Perindopril and amlodipine Mylan Pharma: detailed information

Package leaflet: Information for the patient

Perindopril and Amlodipine Mylan Pharma 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

perindopril tert-butylamine / amlodipine besylate
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What Perindopril and Amlodipine Mylan Pharma is and what it is used for
2. What you need to know before taking Perindopril and Amlodipine Mylan Pharma
3. How to take Perindopril and Amlodipine Mylan Pharma
4. Possible side effects
5. How to store Perindopril and Amlodipine Mylan Pharma
6. Contents of the pack and other information

1. What Perindopril and Amlodipine Mylan Pharma is and what it is used for

Perindopril and Amlodipine Mylan Pharma 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
flow 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 and Amlodipine Mylan Pharma containing both active substances.
Perindopril and Amlodipine Mylan Pharma is a combination of two active substances, perindopril and
amlodipine. Perindopril is an angiotensin-converting enzyme (ACE) inhibitor.
Amlodipine is a calcium antagonist (belonging to a class of medicines called dihydropyridines).
In combination, they work by dilating and relaxing blood vessels, thereby making it easier for blood to flow through them and enabling the heart to maintain an adequate level of blood flow.

2. What you need to know before taking Perindopril and Amlodipine Mylan Pharma

Do not take Perindopril and Amlodipine Mylan Pharma

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 better to avoid Perindopril and Amlodipine Mylan Pharma even in the early stages of pregnancy – see the section on pregnancy),
if you have experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe skin rashes related to a previous treatment with ACE inhibitors, or if you or a family member have ever had 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 are suffering from cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body),
if you have severe low blood pressure (hypotension), or if you have heart failure following a heart attack,
if you are undergoing dialysis or any type of blood filtration. Depending on the equipment used, treatment with Perindopril and Amlodipine Mylan Pharma may not be suitable for you,
if you have kidney problems resulting in reduced blood flow to the kidneys (renal artery stenosis),
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 Mylan Pharma if you have any of the following conditions:
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 suffer from a severe increase in blood pressure (hypertensive crisis),
if you suffer from any other heart condition,
if you have liver problems,
if you have kidney problems or are on dialysis,
if you have abnormally high blood levels of a hormone called aldosterone (primary aldosteronism),
if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma, or diabetes,
if you are on a low-salt diet or use salt substitutes containing potassium (maintaining a well-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), especially if you have kidney problems related to diabetes, ‐ aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information in the section “Do not take Perindopril and Amlodipine Mylan Pharma”.
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 prevent rejection of transplanted organs), ‐ sacubitril (available as a fixed-dose combination with valsartan) used to treat chronic heart failure, ‐ linagliptin, saxagliptin, sitagliptin, vildagliptin and other medicines belonging to the class of pharmaceutical products known as gliptins (used for the treatment of diabetes).
if you are of African origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-African patients.

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, causing difficulty in swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril/amlodipine, and rarely intestinal angioedema (abdominal pain with or without nausea). This may occur at any time during treatment. If you develop such symptoms, you must stop taking Perindopril and Amlodipine Mylan Pharma and consult a doctor immediately. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Perindopril and Amlodipine Mylan Pharma 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”).

When taking Perindopril and Amlodipine Mylan Pharma, inform your doctor or medical staff if:

you are due to undergo general anaesthesia and/or major surgery,
you have recently suffered from diarrhoea or vomiting (a state of illness),
you are scheduled for LDL apheresis (blood purification from cholesterol using a machine),
you are undergoing desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

Children and adolescents
The use of Perindopril and Amlodipine Mylan Pharma is not recommended in children and adolescents.

Other medicines and Perindopril and Amlodipine Mylan Pharma

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must avoid taking Perindopril and Amlodipine Mylan Pharma with:

lithium (used to treat mania or depression),
estramustine (used in cancer therapy),
potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (e.g. trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clot formation),
potassium-sparing drugs used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily.

