Label:information for the user

Renitecmax 20mg/6mg tablets

enalapril maleate/hydrochlorothiazide

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 questions, consult your doctor or pharmacist.
• This medication has been prescribed only for 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.

Label contents

1.What Renitecmax is and for what it is used

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

3.How to take Renitecmax

4.Possible adverse effects

5.Storage of Renitecmax

6.Contents of the package and additional information

Your doctor has prescribed Renitecmax to treat your high blood pressure (elevated blood pressure).

The active ingredient enalapril in Renitecmax is a medication that belongs to the group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors) and works by dilating your blood vessels to facilitate the pumping of blood from the heart to all parts of your body. The active ingredient hydrochlorothiazide in Renitecmaxis a medication that belongs to the group of medicationscalled diuretics (medications that increase the elimination of urine) and causes your kidneys to eliminate a greater amount of water and salts. Together, enalapril and hydrochlorothiazide help to reduce elevated blood pressure.

Do not take Renitecmax

• if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other components of this medication (listed in section 6)
• if you have previously been treated with a medication from the same group as this medication (ACE inhibitors) and have experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Do not take this medication if you have experienced reactions of this type without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema
• if you are allergic to any sulfonamide-derived medication. If you are unsure, ask your doctor which medications are derived from sulfonamides
• if you are not urinating
• if you have severe kidney problems
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren
• if you are more than 3 months pregnant. (It is also recommended to avoid Renitecmax at the beginning of pregnancy (see section Pregnancy)
• if you have severe liver problems
• if you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high

If you are unsure whether you should start taking this medication, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Renitecmax.

• Inform your doctor about any medical condition you have or have had, or about any allergy
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Renitecmax, seek medical attention immediately
• Inform your doctor if you have heart disease, blood disorders, liver problems, are undergoing dialysis, or are being treated with diuretics (medications that increase urine production) or if you have recently experienced intense vomiting or diarrhea. Also inform your doctor if you are following a low-sodium diet, taking potassium supplements, medications that conserve potassium, potassium-containing salt substitutes, or other medications that may increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), trimethoprim and cotrimoxazole for bacterial infections, or have diabetes or any kidney problem (including kidney transplant), as they may cause high potassium levels in the blood that can be severe. In these cases, your doctor may need to adjust the dose of Renitecmax or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetic medications or insulin, you should be closely monitored for low blood glucose levels, especially during the first month of treatment with Renitecmax. Inform your doctor if you have ever experienced an allergic reaction with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Patients of black race have a higher risk of experiencing this type of reaction to ACE inhibitors
• Inform your doctor if you are about to undergo a treatment called LDL apheresis or a desensitization treatment to reduce the effect of an allergy to bee or wasp stings
• Inform your doctor if you have low blood pressure (you may notice it as dizziness or lightheadedness, especially when standing up)
• Before any surgical procedure or anesthesia (including dental consultation), inform your doctor or dentist that you are taking Renitecmax, as it may cause a sudden drop in blood pressure associated with anesthesia
• Inform your doctor if you have a vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking alopurinol or procainamide, or any combination of these
• Inform your doctor if you are undergoing a doping test, as this medication may cause a positive result
• 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 used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used during this period (see section Pregnancy)

• 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 cancer (e.g. temsirolimus, sirolimus, everolimus)

• vildagliptin, a medication used to treat diabetes
• If you have had skin cancer or if a skin lesion appears unexpectedly during treatment. The use of hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Renitecmax
• Inform your doctor 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" - e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes
• aliskiren
• Inform your doctor if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to several weeks after taking Renitecmax. If left untreated, this may lead to permanent vision loss. You may be at a higher risk of developing this if you have previously had an allergy to penicillin or sulfonamide

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g. potassium) at regular intervals.

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

Children and adolescents

The safety and efficacy have not been established in children.

Other medications and Renitecmax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Your doctor may need to adjust your dose and/or take other precautions.

