Reaptan

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

5/5; 5/10; 10/5; 10/10

Perindopril/amlodipine [pronounced per-in-do-pril/ am-load-i-peen]

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about REAPTAN.

It does not contain all the available information about this medicine.

Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking REAPTAN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

WHAT REAPTAN IS

The name of your medicine is REAPTAN.

The medicine contains the active ingredient perindopril arginine. Perindopril belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors.

It also contains the active ingredient amlodipine besilate. Amlodipine belongs to a group of medicines called calcium channel blockers.

Calcium channel blockers do not change the amount of calcium in your blood or bones.

REAPTAN has been prescribed for you by your doctor to replace the separate tablets of perindopril and amlodipine you were taking.

One REAPTAN tablet replaces separate tablets of perindopril and amlodipine.

WHAT REAPTAN IS USED FOR

You have been prescribed REAPTAN if you have high blood pressure, also known as hypertension.

Why REAPTAN is used for high blood pressure

Everyone has blood pressure. This pressure helps get your blood all around the body. Your blood pressure may be different at different times of the day, depending on how busy or stressed you are.

You have high blood pressure when your blood pressure stays higher than is needed, even when you are calm or relaxed.

There are usually no symptoms of high blood pressure. The only way of knowing that you have it is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually it can cause stroke, heart disease and kidney failure.

The active ingredients in REAPTAN, perindopril arginine and amlodipine help lower your blood pressure.

You may also have been prescribed REAPTAN if you have coronary heart disease.

Why REAPTAN is used for coronary heart disease

Coronary heart disease is narrowing of the vessels carrying blood to the heart.

In patients with coronary artery disease, REAPTAN has been shown to reduce some of the risks, including heart attacks.

HOW REAPTAN WORKS

REAPTAN works by widening your blood vessels, which reduces pressure in the vessel, making it easier for your heart to pump blood around your body

This helps increase the supply of oxygen to your heart, so that when you place extra demands on your heart, such as during exercise, your heart may cope better and you may not get short of breath as easily.

Ask your doctor if you have any questions about why REAPTAN has been prescribed for you.

REAPTAN is available only with a doctor's prescription.

There is no evidence that REAPTAN is addictive.

BEFORE YOU TAKE REAPTAN

There are some people who shouldn't take REAPTAN. Please read the list below.

If you think any of these situations apply to you or you have any questions, please consult your doctor or pharmacist.

Do not take REAPTAN if:

you are allergic to perindopril or amlodipine, or any of the other ingredients of REAPTAN listed at the end of this leaflet.

you have had an allergic reaction to any other ACE inhibitors or calcium channel blockers

Symptoms of an allergic reaction to REAPTAN may include skin rash, itchiness, shortness of breath, swelling of the face, lips or tongue, muscle pain or tenderness or joint pain.

are pregnant or trying to become pregnant

REAPTAN may affect your developing baby if you take it during pregnancy.

are breastfeeding or plan to breast-feed

REAPTAN passes into breast milk and therefore there is a possibility that the breast-fed baby may be affected.

are undergoing treatments where your blood is treated outside of the body (also known as extracorporeal treatments) that may increase your risk of allergic reactions, treatments such as:

renal dialysis or haemofiltration using polyacrylonitrile membranes

low-density lipoprotein (LDL) apheresis, a technique where LDL is 'filtered' out of the blood, using dextran sulfate.

you are treated with a blood pressure lowering medicine containing aliskiren and have diabetes or impaired kidney function.

you are being treated with sacubitril/valsartan, a medicine for heart failure as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased (see also 'Tell Your Doctor Straight Away' and ‘Taking Other Medicines’ sections).

have renal artery stenosis (narrowing of the blood vessels to one or both kidneys).

have aortic stenosis (narrowing of the main blood vessel leaving from the heart).

have severe hypotension (low blood pressure).

have unstable angina

Unstable angina is a pain or uncomfortable feeling in the chest that lasts longer than a few minutes or occurs with rest and may not be relieved with medication.

have cardiogenic shock which is a sudden and severe drop in blood pressure and blood flow through the body because the heart is not pumping normally.

have heart failure during the first 28 days after a heart attack (Heart failure means that the heart muscle cannot pump blood strongly enough to supply all the blood needed throughout the body. It does not mean that the heart stops working).

have experienced swelling of the face, tongue, lips or throat either spontaneously or in response to another medicine in the past. (This rare condition is known as angio-oedema).

the packaging is damaged or shows sign of tampering.

the expiry date (EXP) on the pack has passed.

