Perindopril and amlodipine EG Stada: detailed information

Patient Information Leaflet

PERINDOPRIL AND AMLODIPINE EG STADA 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet

What PERINDOPRIL AND AMLODIPINE EG STADA is and what it is used for
What you need to know before taking PERINDOPRIL AND AMLODIPINE EG STADA
How to take PERINDOPRIL AND AMLODIPINE EG STADA
Possible side effects
How to store PERINDOPRIL AND AMLODIPINE EG STADA
Contents of the pack and other information

1. What PERINDOPRIL E AMLODIPINA EG STADA is and what it is used for

PERINDOPRIL E AMLODIPINA EG STADA is prescribed for the treatment of high blood pressure (hypertension) and/or for the treatment of stable coronary artery disease (a condition in which blood supply to the heart is reduced or blocked).
Patients who are already taking perindopril and amlodipine as separate tablets may instead take a single tablet of PERINDOPRIL E AMLODIPINA EG STADA containing both active substances.
PERINDOPRIL E AMLODIPINA EG STADA is a combination of two active substances: perindopril and amlodipine. Perindopril is an ACE (angiotensin-converting enzyme) inhibitor. Amlodipina is a calcium antagonist (belonging to a class of medicines called dihydropyridines). When used in combination, they work by dilating and relaxing blood vessels, making it easier for blood to flow through them and enabling the heart to maintain adequate blood flow.

2. What you need to know before taking PERINDOPRIL AND AMLODIPINE EG STADA

DO NOT take PERINDOPRIL AND AMLODIPINE EG STADA
if you are allergic to perindopril or any other ACE inhibitor, to amlodipine or any other calcium antagonist, or to any of the other ingredients of this medicine (listed in section 6),
if you are more than 3 months pregnant (it is best to avoid PERINDOPRIL AND AMLODIPINE EG STADA even in the early stages of pregnancy – see section on pregnancy),
if you have symptoms such as shortness of breath, swelling of the face or tongue, intense itching or severe skin rashes related to previous treatment with ACE inhibitors, or if you or a family member have ever experienced such symptoms under any circumstances (a condition called angioedema),
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren,
if you have narrowing of the heart's aortic valve (aortic stenosis) or if you are in cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body),
if you suffer from severe low blood pressure (hypotension),
if you have heart failure following a heart attack,
if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking PERINDOPRIL AND AMLODIPINE EG STADA
if you have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidneys),
if you suffer from heart failure,
if you have a 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 are on dialysis,
if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
if you have diabetes,
if you are on a diet restricting salt intake or use potassium-containing salt substitutes (maintaining a balanced blood potassium level is essential),
if you are elderly and dosage adjustment is required,
if you are taking any of the following medicines used to treat high blood pressure:

an angiotensin II receptor antagonist (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes,
aliskiren. If you are taking any of the following medicines, the risk of angioedema (rapid subcutaneous swelling, for example in the throat) may be increased:
racecadotril, a medicine used to treat diarrhoea,
medicines used to prevent organ transplant rejection and to treat cancer (such as sirolimus, everolimus, temsirolimus) and other medicines belonging to the class of so-called mTOR inhibitors,
vildagliptin, a medicine used to treat diabetes.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information in section “DO NOT take PERINDOPRIL AND AMLODIPINE EG STADA”.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). PERINDOPRIL AND AMLODIPINE EG STADA is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).

If you are taking PERINDOPRIL AND AMLODIPINE EG STADA, inform your doctor or medical staff:
if you are due to undergo general anaesthesia and/or major surgery,
if you have recently had diarrhoea or vomiting (a state of illness),
if you are scheduled for LDL apheresis (removal of cholesterol from the blood using a machine),
if you are due to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

Children and adolescents
The use of PERINDOPRIL AND AMLODIPINE EG STADA is not recommended in children and adolescents.

Other medicines and PERINDOPRIL AND AMLODIPINE EG STADA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take PERINDOPRIL AND AMLODIPINE EG STADA with sacubitril/valsartan, a medicine used to treat chronic heart failure in adults. See section 2 “DO NOT take PERINDOPRIL AND AMLODIPINE EG STADA”.
You must not take PERINDOPRIL AND AMLODIPINE EG STADA with:
lithium (used to treat mania or depression),
estramustine (used in cancer therapy),
potassium-sparing diuretics (spironolactone, triamterene), potassium supplements (including potassium-containing salt substitutes), and other medicines that may increase blood potassium levels (such as trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clot formation).

