Perindopril/Amlodipine 8 Mg/5 Mg Tablets
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
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 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),
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
- 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),
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
- 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),
- tacrolimus (used to control your body’s immune response, enabling your body to accept the transplanted organ),
- 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, 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),
- dantrolene (infusion for severe body temperature abnormalities).
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 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
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
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
The safety of amlodipine in human pregnancy has not been established. 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.
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.
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
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:
- Sensation of noises in the ears (tinnitus) (Common: may affect up to 1 in 10 people),
- Foamy or dark urine, swelling, excessive thirst or any similar signs which would indicate kidney problems (Uncommon: may affect up to 1 in 100 people)
- Signs indicating disorders of the blood, e.g. fever, sore throat, tiredness, unexplained bruising bleeding, mouth ulcers (Very rare: may affect up to 1 in 10,000 people)
- Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell (Very rare: may affect up to 1 in 10,000 people)
- Signs indicating liver problems, e.g. yellowing of the skin, nausea, stomach pain (Very rare: may affect up to 1 in 10,000 people)
- Gastro-intestinal disorders (nausea, vomiting, abdominal pain, dyspepsia or difficulty of digestion, diarrhoea, constipation) (Common: may affect up to 1 in 10 people)
- Swelling of the face, lips, mouth, tongue or throat, difficulty in breathing (angioedema) (Uncommon: may affect up to 1 in 100 people)
- Severe dizziness or fainting due to low blood pressure (Common: may affect up to 1 in 10 people)
- Unusual fast or irregular heart beat (Uncommon: may affect up to 1 in 100 people), chest pain (angina) or heart attack (Very rare: may affect up to 1 in 10,000 people)
- Weakness of arms or legs, or problems speaking which could be sign of a possible stroke (Very rare: may affect up to 1 in 10,000 people)
- Sudden wheeziness, chest pain, shortness of breath, or diffuculty in breathing (bronchospasm) (Uncommon: may affect up to 1 in 100 people)
- 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) or other allergic reactions (Very rare: may affect up to 1 in 10,000 people)
Other side effects include:
PERINDOPRIL
Common: may affect up to 1 in 10 people
- Headache
- Dizziness
- Vertigo
- Pins and needles
- Vision disturbances
- Cough
- Shortness of breath (dyspnoea)
- Allergic reactions (such as skin rashes, itching)
- Muscle cramps
- Feeling of weakness
- Taste disturbances
Uncommon: may affect up to 1 in 100 people
- Mood swings
- Sleep disturbances
- Dry mouth
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
- Intense itching or severe skin rashes
- Formation of blister clusters over the skin
- Impotence (inability to obtain an erection)
- Sweating
- Excess of eosinophils (a type of white blood cells)
- Tachycardia (fast heart beat)
- Myalgia (muscle pain)
- Chest pain
- Malaise (general feeling of illness/feeling unwell)
- Oedema peripheral (swelling of the ankles)
- Fever
- Change in laboratory parameters: high blood level of potassium reversible on discontinuation, low level of sodium, hypoglycaemia (very low blood sugar level) in case of diabetic patients, increased blood urea, and increased blood creatinine
Rare: may affect up to 1 in 1,000 people
- Changes in laboratory parameters: Increased level of liver enzymes, high level of serum bilirubin
Very rare: may affect up to 1 in 10,000 people
- Confusion
- Eosinophilic pneumonia (a rare type of pneumonia)
- Rhinitis (blocked up or runny nose)
- Sudden kidney failure
Not known: cannot be estimated from the available data
- Vasculitis (inflammation of blood vessels) often with skin rash
AMLODIPINE
Very common: may affect more than 1 in 10 people
- Oedema (fluid retention)
Common: may affect up to 1 in 10 people
- Headache (especially at the beginning of treatment) , dizziness, sleepiness
- Palpitations (awareness of your heart beat), flushing
- Visual disturbances, double vision
- Muscle cramps
- Ankle swelling
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: may affect up to 1 in 100 people
- Mood changes, anxiety, depression, sleeplessness
- Trembling, taste abnormalities, fainting
- Numbness or tingling sensation in your limbs; loss of pain sensation
- Low blood pressure
- Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
- Cough
- Dry mouth, vomiting (being sick)
- Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
- Disorder in passing urine, increased need to urinate at night, increased number of times of
passing urine
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
- Inability to obtain an erection; discomfort or enlargement of the breasts in men
- Pain, feeling unwell
- Joint or muscle pain, back pain
- Weight increase or decrease
Rare: may affect up to 1 in 1,000 people
- Confusion
Very rare: may affect up to 1 in 10,000 people
- Excess sugar in blood (hyperglycaemia)
- A disorder of the nerves which can cause weakness, tingling or numbness
- Swelling of the gums
- Abdominal bloating (gastritis)
- Increased muscle tension
- Inflammation of blood vessels, often with skin rash
- Sensitivity to light
- Disorders combining rigidity, tremor, and/or movement disorders Not known: 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 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 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
|
1.3.1 |
Perindopril + Amlodipine |
|
SPC, Labeling and Package Leaflet |
GB |
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 08/2016
SmPCPIL079848 4 05.07.2016 - Updated: 13.09.2016 Page 9 of 9