Leaflet: information for the user

CO‑RENITEC 20mg/12,5mg tablets

enalapril maleate/hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Co‑Renitec and what it is used for

2.What you need to know before taking Co‑Renitec

3.How to take Co‑Renitec

4.Possible side effects

5.Storage of Co‑Renitec

6.Contents of the pack and additional information

This medication contains two active principles, enalapril and hydrochlorothiazide, which belong to the group of antihypertensives and, through different mechanisms, reduce elevated blood pressure.

The enalapril component of Co-Renitec is a medication that belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which acts by dilating blood vessels to make it easier for the heart to pump blood to all parts of the body. The hydrochlorothiazide component of Co-Renitec belongs to the group of medications known as thiazide diuretics (medications that increase the elimination of urine). Together, enalapril and hydrochlorothiazide help to decrease elevated blood pressure.

Your doctor has prescribed Co-Renitec to treat hypertension (high blood pressure) because it is not adequately controlled with enalapril or an ACE inhibitor alone.

Do not take Co‑Renitec

• If you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients in this medication (listed in section6).
• If you are allergic to sulfonamide derivatives. Ask your doctor if you are unsure what sulfonamide derivatives are.
• If you have previously been treated with a medication from the same group as Co‑Renitec (ACE inhibitors), and have had allergic reactions with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing.
• If you have had such allergic reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema (a condition of the immune system that causes inflammation in the face and respiratory tract, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you are anuric (do not urinate).
• 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 3months pregnant. (It is also best to avoid Co‑Renitec at the beginning of pregnancy‑see the pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medication 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 unsure whether you should start taking Co‑Renitec, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Co‑Renitec.

Your doctor may need to adjust your Co‑Renitec dose or monitor your potassium levels in the blood in the following situations:

• 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 Co‑Renitec, seek medical attention immediately.
• If you have a heart condition that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow from the left chamber of the heart (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., intense vomiting, diarrhea, or treatment with high doses of medications that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust your diabetes medication dose. Diabetes can cause high potassium levels in the blood, which can be severe.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high potassium levels in the blood, which can be severe.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, medications that conserve potassium (medications that increase potassium levels), potassium-containing salt substitutes, or other medications that may increase potassium levels, such as heparin (a medication used to prevent blood clots), trimethoprim, or co-trimoxazole (medications used to treat bacterial infections).
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Note that patients of black race are more sensitive to this type of medication.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove LDL or bad cholesterol particles from the blood in cases where it is excessively elevated).
• If you are about to undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as the use of Co‑Renitec, especially in the first doses, may cause a sudden drop in blood pressure (you may feel dizzy or lightheaded, especially when standing up).
• Consult your doctor before starting to take Co‑Renitec if you have had skin cancer or if you develop an unexpected skin lesion 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 Co‑Renitec.

• 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).
• vildagliptin, a medication used to treat diabetes.

• Inform your doctorif you are taking any of the following medications used to treat high blood pressure:
• • an angiotensin 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, which can occur within a few hours to several weeks after taking Co‑Renitec. If left untreated, this can lead to permanent vision loss. You may be at higher risk if you have previously had an allergy to penicillin or sulfonamide.

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

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

Before undergoing surgery or anesthesia (including dental consultation), inform your doctor or dentist that you are taking Co‑Renitec, as you may experience a sudden drop in blood pressure due to the anesthesia.

You should inform your doctor if you think you may be pregnant (or could be). Co‑Renitec is not recommended at the beginning of pregnancy and should not be used if you are more than 3months pregnant, as it can cause severe harm to your baby if used after the third month (see the pregnancy section).

Children and adolescents

The safety and efficacy of Co‑Renitec have not been established in this age group, so it is not recommended for use in children.

Use in the elderly

In studies where enalapril and hydrochlorothiazide were taken together, the effect of the medications and tolerability were similar in young adult and elderly patients with high blood pressure.

Other medications and Co‑Renitec

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 modify your dose and/or take other precautions.

