ENIT 10 mg/20 mg TABLETS

Introduction

Package Leaflet: Information for the User

ENIT 10 mg/20 mg tablets

Enalapril maleate/Nitrendipine

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Enit is and what it is used for
2. What you need to know before you take Enit
3. How to take Enit
4. Possible side effects
5. Storage of Enit
6. Contents of the pack and other information

1. What Enit is and what it is used for

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

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

2. What you need to know before you take Enit

Do not take Enit

• If you are allergic (hypersensitive) to enalapril maleate, nitrendipine or any of the other ingredients of this medicine (see section 6).
• If you have had allergic reactions to similar medicines.
• If you are pregnant for more than 3 months. (It is also best to avoid Enit in the early stages of pregnancy – see section on pregnancy and breastfeeding).
• If you have cardiovascular shock, heart failure, and if you have been diagnosed with angina pectoris, myocardial infarction or cerebral infarction in the previous days.
• If you have severe renal impairment or are undergoing hemodialysis.
• If you have severe hepatic impairment.
• If you have diseases caused by narrowing of the heart valves.
• If you have narrowing of the renal arteries.
• If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• In the case of children and adolescents.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 medicines, the risk of suffering from angioedema may increase:

• Racecadotril, a medicine used to treat diarrhea.
• Medicines used to prevent organ rejection and cancer (e.g., temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.

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

Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole for bacterial infections; cyclosporin, an immunosuppressive medicine used to prevent organ rejection; and heparin, a medicine used to thin the blood to prevent clots).

Warnings and precautions

Talk to your doctor before starting to take Enit.

• If you experience swelling of the face, lips, tongue and/or larynx, you should stop treatment immediately 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 therapy that reduces the body's defense system (immunosuppressive therapy) and/or are receiving treatment with allopurinol or procainamide, 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 it necessary to perform certain tests during treatment with this medicine.
• If you have mild or moderate liver function impairment.
• If you think you may be pregnant (or might become pregnant), you should inform your doctor. Enit is not recommended during the first months of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used during this stage (see section on pregnancy and breastfeeding).
• If you experience fever or infection during treatment, you should 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 suffer from life-threatening hypersensitivity reactions. Your doctor should temporarily replace Enit with another medicine for high blood pressure.
• If you experience side effects at the start of treatment
• If you lose fluids due to the use of diuretic medicines, diarrhea or vomiting; due to a low-salt diet, or for other reasons, as you may feel dizzy when changing positions abruptly.
• If you are taking any of the following medicines used to treat high blood pressure:
• • An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • Aliskiren

Your doctor may check 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 ENIT”.

Talk to your doctor, even if any of the above circumstances have occurred to you at any time

During treatment with Enit, your doctor will perform medical tests on you regularly. Keep your scheduled medical appointments.

Taking Enit with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Your doctor may need to change 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 medicines for the treatment of high blood pressure.

• Do not takeEnit with
• • Potassium-sparing diuretics (a type of diuretic that can increase potassium levels).
  • Potassium supplements (salt substitutes that contain potassium).
  • Or other medicines that increase potassium levels in the blood.

• Be carefulif you are being treated with any of the following medicines:
• • Lithium (a medicine used to treat some types of psychiatric diseases).
  • Muscle relaxants (a type of medicine used to relieve symptoms such as muscle spasms).
  • Non-steroidal anti-inflammatory drugs (a type of medicine used to relieve pain, swelling, and other symptoms of inflammation).
  • Oral antidiabetics.
  • Baclofen (a medicine used to treat spasticity).
  • Antipsychotics (a type of medicine used to treat some types of psychiatric disorders).
  • Antidepressants.
  • Allopurinol (a medicine used to treat chronic gout).
  • Cytostatics (a type of medicine used to treat malignant diseases, such as cancer).
  • Immunosuppressants (a type of medicine used to induce suppression of the immune system (used to prevent organ rejection)).
  • Systemic glucocorticoids
  • Procainamide (a medicine used to treat cardiac arrhythmias).
  • Amifostine (a medicine used during the treatment of some types of malignant diseases, such as cancer).
  • Cimetidine (a medicine used to treat duodenal or gastric ulcers).
  • Ranitidine (a medicine used to treat duodenal or gastric ulcers).
  • Digoxin (a medicine used to treat congestive heart failure).
  • Anticonvulsants
  • Rifampicin (an antibiotic).
  • And medicines for the treatment of fungal infections.

Taking Enit with food and drinks

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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are (or think you may be) pregnant. Your doctor will normally advise you to stop treatment with Enit before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enit. Enit is not recommended during the early stages of pregnancy, and it should not be taken if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. Enit is not recommended for mothers who are breastfeeding, and your doctor should 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 of Enit, has been associated with altered sperm function. In men, in cases where repeated paternity failure of in vitro fertilization occurs, and when there is no other explanation, Enit may be considered as a possible cause.

Driving and using machines

This medicine may affect your ability to drive or use machines at the start of treatment, so caution is recommended during this period.

Enit contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Enit

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of treatment with Enit. Do not stop treatment before.

The recommended dose is 1 tablet per day, swallowed with a little water. The tablets should be taken whole, without splitting or chewing them.

If you take more Enit than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Enit

Do not take a double dose to make up for forgotten doses.

If you stop treatment with Enit

Do not stop treatment unless your doctor tells you to.

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

4. Possible side effects

Like all medicines, Enit can cause side effects, although not everybody gets them.

• Common side effects (frequent, 1-10%):headache, facial flushing, cough, and swelling of the legs.
• Uncommon side effects (0.1-1%):dizziness, tachycardia, flushing, nausea, gastrointestinal disorders, and hypotension.
• Very rare (<0.01%):Isolated cases of weakness, hypothermia, palpitations, peripheral ischemia, blood in urine, pharyngitis, tracheitis, respiratory distress, abdominal distension, alteration of liver function tests, alteration of potassium levels in blood, somnolence, tingling sensation, tremor, and muscle cramps.

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

General:

Occasionally: flu-like symptoms.

Cardiovascular 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: impaired renal function.

Rarely (including isolated cases): oliguria (deficient urine production), proteinuria (presence of proteins in urine), urinary urgency, increased urine output, 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 tract/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 cholestatic jaundice (yellowing of the skin and mucous membranes due to bile duct obstruction) and progresses to hepatic necrosis with fatal results in some cases).

Skin, blood vessels:

Occasionally: allergic skin reactions.

Rarely (including isolated cases): urticaria, pruritus, severe skin reactions, psoriatic-like eruptions, photosensitivity, diaphoresis (excessive sweating), hair loss, onycholysis (nail detachment), skin reactions that may be associated with fever, sudden swelling of the face, mouth, and/or limbs, inflammation of blood vessels, 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).

Senses 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, modified uric acid levels.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Enit

No special storage conditions are required.

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

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Composition of Enit

• The active ingredients 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, corn starch, povidone, sodium lauryl sulfate, and magnesium stearate.

Appearance of the Product and Package Contents

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

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: CENIPRES 10 mg/20 mg Tabletten

Greece: ENIT 10 mg/20 mg δισκ?α

Spain: ENIT 10 mg/20 mg tablets

Date of the last revision of this leaflet: March 2019

Version: March 2019

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.