Coverlam

Patient Information Leaflet

COVERLAM 5mg/5mg tablets, 5mg/10mg tablets, 10mg/5mg tablets, 10mg/10mg tablets

perindopril arginine/amlodipine
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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT COVERLAM IS AND WHAT IT IS USED FOR

Coverlam 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 Coverlam, which contains both active substances.
Coverlam 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 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 SHOULD KNOW BEFORE TAKING COVERLAM

Do not take Coverlam

• 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), or if you are more than three months pregnant. (It is advisable to avoid Coverlam also during early pregnancy) (see section "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 aortic heart 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 are undergoing dialysis or any type of blood filtration. Depending on the equipment used, Coverlam therapy may not be suitable for you,
• if you have kidney problems causing 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 section "Warnings and precautions" and "Other medicines and Coverlam").

Warnings and precautions
Before starting treatment with Coverlam, speak with your doctor or pharmacist 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 problems,
• 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 aldosteronism),
• 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 - 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 Coverlam".
• if you are taking any of the following medicines, which 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 Coverlam. This
may occur at any time during treatment. If you develop such symptoms, stop taking Coverlam 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 a possibility of becoming pregnant). Coverlam 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 Coverlam, inform your general practitioner 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 (blood purification from cholesterol using a machine),
• if you are undergoing desensitisation treatment to reduce the effects of allergy to bee or wasp stings.

Children and adolescents
Coverlam is not recommended for use in children and adolescents.
Other medicines and Coverlam
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine.
Do not take Coverlam 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 drugs that may increase blood potassium levels (such as heparin and co-trimoxazole, also known as trimethoprim/sulfamethoxazole),
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg daily.

Treatment with Coverlam may be affected by concomitant use of other medicines. Your doctor may need to adjust the 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 section "Do not take Coverlam" and "Warnings and precautions") or diuretics (medicines that increase urine production by the kidneys),
• medicines used primarily to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section "Warnings and precautions",
• Sacubitril/valsartan (used for long-term treatment of heart failure). See section "Do not take Coverlam" 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 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).

Coverlam with food and drinks
Coverlam should be taken before meals.
Patients taking Coverlam must not consume grapefruit or drink grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially leading to an unpredictable increase in the antihypertensive effect of Coverlam.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, 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 a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Coverlam before becoming pregnant or as soon as you learn you are pregnant, and will recommend an alternative medicine instead of Coverlam.
Coverlam is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken beyond the first trimester.
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. Coverlam 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
Coverlam 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.
Coverlam contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE COVERLAM

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Swallow the tablet with water, preferably at the same time every day, in the morning and always before a meal. Your doctor will determine the appropriate dose for you. Usually, the dose is one tablet per day.
Coverlam is generally prescribed to patients who are already taking perindopril and amlodipine as separate tablets.

Use in children and adolescents
Coverlam is not recommended for use in children and adolescents.

If you take more Coverlam 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 low blood pressure, which may make you feel dizzy or weak. In this case, lying down with your legs raised may be helpful.

If you forget to take Coverlam
It is important to take the medicine every day, as regular treatment is more effective. However, if you forget to take a dose of Coverlam, take the next dose as usual. Do not take a double dose to make up for the forgotten dose.

If you stop taking Coverlam
Since treatment with Coverlam is usually lifelong, speak with your doctor before stopping this medicine.

If you have any doubts about how to use Coverlam, 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 dyspnea, chest pain, shortness of breath, or difficulty breathing,
• Swelling of the eyelids, face, or lips,
• Swelling of the tongue and throat which may cause significant breathing difficulty,
• Severe skin reactions including intense rash, urticaria, redness of the skin over the entire body, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome, Toxic Epidermal Necrolysis), or other allergic reactions,
• Severe dizziness or fainting,
• Myocardial infarction, arrhythmia, or chest pain,
• Pancreatic inflammation which may cause severe abdominal and back pain associated with a marked feeling of malaise.

The following common adverse reactions have been reported. If any of these occur or 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, numbness or tingling sensations in the limbs, visual disturbances (including double vision), tinnitus (sensation of ringing in the ears), 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 difficulty digesting, 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 included in the following list. If any of these become serious, or if you notice any adverse reactions 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 disorders, tremor, 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, discomfort, malaise, bronchospasm (tightening of the chest, shortness of breath and difficulty breathing), dry mouth, angioedema (symptoms such as breathlessness, swelling of the face or tongue), formation of clusters of blisters on the skin, kidney problems, impotence, increased sweating, eosinophilia (an excess of a type of white blood cells), breast discomfort or enlargement in men, weight gain or loss, tachycardia, vasculitis (inflammation of blood vessels), photosensitivity reaction (increased skin sensitivity to sunlight), fever, fall, changes in laboratory parameters: 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): acute renal failure; dark-coloured urine, feeling unwell (nausea) or unwell state (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; worsening of psoriasis; changes in laboratory parameters: increased liver enzyme levels, elevated serum bilirubin.

• 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 significant breathing difficulty, severe skin reactions including intense rash, urticaria, redness of the skin over the entire body, severe itching, blisters, skin peeling and swelling, inflammation of mucous membranes (Stevens-Johnson syndrome), erythema multiforme (a skin eruption often presenting as itchy red papules on the face, arms or legs), light sensitivity, changes in blood parameters such as decreased numbers of white and red blood cells, lower haemoglobin, reduced platelet count, blood disorders, pancreatic inflammation which may cause severe abdominal and back pain associated with a marked feeling of malaise, 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 causing weakness, tingling or numbness, increased muscle tone, gum swelling, high blood sugar levels (hyperglycaemia).

• • Frequency not known (frequency cannot be estimated from the available data): tremors, postural rigidity, mask-like facial expression, slow and shuffling movements, unbalanced and dragging gait, abnormal colour, numbness and pain in fingers or toes (Raynaud's phenomenon). If you experience any of these symptoms, consult your doctor immediately.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult 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 COVERLAM

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 no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Coverlam contains

• The active substances are perindopril arginine and amlodipine.
  Coverlam 5 mg/5 mg: one tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine.
  Coverlam 10 mg/5 mg: one tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine.
  Coverlam 5 mg/10 mg: one tablet contains 5 mg of perindopril arginine and 10 mg of amlodipine.
  Coverlam 10 mg/10 mg: 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 Coverlam and pack contents
Coverlam 5 mg/5 mg tablets are white, elongated in shape, with the mark "5/5"

imprinted on one side and the logo on the other.
Coverlam 10 mg/5 mg tablets are white, triangular in shape, with the mark "10/5"

imprinted on one side and the logo on the other.
Coverlam 5 mg/10 mg tablets are white, square-shaped, with the mark "5/10"

imprinted on one side and the logo on the other.
Coverlam 10 mg/10 mg tablets are white, round-shaped, with the mark "10/10"

imprinted 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex – France

Local Representative of the Marketing Authorization Holder
Servier Italia S.p.A.
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

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium COVERAM
Bulgaria PRESTARIUM-CO
Cyprus COVERAM
Czech Republic PRESTANCE
Denmark COVERSICAL
Estonia COVERAM
Finland COVERAM
France COVERAM
Greece COVERAM
Ireland ACERYCAL
Italy COVERLAM
Latvia PRESTERAM
Lithuania PRESTERAM
Luxembourg COVERAM
Malta COVERAM
Netherlands COVERAM arg
Poland Co-Prestarium
Portugal COVERAM
Romania PRESTANCE
Slovakia PRESTANCE
Slovenia PRESTANCE