ENALAPRIL 20 mg Таблетка

Содержание инструкции

1. Enalapril Sandoz 5 mg tablets, 20 mg tablets
   1. What is Enalapril Sandoz and what is it used for
   2. What you need to know before taking Enalapril Sandoz
   3. How to take Enalapril Sandoz
   4. Possible side effects
   5. How to store Enalapril Sandoz
   6. Package Contents and Other Information

Enalapril Sandoz 5 mg tablets, 20 mg tablets

enalapril maleate

Generic medicine

Read this leaflet carefully before 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

• Enalapril Sandoz contains enalapril maleate. Enalapril belongs to a group of medicines known as ACE inhibitors, which work by widening blood vessels. The effect of these drugs is to reduce blood pressure.
• Enalapril Sandoz is used to treat high blood pressure (hypertension).
• Enalapril is also used to treat a heart condition sometimes referred to as "heart failure". This means that the heart does not work as well as it should to pump blood around the body, which causes a feeling of tiredness after mild activity, shortness of breath and swelling of the ankles and feet. Enalapril Sandoz can help to treat these symptoms.
• In many patients with damage to the heart muscle, but without symptoms, Enalapril Sandoz can help to prevent the development of symptoms such as shortness of breath and swelling.

2. What you need to know before taking Enalapril Sandoz

Do not take Enalapril Sandoz

• If you are allergic to
• enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
• other ACE inhibitors. The signs may have been itching, hives, difficulty breathing or swelling of the hands, throat, mouth or eyelids.
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).
• if you are more than 3 months pregnant (it is best to avoid Enalapril Sandoz even at the beginning of pregnancy - see section “Pregnancy”)
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren. If any of the above situations apply to you, do not take Enalapril Sandoz. If you are not sure, ask your doctor or pharmacist before taking Enalapril Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Enalapril Sandoz:

• if you suffer from kidney disorders, have recently had a kidney transplant, are a patient undergoing dialysis or are taking diuretics
• if you are following a low-salt diet or have recently suffered from severe vomiting or diarrhea
• if you suffer from a heart condition called “aortic stenosis”, “hypertrophic cardiomyopathy” or “outflow obstruction”
• if you suffer from a collagen vascular disease or are undergoing immunosuppressive therapy (used for the treatment of autoimmune diseases such as rheumatoid arthritis or following surgical transplantation)
• if you are taking allopurinol (used for the treatment of gout) or procainamide (used for the treatment of heart rhythm abnormalities). If you develop an infection (whose symptoms may be high temperature or fever) inform your doctor immediately. The latter may prescribe you periodic blood tests to check the white blood cell count
• if you have had “angioedema” in the past caused by taking other medicines. The signs may have been itching, hives, difficulty breathing or swelling of the hands, throat, mouth or eyelids
• if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased: racecadotril, a medicine used to treat diarrhea.
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors
• vildagliptin (a medicine used to treat diabetes).
• if you suffer from diabetes and are taking antidiabetic drugs, including insulin, to control diabetes (in this case it is necessary to monitor blood for low glucose levels, especially during the first month of treatment)
• if you are taking potassium supplements, diuretics, salt substitutes containing potassium or other medicines that may increase potassium in the blood (e.g. trimethoprim and

cotrimoxazole for infections caused by bacteria; cyclosporine, a medicine
immunosuppressant used to prevent organ transplant rejection and heparin, a
medicine used to thin the blood to prevent the formation of clots)

• if you are taking lithium, used to treat some mental disorders
• if you are taking one of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes.
• aliskiren The doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also what is stated under “Do not take Enalapril Sandoz”.
• If your doctor has diagnosed you with an intolerance to certain sugars

If you develop any of the following symptoms during treatment with Enalapril Sandoz, tell your
doctor immediately:

• jaundice (yellowing of the skin and whites of the eyes)
• dry, persistent cough for a long period of time

If you are going to undergo any of the following procedures, tell your doctor that you are
taking Enalapril Sandoz:

• any surgery or administration of anesthetics (even from the dentist)
• a treatment called “LDL-apheresis”, to remove cholesterol from the blood using a special device
• a desensitizing treatment, to reduce the effects of an allergy to bee or wasp stings.

