Perindopril 2mg Tablets
teva UK Ref 231-30-87409-V LEA PERINDOPRIL 2MG and 4MG TAB TUK XKRKA Version: 4 3 July 2014
PERINDOPRIL 2 mg TABLETS PERINDOPRIL 4 mg TABLETS Perindopril tert-butylamine
PACKAGE LEAFLET: INFORMATION FORTHE USER
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 is and what it is used for
2. Before you take Perindopril
3. How to take Perindopril
4. Possible side effects
5. How to store Perindopril
6. Further information
OWHAT PERINDOPRIL IS AND WHAT IT IS USED FOR
The active substance of Perindopril tablets belongs to the group of medicines called angiotensin converting enzyme (ACE) inhibitors.
Perindopril tablets are used:
• to treat high blood pressure (hypertension) • to treat symptomatic 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.
0 BEFORE YOU TAKE PERINDOPRIL
Do not take Perindopril
• if you are allergic (hypersensitive) to perindopril, any of the other ingredients of Perindopril or any other ACE inhibitor • if you have had in the past a hypersensitivity reaction with sudden swelling of the lips and face, neck, possibly also hands and feet, or suffocation or hoarseness —(angi oedema) -after^use-of an AGE-inhibiton • if you have had angioedema in your family or you have had angioedema in any other circumstances
• if you are more than 3 months pregnant. (It is also better to avoid Perindopril in early pregnancy - see pregnancy section).
Take special care with Perindopril It is possible that Perindopril is not convenient for you, or a personal control is needed regularly.Therefore, before starting to take Perindopril tablets, inform your doctor on the following:
• if you have been told that you have reduced or blocked blood supply to the heart (stable coronary artery disease)
• if you have been told that your heart muscle is enlarged or you have a problem in the valves of your heart • if you have been told that you have narrowing of the artery supplying the kidney with blood (renal artery stenosis)
• if you suffer from diabetes • if you are suffering from any other renal, liver or heart disease
• if you are receiving dialysis or have had a recent kidney transplantation • if you are on a salt restriction diet, or have suffered from excessive vomiting or diarrhoea or have used medicines that increase the amount of urine (diuretics)
• if you are taking lithium, medicine used for the treatment of mania or depression • if you are taking potassium supplements or potassium containing salt substitutes.
You must tell your doctor if you think you are (or might become) pregnant. Perindopril 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 section).
While taking Perindopril If you develop any of the following symptoms you should let your doctor know immediately: • You feel dizzy after your first dose. A few people react to their first dose or when their dose is increased by feeling dizzy, weak, faint and sick.
• Sudden swelling of the lips and face, neck, possibly also hands and feet, or wheezing or hoarseness.This condition is called angioedema.This may occur at any time during treatment. ACE inhibitors cause a higher rate of angioedema in black patients than in non-black patients.
• High temperature, sore throat or mouth ulcers (these may be symptoms of infection caused by the lowering of the number of white blood cells)
• Yellowing of the skin and whites of eyes (jaundice) that may be sign of liver disease
• A dry cough which is persistent for a long time. Cough has been reported with the use of ACE inhibitors but may be also a symptom of other upper respiratory tract diseases.
At the beginning of treatment and/or during the period of dosage adjustment, increasing the frequency of medical check-ups may be necessary. You should not skip these visits even if you feel well. Your doctor will determine the frequency of control examinations.
To prevent any possible complications during treatment with Perindopril, you should also inform your doctor that you are taking Perindopril tablets:
• if you are to undergo anaesthesia and/or surgery (even at the dentist)
• if you are going to have treatment to reduce the effects of an allergy to bee or wasp stings (desensitisation)
• if you are to undergo haemodialysis or LDL cholesterol apheresis (which is removal of cholesterol from your body by a machine).
