Perindopril And Indapamide 2mg/0.625mg Tablets
Package leaflet: Information for the user
Perindopril+Indapamide 4 mg/1.25 mg tablets Perindopril+Indapamide 2 mg/0.625 mg tablets
perindopril tert-butylamine /indapamide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. Y ou 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 is and what it is used for
2. What you need to know before you take Perindopril+Indapamide
3. How to take Perindopril+Indapamide
4. Possible side effects
5. How to store Perindopril+Indapamide
6. Contents of the pack and other information
1. What Perindopril+Indapamide is and what it is used for
Perindopril+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. What you need to know before you take Perindopril+Indapamide
Do not take Perindopril+Indapamide
• if you are allergic to perindopril or any other ACE inhibitor, or to indapamide or any other sulphonamides 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 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 diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
• 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 in early pregnancy - see "Pregnancy and breast-feeding” section),
if you are breastfeeding.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Perindopril+Indapamide.
If any of the following apply to you please talk to your doctor before taking Perindopril+Indapamide:
• if you have aortic stenosis (narrowing of the main blood vessel leading from the heart), mitral valve stenosis 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 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+Indapamide should be avoided (see “Other medicines and Perindopril+Indapamide”),
• 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.
• if you are taking any of the following medicines, the risk of angioedema is increased:
- racecadotril (used to treat diarrhoea)
- sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs).
You must tell your doctor if you think that you are (or might become) pregnant. Perindopril+Indapamide 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” section).
See also information under the heading “Do not take Perindopril+Indapamide”.
When you are taking Perindopril+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, 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)
Athletes should be aware that Perindopril+Indapamide contains an active ingredient (indapamide) which may give a positive reaction in drug tests.
Children and adolescents
Perindopril+Indapamide should not be given to children and adolescents.
Other medicines and Perindopril+Indapamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should avoid Perindopril+Indapamide with:
• lithium (used to treat depression),
• potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Treatment with Perindopril+Indapamide can be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. 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, including angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take {Invented 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 of malaria),
• pentamidine (used to treat pneumonia),
• injectable gold (used to treat rheumatoid polyarthritis),
• vincamine (used to treat symptomatic cognitive disorders in elderly including memory loss),
• bepridil (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),
• medicines, which is most often used to treat diarrhoea (racecadotril) or avoid rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section “Warnings and precautions”.
•
Perindopril+Indapamide with food, drink and alcohol
It is preferable to take Perindopril+Indapamide before a meal.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think that 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 of Perindopril+Indapamide. Perindopril+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 used after the third month of pregnancy.
Breast-feeding
Tell your doctor immediately if you are breast-feeding or about to start breast-feeding. Perindopril+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. See your doctor immediately.
Driving and using machines
Perindopril+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.
Perindopril+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+Indapamide
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended 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 and adolescents
The safety and efficacy of Perindopril+Indapamide in children and adolescents have not been established. Therefore, Perindopril+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+Indapamide than you should
If you take too many tablets, contact your doctor or nearest hospital casualty department 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+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+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+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 medicine, ask your doctor or pharmacist.
4. Possible side effects
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,
- Unusual fast or irregular heart beat.
- A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and
genitals (Stevens Johnson syndrome).
- Reduction in blood platelets, which increases risk of bleeding or bruising.
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. 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):
increased calcium levels in the blood, psoriasis worsening.
Very rare (may affect up to 1 in 10,000 people):
confusion, cardiovascular disorders (irregular heartbeat, angina, heart attack), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), severe skin manifestations such as erythema multiforme, toxic epidermal necrolysis and Stevens Johnson syndrome. Cases of photosensitivity reactions (change in skin appearance) after exposure to the sun or artificial UVA have also been reported. Reduction in number of white blood cells which makes infections more likely, reduction in red blood cells which can make the skin pale and cause weakness or breathlessness and reduction in the number of thrombocytes (low platelet count) which increases risk of bleeding or bruising.
Severe disorders of the kidney, liver or pancreas.
Not known (frequency 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). Fainting. Life-threatening irregular heartbeat (Torsade de Pointes), abnormal ECG heart tracing, increased levels of liver enzymes. 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.
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 (see details below). By reporting side
effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Perindopril+Indapamide
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
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 protect the environment.
6. Contents of the pack and other information What Perindopril+Indapamide contains
The active substances are perindopril tert-butylamine and indapamide.
Perindopril+Indapamide 4 mg/1.25 mg tablets: each tablet contains 4 mg perindopril tert-butylamine and 1.25 mg indapamide.
Perindopril+Indapamide2 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+Indapamide looks like and contents of the pack
Perindopril+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+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.
H-1103 Budapest, Gyomroi ut 19-21.
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:
Hungary: Vidotin Komb 4 mg; 1.25 mg tabletta
Romania: Danurit 4 mg; 1.25 mg comprimate
United Kingdom: Perindopril+Indapamaide 4 mg; 1.25 mg tablets
Hungary: Vidotin Komb 2 mg; 0.625 mg tabletta
Romania: Danurit 2 mg; 0.625 mg comprimate
United Kingdom: Perindopril+Indapamide 2 mg; 0.625 mg tablets
This leaflet was last revised in October 2016
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