Co-Renitec 20 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CO‑RENITEC 20mg/12.5mg tablets

enalapril maleate/hydrochlorothiazide

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 Co‑Renitec is 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. How to store Co‑Renitec
6. Contents of the pack and other information

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

This medicine contains two active substances, enalapril and hydrochlorothiazide, which belong to the class of antihypertensive agents and reduce high blood pressure through different mechanisms.

The enalapril component of Co-Renitec is a medicine belonging to a class of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors), which works by dilating blood vessels to allow the heart to pump blood more easily throughout the body. The hydrochlorothiazide component of Co-Renitec belongs to a group of medicines known as thiazide diuretics (medicines that increase urine elimination). Together, enalapril and hydrochlorothiazide help lower high blood pressure.

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

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

Do not take Co‑Renitec

• If you are allergic to enalapril maleate, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same class as Co‑Renitec (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by 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 (an immune system disorder causing swelling in the face and airways, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you suffer from anuria (you do not urinate).
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (Co‑Renitec should also be avoided in early pregnancy – see pregnancy section).
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin, e.g., in the throat) is high.

If you are unsure whether you should start taking Co‑Renitec, consult your doctor.

Warnings and precautions

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

In the following situations, your doctor may need to adjust your dose of Co‑Renitec or monitor your blood potassium levels:

• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Co‑Renitec, seek medical attention immediately.

• If you have a heart condition involving narrowing of heart valves (mitral or aortic stenosis) or other factors reducing blood flow from the left side of the heart (obstructive hypertrophic cardiomyopathy).

• If you have conditions that reduce fluid volume or sodium levels in the body (e.g., severe vomiting, diarrhea, or if you are on high doses of medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking medicines for diabetes, including insulin, as a dose adjustment of your diabetes medicines may be needed. Diabetes can cause high potassium levels in the blood, which may be serious.

• If you have liver problems.

• If you have kidney problems (including after kidney transplant), as these may lead to high blood potassium levels, which can be serious.

• If you are undergoing dialysis.

• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines (medicines that increase potassium levels), potassium-containing salt substitutes, or other medicines that may increase blood potassium, such as heparin (a medicine used to prevent blood clots), medicines containing trimethoprim or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections).

• If you develop an allergic reaction with swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing during treatment. Note that patients of Black race may be more sensitive to this type of medicine.

• If you are about to undergo LDL apheresis (a procedure similar to dialysis used to remove LDL or "bad" cholesterol particles from the blood when levels are excessively high).

• If you are scheduled to undergo desensitization therapy to reduce the effects of an allergy to bee or wasp stings.

• If you have low blood pressure, as taking Co‑Renitec, especially in the first doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, especially when standing up).

• Consult your doctor before starting Co‑Renitec if you have had skin cancer or 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 non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Co‑Renitec.

• 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.

• Inform your doctor 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), particularly if you have kidney problems related to diabetes.
  • aliskiren

• Inform your doctor if you experience vision changes or eye pain, as these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Co‑Renitec. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamide.

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

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

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

Inform your doctor if you think you are pregnant (or could be). Co‑Renitec is not recommended in early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see pregnancy section).

Children and adolescents

The safety and efficacy of Co‑Renitec have not been established in this population group, and its use is therefore not recommended in children.

Use in the elderly

In studies combining enalapril and hydrochlorothiazide, the effects and tolerability of the medicines were similar in younger and older adult patients with high blood pressure.

Other medicines and Co‑Renitec

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

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

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Co‑Renitec” and “Warnings and precautions”)
• Antihypertensive medicines (lower high blood pressure), e.g., vasodilators, beta-blockers, diuretics.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (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 the information in the “Warnings and precautions” section.
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medicines used to treat severe pain).
• Medicines used to treat diabetes, such as insulin or oral antidiabetics (e.g., metformin).
• Medicines used to treat pain or certain inflammations, such as non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, and selective COX-2 inhibitors.
• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).
• Pressor amines, such as noradrenaline.
• Muscle relaxants such as tubocurarine.
• Thrombolytic medicines (prevent blood clot formation).
• Calcium and vitamin D salts.
• Ion-exchange resins (used to lower blood cholesterol), such as cholestyramine and colestipol.
• Antiarrhythmics (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (reduce gastric emptying speed), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson’s disease).
• Medicines for gout treatment, such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent transplant rejection), such as cyclosporine.
• Antibiotics (used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).
• Concomitant use of mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) may increase the risk of an allergic reaction called angioedema.
• 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 the sections “Do not take Co‑Renitec” and “Warnings and precautions”.

Taking Co‑Renitec with food and drink

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

Alcohol may enhance the blood pressure-lowering effect of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 Co‑Renitec before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Co‑Renitec is not recommended during 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 planning to breastfeed. Co‑Renitec is not recommended for breastfeeding mothers.

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

Driving and using machines

It is unlikely that Co‑Renitec will affect your ability to drive or use machines. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure, especially at the beginning. If you experience these effects, consult your doctor before performing such activities.

