Perindopril / Indapamide 2 Mg/0.625 Mg Tablets
SAME SIZE ARTWORK
LEAFLET SIZE: 180 mm x 400 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Perindopril/Indapamide 2 mg/0.625 mg and 4 mg/1.25 mg Tablets
Perindopril tert-butylamine 2 mg / Indapamide 0.625 mg Perindopril tert-butylamine 4 mg / Indapamide 1.25 mg
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 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 is and what it is 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 ofthe pack and other information
Perindopril/Indapamide Tablets is a combination of two active ingredients, Perindopril and Indapamide. They belong to a group of anti-hypertensive medicines, which are 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 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. Diuretics increase the amount of urine produced by the kidneys. 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.
Do not take Perindopril/Indapamide Tablets
- If you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamide or any of the other ingredients of this medicine (listed in section 6).
- If you have experienced symptoms such as wheezing, swelling of the face or tongue intense itches 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),
- if you have severe liver disease or suffer from a condition called hepatic encephalopathy (degenerative disease ofthe brain),
- if you have a severe kidney disease or if you are receiving dialysis,
- if you have low or high blood potassium,
- if you are suspected of having untreated decompensated heart failure (severe water retention, difficulty in breathing),
- If you are more than 3 months pregnant. (It is also better to avoid Perindopril/Indapamide Tablets in early pregnancy see ''Pregnancy and Breast-feeding”.)
- If you are breastfeeding
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and Precautions
If any of the following apply to you please talk to your doctor before taking Perindopril/Indapamide 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 ofthe artery supplying the kidney with blood),
- ifyou have any other heart problems or problems with your kidneys,
- ifyou have liver problems,
- if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
- ifyou have atherosclerosis (hardening ofthe arteries),
- if you suffer from hyperparathyroidism (overactive parathyroid gland),
- if you suffer from gout,
- Ifyou have diabetes
- If you are on a salt restricted diet or use salt substitutes, which contain potassium
- If you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril/ Indapamide Tablets should be avoided (see "Other medicines and Perindopril/Indapamide Tablets").
- If you 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 under heading “Do not take Perindopril/Indapamide Tablets”.
When you are taking<product name>, you should also inform your doctor or the medical staff:
- If you are to undergo dialysis or LDL apheresis (which is removal of cholesterol from your blood by a machine).
- Ifyou are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.
- If you 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 contains an active ingredient (indapamide) which may give a positive reaction in drug tests.
Children and adolescents
Perindopril/Indapamide Tablets should not be given to children.
Other medicines and Perindopril/Indapamide Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
You should avoid Perindopril/Indapamide Tablets with:
- lithium (used to treat depression),
- potassium-sparing diuretics (e.g. spironolactone, triamterene) potassium salts
Treatment with Perindopril/Indapamide Tablets can be affected by other medicines. Your doctor may need to change your dose and/or to take other precuations. Tell your doctor if you are taking any of the following medicines as special care may be required:
- other medicines for treating high blood pressure including angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Product name” and “Warnings and precautions”),,
- 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 for the 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 ofmalaria)
- pentamidine (used to treat pneumonia)
- injectable gold (used to treat rheumathoid polyarthritis),
- vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss
- bepidril (used to treat angina pectoris),
- sultopride (for the treatment of psychoses),
- medicines used for heart rhythm problems (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol),
- digoxin or other cardiac glycosides (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 including calcium supplements,
- 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)
Perindopril/Indapamide Tablets with food and drink
It is preferable to take Perindopril/Indapamide Tabletsbefore 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 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
You must not take Perindopril/Indapamide Tablets if you are breast-feeding. Tell your doctor if you are breast-feeding or about to start breast-feeding.
See your doctor immediately Driving and using machines
Perindopril/Indapamide Tablets usually does 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 operate machinery may be impaired.
Perindopril/Indapamide Tablets contains lactose
Perindopril/Indapamide Tablets contains lactose. If you have been told by your doctor that you have an intolerance to some
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sugars, contact your doctor before taking this medicinal product.
Always take Perindopril/Indapamide Tablets exactly as your doctor has told you. You should 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 the dosage regimen if you suffer from renal impairment. Take your tablet preferably in the morning and before a meal. Swallow the tablet with a glass of water.
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 Tablets than you should
If you take more 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 faitness, lying down with legs raisedcan 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 of Perindopril/Indapamide Tablets, 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 product, ask your doctor or pharmacist.
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 30OC.
Any remaining tablets should be discarded two months after opening the pouch.
Do not use this medicine 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 that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, stop taking the medicinal product at once and tell your doctor immediately:
• swelling of the face, lips, mouth, tongue or throat, difficulty in breathing, severe dizziness or fainting, cardiovascular disorders (irregular heartbeat, angina, heart attack).
• severe skin manifestations such as erythema multiforme.
• signs of blood problems (e.g. decreased levels of certain blood cells which may develop as fever, sore throat, tiredness, unexplained bruising or bleeding, mouth sores).
• disorders of the blood, 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. In cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain).
In decreasing order of frequency, side effects can include: Common: may affect up to 1 in 10 people: headache, feelings of 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, gastrointestinal disorders (nausea, epigastric pain, anorexia, vomiting, abdominal pain, taste disturbances, dry mouth, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), cramps, feeling of tiredness,
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, purpura (red pinpoints on skin), kidney problems, impotence, sweating
Rare: may affect up to 1 in 1000 people: hypercalcaemia (high blood levels of calcium).
Very rare: may affect up to 1 in 10,000 people:
- confusion, eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose),. If you suffer from systemic lupus erythematosus (a type of collagen disease), this might get worse. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported.
Not known (frequency cannot be estimated from the available data): fainting, life-threatening irregular beat (Torsade de Pointes), abnormal ECG heart tracing, increased levels of liver enzymes.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
What Perindopril/Indapamide Tablets 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
- Each tablet contains 4mg Perindopril tert-butylamine equivalent to 3.338mg perindopril and 1.25mg Indapamide
- The other ingredients are:
Lactose Monohydrate Magnesium stearate Silica, hydrophobic colloidal Cellulose, Microcrystalline
What Perindopril/Indapamide Tablets 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 break-line on the other side. The tablet can be broken into equal halves.
Perindopril/Indapamide 4mg/1.25mg Tablet
White rod shaped tablets having 'PI' debossed on one side and
plain on the other.
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
2mg/0.625mg: 20, 30, 90 and 100 4mg/1.25mg: 30, 90 and 100 *Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2B Draycott Avenue,
Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer (s)
Glenmark Pharmaceuticals S.R.O.
Hvezdova 1716/2b, 140 78 Praha 4,
Czech Republic
Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium
Denmark
Germany
Greece
Italy
The Netherlands
Portugal
Spain
Perindopril/Indapamide Glenmark 2/0.625mg and 4/1.25mg Tabletten Perindopril tert-butylamin/Indapamid Glenmark
Perindopril/Indapamid Glenmark 2mg/0.625mg and 4mg/1.25mg Tabletten
Perindopril/Indapamide Glenmark Perindopril E Indapamide EG 2/0.625mg and 4/1.25mg Perindopril tert-butylamine /Indapamide Glenmark 2/0.625mg and 4/1.25mg Tabletten
Perindopril+Indapamida Labesfal 2+0.625mg and 4+1.25mg Comprimidos
Perindopril/Indapamide Viso Farmaceutica 2/0.625mg and 4/1.25mg comprimidos
This leaflet was last revised in : 02/2016.
Keep out of the sight and reach of children.
Store in the original package to protect from moisture.
FONT: Times New Roman FONT SIZE: 9 pt DATE: 10-02-2016 VERSION: 01 (UK)