Label: information for the user

Renitec 20mg tablets

enalapril maleate

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

1.What is Renitec and for what it is used

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

3.How to take Renitec

4.Possible adverse effects

5.Storage of Renitec

6.Contents of the package and additional information

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

Renitec is used for:

• treatment of high blood pressure (hypertension)
• treatment of heart failure (weakening of the heart function). It may reduce the need for hospital visits and may help some patients live longer
• prevention of signs of heart failure. The signs include: difficulty breathing, fatigue 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 one hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the greatest effect on their blood pressure.

Do not take Renitec

• if you are allergic to enalapril maleate or any of the other ingredients of this medication (listed in section6)
• if you have ever been treated for an allergic reaction to a similar medication to this one, known as an ACE inhibitor
• if you have ever had swelling of the face, lips, mouth, tongue, or throat that caused 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 medication to lower blood pressure that contains aliskirén
• if you are more than 3months pregnant. (It is also best to avoid Renitec at the beginning of pregnancy - see the Pregnancy section)
• if you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type ofchronic 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 medication if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 white blood cell count (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), follow a low-sodium diet, are taking potassium supplements, potassium-sparing medications, salt substitutes containing potassium, or other medications that may increase potassium levels in the blood such as heparin (a medication used to prevent blood clots), trimethoprim, or cotrimoxazol (medications used to treat infections). This may cause high levels of potassium in the blood that can be serious. Your doctor may need to adjust your Renitec dose or monitor your potassium levels in the blood. See also the information under the heading “Other medications and Renitec”
• if you are undergoing dialysis
• if you have had many vomiting episodes (excessive vomiting) or have had intense diarrhea recently
• if you have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your potassium levels 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 patients of black race have a higher risk of suffering this type of reaction to ACE inhibitors
• if you have low blood pressure (you may notice it as dizziness or lightheadedness, especially when standing up)
• if you have a disease that affects the blood vessels, such as lupus erythematosus, rheumatoid arthritis, or scleroderma, are being treated with immunosuppressive medications, are taking alopurinol or procainamide, or any combination of these

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

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

• if you are taking any of the following medications used to treat high blood pressure:
• an angiotensin II receptor antagonist (ARA) (also known as “sartanes” - for example, valsartán, telmisartán, irbesartán, etc.), particularly if you have kidney problems related to diabetes
• aliskirén

Your doctor may need to monitor your kidney function, blood pressure, and electrolyte levels in the blood (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 may be pregnant (or could be). This medication is not recommended at the beginning of pregnancy and should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used in this stage (see the Pregnancy section).

You should be aware that this medicationreduces blood pressure in black patients less effectively than in patients who are not black.

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

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 (even at the dentist's office)
• a treatment to remove cholesterol from your blood called “apheresis of LDL”
• a desensitization treatment to reduce the effect of an allergy to a bee or wasp sting

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Other medications and Renitec

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes herbal remedies. This is because Renitec may affect how other medications work. Other medications may also affect how Renitec works. Your doctor may need to modify your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Renitec” and “Warnings and precautions”)
• other medications to reduce blood pressure, such as beta-blockers or diuretics
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots). See also the information in the section “Warnings and precautions”
• diabetes medications (including oral antidiabetic medications and insulin)
• litium (a medication used to treat certain types of depression)
• tricyclic antidepressants
• antipsychotic medications
• certain medications for cough and cold and weight loss medications that contain a substance called “sympathomimetic”
• certain medications for pain or arthritis, including gold treatment
• an mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus; medications used to treat certain types of cancer or to prevent organ transplant rejection). See also the information in the section “Warnings and precautions”
• a medication that contains a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartán), racecadotril, or vildagliptina. 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”
• nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and may be used to help you relieve pain)
• aspirin (acetylsalicylic acid)
• medications used to dissolve blood clots (thrombolytics)
• alcohol

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

Taking Renitec with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant (or could be, or plan to become pregnant, consult your doctor before using this medication. Your doctor will usually advise you to stop taking Renitec before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Renitec. This medication is not recommended at the beginning of pregnancy and should not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used in this stage.

Breastfeeding

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

Driving and operating machinery

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

Renitec contains lactose

This medication contains lactose, a type of sugar. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Renitec contains sodium

This medication contains less than 23mg of sodium (1mmol) per tablet; that is, it is essentially “sodium-free”.

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

• It is very important thatyou continueto take this medication for the time your doctor prescribes.
• Do not take more tablets than those prescribed to you.
• The groove is only for breaking the tablet if it is difficult for you to swallow it whole.

Hypertension

• The usual initial doseranges from 5 to 20mg, administered once a day.
• Some patients may need a lower initial dose.
• The usual long-term dose is 20mg administered once a day.
• The maximum long-term dose is 40mg administered once a day.

Heart failure

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

Patients with kidney problems

Your medication dose will change depending on how well your kidneys are functioning:

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

Older patients

Your doctor will decide the dose and will base it on how well your kidneys are functioning.

Use in children

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

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

The dose may be adjusted as needed:

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

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you take more Renitecthan you should

If you take more Renitec than you should, consult your doctor or go to the hospital immediately. Bring the medication packaging with you. The following effects may occur: a feeling of dizziness or vertigo. This is due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, phone: 91 562 04 20,indicating the medication 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 the missed doses.

If you interrupt treatment with Renitec

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

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

Like all medicines, this medicinemay cause side effects, although not everyone will experience them.

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

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

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

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

Other side effects include:

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

• feeling dizzy, weakness, or vomiting
• blurred vision
• cough.

Common(may affect up to 1 in 10people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeats, chest pain, or chest discomfort
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (tiredness)
• eruption, 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 (usually both are detected in a blood test).

Rare(may affect up to 1 in 100people)

• rubefaction
• 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 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, nervousness
• sensation of itching or numbness on your skin
• dizziness (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma‑associated with chest tightness
• slow movement of food through your intestine (ileus), inflammation of the pancreas
• vomiting, indigestion, constipation, loss of appetite
• irritated stomach (gastritis), dry mouth, ulcers
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of being unwell, elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in a blood test)
• low levels of sugar or sodium in the blood, high levels of urea in the blood (all determined in a blood test).

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

• swelling in your intestine (intestinal angioedema)

Frequency unknown(the frequency cannot be estimated from the available data)

• overproduction of the antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion
• a complex symptom syndrome that may include any or all of the following symptoms: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the 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 use this medicationafterthe expiration date that appears on the blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofRenitec

• The active ingredient is enalapril maleate. Each tablet contains 20mg of enalapril.
• The other components 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 contents of the package

Renitec is presented in the form of tablets. The tablet is salmon-colored, with a rounded triangular shape, scored on one side and engraved “MSD714” on the other.

Renitec20mg - aluminum-aluminum blister packs containing10, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 60, 84, 90, 98, 100 or 500tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Tel.: 915911279

Responsible manufacturer:

Organon Heist bv

Industriepark30

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) with the following names:

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

RENITEC

Germany:

XANEF

Italy:

ENAPREN

United Kingdom (Northern Ireland), Ireland:

INNOVACE

Last review date of this leaflet:06/2021.

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