Perindopril And Indapamide 2mg/0.625mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Perindopril and Indapamide 4 mg/1.25 mg tablets Perindopril and Indapamide 2 mg/0.625 mg tablets
perindopril tert-butylamine /indapamide
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 and Indapamide is and what it is used for
2. Before you take Perindopril and Indapamide
3. How to take Perindopril and Indapamide
4. Possible side effects
5. How to store Perindopril and Indapamide
6. Further information
1. WHAT Perindopril and Indapamide IS AND WHAT IT IS USED FOR
Perindopril and Indapamide is a combination of two active ingredients, perindopril and indapamide. It 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. 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. BEFORE YOU TAKE Perindopril and Indapamide
Do not take Perindopril and Indapamide
• if you are allergic (hypersensitive) to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides or any of the other ingredients of Perindopril and Indapamide,
• if you 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),
• 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 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 and Indapamide in early pregnancy - see below).
• if you are breastfeeding.
Take special care with Perindopril and Indapamide
If any of the following apply to you please talk to your doctor before taking Perindopril and Indapamide:
• if you have aortic stenosis (narrowing of the main blood vessel leading from the heart), mitral valve stenosis or hypertrophic cardiomyopathy (cardiac 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 such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you suffer from hyperparathyroidism (dysfunctioning of the parathyroid gland),
• if you suffer from gout,
• if you have diabetes,
• if you are on a salt restricted diet or use salt substitutes which contain potassium,
• if you are of black origin as ACE inhibitors may be less effective, but you may also more readily
get angioedema
• if you take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use with Perindopril and Indapamide should be avoided (see “Taking other medicines”).
You must tell your doctor if you think you are (or might become) pregnant. Perindopril and Indapamide is not recommended in early pregnancy, and may cause serious harm to your baby after 3 months of pregnancy (see pregnancy section).
When you are taking Perindopril and Indapamide, 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,
• 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 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 and Indapamide contains an active ingredient (indapamide) which may give a positive reaction in drug tests.
Perindopril and Indapamide should not be given to children.
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 and Indapamide with:
• lithium (used to treat depression),
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Treatment with Perindopril and Indapamide 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 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 elderly including memory loss),
• bepridil (used to treat angina pectoris),
• sultopride (antipsychotic treatment),
• 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,
• 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),
• gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid arthritis).
• tetracosactide (to treat Crohn’s disease).
Taking Perindopril and Indapamide with food and drink
It is preferable to take Perindopril and Indapamide before a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Usually, your doctor will advise you to take another medicine instead of Perindopril and Indapamide, as Perindopril and Indapamide 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 it is used after 3 months of pregnancy. Your doctor will normally advise you to stop taking Perindopril and Indapamide as soon as you know you are pregnant.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril and Indapamide is contraindicated 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.
Driving and using machines
Perindopril and Indapamide 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 to operate machinery may be impaired.
Important information about some of the ingredients of Perindopril and Indapamide
Perindopril and Indapamide contains 60 mg lactose monohydrate. 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 and Indapamide
Always take Perindopril and Indapamide 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.
Use in children
Perindopril and Indapamide is not recommended for use in children and adolescents.
Use in older patients
The combination should be administered with caution in the elderly. Patients should avoid being dehydrated (loosing too much water) and regular medical follow-up should include frequent monitoring of kidney function (creatinine and potassium level).
If you take more Perindopril and Indapamide than you should
If you take too many tablets, contact your doctor or nearest hospital casualty immediately. 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 and Indapamide
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 and Indapamide, 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 and Indapamide
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 and Indapamide can cause side effects, although not everybody gets them.
These can include:
Common (less than 1 per 10 but more than 1 per 100):
gastro-intestinal disorders (stomach or abdominal pain, loss of appetite, nausea, vomiting, constipation, diarrhoea, taste disturbance, indigestion), dry mouth, dry cough, pins and needles, headache, feeling of tiredness, dizziness, spinning sensation, vision disturbances, ringing or buzzing in the ear, low blood pressure whether orthostatic (light-headedness occuring when standing up) or not, rashes, itching, muscle cramps.
Uncommon (less than 1 per 100 but more than 1 per 1000):
mood swings, sleep disturbances, purpura (red pinpoints on skin), bronchospasm (tightening of the chest, wheezing and shortness of breath), angioedema (symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rashes), increased sweating, kidney problems, impotence. If you suffer from systemic lupus erythematosus (a type of collagen disease) this might get worse.
Very rare (less than 1 per 10.000):
blocked up or runny nose, confusion, irregular heart beat, angina, heart attack, inflammation of the lungs, inflammation of the pancreas or the liver, severe skin manifestations on a large surface of the body, acute kidney failure.
Rare (less than 1 per 1000 but more than 1 per 10.000):
increased calcium levels in the blood.
Not known (cannot be estimated from the available data):
In cases of hepatic insufficiency (liver problems), there is a possibility of onset of hepatic encephalopathy (degenerative disease in the brain). Cases of photosensitive skin reactions have been reported. Changes of laboratory results have been reported (potassium, sodium, uric acid, glucose, urea, creatinine).
Your doctor may need to give you blood tests to monitor your condition.
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.
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.
5. HOW TO STORE Perindopril and Indapamide
Keep out of the reach and sight of children.
Do not use Perindopril and Indapamide after the expiry date. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not store above 25°C.
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 and Indapamide contains
The active substances are perindopril tert-butylamine and indapamide.
Perindopril and Indapamide 4 mg/1.25 mg tablets: each tablet contains 4 mg perindopril tert-butylamine and 1.25 mg indapamide.
Perindopril and Indapamide 2 mg/0.625 mg tablets: each tablet contains 2 mg perindopril tert-butylamine and 0.625 mg indapamide.
The other ingredients are:
Cellulose microcrystalline,
Lactose monohydrate,
Silica, hydrophobic colloidal Magnesium stearate
What Perindopril and Indapamide looks like and contents of the pack
Perindopril and Indapamide 4 mg/1.25 mg tablets are white, round, flat tablets, with bevelled edges, engraved with C64 on one side and without engraving on the other side, diameter 6 mm.
Perindopril and Indapamide 2 mg/0.625 mg tablets are round, flat, white tablets, with bevelled edges, engraved with C63 on one side and without engraving on the other side, diameter 6 mm
The tablets are packed in Al//PA/Al/PVC blisters, the blister packs are packed in folded carton box with patient leaflet.
Pack size: 30, 50, 90, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GEDEON RICHTER PLC
GYOMROI UTCA 19-21
BUDAPEST
HU-1103
HUNGARY
Manufacturer
Gedeon Richter Polska Sp. z o.o. ul. ks. J. Poniatowskiego 5 05-825 Grodzisk Mazowiecki Poland
This medicinal product is authorised in the Member States of the EEA under the following names:
<[To be completed nationally]>
This leaflet was last approved in 12/2010.
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