Package leaflet: Information for the patient

REAPTAN 5mg/5mg tablets, 5mg/10mg tablets, 10mg/5mg tablets, 10mg/10mg tablets

perindopril arginine/amlodipine
Please read all of 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
1. What Reaptan is and what it is used for
2. What you need to know before taking Reaptan
3. How to take Reaptan
4. Possible side effects
5. How to store Reaptan
6. Contents of the pack and other information

1. WHAT REAPTAN IS AND WHAT IT IS USED FOR

Reaptan 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 Reaptan, which contains both active substances.
Reaptan is a combination of two active substances, perindopril and amlodipine.
Perindopril is an ACE (angiotensin-converting enzyme) inhibitor. Amlodipine is a calcium antagonist
(belonging to the class of medicines known as dihydropyridines). When used in combination, they act 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 REAPTAN

Do not take Reaptan

if you are allergic to perindopril or any other ACE inhibitor, or 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 three months pregnant. (It is advisable to avoid REAPTAN even during early pregnancy) (see section “Pregnancy”),
if you have symptoms such as shortness of breath, facial or tongue swelling, intense itching or severe skin rashes related to previous treatment with ACE inhibitors, or if you or a family member have 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 aortic heart valve (aortic stenosis) or 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 are undergoing dialysis or any form of blood filtration. Depending on the equipment used, Reaptan therapy may not be suitable for you,
if you have kidney problems resulting in reduced blood flow to the kidneys (renal artery stenosis),
if you are being treated with sacubitril/valsartan, a medicine used to treat heart failure (see information under “Warnings and precautions” and “Other medicines and Reaptan”).

Warnings and precautions
Before starting treatment with Reaptan, speak with your doctor if any of the following conditions apply to you:

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 severe high blood pressure (hypertensive crisis),
if you suffer from other heart conditions,
if you have liver problems,
if you have kidney problems or are on dialysis,
if you have abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism),
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 low-salt diet or use potassium-containing salt substitutes (maintaining a balanced blood potassium level is essential),
if you are elderly and dosage adjustment is needed,
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 (e.g., valsartan, telmisartan, irbesartan), particularly 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 section "Do not take Reaptan".
if you are taking any of the following medicines, which may increase the risk of angioedema:
racecadotril (used to treat diarrhoea),
sirolimus, everolimus, temsirolimus, and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent transplant rejection),
sacubitril (available as a fixed-dose combination with valsartan), used for long-term treatment of heart failure,
if you are of African descent, as you may have a higher risk of angioedema, and this medicine may be less effective in lowering your blood pressure compared to non-black 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 Reaptan. This may occur at any time during treatment. If you develop such symptoms, stop taking Reaptan immediately and contact a doctor without delay. See also section 4.
You must inform your doctor if you think you may be pregnant (or if there is any possibility of becoming pregnant). Reaptan is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).
If you are taking Reaptan, inform your general practitioner or medical staff:

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

Children and adolescents
Reaptan is not recommended for use in children and adolescents.

Other medicines and Reaptan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must not take Reaptan with:

lithium (used to treat mania or depression),
estramustine (used in cancer therapy),
potassium-sparing medicines (triamterene, amiloride), potassium supplements, or potassium-containing salt substitutes, or other medicines that may increase blood potassium levels (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
potassium-sparing medicines used in heart failure treatment: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily.

Treatment with Reaptan 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:

other medicines for treating high blood pressure, including an angiotensin II receptor antagonist (AIIRA), aliskiren (see also sections "Do not take Reaptan" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys),
medicines used primarily for treating diarrhoea (racecadotril) or for preventing organ transplant rejection (sirolimus, everolimus, temsirolimus and other so-called mTOR inhibitors). See section “Warnings and precautions”,
sacubitril/valsartan (used for long-term treatment of heart failure). See sections "Do not take Reaptan" 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 suppress the body’s defence mechanisms) used to treat autoimmune disorders or after surgical transplantation (e.g., cyclosporine, tacrolimus),
trimethoprim and co-trimoxazole (for treating infections),
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 hypotension, shock or asthma),
baclofen or dantrolene (infusion), both used to treat muscle stiffness in conditions such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia during anaesthesia (symptoms include very high fever and muscle rigidity),
certain antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections),
Hypericum perforatum (St. John’s wort, a herbal remedy used to treat depression),
simvastatin (a cholesterol-lowering medicine),
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 drugs 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).

Reaptan with food and drinks
Reaptan should be taken before meals.
Patients taking Reaptan must not eat grapefruit or drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active substance amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of Reaptan.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or 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 any possibility of becoming pregnant). Your doctor will usually advise you to stop taking REAPTAN before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of REAPTAN.
REAPTAN is not recommended during early pregnancy and must not be taken if you are more than three 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 passes into breast milk in small amounts. Inform your doctor if you are breastfeeding or planning to breastfeed. REAPTAN is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.

Driving and using machines
Reaptan may affect your ability to drive or operate machinery. If the tablets cause you discomfort, dizziness, fatigue, or headache, avoid driving or operating machinery and contact your doctor immediately.

Reaptan contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. HOW TO TAKE REAPTAN

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablet with water, preferably at the same time each day, in the morning and always before a meal. Your doctor will determine the appropriate dose for you. Usually, the dose is one tablet daily.
Generally, Reaptan will be prescribed to patients who are already taking perindopril and amlodipine as separate tablets.
Use in children and adolescents
Reaptan is not recommended for use in children and adolescents.
If you take more Reaptan than you should
If you have taken an excessive amount of tablets, go immediately to the nearest emergency room or contact your doctor. The most likely effect of an overdose is a drop in blood pressure, which may make you feel dizzy or weak. In such a case, lying down with your legs raised may be helpful.
If you forget to take Reaptan
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of Reaptan, take the next dose as usual. Do not take a double dose to make up for the missed dose.
If you stop taking Reaptan
Since treatment with Reaptan is usually lifelong, speak with your doctor before stopping this medicine.
If you have any doubts about the use of Reaptan, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, 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 breathing,
Severe skin reactions including intense skin rash, urticaria, widespread redness of the skin, severe itching, blisters, skin peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis) or other allergic reactions,
Severe dizziness or fainting,
Myocardial infarction, arrhythmia, or chest pain,
Pancreatitis which may cause severe abdominal and back pain associated with a marked feeling of illness.

