Enalapril/hydrochlorothiazide STADA 20/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril/Hydrochlorothiazide STADA 20 mg/12.5 mg tablets EFG

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Enalapril/Hydrochlorothiazide Stada is and what it is used for

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

The enalapril component of Enalapril/Hydrochlorothiazide Stada is a medicine that belongs to a group 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 enalapril/hydrochlorothiazide belongs to the 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 enalapril/hydrochlorothiazide 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 Enalapril/Hydrochlorothiazide Stada

Do not take Enalapril/Hydrochlorothiazide Stada:

• If you are allergic to enalapril, hydrochlorothiazide, thiazides, 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 of the same class as enalapril/hydrochlorothiazide (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. (It is also advisable to avoid enalapril/hydrochlorothiazide 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 beneath the skin, for example in the throat) is high.

If you are unsure whether you should start taking enalapril/hydrochlorothiazide, consult your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting Enalapril/Hydrochlorothiazide Stada.

In the following situations, your doctor may need to adjust your dose of enalapril/hydrochlorothiazide or monitor your blood potassium levels:

• If you have previously experienced respiratory 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 enalapril/hydrochlorothiazide, seek medical attention immediately.
• If you have a heart condition involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors reducing blood flow from the left chamber 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 medications that increase urine output).
• If you have blood disorders.
• If you have diabetes and are taking antidiabetic medicines, including insulin, as dose adjustments of your diabetes medications may be necessary. Diabetes can lead to high blood potassium levels, which may be serious.
• If you have liver problems.
• If you have kidney problems (including after kidney transplant), as these may cause high blood potassium levels that could be serious.
• If you are undergoing dialysis.
• If you are on a salt-free diet, take potassium supplements, potassium-sparing medications (medicines that increase potassium levels), or potassium-containing salt substitutes, or other medicines that may increase blood potassium such as heparin (a medicine used to prevent blood clots), trimethoprim-containing medicines, or cotrimoxazole (also known as trimethoprim/sulfamethoxazole, used to treat infections).
• If you develop an allergic reaction during treatment, with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing. Note that black patients are more sensitive to this type of medicine.
• If you are about to undergo LDL apheresis (a procedure similar to dialysis to remove LDL or "bad" cholesterol particles from the blood when levels are excessively high).
• If you are scheduled to receive desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• If you have low blood pressure, as using enalapril/hydrochlorothiazide, especially with the first doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, particularly when standing up).
• Talk to your doctor before starting enalapril/hydrochlorothiazide 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 sun and UV exposure while taking enalapril/hydrochlorothiazide.
• If you are taking any of the following medicines, the risk of developing angioedema (rapid swelling under the skin, e.g., in the throat) 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, which could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, occurring within hours to weeks after taking enalapril/hydrochlorothiazide. If untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulfonamide.

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 Enalapril/Hydrochlorothiazide Stada”.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking enalapril/hydrochlorothiazide, 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). Enalapril/hydrochlorothiazide 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 enalapril/hydrochlorothiazide have not been established in this population group, so its use is not recommended in children.

Elderly patients

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 Enalapril/Hydrochlorothiazide Stada

Inform 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 that you 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 Enalapril/Hydrochlorothiazide Stada” and “Warnings and precautions”)
• Antihypertensive medicines (lower high blood pressure), e.g., vasodilators, beta-blockers, diuretics
• Potassium-containing medicines (including dietary 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 in treating 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 (medicines 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
• Procainamide (a medicine for treating heart rhythm problems)
• Antivirals (medicines for treating viral infections), such as amantadine
• Cytotoxic medicines (used for cancer treatment), such as cyclophosphamide and methotrexate
• Immunosuppressants (used to prevent organ transplant rejection), such as cyclosporine
• Antibiotics (medicines for treating 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 the information in the sections “Do not take Enalapril/Hydrochlorothiazide Stada” and “Warnings and precautions”.

Taking Enalapril/Hydrochlorothiazide Stada with food, drinks, and alcohol

Enalapril/hydrochlorothiazide can be taken with or without food. Most people take enalapril/hydrochlorothiazide with a glass of water.

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

Pregnancy, breastfeeding, and fertility

Talk to 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 or pharmacist before using this medicine.

Your doctor will usually advise you to stop taking enalapril/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril/hydrochlorothiazide 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 about to start breastfeeding. Enalapril/hydrochlorothiazide is not recommended for breastfeeding mothers.

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

Driving and using machines

It is unlikely that enalapril/hydrochlorothiazide 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 engaging in such activities.

Enalapril/Hydrochlorothiazide Stada contains lactose and sodium

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

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

Use in athletes

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

Interference with diagnostic tests

If you are scheduled for any diagnostic test to assess parathyroid gland function, inform your doctor that you are being treated with enalapril/hydrochlorothiazide, as it may alter test results.

3. How to take Enalapril/Hydrochlorothiazide Stada

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. 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 enalapril/hydrochlorothiazide every day, exactly as directed by your doctor. It is very important that you continue taking this medicine for as long as your doctor has prescribed it.

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

The initial dose may cause a greater drop in blood pressure than occurs later during continued treatment. You may experience fainting or dizziness, 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 administered orally.

Take the enalapril/hydrochlorothiazide tablets with a glass of water. Enalapril/hydrochlorothiazide may be taken before or after meals.

If you take more Enalapril/Hydrochlorothiazide Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

It is recommended to bring the medicine packaging and leaflet to healthcare professionals.

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

If you forget to take Enalapril/Hydrochlorothiazide Stada

You should take enalapril/hydrochlorothiazide as prescribed. Do not take a double dose to make up for missed doses. Simply take the next dose as usual.

If you stop taking Enalapril/Hydrochlorothiazide Stada

Your doctor will tell you how long you should take enalapril/hydrochlorothiazide. Do not stop treatment early, even if you feel better.

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 will experience them.

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

Very common: (may affect more than 1 in 10 people)
Common: (may affect up to 1 in 10 people)
Uncommon: (may affect up to 1 in 100 people)
Rare: (may affect up to 1 in 1,000 people)
Very rare: (may affect up to 1 in 10,000 people)
Frequency not known: (cannot be estimated from the available data)

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

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 (the protein in red blood cells that carries oxygen), decrease in platelet count, decrease in hematocrit (proportion of red blood cells in the 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:

Not known: syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Metabolism and nutrition disorders:

Common: high 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 blood calcium levels

Nervous system disorders:

Common: headache, fainting, 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
Not known: visual disturbances, reduced vision or eye pain due to increased pressure—possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma

Ear and labyrinth disorders:

Uncommon: ringing in the ears

Cardiac and vascular disorders:

Very common: dizziness
Common: low blood pressure associated with fainting, heart rhythm disorders, angina pectoris, tachycardia (rapid heartbeat)
Uncommon: flushing, palpitations (sensation of rapid or irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive lowering of 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) and asthma
Rare: pulmonary infiltrates, breathing difficulty (including pneumonia and pulmonary edema), inflammation of nasal mucosa, allergic alveolitis (inflammation of 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 (symptoms 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 mouth mucosa, inflammation of the tongue
Very rare: intestinal angioedema (inflammation of the intestinal wall)

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema)
Hypersensitivity/angioedema: swelling of the face, limbs, 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 loss of skin and hair, skin peeling, appearance of red spots on the skin, skin disorders, skin redness.

A symptomatic complex has been reported that may include any or all of the following symptoms: fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, 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: reduced 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: high 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 enalapril/hydrochlorothiazide
  † The frequency of muscle cramps as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in enalapril/hydrochlorothiazide, although the event frequency is "uncommon", and applies to the 6 mg dose of hydrochlorothiazide as in enalapril/hydrochlorothiazide.

Reporting of adverse effects:

If you experience any adverse effect, talk to 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril/Hydrochlorothiazide Stada

Keep out of sight and reach of children.

No special storage conditions are required. Store in the original container.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Enalapril/Hydrochlorothiazide Stada

• The active substances are enalapril in the form of 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, yellow iron oxide (E-172), and magnesium stearate.

Appearance of the medicine and contents of the pack

Enalapril/Hydrochlorothiazide Stada is available as yellow, elongated, biconvex tablets, scored on one side.

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

Each pack contains 28 or 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

or

KeVaRo GROUP Ltd

9 Tsaritza Eleonora Str., office 23

1618 Sofia

Bulgaria

Date of the most recent revision of this leaflet: March 2024

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