If you think any of these situations apply to you, or you have any doubts or questions about taking REAPTAN speak to your doctor or pharmacist.

For older people and patients with renal impairment

REAPTAN can generally be used safely by elderly people.

Reduced kidney function is often found in elderly people and in this case, the starting dose should always be 2.5 mg of perindopril arginine and 2.5 mg of amlodipine taken as separate tablets.

For children

REAPTAN is not recommended for children.

Driving and using machines

REAPTAN may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, weak or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Tell your doctor straight away if:

you are pregnant or become pregnant while taking REAPTAN, as it may cause serious harm to your baby.

you are undergoing desensitisation treatment or have had an allergic reaction during previous desensitisation treatment (e.g. treatments using bee, wasp or ant venom).

you are undergoing, or you are intending to undergo, treatments where your blood is treated outside of the body (also known as extracorporeal treatments) you are to undergo anaesthesia and/or surgery.

you have recently suffered from diarrhoea or vomiting.

you are on a salt restricted diet or use salt substitutes which contain potassium.

you have an intolerance to some sugars as REAPTAN contains lactose.

you are taking any of the following medicines used to treat high blood pressure:

an 'angiotensin II receptor blocker' (also known as ARBs or sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems

aliskiren.

you are treated with immunosuppressant therapy or allopurinol or procainamide.

you have any other health problems, including:

kidney disease or if you are on renal dialysis

liver disease

high or low levels of potassium, or other problems with salt balance

diabetes

heart disease, severe increase in blood pressure or other heart problems

Systemic lupus erythematous or scleroderma (a disease affecting the skin, joints and kidneys)

abnormally increased levels of a hormone called aldosterone in your blood (primary hyperaldosteronism).

If you think any of these situations apply to you, or you have any doubts or questions about taking REAPTAN consult your doctor or pharmacist.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop.

Taking REAPTAN may change the effect of some medicines, and some medicines may affect how well REAPTAN works. You may need different amounts of your medication or to take different medicines.

The medicines that may interact with REAPTAN include the following:

Some treatments where your blood is treated outside of the body, also known as extracorporeal treatments (see also 'Do Not Take REAPTAN If' and 'Tell Your Doctor Straight Away' sections)

some antibiotic medicines such as erythromycin, clarithromycin and rifampicin

some medicines used to treat fungal infections such as ketoconozole or itracanazole

some anti-inflammatory drugs (including high dose aspirin, ibuprofen to relieve pain swelling and other symptoms of inflammation, including arthritis, and gold injections to treat rheumatoid arthritis)

medicines used to treat mood swings and some types of depression (lithium, tricyclic antidepressants, antipsychotics)

potassium-sparing medicines (spironolactone, triamterene, amiloride, eplerenone), sources of potassium, like potassium tablet and salt substitutes containing potassium, other drugs which can increase potassium in your body (such as heparin, a medicine used to thin blood to prevent clots; co-trimoxazole also known as trimethoprim/sulfamethoxazole for infections caused by bacteria; and ciclosporin, an immunosuppressant medicine used to prevent organ transplant rejection)

some medications used to treat high blood pressure (including angiotensin receptor blocker, beta-blockers, alpha-blockers) aliskiren (see also 'Do Not Take REAPTAN If' and 'Tell Your Doctor Straight Away' sections), or diuretics (sometimes called 'fluid' or 'water' tablets because they increase the amount of urine passed each day)

vasodilators including nitrates

medicines used to treat diabetes (tablets and insulin)

muscle relaxants such as baclofen and dantrolene; dantrolene is also used to treat hyperthermia during anaesthesia (symptoms include very high fever and muscle stiffness)

medicines used to treat epilepsy such as carbamazepine, phenobarbitone, phenytoin or primidone

