RENITECMAX 20 mg / 6 mg TABLETS

2. What you need to know before taking Renitecmax

Do not take Renitecmax

• if you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if you have been previously treated with a medicine from the same group of medicines as this medicine (ACE inhibitors) and have suffered allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing. You should not take this medicine if you have suffered such reactions without a known cause or if you have been diagnosed with hereditary or idiopathic angioedema
• if you are allergic to any sulphonamide-derived medicine. If you are not sure, ask your doctor which medicines are sulphonamide-derived
• if you do not urinate
• if you have severe kidney problems
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren
• if you are pregnant for more than 3 months. (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 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.

If you are not sure whether you should start taking this medicine, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Renitecmax.

• Tell your doctor about any medical condition you have or have had or about any allergy.
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Renitecmax, seek medical attention immediately.
• Tell your doctor if you have a heart condition, blood disorders, liver problems, if you are undergoing dialysis, or if you are being treated with diuretics (pills that increase urine production) or if you have recently had severe vomiting or diarrhea. Also, tell your doctor if you are on a low-salt diet, if you take potassium supplements, potassium-sparing medicines, 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, or cotrimoxazole (medicines used to treat infections), have diabetes, or any kidney problems (including kidney transplant), as they may cause high levels of potassium in the blood, which can be serious. 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 antidiabetics or insulin, you should be closely monitored for low blood sugar levels, especially during the first month of treatment with Renitecmax. Tell your doctor if you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing. You should be aware that black patients have a higher risk of suffering from these types of reactions to ACE inhibitors.
• Tell your doctor if you are about to undergo a treatment called LDL apheresis or desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• Tell your doctor if you have low blood pressure (you may notice it as fainting or dizziness, especially when standing up).
• Before any surgical procedure or anesthesia (even in a 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.
• Tell your doctor if you have a collagen vascular disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking allopurinol or procainamide, or any combination of these.
• Tell your doctor if you have undergone or are going to undergo a doping test, as this medicine may give a positive result.
• You should inform your doctor if you think you are pregnant (or might be). This medicine is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

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

• vildagliptin, a medicine used to treat diabetes.
• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Renitecmax
• Tell your doctor if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
• aliskiren.
• Tell your doctor if you experience a decrease in vision or eye pain, as these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which can occur within hours to weeks after taking Renitecmax. If left untreated, this can lead to permanent vision loss. You may have a higher risk if you have previously been allergic to penicillin or sulphonamide.

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 Renitecmax".

Children and adolescents

The safety and efficacy have not been established in children.

Other medicines and Renitecmax

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

In general, Renitecmax can be taken with other medicines. It is especially important that your doctor knows 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 Renitecmax" and "Warnings and precautions")
• Other antihypertensives (medicines that lower high blood pressure)
• Diuretics (medicines that increase urine production)
• 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; cyclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also the information in the section "Warnings and precautions"
• Lithium (a medicine used to treat manic depression or bipolar disorders)
• Tricyclic antidepressants (medicines used to treat depression)
• Antipsychotics (medicines used to treat schizophrenia)
• Sympathomimetics (medicines used to treat certain heart and blood vessel problems and in some cold medicines)
• Antidiabetics (medicines used to treat diabetes)
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines used to treat pain and arthritis, including treatment with gold)
• 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 Renitecmax" and "Warnings and precautions"
• Cytostatics (medicines 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 breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Normally, your doctor will 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 medicine instead of Renitecmax. This medicine is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. This medicine is not recommended in breastfeeding mothers.

Driving and using machines

Individual responses to the medicine may vary. Certain side effects that have been reported with this medicine may affect some patients' ability to drive or operate machines (see Possible side effects).

Renitecmax 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 them before taking this medicine.

Renitecmax contains sodium

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

Use inathletes: this medicine contains hydrochlorothiazide, which may produce a positive result in doping tests.

3. How to take Renitecmax

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

The recommended dose is one tablet once a day. Most people take this medicine with a little water.

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

Previous treatment with diuretics should be discontinued 2-3 days before starting treatment with this medicine.

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again. It is very important that you continue taking this medicine for the time your doctor prescribes it. 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 dizziness or lightheadedness due to a sudden or excessive drop in blood pressure, intense thirst, cough, confusion, rapid breathing, anxiety, decreased urine production, or rapid or slow heart rate.

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

If you forget to take Renitecmax

You should take this medicine as prescribed. Do not take a double dose to make up for forgotten doses. Just take the next tablet as usual.

If you stop takingRenitecmax

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.

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

Very common (may affect at least 1 in 10 patients treated)

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

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

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

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

Frequency not known (frequency cannot be estimated from the available data)

Benign, malignant, and unspecified neoplasms (including cysts and polyps)

Frequency not known: 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, lower platelet count, inflamed glands in the neck, armpits, or groin

Endocrine disorders:

Frequency not known: overproduction 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 (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

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

Nervous system disorders:

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

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

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

Eye disorders:

Very common: blurred vision

Frequency not known: decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

Ear disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

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

Uncommon: flushing, rapid or irregular heartbeat (palpitations), myocardial infarction, stroke possibly due to excessively low blood pressure in high-risk patients (patients with coronary or cerebral blood flow disorders)

Rare: poor blood flow to the limbs (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, fluid or substance accumulation in the lungs (as seen on X-rays), difficulty breathing, respiratory distress (including pneumonitis, pulmonary edema, allergic/alveolar eosinophilia)

Very rare: acute respiratory distress (symptoms 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), 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: intestinal swelling (intestinal angioedema)

Liver and biliary disorders:

Rare: hepatitis, potentially fatal liver failure, 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 with difficulty swallowing or breathing

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

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

Frequency not known: 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). Skin rash, photosensitivity, or other skin manifestations may also occur.

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps**

Uncommon: joint pain*

Renal and urinary disorders:

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

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

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men (gynecomastia)

General disorders:

Very common: weakness

Common: chest pain, fatigue

Uncommon: malaise (general discomfort), fever

Investigations:

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 liver enzyme or bilirubin levels.

Other adverse effects may also occur, some of which may be rare or serious. If you need more information about adverse effects, consult your doctor or pharmacist. They have a more complete list of adverse effects.

Report any of these or any other unusual symptoms to your doctor or pharmacist promptly.

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

• if swelling of the face, lips, tongue, and/or throat occurs, which may cause difficulty swallowing or breathing
• if swelling of the hands, feet, or ankles occurs
• if hives appear

The initial dose may cause a drop in blood pressure greater than that which will occur with continued treatment. You may notice this as fainting or dizziness, and lying down may help. If you are concerned, please consult your doctor.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

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

Reporting of adverse reactions:

If you experience any adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Renitecmax

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

Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition ofRenitecmax

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

Renitecmax is available in packs of 28 tablets.

Appearance of the product and package contents

Renitecmax tablets are blue, triangular, and engraved with "MSD 734" on one side and a triangle on the other.

Aluminum press-through blisters with a PVC layer containing 10, 14, 28, 30, 50, 56, 98, 100, or 300 tablets.

Aluminum unit-dose blisters containing 28 tablets.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

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 RENITEC PLUS

Denmark SYNERPRIL

Italy SINERTEC

Netherlands RENITEC PLUS

Spain RENITECMAX

Date of the last revision of this leaflet:06/2022.

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/)