Renitecmax can usually be taken with other medications. To prescribe the correct dose of Renitecmax, it is especially important that your doctor knows if you are taking any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Renitecmax” and “Warnings and precautions”)
• Other antihypertensive medications (medications that reduce high blood pressure)
• Diuretics (medications that increase urine production)
• Potassium supplements (including salt substitutes), diuretics that conserve potassium, and other medications that may increase potassium levels in the blood (e.g. trimethoprim and cotrimoxazole for bacterial infections; ciclosporin, 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”
• Lithium (a medication used to treat manic depression or bipolar disorders)
• Tricyclic antidepressants (medications used to treat depression)
• Antipsychotics (medications used to treat schizophrenia)
• Sympathomimetics (medications used in the treatment of certain heart and blood vessel problems and in some cold medications)
• Antidiabetic medications
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications used to treat pain and arthritis, including gold treatment)
• mTOR inhibitors (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 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 the information in the sections “Do not take Renitecmax” and “Warnings and precautions”
• Cytostatics (medications used to treat cancer)

Taking Renitecmax with food and drinks

Most people take Renitecmax with a little water.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or think you may be pregnant (or could be), consult your doctor before using this medication. Your doctor will usually advise you to stop taking Renitecmax before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Renitecmax. This medication is not recommended during pregnancy and should not be used if you are more than 3 months pregnant, as it may cause severe damage to your baby if used during this period (see section Pregnancy)

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. This medication is not recommended for breastfeeding mothers.

Driving and operating machinery

Individual responses to medication may vary. Certain adverse effects that have been reported with this medication may affect the ability of some patients to drive or operate machinery (see Possible adverse effects).

Renitecmax contains lactose

This medication 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 medication.

Renitecmax contains sodium

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

Use in athletes: this medication contains hydrochlorothiazide, which may cause a positive result in doping tests.

Your doctor will decide on the appropriate dose based on your condition and any other medications you are taking.

The recommended dose is one tablet once a day. Most people take this medication with a small amount of water.

Patients with a history of kidney problems may require a lower dose of this medication.

Treatment with diuretics should be discontinued 2-3 days before starting treatment with this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. It is very important that you continue taking this medication for the time prescribed by your doctor. Do not take more tablets than the prescribed dose.

If you take more Renitecmax than you should

In case of overdose, consult your doctor immediately so that you can receive medical attention as soon as possible. The most likely symptoms would be a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure, intense thirst, cough, confusion, rapid breathing, anxiety, a decrease in the amount of urine eliminated or rapid or slow heart rate.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Renitecmax

You should take this medication as prescribed. Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next tablet as usual.

If you interrupt treatment with Renitecmax

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 medicine can cause side effects, although not everyone will experience them.

The following terms are used to describe how often side effects have been reported.

Frequent (may affect at least 1 in 10 patients treated)

Common (may affect at least 1 in 100 patients but fewer than 1 in 10 patients treated)

Uncommon (may affect at least 1 in 1,000 patients but fewer than 1 in 100 patients treated)

Rare (may affect at least 1 in 10,000 patients but fewer than 1 in 1,000 patients treated)

Very rare (may affect fewer than 1 in 10,000 patients treated)

Unknown frequency (the frequency cannot be estimated from available data)

Malignant, benign, and unspecified neoplasms (including cysts and polyps)

Unknown frequency: skin and lip cancer (non-melanoma skin cancer).

Blood disorders:

Uncommon: anemia (including aplastic and hemolytic anemia)

Rare: changes in blood values such as a lower number of white or red blood cells, lower hemoglobin levels, lower platelet counts in blood, inflamed lymph nodes in the neck, armpits, or groin

Endocrine disorders:

Unknown frequency: excessive production of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion

Metabolic and nutritional disorders:

Common: low potassium levels in the blood, increased cholesterol or fat levels in the blood, high uric acid levels in the blood

Uncommon: low blood glucose levels (hypoglycemia), low magnesium levels in the blood (hypomagnesemia), disease with pain, swelling of the joints caused by uric acid crystals (gout)*

Rare: high blood glucose levels

Very rare: high calcium levels in the blood (hypercalcemia)

Nervous system disorders:

Common: headache, depression, dizziness (syncope), altered taste

Uncommon: confusion, drowsiness, insomnia, nervousness, numbness without cause (paresthesia), dizziness (vertigo), decreased libido*

Rare: strange dreams, sleep problems, muscle weakness sometimes due to low potassium (paresis)

Eye disorders:

Very common: blurred vision

Unknown frequency: decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage)).