Treatment with Perindopril and Amlodipine Mylan Pharma may be affected by concomitant use of other medicines. Your doctor may need to adjust your dose and/or take additional precautions. Inform your doctor if you are taking any of the following medicines, as special attention may be required:

medicines used mainly to treat diarrhoea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTor inhibitors). See section “Warnings and precautions”,
other medicines for treating high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also information in sections “Do not take Perindopril and Amlodipine Mylan Pharma” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
sacubitril/valsartan (used to treat chronic heart failure). See sections “Do not take Perindopril and Amlodipine Mylan Pharma” and “Warnings and precautions”,
non-steroidal anti-inflammatory drugs (e.g. ibuprofen) for pain relief or high-dose aspirin,
medicines for treating diabetes (such as insulin),
medicines for treating mental disorders such as depression, anxiety, schizophrenia, etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics),
immunosuppressants (medicines that reduce the body’s defence mechanisms) used to treat autoimmune disorders or after organ transplantation (e.g. cyclosporine, tacrolimus),
trimethoprim and cotrimoxazole (for treating infections),
allopurinol (for treating gout),
procainamide (for treating irregular heartbeat),
vasodilators, including nitrates (substances that dilate blood vessels),
heparin (a medicine used to thin the blood),
ephedrine, noradrenaline or adrenaline (medicines used to treat low blood pressure, shock or asthma),
baclofen or dantrolene (for 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),
certain antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections),
Hypericum perforatum (St. John’s wort, a herbal medicine used to treat depression),
simvastatin (a medicine to lower cholesterol),
antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
itraconazole, ketoconazole (medicines used to treat fungal infections),
alpha-blockers used to treat prostate enlargement (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 Mylan Pharma with food and drinks
Grapefruit and grapefruit juice must not be consumed by people taking Perindopril and Amlodipine Mylan Pharma. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Perindopril and Amlodipine Mylan Pharma.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, 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 Mylan Pharma before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe another medicine instead. Perindopril and Amlodipine Mylan Pharma 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
Inform your doctor if you are breastfeeding or planning to breastfeed. Perindopril and Amlodipine Mylan Pharma 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 premature.
It has been shown that amlodipine passes into breast milk in small amounts.

Driving and using machines
Perindopril and Amlodipine Mylan Pharma may affect your ability to drive and use machinery. If the tablets cause you to feel unwell, dizzy, weak or fatigued, or if you experience headaches, do not drive or operate machinery and contact your doctor immediately.

Sodium content
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 Mylan Pharma

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
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 is one tablet per day. Perindopril and Amlodipine Mylan Pharma is generally prescribed to patients who are already taking perindopril and amlodipine as separate tablets.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more Perindopril and Amlodipine Mylan Pharma than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency department or contact your doctor immediately. The most likely effect of an overdose is low 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 Mylan Pharma
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 Mylan Pharma, take the next dose at your usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Perindopril and Amlodipine Mylan Pharma
Since treatment with Perindopril and Amlodipine Mylan Pharma is usually lifelong, talk to your doctor before stopping the tablets. If you have any questions about using 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 wheezing, 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 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, unusually fast or irregular heartbeat, or chest pain,
inflammation of the pancreas which may cause severe abdominal and back pain accompanied by a marked feeling of illness.

The following common side effects have been reported. Contact your doctor if these effects
bother you or if they last for more than one week.
Very common side effects (may affect more than 1 in 10 people):

oedema (fluid retention).
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, visual disturbances (including double vision), tinnitus (ringing in the ears), palpitations (awareness of heartbeat), flushing,
lightheadedness due to low blood pressure, cough, shortness of breath, nausea (feeling unwell), vomiting (feeling sick), abdominal pain, altered taste, indigestion or digestive discomfort, changes in bowel habits, diarrhoea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swollen ankles (peripheral oedema).

Other possible side effects
Uncommon (may affect up to 1 in 100 people):

rhinitis (blocked or runny nose),
elevated eosinophils (a type of white blood cells),
angioedema (symptoms such as wheezing, swelling of the face or tongue),
hypoglycaemia (very low blood sugar levels) in diabetic patients,
high potassium levels in the blood, reversible upon discontinuation,
mood swings, anxiety, depression, insomnia, sleep disorders,
dry mouth,
tremor, fainting, loss of pain sensation,
irregular heartbeat, tachycardia,
vasculitis (inflammation of blood vessels),
blistering of the skin, increased sweating, photosensitivity reaction (increased skin sensitivity to sunlight),
bronchospasm (tightening of the chest, wheezing and shortness of breath),
hair loss, red spots on the skin, abnormal skin pigmentation,
back pain, arthralgia (joint pain), myalgia (muscle pain), chest pain,
kidney problems, urinary disorders, increased need to urinate at night, increased frequency of urination, pain,
impotence, discomfort or breast enlargement in men,
feeling unwell,
fever,
weight gain or weight loss,
increased sweating,
changes in laboratory test results, low sodium levels, increased blood urea and increased blood creatinine,
falls.

