PERINDOPRIL/AMLODIPINE 8 MG / 5 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - PERINDOPRIL/AMLODIPINE 8 MG / 5 MG TABLETS

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/Amlodipine is and what it is used for
2. What you need to know before you take Perindopril/Amlodipine
3. How to take Perindopril/Amlodipine
4. Possible side effects
5. How to store Perindopril/Amlodipine
6. Contents of the pack and other information

1. what perindopril/amlodipine is and what it is used for

Perindopril/Amlodipine is prescribed for treatment of high blood pressure (hypertension) and/or treatment of stable coronary artery disease (a condition where the blood supply to the heart is reduced or blocked).

Patients already taking perindopril and amlodipine from separate tablets may instead receive one tablet of Perindopril/Amlodipine which contains both ingredients.

Perindopril/Amlodipine is a combination of two active ingredients, perindopril and amlodipine.

Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a calcium antagonist (which belongs to a class of medicines called dihydropyridines). Together they work to widen and relax the blood vessels, which results in a reduction of blood pressure. Blood can flow through the body more easily and the heart does not need to work so hard.

2. what you need to know before you take perindopril/amlodipine- if you are allergic to perindopril tert-butylamine or any other ace inhibitor, amlodipine

besylate or any other dihydropyridines, 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 Perindopril/Amlodipine in

early pregnancy – see pregnancy section.),

– 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 cardiogenic shock (when the heart is unable to supply sufficient blood to the body),

aortic stenosis (narrowing of the main blood vessels leading from the heart) or unstable angina

(chest pain that may occur when resting),

– if you have severe low blood pressure (severe hypotension),
– if you suffer from heart failure (the heart fails to pump blood adequately resulting in the

shortness of breath or peripheral swellings such as swelling of the legs, ankles or feet) after an acute heart attack,

– if you have diabetes or impaired kidney function and you are treated with a blood pressure

lowering medicine containing aliskiren,

– if you are having dialysis or any other type of blood filtration. Depending on the machine that is

used, Perindopril/Amlodipine may not be suitable for you,

– if you have kidney problems where the blood supply to your kidneys is reduced (renal artery

stenosis),

– if you are being treated with sacubitril/valsartan, a medicine for heart failure (see “Warnings

and precautions” and “Other medicines and Perindopril/Amlodipine”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Perindopril/Amlodipine:

– if you have hypertrophic cardiomyopathy (cardiac muscle disease) or renal artery stenosis

(narrowing of the artery which supplies the kidney with blood),

– if you have any other heart problems,
– if you have impaired liver function,
– if you have kidney problems or if you are receiving dialysis,
– if you have abnormally increased levels of a hormone called aldosterone in your blood (primary

aldosteronism),

– if you have 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 (a well

balanced potassium blood level is essential),

– if you are elderly and your dose needs to be increased,
– 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

– if you are taking any of the following medicines, the risk of angioedema is increased:

- racecadotril (used to treat diarrhea)
- sirolimus, everolimus, temsirolimus and other medicines belonging to the class of

so-called mTOR inhibitors (used to avoid rejection of transplanted organs),

– sacubitril (available as fixed dose combination with valsartan) used to treat long-term

heart failure,

– if you are of black origin since you may have a higher risk of angioedema and this medicine

may be less effective in lowering blood pressure than in non-black patients.

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/Amlodipine”.

Angioedema

Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This may occur at any time during treatment. If such symptoms develop, you should stop taking Perindopril/Amlodipine and see a doctor immediately. See also Section 4.

You must tell your doctor if you think you are (or might become) pregnant. Perindopril/Amlodipine 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).

When you are taking Perindopril/Amlodipine, you should also inform your doctor or the medical staff if you:

– are going to have a general anaesthetic and/or major surgery,
– have recently suffered from diarrhoea or vomiting (being sick),
– are to undergo LDL apheresis (the removal of cholesterol from your blood by a machine),
– are going to have desensitisation treatment to reduce the effects of an allergy to bee or wasp

stings.

Children and adolescents

Perindopril/Amlodipine is not recommended for use in children and adolescents.

