Perindopril/Amlodipine 4 Mg/10 Mg Tablets
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PACKAGE LEAFLET
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Perindopril + amlodipine |
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Package leaflet: Information for the patient
Perindopril/Amlodipine 4 mg/5 mg tablets Perindopril/Amlodipine 4 mg/10 mg tablets Perindopril/Amlodipine 8 mg/5 mg tablets Perindopril/Amlodipine 8 mg/10 mg tablets
Perindopril tert-butylamine/Amlodipine
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 ue Perindopril/Amlodipine
Do not 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),
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- 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.
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 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 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/Amlodipine”.
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),
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- estramustine (used in cancer therapy),
- potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or salt substitutes containing potassium.
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 diuretics (medicines which increase the amount of urine produced by the kidneys),
- 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),
- allopurinol (for the treatment of gout),
- procainamide (for the treatment of an irregular heart beat),
- vasodilators including nitrates (products that widen the blood vessels),
- heparin (medicines used to thin blood),
- ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma),
- baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
- some antibiotics such as rifampicin,
- 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).
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/Amlodipine” and “Warnings and precautions”.
Perindopril/Amlodipine with food and drink
Perindopril/Amlodipine should be taken before a meal.
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.
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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.
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.
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.
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:
- symptoms of allergic reaction such as swelling of the face, lips, mouth, tongue or throat, difficulty in breathing,
- severe dizziness or fainting,
- unusual fast or irregular heart beat.
Other side effects include:
- Common side effects (occur in less than 1 in 10 users but in more than 1 in 100 users): headache, dizziness, vertigo, pins and needles, somnolence (sleepiness), vision disturbances,
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tinnitus (sensation of noises in the ears), palpitations (very fast heartbeat), flushing (hot or warm feeling in your face), 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, diarrhoea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, feeling of tiredness, oedema (swelling of your legs or ankles).
- Uncommon side effects (occur in less than 1 in 100 users but in more than 1 in 1000 users): mood swings, sleep disturbances, trembling, syncope (temporary loss of consciousness), loss of pain sensation, rhinitis (blocked up or runny nose), changed bowel habits, hair loss, red or discoloured patches on skin, back, muscle or joint pain, chest pain, increased need to urinate especially during the night, malaise (general feeling of being unwell), bronchospasm (tightening of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), kidney problems, impotence, increased sweating, breast enlargement in men, weight increase or decrease.
- Very rare side effects (occur in less than 1 in 10,000 users):
confusion, cardiovascular disorders (irregular heart beat, angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), erythema multiforme (a skin rash which often starts with red itchy patches on your face, arms or legs), disorders of the blood, pancreas, stomach or liver, peripheral neuropathy (disease that produces loss of sensations, pain, inability to control muscles), hypertonia (abnormal increase in muscle tension), vasculitis (inflammation of blood vessels of the skin), swelling of the gums, high blood sugar.
The following side effects have also been reported by patients taking Perindopril/Amlodipine:
hypoglycaemia (very low blood sugar level), vasculitis (inflammation of blood vessels).
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 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/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 What Perindopril/Amlodipine contains
- 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
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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),
pregelatinised maize starch, sodium starch glycolate (type A), colloidal anhydrous silica and magnesium stearate (E572).
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.
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 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.
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 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 Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany
This leaflet was last revised in 12/2014
SmPCPIL056234 2 06.10.2014 - Updated: 12.12.2014 Page 81 of 81