It is especially important to inform your doctor if you are using or have used recently any of the following medications:

• An angiotensin receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Co‑Renitec” and “Warnings and precautions”)
• Anti-hypertensive medications (reduce elevated blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), diuretics that conserve potassium, and other medications that may increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole for bacterial infections; ciclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots). See also the information in the “Warnings and precautions” section.
• Medications used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g., metformin).
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, and selective COX‑2 inhibitors.
• Sympathomimetic medications (medications used to treat certain heart and blood vessel disorders and some medications for colds).
• Adrenergic agonists, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts and vitamin D.
• Ion exchange resins (medications used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, and amiodarone.
• Anticholinergic medications (medications that decrease gastric emptying rate), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medications (used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent organ transplant rejection), such as ciclosporin.
• Antibiotics (medications used to treat bacterial infections), such as tetracyclines and amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• The simultaneous administration of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• A medication containing an ACE 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 “Do not take Co‑Renitec” and “Warnings and precautions” sections.

Taking Co‑Renitec with food and drinks

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

Alcohol may increase the blood pressure-lowering effect of this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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 Co‑Renitec before becoming pregnant or as soon as you know you are pregnant and will recommend taking a different medication instead of Co‑Renitec. Co‑Renitec is not recommended during pregnancy and should not be taken if you are more than 3months pregnant, as it can cause severe harm to your baby if used after the third month (see the pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Co‑Renitec is not recommended for mothers who are breastfeeding.

The two active ingredients in Co‑Renitec, enalapril, and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor.

Driving and operating machinery

It is unlikely that Co‑Renitec will affect your ability to drive or operate machinery. However, you may occasionally experience dizziness or fatigue during high blood pressure treatment, especially at the beginning. If you experience these effects, consult your doctor before engaging in these activities.

Co‑Renitec contains lactose

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

Co‑Renitec contains sodium

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

Use in athletes:iste medicamento containshydrochlorothiazidethat may produce a positive result in doping control tests.

Interference with diagnostic tests

If you need to undergo any diagnostic tests to evaluate parathyroid gland function, inform your doctor that you are taking Co‑Renitec, as it may alter the test results.

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

Remember to take your medication.

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

Take Co-Renitec every day, exactly as indicated by your doctor. It is very important that you continue taking this medication for the time your doctor prescribes. Do not take more tablets than the prescribed dose.

The recommended dose is one or two tablets administered once a day. Take Co-Renitec every day, exactly as indicated by your doctor. It is very important that you continue taking this medication for the time your doctor prescribes. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than the one that will occur after continued treatment. You may notice dizziness or dizziness and lying down may help. If you are concerned, consult your doctor.

Use in patients with altered kidney function:

If you have any kidney disease, your doctor will indicate the most suitable dose.

Administration form

This medication is administered orally.

Take the Co-Renitec tablets with the help of a glass of water.

Co-Renitec can be taken before or after meals.

If you take more Co-Renitec than you should

If you have taken more Co-Renitec than you should, 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 staff.

The most likely symptoms would be a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure and/or excessive thirst, disorientation, decreased urine production and/or tachycardia.

If you forgot to take Co-Renitec

You should take Co-Renitec as prescribed. Do not take a double dose to compensate for the missed doses. Limit yourself to taking the next dose in the usual way.

If you interrupt the treatment with Co-Renitec

Your doctor will indicate the duration of your treatment with Co-Renitec. Do not stop treatment before, even if you feel better.

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

If you have any other doubts 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 reported side effects are detailed below according to the following frequencies:

Very common: (occurs in at least 1 in 10patients treated)

Common: (occurs in at least 1 in 100 and less than 1 in 10patients treated)

Uncommon: (occurs in at least 1 in 1,000 and less than 1 in 100patients treated)

Rare: (occurs in at least 1 in 10,000 and less than 1 in 1,000patients treated)

Very rare: (occurs in less than 1 in 10,000patients treated)

Frequency not known: (cannot be estimated from available data)

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

frequency not known: skin and lip cancer (non-melanoma skin cancer).

Blood and lymphatic system disorders:

uncommon: decrease in red blood cells (cells that transport oxygen)

rare: reduction of a type of white blood cell (neutrophils), decrease in hemoglobin (protein in red blood cells that transports oxygen), decrease in platelets in the blood, decrease in hematocrit (proportion of red blood cells in the blood), decrease in white blood cells, bone marrow depression (decrease in the body's ability to form blood cells), lymph node inflammation, immune system diseases.

Endocrine disorders:

frequency not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

common: low potassium levels in the blood, increased cholesterol, increased triglycerides, increased uric acid in the blood

uncommon: low glucose and magnesium levels in the blood, gout

rare: increased glucose levels in the blood

very rare: elevated calcium levels in the blood

Nervous system disorders:

common: headache, dizziness, altered taste

uncommon: confusion, drowsiness, insomnia, numbness, vertigo

rare: paralysis (due to low potassium levels in the blood).