Routine tests
At the beginning of treatment with Enalapril Sandoz, your doctor will frequently check your blood
pressure to make sure you are receiving the correct dosage. In some patients, the doctor may also
decide to perform some tests to measure levels of potassium, creatinine and liver enzymes.
Pregnancy
Tell your doctor or pharmacist before taking Enalapril Sandoz if you think you are pregnant (or
may become pregnant). Enalapril Sandoz is not recommended at the beginning of pregnancy and should
not be taken if you are pregnant for more than 3 months, as it can cause serious harm to the baby (see
section Pregnancy).

Breastfeeding
If you are breastfeeding, or are about to start breastfeeding, tell your doctor. During
treatment with Enalapril Sandoz, breastfeeding of newborns (in the first few weeks after
birth), especially premature babies, is not recommended. In the case of an older child, the doctor
should inform you about the benefits and risks of taking Enalapril Sandoz during breastfeeding
compared to other treatments.

Driving and operating machinery
Some side effects, such as dizziness and fatigue, have been reported with Enalapril Sandoz,
which in some patients may impair the ability to drive or operate machinery.

Enalapril Sandoz contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

Enalapril Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
'sodium-free'.

3. How to take Enalapril Sandoz

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have doubts, ask your doctor or pharmacist.

Taking the medicine

• Take this medicine by mouth.
• The number of tablets to take each day will depend on the severity of your condition.
• Enalapril Sandoz can be taken with or without food

Dose for high blood pressure
The initial dose is from 5 mg per day to 20 mg per day, depending on blood pressure.
In patients with blood pressure levels slightly above normal, the recommended dose is 5-
10 mg per day. In patients with kidney or heart problems, or with decreased sodium and/or
blood volume, a starting dose of 5 mg or less should be used.
If you are taking high doses of diuretics, your doctor may prescribe you to stop them
2-3 days before taking Enalapril Sandoz. The recommended initial dose is 5 mg
or less.
Once blood pressure is under control, the usual maintenance dose is 20 mg
per day, up to a maximum of 40 mg per day.

Dose for heart problems
In patients with heart problems, Enalapril Sandoz is used in addition to diuretics and, when
necessary, digitalis (a drug used in case of congestive heart failure or irregular heartbeat) or beta-blockers (drugs used for the treatment of high blood pressure, angina
pectoris and heart problems). The initial dose is 2.5 mg and should be gradually increased to
the usual maintenance dose of 20 mg, administered as a single dose or divided into two doses,
for a period of 2-4 weeks. The maximum dose is 40 mg per day, administered in two doses
separated.

Reduced kidney function
In patients with kidney problems, the dosage of enalapril must be adjusted based on
kidney function. The latter is calculated by measuring the amount of creatinine (a waste
product) in the urine, as well as through blood tests.
If you are undergoing dialysis, your dose will vary from day to day. Your doctor will prescribe you the most
suitable dose.

Use in the elderly
The dose will be established by the doctor and will depend on your kidney function.

Use in children and adolescents
Experience in the use of Enalapril Sandoz in children and adolescents with high blood pressure
is limited. If the child is able to swallow the tablets, the dose will be established based on
the child's weight and blood pressure response. The recommended initial dose is 2.5 mg in
children with a body weight of 20 kg to less than 50 kg and 5 mg in children over 50 kg.
Enalapril Sandoz should be administered once a day. The dose should be adjusted according to
the child's needs, up to a maximum of 20 mg per day in children from 20 kg to less than 50 kg
and 40 mg in children over 50 kg.

Infants and children with kidney problems
Enalapril Sandoz should not be used in infants or children with kidney problems.

