Perindopril 8 Mg Tablets
Package Leaflet: Information for the user Perindopril
2mg, 4mg and 8mg Tablets Perindopril tert-butylamine
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 Perindopril Tablets are and what they are used for.
2. What you need to know before you take Perindopril Tablets.
3. How to take Perindopril Tablets.
4. Possible side effects.
5. How to store Perindopril Tablets.
6. Contents of the pack and other information.
1. What Perindopril Tablets are and what they are used for The active ingredient in Perindopril Tablets is Perindopril tert-Butylamine.This 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. For the other ingredients in Perindopril Tablets (see section 6).
Your doctor has prescribed Perindopril Tablets for the treatment of high blood pressure (hypertension). They can also be used to treat heart failure and 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.
2. What you need to know before you take Perindopril Tablets
Do not take Perindopril Tablets:
- If you are allergic to the active substance Perindopril ter t-Butylamine, or any of the other ingredients (listed in section 6).
- If you have had symptoms such as wheezing, swelling of the face, tongue or throat, intense itching, skin rashes, fainting or dizziness with previous ACE inhibitor treatment or have had these symptoms in any other circumstances (this is a condition called angioedema)
- if you are more than 3 months pregnant. (It is also better to avoid Perindopril tablets in early pregnancy - see pregnancy section)
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
If you think any of the above situations applies to you, do not take the tablets.
Consult your doctor and take his/her advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril Tablets:
- 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 or liver or kidney problems, or if you are receiving dialysis
- if you suffer from a collagen disease such as systemic lupus erythematosus or scleroderma
- If you are on a salt restricted diet or use salt substitutes which contain potassium
- If you suffer from diabetes, which is not well controlled
- You must tell your doctor if you think you are (or might become) pregnant. Perindopril tablets are 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 section).
- 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 Tablets”.
You should also inform your doctor or the medical staff that you are taking Perindopril Tablets:
- If you are to undergo anaesthesia and/or surgery
- If you have suffered from recent diarrhoea or vomiting
- 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 LDL apheresis (which is removal of cholesterol from your blood by a machine)
Other medicines and Perindopril Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 Perindopril Tablets” and “Warnings and precautions”). In particular, you should check with your doctor if you are taking any of the following to be sure that it is safe to take Perindopril Tablets at the same time:
- other medicines for treating high blood pressure including diuretics (water tablets)
- potassium-sparing diuretics (eg spironolactone, triamterene or amiloride), potassium supplements and potassium-containing salt substitutes
- medicines for the treatment of diabetes (insulin or tablets) to lower blood sugar lithium for mania or depression
- medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia or other psychoses
- allopurinol used for the treatment of gout
- immunosuppressants used for the treatment of auto-immune disorders (e.g. rheumatoid arthritis) or following transplant surgery
- procainamide, a treatment for irregular heartbeat
- non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief, including aspirin
- medicines used for the treatment of low blood pressure, shock or asthma (e.g. ephedrine, noradrenaline or adrenaline)
- vasodilators including nitrates (products that make the blood vessels become wider)
- heparin (used to thin the blood)
Ask your doctor if you are not sure what these medicines are. Perindopril Tablets with food and alcohol
It is recommended that Perindopril Tablets should be taken before a meal in order to reduce the influence of food on the way in which the medicine works. Drinking alcohol with Perindopril Tablets may make you feel dizzy or light-headed. You should check with your doctor whether drinking is advisable for you.
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 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 tablets. Perindopril tablets are 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 breastfeeding. Perindopril tablets are 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.
Children
Perindopril Tablets should not be given to children.
Driving and using machines
You may experience dizziness or weariness while taking Perindopril Tablets. If this occurs do not drive or use machinery. You should talk to your doctor.
(Now please read the rest of this leaflet. It has other important
information for your
safety.)
3. How to take Perindopril Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines.
Do not change your dosage unless your doctor tells you to do so. Perindopril Tablets may be used on its own or with other medicines, which lower blood pressure.
The usual dosages for Perindopril Tablets are as follows:
- High blood pressure: the usual starting and maintenance dose for treatment in adults is 4 mg once a day. After a month, this can be increased to 8 mg a day, which is the maximum recommended dose
- In the elderly, the usual starting dose is 2 mg once a day. After a month, this can be increased to 4 mg a day and if necessary to 8 mg a day
- Heart failure: treatment should be started under close medical supervision with 2 mg once a day. After two weeks, it can be increased to 4 mg once a day if required
Take your tablet(s) with a glass of water, preferably at the same time each day, in the morning, before a meal. If you are taking water tablets (diuretics), your doctor may decide to reduce or even discontinue these at the beginning of your treatment with Perindopril Tablets.
