Perindopril tert-butylamine/Amlodipine Stada 8 mg/10 mg Tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

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Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
amlodipinbesilat; perindopril-tert-butylamin
Tillgänglig från:
STADA Arzneimittel AG
ATC-kod:
C09BB04
INN (International namn):
amlodipine besylate; perindopril tert-butylamine
Dos:
8 mg/10 mg
Läkemedelsform:
Tablett
Sammansättning:
amlodipinbesilat 13,88 mg Aktiv substans; perindopril-tert-butylamin 8 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Bemyndigande status:
Avregistrerad
Godkännandenummer:
52345
Tillstånd datum:
2016-10-27

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Package leaflet: Information for the user

Perindopril tert-butylamine/Amlodipine Stada 4 mg/5 mg tablets

Perindopril tert-butylamine/Amlodipine Stada 4 mg/10 mg tablets

Perindopril tert-butylamine/Amlodipine Stada 8 mg/5 mg tablets

Perindopril tert-butylamine/Amlodipine Stada 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

What Perindopril tert-butylamine/Amlodipine Stada is and what it is used for

What you need to know before you take Perindopril tert-butylamine/Amlodipine Stada

How to take Perindopril tert-butylamine/Amlodipine Stada

Possible side effects

How to store Perindopril tert-butylamine/Amlodipine Stada

Contents of the pack and other information

1.

What Perindopril tert-butylamine/Amlodipine Stada is and what it is used for

Perindopril tert-butylamine/Amlodipine Stada contains two active substances: perindopril

tert-butylamine and amlodipine. Perindopril belongs to a group of medicines called ACE

inhibitors (Angiotensin Converting Enzyme inhibitors). Amlodipine belongs to a group of

medicines called calcium antagonists.

Perindopril

tert-butylamine/Amlodipine

Stada

prescribed

treatment

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 tert-butylamine/Amlodipine Stada which contains both ingredients.

2.

What you need to know before you take Perindopril tert-butylamine/Amlodipine

Stada

Do not take Perindopril tert-butylamine/Amlodipine Stada

if you are allergic to perindopril or any other ACE inhibitor, amlodipine or any other

calcium antagonist, or any of the other ingredients of this medicine (listed in section 6)

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 you family have had these symptoms in any other circumstances (a condition

called angioedema)

more

than

3 months

pregnant.

also

better

avoid

Perindopril

tert-butylamine/Amlodipine Stada in early pregnancy – see pregnancy section)

if you have cardiogenic shock (when the heart is unable to supply sufficient blood to the

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

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 swelling 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 tert-butylamine/Amlodipine Stada

if you have collagen vascular disease (disease of the connective tissue) such as systemic

lupus erythematosus or scleroderma

if you have hypertrophic cardiomyopathy (heart 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 cerebrovascular disease

if you have kidney problems or if you are receiving dialysis

if you have impaired liver function

if you are on salt restricted diet or use salt substitutes which contain potassium (a

well-balanced potassium blood level is essential)

if you have diabetes

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 tert-butylamine/Amlodipine

Stada”

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

tert-butylamine/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).

Perindopril tert-butylamine/Amlodipine Stada may be less effective in lowering the blood

pressure in black patients.

If you develop a dry cough which is persistent for a long time, contact your doctor or

pharmacist.

When you are taking Perindopril tert-butylamine/Amlodipine Stada, you should also inform

you doctor or the medical staff if you:

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

have recently suffered from diarrhoea or vomiting (being sick)

are going to have a general anaesthetic and/or major surgery

Children and adolescents

Perindopril tert-butylamine/Amlodipine Stada is not recommended for use in children and

adolescents.

Other medicines and Perindopril tert-butylamine/Amlodipine Stada

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

medicines.

You should avoid Perindopril tert-butylamine/Amlodipine Stada with:

potassium-sparing

diuretics

(e.g.

spironolactone,

triamterene,

amiloride),

potassium

supplements or salt substitutes containing potassium

lithium (used to treat mania or depression)

estramustine (used in cancer therapy)

tacrolimus (used to control your body’s immune response, enabling your body to accept

the transplanted organ)

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 tert-butylamine/Amlodipine Stada” and “Warnings and

precautions”)

medicines, which are 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”.

