Leaflet: Information for the user

ENIT 10 mg/20 mg tablets

Enalapril maleate/Nitrendipine

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Enalapril maleate belongs to a group of medications known as angiotensin-converting enzyme inhibitors (ACE inhibitors). Nitrendipine belongs to a group of medications known as calcium channel blockers.

It is indicated for the treatment of essential hypertension in patients who are not adequately controlled with enalapril or nitrendipine alone.

Do not take Enit

• If you are allergic (hypersensitive) to enalapril maleate, nitrendipine, or any of the other components of this medication (see composition in section 6).
• If you have had allergic reactions to similar medications.
• If you are more than 3 months pregnant. (It is also best to avoid Enit in the early stages of pregnancy – see pregnancy and breastfeeding section).
• If you have cardiovascular shock, heart failure, and if you have been diagnosed with angina pectoris, myocardial infarction, or cerebral infarction in the past few days.
• If you have severe kidney failure or are undergoing hemodialysis.
• If you have severe liver failure.
• If you have diseases caused by narrowing of the heart valves.
• If you have narrowing of the renal arteries.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskiren.
• In children and adolescents.
• If you have taken or are currently taking sacubitril/valsartan, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

If you are taking any of the following medications, the risk of angioedema may increase:

•Racecadotril, a medication used to treat diarrhea.

•Medications used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus).

•Vildagliptin, a medication used to treat diabetes.

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any of the following medications:

Supplements of potassium (including salt substitutes) and other medications that may increase blood potassium levels (e.g., trimetoprima and cotrimoxazol for bacterial infections; ciclosporina, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medication used to dilute blood to prevent clots).

Warnings and precautions

Consult your doctor before starting to take Enit.

• If you experience swelling of the face, lips, tongue, and/or larynx, you must immediately stop treatment and inform your doctor immediately.
• If you have a disease of the connective tissue affecting the vascular system (vascular collagen disease), if you are receiving immunosuppressive therapy, and/or receiving alopurinol or procainamida treatment, especially if you have impaired renal function. Your doctor will regularly monitor your white blood cell count.
• If you have kidney disease, your doctor may consider performing certain tests during treatment with this medication.
• If you have mild or moderate liver impairment.
• If you think you may be pregnant (or could become pregnant), you must inform your doctor. Enit is not recommended in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage (see pregnancy and breastfeeding section).
• If you experience fever or infection during treatment, inform your doctor as soon as possible.
• If you have heart problems
• If you are being treated due to a severe metabolic disorder (LDL-apheresis) or due to an allergic reaction to insect bites (immune therapy), as you may experience hypersensitivity reactions that can put your life at risk. Your doctor must temporarily substitute Enit with another medication for high blood pressure.
• If you experience side effects at the beginning of treatment
• If you experience fluid loss due to diuretic medication, diarrhea, or vomiting; due to a low-sodium diet, or for other reasons, as you may experience dizziness when changing positions suddenly.
• 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" - e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • Aliskiren

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

• See also the information under the heading “Do not take Enit”.

Inform your doctor, even if any of the circumstances mentioned above have occurred at any time

During treatment with Enit, your doctor will perform regular medical tests. Follow the scheduled doctor's visits established by your doctor.

Enit with other medications

Inform your doctor or pharmacist if you are taking, or have taken recently, any other medication, even those purchased without a prescription.

Your doctor may need to modify your dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings “Do not take Enit” and “Warnings and precautions”).

Enit may increase the effect of other medications for high blood pressure treatment.

• Do not takeEnit with
• • potassium-sparing diuretics (a type of diuretic that can increase potassium levels).
  • potassium supplements (salt substitutes containing potassium).
  • or other medications that increase plasma potassium levels.

• Be cautiousif you are being treated with any of the following medications:
• • Lithium (a medication used to treat certain psychiatric disorders.
  • Muscle relaxants (a type of medication used to alleviate symptoms such as muscle spasms).
  • Nonsteroidal anti-inflammatory drugs (a type of medication used to alleviate pain, swelling, and other symptoms of inflammation).
  • Oral antidiabetics.
  • Baclofen (a medication used to treat spasticity).
  • Antipsychotics (a type of medication used to treat certain psychiatric disorders).
  • Antidepressants.
  • Alopurinol (a medication used to treat chronic gout).
  • Cytostatics (a type of medication used to treat malignant diseases, such as cancer).
  • Immunosuppressants (a type of medication used to suppress the immune system, used to prevent organ transplant rejection).
  • Systemic glucocorticoids
  • Procainamide (a medication used to treat cardiac arrhythmias).
  • Amifostina (a medication used during the treatment of certain malignant diseases, such as cancer).
  • Cimetidine (a medication used to treat duodenal or gastric ulcers).
  • Ranitidine (a medication used to treat duodenal or gastric ulcers).
  • Digoxin (a medication used to treat congestive heart failure).
  • Anticonvulsants
  • Rifampicin (an antibiotic).
  • and medications used to treat fungal infections.

Enit with food and beverages

Enit can be taken with meals.

Do not take grapefruit juice at the same time as Enit.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You must inform your doctor if you are (or think you may be) pregnant. Your doctor will usually advise you to stop taking Enit before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medication instead of Enit. Enit is not recommended in the early stages of pregnancy, and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage (see pregnancy and breastfeeding section).

