Enalapril/hydrochlorothiazide Pensa 20/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Enalapril/Hydrochlorothiazide Pensa 20 mg/12.5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

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

Enalapril/Hydrochlorothiazide Pensa is a medicine containing two components: enalapril and hydrochlorothiazide.

Enalapril belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by dilating blood vessels, thereby lowering blood pressure.

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

Together, enalapril and hydrochlorothiazide help reduce high blood pressure.

Enalapril/Hydrochlorothiazide Pensa is indicated for the treatment of arterial hypertension (high blood pressure) in patients whose blood pressure has not been adequately controlled with each of the individual components, enalapril and hydrochlorothiazide, taken separately.

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 components of Enalapril/Hydrochlorothiazide Pensa.
• If you are allergic to sulfonamide-derived substances. Ask your doctor if you are unsure what sulfonamide-derived medicines are.
• If you have previously been treated with a medicine from the same group as Enalapril/Hydrochlorothiazide Pensa (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 have 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. (Enalapril/Hydrochlorothiazide Pensa should also be avoided in early pregnancy – see Pregnancy section).

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

Take special care with Enalapril/Hydrochlorothiazide Pensa

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

• If you have heart disease involving narrowing of heart valves (mitral or aortic valve stenosis) or other factors reducing blood flow from the left heart chamber (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 diuretic medicines).
• If you have blood disorders.
• If you have diabetes and are taking antidiabetic medicines, including insulin, as a dose adjustment of your diabetes treatment may be necessary. Diabetes may lead to elevated blood potassium levels, which can be serious.
• If you have liver problems.
• If you have kidney problems (including kidney transplant), as these may cause elevated blood potassium levels that can be serious.
• If you are undergoing dialysis.
• If you are on a salt-free diet, taking potassium supplements, potassium-sparing medicines (medicines that increase potassium levels), or potassium-containing salt substitutes.
• If you develop an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing during treatment. Note that patients of Black race are more susceptible 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 undergo desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure, as using Enalapril/Hydrochlorothiazide Pensa, especially in the first doses, may cause a sudden drop in blood pressure (you may experience fainting or dizziness, particularly when standing up).
• 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 breathing difficulty after taking Enalapril/Hydrochlorothiazide Pensa, seek medical attention immediately.
• If you are taking any of the following medicines for high blood pressure (hypertension):
  • An angiotensin II receptor antagonist (ARA) (also known as “sartans” – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems associated with diabetes.
  • Aliskiren

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 Pensa”.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking Enalapril/Hydrochlorothiazide Pensa, 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 Pensa is not recommended during early 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 at this stage (see Pregnancy section).

Consult your doctor before starting Enalapril/Hydrochlorothiazide Pensa

• 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 Pensa.
• if you experience vision loss or eye pain, as these could be symptoms of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Enalapril/Hydrochlorothiazide Pensa.

Use in children

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

Use in elderly patients

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

Use of other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use other medicines, including over-the-counter, homeopathic, herbal medicines, and other health-related products, as your doctor may need to adjust your dose and/or take other precautions, such as interrupting treatment or adjusting the dose of one or more medicines.

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

• an angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril/Hydrochlorothiazide Pensa” and “Take special care with Enalapril/Hydrochlorothiazide Pensa”).
• Other antihypertensive medicines (lower high blood pressure), 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.
• 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), like acetylsalicylic acid, including selective cyclooxygenase-2 (COX-2) inhibitors.
• Sympathomimetic medicines (used to treat certain heart and blood vessel disorders and some cold remedies).
• Pressor amines, such as noradrenaline.
• Muscle relaxants such as tubocurarine.
• Thrombolytic medicines (prevent blood clot formation).
• Calcium salts with vitamin D.
• Ion-exchange resins (used to lower blood cholesterol), such as cholestyramine and colestipol.
• Antiarrhythmics (used to prevent and control heart rhythm disorders), such as digital glycosides, quinidine, amiodarone.
• Anticholinergic medicines (reduce gastric emptying speed), such as atropine (used before general anesthesia or to prevent spasms) or biperiden (used in patients with Parkinson's disease).
• Medicines for gout treatment such as probenecid, sulfinpyrazone, and allopurinol.
• Antivirals (medicines to treat viral infections), such as amantadine.
• Cytotoxic medicines (used in cancer treatment), such as cyclophosphamide and methotrexate.
• Immunosuppressants (used to prevent organ transplant rejection), such as cyclosporine.
• Antibiotics (medicines 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 enhance the hypotensive effect (blood pressure-lowering effect) of this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Enalapril/Hydrochlorothiazide Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril/Hydrochlorothiazide Pensa 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. Enalapril/Hydrochlorothiazide Pensa is not recommended for 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 should be aware that this medicine contains a component that may lead to a positive result in doping control tests.