St. John's Wort

medicines which lower your immune system, such as corticosteroids, cyclosporin, tacrolimus or medicines used to treat cancer (including radiation therapy)

simvastatin (cholesterol lowering medicine)

tetracosactide, a medicine used to treat adrenal insufficiency

medicines which may affect the blood cells, such as allopurinol, procainamide

medicines affecting the part of the nervous system that controls the activities of the heart and blood vessels, including ephedrine, noradrenaline or adrenaline

alpha-blockers used for the treatment of enlarged prostate such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin

amifostine (used to prevent or reduce side effects caused by other medicines or radiation therapy that are used to treat cancer)

corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis)

medicines used to treat HIV infection such as indinavir, ritonavir (also called 'protease inhibitors')

mammalian target of rapamycin (mTOR) inhibitors used to avoid rejection of transplanted organs (e.g. temsirolimus, sirolimus, everolimus)

sacubitril/valsartan (used to treat long-term heart failure) (see also 'Do Not Take REAPTAN If' and 'Tell Your Doctor Straight Away' sections)

gliptins used to treat diabetes (e.g. linagliptin, saxagliptin, sitagliptin, vildagliptin, alogliptin)

It is a good idea to remind your doctor of all other medicines you take. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking REAPTAN.

HOW TO TAKE REAPTAN

Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

How much to take

Your doctor will select a dose when they prescribe REAPTAN for you. The usual dose is one tablet once daily.

How to take it

Swallow your tablet(s) with a glass of water.

Grapefruit juice and grapefruit should not be consumed by people who are taking REAPTAN. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of REAPTAN.

When to take it

Take REAPTAN at about the same time each day unless your doctor tells you otherwise.

Taking your tablet at the same time each day will have the best effect. It will also help you remember when to take the tablets.

REAPTAN should be taken in the morning before a meal. If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose that you missed.

How long to take it for

REAPTAN helps control your blood pressure and/or treat your coronary heart disease but does not cure it. Continue taking the tablets for as long as your doctor tells you.

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26 in Australia) if you think you or anyone else may have taken too much REAPTAN. Do this even if there are no signs of discomfort or poisoning.

WHILE YOU ARE TAKING REAPTAN

Things you must do

If you become pregnant while you are taking REAPTAN, tell your doctor.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking REAPTAN.

Tell all doctors, dentists and pharmacists involved with your treatment that you are taking REAPTAN.

Take REAPTAN exactly as your doctor has prescribed. Otherwise you may not get the benefits from treatment.

If any of the signs below occur, then tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

swelling of your lips, face, mouth, tongue or throat

purple spots with occasional blisters on the front of your arms and legs and/or around your neck and ears (a rare condition known as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis (TEN))

severe blisters, skin rash, itching or other allergic reactions.

These side effects are extremely rare but can become serious.

If you have stopped treatment with REAPTAN due to an allergic reaction you should not start taking REAPTAN again.

Things you must not do

do not give REAPTAN to anyone else, even if they have the same condition as you.

do not use REAPTAN to treat other complaints unless your doctor tells you to.

do not stop taking REAPTAN or change the dosage, without checking with your doctor.

do not stop taking your tablets because you are feeling better, unless advised by your doctor.

Things that may help your condition

Some self - help measures suggested below may help your condition. Talk to your doctor or pharmacist about these measures and for more information.

