Perindopril / Indapamide 2mg/0.625mg Tablets
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Perindopril/Indapamide 2 mg/0.625 mg, tablets
Perindopril tert-butylamine 2mg / Indapamide 0.625mg
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 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Perindopril/Indapamide is and what it is used for
2. Before you take Perindopril/Indapamide
3. How to take Perindopril/Indapamide
4. Possible side effects
5. How to store Perindopril/Indapamide
6. Further information
1. WHAT PERINDOPRIL/INDAPAMIDE IS AND WHAT IT IS USED FOR
Perindopril/Indapamide is a combination of Perindopril and Indapamide. They belong to a group of antihypertensive medicines, which are used in the treatment of high blood pressure.
Perindopril belongs to a class of ACE inhibitors. These work by widening the blood vessels in your body, which make it easier for your heart to pump blood around through them.
Indapamide belongs to a group of medicines called diuretics. These work by allowing your kidneys to produce more urine than normal.
Each of the individual medicines work together to lower your blood pressure and control it.
2. BEFORE YOU TAKE PERINDOPRIL/INDAPAMIDE
Do not take Perindopril/Indapamide
- If you are allergic (hypersensitive) to Perindopril or Indapamide or any of the other ingredients of Perindopril/Indapamide.
- If you are allergic to any other ACE inhibitors or diuretics (Sulphonamides).
- If you have experienced swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, with previous ACE inhibitor therapy. This is a condition called angioneurotic oedema (Quincke’s oedema)
- Alternatively, if you or any of you family members have had these symptoms tell your doctor as soon as possible.
- If you have heart problems or are on medication (See “Taking other medicines”)
- If you are more than 3 months pregnant. It is also better to avoid Perindopril/Indapamide in early pregnancy - see pregnancy section.
- If you are breastfeeding
- If you have kidney failure or are receiving dialysis
- If you have serious liver disease or suffer from a condition called hepatic encephalopathy (which is brain and nervous system impairment caused by severe liver disease)
- If your doctor has told you, that you have low or high blood potassium.
Take special care with Perindopril/Indapamide
Tell your doctor before you start to take this medicine:
- If you have bilateral renal artery stenosis (narrowing of the main blood vessel leading to the kidney) or a single functioning kidney
- If you have diabetes
- If you are on a low salt diet or use salt substitutes, which contain potassium
- If you take lithium or potassium-sparing diuretics (e.g. Spironolactone, Triamterene)
- If you are taking a medicine which is a combination with a potassium-sparing diuretic
- If you are going to have an operation under general anaesthetic, as you may need to stop treatment a few days beforehand.
- If you have Atherosclerosis (a disease of the arteries in which blood vessel walls thicken and harden due to cholesterol deposit)
- If you are to undergo LDL apheresis (which is removal of cholesterol from your blood by a machine.
- - If you are going to have desensitisation treatment to reduce the effects of an allergy (e.g. bee or wasp sting)
- If you are to undergo a medical test that requires injection of a substance that makes organs like the kidney or stomach visible on an x-ray (iodinated contrast agent)
- if you have anaemia (a condition when the red blood cells in your body carry less oxygen, some of the symptoms of anaemia include tiredness, headaches, dizziness)
- If you have Gout (a disease where uric acid crystals cause swollen joints)
- If you have a collagen disease such as systemic lupus erythematosus or scleroderma.