If you take more Enalapril Sandoz than you should
If you believe you have taken more tablets than prescribed, contact
your doctor immediately. The most common signs and symptoms of overdose are a drop in
blood pressure and stupor (a state of almost total unconsciousness). Other symptoms
may include dizziness or lightheadedness, due to a sudden drop in pressure,
strong and rapid heartbeat, accelerated pulse, anxiety, cough, kidney failure and
labored breathing.

If you forget to take Enalapril Sandoz
If you forget to take a tablet, skip the missed dose.
Take the next dose as usual.
Do not take a double dose to make up for the missed dose.

If you stop taking Enalapril Sandoz
Do not stop treatment unless directed by your doctor. If you stop therapy, your
blood pressure may increase and, if it becomes too high, compromise
kidney and heart function.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With this medicine, the following side effects may occur.

If you begin to experience the following symptom, it is vitally important that you stop
taking Enalapril Sandoz immediately and consult a doctor:

• allergic reaction: you may experience itching, shortness of breath or dyspnea and develop swelling of hands, mouth, throat, face or eyes.

If you experience any of the following side effects, stop taking Enalapril Sandoz immediately
and consult your doctor:

• severe dizziness, lightheadedness, especially at the beginning of treatment, with each dose increase or when assuming an upright position, excessive skin flushing, blistering, skin peeling.

Other side effects
Verycommon(may affect more than 1 in 10 people)

• blurred vision, cough, feeling unwell (nausea), weakness.

Common(may affect up to 1 in 10 people)

• headache, depression, low blood pressure, fainting
• chest pain, heart rhythm disturbances, angina, fast heartbeat, shortness of breath
• diarrhea, pain in the stomach area (abdomen), taste disturbances, feeling tired
• skin rash, allergic reactions with swelling of the arms and legs, face, lips, tongue or throat with difficulty swallowing or breathing
• increased levels of potassium in the blood, increased serum creatinine (both are usually identified by appropriate tests).

Uncommon(may affect up to 1 in 100 people)

• anemia, anxiety, a heightened sense of awareness or a feeling of instability (due to low blood sugar), confusion, drowsiness, sleep disturbances, nervousness, tingling or numbness, feeling dizzy (vertigo)
• low blood pressure (which can cause dizziness when getting up), irregular heartbeat, heart attack or stroke (in patients at high risk)
• runny nose, sore throat and hoarseness, difficulty breathing or asthma
• intestinal blockage (ileus), pancreatitis, feeling unwell, indigestion, constipation, loss of appetite (anorexia), stomach irritation, dry mouth
• burning, sharp pain accompanied by a feeling of emptiness and hunger, especially on an empty stomach (due to a peptic ulcer), excessive sweating, itching, hives, hair loss, presence of protein in the urine (usually identified by a specific test)
• impotence, muscle cramps, hot flushes, ringing in the ears, feeling lethargic, increased temperature
• problems with kidney function
• renal failure, increased levels of urea and decreased levels of sodium in the blood (usually identified by appropriate tests).

Rare(may affect up to 1 in 1,000 people)

• strange dreams, sleep disorders
• decreased white blood cell, red blood cell and platelet count, bone marrow depression (all effects are usually identified by appropriate tests)
• swelling of the face and abnormalities in the lymph nodes (lymphadenopathy)
• decreased blood flow to the fingers and toes, causing redness and pain (Raynaud's disease), fluid accumulation in the lungs, runny nose or nasal irritation
• increased immune response (autoimmune disease)
• eosinophilic pneumonia (signs may include cough, fever and difficulty breathing)
• pain, swelling or ulcers in the mouth, infections or pain and swelling of the tongue, kidney disorders, such as reduced urine volume
• liver failure or hepatitis, which may cause yellowing of the skin (jaundice)
• excessive skin flushing, blistering, skin peeling
• development of breast tissue in men
• increased liver enzymes or bilirubin in the blood (usually identified by blood tests), decreased blood glucose level.

