ACOVIL 2.5 mg TABLETS

Introduction

Package Leaflet: Information for the User

ACOVIL 2.5 mg Tablets

Ramipril

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Acovil and what is it used for
2. What you need to know before you take Acovil
3. How to take Acovil
4. Possible side effects
5. Storing Acovil

1. Contents of the pack and other information

1. What is Acovil and what is it used for

Acovil contains a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Acovil works by:

• Reducing the production of substances in your body that could increase your blood pressure.
• Relaxing and widening your blood vessels.
• Making it easier for your heart to pump blood around your body.

Acovil can be used:

• To treat high blood pressure (hypertension).
• To reduce the risk of you having a heart attack or stroke.
• To reduce the risk or delay the worsening of kidney problems (whether you have diabetes or not).
• To treat your heart when it cannot pump enough blood to the rest of your body (heart failure).
• As treatment after a heart attack (myocardial infarction) complicated by heart failure.

2. What you need to know before you take Acovil

Do not take Acovil

• If you are allergic to ramipril, any other ACE inhibitor or any of the other ingredients of this medicine (listed in section 6).

The symptoms of an allergic reaction can include rash, difficulty swallowing or breathing, swelling of your face, lips, throat or tongue.

• If you have ever had a severe allergic reaction called “angioedema”. The symptoms include intense itching, hives, red patches on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are having dialysis or any other type of blood filtration. Depending on the machine used, Acovil may not be suitable for you.
• If you have a narrowing of the renal artery (a blood vessel that supplies the kidney) which could worsen with Acovil.
• During the last 6 months of pregnancy (see section “Pregnancy and breast-feeding” below).
• If your blood pressure is abnormally low or unstable. Your doctor will need to evaluate this.
• If you have diabetes or kidney problems and are treated with a blood pressure lowering medicine containing aliskiren.

Do not take Acovil if any of the above applies to you. If you are not sure, talk to your doctor before taking Acovil.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acovil:

• If you have heart, liver or kidney problems.
• If you have lost a lot of body salts or fluids (for example, due to vomiting, diarrhea, excessive sweating, low-salt diet, long-term diuretic therapy or dialysis).
• If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are going to receive an anesthetic. This may be given for an operation or any dental work. You may need to stop taking Acovil one day beforehand; ask your doctor.
• If you have high levels of potassium in your blood (shown in blood tests).
• If you are taking medicines or have conditions that may decrease sodium levels in your blood. Your doctor may check your blood periodically, especially if you are elderly.
• If you are taking medicines that may increase the risk of angioedema, a severe allergic reaction, such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin, NEP inhibitors (e.g. racecadotril) or sacubitril/valsartán. For sacubitril/valsartán, see section 2 “Do not take Acovil”.
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• Tell your doctor if you are pregnant (or think you might be). Acovil is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after the 3rd month of pregnancy (see section “Pregnancy and breast-feeding”).
• If you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARB) (also known as “sartans” - for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• Aliskiren.

Your doctor may check your kidney function, blood pressure and levels of electrolytes (such as potassium) in your blood at regular intervals. See also the information under the heading “Do not take Acovil”.

Children and adolescents

The use of Acovil in children and adolescents under 18 years is not recommended because the safety and efficacy of Acovil in children have not been established.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Acovil.

Using Acovil with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Acovil may affect the way other medicines work. Some medicines may also affect the way Acovil works.

Tell your doctor if you have taken or are taking any of the following medicines, which may make Acovil work less effectively:

• Pain and inflammation relievers (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

Tell your doctor if you are taking any of the following medicines. These may increase the risk of side effects if taken with Acovil:

• Sacubitril/valsartan: used to treat a type of long-term (chronic) heart failure in adults (see section 2 “Do not take Acovil”).
• Pain and inflammation relievers (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin, and aspirin).
• Cancer treatments (chemotherapy).
• Medicines to prevent transplant rejection, such as cyclosporin.
• Diuretics, such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim (alone or in combination with sulfamethoxazole for infections) and heparin (to make your blood more fluid).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to reduce uric acid in your blood).
• Procainamide (for heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhea).
• Your doctor may need to change your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also the information under the headings “Do not take Acovil” and “Warnings and precautions”).

Tell your doctor if you are taking any of the following medicines. These may be affected by Acovil:

• Medicines for diabetes, such as oral glucose-lowering medicines and insulin. Acovil may lower your blood sugar levels. Monitor your blood sugar levels closely while taking Acovil.
• Lithium (for mental health problems). Acovil may increase the levels of lithium in your blood. Your doctor will closely monitor your lithium levels.

If any of the above applies to you (or you are not sure), talk to your doctor before taking Acovil.

Taking Acovil with food and drink

• Drinking alcohol with Acovil may make you feel dizzy or lightheaded. If you are concerned about how much you can drink while taking Acovil, talk to your doctor, as blood pressure medicines and alcohol can have additive effects.
• Acovil can be taken with or without food.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you are pregnant (or think you might be).

