Acofil 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ACOVIL 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Acovil is and what it is used for

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

Acovil works in the following ways:

• By reducing the body's production of substances that could increase blood pressure.
• By relaxing and widening blood vessels.
• By making it easier for the heart to pump blood around the body.

Acovil may be used:

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

2. What you need to know before starting to take Acovil

Do not take Acovil

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

Symptoms of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of your lips, face, throat, or tongue.

• If you have ever had a serious allergic reaction called "angioedema". Symptoms include 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 currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the type of machine used, Acovil may not be suitable for you.
• If you have renal artery stenosis (narrowing of the renal artery that reduces blood flow to your kidneys).
• During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding" below).
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Acovil:

• If you have heart, liver, or kidney problems.

• If you have lost significant amounts of minerals or body fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term diuretic use, or dialysis).

• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).

• If you are to receive an anesthetic. This may be given for surgery or dental procedures. You may need to stop taking Acovil one day before the procedure; consult your doctor.

• If you have high levels of potassium in your blood (as shown by blood test results).

• If you are taking medications or have a medical condition that may reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.

• If you are taking medications that may increase the risk of angioedema, a serious allergic reaction, such as mTOR inhibitors (e.g., temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril), or sacubitril/valsartan. For sacubitril/valsartan, see section 2 “Do not take Acovil”.

• If you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus.

• Inform your doctor if you are pregnant (or suspect you might be). Acovil is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnancy and breastfeeding”).

• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" – for example, 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 the information under the heading “Do not take Acovil”.

Children and adolescents

The use of Acovil in children and adolescents under 18 years of age is not recommended, as the safety and efficacy of Acovil in this population have not yet been established.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking Acovil.

Use of Acovil with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine. This is because Acovil may affect how other medicines work. Likewise, some medicines may affect how Acovil works.

Inform your doctor if you have taken or are currently taking any of the following medicines, as they may make Acovil less effective:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, 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 monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. These may increase the likelihood of adverse effects when taken together with Acovil:

• Sacubitril/valsartan: used to treat a type of chronic heart failure in adults (see section 2 “Do not take Acovil”).
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indometacina, and aspirin).
• Medicines used for cancer treatment (chemotherapy).
• Medicines used to prevent organ rejection after transplantation, such as cyclosporine.
• Diuretics such as furosemide.
• Medicines that may increase blood potassium levels, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin (to thin the blood).
• Steroid medicines for inflammation, such as prednisolone.
• Allopurinol (used to lower uric acid levels in your blood).
• Procainamide (used to treat heart rhythm problems).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent graft rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhoea).
• Your doctor may need to adjust your dose and/or take other precautions if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Acovil” and “Warnings and precautions”).

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

• Medicines for the treatment of diabetes, such as oral glucose-lowering agents and insulin. Acovil may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking Acovil.
• Lithium (used to treat mental health conditions). Acovil may increase lithium levels in your blood. Your doctor will closely monitor your blood lithium levels.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking Acovil.

Taking Acovil with food and alcohol

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

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant (or suspect you might be pregnant).

You must not take Acovil during the first 12 weeks of pregnancy and must not take it at all from week 13 onwards, as its use during pregnancy may cause harm to your baby. If you become pregnant while being treated with Acovil, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before planning a pregnancy.

Breastfeeding

You must not take Acovil if you are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

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

Acovil contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially, it is "sodium-free".

3. How to take Acovil

Follow exactly the instructions for administering this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

How much medicine to take

Treatment of high blood pressure

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

To reduce the risk of heart attack or stroke

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

Treatment to reduce or delay worsening of kidney problems

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

Treatment for heart failure

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

Treatment after having had a heart attack

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

Elderly patients

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

Taking this medicine

• Take this medicine orally 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

Contact your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital; ask someone to take you or call an ambulance. Bring the medicine packaging with you. This way, your doctor will know what you have taken.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Acovil:

• If you forget to take a dose, take your usual dose at the next scheduled time.
• Do not take a double dose to make up for forgotten doses.

If you have any further questions about 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 everyone will experience them.

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

• Swelling of the face, lips, or throat, which may make swallowing or breathing difficult, along with itching and rash. This could be a sign of a severe allergic reaction to Acovil.
• Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blisters, or skin peeling (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

• Faster heartbeat, irregular or forceful heartbeats (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
• Difficulty breathing or cough. These may be symptoms of lung problems.
• Easy bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, or increased susceptibility to infections, sore throat, and fever, feeling tired, dizzy, or pale skin. These may be symptoms of blood or bone marrow problems.
• Severe stomach pain that may radiate to your back. This could be a sign of pancreatitis (inflammation of the pancreas).
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice). These may be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage.

Other adverse effects include:

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

Common (may affect up to 1 in 10 patients)

• Headache or feeling tired.
• Dizziness. This is more likely when you first start taking Acovil or when you start taking a higher dose.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Dry, irritating cough, sinus swelling (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhea, indigestion, feeling unwell.
• Skin rash, with or without raised areas.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher than normal potassium levels in your blood.

Uncommon (may affect up to 1 in 100 patients)

• Balance problems (dizziness).

• Itching and abnormal skin sensations such as numbness, tingling, prickling, burning, or chills on the skin (paresthesia).

• Loss or changes in taste.

