Coversoral, 5 mg comprimidos bucodispersables

Patient Information Leaflet

Coversoral 5mg buccal dispersible tablets

perindopril arginina

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

-Keep this leaflet, as 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 others, even if they have the same symptoms as you, as it may harm them.

-Inform your doctor or pharmacist or nurse if you experience any side effects, even if they are not listed in this leaflet. See section 4.

1.What is Coversoral and what it is used for

2.What you need to know before you start taking Coversoral

3.How to take Coversoral

4.Possible side effects

5.Storage of Coversoral

6.Contents of the pack and additional information

Coversoral is an angiotensin-converting enzyme inhibitor (ACEI). It works by widening blood vessels, making it easier for the heart to pump blood through them.

Coversoral is used for:

-treatment ofhigh blood pressure(hypertension),

-treatment ofheart failure(a condition in which the heart is unable to pump enough blood to meet the body's needs),

-reducing the risk of cardiac events, such as heart attacks, in patients withstable coronary artery disease(a condition in which blood supply to the heart is reduced or blocked) who have already experienced a heart attack and/or a procedure to improve blood supply to the heart by widening the blood vessels that supply it.

Do not take Coversoral

-if you are allergic to perindopril, or to any of the other ingredients of this medicine (listed in section 6), or to any other ACE inhibitor,

-if you have experienced symptoms such as wheezing, swelling of the face, lips, tongue or throat, intense itching or severe skin eruptions with any previous treatment with ACE inhibitors or if you or a family member has had these symptoms in any other circumstance (a condition called angioedema),

-if you are more than 3 months pregnant (It is also best to avoid Coversoral at the beginning of pregnancy – see section Fertility, pregnancy and breastfeeding),

-if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén,

-if you are receiving dialysis or any other type of blood filtration. Depending on the machine used, Coversoral may not be suitable for you,

-if you have kidney problems that reduce blood flow to your kidneys (renal artery stenosis),

-if you have taken or are currently taking sacubitril/valsartan, a medicine for heart failure, as it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat)(see “Warnings and precautions” and “Use of Coversoral with other medicines”).

Warnings and precautions

If any of the following circumstances apply, consult your doctor, pharmacist or nurse before taking Coversoral, if you:

- suffer from aortic stenosis (narrowing of the main blood vessel that leaves the heart) or hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery that carries blood to the kidneys),

- suffer from any other heart problem,

- suffer from liver problems,

- suffer from kidney failure or if you are on dialysis,

- have abnormally high levels of a hormone called aldosterone in the blood (primary aldosteronism),

- suffer from a vascular disease of the connective tissue (such as systemic lupus erythematosus or scleroderma),

- have diabetes,

- are following a low-salt diet or using salt substitutes that contain potassium,

- are about to undergo anaesthesia and/or major surgery,

- are about to undergo LDL apheresis (which involves the removal of cholesterol from your blood using a machine),

- are about to receive a treatment to make you less sensitive to the effects of an allergy to a bee or wasp sting,

- have recently had diarrhoea or vomiting, or are dehydrated,

- have informed your doctor that you have intolerance to some sugars,

- have informed your doctor that you have phenylketonuria,

- are of black origin, as you may have a higher risk of angioedema and this medicine may be less effective in lowering your blood pressure than in patients who are not of black origin,

- are taking any of the following medicines used to treat high blood pressure (hypertension):

- an angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.

- aliskirén.

Your doctor may need to monitor your kidney function, blood pressure and electrolyte levels (such as potassium) at regular intervals.

See also the information under the heading “Do not take Coversoral”.

• if you are taking any of the following medicines, the risk of angioedema increases:
• racecadotril (used to treat diarrhoea)
• sirolimus, everolimus, temsirolimus and other medicines belonging to the class called mTor inhibitors (used to prevent rejection in organ transplants and for cancer),
• sacubitril (available as a fixed-dose combination with valsartan), used to treat heart failure over a long period,
• linagliptina, saxagliptina, sitagliptina, vildagliptina and other medicines belonging to the class of gliptins (used to treat diabetes).

Angioedema

In patients treated with ACE inhibitors, including Coversoral, angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat, making it difficult to swallow or breathe) has been reported. This can occur at any time during treatment. If you develop these symptoms, you should stop taking Coversoral and see your doctor immediately. See also Section 4.

You should inform your doctor if you think you (or could become) are pregnant. Coversoral is not recommended at the beginning of pregnancy, and you should not take it if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section “Pregnancy”).

Children and adolescents

Coversoral is not recommended for use in children and adolescents.

Use of Coversoral with other medicines

Inform your doctor or pharmacist that you are using or have used recently you may need to use any other medicine.

