COVERLAM 5 mg/5 mg Tablets

Зміст інструкції

1. COVERLAM 5mg/5mg tablets, 5mg/10mg tablets, 10mg/5mg tablets, 10mg/10mg tablets
   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. PACKAGE CONTENTS AND OTHER INFORMATION

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

perindopril arginine/amlodipine

Read this leaflet carefully before you start 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even 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 you take 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 the blood supply to the heart is reduced or blocked).
Patients who are already taking perindopril and amlodipine in separate tablets may take a single Coverlam tablet instead, which contains both active ingredients.
Coverlam is a combination of two active ingredients, perindopril and amlodipine.
Perindopril is an ACE (angiotensin converting enzyme) inhibitor. Amlodipine is a calcium channel blocker (belonging to the class of drugs called dihydropyridines). In combination, they work by widening and relaxing blood vessels so that it is easier for blood to flow through and for the heart to maintain a good level of blood flow.

2. WHAT YOU NEED TO KNOW BEFORE TAKING COVERLAM

Do not take Coverlam

• if you are allergic to perindopril or to any other ACE inhibitor, or to amlodipine or to any other calcium channel blocker, or to any of the other ingredients of this medicine (listed in section 6), if you are pregnant for more than three months. (It is best to avoid Coverlam even in the early stages of pregnancy) (see section “Pregnancy”),
• if you experience symptoms such as shortness of breath, swelling of the face or tongue, intense itching or severe skin rashes related to a previous treatment with ACE inhibitors or if you or a family member have experienced such symptoms in any other circumstance (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 heart valve (aortic stenosis) or in case of cardiogenic shock (a condition in which the heart is unable to deliver enough blood to the body),
• if you suffer from severe low blood pressure (hypotension),
• if you suffer from heart failure following a heart attack,
• if you are undergoing dialysis or any type of blood filtration. Depending on the machine used, therapy with Coverlam may not be suitable for you,
• if you have kidney problems, where blood flow to the kidneys is reduced (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, talk to your doctor or pharmacist if any of the following conditions apply to you:

• if you have hypertrophic cardiomyopathy (disease of the heart muscle) 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 have other heart problems,
• if you have liver problems,
• if you have kidney problems or are on dialysis,
• if you have an abnormal increase in the levels of a hormone called aldosterone in the blood (primary aldosteronism),
• if you have a collagenous vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• if you have diabetes,
• if you are following a diet that restricts salt intake or use potassium-containing salt substitutes (a well-balanced blood potassium level is essential),
• if you are elderly and the dosage may need to be increased,
• 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 check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also section "Do not take Coverlam".
• if you are taking any of the following medicines, increases the risk of angioedema:
• racecadotril (used to treat diarrhea),
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors (used to prevent rejection after transplantation),
• sacubitril (available as a fixed-dose combination with valsartan), used in the long-term treatment of heart failure
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in reducing your blood pressure compared to non-black patients

Angioedema
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Coverlam. This can happen at any time during treatment. If you develop these symptoms, stop taking Coverlam and call your doctor immediately. See also section 4.
You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Coverlam is not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see section “Pregnancy”).
If you are taking Coverlam, inform your doctor or medical staff:

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

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

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

• lithium (used to treat mania or depression),
• estramustine (used in cancer therapy),
• potassium-sparing medicines (triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other medicines that can increase potassium levels in the blood (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 per day.

Treatment with Coverlam may be affected by taking other medicines. Your doctor may need to adjust the dose and/or take other precautions. Tell your doctor if you are taking any of the following medicines as special care may be needed:

• other medicines to treat 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 the amount of urine produced by the kidneys),
• medicines used mainly for the treatment of diarrhea (racecadotril) or for the prevention of rejection after organ transplantation (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• Sacubitril/valsartan (used for the 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 doses of aspirin,
• 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 suppress the body's defense mechanism) used to treat autoimmune disorders or following a surgical transplant (e.g. cyclosporine, tacrolimus),
• trimethoprim and Co-trimoxazole (for the treatment of infections),
• allopurinol (for the treatment of gout),
• procainamide (for the treatment of irregular heartbeat),
• vasodilators, including nitrates (products that dilate blood vessels),
• ephedrine, norepinephrine or adrenaline (drugs used to treat hypotension, shock or asthma),
• baclofen or dantrolene (infusion) both used in the treatment of muscle stiffness in conditions such as multiple sclerosis; dantrolene is also used in the treatment of malignant hyperthermia during anesthesia (symptoms include high fever and muscle stiffness),
• some antibiotics such as rifampicin, erythromycin, clarithromycin (for bacterial infections),
• hypericum perforatum (St. John's wort, a herbal medicine used to treat depression),
• simvastatin (cholesterol-lowering medicine),
• antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone,
• itraconazole, ketoconazole (medicines used to treat fungal infections),
• alpha-blockers used for the treatment of prostatic hyperplasia such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin,
• amifostine (used in the prevention or reduction of 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 with intravenous administration (used to treat the symptoms of rheumatoid arthritis),
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV).

