Patient leaflet - Perindopril/amlodipine Stada 8 mg/5 mg tablet
1. What Perindopril/Amlodipine STADA is and what it is used for
Perindopril/Amlodipine STADA 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 STADA which contains both ingredients.
Perindopril/Amlodipine STADA 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 so that blood passes through them more easily and makes it easier for your heart to maintain a good blood flow.
2. What you need to know before you take Perindopril/Amlodipine STADA
DO NOT take Perindopril/Amlodipine STADA
- if you are allergic to perindopril or any other ACE inhibitor, amlodipine or any other calcium antagonists, 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 STADA 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 diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
- if you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
- if you have severe low blood pressure (hypotension)
- if you suffer from heart failure after a heart attack
Warnings and precautions
Talk to your doctor or pharmacist before taking Perindopril/Amlodipine STADA
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 heart failure
- if you have severe increase in blood pressure (hypertensive crisis)
- if you have any other heart problems
- if you have liver problems
- 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 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 (rapid swelling under the skin in area such as the throat) is increased:
- racecadotril (used to treat diarrhoea)
- sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors (used to avoid rejection of transplanted organs)
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 STADA”
You must tell your doctor if you think you are (or might become) pregnant. Perindopril/Amlodipine STADA 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 STADA, 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 STADA is not recommended for use in children and adolescents.
Other medicines and Perindopril/Amlodipine STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should avoid Perindopril/Amlodipine STADA with:
- lithium (used to treat mania or depression)
- estramustine (used in cancer therapy)
- potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or potassium-containing salt substitutes
- or other drugs which can increase potassium in your body, such as heparin (medicine used to thin blood) and co-trimoxazole also known as trimethoprim/sulfamethoxazole (for the treatment of infections)
Treatment with Perindopril/Amlodipine STADA may be affected by other medicines. Your doctor may need to change your dose and/or to take other precautions. 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 STADA” and “Warnings and precautions”) or diuretics (medicines which increase the amount of urine produced by the kidneys)
- medicines, which are most often used to treat diarrhea (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”
- 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)
- 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
- 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)
- ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)
Perindopril/Amlodipine STADA with food and drink
Perindopril/Amlodipine STADA should be taken before a meal.
Grapefruit juice and grapefruit should not be consumed by people who are taking Perindopril/Amlodipine STADA. 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 STADA.
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 STADA 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 STADA. Perindopril/Amlodipine STADA 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
Amlodipine, one of the two active ingredients in /…/ has been shown to pass into breast milk in small amounts.
Tell your doctor if you are breast-feeding or about to start breast-feeding. Perindopril/Amlodipine STADA 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 STADA may affect your ability to drive or use machines. If theses 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.
3. How to take Perindopril/Amlodipine STADA
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one tablet once a day.
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 STADA will usually be prescribed for patients already taking perindopril and amlodipine from separate tablets.
If you take more Perindopril/Amlodipine STADA than you should
If you take too many tablets, contact your nearest accident and emergency department or tell your doctor immediately. The most likely effect in case of overdose is 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 STADA
It is important to take your medicine every day as regular treatment works better. However, if you forget to taka a dose of Perindopril/Amlodipine STADA , take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Perindopril/Amlodipine STADA
As the treatment with Perindopril/Amlodipine STADA 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,
- 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. 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
- diarrhoea
- constipation
- allergic reactions (such as skin rashes, itching)
- muscle cramps
- tiredness
- weakness
- ankle swelling (oedema)
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
- rhinitis (blocked up or runny nose)
- altered bowel habits
- hair loss
- red patches on skin, skin discolouration
- back pain, muscle or joint 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)
- kidney problems
- impotence
- increased sweating
- discomfort or enlargement of the breasts in men
- weight increase or decrease
Rare side effects (may affect up to 1 in 1,000 people):
- confusion
- psoriasis worsening
- elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can, in severe cases, trigger yellow skin and eyes
Very rare side effects (may affect up to 1 in 10,000 people):
- cardiovascular disorders (irregular heartbeat, 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
- disorders of the blood
- inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell
- 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
- vasculitis (inflammation of blood vessels)
- swelling of the gums
- excess sugar in blood (hyperglycaemia)
The following side effects have also been reported by patients taking Perindopril/Amlodipine STADA:
- hypoglycaemia (very low blood sugar level),disorders combining rigidity, tremor, and/or movements disorders.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Perindopril/Amlodipine STADA
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 label, carton or bottle after “EXP”. The expiry date refers to the last day of that month.
Blister pack (Al/Al): Store in original package in order to protect from light and moisture. HDPE bottle pack: Do not store above 30°C. Store in original package in order to protect from light and moisture. Use within 3 months after first opening
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 STADA contains
- The active substances are perindopril tert-butylamine and amlodipine.
- Each tablet contains 8 mg perindopril tert-butylamine and 10 mg amlodipine.
- The other ingredients are sodium starch glycolate (type A), glycerol dibehenate, calcium hydrogen phosphate, anhydrous, trehalose dihydrate, cellulose microcrystalline, magnesium oxide light, crospovidone, magnesium stearate
What Perindopril/Amlodipine STADA looks like and contents of the pack
Perindopril/Amlodipine STADA 8 mg/10 mg tablets are white to off-white, round, biconvex, diameter 9 mm marked 8|10 on one side and plain on the other side
Pack sizes:
Blister packs (Al-Al): 10, 30, 60, 90 tablets
Tablet container: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Actavis ehf.
Reykjavikurvegur 78,
Hafnarfjörður, IS-220,
Iceland
Actavis Ltd.
BLB 016, Bulebel Industrial
Estate, Zejtun ZTN 3000,
Malta
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
This medicinal product is authorised in the Member States of the EEA under the following names:
UK Perindopril/Amlodipine STADA 8 mg/10 mg tablets
FR PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE EG 8 mg/10 mg, comprimé IT Perindopril e Amlodipina Eurogenerici
SK Perindamlostad 8mg/10mg tablety