PATIENT INFORMATION LEAFLET

Enalapril/ Hidroclorotiazida pensa 20 mg/12,5 mg tablets EFG

Read this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you think you have suffered a side effect, you can help us by reporting it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Enalapril/Hidroclorotiazida Pensa is a medication with two components: enalapril and hidroclorotiazida.

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

Hidroclorotiazida belongs to a group of medicines called thiazide diuretics (urine-producing medicines).

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

Enalapril/Hidroclorotiazida Pensa is indicated for the treatment of high blood pressure (hypertension) in patients in whom blood pressure has not been adequately controlled with either of the components, enalapril or hidroclorotiazida, alone.

Do not take Enalapril/Hidroclorotiazida Pensa

• If you are allergic (hypersensitive) to enalapril, to hidroclorotiazida or to any of the other components of Enalapril/Hidroclorotiazida Pensa.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived substances are.
• If you have previously been treated with a medication from the same group as Enalapril/Hidroclorotiazida Pensa (ACE inhibitors), and have had allergic reactions with facial swelling, 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 tracts, and abdominal cramps).
• If you have severe liver disease.
• If you have severe kidney disease.
• If you have anuria (do not urinate).
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant. (It is also best to avoid Enalapril/Hidroclorotiazida Pensa at the beginning of pregnancy – see the pregnancy section).

If you are unsure whether you should start taking Enalapril/Hidroclorotiazida Pensa, consult your doctor.

Be especially careful with Enalapril/Hidroclorotiazida Pensa

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

• If you have a heart disease that involves narrowing of the heart valves (mitral or aortic stenosis) or other factors that reduce blood flow to the left chamber of the heart (hypertrophic obstructive cardiomyopathy).
• If you have conditions that reduce the volume of fluids or the level of sodium in the body (for example: intense vomiting, diarrhea, or if you are being treated with high doses of medications that increase urine production).
• If you have any blood abnormalities.
• If you have diabetes and are taking medications to treat diabetes, including insulin, as you may need to adjust the dose of the medications used to treat diabetes. Diabetes can cause high levels of potassium in the blood that 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 that can be serious.
• If you are undergoing dialysis.
• If you are following a low-sodium diet, taking potassium supplements, potassium-sparing medications (medications that increase potassium levels), or salt substitutes that contain potassium.
• If you experience an allergic reaction with facial swelling, lips, tongue, and/or throat with difficulty swallowing or breathing. Note that patients of black race are more sensitive to this type of medication.
• If you are about to undergo a treatment called LDL apheresis (a procedure similar to dialysis, to remove from the blood LDL particles or bad cholesterol in cases where it is excessively elevated).
• If you are about to undergo a 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/Hidroclorotiazida Pensa, especially in the first doses, can cause a sudden drop in blood pressure (you may notice it as dizziness or dizziness, especially when standing up).
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking Enalapril/Hidroclorotiazida Pensa, see your doctor immediately.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as “sartanes” – for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems associated with diabetes.
  • Aliskirén

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril/Hidroclorotiazida Pensa”.

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

You should inform your doctor if you think you may be pregnant. Enalapril/Hidroclorotiazida Pensa is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious damage to your baby if used in this stage (see the pregnancy section).

Consult your doctor before starting to take Enalapril/Hidroclorotiazida Pensa

- if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, especially long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Enalapril/Hidroclorotiazida Pensa.

- if you experience a decrease in vision or eye pain, which may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within a few hours to a week after taking Enalapril/Hidroclorotiazida Pensa.

Use in children

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

Use in elderly patients

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

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as your doctor may need to modify your dose and/or take other precautions, such as interrupting treatment or adjusting the dose of one of them.

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

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril/Hidroclorotiazida Pensa” and “Be especially careful with Enalapril/Hidroclorotiazida Pensa”.
• Other antihypertensive medications (reduce elevated blood pressure), such as vasodilators, beta-blockers, diuretics.
• Medications with potassium (including salt substitutes).
• Medications used to treat certain mental disorders such as lithium, antipsychotics, or tricyclic antidepressants.
• Anesthetics.
• Opioids (medications used to treat intense pain).
• Medications used to treat diabetes, such as insulin or oral antidiabetic medications (e.g. metformin).
• Medications used to treat pain or certain inflammation, such as nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, including selective COX-2 inhibitors.
• Sympathomimetics (medications used to treat certain heart and blood vessel disorders and some medications for colds).
• Amines pressors, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Thrombolytic medications (that prevent blood clot formation).
• Calcium salts with vitamin D.
• Ionic exchange resins (medications used to reduce cholesterol in the blood), such as cholestyramine and colestipol.
• Antiarrhythmic medications (used to prevent and control heart rhythm disorders), such as digitalis glycosides, quinidine, amiodarone.
• Anticholinergic medications (medications that decrease gastric emptying), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medications used to treat gout, such as probenecid, sulfinpyrazone, and allopurinol.
• Antiviral medications (used to treat viral infections), such as amantadine.
• Cytotoxic medications (used to treat cancer), such as cyclophosphamide and methotrexate.
• Immunosuppressive medications (used to prevent rejection in organ transplants), such as cyclosporine.
• Antibiotics (medications used to treat certain infections), such as tetracyclines, amphotericin B.
• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Taking Enalapril/Hidroclorotiazida Pensa with food and drinks

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

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You should inform your doctor if you think you may be pregnant. Enalapril/Hidroclorotiazida Pensa is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it can cause serious damage to your baby if used in this stage (see the pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start breastfeeding. Enalapril/Hidroclorotiazida Pensa is not recommended for mothers who are breastfeeding.