Coverlam with food and drink
Coverlam should be taken before meals.
People taking Coverlam should not consume grapefruit or drink grapefruit juice as grapefruit and its juice can increase the levels of the active ingredient amlodipine in the blood, and this may lead to an unpredictable increase in the hypotensive effect of Coverlam.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking Coverlam before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Coverlam.
Coverlam is not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Coverlam is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newly born, or was born prematurely.

Driving and using machines
Coverlam may affect your ability to drive or operate machinery. If the tablets make you feel unwell, dizzy, or tired, or give you a headache, do not drive or operate machinery and contact your doctor immediately.

Coverlam contains lactose monohydrate
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE COVERLAM

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablet with water, preferably every day at the same time, in the morning and
in any case before meals. Your doctor will decide the appropriate dose for you. Usually the dose will be
one tablet a day.
Generally, Coverlam will be prescribed to patients who are already taking perindopril and amlodipine in
separate tablets.

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

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
consult your doctor. The most likely effect in case of overdose is a lowering of blood
pressure which may make you feel dizzy or weak. In this case, it may be helpful to lie down with your legs
raised.

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 a missed dose.

If you stop taking COVERLAM
Since treatment with Coverlam is usually lifelong, talk to your doctor before stopping
taking this medicine.
If you have any doubts about the use of Coverlam, ask your doctor, pharmacist or nurse.

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

immediatelyyour doctor:
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 can cause significant difficulty breathing,
Severe skin reactions including intense skin 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, Toxic Epidermal Necrolysis) or other allergic reactions,
severe dizziness or fainting,
myocardial infarction, arrhythmia, or chest pain,
inflammation of the pancreas which can cause severe abdominal and back pain combined
with a feeling of severe malaise.
The following common side effectshave been reported. If any of these effects occur or if persist
for more thanone week, consult your doctor.

• Very common (may affect more than 1 in 10 people): edema (fluid retention)
• Common (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the beginning of treatment), vertigo, sensation of numbness or tingling in the limbs, visual disturbances (including double vision), tinnitus (ringing in the ears), palpitations (feeling your heartbeat), hot flushes, dizziness due to hypotension, cough, shortness of breath, nausea (feeling sick), vomiting (feeling unwell), abdominal pain, altered taste, dyspepsia or difficulty digesting food, altered bowel habits, diarrhea, constipation,

allergic reactions (such as skin rashes, itching), muscle cramps, feeling tired,
weakness, swelling of the ankles (peripheral edema).
Other side effects that have been reported are included in the following list. If any of these becomes
pharmacist.

• Uncommon (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disorders, tremor, fainting, loss of sensation of pain, 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 urination, pain, malaise, 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, excess eosinophils (a type of white blood cells), discomfort or enlargement of the breasts in men, increase or decrease in body weight, tachycardia, vasculitis (inflammation of blood vessels), photosensitivity reaction (increased sensitivity of the skin to the sun), fever, falls, changes in laboratory parameters: high potassium level in the blood reversible with discontinuation of treatment, low sodium level, hypoglycemia (very low blood sugar) in diabetic patients, increased urea in the blood and increased plasma creatinine.
• Rare (may affect up to 1 in 1,000): acute renal failure; dark urine, feeling sick (nausea) or unwell (vomiting), muscle cramps, confusion and convulsions. These symptoms may be due 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, high serum bilirubin levels,
• Very rare (may affect up to 1 in 10,000): 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 can cause significant difficulty breathing, severe skin reactions including intense skin 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 (skin rash that often manifests with itchy red papules located on the face, arms or legs), sensitivity to light, changes in blood parameters such as lowering of the number of white blood cells and red blood cells, lower hemoglobin, lower number of blood platelets, blood disorders, inflammation of the pancreas which can cause severe abdominal and back pain combined with a feeling of severe malaise, abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which can lead to changes in some clinical tests, abdominal bloating (gastritis), nervous disorder that can cause weakness, tingling or numbness, increased muscle tension, swelling of the gums, high blood sugar levels (hyperglycemia).
• - Frequency not known (frequency cannot be estimated from the available data): tremors, postural rigidity, mask-like face, slow and random movements, unbalanced and shuffling gait, abnormal color, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon). If you experience these symptoms, see your doctor immediately. Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. You can also report side effects directly through 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 COVERLAM

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 package and the 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 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 Coverlam contains

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

Description of the appearance of Coverlam and package contents
Coverlam 5mg/5mg tablets are white, elongated in shape, with the indication 5/5
embossed on one side and the logo on the other.
Coverlam 10mg/5mg tablets are white, triangular in shape, with the indication 10/5
embossed on one side and the logo on the other.
Coverlam 5mg/10mg tablets are white, square in shape with the indication 5/10
embossed on one side and the logo on the other.
Coverlam 10mg/10mg tablets are white, round in shape with the indication 10/10
embossed 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

Les Laboratoires Servier
50, rue Carnot
92284 Suresnes cedex– France

Local Representative of the Marketing Authorisation Holder
Servier Italia S.p.A
Via Luca Passi, 85
00166 Roma - 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 authorised in the Member States of the European Economic Area 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