Renitecmax 20 mg/6 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Renitecmax 20mg/6mg 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 may 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 Renitecmax is and what it is used for
2. What you need to know before taking Renitecmax
3. How to take Renitecmax
4. Possible side effects
5. How to store Renitecmax
6. Contents of the pack and other information

1. What Renitecmax is and what it is used for

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

The active ingredient enalapril in Renitecmax is a medicine that belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by dilating your blood vessels, making it easier for the heart to pump blood to all parts of the body. The active ingredient hydrochlorothiazide in Renitecmax is a medicine that belongs to a group of medicines called diuretics (medicines that increase urine elimination), and causes the kidneys to remove more water and salts. Together, enalapril and hydrochlorothiazide help reduce high blood pressure.

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 previously been treated with a medicine from the same class as this medicine (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. You must not take this medicine if you have had such reactions without a known cause, or if you have been diagnosed with hereditary or idiopathic angioedema
• if you are allergic to any sulfonamide-derived medicines. If you are unsure, ask your doctor which medicines are sulfonamide-derived
• if you are not passing urine
• if you have severe kidney problems
• if you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren
• if you are more than 3 months pregnant. (Renitecmax should also be avoided in early pregnancy – see Pregnancy section)
• if you have severe liver problems
• 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 this medicine, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Renitecmax.

• Inform your doctor about any medical conditions you currently have or have had in the past, or about any allergies.

• 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 Renitecmax, seek medical attention immediately.

• Inform your doctor if you have heart disease, blood disorders, liver problems, are undergoing dialysis, or are receiving treatment with diuretics (tablets that increase urine output), or if you have recently had severe vomiting or diarrhea. Also inform your doctor if you are on a low-salt diet, take potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes, or other medicines that may increase blood potassium levels, such as heparin (a medicine used to prevent blood clots), trimethoprim or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections), have diabetes, or any kidney problems (including kidney transplant), as these may lead to high blood potassium levels, which can be serious. In such cases, your doctor may need to adjust your Renitecmax dose or monitor your blood potassium levels. If you have diabetes and are taking oral antidiabetic medicines 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 had an allergic reaction with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Note that patients of Black race have a higher risk of such reactions to ACE inhibitors.

• Inform your doctor if you are about to undergo LDL apheresis or desensitization treatment to reduce the effects of bee or wasp sting allergies.

• Inform your doctor if you have low blood pressure (you may experience dizziness or fainting, especially when standing up).

• Before any surgery or anesthesia (including dental procedures), 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 collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are taking medicines that suppress your immune system, or are taking allopurinol, procainamide, or any combination of these.

• Inform your doctor if you are undergoing or about to undergo anti-doping testing, as this medicine may result in a positive test.

• Inform your doctor if you think you are pregnant (or could be). This medicine is not recommended in early pregnancy and must not be used if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see Pregnancy section).

• The risk of developing angioedema may increase if you are taking any of the following medicines:

• racecadotril, a medicine used to treat diarrhea.

• medicines used to prevent organ transplant rejection or to treat cancer (e.g., temsirolimus, sirolimus, everolimus).

• vildagliptin, a medicine used to treat diabetes.

• 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 cancer and lip cancer. Protect your skin from sun and UV exposure while taking Renitecmax.

• 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), especially if you have kidney problems related to diabetes.

• aliskiren.

• Inform your doctor if you experience vision changes or eye pain, as these could be signs 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 Renitecmax. If untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

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 Renitecmax”.

Children and adolescents

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 need to 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. However, it is especially important that your doctor knows if you are taking any of the following:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under “Do not take Renitecmax” and “Warnings and precautions”)
• Other antihypertensives (medicines that lower high blood pressure)
• Diuretics (medicines that increase urine output)
• Potassium supplements (including potassium-containing 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 information in the “Warnings and precautions” section
• Lithium (a medicine used to treat manic depression or bipolar disorder)
• Tricyclic antidepressants (medicines used to treat depression)
• Antipsychotics (medicines used to treat schizophrenia)
• Sympathomimetics (medicines used to treat certain heart and blood vessel conditions, and in some cold remedies)
• Antidiabetics (medicines used to treat diabetes)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain and arthritis, including gold therapy)
• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus: medicines used to treat certain cancers or to prevent immune rejection of transplanted organs). See also information in the “Warnings and precautions” section
• A medicine containing a neprilysin inhibitor such as sacubitril (available in a fixed-dose combination with valsartan), racecadotril, or vildagliptin. These may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also information in sections “Do not take Renitecmax” and “Warnings and precautions”
• Cytostatics (medicines used to treat cancer)

Taking Renitecmax with food and drink

Most people take Renitecmax with a little water.