The active ingredients of Enalapril/Hidroclorotiazida Pensa, enalapril and hidroclorotiazida, pass into breast milk. If you are breastfeeding your baby or plan to do so, consult your doctor.

Use in athletes

It is reported to athletes that this medication contains a component that can produce a positive result in doping control tests.

Driving and operating machines

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

Important information about some of the components of Enalapril/Hidroclorotiazida Pensa

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

Interference with diagnostic tests

If you need to undergo any diagnostic tests to assess the function of the parathyroid gland, inform your doctor that you are taking Enalapril/Hidroclorotiazida Pensa, as it may alter the results.

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

Remember to take your medication.

Dosage

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

Symptomatic hypotension may appear after administration of the initial dose of enalapril/hidroclorotiazida, especially in patients with volume or salt depletion.

If you have taken diuretics before starting treatment, or are following a low-sodium diet, your doctor will discontinue the diuretic 2 or 3 days before starting treatment.

Patients with renal insufficiency or advanced age:

Your doctor will indicate the most suitable dose (see section “Do not take Enalapril/Hidroclorotiazida Pensa”).

Administration Form

Enalapril/Hidroclorotiazida 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/Hidroclorotiazida Pensa than you should

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

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 tachycardia.

If you forget to take Enalapril/Hidroclorotiazida Pensa

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Enalapril/Hidroclorotiazida Pensa

Your doctor will indicate the duration of your treatment with Enalapril/Hidroclorotiazida Pensa. Do not discontinue treatment abruptly or before, as your condition may recur or you may experience other symptoms.

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

Like all medicines Enalapril/Hidroclorotiazida Pensa can cause side effects, although not everyone will experience them.

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

Very common: (occur in at least1 in 10 patients treated)

Common: (occur in at least1 in 100 and fewer than 1 in 10 patients treated)

Uncommon: (occur in at least1 in 1,000 and fewer than 1 in 100 patients treated)

Rare: (occur in at least1 in 10,000 and fewer than 1 in 1,000 patients treated)

Very rare: (occur in fewer than1 in 10,000 patients treated)

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

Blood and lymphatic system disorders:

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

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

Endocrine disorders:

Unknown: syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Metabolism and nutrition disorders:

Common: 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 levels in the blood.

Very rare: high calcium levels in the blood.

Nervous system disorders:

Common: headache, dizziness, altered taste.

Uncommon: confusion, drowsiness, insomnia, numbness, vertigo.

Rare: paralysis (due to low potassium levels).

Mental and behavioural 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 high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal haemorrhage) or acute angle-closure glaucoma]

Ear and labyrinth disorders:

Uncommon: ringing in the ears.

Cardiac and vascular disorders:

Very common: dizziness.

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

Uncommon: flushing, palpitations (sensation of irregular heartbeats), myocardial infarction or stroke, possibly secondary to excessive hypotension in high-risk patients (see sectionBe careful with Enalapril/Hidroclorotiazida Pensa).

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

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Common: shortness of breath.

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

Rare: pulmonary infiltrates, respiratory distress (including pneumonia and pulmonary oedema), inflammation of nasal mucosa, allergic alveolitis (inflammation of the alveolar lung by 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 respiratory distress, fever, weakness, and confusion).

Gastrointestinal disorders:

Very common: nausea.

Common: diarrhoea, abdominal pain.

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

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

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

Hepatobiliary disorders:

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

Skin and subcutaneous tissue disorders:

Common: skin rash (exanthema), hypersensitivity/angioneuritic edema: swelling of the face, lips, tongue, 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 and hair loss, skin peeling, appearance of red spots on the skin, skin alteration, vesicles on the skin.

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

Musculoskeletal, connective tissue, and bone disorders:

Common: muscle cramps**.

Uncommon: joint pain*.

Renal and urinary disorders:

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

Rare: inadequate urine secretion, inflammation of kidney cells.

Reproductive and breast disorders:

Uncommon: impotence.

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: fatigue.

Common: chest pain, fatigue.

Uncommon: general malaise, fever.

Investigations:

Common: high potassium levels in the blood, increases in serum creatinine.

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

Rare: increases in liver enzymes, increases in 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 “common” 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 side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not store at a temperature above 25°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Enalapril/Hidroclorotiazida Pensa

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

Appearance of the product and contents of the package

Enalapril/Hidroclorotiazida Pensa 20 mg/12.5 mg tablets are presented in packages of 28 tablets.

The tablets of Enalapril/Hidroclorotiazida Pensa are round and white.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

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

Rua da Tapada Grande, nº 2

Abrunheira, 2710-089 Sintra

Portugal

This prospectus has been reviewed in November 2021

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