Enalapril Tarbis 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril Tarbis 5 mg tablets EFG

Enalapril maleate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Enalapril Tarbis 5 mg tablets are and what they are used for
2. What you need to know before taking Enalapril Tarbis 5 mg tablets
3. How to take Enalapril Tarbis 5 mg tablets
4. Possible side effects
5. How to store Enalapril Tarbis 5 mg tablets
6. Contents of the pack and other information

1. What Enalapril Tarbis 5 mg tablets are and what they are used for

Enalapril Tarbis belongs to a group of medicines known as angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Tarbis is indicated for:

• Treating hypertension (high blood pressure)
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

2. What you need to know before taking Enalapril Tarbis 5 mg tablets

Do not take Enalapril Tarbis

• If you are allergic to enalapril or to any of the other components of this medicine (listed in section 6).
• If you have previously been treated with a medicine from the same drug class as Enalapril Tarbis (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 been diagnosed with hereditary or idiopathic angioedema (a condition characterized by the development of large welts on the skin surface, especially around the eyes and lips, which may also affect hands, feet, and throat, and may cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).
• 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. (It is also advisable to avoid Enalapril 5 mg Tarbis 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, such as in the throat) is increased.
• If you are currently taking any of the following medicines, the risk of developing angioedema may increase:
  • Racecadotril, a medicine used to treat diarrhoea.
  • Medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

Warnings and precautions

Consult your doctor or pharmacist before taking Enalapril Tarbis

• If you have heart disease.
• If you have a condition affecting the blood vessels in the brain.
• If you have blood disorders such as low levels or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medicines that increase urine elimination).
• If you have recently experienced excessive vomiting or diarrhoea.
• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines associated with increased blood potassium levels (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problems (including kidney transplant), as these may lead to high blood potassium levels, which can be serious.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing. Please note that black patients are more susceptible to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis, or a desensitization treatment to reduce the effects of an allergy to bee or wasp stings.
• If you have low blood pressure (you may experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).
• If you have a vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are receiving immunosuppressive medicines, or are taking allopurinol, procainamide, or any combination of these.
• If you are taking any of the following medicines for high blood pressure (hypertension):
  • An angiotensin II receptor antagonist (ARA) (also known as "sartans" – for example, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to 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 Tarbis”.

You should inform your doctor if you think you are pregnant (or could be). Enalapril Tarbis is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

Please note that Enalapril Tarbis is less effective in lowering blood pressure in black patients compared to non-black patients.

In all these cases, inform your doctor, as you may require a dose adjustment, discontinuation of Enalapril Tarbis, or monitoring of your blood potassium levels. If you have diabetes and are taking oral antidiabetic medicines or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Enalapril Tarbis.

Before undergoing surgery or anaesthesia (including at the dentist's), inform your doctor or dentist that you are taking Enalapril Tarbis, as a sudden drop in blood pressure may occur in association with anaesthesia.

Taking Enalapril Tarbis with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Enalapril Tarbis. Your doctor may need to adjust your dose and/or take other precautions, such as temporarily stopping one of the treatments.

In particular, speak with your doctor or pharmacist if you are taking, have recently taken, or might need to take any of the following medicines:

: An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril Tarbis” and “Warnings and precautions”).

• Other antihypertensive medicines (lower elevated blood pressure)
• Diuretics (medicines that increase urine elimination)
• Potassium supplements (including 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).
• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (medicines used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anaesthetics
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold therapy
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

Taking Enalapril Tarbis with food, drinks, and alcohol

Food does not affect the absorption of Enalapril Tarbis.

Alcohol enhances the hypotensive effect (blood pressure lowering) of enalapril. Therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 Enalapril Tarbis before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Enalapril Tarbis is not recommended during early 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 onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Breastfeeding is not recommended in newborns (first weeks after birth) while taking Enalapril Tarbis, and especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking Enalapril Tarbis compared to other treatments during breastfeeding.

Driving and using machines

Individual responses to medication may vary.

Since Enalapril Tarbis may cause dizziness or fatigue, avoid performing tasks that require special attention (such as driving vehicles or operating machinery) until you know how you react to the medicine.

3. How to take Enalapril Tarbis 5 mg tablets

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

Enalapril Tarbis 5 mg is administered orally.

Remember to take your medicine.

Your doctor will tell you how long to take Enalapril Tarbis. Do not stop treatment prematurely.

Enalapril Tarbis may be taken with meals or between meals with a glass of water.

Your doctor will decide the appropriate dose of Enalapril Tarbis for you, depending on your condition and whether you are taking other medicines.

The recommended dose is:

Hypertension

For most patients, the usual recommended starting dose is 5 to 20 mg once daily. Some patients may require a lower initial dose.

The usual long-term dose is 20 mg once daily.

Heart failure

The usual recommended starting dose is 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for your case is reached. The usual long-term dose is 20 mg per day in one or two doses.

Extra precautions should be taken at the beginning of treatment due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think that the effect of Enalapril Tarbis 5 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Enalapril Tarbis than you should

If you take more Enalapril Tarbis than you should, consult your doctor or pharmacist immediately.

