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PERINDOPRIL/AMLODIPINE STADA 4 MG/5 MG TABLET

Active substance(s): AMLODIPINE / PERINDOPRIL TERT-BUTYLAMIN / AMLODIPINE / PERINDOPRIL TERT-BUTYLAMIN

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

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

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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 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 potassiumcontaining salt substitutes
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

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“Warnings and precautions”) or diuretics (medicines which increase the amount of urine produced
by the kidneys)
medicines, which is 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)
heparin (medicines used to thin blood)
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
Ask your doctor or pharmacist for advice before taking any 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
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.

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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) 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

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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.
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

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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 the Yellow Card Scheme
at: 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 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
dispose of medicines no longer required. 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 4 mg perindopril tert-butylamine and 5 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 4 mg/5 mg tablets are white to off-white, oval, biconvex, 5 mm x
9 mm marked 4|5 on one side and plain on the other side

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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 4 mg/5 mg tablets
FR
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE EG 4 mg/5 mg, comprimé
IT
Perindopril e Amlodipina Eurogenerici
SK
Perindamlostad 4mg/5mg tablety

This leaflet was last revised in April 2017.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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