Very rare(may affect up to 1 in 10,000 people)

• intestinal angioedema: signs may include stomach pain, feeling unwell and vomiting, high levels of calcium in the blood.

Not known(frequency cannot be estimated from the available data)

• feeling unwell, confusion and/or weakness, feeling sick (nausea), loss of appetite, irritability. This may be a symptom called inappropriate antidiuretic hormone secretion syndrome (SIADH).
• A complex of side effects has also been reported that may include some or all of the following symptoms:
• fever, inflammation of blood vessels, pain and inflammation of muscles or joints
• blood disorders affecting the building blocks of blood (usually identified by blood tests)
• erythema, sensitivity to sunlight and other effects on your skin.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enalapril Sandoz

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 outer packaging and on the
blister/bottle, after the wording Exp. The expiry date refers to the last day of that month.
Aluminum/OPA/Aluminum/PVC blister
Do not store at a temperature above 30°C. Store the medicine in its original
packaging, to protect it from moisture.
HDPE bottle
Do not store at a temperature above 30°C (expiry: 6 months after opening the bottle)
Keep the container tightly closed to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Enalapril Sandoz contains
The active ingredient is enalapril maleate. Each tablet contains 5 or 20 mg of enalapril maleate.
The other ingredients are:
For 5 mg:
hypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, sodium hydrogen
carbonate and talc.
For 20 mg:
lactose monohydrate, magnesium stearate, corn starch, sodium hydrogen carbonate, iron oxide
red (E 172) iron oxide yellow (E 172) and talc.

Description of the appearance of Enalapril Sandoz and package contents
Enalapril Sandoz 5 mg tablets are round, flat, white in color, beveled with a fracture line on one side.
The tablets are packaged in aluminum/OPA/aluminum/PVC blisters containing: 10, 20, 28,
30, 50, 60, 98,100,100x1, 300 or 500 tablets.
Enalapril Sandoz 20 mg tablets are round, flat, light orange in color, beveled with a
fracture line on one side, with white spots on the surface and in the tablet mass.
The tablets are packaged in aluminum/OPA/aluminum/PVC blisters containing: 10, 14, 28,
30, 50, 56, 60, 98, 100, 100x1 or 500 tablets.
The fracture line is only to facilitate breaking the tablet if you have difficulty
swallowing it whole.
HDPE container with PP cap, tamper-evident ring and integrated desiccant
For 5 mg and 20 mg
Packs: 30, 100 or 250 tablets
Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA)

Manufacturer
Salutas Pharma GmbH

• Otto-von-Guericke-Allee 1 - 39179 Barleben - Germany

Lek Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana - Slovenia

This medicinal product is authorised in the member states of the EEA under the following
denominations:
Austria: Enalapril Sandoz 5 mg - Tablets
Enalapril Sandoz 10 mg - Tablets
Enalapril Sandoz 20 mg - Tablets
Belgium: Enalapril Sandoz 5 mg tablets
Enalapril Sandoz 20 mg tablets
Denmark: Enalapril Sandoz 2.5 mg
Enalapril Sandoz 5 mg
Enalapril Sandoz 10 mg
Enalapril Sandoz 20 mg
Finland: Linatilsan
Italy: Enalapril Sandoz 5 mg tablets
Enalapril Sandoz 20 mg tablets
Norway: Enalapril Sandoz 2.5 mg
Enalapril Sandoz 5 mg
Enalapril Sandoz 10 mg
Enalapril Sandoz 20 mg
Portugal: Enalapril Sandoz 5 mg Tablets
Enalapril Sandoz 20 mg Tablets
Spain: Enalapril Sandoz 5 mg film-coated tablets
Enalapril Sandoz 20 mg film-coated tablets
Sweden: Enalapril Sandoz 2.5 mg
Enalapril Sandoz 5 mg
Enalapril Sandoz 10 mg
Enalapril Sandoz 20 mg