PERINDOPRIL 4 mg/5 mg Tablets

Зміст інструкції

1. Perindopril and amlodipine HCS 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets
   1. What is Perindopril and amlodipine HCS and what it is used for
   2. What you need to know before taking Perindopril and amlodipine HCS
   3. How to take Perindopril and amlodipine HCS
   4. Possible side effects
   5. How to store Perindopril e amlodipina HCS
   6. Package contents and other information

Perindopril and amlodipine HCS 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

Perindopril tert-butylamine/Amlodipine

Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Perindopril and amlodipine HCS is and what it is used for
• 2. What you need to know before you take Perindopril and amlodipine HCS
• 3. How to take Perindopril and amlodipine HCS
• 4. Possible side effects
• 5. How to store Perindopril and amlodipine HCS
• 6. Contents of the pack and other information

1. What is Perindopril and amlodipine HCS and what it is used for

Perindopril and amlodipine HCS is prescribed for the treatment of high blood pressure (hypertension) and/or
for the treatment of stable coronary artery disease (a condition in which the blood supplied to the heart
is reduced or blocked). Patients who are already taking perindopril and amlodipine in separate tablets
may take Perindopril and amlodipine HCS tablet instead, which contains both
active ingredients.
Perindopril and amlodipine HCS is a combination of two active ingredients, perindopril and amlodipine.
Perindopril is an ACE inhibitor (angiotensin converting enzyme). Amlodipine is a calcium
antagonist (which belongs to a class of medicines called dihydropyridines). Together they work to
dilate and relax blood vessels so that blood can flow more easily and the heart
maintains a good blood flow.

2. What you need to know before taking Perindopril and amlodipine HCS

Do not takePerindopril and amlodipine HCS:

• if you are allergic (hypersensitive) to perindopril or to any ACE inhibitor, or to amlodipine or to any other calcium channel blocker, or to any of the other ingredients of Perindopril and amlodipine HCS,
• if you are pregnant for more than 3 months (it is best to avoid Perindopril and amlodipine HCS even at the beginning of pregnancy - see the section on pregnancy),
• if you have previously experienced symptoms such as breathlessness, swelling of the face or tongue, intense itching or severe skin rashes with a previous treatment with ACE inhibitors or if you or a member of your family has had these symptoms in other circumstances (a condition called angioedema),
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren,
• if you have a narrowing of the aortic valve (aortic stenosis) or in case of cardiogenic shock (a

condition in which the heart is unable to provide enough blood to the body),

• if you suffer from severe low blood pressure (hypotension),
• if you suffer from heart failure after a heart attack.

Warnings and precautions
If you have any of the following conditions, consult your doctor before taking Perindopril and amlodipine
HCS:

• if you suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney),
• if you have 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 if you are on dialysis,
• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• diabetes,
• if you are following a low-salt diet or using salt substitutes that contain potassium (a well-balanced potassium level in the blood 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 (ARB) (also known as sartans
• for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren.
• if you are taking the following medicines, the risk of angioedema is increased:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines that belong to the class of so-called mTOR inhibitors (used to prevent rejection of transplanted organs).

The doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take Perindopril and amlodipine HCS”.
You must inform your doctor if you think you are (or could become) pregnant. Perindopril and
amlodipine HCS is not recommended at the beginning of pregnancy and must not be taken if you are
pregnant for more than 3 months as it can cause serious harm to the baby if used at this stage
(see section on pregnancy).
When taking Perindopril and amlodipine HCS, you must inform your doctor or healthcare professional:

• if you are about to undergo general anesthesia and/or major surgery,
• if you have recently suffered from diarrhea or vomiting (state of malaise),
• if you are to undergo LDL apheresis (removal of cholesterol from your blood through a machine),
• if you are about to undergo a desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

Children and adolescents
Perindopril and amlodipine HCS is not recommended in children and adolescents.

Other medicines and Perindopril and amlodipine HCS
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must avoid Perindopril and amlodipine HCS with:

• lithium (used to treat mania or depression)
• estramustine (used in cancer therapy)
• potassium-sparing diuretics (spironolactone, triamterene), potassium supplements or salt substitutes containing potassium.

