Enalapril Stada 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enalapril STADA 5 mg tablets EFG

Enalapril maleate

Read all of this 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 only, 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 experience any adverse effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Enalapril STADA is and what it is used for
2. What you need to know before taking Enalapril STADA
3. How to take Enalapril STADA
4. Possible adverse effects
5. How to store Enalapril STADA
6. Contents of the pack and other information

1. What Enalapril Stada is and what it is used for

Enalapril Stada belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Stada 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 Stada

Do not take Enalapril Stada:

• 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 (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 hives on the skin surface, especially around the eyes and lips, which may also affect the 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• if you are more than three months pregnant. (It is also advisable to avoid enalapril 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 high.

Warnings and precautions

Consult your doctor or pharmacist before starting Enalapril Stada.

• if you have heart disease.
• if you have a disease 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 diabetes mellitus or any kidney problems (including kidney transplant), as these may lead to high potassium levels in the blood, which can be serious.
• 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 diarrhea.
• if you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, or 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 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 LDL apheresis treatment or desensitization therapy 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 collagen vascular disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with 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" – e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren
• if you are using any of the following medicines, the risk of angioedema (rapid swelling beneath the skin, such as in the throat) may increase:
  • racecadotril, a medicine used to treat diarrhea
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus) and other medicines in the class of mTOR inhibitors
• vildagliptin, a medicine used to treat diabetes

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 Stada”.

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

Please note that enalapril 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, 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.

Before undergoing surgery or anesthesia (including at the dentist), inform the doctor or dentist that you are taking enalapril, as there may be a sudden drop in blood pressure associated with anesthesia.

Other medicines and Enalapril Stada

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Certain medicines may interact with enalapril; in such cases, your doctor may need to adjust your dose and/or take other precautions.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also information under the headings “Do not take Enalapril Stada” and “Warnings and precautions”)
• Other antihypertensive medicines (reduce high blood pressure)
• Diuretics (medicines that increase urine elimination)
• Potassium-containing medicines (including dietary salt substitutes)
• Lithium (a medicine used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Medicines for diabetes (including oral antidiabetics and insulin)
• 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)

This is especially important if you are also taking:

• Medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitor class medicines). See section “Warnings and precautions”.
• Potassium supplements (including salt substitutes), diuretics (water pills, especially potassium-sparing types), 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 and prevent clots).

Taking Enalapril Stada with food, drinks, and alcohol

Food does not affect the absorption of enalapril.

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, breastfeeding, think you might 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 might be). Your doctor will usually advise you to stop taking enalapril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Enalapril is not recommended in early pregnancy and must not be taken after the first three 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. Breastfeeding is not recommended in newborns (first weeks after birth) while taking enalapril, especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking enalapril versus other treatments while breastfeeding.

Driving and using machines

Individual responses to medication may vary.

Since enalapril may cause dizziness or fatigue, avoid performing tasks requiring special attention (such as driving or operating machinery) until you know how you tolerate the medicine.

Enalapril Stada contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Enalapril Stada

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

Your doctor will determine how long you should take enalapril. Do not stop treatment prematurely.

Enalapril Stada may be taken with meals or between meals, together with a glass of water.

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

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 condition is reached. The usual long-term dose is 20 mg daily, taken in one or two divided doses.

Particular caution is required 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 is too strong or too weak, tell your doctor or pharmacist.

If you take more Enalapril Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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

If you forget to take Enalapril Stada

Continue taking enalapril exactly as prescribed. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse reactions reported for enalapril are detailed below:

Frequencies are defined as follows: very common (affects more than 1 in 10 people); common (affects between 1 and 10 in 100 people); uncommon (affects between 1 and 10 in 1,000 people); rare (affects between 1 and 10 in 10,000 people); very rare (affects fewer than 1 in 10,000 people).

Blood and lymphatic system disorders

Uncommon: anaemia (including aplastic and haemolytic anaemia).

Rare: blood disorders such as abnormally low neutrophil count, low haemoglobin levels, reduction or complete absence of granulocytes, deficiency of all blood cell components, bone marrow depression, lymph node disease or abnormal immune response.

Metabolism and nutrition disorders

Uncommon: low blood glucose levels (hypoglycaemia).

Nervous system and psychiatric disorders

Common: headache, depression.

Uncommon: confusion, drowsiness or inability to sleep, nervousness, tingling or numbness sensation, 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, irregular heartbeat, angina pectoris, rapid heartbeat.

Uncommon: orthostatic hypotension (decrease in blood pressure when sitting or standing up), rapid and forceful 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, which cause spasms leading to pale skin or red to blue discoloration (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: inflammation and ulcers of the mouth, inflammation of the tongue.

Very rare: intestinal angioedema (intestinal swelling)

Hepatobiliary disorders

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

A symptomatic complex has been observed which may include one or more 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 renal failure, presence of protein in the urine. Rare: reduced daily urine output.

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, ringing in the ears, general malaise, fever.

Clinical laboratory tests

Common: high potassium levels 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 STADA and consult your doctor immediately if any of the following occur:

• If your face, lips, tongue and/or throat swell so that it is difficult for you to breathe or swallow.
• If your hands, feet or ankles swell.
• If you develop urticaria (itching and redness in certain areas of the body).

Please note that patients of black race are more susceptible to these types of adverse reactions. If you notice any other reaction not described in this leaflet, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Enalapril Stada

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. Doing so helps protect the environment.

6. Contents of the pack and other information

Composition of Enalapril Stada

• The active substance is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other components are monohydrate lactose, sodium hydrogen carbonate, corn starch, and magnesium stearate.

Appearance of the product and contents of the pack

Enalapril Stada 5 mg is presented as white, round, flat-faced bevelled tablets, with a score on one side and the imprint “5” on the other.

The score is intended only to facilitate breaking and swallowing, but not for dividing into equal doses.

Each pack contains 10, 60 or 500 tablets (hospital pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

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

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