RENITEC 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Renitec 20mg tablets

Enalapril maleate

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

1. What is Renitec and what is it used for

Renitec contains the active substance enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).

Renitec is used to:

• treat high blood pressure (hypertension)
• treat heart failure (weakening of the heart's function). It may reduce the need to go to the hospital and may help some patients live longer
• prevent signs of heart failure. The signs include: difficulty breathing, tiredness after light physical activity such as walking or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This reduces your blood pressure. Normally, the medicine starts to work within an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before the full effect on blood pressure is seen.

2. What you need to know before you take Renitec

Do not take Renitec

• if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• if you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor
• if you have ever had swelling of the face, lips, tongue or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary
• if you have diabetes or kidney problems and are taking a blood pressure medicine that contains aliskiren
• if you are more than 3 months pregnant. (It is also better to avoid Renitec at the start of pregnancy - see section Pregnancy)
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Do not take this medicine if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking Renitec:

• if you have a heart problem
• if you have a disease that affects the blood vessels in the brain
• if you have blood disorders such as low or absent white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia) or low red blood cell count (anemia)
• if you have a liver problem
• if you have a kidney problem (including kidney transplant), are on a low-salt diet, are taking potassium supplements, potassium-sparing diuretics, salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood (such as heparin, a medicine used to prevent blood clots; trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and certain medicines for cancer). This may cause high levels of potassium in your blood, which can be serious. Your doctor may need to adjust your dose of Renitec or monitor your potassium levels in the blood. See also the information under the heading “Other medicines and Renitec”
• if you are on dialysis
• if you have recently had severe vomiting (excessive vomiting) or severe diarrhea
• if you have diabetes. You should monitor your blood for low blood sugar levels, especially during the first month of treatment. Your potassium level in the blood may also be higher
• if you have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing. You should be aware that black patients have a higher risk of these reactions to ACE inhibitors
• if you have low blood pressure (you may notice this as dizziness or fainting, especially when standing up)
• if you have a disease of the collagen vascular system (e.g. lupus erythematosus, rheumatoid arthritis or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide or any combination of these.

• if you are taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea.
• medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus).
• vildagliptin, a medicine used to treat diabetes.

• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Renitec” and “Warnings and precautions”)
• other medicines to lower blood pressure, such as beta blockers or water pills (diuretics)

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

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

You should inform your doctor if you think you are pregnant (or might be). Your doctor will normally advise you to stop taking Renitec before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Renitec. This medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

You should be aware that this medicine lowers blood pressure in black patients less effectively than in non-black patients.

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking Renitec:

• any surgery or if you are going to receive anesthetics (even at the dentist)
• a treatment to remove cholesterol from your blood called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bee or wasp stings

If any of the above applies to you, consult your doctor or dentist before undergoing the procedure.

Other medicines and Renitec

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal treatments. This is because Renitec may affect the way other medicines work. Other medicines may also affect the way Renitec works. Your doctor may need to change your dose and/or take other precautions.

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Renitec” and “Warnings and precautions”)
• other medicines to lower blood pressure, such as beta blockers or water pills (diuretics)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to prevent blood clots). See also the information in the section “Warnings and precautions”
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat a certain type of depression)
• medicines for depression called “tricyclic antidepressants”
• medicines for mental problems called “antipsychotics”
• certain cough and cold medicines and weight loss medicines that contain a substance called “sympathomimetic medicine”
• certain medicines for pain or arthritis, including gold treatment
• an mTOR inhibitor (e.g. temsirolimus, sirolimus, everolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ). See also the information in the section “Warnings and precautions”
• a medicine that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also the information in the sections “Do not take Renitec” and “Warnings and precautions”
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Renitec.

Taking Renitec with food and drink

Renitec can be taken with or without food. Most people take Renitec with a little water.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Renitec before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Renitec. This medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. While taking this medicine, breast-feeding is not recommended in newborns (first few weeks after birth) and especially in premature babies. In the case of an older baby, your doctor will advise you on the benefits and risks of taking this medicine, compared to other treatments, while breast-feeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this happens, do not drive or use tools or machines.

Renitec contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Renitec contains sodium

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

3. How to take Renitec

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.