Alcohol - your doctor may advise you to limit your alcohol intake

Diet - eat a healthy low-fat diet which includes plenty of fresh vegetables, fruit, bread, cereals and fish. Also eat less fat and sugar

Exercise - regular exercise helps to reduce blood pressure and helps get the heart fitter, but it is important not to overdo it. Walking is good exercise but try to find a route that is reasonably flat. Before starting any exercise, ask your doctor about the best kind of program for you

Salt - your doctor may advise you to watch the amount of salt in your diet. To reduce your salt intake you should avoid using salt in cooking or at the table

Smoking - your doctor may advise you to stop or at least cut down smoking

Weight - your doctor may suggest losing some weight to help lower your blood pressure and help lessen the amount of work your heart has to do. Some people may need a dietician's help to lose weight.

SIDE EFFECTS

Angioedema (a severe allergic reaction) has been reported in patients treated with ACE inhibitors, including REAPTAN. This may occur at any time during treatment. If you develop such symptoms described below you should tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital. These side effects are extremely rare but can become serious:

swelling of your extremities (limbs, hands or feet), lips, face, mouth, tongue or throat

purple spots with occasional blisters on the front of your arms and legs and/or around your neck and ears (a rare condition known as Stevens-Johnson Syndrome)

painful red areas, developing large blisters and peeling of layers of skin. This is accompanied by fever and chills

red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body

difficulty in breathing

a fast and irregular heartbeat.

Talk to your doctor or pharmacist or nurse if you notice any of the following side effects:

Some of the side effects are usually only identified after blood tests.

Very common (may affect more than 1 in 10 people) side effects can include:

dizziness

cough, often described as dry and irritating, shortness of breath, discomfort on exertion

oedema (fluid retention)

swelling of hands, ankles or feet, joint swelling (ankle swelling).

Common (may affect up to 1 in 10 people) side effects can include:

chest pain

nosebleeds

headache, vertigo, pins and needles

changes in the rhythm or rate of the heartbeat, fast or irregular heartbeat

feeling tired, lethargic or weak

feeling sleepy (somnolence)

tinnitus (persistent noise in the ears), vision impairment (including double vision)

low blood pressure (and related effects), flushing, impaired peripheral circulation, blood vessel inflammation (vasculitis)

nausea, vomiting, taste disturbances, indigestion, diarrhoea, constipation, change of bowel habits, stomach pain or discomfort

dry mouth

muscle spasms

fatigue

rash, pruritus (itching), red raised skin rash

eczema

erectile dysfunction

drowsiness

chest tightness (dyspnoea), discomfort on exertion.

Uncommon (may affect up to 1 in 100 people) side effects can include:

conjunctivitis - discharge with itching of the eyes and crusty eyelids, swollen runny eyes

runny or blocked nose, sneezing, facial pressure or pain

bleeding or bruising more easily than normal caused by a low blood platelet count (thrombocytopenia)

frequent infections such as fever, severe chills, sore throat or mouth ulcers caused by a lack of white blood cells (leukopenia)

hyperglycaemia (high blood sugar levels),

hypoglycaemia (low blood sugar levels)

thirst

numbness or weakness of the arms and legs

tremor

numbness, or reduced sense of touch

high levels in the blood of potassium, urea and/or creatinine, low sodium levels in the blood

peripheral ischaemia - a condition caused by reduced blood flow to the limbs, hands and feet

orthostatic hypertension - dizziness on standing up, especially when getting up from a sitting or lying position

mood disturbance, depression, nervousness, depersonalisation, sleep disturbances (difficulty sleeping, abnormal dreams), feeling sleepy or drowsy, fainting

difficulty breathing or wheezing

decreased appetite

difficulty in swallowing

flatulence or 'passing wind'

bleeding, tender or enlarged gums

inflammation of the pancreas (pancreatitis)

swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing

unusual hair loss or thinning

purpura - unusual bleeding or bruising under the skin, or purple or red-brown spots visible through the skin

excessive sweating

increased sensitivity of the skin to sun, skin rash or inflammation of the skin often including blisters that weep and become crusted

skin discolouration

hypersensitivity reactions, mainly skin reactions, in patients with allergies and asthmatic reactions

pemphigoid - a skin disease usually affecting older people

increase in some white blood cells (eosinophilia).

pollakiuria

need to urinate during the night

passing urine more often than usual

sexual dysfunction

breast enlargement in men

fever or high temperature

kidney problems

decreased blood sugar levels

osteoarthritis

aching muscles, not caused by exercise

back pain

generally feeling unwell

falls

diplopia, eye pain

fast, slow or irregular heartbeat

peripheral coldness

hives or skin rash (urticaria)

joint pain

malaise, pain, chills

blood urea/creatinine increase

weight gain/weight decrease.