The treatment with Perindopril and amlodipine HCS can be affected by other medicines. Make sure
to inform your doctor if you are taking any of the following medicines as particular care may be
needed:

• other medicines for high blood pressure, including angiotensin II receptor blockers (ARBs), aliskiren (see also information in the section "Do not take Perindopril and amlodipine HCS" and "Warnings and precautions with Perindopril and amlodipine HCS"), or diuretics (medicines that increase the amount of urine produced by the kidneys),
• non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen) for pain relief or high-dose acetylsalicylic acid,
• medicines for the treatment of diabetes (such as insulin),
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),
• immunosuppressants (medicines that can reduce the body's defense mechanism) used to treat autoimmune diseases or following transplantation (e.g. cyclosporine),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeat),
• vasodilators including nitrates (products that dilate blood vessels),
• heparin (a medicine used to make the blood more fluid),
• ephedrine, noradrenaline or adrenaline (a medicine 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 anesthesia (symptoms include very high fever and muscle stiffness),
• some antibiotics such as rifampicin, erythromycin, clarithromycin (for infections caused by bacteria),
• antiepileptic drugs such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat 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 used to treat cancer),
• corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis),
• gold salts, particularly in intravenous administration (used to treat the symptoms of rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV)
• tacrolimus (a medicine used to alter the way the immune system works allowing the body to accept transplanted organs),
• medicines, usually used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See the section "Warnings and precautions".

Perindopril and amlodipine HCS with food and drink
Perindopril and amlodipine HCS should be taken before a meal.
Grapefruit and grapefruit juice should not be consumed by patients who are
taking Perindopril and amlodipine HCS. This is because grapefruit and grapefruit juice
can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an
unpredictable increase in the blood pressure lowering effect of Perindopril and
amlodipine HCS.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must inform your doctor if you think you are (or could become) pregnant. Normally the
doctor will advise you to stop taking Perindopril and amlodipine HCS before becoming
pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of
Perindopril and amlodipine HCS. Perindopril and amlodipine HCS is not recommended at the beginning of
pregnancy, and must not be taken if you are pregnant for more than 3 months as it can cause serious
harm to your baby if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or are about to start breastfeeding. Perindopril and amlodipine HCS
is not recommended in breastfeeding mothers and if you wish to breastfeed your doctor may choose another
treatment for you, especially if your baby is newly born or premature.

Driving and using machines
Perindopril and amlodipine HCS can affect your ability to drive and use machines. If the
tablets cause you to feel unwell, dizzy, weak or tired, do not drive or use machines and
immediately inform your doctor.

3. How to take Perindopril and amlodipine HCS

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
Swallow the tablet whole with a glass of water, preferably always at the same time of the
day, in the morning, before a meal. The doctor will decide the correct dose for you. This will usually
be one tablet a day.
Perindopril and amlodipine HCS is usually prescribed for patients who are already taking
perindopril and amlodipine in separate tablets.

If you take more Perindopril and amlodipine HCS than you should
If you take too many tablets, contact the nearest emergency room or inform your
doctor immediately. The most likely symptoms of an overdose are low blood pressure which may make you feel
dizzy or give you a feeling of fainting. If this happens, it may help to lie down with your legs
raised.

If you forget to take Perindopril and amlodipine HCS
It is important that you take your medicine every day as regular treatment works best.
However, if you forget to take a dose of Perindopril and amlodipine HCS, take the dose
next at the usual time.
Do not take a double dose to make up for a missed dose.

If you stop taking Perindopril and amlodipine HCS
Because treatment with Perindopril and amlodipine HCS is usually for life, you should discuss with
your doctor before stopping 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 everyone will experience them.
If you experience any of the following side effects, stop taking this medicine and
inform your doctor immediately:

• sudden shortness of breath, chest pain, breathlessness or difficulty breathing
• swelling of the eyelids, face or lips
• swelling of the tongue and throat causing severe difficulty breathing
• 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 the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions
• severe dizziness or fainting,
• heart attack, abnormal heartbeat
• inflammation of the pancreas which can cause severe pain in the abdomen and back accompanied by a feeling of unwellness.