The following common adverse reactions have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.

Very common (may affect more than 1 in 10 people): oedema (fluid retention)
Common (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the beginning of treatment), vertigo, tingling or numbness sensation in limbs, visual disturbances (including double vision), tinnitus (sensation of noise in the ear), palpitations (awareness of heartbeat), hot flushes, dizziness due to hypotension, cough, shortness of breath, nausea (feeling unwell), vomiting (state of feeling unwell), abdominal pain, taste disturbances, dyspepsia or indigestion, changes in bowel habits, diarrhoea, constipation,
allergic reactions (such as skin rashes, itching), muscle cramps, feeling of fatigue,
weakness, swelling of the ankles (peripheral oedema).

Other adverse reactions that have been reported are listed below. If any of these become serious, or if you notice any adverse reaction not listed in this leaflet, contact your doctor or pharmacist.

Uncommon (may affect up to 1 in 100 people): mood changes, anxiety, depression, lack of sleep, sleep disturbances, tremor, fainting, loss of pain sensation, irregular heartbeat, rhinitis (stuffy or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, arthralgia (joint pain), myalgia (muscle pain), chest pain, urinary disorders, increased need to urinate at night, frequent need to urinate, pain, discomfort, bronchospasm (tightening of the chest, shortness of breath and difficulty breathing), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), formation of clusters of blisters on the skin, kidney problems, impotence, increased sweating, eosinophilia (an increased number of eosinophils, a type of white blood cell), breast tenderness or enlargement in men, weight gain or loss, tachycardia, vasculitis (inflammation of blood vessels), photosensitivity reaction (increased sensitivity of the skin to sunlight), fever, falls, laboratory test abnormalities: high blood potassium levels (reversible upon discontinuation of treatment), low sodium levels, hypoglycaemia (very low blood sugar levels) in diabetic patients, increased blood urea and increased plasma creatinine.
Rare (may affect up to 1 in 1,000 people): confusion, worsening of psoriasis, laboratory test abnormalities: increased liver enzyme levels, elevated serum bilirubin levels.
Very rare (may affect up to 1 in 10,000 people): cardiovascular disorders (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 which may cause severe difficulty breathing, severe skin reactions including intense skin rash, urticaria, widespread redness of the skin, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), erythema multiforme (skin rash often presenting as itchy red papules on the face, arms or legs), light sensitivity, blood test abnormalities such as reduced numbers of white and red blood cells, lower haemoglobin, reduced platelet count, blood disorders, pancreatitis which may cause severe abdominal and back pain associated with a marked feeling of illness, acute renal failure, abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain clinical tests, abdominal swelling (gastritis), neurological disorder which may cause weakness, tingling or numbness, increased muscle tension, gum swelling, high blood sugar levels (hyperglycaemia).
Frequency not known (frequency cannot be estimated from the available data): tremors, postural rigidity, mask-like face, slow and random movements, unsteady and shuffling gait, abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon).

With the use of ACE inhibitors, very concentrated (dark-coloured) urine, sensation or feeling of malaise, muscle cramps, confusion and seizures may occur, probably due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, consult your doctor immediately.

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

5. HOW TO STORE REAPTAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and container. The expiry date refers to the last day of the month.
Keep the container tightly closed to protect the medicine from moisture. Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Reaptan contains

The active substances are perindopril arginine and amlodipine. Reaptan 5mg/5mg: one tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine. Reaptan 10mg/5mg: one tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine. Reaptan 5mg/10mg: one tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine. Reaptan 10mg/10mg: one tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine.
The excipients contained in the tablet are: monohydrate lactose, magnesium stearate (E470B), microcrystalline cellulose (E460), anhydrous colloidal silica (E551).

Description of the appearance of Reaptan and pack contents
Reaptan 5mg/5mg tablets are white, elongated in shape, with "5/5" marked on one side and the logo on the other.
Reaptan 10mg/5mg tablets are white, triangular in shape, with "10/5" marked on one side and the logo on the other.
Reaptan 5mg/10mg tablets are white, square-shaped, with "5/10" marked on one side and the logo on the other.
Reaptan 10mg/10mg tablets are white, round-shaped, with "10/10" marked on one side and the logo on the other.
The tablets are available in packs of 5, 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
I.F.B. STRODER S.r.l.
Via Luca Passi, 85
00166 Rome - Italy

Manufacturers responsible for batch release
Les Laboratoires Servier Industrie
905 route de Saran
45520 Gidy - France
and
Servier (Ireland) Industries Ltd
Gorey Road
Arklow - Co. Wicklow – Ireland
and
Anpharm Przedsiebiorstwo Farmaceutyczne S.A.
Ul. Annopol 6B
03-236 Warsaw – Poland
and
Egis Pharmaceuticals Public Limited Company
Site 3: H-9900, Körmend
Mátyás király u. 65 – Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Perindopril arginine /Amlodipine Servier
France: Perindopril arginine /Amlodipine Servier
Hungary: COVERCARD
Ireland: Perindopril arginine /Amlodipine Servier
Italy: REAPTAN
Latvia: Perindopril arginine /Amlodipine Servier