Treatment

with

Perindopril

tert-butylamine/Amlodipine

Stada

affected

other

medicines. Make sure to tell your doctor if you are taking any of the following medicines as

special care may be required:

non-steroidal

anti-inflammatory

drugs

(e.g.

ibuprofen)

pain

relief

high

dose

acetylsalicylic acid

medicines to treat diabetes (such as insulin or metformin)

ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)

some antibiotics such as rifampicin, erythromycin, clarithromycin (for infections caused by

bacteria)

itraconazole, ketoconazole (medicines used for treatment of fungal infections)

verapamil, diltiazem (heart medicines)

The herbal medicine St. John´s Wort (hypericum perforatum)

baclofen used to treat muscle stiffness in diseases such as multiple sclerosis

other medicines for high blood pressure, including diuretics (medicines which increase the

amount of urine produced by the kidneys)

ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure,

shock or asthma)

gold

salts,

especially

with

intravenous

administration

(used

treat

symptoms

rheumatoid arthritis)

bisoprolol, carvedilol and metoprolol (beta-blockers used in heart failure)

vasodilators including nitrates (products that widen the blood vessels)

corticosteroids (used to treat various conditions including severe asthma and rheumatoid

arthritis

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)

medicines to treat mental disorders such as depression, anxiety, schizophrenia etc. (e.g.

tricyclic antidepressants, antipsychotics, anaesthetics)

simvastatin (cholesterol lowering medicine)

immunosuppressants (medicines which reduce the defence mechanism of the body) used

for the treatment of auto-immune disorders

allopurinol (for the treatment of gout)

procainamide (for the treatment of an irregular heart beat)

heparin (medicine used to thin blood)

co-trimoxazole

also

known

trimethoprim/sulfamethoxazole

(for

treatment

infections)

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 tert-butylamine/Amlodipine Stada before you

become pregnant or as soon as you know you are pregnant and will advise you to take

another

medicine

instead

Perindopril

tert-butylamine/Amlodipine

Stada.

Perindopril

tert-butylamine/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 Perindopril tert-butylamine/Amlodipine

Stada, 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 tert-butylamine/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 tert-butylamine/Amlodipine Stada may affect your ability to drive or use machines.

If the tablets make you feel sick, dizzy, weak or tired, or give you headache, do not drive or

use machines and contact your doctor immediately.

3.

How to take Perindopril tert-butylamine/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.

Take your tablet preferably in the morning, before a meal. Swallow the tablet with a glass of

water.

Your

doctor

will

decide

appropriate

strength

you.

Perindopril

tert-butylamine/Amlodipine

Stada

will

usually

prescribed

patients

already

taking

perindopril and amlodipine from separate tablets.

If you are currently being treated with another perindopril containing tablet, please be aware

that the strength may be expressed in a different way for this medicine even though the

amount of perindopril is the same. Always check with your doctor if you are unsure about

what dose you should take.

If you take more Perindopril tert-butylamine/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 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 tert-butylamine/Amlodipine Stada

It is important to take your medicine every day as regular treatment works better. However, if

you forget to take a dose of Perindopril tert-butylamine/Amlodipine Stada, 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 tert-butylamine/Amlodipine Stada

As the treatment with Perindopril tert-butylamine/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:

severe dizziness or fainting (common – may affect up to 1 in 10 people),

symptoms of allergic reactions such as swelling of the face, lips, mouth, tongue or throat,

difficulty in breathing. These allergic reactions may also affect the gut and cause stomach

pain (with or without nausea and vomiting). You should be aware that black patients are at

increased risk of these types of reaction (uncommon – may affect up to 1 in 100 people),

unusual

fast

(common

affect

people)

irregular

heartbeat

(uncommon – may affect up to 1 in 100 people),

sudden wheeziness, tightening of the chest, and shortness of breath (bronchospasm)

(uncommon – may affect up to 1 in 100 people),

skin rash which often starts with red itchy patches on your face, arms or legs (erythema

multiforme) (very rare - may affect up to 1 in 10,000 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 (very rare - may affect up to 1 in

10,000 people), toxic epidermal necrolysis (not known - frequency cannot be estimated

from the available data)).

Other side effects include:

Common (may affect up to 1 in 10 people):

sleepiness, dizziness, headache, pins and needles, a sensation of spinning (vertigo),

visual disturbances,

a sensation of noises in the ears (tinnitus),

flushing (hot or warm feeling in your face),

shortness of breath, cough,

abdominal pain, nausea (feeling sick), vomiting (being sick), heartburn or difficulty to

digest food, changed bowel habits, taste disturbances, diarrhoea, constipation,

allergic reactions (such as skin rashes, itching),

muscle cramps,

swelling of your legs or ankles (oedema),

feeling of tiredness or weakness.

