Baripril Diu 20 mg/12.5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Baripril Diu 20 mg/12.5 mg tablets

Enalapril/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 and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you consider any of the side effects you experience to be 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 Baripril Diu is and what it is used for
2. What you need to know before taking Baripril Diu
3. How to take Baripril Diu
4. Possible side effects
5. How to store Baripril Diu
6. Contents of the pack and other information

1. What Baripril Diu is and what it is used for

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

The enalapril component of Baripril Diu 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 to all parts of the body. The hydrochlorothiazide component of Baripril Diu 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 Baripril Diu 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 Baripril Diu

Do not take Baripril Diu

• If you are allergic (hypersensitive) to enalapril, hydrochlorothiazide, or any of the other components of Baripril Diu.
• 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 Baripril Diu (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 (a condition 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 insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant (Baripril Diu should also be avoided early in pregnancy – see Pregnancy section).

If you are unsure whether you should start taking Baripril Diu, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Baripril Diu

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Baripril Diu.
  • If you experience vision changes or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking Baripril Diu.
  • If you have had respiratory or lung problems (such as lung inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Baripril Diu, seek medical attention immediately.

In the following situations, your doctor may need to adjust your dose of Baripril Diu or monitor your blood potassium levels:

• If you have heart disease involving narrowing of heart valves (mitral or aortic 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 medicines that increase urine output).

• If you have blood disorders.

• If you have diabetes and are taking medicines for diabetes, including insulin, as dose adjustments of diabetes medicines may be needed. Diabetes can cause high potassium levels in the blood, which may be serious.

• If you have liver problems.

• If you have kidney problems (including kidney transplant), as these may cause high blood potassium levels that could be serious.

• If you undergo dialysis.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines (diuretics), or salt substitutes containing potassium.

• If you develop an allergic reaction during treatment with swelling of the face, lips, tongue, and/or throat, with 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 particles or "bad cholesterol" from the blood when levels are excessively high).

• If you are scheduled to receive desensitization treatment to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure, as use of Baripril Diu, especially with the first doses, may cause a sudden drop in blood pressure (you may feel faint or dizzy, particularly when standing up).

• If you are taking any of the following medicines used to treat 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 related to diabetes.

• Aliskiren

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium).

See also information under the heading “Do not take Baripril Diu tablets”.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking Baripril Diu, 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). Baripril Diu is not recommended in early pregnancy and must not be used after 3 months of pregnancy, as it may cause severe harm to your baby if used during this stage (see Pregnancy and breastfeeding section).

Taking Baripril Diu with other medicines

Inform your doctor or pharmacist if you are using or have recently used any other
medicines, or if you may need to take any other medicine, including over-the-counter, homeopathic, herbal remedies, and other health-related products, as your doctor may need to adjust your dose and/or take other precautions.

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 Baripril Diu” and “Warnings and precautions”).

• Antihypertensive medicines (lower high blood pressure), e.g., vasodilators, beta-blockers, diuretics.

• Medicines containing potassium (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), including acetylsalicylic acid, and selective cyclooxygenase-2 (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 (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 rate), such as atropine (used before general anesthesia or to prevent spasms) or
  biperiden (used in patients with Parkinson’s disease).

• Medicines for treating gout, such as probenecid, sulfinpyrazone, and allopurinol.

• Antivirals (used 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 (used to treat certain infections), such as tetracyclines, amphotericin B.

• Gold salts (used to treat rheumatic diseases such as rheumatoid arthritis).

Taking Baripril Diu with food, drinks, and alcohol

Baripril Diu may be taken before or after meals.

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

Pregnancy and breastfeeding

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.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking Baripril Diu before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Baripril Diu 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. Baripril Diu is not recommended for breastfeeding mothers.

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

Use in children and adolescents

The safety and efficacy of Baripril Diu have not been established in this population group, and therefore its use is not recommended in children.

Use in elderly

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

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive doping test.

Driving and using machines

It is unlikely that Baripril Diu 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 performing such activities.

Baripril Diu contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially "sodium-free".

Interference with diagnostic tests

If you are due to undergo any diagnostic tests to assess parathyroid gland function, inform your doctor that you are being treated with Baripril Diu, as it may alter test results.

3. How to take Baripril Diu

Follow exactly the instructions for use of Baripril Diu as given by your doctor. If in doubt, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will determine the appropriate dose, depending on your condition and whether you are taking other medications.

The usual dose is one or two tablets taken once daily. Take Baripril Diu every day, exactly as directed by your doctor. It is very important to continue taking this medicine for the length of time recommended by your doctor. Do not take more tablets than the prescribed dose.

The initial dose may cause a greater drop in blood pressure than occurs with 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 advise you on the most appropriate dose.

Method of administration

This medicine is administered orally.

Take the Baripril Diu tablets with a glass of water. Baripril Diu may be taken before or after meals.

If you take more Baripril Diu than you should

If you have taken more Baripril Diu than you should, 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 taken.

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

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

If you forget to take Baripril Diu

You should take BARIPRIL DIU exactly as directed by your doctor.

Do not take a double dose to make up for forgotten doses. Simply take the next dose as usual.

If you stop taking Baripril Diu

Your doctor will advise you on how long your treatment with Baripril Diu should last. Do not stop treatment earlier, even if you feel better.

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

4. Possible adverse effects

Like all medicines, Baripril Diu may cause adverse effects, although not everyone experiences them.

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

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

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

Metabolism and nutrition disorders:

Common: elevated 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: 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: 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: drop in blood pressure associated with fainting, cardiac rhythm disturbances, angina pectoris, tachycardia (rapid heartbeat)

Uncommon: flushing, palpitations (rapid and irregular sensation of heartbeat), myocardial infarction or stroke, possibly secondary to excessive drop in blood pressure in high-risk patients (see section "Take special care with Baripril Diu")

Rare: changes in skin color 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 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, 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 failure, hepatic necrosis (which may be fatal), liver inflammation, suppression or cessation of bile secretion, yellowing of the skin or eyes, 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: skin redness, severe blistering or bleeding in the skin (Stevens-Johnson syndrome), severe skin redness/rash with skin and hair loss, skin peeling, appearance of red spots on the skin, skin disorders, skin redness, blister formation on the skin, Stevens-Johnson syndrome

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

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, 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: enlargement of the 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

* Observed only with hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Baripril Diu

† The classification of muscle spasms as "common" applies to hydrochlorothiazide doses of 12.5 mg and 25 mg, as found in Baripril Diu, although the actual frequency of this event is "uncommon".

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects: If you experience any type of adverse effect, consult 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 Baripril Diu

Keep out of the reach and sight of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Baripril Diu

The active substances are enalapril in the form of maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril and 12.5 mg of hydrochlorothiazide.

The other components are monohydrate lactose (lactose), sodium hydrogen carbonate (E-500), corn starch, pregelatinized corn starch (corn starch), magnesium stearate (E-470b), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Baripril Diu is supplied in packs of 28 tablets. The tablets are biconvex, elongated, yellow in colour, and scored on one side.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

KeVaRo Group Ltd

9 Tsaritsa Eleonora Str., office 23,

1618 Sofia

Bulgaria

Date of the most recent revision of this leaflet: September 2022

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/.