Perindopril 5 Mg Film-Coated Tablets
I teva UK Ref: 231-30-40550-D LEA PERINDOPRIL TOSILATE A/S TAB TUK <DEB
ion: 2 09 December 2014
PACKAGE LEAFLET: INFORMATION FORTHE USER
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.
1. What Perindopril Tosilate Film-coated Tablets are and what they are used for
2. What you need to know before you take Perindopril Tosilate Film-coated Tablets
3. How to take Perindopril Tosilate Film-coated Tablets
4. Possible side effects
5. How to store Perindopril Tosilate Film-coated Tablets
6. Contents of the pack and other information
OWHAT PERINDOPRIL TOSILATE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Perindopril Tosilate is an angiotensin converting enzyme (ACE) inhibitor. These work by widening the blood vessels, which makes it easier for your heart to pump blood through them.
Perindopril Tosilate Film-coated Tablets are used:
• to treat high blood pressure
(hypertension)
♦ 2.5 mg and 5 mg strengths to treat heart failure (a condition where the heart is unable to pump enough blood to meet the body's needs)
♦ to reduce the risk of cardiac events, such as heart attack, in patients with stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) and who have already had a heart attack and/or an operation to improve the blood supply to the heart by widening the vessels that supply it.
©WHAT YOU NEED TO KNOW BEFORE YOU TAKE PERINDOPRIL TOSILATE FILM-COATED TABLETS
Do not take Perindopril Tosilate Film-coated Tablets
♦ if you are allergic to perindopril, to any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6)
♦ if you are more than 3 months pregnant. (It is also better to avoid PerindoprilTosilate in early pregnancy - see section 2: Pregnancy, breast-feeding and fertility).
♦ if you have experienced symptoms such as wheezing, swelling of the face, tongue or throat, 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.
Warnings and precautions
Talk to your doctor before taking Perindopril Tosilate if any of the following apply:
♦ 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 of the artery supplying the kidney with blood)
♦ if you have any other heart problems
♦ if you have liver problems ♦ if you have kidney problems or if you are receiving dialysis ♦ if you suffer from a collagen vascular disease (disease of the connective tissue) such as systemic lupus erythematosus or scleroderma ♦ if you have diabetes ♦ if you are on a salt restricted diet or use salt substitutes which contain potassium ♦ if you are to undergo anaesthesia and/or major surgery ♦ 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 have recently suffered from diarrhoea or vomiting, or are dehydrated
♦ if you have been told by your doctor that you have an intolerance to some sugars.
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 Perindopril Tosilate'.
You must tell your doctor if you think that you are (or might become) pregnant. Perindopril Tosilate Film-coatedTablets 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 2: Pregnancy, breast-feeding and fertility).
Children and adolescents Perindopril Tosilate Film-coated Tablets is not recommended for use in children and adolescents.
Other medicines and Perindopril Tosilate Film-coated Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Treatment with Perindopril Tosilate Film-coated Tablets can be affected by other medicines.These include:
♦ other medicines for high blood pressure, including diuretics (medicines which increase the amount of urine produced by the kidneys)
♦ 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 PerindoprilTosilate' and 'Warnings and precautions')
♦ potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium supplements or potassium-containing salt substitutes
♦ lithium for mania or depression
♦ non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose aspirin
♦ medicines to treat diabetes (such as insulin or metformin)
♦ medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic antidepressants, antipsychotics)
♦ immunosuppressants (medicines which reduce the defence mechanism of the body) used for the treatment of auto-immune disorders or following transplant surgery (e.g. ciclosporin)
♦ allopurinol (for the treatment of
♦ procainamide (for the treatment of an irregular heart beat)
♦ vasodilators including nitrates (products that make the blood vessels become wider)
♦ heparin (medicines used to thin blood)
♦ medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline).
Perindopril Tosilate Film-coated Tablets with food and drink
It is preferable to take Perindopril Tosilate Film-coatedTablets 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 Tosilate Film-coated Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of PerindoprilTosilate Film-coated Tablets. Perindopril Tosilate Film-coatedTablets 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 if you are breast-feeding or about to start breast-feeding. Perindopril Tosilate Film-coated Tablets is not recommended 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.
Fertility
Effects on fertility by perindopril in humans are not known.
Driving and using machines
Perindopril Tosilate Film-coated Tablets usually does not affect alertness but dizziness or weakness due to low blood pressure may occur in certain patients. If you are affected in this way, your ability to drive or to
operate machinery may be impaired.