- 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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead. Perindopril/Indapamide is not recommended in early pregnancy, and must not be taken when you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
You should avoid Perindopril/Indapamide with:
- Lithium
- Potassium-sparing diuretics (e.g. spironolactone, triamterene alone or in combination) potassium salts
- Allopurinol (treatment of gout)
- Procainamide (treatment of irregular heartbeat)
- Systemic corticosteroids (used to treat various conditions including severe asthma and rheumatoid artheritis)
- Other medicines to treat high blood pressure
- immunosuppressants used for the treatment of auto-immune disorders or following transplant surgery to prevent rejection (e.g Ciclosporin)
Treatment with Perindopril/Indapamide can be affected by other medicines. Tell your doctor if you are
taking any of the following medicines as special care may be required:
- Astemizole or Terfenadine ( antihistamines for hayfever or allergies)
- Bepridil ( used to treat angina pectoris - an uncomfortable feeling in this chest)
- Erythromycin by injection, Moxifloxacin, Sparfloxacin (antibiotics)
- Halofantrine ( used to treat certain types ofmalaria)
- Pentamidine (used to treat pneumonia which is a serious lung infection)
- Vincamine (used to treat disorders of the brain in elderly)
- Baclofen ( to treat muscle stiffness occurring in diseases such as multiple sclerosis)
- Medicines to treat diabetes such as insulin, Metformin or hypoglycaemic sulphonamides
- Non-Steroidal anti-inflammatory drugs (e.g. Ibuprofen) or high dose salicylates (e.g. Asprin)
- Potassium lowering drugs e.g. Amphotericin B (by injection. to treat severe fungal disease), glucocorticoids and mineralocorticoids (systemic route), or stimulant laxatives (e.g. Senna)
- Potassium-sparing diuretics (amiloride, spironolactone, triamterene)
- Thiazide or loop diuretics
- Medicines to treat irregular heart beat such as Quinidine, Hydroquinidine, Disopyramide, Amiodarone, Bretylium, Dofetilide, Ibutilide and Sotalol.
- Medicines to treat mental disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, neuroleptics such as Chlorpromazine, Cyamemazine,
- Levomepromazine, Thioridazine, Trifluoperazine, Amisulpiride, Tiapride, Droperidol, Haloperidol, Pimozide)
- Cisapride, Diphemanil, Mizolastine
- Methadone
- Sultopride (used in the treatment ofpsychotic disorders)
- Tetracosactide (used to treat Crohn’s disease)
- Calcium salts
Taking Perindopril/Indapamide with food and drink
It is recommended that Perindopril/Indapamide are taken in the morning on an empty stomach. Swallow the tablets with a glass of water.
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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead.. Perindopril/Indapamide is not recommended in early pregnancy, and must not be taken when you are 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. Perindopril/Indapamide should not be taken by 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
Perindopril/Indapamide has minor or moderate influence on the ability to drive and use machines. This medicine does not affect alertness but reactions related to low blood pressue may occur in some patients. This can cause dizziness or weakness.If affected your ability to drive or operate machinery may be impaired therefore caution is advised.
Important information about some of the ingredients of Perindopril/Indapamide
Perindopril/Indapamide contains a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, (Rare hereditaryproblems, galactose intolerance, the Lapp lactose deficiency of glucose-galactose malabsorption) you should contact your doctor before taking the medicine.
3. HOW TO TAKE PERINDOPRIL/INDAPAMIDE
Always take Perindopril/Indapamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose may be increased depending on your condition and other medicines you are taking. Take Perindopril/Indapamide your medicine by mouth only.
The usual dose is:
High Blood pressure:
It is recommended that one Perindopril/Indapamide 2mg/0.625mg tablet is taken in the morning before breakfast. If your blood pressure is not controlled then your doctor may increase your dose to one Perindopril/Indapamide 4mg/1.25mg tablet daily.
In older people with high blood pressure:
It is recommended that one Perindopril/Indapamide 2mg/0.625mg tablet is taken in the morning before breakfast.
If you take more Perindopril/Indapamide than you should
If you take more Perindopril/Indapamide than you should or someone else has taken your medicine contact your doctor or pharmacist immediately. The most common effect of an overdose is low blood pressure, the symptoms of this can be dizziness, sleepiness or nausea. It may help lying down with your legs raised up into the air.