The treatment with Coversoral may be affected by other medicines.You may need to modify your dose and/or take other precautions.These include:

- other medicines for high blood pressure, including angiotensin II receptor antagonists (ARAs), aliskirén (see also the information under the headings “Do not take Coversoral” and “Warnings and precautions”), or diuretics (medicines that increase the amount of urine produced by the kidneys),

- potassium-sparing medicines (e.g., triamtereno, amilorida), potassium supplements or salt substitutes that contain potassium, other medicines that may increase potassium in your body (such as heparin, a medicine used to thin the blood and prevent clots; trimetoprima and cotrimoxazol also known as trimetoprima/sulfametoxazol for infections caused by bacteria),

- potassium-sparing medicines used in the treatment of heart failure: eplerenona and espironolactona at doses between 12.5 mg and 50 mg per day,

- lithium for mania or depression,

- non-steroidal anti-inflammatory medicines (e.g., ibuprofen) for the treatment of pain or high doses of acetylsalicylic acid, a substance present in many medicines used to relieve pain and reduce fever, as well as to prevent blood clotting,

- medicines used to treat diabetes (such as insulin or metformina),

- baclofeno (used to treat muscle stiffness in diseases such as multiple sclerosis),

- medicines used to treat mental disorders such as depression, anxiety, schizophrenia, etc (e.g.

tricyclic antidepressants, antipsychotics),

- immunosuppressants (medicines that reduce the body's defence mechanism) used

to treat autoimmune disorders or after a transplant (e.g. Ciclosporina, tacrolimus),

- trimetoprima (for the treatment of infections),

- estramustina (used in the treatment of cancer),

- medicines that are frequently used to treat diarrhoea (racecadotril) or to prevent rejection of organ transplants (sirolimus, everolimus, temsirolimus and other medicines belonging to the class called mTor inhibitors). See section “Warnings and precautions”,

- sacubitril/valsartan (used to treat heart failure over a long period). See sections “Do not take Coversoral” and “Warnings and precautions”,

- alopurinol (for the treatment of gout),

- procainamida (for the treatment of irregular heartbeats),

- vasodilators including nitrates (medicines that produce the widening of the blood vessels),

- medicines used to treat low blood pressure, shock or asthma (e.g. efedrina,

noradrenalina or adrenalina),

- gold salts, especially in intravenous administration (used for the symptomatic treatment of rheumatoid arthritis).

Taking Coversoral with food and drink

It is best to take Coversoral before a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you (or could become) are pregnant, consult your doctor or pharmacist before using any medicine.

Pregnancy

You should inform your doctor if you think you (or could become) are pregnant. Normally, your doctor will advise you to stop taking Coversoral before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Coversoral. Coversoral is not recommended at the beginning of pregnancy, and you should not take it if you are more than three months pregnant, as it may cause serious harm to your baby if taken after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding. Coversoral is not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to continue breastfeeding, especially if your baby is newborn or premature.

Driving and operating machinery

Coversoraldoes not affect your alertness, but due to the lowering of blood pressure some patients may notice different reactions such as dizziness or weakness. If this happens to you, your ability to drive or use machinery may be impaired.

Coversoral contains lactose and aspartamo.

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 0.2 mg of aspartamo in each tablet. Aspartamo contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for Coversoral indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Place the tablet on the tongue to disintegrate and swallow with saliva, preferably at the same time every day, in the morning, before breakfast.

Your doctor will decide on the correct dose for you.

The recommended doses are as follows:

Hypertension:The initial and maintenance dose is generally 5 mg per day. If necessary, after one month of treatment, your doctor may increase the dose to 10 mg per day. The maximum recommended dose for hypertension is 10mg per day.

If you are 65 years or older, the initial dose is generally 2.5mg per day. If necessary, after one month of treatment, your doctor may increase the dose to 5mg per day, and if necessary up to 10mg per day.

Heart failure:The initial dose is generally 2.5 mg per day. If necessary, after two weeks of treatment, your doctor may increase the dose to 5 mg per day, which is the maximum recommended dose for heart failure.

Stable coronary disease: The initial dose is generally 5mg per day. If necessary, after two weeks of treatment, your doctor may increase the dose to 10mg per day, which is the maximum recommended dose for this indication.

If you are 65 years or older, the initial dose is generally 2.5mg per day. If necessary, after one week of treatment, your doctor may increase the dose to 5mg per day, and if necessary, one week later, it may be increased up to 10mg per day.

If you take more Coversoral than you should

If you have taken more Coversoral 5mg tablets than you should, contact your doctor immediately or call the Toxicological Information Service, phone 91-562 04 20.

The most common symptom in case of overdose is a decrease in blood pressure with possible symptoms of dizziness or fainting. If this occurs, you can help by lying down with your legs elevated.

Use in children and adolescents

It is not recommended to use in children and adolescents.

