of an iodinated contrast agent (a substance that makes organs like kidney or stomach visible on an X-ray)
Athletes should be aware that Perindopril / Indapamide Tablets contain an active ingredient (indapamide) which may give a positive reaction in drug tests. Perindopril / Indapamide Tablets should not be given to children.
Other medicines and Perindopril / Indapamide Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or to take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Perindopril / Indapamide Tablets” and “Warnings and precautions”).
You should avoid Perindopril / Indapamide Tablets with:
• lithium (used to treat depression)
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts
Treatment with Perindopril / Indapamide Tablets can be affected by other medicines. Make sure to tell your doctor if you are taking any of the following medicines as special care may be needed:
• other medicines for treating high blood pressure
• procainamide (for the treatment of an irregular heart beat)
• allopurinol (for the treatment of gout)
• terfenadine or astemizole (antihistamines for hay fever or allergies)
• corticosteroids used to treat various conditions including severe asthma and rheumatoid arthritis
• immunosuppressants used forthe treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g. ciclosporin)
• medicines for the treatment of cancer
• erythromycin by injection (an antibiotic)
• halofantrine (used to treat certain types of malaria)
• pentamidine (used to treat pneumonia)
• vincamine (used to treat symptomatic cognitive disorders in the elderly including memory loss)
• bepridil (used to treat angina pectoris)
• medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol)
• digoxin (for the treatment of heart problems)
• baclofen (to treat muscle stiffness occurring in diseases such as multiple sclerosis)
• medicines to treat diabetes such as insulin or metformin
• calcium
• stimulant laxatives (e.g. senna)
• non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high dose salicylates (e.g. aspirin)
• amphotericin B by injection (to treat severe fungal disease)
• medicines to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics)
• tetracosactide (to treat Crohn's disease)
• gold (used to treat rheumatoid arthritis)
Perindopril / Indapamide Tablets with food and drink
It is preferable to take Perindopril / Indapamide Tablets before a meal.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril / Indapamide Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril / Indapamide Tablets. Perindopril / Indapamide Tablets 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril / Indapamide Tablets 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.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Perindopril / Indapamide Tablets do not affect alertness but different reactions such as dizziness or weakness in relation to the decrease in blood pressure may occur in certain patients. If affected, your ability to drive or to operate machinery may be impaired.
Perindopril / Indapamide Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Perindopril / Indapamide Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one tablet once a day. Your doctor may decide to modify your dose if your kidneys are not working properly. Take your tablet with a glass of water preferably in the morning and before a meal. Swallow the tablet with a glass of water. Treatment for high blood pressure is usually life-long.
If you take more Perindopril / Indapamide Tablets than you should
If you take too many tablets, contact your doctor or nearest hospital casualty department. The most likely effect in case of overdose is low blood pressure. If marked low blood pressure occurs (symptoms such as dizziness or faintness), lying down with the legs raised can help.
If you forget to take Perindopril / Indapamide Tablets
It is important to take your medicine every day as regular treatment is more effective. However, if you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Perindopril / Indapamide Tablets
As the treatment for high blood pressure is usually life-long, you should discuss with your doctor before stopping this medicinal product.
If you have any further questions on the use of this medicine, askyour doctor or pharmacist.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets them.