Perindopril Tosilate Film-coated 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.
HOW TO TAKE PERINDOPRIL TOSILATE FILM-COATED TABLETS
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal. Your doctor will decide on the correct dose for you.
The recommended dosages are as follows:
High blood pressure: the
recommended starting and maintenance dose is 5 mg once daily. After one month, this can be increased to 10 mg once a day if required. 10 mg a day is the maximum recommended dose for high blood pressure.
If you are 65 or older, the recommended starting dose is
2.5 mg once a day. After a month this can be increased to
5 mg once a day and then if necessary to 10 mg once daily.
2.5 mg and 5 mg strengths only -Heart failure: the recommended starting dose is 2.5 mg once daily. After two weeks, this can be increased to 5 mg once a day, which is the maximum recommended dose for heart failure.
Stable coronary artery disease: the
recommended starting dose is 5 mg once daily. After two weeks, this can be increased to 10 mg once daily, which is the maximum recommended dose in this indication.
If you are 65 or older, the recommended starting dose is
2.5 mg once a day. After a week this can be increased to 5 mg once a day and after a further week to 10 mg once daily.
If you take more Perindopril Tosilate Film-coated Tablets 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 Perindopril Tosilate Film-coated Tablets
It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril Tosilate Film-coatedTablets, 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 Tosilate Film-coated Tablets
As the treatment with Perindopril Tosilate Film-coated Tablets 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.
^ 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
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE PERINDOPRIL TOSILATE FILM-COATED TABLETS
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 after EXP The expiry date refers to the last day of that month.
Keep the container tightly closed in order to protect from light and 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.
©CONTENTS OF THE PACK AND OTHER INFORMATION
What Perindopril Tosilate Film-coated Tablets contains:
♦ The active substance is perindopril tosilate. One film-coated tablet contains 1.704 mg perindopril (corresponding to 2.5 mg perindopril tosilate), or 3.408 mg perindopril (corresponding to 5 mg perindopril tosilate), or 6.816 mg perindopril (corresponding to 10 mg perindopril tosilate).
♦ The other ingredients are lactose monohydrate, maize starch, sodium hydrogen carbonate, pregelatinized starch, povidone K30, magnesium stearate, Poly(vinyl alcohol) - part hydrolysed, titanium dioxide E171, macrogol 3350, talc and for the 5 mg and 10 mg tablets indigo carmine E132, brilliant blue FCF E133, iron oxide yellow E172 and quinoline yellow E104.
What Perindopril Tosilate Film-coated Tablets look like and contents of the pack
Perindopril Tosilate 2.5 mg tablets are white, round, biconvex, film-coated tablets of approx.
5 mm diameter, debossed "T" on one side and plain on the other. Perindopril Tosilate 5 mg tablets are light-green, capsule-shaped, biconvex film-coated tablets of approx. 4 mm width and 8 mm length, debossed "T" on one side, plain on the other side with breaklines on both edges. Perindopril Tosilate 10 mg tablets are green, round, biconvex, film-coated tablets of approx.
8 mm diameter, debossed "10" on one side and "T" on the other.
5 mg - The tablets are available in containers of 10, 30, 60, 90, 90 (3x30) or 100 film-coated tablets. 2.5 mg & 10 mg -The tablets are available in containers of 30, 60,
90, 90 (3x30) or 100 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, United Kingdom.
Manufacturer
Teva Pharmaceutical Works Private Limited Company, Pallagi ut 13, 4042 Debrecen, Hungary.
This leaflet was last revised in December 2014.
PL 00289/1693, PL 00289/1694 PL 00289/1695
In decreasing order of frequency,
side effects can include:
♦ Common (may affect up to 1 in 10 people): headache, 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, vomiting, abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, diarrhoea, constipation), allergic reactions (such as skin rashes, itching), muscle 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), dry mouth, angioedema (symptoms such as wheezing, swelling of the face, tongue or throat, intense itching or severe skin rashes), kidney problems, impotence, sweating
♦ Very rare (may affect up to 1 in 10,000 people): confusion, cardiovascular disorders (irregular heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), rhinitis (blocked up or runny nose), erythema multiforme, disorders of the blood, pancreas or liver
♦ In case of diabetic patients, hypoglycaemia (very low blood sugar level) can occur
♦ Vasculitis (inflammation of blood vessels) have been reported.
TFWTI 40550-D