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

dark-coloured urine, feeling unwell (nausea) or being unwell (vomiting), muscle cramps, confusion and seizures. These symptoms may be related to a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion). If you develop these symptoms, contact your doctor as soon as possible.
acute renal failure,
reduced or absent urine output,
confusion,
worsening of psoriasis,
changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin levels.

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

changes in blood values, such as reduced white blood cells and red blood cells, decreased haemoglobin, reduced platelets in the blood, blood disorders,
excess sugar in the blood (hyperglycaemia),
swelling of the eyelids, face or lips, swelling of the tongue and throat causing severe difficulty in breathing,
cardiovascular disorders (angina, heart attack and stroke),
eosinophilic pneumonia (a rare type of pneumonia),
inflamed pancreas which may cause severe abdominal and back pain accompanied by a marked feeling of illness, abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests, abdominal swelling (gastritis), swollen gums,
severe skin reactions including intense 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), erythema multiforme (a skin rash often starting with itchy red spots on the face, arms or legs), light sensitivity,
increased muscle tension,
nerve disorders which may cause weakness, tingling or numbness.

Not known (frequency cannot be estimated from the available data):

tremors, rigid posture, mask-like facial expression, slow shuffling gait, unbalanced walking,
changes in colour, numbness and pain in fingers or toes (Raynaud's phenomenon).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
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 Mylan Pharma

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 and blister after the
word “Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
For the 4 mg/10 mg strength:
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Perindopril and Amlodipine Mylan Pharma contains
The active substances are perindopril tert-butylamine and amlodipine besilate.
Each 4 mg/5 mg tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.338 mg of
perindopril) and 5 mg of amlodipine (equivalent to 6.94 mg of amlodipine besilate).
Each 4 mg/10 mg tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.338 mg of
perindopril) and 10 mg of amlodipine (equivalent to 13.88 mg of amlodipine besilate).
Each 8 mg/5 mg tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.676 mg of
perindopril) and 5 mg of amlodipine (equivalent to 6.94 mg of amlodipine besilate).
Each 8 mg/10 mg tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.676 mg of
perindopril) and 10 mg of amlodipine (equivalent to 13.88 mg of amlodipine besilate).
The other components are:
Sodium starch glycolate (see section 2, "Sodium content"), glycerol dibehenate, calcium hydrogen phosphate, trehalose dihydrate, microcrystalline cellulose, magnesium oxide, crospovidone type A, magnesium stearate.

Description of the appearance of Perindopril and Amlodipine Mylan Pharma and contents of the pack
Perindopril and Amlodipine Mylan Pharma 4 mg/5 mg are white to off-white, oval, biconvex tablets, with "4/5" engraved on one side.
Perindopril and Amlodipine Mylan Pharma 4 mg/10 mg are white to off-white, rectangular, biconvex tablets, with "4/10" engraved on one side.
Perindopril and Amlodipine Mylan Pharma 8 mg/5 mg are white to off-white, triangular, biconvex tablets, with "8/5" engraved on one side.
Perindopril and Amlodipine Mylan Pharma 8 mg/10 mg are white to off-white, round, biconvex tablets, with "8/10" engraved on one side.
Perindopril and Amlodipine Mylan Pharma tablets are available in blisters containing 10, 30, 90 or 120 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy
Manufacturer
Actavis Ltd.
BLB 015-016, Bulebel Industrial Estate,
Zejtun ZTN 3000,
MALTA

This medicinal product is authorised in the European Economic Area countries under the following names:
France PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 4 mg/5 mg, tablet
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 4 mg/10 mg, tablet
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 8 mg/5 mg, tablet
PERINDOPRIL TERT-BUTYLAMINE/AMLODIPINE VIATRIS 8 mg/10 mg, tablet
Italy Perindopril and Amlodipine Mylan Pharma
Portugal Perindopril + Amlodipina Mylan