Treatment with PERINDOPRIL AND AMLODIPINE EG STADA may be affected by the use of other medicines. Your doctor may need to adjust your dose and/or take other precautions.
Inform your doctor if you are taking any of the following medicines, as special attention may be required:
other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also information in sections “DO NOT take PERINDOPRIL AND AMLODIPINE EG STADA” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
medicines used mainly to treat diarrhoea (racecadotril) or to prevent organ transplant rejection and to treat cancer (sirolimus, everolimus, temsirolimus and other medicines 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 doses of acetylsalicylic acid,
medicines for treating diabetes (such as insulin, vildagliptin),
medicines for treating mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),
immunosuppressants (medicines that suppress the body's defence mechanisms) used to treat autoimmune disorders or following organ transplantation,
allopurinol (for treating gout),
procainamide (for treating irregular heartbeat),
vasodilators, including nitrates (substances that dilate blood vessels),
ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma),
baclofen or dantrolene (by infusion), both used to treat muscle stiffness occurring in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anaesthesia (symptoms include high fever and muscle rigidity),
some antibiotics such as rifampicin, erythromycin, clarithromycin,
antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
itraconazole, ketoconazole (medicines used to treat fungal infections),
alpha-blockers used to treat benign prostatic hyperplasia such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
amifostine (used to prevent or reduce side effects caused by other medicines or radiotherapy in cancer treatment),
corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis),
gold salts, especially when administered intravenously (used to treat symptoms of rheumatoid arthritis),
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV).

PERINDOPRIL AND AMLODIPINE EG STADA with food and drinks
PERINDOPRIL AND AMLODIPINE EG STADA should be taken before a meal.
Grapefruit and grapefruit juice must not be consumed by people taking PERINDOPRIL AND AMLODIPINE EG STADA. This is because grapefruit and grapefruit juice can increase blood levels of the active ingredient amlodipine, which may lead to an unpredictable increase in the blood pressure-lowering effect of PERINDOPRIL AND AMLODIPINE EG STADA.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop treatment with PERINDOPRIL AND AMLODIPINE EG STADA before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine to replace PERINDOPRIL AND AMLODIPINE EG STADA.
PERINDOPRIL AND AMLODIPINE EG STADA is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
It has been shown that amlodipine, one of the two active substances in PERINDOPRIL AND AMLODIPINE EG STADA, passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or intend to breastfeed. PERINDOPRIL AND AMLODIPINE EG STADA is not recommended for breastfeeding mothers. If you wish to continue breastfeeding, your doctor may decide to prescribe an alternative treatment, especially if your baby is newborn or was born prematurely.

Driving and using machines
PERINDOPRIL AND AMLODIPINE EG STADA may affect your ability to drive and use machines. If the tablets cause you to feel unwell, dizzy, weak or fatigued, or if you experience headache, avoid driving or operating machinery and contact your doctor immediately.

PERINDOPRIL AND AMLODIPINE EG STADA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take PERINDOPRIL AND AMLODIPINE EG STADA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one tablet per day.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning before a meal. Your doctor will decide the appropriate dose for you. Usually, the dose will be one tablet per day.
Generally, PERINDOPRIL AND AMLODIPINE EG STADA is prescribed for patients who are already taking perindopril and amlodipine as separate tablets.

If you take more PERINDOPRIL AND AMLODIPINE EG STADA than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency department or contact your doctor. The most likely effect of an overdose is a drop in blood pressure, which may cause dizziness or fainting. In such a case, it may help to lie down with your legs raised.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take PERINDOPRIL AND AMLODIPINE EG STADA
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of PERINDOPRIL AND AMLODIPINE EG STADA, take the next dose at your usual time. Do not take a double dose to make up for the missed dose.

If you stop taking PERINDOPRIL AND AMLODIPINE EG STADA
Since treatment with PERINDOPRIL AND AMLODIPINE EG STADA is usually lifelong, speak with your doctor before stopping the tablets.

If you have any questions about the use of this medicine, consult 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 side effects, stop taking the medicine immediately and inform your
doctor immediately:
sudden onset of shortness of breath, chest pain, breathlessness or difficulty breathing,
swelling of the eyelids, face or lips,
swelling of the tongue and throat which may cause severe difficulty in breathing,
severe skin reactions, including intense skin rash, hives, redness of the skin all over the 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, abnormally fast or irregular heartbeat,
inflammation of the pancreas which may cause severe abdominal and back pain associated with a
marked feeling of illness.

The following common side effects have been reported. Tell your doctor if these effects cause you
problems or if they last for more than one week.
Common side effects (may affect up to 1 in 10 people):
Headache.
Dizziness.
Drowsiness (especially at the beginning of treatment).
Vertigo.
Numbness or tingling sensations in the limbs.
Vision disturbances (including double vision).
Tinnitus (ringing in the ears).
Palpitations (awareness of your heartbeat).
Flushing.
Feeling of light-headedness due to low blood pressure.
Cough.
Shortness of breath.
Nausea (feeling unwell), vomiting (feeling sick).
Abdominal pain.
Altered sense of taste.
Dyspepsia or digestive difficulties.
Diarrhoea.
Constipation.
Allergic reactions (such as skin rashes, itching).
Muscle cramps.
Tiredness.
Weakness.
Swollen ankles (oedema).