• It is very important that you continue to take this medicine for as long as your doctor prescribes it.
• Do not take more tablets than your doctor has prescribed.
• The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

High blood pressure

• The usual starting dose is between 5 and 20 mg, taken once a day.
• Some patients may need a lower starting dose.
• The usual long-term dose is 20 mg taken once a day.
• The maximum long-term dose is 40 mg taken once a day.

Heart failure

• The usual starting dose is 2.5 mg, taken once a day.
• Your doctor will gradually increase this amount until the right dose for you is reached.
• The usual long-term dose is 20 mg per day, taken in one or two doses.
• The maximum long-term dose is 40 mg per day, divided into two doses.

Patients with kidney problems

Your dose of medicine will depend on how well your kidneys are working:

• moderate kidney problems - 5 mg to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if you are on dialysis - 2.5 mg per day. On days when you are not on dialysis, your dose may change depending on how low your blood pressure is.

Patients over 65 years old

Your doctor will decide on your dose and will be based on how well your kidneys are working.

Use in children

Experience with Renitec in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual starting doses are:

• between 20 kg and 50 kg - 2.5 mg per day
• over 50 kg - 5 mg per day.

The dose can be changed according to the child's needs:

• up to 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• up to 40 mg per day can be used in children who weigh over 50 kg.

This medicine is not recommended in newborn babies (first few weeks after birth) or in children with kidney problems.

If you take more Renitec than you should

If you take more Renitec than you should, consult your doctor or go to the hospital immediately. Take the medicine pack with you. The following effects may happen: feeling dizzy or faint. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Renitec

• If you forget to take a tablet, do not take the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for forgotten doses.

If you stop taking Renitec

Do not stop taking your medicine unless your doctor tells you to.

If you have any further 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.

If you experience any of the following symptoms, stop taking Renitec and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing
• swelling of your hands, feet, or ankles
• if you develop a red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of suffering from this type of reaction. If you experience any of the above reactions, stop taking Renitec and talk to your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or dizziness. If this happens, lying down can help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please talk to your doctor.

Other adverse effects include:

Very Common(may affect more than 1 in 10 people)

• feeling of dizziness, weakness, or vomiting
• blurred vision
• cough.

Common(may affect up to 1 in 10 people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeats, chest pain, or angina
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing
• high levels of potassium in the blood, high levels of creatinine in the blood (both usually detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeats (palpitations)
• heart attack (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in heart or brain blood flow)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• feeling of itching or numbness in the skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through the intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastric irritation), dry mouth, ulcer
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• malaise (general discomfort), elevated temperature (fever)
• impotence
• high levels of protein in the urine (determined in a test)
• low levels of sugar or sodium in the blood, high levels of urea in the blood (all determined in a blood test).

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

• "Raynaud's phenomenon" in which your hands and feet can become very cold and white due to low blood flow
• changes in blood values such as a lower number of white or red blood cells, lower amount of hemoglobin, lower number of platelets in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or substance accumulation in the lungs (as seen on X-rays)
• inflammation of the nose
• inflammation of the lungs causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small fluid-filled blisters on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in a test)
• breast enlargement in men (gynecomastia).

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

• swelling in your intestine (intestinal angioedema)

Frequency Not Known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a symptomatic complex has been reported that may include all or some of the following symptoms: fever, blood vessel inflammation (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity, or other skin manifestations may occur.

Reporting of Adverse Effects:

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

5. Storage of Renitec

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from moisture.

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

6. Package Contents and Additional Information

Composition ofRenitec

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril.
• The other ingredients are lactose monohydrate, sodium hydrogen carbonate, cornstarch, pregelatinized cornstarch, and magnesium stearate. The tablets also contain red iron oxide (E-172) and yellow iron oxide (E-172).

Appearance of the Product and Package Contents

Renitec is presented in the form of tablets. The tablet is salmon-colored, with a rounded triangular shape, scored on one side, and engraved "MSD 714" on the other.

Renitec 20 mg - Al-Al blister packs containing 10, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 60, 84, 90, 98, 100, or 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Manufacturer:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

or

Merck Sharp & Dohme, B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Belgium, Finland, France, Greece, Luxembourg, Netherlands, Portugal, Spain, Sweden:

RENITEC

Germany:

XANEF

Italy:

ENAPREN

United Kingdom (Northern Ireland), Ireland:

INNOVACE

Date of Last Revision of this Prospectus:06/2021.

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/)