Rare (may affect up to 1 in 1,000 people) side effects can include:

increased appetite

confusion, agitation,

apathy - lack of interest, enthusiasm, concern

loss of memory

ataxia - clumsiness and lack of coordination, affecting balance and manner of walking, limb or eye movements and/or speech. Unsteadiness when walking

migraine

inability to smell

unusual muscle stiffness causing poor control of movement

muscle weakness

blurred vision

dry eyes

myocardial infarction, angina pectoris (a feeling of tightness, pressure or heaviness in the chest)

cardiac failure - disease of the heart with heart failure, symptoms include shortness of breath, swelling of the feet or legs due to fluid build-up

gastritis - inflammation of the stomach where symptoms include pain, nausea, vomiting, vomiting blood, blood in the bowel motions

red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body

dry skin

cold and clammy skin

dermatitis

elevation of bilirubin levels in the blood, increases in liver enzymes

hepatitis (liver disease)

yellowing of the skin and/or eyes, also called jaundice

muscle twitching

muscular weakness

painful or difficult urination

worsening of psoriasis

acute kidney disease

problems with production or passing of urine

concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits which may be due to inappropriate anti-diuretic hormone (ADH) secretion can occur with ACE inhibitors. If you have these symptoms contact your doctor as soon as possible.

Very rare (may affect up to 1 in 10,000 people) side effects can include:

hallucination

cerebrovascular accident

Quicke's oedema

Steven Johnson syndrome

eosinophilic pneumonia

illnesses resulting from a lack or destruction of red blood cells - (anaemia, pancytopenia)

illnesses resulting from a lack of white blood cells (agranulocytosis, neutropenia, pancytopenia)

severe flaking or peeling of the skin

Not known (frequency cannot be estimated from the data available):

extrapyramidal syndrome - unusual movements, including trembling and shaking of the hands and fingers, rigid posture, mask-like face, slow movements of the body, shuffling unbalanced walk and stiffness of the arms and legs

discolouration, numbness and pain in fingers or toes (Raynaud’s phenomenon).

Consult your doctor, pharmacist or nurse if you experience any of these or notice anything else that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Other uncommon side effects have been reported and you should ask your doctor, pharmacist or nurse if you want to know more.

AFTER TAKING REAPTAN

Storage

Keep your REAPTAN tablets in the bottle until it is time to take them.

REAPTAN will not keep as well outside its packaging.

Keep your REAPTAN tablets in a cool, dry place away from light where the temperature stays below 25°C.

Do not store medicines in a bathroom or near a sink. Do not leave them in a car or on a window sill.

Heat and dampness can destroy some medicines.

Keep your REAPTAN tablets where children cannot reach them.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking REAPTAN, or the tablets have passed their expiry date, return any leftover tablets to your pharmacist for disposal.

PRODUCT DESCRIPTION

What it looks like

REAPTAN 5/5 tablets are white and rod-shaped engraved with 5/5 on one face and the Servier Logo on the other face, supplied in a bottle of 30 tablets.

REAPTAN 5/10 tablets are white and square-shaped engraved with 5/10 on one face and the Servier Logo on the other face, supplied in a bottle of 30 tablets.

REAPTAN 10/5 tablets are white and triangular-shaped engraved with 10/5 on one face and the Servier Logo on the other face, supplied in a bottle of 30 tablets.

REAPTAN 10/10 tablets are white and round engraved with 10/10 on one face and the Servier Logo on the other face, supplied in a bottle of 30 tablets.

Thirty (30) tablets are supplied in a white bottle containing desiccant sachets and equipped with a white child-resistant screw-on cap.