Do not take Acovil during the first 12 weeks of pregnancy and do not take it at all after the 13th week, as it may cause serious harm to your baby. If you become pregnant while taking Acovil, tell your doctor immediately. A switch to a suitable alternative treatment should be made before planning a pregnancy.

Breast-feeding

Do not take Acovil if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel dizzy while taking Acovil, which is more likely to happen when you start taking Acovil or start taking a higher dose of Acovil. If this happens, do not drive or operate tools or machines.

Acovil contains sodium

This medicine contains less than 23 mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

3. How to take Acovil

Follow exactly the instructions given to you by your doctor. Ask your doctor or pharmacist if you are unsure.

How much to take

Treating high blood pressure

• The usual starting dose is 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you take to control your blood pressure.
• The maximum daily dose is 10 mg once a day.
• If you are already taking diuretics, your doctor may stop or reduce the diuretic you were taking before starting Acovil.

Reducing the risk of heart attack or stroke

• The usual starting dose is 2.5 mg once a day.
• Your doctor may decide to increase the amount you take.
• The usual dose is 10 mg once a day.

Treating or slowing the worsening of kidney problems

• You may start with a dose of 1.25 mg or 2.5 mg once a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once a day.

Treating heart failure

• The usual starting dose is 1.25 mg once a day.
• Your doctor will adjust the amount you are taking.
• The maximum daily dose is 10 mg once a day. It is preferable to take it twice a day.

Treating after a heart attack

• The usual starting dose is 1.25 mg once a day to 2.5 mg twice a day.
• Your doctor will adjust the amount you are taking.
• The usual dose is 10 mg once a day. It is preferable to take it twice a day.

Elderly patients

Your doctor will lower the initial dose and adjust your treatment more slowly.

Taking this medicine

• Take this medicine by mouth at the same time each day.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets.

If you take more Acovil than you should

See a doctor immediately or go to the casualty department of your nearest hospital. Do not drive to the hospital, ask someone to drive you or call an ambulance. Take the medicine pack with you. This will help your doctor know what you have taken.

You can also contact the National Poison Information Service on 91 562 04 20, quoting the medicine and the amount taken.

If you forget to take Acovil

• If you forget to take a dose, take your normal dose when it is next due.
• Do not take a double dose to make up for a forgotten dose.

If you have any other questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Stop taking Acovil and go to the doctor immediately if you notice any of the following serious adverse effects, you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can make it difficult to swallow or breathe, as well as itching and rash. This can be a symptom of a severe allergic reaction to Acovil.
• Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Tell your doctor immediately if you experience:

• Faster heart rate, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke.
• Difficulty breathing or coughing. These can be symptoms of lung problems.
• Easy bruising, bleeding for longer than normal, any sign of bleeding (e.g., from the gums), purple spots on the skin, or getting infections more easily than normal, sore throat, and fever, feeling tired, dizzy, or pale skin. These can be symptoms of blood or bone marrow problems.
• Severe stomach pain that can reach your back. This can be a symptom of pancreatitis (inflammation of the pancreas).
• Fever, chills, tiredness, loss of appetite, stomach pain, nausea (vomiting), yellow skin or eyes (jaundice). These can be symptoms of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other adverse effects include:

Tell your doctor if any of the following worsen or last more than a few days.

Frequent(may affect up to 1 in 10 patients)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to occur when you start taking Acovil or when you start taking a higher dose.
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up or feeling quickly.
• Dry cough, sinus inflammation, or bronchitis, shortness of breath.
• Stomach pain or abdominal pain, diarrhea, indigestion, feeling sick.
• Rash on the skin, with or without raised areas.
• Chest pain.
• Cramps or muscle pain.
• Blood tests showing higher than normal potassium levels in your blood.

Uncommon(may affect up to 1 in 100 patients)

• Balance problems (vertigo).
• Itching and abnormal sensations on the skin such as numbness, tingling, pinching, burning, or chilliness on your skin (paresthesia).
• Loss or change in taste.
• Sleep problems.
• Feeling sad, anxious, more nervous than usual, or tired.
• Stuffy nose, difficulty breathing, or worsening asthma.

• A swelling in your abdomen called "intestinal angioedema" that presents symptoms such as abdominal pain, vomiting, and diarrhea.

• Heartburn, constipation, or dry mouth.
• Urinating more than usual during the day.
• Sweating more than usual.
• Losing appetite (anorexia).
• Increased or irregular heartbeats.
• Swelling of arms and legs. This can be a sign that your body is retaining more water than normal.
• Redness.
• Blurred vision.
• Pain in your joints.
• Fever.
• Sexual dysfunction in men, decreased sexual desire in men or women.
• Increased number of certain white blood cells in the blood (eosinophilia) found during a blood test.
• Blood tests showing changes in how your liver, pancreas, or kidneys are working.

