Perindopril / Indapamide 4mg/1.25mg Tablets
Out of date information, search anotherPERINDOPRIL TERT-BUTYLAMINE/ INDAPAMIDE TABLETS MODULE 1- ADMINISTRATION INFORMATION AND PRESCRIBING INFORMATION PACKAGE LEAFLET: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.
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 of the pack and other information
1. What Perindopril/Indapamide Tablets is and what it is used for
Perindopril/Indapamide Tablets 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. What you need to know before you take Perindopril/ Indapamide
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 Perindopril/Indapamide Tablets.
- 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 of the 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 section.)
- If you are breastfeeding
if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Take special care with Perindopril/Indapamide Tablets
If any of the following apply to you please talk to your doctor beforetaking Perindopril/Indapamide Tablets:
- If you have aortic stenosis (narrowing of the main blood vessel leadingfrom the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying the kidney with blood),
- if you have any other heart problems or problems with your kidneys,
- if you have liver problems,
- if you suffer from a collagen disease (skin disease) such as systemic lupus erythematosus or scleroderma,
- if you have atherosclerosis (hardening of the arteries),
- if you suffer from hyperparathyroidism (overactive parathyroid gland),
- if you suffer from gout,
- 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 (spironolactone, triamterene) as their use with Perindopril/ Indapamide Tablets should be avoided (see “Taking other medicines”).
You must tell your doctor if you think that 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 and Breast-feeding”).
When you are taking Perindopril/Indapamide Tablets, you should also inform your doctor or the medical staff:
- if you are to undergo anaesthesia and/or surgery,
- if you have recently suffered from diarrhoea or vomiting,
or are dehydrated,
- If you are to undergo dialysis or 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 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)
- you are taking any of the following medicines used to treat high blood pressure:
o an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. o 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 Perindopril/Indapamide Tablets”.
Athletes should be aware that Perindopril/Indapamide Tablets contains an active ingredient (indapamide) which may give a positive reaction in drug tests.
Perindopril/Indapamide Tablets should not be given to children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
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. Make sure to 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,
- 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 autoimmune 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)
- 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)
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 Perindopril” and “Warnings and precautions”)
Ask your doctor if you are not sure what these medicines are. Tell the doctor if you have taken any of the medicines listed above in the past, but have now stopped.
Taking 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.
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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.
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.
Important information about some of the ingredients of Perindopril/Indapamide Tablets
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 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.
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 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.
4. Possible side effects
Like all medicines Perindopril/Indapamide Tablets 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,
• unusual fast or irregular heart beat.
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, gastro-intestinal 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:
- Raised levels of calcium in the blood Very rare: may affect up to 1 in 10,000 people:
- confusion, cardiovascular disorders (irregular heart beat, angina, heart attack), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), severe skin manifestations such as erythema multiforme. 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.
- 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).
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 Tablets 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.
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.
5. How to store Perindopril/Indapamide tablets
Keep out of the sight and reach 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 Tablets 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. Contents of the pack and other information 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 Perindopril/Indapamide Glenmark
2/0.625mg and 4/1.25mg Tabletten Denmark Perindopril tert-butylamin/Indapamid
Glenmark
Germany Perindopril/Indapamid Glenmark
2mg/0.625mg and 4mg/1.25mg Tabletten Greece Perindopril/Indapamide Glenmark
Italy Perindopril E Indapamide EG 2/0.625mg
and 4/1.25mg
The Netherlands Perindopril tert-butylamine /Indapamide Glenmark 2/0.625mg and 4/1.25mg Tabletten
Portugal Perindopril+Indapamida Labesfal
2+0.625mg and 4+1.25mg Comprimidos Spain Perindopril/Indapamide Glenmark
2/0.625mg and 4/1.25mg comprimidos
This leaflet was last revised in : 03/2015.
|
G GLENMARK GENERICS LTD. |
05.03.2015 |
Black | |
|
Perindopril-Indapamide 2-4mg Insert-UK AE (Ins-Bk ^^^^Wjjjxjjjjjjjjjjj vFBsinN- mum ^^^^^jxxxxxxxxxxxxxxxxxxx^^^^^B |
Item code, Version, Consistency of Design, overprint area, Pack size, Dimensions & Layout | ||
|
RA |
Regulatory Text | ||
|
UK |
QA: |
Entire Text | |
|
Goa 34 x 180 mm | |||
|
PRODUCTION: |
Machine Suitability | ||
|
400 x 180 mm | |||
|
40 gsm Bible Paper | |||
Temple Packaging Pvt. Ltd.
Font: 9 pt Times New Roman
Sap code: 30100007526 File: 37269 V.02 Stj