You should stop taking your tablets at once and tell your doctor immediately if you experience any of the following effects of angioedema:
• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing
• dizziness or fainting
• unusually fast or irregular heartbeat
This is an uncommon but serious reaction which can occur with all drugs of this type (ACE inhibitors). It must be treated immediately, usually in hospital. Common may affect up to 1 in 10 people
• headache
• dizziness
• vertigo
• pins and needles
• vision disturbances
• tinnitus (sensation of noises in the ears)
• light-headedness due to low blood pressure
• cough
• shortness of breath
• nausea, vomiting, abdominal pain, taste disturbances, dry mouth, indigestion or difficulty of digestion, diarrhoea, constipation
• red, raised skin rash, skin rashes, itching
• muscle cramps
• feeling of weakness
Uncommon may affect up to 1 in 100 people
• mood swings
• sleep disturbances
• bronchospasm (tightening of the chest, wheezing and shortness of breath)
• angioedema (symptoms such as wheezing, swelling of the face or tongue)
• urticaria (a raised itchy and painful rash)
• purpura (red pinpoints on skin)
• kidney problems
• impotence
• sweating
• If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse
Rare may affect up to 1 in 1,000 people
• raised levels of calcium in the blood Very rare may affect up to 1 in 10,000 people
• bone marrow depression which makes infections more likely
• reduction in red blood cells
• reduction in blood platelets which increases risk of bleeding or bruising
• severe reduction in number of white blood cells which makes infection more likely
• illness resulting from the destruction of red blood cells
• confusion
• inflammation of the pancreas with severe upper stomach pain
• swellings in the intestine
• hepatitis with yellowing of the skin
• irregular heart beat, angina, heart attack
• eosinophilic pneumonia (a rare type of pneumonia)
• rhinitis (blocked up or runny nose)
• rash involving reddening, swelling and peeling of the skin that resembles severe burns
• a severe and widespread reddening of the skin with blistering
• a painful reddening of the skin with lumps and blisters
• sensitivity to the sun or artificial UVA
• acute kidney failure
• changes in laboratory parameters (blood tests) for different salts in the body and sugar levels. Your doctor may need to give you blood tests to monitor your condition
• in cases of liver problems, there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• dry mouth
• dry cough
• gastro-intestinal disorders (stomach or abdominal pain, loss of appetite, nausea, constipation and taste disturbance)
Uncommon may affect up to 1 in 100 people
• feeling of tiredness
• dizziness
• headache
• mood swings
• sleep disturbances
• cramps
• pins and needles
• allergic reactions such as skin rashes
• purpura (red pinpoints on skin)
• hypotension (low blood pressure) whether orthostatic (lightheadedness occurring when standing up) or not
• if you suffer from systemic lupus erythematosus (allergic condition which causes joint pain, skin rashes and fever) this might get worse
Very rare may affect up to 1 in 10,000 people
• increased risk of dehydration in the elderly and patients suffering from heart failure
• in cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease of the brain)
• increase in levels of calcium in your blood
• changes in blood cell count associated with increased susceptibility to infections or with bruises and a tendency to bleeding or feeling generally unwell
• disorders of the kidney, liver or pancreas and changes in laboratory parameters (blood tests) can occur. Your doctor may need to give you blood tests to monitor your condition.
Reporting of side effects
If 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 Website: 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 Perindopril / Indapamide Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.
Do not store your tablets above 30°C. Store in the original package to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Perindopril / Indapamide Tablets contain Active ingredients
Perindopril/Indapamide 2mg/0.625mg Tablets, contain perindopril tert-butylamine equivalent to 1.669mg perindopril and 0.625mg indapamide. Perindopril/Indapamide 4mg/1.25mg Tablets, contain perindopril tert-butylamine equivalent to 3.338mg perindopril and 1.25mg indapamide.
Other ingredients
Lactose monohydrate, microcrystalline cellulose, magnesium stearate and colloidal hydrophobic silica.
What Perindopril / Indapamide Tablets looks like and the contents of the pack
Perindopril/Indapamide 2mg/0.625mg Tablets are white to off-white; capsule shaped uncoated tablets, with a scoreline on both sides. The tablets can be divided into equal halves.
Perindopril / Indapamide 4mg/1.25mg Tablets are white to off-white; capsule shaped uncoated tablets, plain on both sides.
Perindopril / Indapamide 2mg/0.625mg and 4mg/1.25mg Tablets are supplied in blisters packed in an aluminium pouch containing desiccant silica gel. The tablets are available in pack sizes of 1,7, 10,14, 20, 28, 30, 50, 56, 60, 84, 90, 98,100 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire WA16 OPF United Kingdom
This leaflet was last revised in September 2014
ID#: 221164