Driving and using machines

It is unlikely that Enalapril/Hydrochlorothiazide Pensa will affect your ability to drive or operate machinery. 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.

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

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

Interference with diagnostic tests

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

3. How to take Enalapril/Hydrochlorothiazide Pensa

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

Remember to take your medication.

Dosage

Your doctor will determine the appropriate dose depending on your condition and whether you are taking other medications. The usual dose is 1 tablet once daily. If necessary, your doctor may increase the dose to two tablets taken once daily.

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

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

Patients with renal impairment or elderly patients:
Your doctor will advise you on the most appropriate dose (see section “Do not take Enalapril/Hydrochlorothiazide Pensa”).

Method of administration

Enalapril/Hydrochlorothiazide Pensa are tablets for oral administration.

You may 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating 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 output, and/or tachycardia.

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 advise you on the duration of your treatment with Enalapril/Hydrochlorothiazide Pensa. Do not stop treatment prematurely or abruptly, as your condition may return 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 medicines, Enalapril/Hydrochlorothiazide Pensa can cause adverse effects, although not everyone experiences them.

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

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

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

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

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

Very rare: (occurs in less than 1 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 (blood cells that carry oxygen).

Rare: reduction in a type of white blood cells (neutrophils), decrease in hemoglobin (a protein in red blood cells that carries oxygen), decreased platelet count in blood, decreased hematocrit (proportion of red blood cells in blood), decreased 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: elevated potassium levels in blood, increased cholesterol, increased triglycerides, elevated uric acid in blood.

Uncommon: low blood glucose and magnesium levels, gout.

Rare: increased blood glucose.

Very rare: elevated calcium levels in blood.

Nervous system disorders:

Common: headache, syncope, taste disturbance.

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

Rare: paralysis (due to low potassium levels).

Psychiatric disorders:

Common: depression.

Uncommon: nervousness, decreased libido*.

Rare: abnormal dreams, sleep disorders.

Eye disorders:

Very common: blurred vision.

Frequency not known: Decreased vision or eye pain due to 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 (rapid and irregular heartbeat sensation), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section Take special care with Enalapril/Hydrochlorothiazide Pensa).

Rare: changes in skin coloration of fingers, toes, nose or ears (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Common: difficulty breathing.

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

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

Very rare: acute respiratory 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, vomiting, digestive discomfort, constipation, loss of appetite, gastric irritation, dry mouth, peptic ulcer, flatulence*.

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 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 in the biliary tract).

Skin and subcutaneous tissue disorders:

Common: 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 redness/rash with loss of skin and hair, skin peeling, appearance of red spots on the skin, skin disorders, blister formation on the skin.

A symptomatic complex has been observed which 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, photosensitivity, and 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: enlargement of breasts in men.

General disorders and administration site conditions:

Very common: fatigue.

Common: chest pain, tiredness.

Uncommon: general malaise, fever.

Additional investigations:

Common: elevated potassium levels in blood, increased serum creatinine.

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

Rare: increased liver enzymes, increased serum bilirubin.

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

• Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Enalapril/Hydrochlorothiazide Pensa

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

Appearance of the medicinal product and contents of the container

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

Enalapril/Hydrochlorothiazide Pensa tablets are round and white in color.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Atlantic Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2
Abrunheira, 2710-089 Sintra
Portugal

This patient information leaflet was last reviewed in November 2021

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