If you forget to take Perindopril/Indapamide
Take your tablet as soon as you remember unless it is time for your next dose. Take your 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
If you stop taking Perindopril/Indapamide tell your doctor as soon as possible. Normally the treatment for high blood pressure is long term.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Perindopril/Indapamide can cause side effects, although not everybody gets them. These can include:
Common: affects 1 to 10 users in 100
• Dry cough
• Dry mouth
• Constipation
• Nausea (feeling sick)
• Stomach pain or discomfort
• Loss of appetite
• Taste loss
• Low levels of potassium
Uncommon: affects 1 to 10 users in 1,000
• Low blood pressure
• Headache
• Feeling light headed when standing up
• Feelings of dizziness
• Mood swings
• Sleep disturbance
• Hypersensitivity reaction (allergic reaction)
• Cramps
• Paresthesia (numbness or pins and needles on your hands or feet)
Rare: affects 1 to 10 users in 10,000
• Raised levels of calcium in the blood
Very rare: affetcs less than 1 user in 10,000
• Thrombocytopenia: Low blood platelet count. Symptoms may include bleeding or bruising more easily than normal.
• Leucopenia or Agranulocytosis: lack of white blood cells. Symptoms may include frequent infections such as fever, severe chills, sore throat or mouth ulcers
• Aplastic anaemia: a rare type of anaemia in which there is a reduction in your red blood cells, white blood cells and platelets
• Haemolytic anaemia: illness resulting from the destruction of red blood cells
• Anaemia in patients following a kidney transplant or on haemodialysis
• Pancreatitis: inflammation of the pancreas in case of hepatic failure
• Hepatic encephalopathy: brain and nervous system damage related to complicated liver disease
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.
If you have any blood tests, tell the doctor that you are taking Perindopril/Indapamide since the following may be seen:
Low or high levels of potassium
Low levels of sodium
High levels of uric acid and glucose
Slightly high levels of urea and creatinine.
5. HOW TO STORE PERINDOPRIL/INDAPAMIDE
Keep out of the reach and sight of children.
Store in the original package to protect from moisture.
When unopened, this medicinal product does not require any special temperature storage conditions. Once the laminated pouch is opened, blister strips should be stored in the outer box below 30°C.
Any remaining tablets should be discarded two months after opening the pouch.
Do not use Perindopril/Indapamide after the expiry date which is stated on the label , blister, pouch and carton after EXP. The expiry date refers to the last day of the 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 Perindopril/Indapamide contains
- The active substances are Perindopril tert-butylamine and Indapamide
- Each tablet contains 2mg Perindopril tert-butylamine equivalent to 1.669mg perindopril and 0.625mg Indapamide
- The other ingredients are:
Lactose Monohydrate Magnesium stearate
Silica, hydrophobic colloidal Cellulose, Microcrystalline
What Perindopril/Indapamide looks like and contents of the pack Perindopril/Indapamide 2mg/0.625mg Tablet
White, rod shaped tablets engraved with ‘P’ and ‘I’ on either side of the break-line on one side and a breakline on the other side. The tablet can be broken into equal halves.
The tablets are packed in PVC / PVdC - Aluminium blisters within a protective aluminium pouch, including a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.
Pack Sizes
30, 90 and 100
*Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvezdova 1716/2b, 140 78 Praha 4 Czech Republic
This medicinal product is authorised in the Member States of the EEA under the following names:
|
United Kingdom |
Perindopril Indapamide 2 mg/0.625 mg, Tablets |
|
Bulgaria |
Prindex Plus 2 mg/0.625 mg tablets |
|
Czech Republic |
Gleperil Combi 2 mg/0.625 mg tablety |
|
Estonia |
Prindex Plus 2 mg/0,625 mg |
|
Hungary |
Gleperil Plus 2/0.625 mg |
|
Latvia |
Prindex Plus 2 mg/0,625 mg |
|
Lithuania |
Prindex Plus 2 mg/0,625 mg tabletes |
|
Poland |
Lextril Combo |
|
Portugal |
Prindex Plus 2/0.625 mg |
|
Romania |
Prindex Plus 2 mg/0,625 mg |
|
Slovak Republic |
Prindex Combi 2 mg/0,625 mg |
This leaflet was last approved in 05/2011.
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