Other medicines and Perindopril/Amlodipine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should avoid Perindopril/Amlodipine with:

– lithium (used to treat mania or depression),
– estramustine (used in cancer therapy),
– potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or salt

substitutes containing potassium, or other drugs which can increase potassium in your body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole),

– potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at

doses between 12.5 mg to 50 mg by day.

Treatment with Perindopril/Amlodipine 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 high blood pressure, including angiotensin II receptor blocker (ARB),

aliskiren (see also information under the headings „Do not take Perindopril/Amlodipine“ and „Warnings and precautions“), or diuretics (medicines which increase the amount of urine produced by the kidneys),

– sacubitril/valsartan (used to treat long-term heart failure): See sections “Do not take

Perindopril/Amlodipine” and “Warnings and precautions”,

– non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high dose

acetylsalicylic acid,

– medicines to treat diabetes (such as insulin),
– medicines to treat mental disorders such as depression, anxiety, schizophrenia etc (e.g. tricyclic

antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),

– 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, tacrolimus),

– trimethoprim and Co-trimoxazole (for the treatment of infections),
– allopurinol (for the treatment of gout),
– procainamide (for the treatment of an irregular heart beat),
– vasodilators including nitrates (products that widen the blood vessels),
– ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or

asthma),

– baclofen or dantrolene (infusion) both used to treat muscle stiffness in diseases such as multiple

sclerosis; dantrolene is also used to treat malignant hyperthermia during anaesthesia (symptoms including very high fever and muscle stiffness),

– some antibiotics such as rifampicin, erythromycin
– clarithromycin (for infections caused by bacteria),
– antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
– itraconazole, ketoconazole (medicines used for treatment of fungal infections),
– 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),

– gold salts, especially with intravenous administration (used to treat symptoms of rheumatoid

arthritis),

– simvastatin (cholesterol lowering medicine),
– ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV),
– hypericum perforatum (St. John’s Wort),
– verapamil, diltiazem (heart medicines),
– medicines, which is most often used to treat diarrhoea (racecadotril) or avoid rejection of

transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”.

Perindopril/Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Perindopril/Amlodipine with food and drink

Perindopril/Amlodipine should be taken before a meal.

Grapefruit juice and grapefruit should not be consumed by people who are taking Perindopril/Amlodipine. 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 Perindopril/Amlodipine.

Pregnancy and breast-feeding

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 you are (or might become) pregnant. Your doctor will normally advise you to stop taking Perindopril/Amlodipine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Perindopril/Amlodipine. Perindopril/Amlodipine 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.

Breastfeeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril/Amlodipine 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. Amlodipine has been shown to pass into breast milk in small amounts.

Driving and using machines

Perindopril/Amlodipine does not affect alertness but you might experience dizziness or weakness due to low blood pressure which could affect your ability to drive or operate machinery. You are advised not to drive a car or operate machinery until you know how Perindopril/Amlodipine affects you.

Perindopril/Amlodipine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take perindopril/amlodipine

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. This will normally be one tablet per day. Perindopril/Amlodipine will usually be prescribed for patients already taking perindopril and amlodipine from separate tablets.

Use in children and adolescents

Use in children and adolescents is not recommended.

If you take more Perindopril/Amlodipine than you should

If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely symptoms of overdose are low blood pressure which can make you feel dizzy or faint. If this happens, lying down with your legs raised can help.

If you forget to take Perindopril/Amlodipine

It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Perindopril/Amlodipine, take the next dose at the usual time.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Perindopril/Amlodipine

As the treatment with Perindopril/Amlodipine is usually life-long, you should discuss with your doctor before you stop taking your tablets.

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:

– sudden wheeziness, chest pain, shortness of breath, or difficulty in breathing,
– swelling of eyelids, face or lips,
– swelling of the tongue and throat, which causes great difficulty breathing,
– severe skin reactions including intense skin rash, hives, reddening of the skin over your whole

body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions,

– severe dizziness or fainting,
– heart attack, unusual fast or abnormal heart beat, or chest pain.
– inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling

very unwell.