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, drowsiness (especially at the beginning of treatment), vertigo, numbness or tingling of the limbs, visual disturbances (including double vision), tinnitus (sensation of noises in the ears), palpitations (awareness of heartbeat), flushing, confusion due to low blood pressure, cough, shortness of breath, nausea (feeling unwell), vomiting (feeling sick), abdominal pain, taste disturbances, dyspepsia or difficulty digesting food, diarrhea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, fatigue, weakness, ankle swelling (edema).

Other side effects reported include the following. If any of these worsen or if

• Uncommon side effects (may affect up to 1 in 100 people): mood swings, anxiety, depression, insomnia, sleep disturbances, tremor, fainting, loss of sensation of pain, rhinitis (stuffy or runny nose), change in bowel habits, hair loss, red spots on the skin, skin discoloration, back pain, muscle or joint pain, chest pain, difficulty urinating, increased need to urinate at night, increased number of times you urinate, pain, malaise, bronchospasm (tightness in 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, increase or decrease in weight.
• Rare side effects (may affect up to 1 in 1,000): confusion, worsening of psoriasis.
• Very rare side effects (may affect up to 1 in 10,000): 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 severe difficulty breathing, 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 the mucous membranes (Stevens Johnson syndrome), erythema multiforme (a rash that often starts with itchy spots on the face, arms or legs), sensitivity to light, blood disorders, inflammation of the pancreas which can cause abdominal and back pain accompanied by a feeling of unwellness, abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can have an effect

on some clinical tests, abdominal bloating (gastritis), nerve disorders that can
cause weakness, tingling or numbness, increased muscle tension, vasculitis
(inflammation of blood vessels), gum swelling, excess sugar in the blood
(hyperglycemia).

• Side effects with unknown frequency (frequency cannot be estimated based on available data): tremor, rigidity, face like a mask (lacking expression), slow movements and unbalanced and unsteady gait.
• The following side effects have also been reported by patients taking perindopril/amlodipine: hypoglycemia (very low blood sugar levels), disorders combining rigidity, tremors and/or movement disorders.

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/content/come-
segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Perindopril e amlodipina HCS

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 pack after Exp. The expiry date
refers to the last day of that month.
Store in the original package to protect from light and moisture.
This medicine does not require any special temperature conditions for storage.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Perindopril and amlodipine HCS contains

• The active ingredients are perindopril tert-butylamine and amlodipine. Perindopril and amlodipine HCS 4 mg/5 mg tablets Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 5 mg of amlodipine (as besilate). Perindopril and amlodipine HCS 4 mg/10 mg tablets Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 10 mg of amlodipine (as besilate). Perindopril and amlodipine HCS 8 mg/5 mg tablets Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 5 mg of amlodipine (as besilate). Perindopril and amlodipine HCS 8 mg/10 mg tablets Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 10 mg of amlodipine (as besilate).
• The other ingredients are sodium hydrogen carbonate, microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silica and magnesium stearate (E572).

Description of the appearance of Perindopril and amlodipine HCS and package contents
Perindopril and amlodipine HCS 4 mg/5 mg tablets
This medicine is presented as white to almost white, round, slightly
biconvex tablets with bevelled edges, engraved with the symbol U 1 on one side of the tablet. Diameter:
7 mm.
Perindopril and amlodipine HCS 4 mg/10 mg tablets
This medicine is presented as white to almost white, capsule-shaped,
biconvex tablets with a score line on one side. The tablets are engraved on one side with U and marked with
2 on the other side of the score line. Dimensions: 12.5 mm x 5.5 mm. The score line is to
facilitate swallowing and not to divide the tablet into equal doses.
Perindopril and amlodipine HCS 8 mg/5 mg tablets
This medicine is presented as white to almost white, round, biconvex tablets with the
bevelled edges, engraved with symbol U 3 on one side of the tablet. Diameter: 9 mm.
Perindopril and amlodipine HCS 8 mg/10 mg tablets
This medicine is presented as white to almost white, round, biconvex tablets with the
bevelled edges and a score line on one side. The tablets are engraved with symbol U on one side and
marked with 4 on the other side of the score line. Diameter: 9 mm. The tablet can be divided
into two equal doses.
The tablets are available in boxes containing:

• 10, 30, 60, 90 and 100 tablets in blisters,
• 10 x 1, 30 x 1, 60 x 1, 90 x 1 and 100 x 1 tablets in perforated single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. – Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH,Heinz-Lohmann-Straβe 5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: