ENALAPRIL/ HYDROCHLOROTHIAZIDE PENSA 20/12.5 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril/ Hydrochlorothiazide pensa 20 mg/12.5 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Enalapril/Hydrochlorothiazide Pensa is and what it is used for.
2. Before taking Enalapril/Hydrochlorothiazide Pensa.
3. How to take Enalapril/Hydrochlorothiazide Pensa.
4. Possible side effects.
5. Storage of Enalapril/Hydrochlorothiazide Pensa.
6. Further information.

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

Enalapril/Hydrochlorothiazide Pensa is a medicine that contains two active substances: enalapril and hydrochlorothiazide.

Enalapril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening the blood vessels, which lowers blood pressure.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (water tablets).

Together, enalapril and hydrochlorothiazide help to lower high blood pressure.

Enalapril/Hydrochlorothiazide Pensa is used to treat high blood pressure in patients who have not been adequately controlled with either enalapril or hydrochlorothiazide alone.

2. Before taking Enalapril/Hydrochlorothiazide Pensa

Do not take Enalapril/Hydrochlorothiazide Pensa

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other ingredients of Enalapril/Hydrochlorothiazide Pensa.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are not sure what these medicines are.
• If you have previously been treated with a medicine of the same group as Enalapril/Hydrochlorothiazide Pensa (ACE inhibitors), and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with 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 disease 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 have anuria (you do not urinate).
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant for more than 3 months. (It is also best to avoid Enalapril/Hydrochlorothiazide Pensa at the beginning of pregnancy – see section Pregnancy).

If you are not sure if you should start taking Enalapril/Hydrochlorothiazide Pensa, consult your doctor.

Be especially careful with Enalapril/Hydrochlorothiazide Pensa

In the following situations, your doctor may need to adjust your dose of Enalapril/Hydrochlorothiazide Pensa or monitor your potassium levels in the blood:

• If you have heart disease with narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce the flow of the left ventricle of the heart (hypertrophic cardiomyopathy).
• If you have disorders that reduce the volume of fluids or the level of sodium in the body (e.g., severe vomiting, diarrhea, or if you are being treated with high doses of diuretics).
• If you have any blood disorders.
• If you have diabetes and are taking medicines to treat diabetes, including insulin, as your doctor may need to adjust the dose of your diabetes medicines. Diabetes can cause high levels of potassium in the blood, which can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these can cause high levels of potassium in the blood, which can be serious.
• If you are undergoing dialysis.
• If you follow a low-salt diet, take potassium supplements, or take potassium-sparing medicines (medicines that increase potassium levels) or salt substitutes that contain potassium.
• If you experience an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing during treatment. You should be aware that black patients are more sensitive to this type of medicine.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis to remove LDL or "bad" cholesterol from the blood in cases where it is excessively high).
• If you are going 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 Enalapril/Hydrochlorothiazide Pensa, especially in the first doses, can cause a sudden drop in blood pressure (you may feel dizzy or faint, especially when standing up).
• If you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Enalapril/Hydrochlorothiazide Pensa, seek medical attention immediately.
• If you are taking any of the following medicines to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartans" – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems associated with diabetes.
  • Aliskiren

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

See also the information under the heading "Do not take Enalapril/Hydrochlorothiazide Pensa".

Before undergoing surgery or anesthesia (even at the dentist), inform your doctor or dentist that you are taking Enalapril/Hydrochlorothiazide Pensa, as you may experience a sudden drop in blood pressure due to the anesthesia.

You should inform your doctor if you think you are pregnant (or might be). Enalapril/Hydrochlorothiazide Pensa is not recommended at the beginning of pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used during this period (see section Pregnancy).

Consult your doctor before starting to take Enalapril/Hydrochlorothiazide Pensa

Use in children

The safety and efficacy of Enalapril/Hydrochlorothiazide Pensa have not been established in this population, so its use is not recommended in children.

Use in elderly patients

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

Use of other medicines

Tell your doctor or pharmacist if you are using, or have recently used, other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as your doctor may need to adjust your dose and/or take other precautions, such as stopping treatment or adjusting the dose of one of them.

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 the information under the headings "Do not take Enalapril/Hydrochlorothiazide Pensa" and "Be especially careful with Enalapril/Hydrochlorothiazide Pensa").
• Other blood pressure-lowering medicines (e.g., vasodilators, beta-blockers, diuretics).
• Potassium-containing medicines (including dietary salt substitutes).
• Medicines used to treat certain mental disorders, such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Narcotics (pain-relieving medicines).
• 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), such as acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (medicines used to treat certain heart and blood vessel disorders and some cold medicines).
• Pressor amines, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medicines (which prevent blood clot formation).
• Calcium salts with vitamin D.
• Ion exchange resins (medicines used to lower cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medicines (medicines used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medicines (medicines that slow down gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for the treatment of gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medicines (medicines used to treat viral infections), such as amantadine.
• Cytotoxic medicines (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medicines (used to prevent organ rejection in transplants), such as cyclosporine.
• Antibiotics (medicines used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases, such as rheumatoid arthritis).

Taking Enalapril/Hydrochlorothiazide Pensa with food and drinks

Enalapril/Hydrochlorothiazide Pensa can be taken before or after meals.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Pregnancy

You should inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Enalapril/Hydrochlorothiazide Pensa before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Enalapril/Hydrochlorothiazide Pensa. Enalapril/Hydrochlorothiazide Pensa is not recommended during pregnancy and should not be taken if you are pregnant for more than 3 months, as it can cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Enalapril/Hydrochlorothiazide Pensa is not recommended in breastfeeding mothers.

The active substances of Enalapril/Hydrochlorothiazide Pensa, enalapril and hydrochlorothiazide, pass into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor.

Use in athletes

Athletes are informed that this medicine contains a component that can produce a positive result in doping tests.

Driving and using machines

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

Important information about some of the ingredients of Enalapril/Hydrochlorothiazide Pensa

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Interference with diagnostic tests

If you are to undergo any diagnostic tests to assess the function of the parathyroid gland, inform your doctor that you are being treated with Enalapril/Hydrochlorothiazide Pensa, as it may alter the test results.

3. How to take Enalapril/Hydrochlorothiazide Pensa

Follow the instructions for administration of Enalapril/Hydrochlorothiazide Pensa exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Dosage

Your doctor will decide the appropriate dose depending on your condition and whether you are taking other medicines. The usual dose is 1 tablet once a day. If necessary, your doctor may increase the dose to 2 tablets taken once a day.

Symptomatic hypotension may occur after the administration of the initial dose of enalapril/hydrochlorothiazide, being more likely in patients with volume or salt depletion.

If you have taken diuretics before starting treatment, or follow a low-salt diet, your doctor will stop the diuretic 2 or 3 days before starting treatment.

Patient with kidney problems or elderly:

Your doctor will indicate the most suitable dose (see section "Do not take Enalapril/Hydrochlorothiazide Pensa").

Method of administration

Enalapril/Hydrochlorothiazide Pensa are tablets for oral administration.

You can take the tablets with a glass of water: before, during, or after meals.

If you take more Enalapril/Hydrochlorothiazide Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

The most likely symptoms in case of overdose are: dizziness or vertigo due to a sudden or excessive drop in blood pressure, and/or excessive thirst, disorientation, decreased urine production, and/or rapid heartbeat.

If you forget to take Enalapril/Hydrochlorothiazide Pensa

Do not take a double dose to make up for forgotten doses.

If you stop taking Enalapril/Hydrochlorothiazide Pensa

Your doctor will indicate the duration of your treatment with Enalapril/Hydrochlorothiazide Pensa. Do not stop treatment before or abruptly, as your problem may come back or you may experience other symptoms.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, Enalapril/Hydrochlorothiazide Pensa may produce adverse effects, although not all people suffer from them.

The recorded adverse effects are detailed below according to the following frequencies:

Very frequent: (occur in at least 1 in 10 treated patients)

Frequent: (occur in at least 1 in 100 and less than 1 in 10 treated patients)

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

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

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

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

Blood and lymphatic system disorders:

Uncommon: decrease in red blood cells (cells that carry oxygen in the blood).

Rare: reduction of a type of white blood cell (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 the blood), decrease in white blood cell count, bone marrow depression (decrease in the body's ability to form blood cells), lymph node inflammation, immune system diseases.

Endocrine disorders:

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

Metabolic and nutritional disorders:

Frequent: high 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 in the blood.

Very rare: high calcium levels in the blood.

Nervous system disorders:

Frequent: headache, syncope, altered taste.

Uncommon: confusion, somnolence, insomnia, tingling sensation, vertigo.

Rare: paralysis (due to low potassium levels).

Psychiatric disorders:

Frequent: depression.

Uncommon: nervousness, decreased libido*.

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very frequent: blurred vision.

Frequency not known: Decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]

Ear and labyrinth disorders:

Uncommon: ringing in the ears.

Cardiac and vascular disorders:

Very frequent: dizziness.

Frequent: low blood pressure associated with fainting, cardiac rhythm disorders, chest pain, tachycardia (rapid heartbeats).

Uncommon: flushing, palpitations (rapid and irregular heartbeat), myocardial infarction or stroke, possibly secondary to excessive blood pressure reduction in high-risk patients (see section Be especially careful with Enalapril/Hydrochlorothiazide Pensa).

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

Respiratory, thoracic, and mediastinal disorders:

Very frequent: cough.

Frequent: difficulty breathing.

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

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary edema), inflammation of the nasal mucosa, allergic alveolitis (inflammation of the lung alveoli due to allergy) / eosinophilic pneumonia (disease in which a type of white blood cell, called eosinophils, accumulates in the lungs).

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

Gastrointestinal disorders:

Very frequent: nausea.

Frequent: diarrhea, abdominal pain.

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

Rare: infection or inflammation of the mouth mucosa, tongue inflammation.

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

Hepatobiliary disorders:

Rare: liver failure, liver necrosis (which can be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, inflammation of the gallbladder (particularly in patients with pre-existing bile duct stone formation).

Skin and subcutaneous tissue disorders:

Frequent: skin rash (exanthema), hypersensitivity/angioneurotic edema: swelling of the face, lips, tongue, and/or larynx.

Uncommon: excessive sweating, itching, urticaria, hair loss.

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

A symptomatic complex has been observed that may include some of the following reactions: fever, serositis, vasculitis, muscle inflammation/pain, joint inflammation/pain, positive antinuclear antibody test, increased erythrocyte sedimentation rate, eosinophilia, and leukocytosis. Skin rash, sensitivity to sunlight, and other skin manifestations may also occur.

Musculoskeletal, connective tissue, and bone disorders:

Frequent: muscle cramps**.

Uncommon: joint pain*.

Renal and urinary disorders:

Uncommon: renal dysfunction (alteration of kidney function), renal failure, presence of proteins in the urine.

Rare: inadequate urine secretion, inflammation of kidney cells.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: increased breast size in men.

General disorders and administration site conditions:

Very frequent: fatigue.

Frequent: chest pain, fatigue.

Uncommon: general malaise, fever.

Investigations:

Frequent: high potassium levels in the blood, increased serum creatinine.

Uncommon: increased blood urea, low sodium levels in the blood.

Rare: increased liver enzymes, increased serum bilirubin.

Frequency "not known": Skin and lip cancer (non-melanoma skin cancer).

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

** The frequency of muscle spasms as "frequent" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, although the frequency of the event is "uncommon", and applies to the 6 mg hydrochlorothiazide dose.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

5. Storage of Enalapril/Hydrochlorothiazide Pensa

Keep out of the reach and sight of children.

Do not store above 25°C.

Do not use Enalapril/Hydrochlorothiazide Pensa after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

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

6. Additional information

Composition of Enalapril/Hydrochlorothiazide Pensa

• The active ingredients are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other ingredients are lactose monohydrate, sodium hydrogen carbonate, corn starch (gluten-free), potato starch glycolate, microcrystalline cellulose, magnesium stearate.

Appearance and packaging of the product

Enalapril/Hydrochlorothiazide Pensa 20 mg/12.5 mg tablets are available in packs of 28 tablets.

The Enalapril/Hydrochlorothiazide Pensa tablets are round and white.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Atlantic Pharma – Produções de Especialidades Farmacêutica, S.A.

Rua da Tapada Grande, nº 2

Abrunheira, 2710-089 Sintra

Portugal

This leaflet was last revised in November 2021

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