Psychiatric disorders:

common: depression

uncommon: nervousness, decreased libido*

rare: abnormal dreams, sleep disorders.

Eye disorders:

very common: blurred vision

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

Ear and labyrinth disorders:

uncommon: ringing in the ears.

Cardiac and vascular disorders:

very common: dizziness

common: hypotension associated with fainting, cardiac rhythm disorders, angina pectoris, tachycardia (rapid heartbeats)

uncommon: flushing, palpitations (sensation of rapid and irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see section “Warnings and precautions”)

rare: changes in skin color of fingers, hands, feet, nose, or ears (Raynaud's phenomenon).

Respiratory, thoracic, and mediastinal disorders:

very common: cough

common: shortness of breath

uncommon: mucus secretion, sore throat, and hoarseness, bronchospasm (difficulty breathing) and asthma

rare: pulmonary infiltrates, respiratory difficulty (including pneumonia and pulmonary edema), nasal mucosa inflammation, allergic alveolitis (inflammation of the pulmonary alveolus by allergy)/eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs)

very rare: acute respiratory difficulty (signs include severe respiratory difficulty, fever, weakness, and confusion).

Gastrointestinal disorders:

very common: nausea

common: diarrhea, abdominal pain

uncommon: intestinal obstruction with intense pain, pancreatitis, vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence (gas)*

rare: mouth or tongue inflammation

very rare: intestinal angioedema (inflammation of the intestinal wall).

Hepatobiliary disorders:

rare: liver insufficiency, liver necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, gallbladder inflammation (particularly in patients with pre-existing formation of stones in the bile ducts).

Skin and subcutaneous tissue disorders:

common: skin rash (exanthema)

hypersensitivity/angioneurotic edema: facial swelling, extremities, lips, tongue, glottis, and/or larynx

uncommon: excessive sweating, itching, urticaria, hair loss

rare: skin redness, severe blistering or hemorrhaging in the skin (Stevens-Johnson syndrome), severe skin rash with skin and hair loss, skin peeling, appearance of red patches on the skin, skin alteration, skin redness, vesicles on the skin.

A complex of symptoms has been reported that may include any or all of the following symptoms: fever, serositis, vasculitis, muscle or joint inflammation, positive antinuclear antibodies test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. It may also cause skin rash, sensitivity to sunlight, or other skin manifestations.

Musculoskeletal, connective tissue, and bone disorders:

common: muscle cramps †

uncommon: joint pain *

Renal and urinary disorders:

uncommon: renal dysfunction (alteration of kidney function), renal insufficiency, proteinuria

rare: oliguria, renal cell inflammation.

Reproductive and breast disorders:

uncommon: impotence

rare: breast enlargement in men.

General disorders and administration site conditions:

very common: fatigue

common: chest pain, fatigue

uncommon: general malaise, fever.

Investigations:

common: elevated potassium levels in the blood, increased serum creatinine

uncommon: increased serum urea, low sodium levels in the blood

rare: increased liver enzymes, increased serum bilirubin.

* Only observed with hydrochlorothiazide doses of 12.5mg and 25mg, as found inCo‑Renitec.

† The frequency of muscle cramps as "common" applies to hydrochlorothiazide doses of 12.5mg and 25mg, as found in Co‑Renitec, although the frequency of the event is "uncommon", and applies to the 6mg hydrochlorothiazide dose as in Renitecmax.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for 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.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 25°C.

Store in the original packaging.

Do not use this medication after the expiration date that appears onthe boxafter CAD. 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 packaging and unused medications at the SIGREcollection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Co ‑ Renitec

• The active principles are maleate of enalapril and hydrochlorothiazide. Each tablet contains 20 mg of maleate of enalapril and 12.5 mg of hydrochlorothiazide.
• The other components are lactose monohydrate, sodium hydrogen carbonate, cornstarch, pregelatinized cornstarch, magnesium stearate, and yellow iron oxide (E ‑ 172).

Appearance of the product and contents of the packaging

It is presented in packs of 28 scored tablets. The tablets are biconvex, hexagonal, yellow, scored, and marked with “MSD 718” on one face.

The score is only for breaking the tablet and facilitating swallowing but not for dividing into equal doses.

Holder of the marketing authorization and responsible for manufacturing

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

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