Perindopril Tosilate/Indapamide 5 Mg/1.25 Mg Film-Coated Tablets
PACKAGE LEAFLET
1
Package leaflet: Information for the user
[Product name] 2.5 mg/0.625 mg film-coated tablets
perindopril tosilate / indapamide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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 [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. What [product name] is and what it is used for What is [Product name]?
[Product name] 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).
What is [Product name] used for?
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 [product name]
Do not take [Product name]
- 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 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 [Product name] in early pregnancy -see section “Pregnancy, breast-feeding and fertility”),
- if you are breast-feeding,
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking [Product name]:
- if you have aortic stenosis (narrowing of the main blood vessel leading from the heart) 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 (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 take lithium or potassium-sparing diuretics (spironolactone, triamterene) as their use
with [Product name] should be avoided (see section “Other medicines and [Product name]”).
- 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 the heading “Do not take [Product name]”.
You must tell your doctor if you think that you are (or might become) pregnant. [Product name] 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 section “Pregnancy, breast-feeding and fertility”).
When you are taking [Product name], 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 [Product name] contains an active ingredient (indapamide) which may give a positive reaction in drug tests.
[Product name] should not be given to children.
Other medicines and [Product name]
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should avoid [Product name] with:
- lithium (used to treat depression),
- potassium-sparing diuretics (spironolactone, triamterene), potassium salts.
Treatment with [Product name] 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,
- 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 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 of malaria),
- pentamidine (used to treat pneumonia),
- injectable gold (used to treat rhumatoid 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).
[Product name] with food and drink
It is preferable to take [Product name] 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.
You must tell your doctor if you think that you are (or might become) pregnant.
Pregnancy
Your doctor will normally advise you to stop taking [Product name] before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of [Product name]. [Product name] 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.
You must not take [Product name] if you are breast-feeding.
See your doctor immediately.
Fertility
Effects on fertility by perindopril or indapamide in humans are not known.
Driving and using machines
[Product name] 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.
[Product name] contains 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 [product name]
Always take this medicine exactly as your doctor or pharmacist 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 increase the dose to 2 tablets daily or 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.
If you take more [Product name] than you should
If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is low blood pressure which can make you feel dizzy or faint. If this happens, lying down with the legs raised can help.
If you forget to take [Product name]
It is important to take your medicine every day as regular treatment is more effective. However, if you forget to take a dose of [Product name], 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 [Product name]
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.
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,
- 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).
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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [product name]
Keep this medicine out of the sight and reach of children.
Once opened, use within 100 days.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
Keep the container tightly closed in order to protect from moisture. This medicine does not require any special temperature storage conditions.
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 [Product name] contains
- The active substances are perindopril tosilate and indapamide. One film-coated tablet contains 2.5 mg perindopril tosilate (corresponding to 1.704 mg perindopril) and 0.625 mg indapamide.
- The other ingredients are lactose monohydrate, maize starch, sodium hydrogen carbonate, pregelatinized starch (maize), povidone, magnesium stearate, polyvinyl alcohol - part hydrolized, titanium dioxide E171, macrogol/PEG 3350 and talc.
What [Product name] looks like and contents of the pack
[Product name] 2.5 mg/0.625 mg film-coated tablets are white, capsule shaped biconvex film-coated tablets, debossed with a breakline on one side, plain on the other side.
The tablets are available in containers of 14, 30, 60, 90, 90 (3x30) or 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
[To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
{Name of the Member State} {Name of the medicinal product}
This leaflet was last revised in {MM/YYYY}.
[To be completed nationally]
This is a representation of an electronic record that was signed electronically and this
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE
Teva Pharmaceuticals Europe B.V 1.3.1. PIL (0.6252.5mg) clean
Approvals
|
Signed by |
Meaning of Signature |
Server Date |
|
Marco Saraiva Rafael |
Regulatory Affairs Approval |
08-Apr-2015 12:41:34 PM |
|
Marco Saraiva Rafael |
Regulatory Assessment and Approval |
08-Apr-2015 12:42:43 PM |
REG0157533 Version 0.2 Approved Page 8 of 8