Breastfeeding

Inform your doctor if you are breastfeeding or plan to start. Enit is not recommended for breastfeeding mothers, and your doctor must prescribe another treatment if you plan to be in this situation, especially if your baby is newborn or premature.

Fertility

In isolated cases of in vitro fertilization, nitrendipine, one of the active substances in Enit, has been associated with altered sperm function. In men, in cases where repeated failed paternity of in vitro fertilization occurs, and there is no other explanation, Enit may be considered as a possible cause.

Driving and operating machinery

This medication may affect your ability to drive or operate machinery at the beginning of treatment, so caution is recommended at this stage.

Enit contains lactose

If your doctor has indicated that you have intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of treatment with Enit. Do not discontinue treatment before.

The recommended dose is 1 tablet per day, taken with a little water. Tablets must be swallowed whole, without breaking or chewing them.

If you take more Enit than you should

If you have taken more Enit than you should, you may experience excessive lowering of blood pressure.

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.

If you forgot to take Enit

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

If you interrupt treatment with Enit

Do not discontinue treatment unless your doctor instructs you to.

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

Like all medicines, Enit can cause side effects, although not everyone will experience them.

• Frequent side effects (1-10%):headache, facial flushing, cough, and leg swelling.
• Less common side effects (0.1-1%):dizziness, tachycardia, flushing, nausea, digestive discomfort, and hypotension.
• Very rare (<0.01%):isolated cases of weakness, hypothermia, palpitations, peripheral ischemia, hematuria, pharyngitis, tracheitis, respiratory difficulty, abdominal distension, altered liver function tests, altered potassium levels in the blood, somnolence, paresthesia, tremors, and muscle cramps.

The following side effects may occur since they have been associated with the use of any of the active substances (Enalapril or Nitrendipino) in monotherapy:

General:

Occasionally: flu-like symptoms.

Circulatory system:

Occasionally: heart failure, hypertension, loss of consciousness, arrhythmias, vasodilation.

Rarely (including isolated cases): angina pectoris, chest pain, myocardial infarction, vascular occlusion due to a blood clot, pulmonary embolism.

Kidney:

Occasionally: renal function deterioration.

Rarely (including isolated cases): oliguria (insufficient urine production), proteinuria (presence of proteins in the urine), urinary urgency, increased urine volume, flank pain.

Respiratory tract:

Occasionally: sore throat, hoarseness, bronchitis.

Rarely (including isolated cases): bronchospasm/asthma, pulmonary infiltrates, pneumonia, paranasal sinusitis (inflammation of the paranasal sinuses), common cold, sudden swelling of the pharynx with fatal respiratory constriction in individual cases, with a higher incidence in black patients.

Gastrointestinal / liver:

Occasionally: upper abdominal pain, diarrhea.

Rarely (including isolated cases): constipation, loss of appetite, hepatitis, altered liver function, pancreatitis, ileus (a syndrome that begins with jaundice and progresses to hepatic necrosis with fatal outcomes in some cases).

Skin, blood vessels:

Occasionally: skin allergic reactions.

Rarely (including isolated cases): urticaria, pruritus, severe skin reactions, psoriatic-like rash, photosensitivity, diaphoresis (excessive sweating), hair loss, onycholysis (nail detachment), skin reactions associated with fever, sudden facial, oral, and/or limb swelling, vascular inflammation, skin inflammation.

Nervous system:

Rarely (including isolated cases): somnolence, depression, sleep disorders, impotence, balance disorders, muscle cramps, nervousness, confusion.

Endocrine:

Rarely (including isolated cases): gynecomastia (abnormal development of the male breast gland).

Sensory organs:

Rarely (including isolated cases): changes in taste perception or transient loss of taste, anosmia (loss of sense of smell), tinnitus (ringing or buzzing in the ears), dry eyes, tearing.

Musculoskeletal:

Rarely (including isolated cases): myalgia (muscle pain), arthralgia (joint pain).

Laboratory parameters:

Occasionally: changes in blood cell count, altered uric acid levels.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the blister and on the box after CAD. The expiration date is the last day of the month indicated.

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

Composition of Enit

• The active principles are enalapril maleate and nitrendipine. Each tablet contains 10 mg of enalapril maleate and 20 mg of nitrendipine.
• The other components are sodium hydrogen carbonate, lactose monohydrate, microcrystalline cellulose, cornstarch, povidone, sodium lauryl sulfate, magnesium stearate.

Appearance of the product and contents of the package

The tablets are yellow, oblong, and biconvex, with the imprint “E/N” on one side. Enit is presented in packages of 20, 30, 50, 60, 100, 300, and 500 tablets.

All package sizes may not be marketed.

Holder of the marketing authorization and responsible manufacturer

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:CENIPRES 10 mg/20 mg Tabletten

Germany:ENIT 10 mg/20 mg Tabletten

Greece:ENIT 10 mg/20 mg δισκ?α

Luxembourg:ENIT 10 mg/20 mg comprimés

Portugal:ENIT 10 mg/20 mg Comprimidos

Spain:ENIT 10 mg/20 mg comprimidos

Last review date of this leaflet: March 2019

Version: March 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.