In case of overdose, the most likely symptom is dizziness or vertigo due to a sudden or excessive drop in blood pressure.

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.

If you forget to take Enalapril Tarbis

You should continue taking Enalapril Tarbis as prescribed. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Enalapril Tarbis may cause adverse effects, although not everyone experiences them.

Adverse effects have been classified according to the following frequency definitions:

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).

Blood and lymphatic system disorders:

Uncommon: anaemia (reduction in the number of red blood cells in the blood) (including aplastic and haemolytic anaemia).

Rare: blood disorders such as abnormally low neutrophil count (a type of blood cell), low haemoglobin levels, reduction or complete absence of granulocytes (a type of blood cell), deficiency of all blood cell elements, bone marrow depression (tissue inside the bone that produces blood cells), lymph node disease or abnormal immune response.

Metabolism and nutrition disorders:

Uncommon: low blood glucose levels (hypoglycaemia).

Nervous and psychiatric disorders:

Common: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensations, dizziness.

Rare: sleep disturbances, sleep problems.

Eye disorders:

Very common: blurred vision.

Cardiac and vascular disorders:

Very common: dizziness.

Common: drop in blood pressure (including orthostatic hypotension), fainting, chest pain, heart rhythm disturbances, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease in blood pressure when sitting or standing up), rapid and strong heartbeat, myocardial infarction or stroke possibly due to excessively low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain).

Rare: small arteries, usually in the fingers or toes, causing spasms that make the skin become pale or turn from red to blue (Raynaud's phenomenon).

Respiratory, thoracic and mediastinal disorders:

Very common: cough.

Common: difficulty breathing.

Uncommon: runny nose, sore throat and hoarseness, asthma.

Rare: fluid in the lungs, inflammation of the nasal mucous membrane, allergic inflammation of the lungs.

Gastrointestinal disorders:

Very common: nausea.

Common: diarrhoea, abdominal pain, altered taste.

Uncommon: intestinal obstruction, inflammation of the pancreas, vomiting, indigestion, constipation, anorexia, gastric irritation, dry mouth, peptic ulcer.

Rare: mouth inflammation and ulcers, inflammation of the tongue.

Very rare: intestinal angioedema (swelling in the intestine).

Hepatobiliary disorders:

Rare: liver failure, inflammation of the liver (hepatitis), reduced or obstructed flow of bile from the bile duct to the liver (cholestasis), including yellowing of the skin (jaundice).

Skin and subcutaneous tissue disorders:

Common: skin rash, hypersensitivity or allergic reaction causing swelling of the face, limbs, lips, tongue, glottis and larynx.

Uncommon: sweating, pruritus (itching sensation), urticaria (red, itchy swellings), hair loss.

Rare: severe skin reaction, including excessive redness of the skin, blisters, peeling of the skin.

A symptomatic complex has been observed which may include some of the following reactions: fever, inflammation of blood vessels, muscle and joint pain and swelling, blood disorders affecting blood components and usually detected in a blood test, skin rash, photosensitivity and other skin effects.

Renal and urinary disorders:

Uncommon: reduced kidney function or kidney failure, presence of protein in the urine.

Rare: decreased amount of urine produced per day.

Reproductive system and breast disorders:

Uncommon: impotence.

Rare: breast enlargement in men.

General disorders and administration site conditions:

Very common: weakness.

Common: fatigue.

Uncommon: muscle cramps, flushing, tinnitus (ringing in the ears), general malaise, fever.

Clinical laboratory tests:

Common: high levels of potassium in blood, increased creatinine levels in blood.

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

Rare: increased liver enzymes, increased bilirubin levels in blood.

Stop taking Enalapril Tarbis and consult your doctor immediately if any of the following occur:

• If your face, lips, tongue and/or throat swell so much that you have difficulty breathing or swallowing.
• If your hands, feet or ankles swell.
• If you develop urticaria (itching and redness in certain areas of the body).

Please note that black patients are more susceptible to these types of adverse reactions.

Reporting of adverse effects

If you experience any 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 at Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enalapril Tarbis 5 mg tablets

Keep Enalapril Tarbis 5 mg out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to 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 Point in your pharmacy. If you are unsure, ask your pharmacist how to properly 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 Enalapril Tarbis

• The active substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other components (excipients) are: pregelatinized corn starch, microcrystalline cellulose (E-460i), silicon dioxide (E-551), sodium bicarbonate, and magnesium stearate.

Appearance of the medicine and contents of the pack

Enalapril Tarbis is presented as white, flat, scored tablets on one side. Each pack contains 10 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Manufacturer:

Laboratorios Medicamentos Internacionales, S.A.

Solana, 26

28850 Torrejón de Ardoz (Madrid), Spain

or

FERRER INTERNACIONAL, S.A.

Joan Buscallà, 1-9

08173 Sant Cugat del Vallès (Barcelona), Spain

Date of the most recent review of this leaflet: May 2019

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/