Other side effects that have been reported are listed below. If any of these side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Uncommon side effects (may affect up to 1 in 100 people):
Mood changes.
Anxiety.
Depression.
Insomnia, sleep disturbances.
Tremors.
Fainting.
Loss of pain sensation.
Rhinitis (stuffy or runny nose).
Altered bowel habits.
Hair loss.
Red spots on the skin, skin discoloration.
Back pain, muscle or joint pain, chest pain.
Urinary disorders, need to urinate at night, frequent need to urinate.
Pain.
Feeling unwell.
Bronchospasm (tightness in the chest, wheezing and shortness of breath).
Dry mouth.
Angioedema (symptoms such as wheezing, swelling of face or tongue).
Kidney problems.
Impotence.
Excessive sweating.
Breast discomfort or enlargement in men.
Weight gain or loss.
Rare side effects (may affect up to 1 in 1,000 people):
Confusional state.
Worsening of psoriasis.
Elevated liver function test values (indicative of liver damage), including increased bilirubin in the blood (which may, in severe cases, cause yellowing of the skin and eyes).
Dark-coloured urine, feeling unwell (nausea) or malaise (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion).
Reduced or absent urine output.
Acute renal failure.
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 the eyelids, face or lips, swelling of the tongue and throat causing serious breathing problems.
Severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), erythema multiforme (a skin rash that often starts with itchy red spots on the face, arms or legs).
Light sensitivity.
Blood disorders.
Inflammation of the pancreas which may cause severe abdominal and back pain associated with a marked feeling of illness.
Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain clinical tests.
Abdominal swelling (gastritis).
A nerve disorder that may cause weakness, tingling or numbness.
Increased muscle tension.
Vasculitis (inflammation of blood vessels).
Swollen gums.
High blood sugar levels (hyperglycaemia).
Frequency not known (cannot be estimated from the available data):
Abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon).

The following side effects have also been reported by patients treated with PERINDOPRIL AND AMLODIPINE EG STADA:
hypoglycaemia (severe lowering of blood sugar levels), movement-related disorders such as stiffness,
tremor, and/or movement disturbances.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PERINDOPRIL AND AMLODIPINE EG STADA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, packaging or bottle after the words “EXP.” The expiry date refers to the last day of that month.
Blister pack (Al/Al): Store in the original packaging to protect the medicine from light and moisture.
HDPE bottle packaging: Do not store above 30°C. Store in the original packaging to protect the medicine from light and moisture. Use within 3 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PERINDOPRIL AND AMLODIPINE EG STADA contains
The active substances are perindopril tert-butylamine and amlodipine.
Each tablet contains 4 mg of perindopril tert-butylamine and 5 mg of amlodipine.
Each tablet contains 4 mg of perindopril tert-butylamine and 10 mg of amlodipine.
Each tablet contains 8 mg of perindopril tert-butylamine and 5 mg of amlodipine.
Each tablet contains 8 mg of perindopril tert-butylamine and 10 mg of amlodipine.
The other components are sodium carboxymethyl starch (type A), glycerol dibehenate, calcium hydrogen phosphate,
dihydrated trehalose, microcrystalline cellulose, light magnesium oxide, crospovidone,
magnesium stearate.

Description of the appearance of PERINDOPRIL AND AMLODIPINE EG STADA and package contents
PERINDOPRIL AND AMLODIPINE EG STADA 4 mg/5 mg: white to almost white, oval, biconvex tablets, 5 mm x 9 mm, with "4|5" engraved on one side and smooth on the other.
PERINDOPRIL AND AMLODIPINE EG STADA 4 mg/10 mg: white to almost white, rectangular, biconvex tablets, 8 mm x 8 mm, with "4|10" engraved on one side and smooth on the other.
PERINDOPRIL AND AMLODIPINE EG STADA 8 mg/5 mg: white to almost white, triangular, biconvex tablets, 9 mm side length, with "8|5" engraved on one side and smooth on the other.
PERINDOPRIL AND AMLODIPINE EG STADA 8 mg/10 mg: white to almost white, round, biconvex tablets, 9 mm in diameter, with "8|10" engraved on one side and smooth on the other.

Packaging:
Blister pack (Al/Al): 10, 30, 60, 90 tablets.
Tablet container: 100 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6 - 20136 Milan, Italy

Manufacturer
Actavis Ltd., BLB016, Bulebel Industrial Estate, Zejtun ZTN 3000 – Malta
STADA Arzneimittel AG, Stadastrasse 2-18, Bad Vilbel 61118 – Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
FR Perindopril tert-butylamine /Amlodipine EG 4 mg/5 mg, 4 mg/10 mg, 8 mg/5 mg, 8 mg/10 mg, tablet
IT PERINDOPRIL AND AMLODIPINE EG STADA
SK Perindamlostad 4 mg/5 mg, 4 mg/10 mg, 8 mg/5 mg, 8 mg/10 mg, tablet