Co‑Renitec contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

Co‑Renitec contains sodium

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

Use in athletes: This medicine contains hydrochlorothiazide, which may lead to a positive result in doping tests.

Interference with diagnostic tests

If you are scheduled for diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with Co‑Renitec, as it may alter test results.

3. How to take Co‑Renitec

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

Remember to take your medicine.

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

Take Co‑Renitec every day, exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as your doctor prescribes it. Do not take more tablets than the prescribed dose.

The recommended dose is one or two tablets taken once daily. Take Co‑Renitec every day, exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as your doctor prescribes it. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than occurs during continued treatment. You may feel faint or dizzy, and lying down may help. If you are concerned, consult your doctor.

Use in patients with impaired kidney function:

If you have any kidney disease, your doctor will determine the most appropriate dose for you.

Method of administration

This medicine is taken orally.

Take Co‑Renitec tablets with a glass of water.

Co‑Renitec may 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine pack and leaflet to the healthcare professional.

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

If you forget to take Co‑Renitec

You should take Co‑Renitec as prescribed. Do not take a double dose to make up for a missed dose. Simply take the next dose as usual.

If you stop taking Co‑Renitec

Your doctor will advise you on how long your treatment with Co‑Renitec should last. Do not stop treatment early, even if you feel better.

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

If you have any further questions about 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 everyone experiences them.

The reported adverse effects are listed below according to the following frequencies:

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

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

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

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

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

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

Benign and malignant 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 carry oxygen)

Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (protein in red blood cells that carries oxygen), decrease in platelet count, decrease in hematocrit (proportion of red blood cells in blood), decrease in white blood cell count, bone marrow depression (reduced ability of the body to produce blood cells), lymph node inflammation, immune system disorders.

Endocrine disorders:

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

Metabolism and nutrition disorders:

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

Uncommon: low blood glucose and magnesium levels, gout

Rare: increased blood glucose

Very rare: high calcium levels in blood

Nervous system disorders:

Common: headache, syncope, taste disturbances

Uncommon: confusion, drowsiness, insomnia, tingling sensation, dizziness

Rare: paralysis (due to low potassium levels in 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 elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

Ear and labyrinth disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness

Common: drop in blood pressure associated with fainting, heart rhythm disorders, angina pectoris, tachycardia (rapid heartbeat)

Uncommon: flushing, palpitations (rapid or irregular heartbeat sensation), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section “Warnings and precautions”)

Rare: changes in skin coloration of fingers, toes, 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), asthma

Rare: pulmonary infiltrates, breathing difficulty (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the lung alveoli due to allergy)/eosinophilic pneumonia (a condition in which a type of white blood cells called eosinophils accumulate in the lungs)

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

Gastrointestinal disorders:

Very common: nausea

Common: diarrhea, abdominal pain

Uncommon: intestinal obstruction with severe pain, pancreatitis (inflammation of the pancreas), vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence (gas)*

Rare: infection or inflammation of the mucous membrane of the mouth, inflammation of the tongue

Very rare: intestinal angioedema (inflammation of the intestinal wall)

Hepatobiliary disorders:

Rare: liver failure, hepatic necrosis (which may be fatal), inflammation of the liver, suppression or cessation of bile secretion, yellowing of the skin or eyes (jaundice), gallbladder inflammation (particularly in patients with pre-existing gallstones in the bile ducts)

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)

Hypersensitivity/angioneurotic edema: swelling of the face, extremities, lips, tongue, glottis and/or larynx

Uncommon: excessive sweating, itching, urticaria, hair loss

Rare: redness of the skin, severe blistering or bleeding in the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorders, redness of the skin, formation of blisters on the skin.

A symptomatic complex has been reported which may include all or some of the following symptoms: fever, serositis, vasculitis, muscle pain/inflammation, joint pain/inflammation, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. 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: renal dysfunction (impaired kidney function), renal failure, presence of protein in urine

Rare: decreased urine output, inflammation of kidney cells

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men

General disorders and administration site conditions:

Very common: fatigue

Common: chest pain, tiredness

Uncommon: general malaise, fever

Investigations:

Common: elevated potassium levels in blood, increased serum creatinine

Uncommon: increased blood urea, low sodium levels in blood

Rare: increased liver enzymes, increased serum bilirubin

• Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Co-Renitec.

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Co-Renitec

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

Do not store above 25 °C.

Store in the original packaging.

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

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

6. Contents of the pack and other information

Composition of Co-Renitec

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

Appearance of the product and contents of the pack

The product is supplied in packs of 28 scored tablets. The tablets are biconvex, hexagonal, yellow in colour, scored, and marked with “MSD 718” on one side.

The score is intended only to facilitate tablet splitting for ease of swallowing and not to divide the tablet into equal doses.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder: Organon Salud, S.L. Paseo de la Castellana, 77 28046 Madrid Spain Tel.: 915911279 Manufacturer responsible: Merck Sharp & Dohme, B.V. Waarderweg 39 2031 BN Haarlem The Netherlands or Organon Heist bv Industriepark 30 2220 Heist‑op‑den‑Berg Belgium

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

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