Uncommon (may affect up to 1 in 100 people):

excess of a type of white blood cells, called eosinophils,

itchy skin rash (urticaria),

weight increase or decrease,

depression, mood swings, sleeplessness, sleep disturbances,

trembling, loss of pain sensation,

inflammation of the blood vessels of the skin,

temporary loss of consciousness,

blocked up or runny nose,

dry mouth,

hair loss, red or discoloured patches on skin, increased sweating,

formation of blister clusters over the skin (pemphigoid),

increased sensitivity of the skin to the sun,

back, muscle or joint pain,

increased need to urinate especially during the night, kidney problems,

impotence, breast enlargement in men,

chest pain, pain, a general feeling of being unwell,

fever,

changes seen in blood tests: very low blood sugar level in diabetic patients, low level of

sodium, high blood level of potassium, increase in level of blood urea nitrogen and of

serum creatinine (which can indicate abnormal kidney function),

fall.

Rare (may affect up to 1 in 1,000 people):

psoriasis worsening,

confusion,

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 (may affect up to 1 in 10,000 people):

high blood sugar,

abnormal increase in the muscle tension,

a disease called peripheral neuropathy that causes loss of sensations, pain, inability to

control muscles,

cardiovascular disorders (angina, heart attack and stroke),

a rare type of pneumonia (eosinophilic pneumonia),

swelling of the gums,

Redness and shedding of the skin over a larger area of the body, which may be itchy or

painful (exfoliative dermatitis),

kidney failure (symptoms may be lower back pain and reduction in the volume of urine

passed),

disorders of the blood, pancreas, stomach or liver.

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, pharmacist or nurse. This includes any

possible side effects not listed in this leaflet. You can also report side effects directly via the

national reporting system listed in Appendix V. By reporting side effects you can help provide

more information on the safety of this medicine.

5.

How to store Perindopril tert-butylamine/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 carton after “EXP”. The

expiry date refers to the last day of that month.

Blister pack (Al/Al): This medicinal product does not require any special 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 tert-butylamine/Amlodipine Stada contains

The active substances are perindopril tert-butylamine and amlodipine.

One tablet contains 4 mg perindopril tert-butylamine corresponding to 3.3 mg perindopril

and 5 mg amlodipine corresponding to 6.9 mg amlodipine besilate.

One tablet contains 4 mg perindopril tert-butylamine corresponding to 3.3 mg perindopril

and 10 mg amlodipine corresponding to 13.9 mg amlodipine besilate.

One tablet contains 8 mg perindopril tert-butylamine corresponding to 6.7 mg perindopril

and 5 mg amlodipine corresponding to 6.9 mg amlodipine besilate.

One tablet contains 8 mg perindopril tert-butylamine corresponding to 6.7 mg perindopril

and 10 mg amlodipine corresponding to 13.9 mg amlodipine besilate.

other

ingredients

sodium

starch

glycolate

(type

glycerol

dibehenate,

anhydrous calcium hydrogen phosphate, trehalose dihydrate, microcrystalline cellulose,

magnesium oxide, crospovidone, magnesium stearate.

What Perindopril tert-butylamine/Amlodipine Stada looks like and contents of the pack

Perindopril tert-butylamine/Amlodipine Stada 4 mg/5 mg tablets are white to off-white, oval,

biconvex, 5 mm x 9 mm and with 4|5 on one side

Perindopril

tert-butylamine/Amlodipine

Stada

4 mg/10 mg

tablets

white

off-white,

rectangular, biconvex, 8 mm on side and with 4|10 on one side

Perindopril

tert-butylamine/Amlodipine

Stada

8 mg/5 mg

tablets

white

off-white,

triangular, biconvex, 9 mm high and with 8|5 on one side

Perindopril

tert-butylamine/Amlodipine

Stada

8 mg/10 mg

tablets

white

off-white,

round, biconvex, 9 mm and with 8|10 on one side

[For 4 mg/5 mg]

Blister packs (Al-Al): 10, 30 and 90 tablets

[For 4 mg/10 mg]

Blister packs (Al-Al): 30, 60 and 90 tablets

[For 8 mg/5 mg]

Blister packs (Al-Al): 30 and 90 tablets

[For 8 mg/10 mg]

Blister packs (Al-Al): 30, 60 and 90 tablets

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the

following names:

<[To be completed nationally]>

This leaflet was last revised in April 2018

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