Taking other medicines Do not take non-prescription medicines without consulting your doctor.This mainly applies to:
• cold remedies which contain pseudoephedrine or phenylephrine as active substances
• pain relievers, including acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting)
• potassium supplements
• potassium-containing salt substitutes. Please tell your doctor if you are taking any of the following to be sure that it is safe to take Perindopril at the same time:
• other medicines for treating high blood pressure and/or heart failure, including medicines that increase the amount of urine (diuretics)
• medicines for treatment of irregular heartbeat (procainamide)
• medicines for treatment of diabetes (insulin or oral antidiabetics)
• medicines for treatment of gout (a llopu rinol)
• non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac), including aspirin for pain
• anti-inflammatory medicines (systemic corticosteroids)
• medicines for suppression of tumour growth (cytostatic agents)
• medicines for lowering the body's immune response (immunosuppressive agents)
• medicines with a stimulant action on a certain part of the nervous system such as ephedrine, noradrenaline or adrenaline (sympathomimetics)
•~rheel icirTes fbrYreaTmehTbrmania or “ depression (lithium)
• medicines for mental illness such as depression, anxiety, schizophrenia or other psychosis (tricyclic antidepressants and antipsychotics)
• potassium tablets
• gold by injection for treatment of arthritis (sodium aurothiomalate).
Taking Perindopril with food and drink
It is recommended that Perindopril 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 may make you feel dizzy or light-headed. You should check with your doctor whether drinking is advisable for you. 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. 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 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 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.
Driving and using machines You are advised not to drive a car or operate machinery until you know how Perindopril affects you. Individual reactions such as dizziness or weariness may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication.
As a result the ability to drive or operate machinery may be impaired.
Important information about some of the ingredients of Perindopril
Perindopril tablets also contain 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.
e
0
HOWTOTAKE PERINDOPRIL
Always take Perindopril exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose for the treatment of high blood pressure is 4 mg perindopril (1 Perindopril 4 mg tablet) once daily. When necessary, this may be increased to 8 mg perindopril (2 Perindopril 4 mg tablets) once daily.
The usual dose for the treatment of symptomatic heart failure is 2 mg perindopril (1 Perindopril 2 mg tablet) once daily; this may be increased to 4 mg perindopril (1 Perindopril 4 mg tablet or 2 Perindopril 2 mg tablets) once daily, as necessary.
The usual starting dose for the treatment of stable coronary artery disease is 4 mg perindopril (1 Perindopril 4 mg tablet) once daily; if it is well tolerated the dose may be increased to 8 mg perindopril (2 Perindopril 4 mg tablets) once daily.
Take your tablet with a glass of water, preferably at the same time each day, in the morning, before a meal.
During the course of treatment, your doctor will adjust the dosage according to the effect of treatment, as well as to your needs.
The dosage may be lower than usual and will be determined by a doctor:
• in elderly patients
• in patients with renal impairment
• in patients with high blood pressure caused by narrowing of the arteries that supply blood to the kidneys (renovascular hypertension)
• patients who are being treated concurrently with medicines that increase the amount of urine (diuretics)
• in hypertensive patients in whom the diuretic cannot be discontinued
• in patients with severe heart failure and
• in patients treated with medicines that widen blood vessels - vasodilating agents).
Your doctor will determine the duration of treatment on the basis of your medical condition.
Efficacy and safety of use in children and adolescents under the age of 18 has not been established.Therefore, use in children and adolescents is not recommended.
If you have the impression that the effect of the medicine is too strong or too weak, consult your doctor or pharmacist.
If you take more Perindopril than you should If you have taken too many tablets, consult with your doctor or pharmacist immediately. The most likely sign of overdosage is a sudden drop in blood pressure (hypotension). Other symptoms-may inckjded'ast-or^sfow -heart rate, unpleasant sensations of irregular and/or forceful beating of the heart, excessive rate and depth of respiration, dizziness, anxiety and/or cough.
If blood pressure decreases substantially, you should lie down, prop up your lower extremities, and use only a small pillow as a headrest.
If you forget to take Perindopril
It is important to take your medicine every day. However, if you forget to take one dose, just carry on with the next one as normal. Do not take a double dose to make up for forgotten individual doses. If you forget to take more than one dose, take another as soon as you remember and then go on as prescribed.