Pregnancy and breastfeeding

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 Renitecmax before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, 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 about to start breastfeeding. This medicine is not recommended for breastfeeding mothers.

Driving and using machines

Individual responses to medication may vary. Some adverse effects reported with this medicine may affect the ability of some patients to drive or operate machinery (see Possible side effects).

Renitecmax contains lactose

This medicine contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 in athletes: This medicine contains hydrochlorothiazide, which may result in a positive doping test.

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 daily. Most people take this medicine with some water.

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

Prior treatment with diuretics should be discontinued 2–3 days before starting treatment with this medicine.

Always follow exactly the instructions for use given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. It is very important that you continue taking this medicine for as long as your doctor prescribes. 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 you can receive medical attention as soon as possible. The most likely symptoms would be dizziness or vertigo due to a sudden or excessive drop in blood pressure, intense thirst, cough, confusion, rapid breathing, anxiety, reduced urine output, or fast or slow heart rate.

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

If you forget to take Renitecmax

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

If you stop taking Renitecmax

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

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

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

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

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

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

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

Frequency not known (cannot be estimated from 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: anaemia (including aplastic and haemolytic anaemia)

Rare: changes in blood values such as lower number of white or red blood cells, lower haemoglobin levels, lower number of platelets in blood, swollen glands in the neck, armpits or groin

Endocrine disorders:

Frequency not known: excessive production of antidiuretic hormone, leading to fluid retention, causing weakness, tiredness or confusion

Metabolism and nutrition disorders:

Common: low blood potassium levels, increased cholesterol or blood fat levels, elevated blood uric acid levels

Uncommon: low blood glucose (hypoglycaemia), low blood magnesium levels (hypomagnesaemia), painful joint inflammation caused by uric acid crystals (gout)*

Rare: increased blood glucose

Very rare: high blood calcium levels (hypercalcaemia)

Nervous system disorders:

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

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

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

Eye disorders:

Very common: blurred vision

Frequency not known: reduced vision or eye pain due to increased 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 heartbeat

Uncommon: flushing, rapid or irregular heartbeat (palpitations), myocardial infarction, stroke possibly due to excessively low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain)

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

Respiratory disorders:

Very common: cough

Common: shortness of breath

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

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

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

Gastrointestinal disorders:

Very common: nausea

Common: diarrhoea, 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 biliary disorders:

Rare: inflammation of the liver (hepatitis), liver failure which may 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 causing 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 target-like appearance (erythema multiforme), Stevens-Johnson syndrome and toxic epidermal necrolysis (a serious skin disorder where you have red, peeling and blistered skin), severe skin rash with skin and hair loss (exfoliative dermatitis), cutaneous lupus erythematosus (an immune disease), red rash with skin peeling (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 which may include all or some of the following symptoms: fever, inflammation of blood vessels (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), renal failure, protein in urine (proteinuria)

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

Reproductive system and breast disorders:

Uncommon: impotence

Rare: breast enlargement in men (gynaecomastia)

General disorders:

Very common: weakness

Common: chest pain, fatigue

Uncommon: malaise (general discomfort), fever

Investigations:

Common: elevated blood potassium levels, elevated blood creatinine levels

Uncommon: elevated blood urea levels, low blood sodium levels

Rare: elevated liver enzymes or bilirubin levels.

Other adverse effects may also occur less frequently or rarely, and some may be serious. If you need more information about adverse effects, consult your doctor or pharmacist. Both 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 if:

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

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

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

• Observed only 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, whereas the frequency of the event as "uncommon" applies to the 6 mg hydrochlorothiazide dose.

Reporting of adverse effects:

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

5. Storage of Renitecmax

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the carton. The expiry date is 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 the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Renitecmax

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

Renitecmax is available in packs containing 28 tablets.

Appearance of the product and contents of the pack

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

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

Unit-dose aluminum blisters containing 28 tablets.

Only certain 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

The Netherlands

This medicinal product is authorized in the European Economic Area member states and in the United Kingdom (Northern Ireland) under the following names:

Austria RENITEC PLUS

Denmark SYNERPRIL

Italy SINERTEC

The Netherlands RENITEC PLUS

Spain RENITECMAX

Date of the most recent review of this leaflet: 06/2022.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)