The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

– Very common side effects (may affect more than 1 in 10 people): oedema (fluid retention).
– Common side effects (may affect up to 1 in 10 people): headache, dizziness, sleepiness

(especially at the beginning of treatment), vertigo, numbness or tingling sensation in your limbs, vision disturbances (including double vision), tinnitus (sensation of noises in the ears), palpitations (awareness of your heartbeat), flushing, light-headedness due to low blood pressure, cough, shortness of breath, nausea (feeling sick), vomiting (being sick), abdominal pain, taste disturbances, dyspepsia or difficulty of digestion, change of bowel habit, diarrhoea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, tiredness, weakness, ankle swelling (oedema peripheral).

Other side effects that have been reported include the following list. If any of these get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

– Uncommon side effects (may affect up to 1 in 100 people): mood swings, anxiety, depression,

sleeplessness, sleep disturbances, trembling, fainting, loss of pain sensation, irregular heart beat, rhinitis (blocked up or runny nose), hair loss, red patches on skin, skin discoloration, back pain, arthralgia (joint pain), myalgia (muscle pain), chest pain, disorder in passing urine, increased need to urinate at night, increased number of times of passing urine, pain, feeling unwell, bronchospasm (tightening of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), formation of blister clusters over the skin, kidney problems, impotence, increased sweating, an excess of eosinophils (a type of white blood cells), discomfort or enlargement of the breasts in men, weight increase or decrease, tachycardia, vasculitis (inflammation of blood vessels), photosensitivity reaction (increased sensitivity of the skin to sun), fever, fall, change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypogycemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine.

– Rare side effects (may affect up to 1 in 1,000 people): confusion, psoriasis worsening, changes

in laboratory parameters: increased level of liver enzymes, high level of serum bilirubin.

– Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina,

heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of eyelids, face or lips, swelling of the tongue and throat, which causes great difficulty in breathing, severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome), erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs), sensitivity to light, changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets, disorders of the blood, inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell, acute renal failure, abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests, abdominal bloating (gastritis), disorder of the nerves which can cause weakness, tingling or numbness, increased muscle tension, swelling of the gums, excess sugar in blood (hyperglycaemia).

– Side effects with not known frequency: (frequency cannot be estimated from the available

data): trembling, rigid posture, mask-like face, slow movements and a shuffling, unbalanced walk.

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 Yellow Card Scheme Website:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store perindopril/amlodipine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Store in the original package 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.

6. contents of the pack and other information- the active substances are perindopril tert-butylamine and amlodipine.

Perindopril/Amlodipine 4 mg/5 mg tablets

Each tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and

5 mg amlodipine (as besilate).

Perindopril/Amlodipine 4 mg/10 mg tablets

Each tablet contains 4 mg perindopril tert-butylamine (equivalent to 3.34 mg perindopril) and 10 mg amlodipine (as besilate).

Perindopril/Amlodipine 8 mg/5 mg tablets

Each tablet contains 8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and

5 mg amlodipine (as besilate).

Perindopril/Amlodipine 8 mg/10 mg tablets

Each tablet contains 8 mg perindopril tert-butylamine (equivalent to 6.68 mg perindopril) and 10 mg amlodipine (as besilate).

– The other ingredients are sodium hydrogen carbonate, microcrystalline cellulose (E460),

What Perindopril/Amlodipine looks like and contents of the pack

Perindopril/Amlodipine 4 mg/5 mg tablets

This medicinal product is presented as white to almost white, round, slightly biconvex tablets with bevelled edges, engraved with mark U 1 on one side of the tablet. Diameter: approximately 7 mm. Perindopril/Amlodipine 4 mg/10 mg tablets

This medicinal product is presented as white to almost white, capsule shaped, biconvex tablets scored on one side. The tablets are engraved with mark U on one side and mark 2 on the other side of the breaker score. Dimensions: approximately 12.5 mm x 5.5 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Perindopril/Amlodipine 8 mg/5 mg tablets

This medicinal product is presented as white to almost white, round, biconvex tablets with bevelled edges, engraved with mark U 3 on one side of the tablet. Diameter: approximately 9 mm.

Perindopril/Amlodipine 8 mg/10 mg tablets

This medicinal product is presented as white to almost white, round, biconvex tablets with bevelled edges and a score line on one side. The tablets are engraved with mark U on one side and mark 4 on the other side of the breaker score. Diameter: approximately 9 mm. The tablet can be divided into equal doses.

The tablets are available in carton boxes of 5, 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in 10/2018