If you forgot to take Coversoral

It is essential to take this medication every day since continuous treatment is more effective. However, if you forgot to take a dose of Coversoral, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Coversoral

Since treatment withCoversoralwill usually be lifelong, you should talk to your doctor before stopping this medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist or nurse.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Stop taking this medicine and seek immediate medical attention if you experience any of the following serious side effects:

• swelling of the face, lips, mouth, tongue, or throat, difficulty breathing (angioedema) (See Section 2 “Warnings and precautions”) (Uncommon - may affect up to 1 in 100 people),
• intense dizziness or fainting due to low blood pressure (Common - may affect up to 1 in 10 people),
• abnormally rapid or irregular heartbeat, chest pain (angina) or heart attack (Very rare - may affect up to 1 in 10,000 people),
• weakness in arms or legs, or speech problems that may be a sign of a possible stroke (Very rare - may affect up to 1 in 10,000 people),
• sudden wheezing, chest pain, shortness of breath or difficulty breathing (bronchoconstriction) (Uncommon - may affect up to 1 in 100 people),
• inflammation of the pancreas that can cause severe abdominal and back pain accompanied by discomfort (Very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) that may be a sign of hepatitis (Very rare - may affect up to 1 in 10,000 people),
• skin rash that often begins with red, itchy patches on the face, arms, or legs (erythema multiforme) (Very rare - may affect up to 1 in 10,000 people).

Inform your doctor if you experience any of the following side effects:

- Common (may affect up to 1 in 10 people):

- headache,

- dizziness,

- vertigo,

- numbness,

- visual disturbances,

- tinnitus (sensation of noise in the ears),

- cough,

- shortness of breath (dyspnea),

- gastrointestinal disturbances (nausea, vomiting, abdominal pain, altered taste, dyspepsia or difficulty digesting, diarrhea, constipation),

- allergic reactions (such as skin rashes, itching),

- muscle cramps,

- feeling of weakness.

- Uncommon (may affect up to 1 in 100 people):

- depression,

- mood changes,

- sleep disturbances,

- dry mouth,

- intense itching or severe skin rashes),

- skin blistering,

- kidney problems,

- impotence,

- sweating,

- eosinophilia (an increase in a type of white blood cell),

- drowsiness,

- fatigue,

- palpitations,

- tachycardia,

- vasculitis (inflammation of blood vessels),

- photosensitivity reactions (increased skin sensitivity to the sun),

- arthralgia (joint pain),

- myalgia (muscle pain),

- chest pain,

- general discomfort,

- peripheral edema,

- fever,

- falls,

- change in laboratory values: reversible high potassium levels in blood upon discontinuing treatment, low sodium levels, hypoglycemia in diabetic patients (very low blood sugar levels), elevated urea levels in blood, and elevated creatinine levels in blood.

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

- acute renal insufficiency,

- concentrated urine, feeling unwell (nausea) or vomiting, muscle cramps, confusion, and seizures. These symptoms may be a sign of a condition called SIADH (inadequate secretion of antidiuretic hormone),

- decreased or absent diuresis

- facial flushing,

- worsening of psoriasis,

- changes in laboratory values: elevated liver enzymes, high serum bilirubin levels.

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

- confusion,

- eosinophilic pneumonia (a rare type of pneumonia),

- rhinitis (nasal congestion or runny nose),

- changes in blood parameters such as decreased white and red blood cell count, decreased hemoglobin concentration, and decreased platelet count.

If you experience these symptoms, contact your doctor as soon as possible.

Unknown frequency (cannot be estimated from available data): Change in color, numbness, and pain in the fingers of the hands or feet (Raynaud's disease).

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and on the packaging. The expiration date is the last day of the month indicated.

Keep the packaging perfectly closed to protect it from moisture.

Medicines should not be thrown down the drains or in the trash.Dispose of the packaging and medicines that you no longer need at the SIGRE collection pointofyourusual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicinesthat you no longer need. By doing so, you will help protect the environment.

Composition ofCoversoral5mg

- The active ingredient is perindopril arginina. Each buccal dispersible tablet contains3,395mg of

perindopril (which corresponds to 5mg of perindopril arginina).

- The other components of the buccal dispersible tablet are: magnesium stearate (E470B), colloidal anhydrous silica (E551), dry powdered mixture of lactose and starch (lactose monohydrate 85%, cornstarch 15%), aspartame (E951) and potassium acesulfame (E950).

Appearance of the productand contents of the package

Coversoral 5mg buccal dispersible tablets are white and round.

The tablets are available in packages of 5, 10, 14, 20, 30, 50, 60, 90, 100, 120 or 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex– France

Manufacturer responsible

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.

UI. Annopol 6B-03-236

Warsaw - Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

Last revision date of thisleaflet: October 2021

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.