Renitec 20 mg tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Renitec 20mg Tablets

Enalapril maleate

Read all of this leaflet carefully before you start taking this medicine, as 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Renitec is and what it is used for

Renitec contains an active substance called enalapril maleate. It belongs to a group of medicines known as 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 for hospitalization and may help some patients live longer
• prevent signs of heart failure. Symptoms include: shortness of breath, fatigue after mild physical activity such as walking, or swelling of the ankles and feet.

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

2. What you need to know before taking 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 similar medicine called an ACE inhibitor
• if you have ever had swelling of the face, lips, mouth, tongue, or throat causing difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than 3 months pregnant. (Renitec should also be avoided at the beginning of pregnancy – see Pregnancy section)
• 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, as the risk of angioedema (rapid swelling under the skin, e.g., in the throat) is high.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Renitec:

• if you have a heart condition

• if you have a disease affecting 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 liver problems

• if you have kidney problems (including after kidney transplant), are on a salt-free diet, are taking potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat infections). This may lead to high potassium levels in your blood, which can be serious. Your doctor may need to adjust your dose of Renitec or monitor your blood potassium levels. See also information under the heading “Other medicines and Renitec”

• if you are undergoing dialysis

• if you have recently experienced severe vomiting or intense diarrhea

• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your blood potassium level may also be higher

• if you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat and difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors

• if you have low blood pressure (you may feel faint or dizzy, especially when standing)

• if you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking allopurinol, procainamide, or any combination of these.

• if you are taking any of the following medicines, your risk of developing 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 for high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan, etc.), 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 information under the heading “Do not take Renitec”.

Tell your doctor if you think you are pregnant (or could be). This medicine is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

Please note that this medicine is less effective in lowering blood pressure in black patients compared to non-black patients.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting to take 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 to receive anesthetics (including 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 apply to you, consult your doctor or dentist before starting the procedure.

Other medicines and Renitec

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies. This is because Renitec may affect how other medicines work. Other medicines may also affect how Renitec works. Your doctor may need to adjust 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 information under the headings “Do not take Renitec” and “Warnings and precautions”)
• other medicines to lower blood pressure, such as beta-blockers or diuretics (“water pills”)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also 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)
• antidepressants known as “tricyclic antidepressants”
• medicines for mental health conditions known as “antipsychotics”
• certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic medicine”
• certain medicines for pain or arthritis, including gold therapy
• 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 information in the section “Warnings and precautions”
• a medicine containing 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 information in sections “Do not take Renitec” and “Warnings and precautions”
• non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain)
• aspirin (acetylsalicylic acid)
• medicines used to dissolve blood clots (thrombolytics)
• alcohol

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting to take Renitec.

Taking Renitec with food and drink

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. Your doctor will usually advise you to stop taking Renitec before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Breastfeeding is not recommended while taking this medicine, especially in newborns (first weeks after birth) and particularly in premature infants. For older infants, your doctor will advise you on the benefits and risks of taking this medicine compared to other treatments during breastfeeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Renitec contains lactose

This medicine contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

High blood pressure

• The usual initial dose ranges between 5 and 20 mg, taken once daily.
• Some patients may require a lower initial dose.
• The usual long-term dose is 20 mg once daily.
• The maximum long-term dose is 40 mg once daily.

Heart failure

• The usual initial dose is 2.5 mg, taken once daily.
• Your doctor will gradually increase this dose until the appropriate dose for you is reached.
• The usual long-term dose is 20 mg daily, given in one or two doses.
• The maximum long-term dose is 40 mg daily, divided into two doses.

Patients with kidney problems

Your dose will depend on how well your kidneys are functioning:

• moderate kidney problems – 5 mg to 10 mg daily
• severe kidney problems – 2.5 mg daily
• if undergoing dialysis – 2.5 mg daily. On non-dialysis days, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will determine the dose based on how well your kidneys are functioning.

Use in children

Experience with the use of Renitec in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated according to the child's weight and blood pressure. The usual initial doses are:

• between 20 kg and 50 kg – 2.5 mg daily
• over 50 kg – 5 mg daily.

The dose may be adjusted according to the child's needs:

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

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

If you take more Renitec than you should

If you take more Renitec than prescribed, contact your doctor or go to the hospital immediately. Take the medicine container with you. The following effects may occur: dizziness or vertigo. These are due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number: 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 at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Renitec

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

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.

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

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

Please note that patients of Black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking Renitec and speak with your doctor immediately.

When you start taking this medicine, you may feel faint or dizzy. If this happens, lying down may help. This is due to a drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak with your doctor.

Other adverse effects include:

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

• 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 rate, rapid heartbeat, angina, or chest pain
• headache, depression, fainting (syncope), taste disturbances
• difficulty breathing
• diarrhea, abdominal pain
• tiredness (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing
• elevated levels of potassium in the blood, elevated creatinine levels in the blood (both are usually detected in a blood test).

Uncommon (may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid and irregular heartbeat (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, including those with impaired blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, restlessness
• sensation of itching or numbness in the skin
• vertigo (sensation of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-related chest tightness
• slow movement of food through the intestine (ileus), inflammation of the pancreas
• 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 body temperature (fever)
• impotence
• elevated levels of protein in urine (detected in a test)
• low blood sugar or sodium levels, elevated blood urea levels (all detected in a blood test).

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

• “Raynaud’s phenomenon” in which your hands and feet may become very cold and white due to poor blood flow
• changes in blood values such as reduced numbers of white or red blood cells, reduced hemoglobin, reduced platelet count
• bone marrow depression
• swollen glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• accumulation of fluid or other substances 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, or throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (serious skin disorders in which you have red, peeling skin, blistering ulcers, or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood 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)

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

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Renitec

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

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

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

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

6. Contents of the pack and other information

Composition of Renitec

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

Nature and contents of the container

Renitec is presented as tablets. The tablet is salmon-coloured, rounded triangular in shape, scored on one side and marked “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 responsible:

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

or

Merck Sharp & Dohme, B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

or

N.V. Organon

Kloosterstraat 6

5349 AB Oss

Netherlands

This medicinal product is authorised 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 the most recent review of this leaflet: 06/2021.

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