Ear disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

Common: fainting due to low blood pressure (even low blood pressure when standing up quickly), angina or chest pain, changes in heart rhythm, rapid heart rate

Uncommon: redness, rapid or irregular heartbeat (palpitations), heart attack, possible stroke due to excessively low blood pressure in high-risk patients (patients with heart or brain blood flow abnormalities)

Rare: poor blood flow to the extremities (Raynaud's phenomenon)

Respiratory disorders:

Very common: cough

Common: shortness of breath

Uncommon: runny nose, sore throat, and hoarseness, chest tightness associated with asthma

Rare: nasal inflammation, accumulation of fluid or other substances in the lungs (as seen on X-rays), difficulty breathing,difficulty breathing (including pneumonitis, pulmonary edema, allergic alveolitis/eosinophilic pneumonia)

Very rare: acute difficulty breathing (signs include severe difficulty breathing, fever, weakness, and confusion)

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon:slow movement of food through the intestine (ileus),inflammation of the pancreas (pancreatitis), vomiting, indigestion (dyspepsia), constipation, loss of appetite, stomach pain or gastric irritation, dry mouth, peptic ulcer, excessive gas in the stomach or intestine*

Rare: mouth pain (stomatitis/aphthous ulcer), swollen tongue (glossitis)

Very rare:swelling in the intestine (intestinal angioedema)

Liver and bile duct disorders:

Rare: inflammation of the liver (hepatitis), liver insufficiency that can be fatal, yellowing of the eyes or skin (jaundice), gallbladder problems

Skin disorders:

Common: rash, allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing

Uncommon: increased sweating (diaphoresis), itching (pruritus), hives (urticaria), hair loss (alopecia)

Rare: severe hypersensitivity reaction with high fever,skin rash with a target-like shape(erythema multiforme), Stevens-Johnson syndrome, and toxic epidermal necrolysis (a severe skin disorder in which you have red, peeling, and blistered skin), severe skin rash with skin and hair loss (dermatitis exfoliativa), cutaneous lupus erythematosus (an autoimmune disease), red skin rash with peeling (erythroderma), small fluid-filled blisters on the skin (pemphigus), purple or red skin spots (purpura).

Unknown frequency: A complex of symptoms that may include any or all of the following: fever, inflammation of blood vessels (serositis/vasculitis), muscle pain (myalgia/miositis), joint pain (arthralgia/arthritis). It may also cause a rash, photosensitivity, or other skin manifestations.

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps**

Uncommon: joint pain*

Renal and urinary disorders:

Uncommon: kidney problems (renal dysfunction), kidney insufficiency, protein in the urine (proteinuria)

Rare: decreased urine output (oliguria), kidney disease (interstitial nephritis)

Reproductive and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men (gynecomastia)

General disorders:

Very common: weakness

Common: chest pain, fatigue

Uncommon: general malaise, fever

Complementary examinations:

Common: high potassium levels in the blood, high creatinine levels in the blood

Uncommon: high urea levels in the blood, low sodium levels in the blood

Rare:high levels of liver enzymes or bilirubin.

Other side effects may occur less frequently or rarely, and some may be severe. If you need more information about side effects, consult your doctor or pharmacist. Both have a more complete list of side effects.

Inform your doctor or pharmacist immediately if you experience any of these or any other unusual symptoms.

Stop taking Renitecmax and consult your doctor immediately in the following cases:

• if you experience swelling of the face, lips, tongue, and/or throat that may cause difficulty swallowing or breathing
• if you experience swelling of the hands, feet, or ankles
• if you experience urticaria

The initial dose may cause a drop in blood pressure higher than what will occur with continuous treatment. You may notice it as dizziness or fainting, and lying down may help. If you are concerned, please consult your doctor.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

* Only observed with hydrochlorothiazide doses of 12.5mg and 25mg.

** The frequency of muscle cramps as "common" applies to hydrochlorothiazide doses of 12.5mg and 25mg, while the frequency of the event "uncommon" applies to a hydrochlorothiazide dose of 6mg.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do 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 about the safety of this medicine.

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

Store in the original packaging.

Do not usethis medicationafter the expiration date that appears on the box. The expiration date is the last day of the month indicated.

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

Composition ofRenitecmax

• The active ingredients are enalapril maleate (20 mg) and hydrochlorothiazide (6 mg).
• The other components are sodium hydrogen carbonate, lactose monohydrate, cornstarch, pregelatinized starch, indigo carmine (E-132) and magnesium stearate.

Renitecmax is available in packs of 28 tablets.

Appearance of the product and contents of the pack

Renitecmax tablets are blue, triangular, engraved with “MSD 734” on one face and a triangle on the other.

Aluminum blister pack with a PVC sheet containing 10, 14, 28, 30, 50, 56, 98, 100, or 300 tablets.

Single-dose aluminum blister pack containing 28 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

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

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 RENITEC PLUS

Denmark SYNERPRIL

Italy SINERTEC

Netherlands RENITEC PLUS

Spain RENITECMAX

Last review date of this leaflet:06/2022.

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/)