Enit 10 mg/20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ENIT 10 mg/20 mg tablets

Enalapril maleate/Nitrendipine

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

Leaflet contents:

1. What Enit is and what it is used for
2. What you need to know before taking Enit
3. How to take Enit
4. Possible adverse effects
5. How to store 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 antagonists.

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 taking Enit

Do not take Enit

• If you are allergic (hypersensitive) to enalapril maleate, nitrendipine, or to any of the other components of this medicine (see composition in section 6).
• If you have had allergic reactions to similar medicines.
• If you are more than 3 months pregnant. (It is also advisable to avoid Enit during early pregnancy – see pregnancy and breastfeeding section).
• If you suffer from cardiovascular shock, heart failure, or if you have been diagnosed in the previous days with angina pectoris, myocardial infarction, or cerebral infarction.
• If you have severe renal failure or are undergoing hemodialysis.
• If you have severe hepatic impairment.
• If you have heart valve diseases caused by narrowing of the heart valves.
• If you have renal artery stenosis.
• If you have diabetes or renal failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• In children and adolescents.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, e.g., in the throat) is high.

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

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

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:

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

Warnings and precautions

Talk to your doctor before starting Enit.

• If you experience swelling of the face, lips, tongue, and/or larynx, you must stop treatment immediately and contact your doctor without delay.
• If you have a connective tissue disorder affecting the blood vessels (collagen vascular disease), if you are receiving therapy that suppresses the body's immune system (immunosuppressive therapy), and/or are receiving treatment with allopurinol or procainamide, especially if you have impaired kidney 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 impairment of liver function.
• If you think you are pregnant (or could become pregnant), you must inform your doctor. Enit is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see pregnancy and breastfeeding section).
• If you develop fever or infection during treatment, you must inform your doctor as soon as possible.
• If you have heart problems.
• If you are undergoing treatment for a serious metabolic disorder (LDL apheresis) or for allergic reactions to insect bites (immunotherapy), as you may experience life-threatening hypersensitivity reactions. Your doctor should temporarily replace Enit with another medicine for high blood pressure.
• If you experience side effects at the beginning of treatment.
• If you have fluid loss due to diuretic use, diarrhea, or vomiting; a low-salt diet; or other causes, as you may feel dizzy when changing position suddenly.
• 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.

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

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

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

During treatment with Enit, your doctor will perform regular medical checks. Make sure to attend all scheduled medical appointments.

Taking Enit with other medicines

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

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

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

Enit may enhance the effect of other medicines used to treat high blood pressure.

• Do not take Enit with:

  • potassium-sparing diuretics (a type of diuretic that may increase potassium levels).
  • potassium supplements (potassium-containing salt substitutes).
  • or other medicines that increase plasma potassium levels.

• Exercise special caution if you are being treated with any of the following medicines:

  • Lithium (a medicine used to treat certain psychiatric disorders).
  • muscle relaxants (medicines used to relieve symptoms such as muscle spasms).
  • non-steroidal anti-inflammatory drugs (medicines used to relieve pain, swelling, and other symptoms of inflammation).
  • oral antidiabetics.
  • baclofen (a medicine used to treat spasticity).
  • antipsychotics (medicines used to treat certain psychiatric disorders).
  • antidepressants.
  • allopurinol (a medicine used to treat chronic gout).
  • cytostatics (medicines used to treat malignant diseases such as cancer).
  • immunosuppressants (medicines used to suppress the immune system, e.g., to prevent transplant rejection).
  • systemic glucocorticoids.
  • procainamide (a medicine used to treat cardiac arrhythmias).
  • amifostine (a medicine used during treatment of certain malignant diseases such as cancer).
  • cimetidine (a medicine used to treat duodenal and 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 used to treat fungal infections.

Taking Enit with food and drink

Enit may be taken with meals.

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

Pregnancy, breastfeeding, and fertility

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

You must inform your doctor if you are (or think you might be) pregnant. Your doctor will usually advise you to stop treatment with Enit before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Enit. Enit is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start. Enit is not recommended for breastfeeding mothers, and your doctor should prescribe an alternative treatment if you are in this situation, especially if your baby is a newborn or premature.

Fertility

In isolated cases of in vitro fertilization, nitrendipine, one of the active substances in Enit, has been associated with impaired sperm function. In men experiencing repeated failure of in vitro fertilization with no other explanation, Enit may be considered a possible cause.

Driving and using machines

This medicine may affect your ability to drive or operate machinery at the beginning of treatment. Caution is therefore advised during this period.

Enit contains lactose

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

3. How to take Enit

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

Remember to take your medicine.

Your doctor will tell you how long to take treatment with Enit. Do not stop treatment earlier.

The recommended dose is 1 tablet per day, taken with a little water. The tablets must be swallowed 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 experience excessive lowering of blood pressure.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating 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 interrupt treatment unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, Enit may produce adverse effects, although not everyone experiences them.

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

The following adverse reactions may occur as they have been associated with the use of either of the active substances (Enalapril or Nitrendipine) when used as 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 blood clot, pulmonary embolism.

Kidney:

Occasionally: worsening of renal function.

Rarely (including isolated cases): oliguria (inadequate urine production), proteinuria (presence of proteins in urine), urinary urgency, increased volume of excreted urine, 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 beginning with cholestatic jaundice (yellowing of the skin and mucous membranes due to obstruction of the bile duct) and progressing 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, psoriasis-like rash, photosensitivity, diaphoresis (excessive sweating), hair loss, onycholysis (nail detachment), skin reactions that may be accompanied by fever, sudden swelling of the face, mouth and/or extremities, inflammation of blood vessels, skin inflammation.

Nervous system:

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

Endocrine system:

Rarely (including isolated cases): gynecomastia (abnormal development of 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 (noise or ringing 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 of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 (www.notificaram.es). By reporting adverse 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 stated on the blister and the outer carton after EXP. The expiry date refers to the last day of the month indicated.

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

6. Package contents and additional information

Composition of Enit

• The active substances 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, maize starch, povidone, sodium lauryl sulfate, magnesium stearate.

Presentation of the product and contents of the pack

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

Not all pack 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 comprimidos

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

Version: March 2019

Detailed and up-to-date 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/.