Rare(may affect up to 1 in 1,000 patients)

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe skin peeling, rash, swelling, itching.
• Nail problems (e.g., loss or separation of a nail from its bed).
• Rash or bruising on the skin.
• Redness on your skin and cold extremities.
• Redness, itching, swelling, and tearing of the eyes.
• Hearing disturbances and noises in your ears.
• Feeling weak.
• Blood tests showing a decrease in the number of red blood cells or platelets or the amount of hemoglobin.

Very Rare(may affect up to 1 in 10,000 patients)

• Being more sensitive to the sun than usual.

Other Adverse Effects Reported:

Tell your doctor if any of the following conditions worsen or last more than a few days.

• Difficulty concentrating.
• Mouth swelling.
• Blood tests showing very few blood cells.
• Blood tests showing lower than normal sodium levels.
• Concentrated urine (dark color), feeling unwell or nauseous, muscle cramps, confusion, and convulsions that may be due to inadequate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers on your hands and feet changing color when cold and feeling tingling or pain when warming up (Raynaud's phenomenon).
• Chest enlargement in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting Adverse Effects

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

5. Storage of Acovil

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Acovil

The active ingredient is ramipril.

2.5 mg: Each tablet contains 2.5 mg of ramipril.

The other ingredients are:

2.5 mg tablets

Hypromellose

Pregelatinized corn starch

Microcrystalline cellulose

Sodium stearyl fumarate

Yellow iron oxide (E 172)

Appearance of the Product and Package Contents

Oblong-shaped tablets 8 x 4 mm, yellowish to yellow, with a score line and marked with 2.5 and the logo on the upper face and HMR and 2.5 on the lower face. The tablet can be divided into equal doses.

Acovil 2.5 mg tablets are presented in packages of 7, 10, 14, 15, 18, 20, 28, 30, 45, 50, 60, 90, 98, 99, 100, 300, 320, 500 tablets in aluminum/PVC blisters.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

The marketing authorization holder is:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

The manufacturer is:

Sanofi S.r.l.

Strada Statale 17 km 22

67019 Scoppito (L’Aquila) Italy

Delpharm Dijon

6, Boulevard de L’Europe Quetigny F-21800 France

S.C. ZENTIVA S.A.,

B-dul Theodor Pallady nr. 50, Sector 3, Bucuresti, 032266 – Romania

Sanofi Aventis Deutschland GmbH,

Industriepark Höechst Brüningstraβe 50, 65926 Frankfurt am Main, Germany

This medicine is authorized in the Member States of the European Economic Area with the following names:

Austria:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Belgium:

Tritace 2.5 mg tablets/comprimés/ tablets, Tritace 5 mg tablets/comprimés/ tablets, Tritace 10 mg tablets/comprimés/ tablets

Bulgaria:

Tritace 5 mg tablets, Tritace 10 mg tablets

Cyprus:

Triatec 2.5 mg tablets, Triatec 5 mg tablets

Czech Republic:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Denmark:

Triatec 5 mg tablets

Estonia:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

Finland:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

France:

Triatec 1.25 mg tablet, Triatec 2.5 mg scored tablet, Triatec 5 mg scored tablet, Triatec 10 mg scored tablet

Germany:

Delix 2.5 mg tablets, Delix 5 mg tablets, Delix Protec 10 mg tablets

Delix Protect Startset

Delix 1.25 mg tablets

Delix 1.25 mg capsules, Delix P 2.5 mg capsules, Delix P 5 mg capsules, Delix P 10 mg capsules

Greece:

Triatec 2.5 mg tablets, Triatec 5 mg tablets

Hungary:

Tritace Mite 1.25 mg tablet

Tritace 2.5 mg tablet, Tritace 5 mg tablet, Tritace 10 mg tablet

Ireland:

Tritace 1.25 mg tabs, Tritace 2.5 mg tabs, Tritace 5 mg tabs, Tritace 10 mg tabs

Italy:

Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

Latvia:

Cardace 2.5 mg tablets, Cardace 5 mg tablets, Cardace 10 mg tablets

Lithuania:

Cardace 5 mg tablets, Cardace 10 mg tablets

Luxembourg:

Tritace 2.5 mg tablets/comprimés/ tablets, Tritace 5 mg tablets/comprimés/ tablets, Tritace 10 mg tablets/comprimés/ tablets

Norway:

Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

Poland:

Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Portugal:

Triatec 1.25 mg capsules, Triatec 2.5 mg capsules, Triatec 5 mg capsules, Triatec 10 mg capsules

Romania:

Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Slovakia:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Slovenia:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Spain:

Acovil 2.5 mg tablets, Acovil 5 mg tablets, Acovil 10 mg tablets

Sweden:

Triatec 2.5 mg tablets, Triatec 5 mg tablets, Triatec 10 mg tablets

United Kingdom:

Tritace 1.25 mg tablets, Tritace 2.5 mg tablets, Tritace 5 mg tablets, Tritace 10 mg tablets

Tritace Titration Pack tablets

Date of the Last Revision of this Leaflet: June 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.