If you stop taking Perindopril
Upon discontinuation of treatment, blood pressure may increase again and this can increase the risk of complications due to high blood pressure, especially in the heart, brain and kidneys.The condition of patients with heart failure may worsen in as much as to warrant hospitalization. Therefore, if you consider to stop taking Perindopril, you should discuss this with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Like all medicines, Perindopril can cause side effects, although not everybody gets them. The adverse reactions were categorized according to incidence, as follows:
• hypersensitivity reaction with sudden swelling of face, neck, lips, mucous membranes, tongue or throat (with hoarseness or suffocation), possibly also swelling of hands and feet, (angioedema), hives (urticaria)
• reduced kidney function
• inability to achieve or sustain a penile erection (impotence)
• sweating.
Very rare: affects less than 1 user in 10,000
• confusion
• abnormal heart rhythm (arrhythmia), chest pain (angina pectoris), heart attack and stroke possibly due to excessive lowering of blood pressure in high-risk patients
• inflammation in the lungs associated with accumulation of certain blood cells (eosinophils) into lung tissue (eosinophilic pneumonia), inflammation of the mucous membrane of the nose (rhinitis)
• inflammation of the pancreas (pancreatitis)
• inflammation of the liver (hepatitis)
• allergic rash appearing as pink-red flat spots (erythema multiforme)
• acute kidney failure.
Not known: frequency cannot be estimated from the available data
• low blood sugar (hypoglycaemia)
• inflammation of blood vessels, often with skin rash (vasculitis).
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.
HOWTO STORE PERINDOPRIL
Keep out of the reach and sight of children.
Store in the original package.
Do not store above 30°C.
Expiry date
Do not use Perindopril after the expiry date which is stated on the carton.The expiry date refers to the last day of that month.
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.
Q FURTHER INFORMATION
What Perindopril contains
• The active substance is perindopril tert-butylamine.
Perindopril 2 mg tablets:
• Each tablet contains 2 mg perindopril tert-butylamine salt, equivalent to 1.67 mg perindopril.
Perindopril 4 mg tablets:
• Each tablet contains 4 mg perindopril tert^utylahTirie sa1t,l;qutva1ehrt<y3734 trig " perindopril.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium hydrogen carbonate, colloidal anhydrous silica, magnesium stearate
What Perindopril looks like and contents of the pack
2 mg tablets are white, round, biconvex tablets with bevelled edges.
4 mg tablets are white, oblong, biconvex tablets with bevelled edges and scored on one side.
For each strength, boxes of 7, 14, 28, 30, 50,
60, 90 or 100 tablets in a blister pack are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder KRKA Polska Sp. z o.o, ul. Rownolegta 5, 02-235Warsaw, Poland Manufacturer
KRKA Polska Sp. z o.o, ul. Rownolegta 5, 02-235Warsaw, Poland or
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia or
TAD Pharma GmbH, Heinz-Lohmann-Str.5,
27472 Cuxhaven, Germany
For any information about this medicinal
product, please contact the local
representative of the Marketing Authorisation
Holder.
This leaflet was last revised in July 2014.
Common: affects 1 to 10 users in 100
• headache, dizziness, spinning sensation (vertigo), tingling or pins and needles like sensation in the hands or feet (paraesthesia)
• vision disturbance
• ringing, buzzing, roaring, clicking sound in the ears, etc. (tinnitus)
• low blood pressure (hypotension) and effects related to hypotension
• cough, shortness of breath (dyspnoea)
• feeling sick (nausea), being sick (vomiting), abdominal pain, changes in taste (dysgeusia), indigestion (dyspepsia), diarrhoea, and constipation
• rash, itching (pruritus)
• muscle cramps
• weakness (asthenia).
Uncommon: affects 1 to 10 users in 1,000
• mood or sleep disturbances
• wheezing (bronchospasm)
87409-V
TEVA UK LIMITED
• dry mouth