• Trouble sleeping.

• Feeling sad, anxious, more nervous than usual, or tired.

• Stuffy nose, difficulty breathing, or worsening of asthma.

• Abdominal swelling known as “intestinal angioedema,” with symptoms such as abdominal pain, vomiting, and diarrhea.

• Heartburn, constipation, or dry mouth.

• Urinating more than normal during the day.

• Sweating more than normal.

• Loss or decrease in appetite (anorexia).

• Increased or irregular heartbeat.

• Swelling in arms and legs. This may be a sign that your body is retaining more fluid than normal.

• Redness.

• Blurred vision.

• Joint pain.

• Fever.

• Sexual dysfunction in men, decreased sexual desire in men or women.

• Increase in certain white blood cells (eosinophilia) found during a blood test.

• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.

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

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

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

• Increased sensitivity to sunlight.

Other reported adverse effects:

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

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show very low blood cell counts.
• Blood tests show lower than normal sodium levels.
• Concentrated urine (dark-colored), feeling unwell or nauseous, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers and toes change color in cold conditions and feel tingling or pain when warmed (Raynaud's phenomenon).
• Enlargement of the breasts in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and additional information

Composition of Acovil

The active substance is ramipril.

5 mg: Each tablet contains 5 mg of ramipril.

The other components are:

Hypromellose

Pregelatinized corn starch

Microcrystalline cellulose

Sodium stearyl fumarate

Red iron oxide (E 172)

Appearance of the medicine and contents of the pack

Oblong-shaped tablets of 8 x 4 mm, pale red in colour, with a score line and marked with "5" and the logo on the upper side, and "HMP" and "5" on the lower side. The tablet can be divided into equal doses.

Acovil 5 mg tablets are available in packs of 10, 14, 15, 18, 20, 21, 28, 30, 45, 50, 56, 90, 98, 99, 100, 300, 320, 500 tablets in aluminum/PVC blisters.

Not all pack 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 manufacturers are:

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 under the following names:

Austria:

Tritace 1.25 mg Tabletten, Tritace 2.5 mg Tabletten, Tritace 5 mg Tabletten, Tritace 10 mg Tabletten

Belgium:

Tritace 2.5 mg tabletten/comprimés/Tabletten, Tritace 5 mg tabletten/comprimés/Tabletten, Tritace 10 mg tabletten/comprimés/Tabletten

Bulgaria:

Tritace 5 mg табл., Tritace 10 mg табл.

Cyprus:

Triatec 2.5 mg δισκ., Triatec 5 mg δισκ.

Czech Republic:

Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety

Denmark:

Triatec 5 mg tabletter

Estonia:

Cardace 2.5 mg tabletid, Cardace 5 mg tabletid, Cardace 10 mg tabletid

Finland:

Cardace 2.5 mg tabletit, Cardace 5 mg tabletit, Cardace 10 mg tabletit

France:

Triatec 1.25 mg comprimé, Triatec 2.5 mg comprimé sécable, Triatec 5 mg comprimé sécable, Triatec 10 mg comprimé sécable

Germany:

Delix 2.5 mg Tabletten, Delix 5 mg Tabletten, Delix 10 mg Tabletten

Delix Protect Startset

Delix 1.25 mg Tabletten,

Delix 1.25 mg Kapseln, Delix 2.5 mg Kapseln, Delix 5 mg Kapseln, Delix 10 mg Kapseln

Greece:

Triatec 2.5 mg δισκ., Triatec 5 mg δισκ.

Hungary:

Tritace Mite 1.25 mg tabletta

Tritace 2.5 mg tabletta, Tritace 5 mg tabletta, Tritace 10 mg tabletta

Ireland:

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

Italy:

Triatec 2.5 mg compresse, Triatec 5 mg compresse, Triatec 10 mg compresse

Latvia:

Cardace 2.5 mg tabletes, Cardace 5 mg tabletes, Cardace 10 mg tabletes

Lithuania:

Cardace 5 mg tabletes, Cardace 10 mg tabletes

Luxembourg:

Tritace 2.5 mg tabletten/comprimés/Tabletten, Tritace 5 mg tabletten/comprimés/Tabletten, Tritace 10 mg tabletten/comprimés/Tabletten

Norway:

Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter

Poland:

Tritace 2.5 mg tabletki, Tritace 5 mg tabletki, Tritace 10 mg tabletki

Portugal:

Triatec 1.25 mg cápsulas, Triatec 2.5 mg cápsulas, Triatec 5 mg cápsulas, Triatec 10 mg cápsulas

Romania:

Tritace 2.5 mg comprimate, Tritace 5 mg comprimate, Tritace 10 mg comprimate

Slovakia:

Tritace 1.25 mg tablety, Tritace 2.5 mg tablety, Tritace 5 mg tablety, Tritace 10 mg tablety

Slovenia:

Tritace 1.25 mg tablete, Tritace 2.5 mg tablete, Tritace 5 mg tablete, Tritace 10 mg tablete

Spain:

Acovil 2.5 mg comprimidos, Acovil 5 mg comprimidos, Acovil 10 mg comprimidos

Sweden:

Triatec 2.5 mg tabletter, Triatec 5 mg tabletter, Triatec 10 mg tabletter

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 most recent revision of this leaflet: June 2021

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