Treatment for high blood pressure or heart failure is usually life-long.
Perindopril Tablets are not suitable for use in children.
If you take more Perindopril tablets than you should:
If you have taken too many tablets, contact your nearest hospital accident and emergency department or tell your doctor immediately.
If you forget to take Perindopril tablets:
It is important to take your medicine every day. However, if you forget to take one or more doses, take another as soon as you remember unless it is almost time for your next dose, then go on as prescribed. Do not take a double dose.
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. Please remember:
- The expected benefits of your medicine will usually be greater than the risk of suffering any harmful side effects
- If you notice any other effects not mentioned in this leaflet, please inform your doctor or pharmacist
Common: may affect up to 1 in 10 people
- cough, shortness of breath
- light-headedness due to low blood pressure (particularly after the first few doses, if the dose is increased or when water tablets are also taken) headache, dizziness, vertigo, tiredness, pins and needles, muscle craps, visual disturbances (e.g. blurred vision, eye pain), tinnitus (sensation of noises in the ears)
- nausea, vomiting, abdominal pain, changes in your sense of taste, feeling of indigestion, diarrhoea, constipation
- skin rashes, itching
Uncommon: may affect up to 1 in 100 people
- changes in mood or sleep
- bronchospasm (tightening of the chest, wheezing and shortness of breath)
- dry mouth
- kidney problems
- impotence
- sweating
- angioedema
If you experience any of the following effects, stop taking your tablets at once
And TELL YOUR DOCTOR IMMEDIATELY: swelling of the face, lips, mouth, tongue orthroat, difficulty in breathing, dizziness or fainting, unusually fast or irregular heart beat.
This is a very rare but serious reaction, which can occur with all drugs of this type (ACE inhibitors). It must be treated immediately, usually in hospital.
Very rare: may affect up to 1 in 10,000 people
- confusion
- irregular heart beat, angina, heart attack and stroke (these have been reported with
ACE inhibitors in association with low blood pressure)
- eosinophilic pneumonia (a rare type of pneumonia)
- rhinitis (blocked up or runny nose)
- pancreatitis (inflammation of the pancreas)
- hepatitis (inflammation of the liver)
- erythema multiforme (skin reaction like an allergy)
- changes in the blood: your doctor may decide to carry out blood tests at intervals to monitor for this
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 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 Tablets
Keep this medicine out of the sight and reach of children.
Do not store the tablets above 25°C. Store in the original container.
If your doctor decides to stop the treatment, return any tablets left over to the pharmacist. Only keep them if your doctor tells you to. Do not use this medicine after the expiry date, which is stated on the carton.
The expiry date refers to the last day of that month.
Disposal
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Perindopril Tablets contain
The active substance is perindopril tert-butylamine.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline, magnesium stearate and hydrophobic silica.
What Perindopril Tablets look like and the contents of the pack
Perindopril Tablets are available in three strengths.
- The white, round, biconvex uncoated tablets, plain on one side and debossed with “2” on the other side contain
Perindopril tert-Butylamine 2mg equivalent to 1.669mg of perindopril
- The white capsule shaped uncoated tablets, with breakline on one side and debossed with “4” and “4” on either side of the break line on the other side contain Perindopril tert-Butylamine 4mg equivalent to 3.338mg of perindopril
- The white, round shaped, uncoated tablets, plain on one side and debossed with “8” on the other side contains Perindopril tert-Butylamine 8mg equivalent to 6.676mg of perindopril
The tablets are available in Clear PVC 250 / Aclar 51/ Aluminium blisters, which is further inserted into an aluminium laminated pouch with desiccant 3g silica gel, further packed in cartons. The tablets are available in packs of 30 tablets.
Do not swallow the desiccant (drying agent) enclosed in the aluminium pouch.
Marketing Authorisation Holder and Manufacturer:
Lupin (Europe) Limited Victoria Court Bexton Road Knutsford
Cheshire WA 16 0PF
United Kingdom
Tel.: + 44 (0) 1565 751378
This leaflet was last revised in September 2014
How can you obtain more information about Perindopril Tablets?
This leaflet gives you only some of the most important information about Perindopril
Tablets. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information.
Further information and advice is available from the following organization:
Marketing Authorisation Holder
MANUFACTURER CODE NO: GO/DRUGS/654
ID#: 230676