Package Leaflet: Information for the User

Enalapril Sandoz 5 mg Tablets EFG

Enalapril Sandoz 20 mg Tablets EFG

Enalapril maleate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 Sandoz contains enalapril maleate. Enalapril belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors, which act by widening blood vessels. The effect of these medicines is to lower blood pressure.

Enalapril Sandoz is used to treat high blood pressure (hypertension).

It is also used to treat a heart condition sometimes known as “heart failure”. This means that your heart is not working as well as it should be, to pump blood throughout your body, leading to fatigue after light physical activity, shortness of breath and swelling of ankles and feet.

Enalapril Sandoz may help in the treatment of these symptoms.

Enalapril Sandoz may help in the prevention of symptoms such as difficulty breathing and swelling in many patients with damaged heart muscle, but who do not have symptoms.

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 symptoms may be itching, urticaria, wheezing or swelling of the hands, throat, mouth or eyelids,

• if you have taken or are 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 more than 3 months pregnant. (It is also best to avoid Enalapril Sandoz at the beginning of pregnancy - see section “Pregnancy”),

• if you have diabetes or kidney problems and are taking a medicine to lower your blood pressure that contains aliskiren.

Do not take Enalapril Sandoz if you have any of the above circumstances. If you are unsure, consult your doctor or pharmacist before taking Enalapril Sandoz.

Warnings and precautions

Consult your doctor or pharmacist before taking Enalapril Sandoz if:

• you have kidney problems, have recently had a kidney transplant, are on dialysis or are taking diuretics,
• you are on a low-salt diet, or have had excessive vomiting or diarrhea recently,
• you have a heart condition called “aortic stenosis”, “hypertrophic cardiomyopathy”, or obstruction of blood flow,
• you have a condition called vascular collagen disease, are taking immunosuppressants (used to treat autoimmune diseases such as rheumatoid arthritis or after a transplant),
• you are taking allopurinol (used to treat gout), or procainamide (used to treat heart rhythm disorders). If you develop an infection (the symptoms may be an increase in temperature or fever), tell your doctor immediately. Your doctor may take a blood sample at regular intervals to check your white blood cell count,
• you have a history of “angioedema” while taking other medicines. The symptoms may be itching, urticaria, wheezing or swelling of the hands, throat, mouth or eyelids,
• if you are taking any of the following medicines, the risk of angioedema may increase (rapid swelling under the skin in areas such as the throat):

• racecadotril (a medicine used to treat diarrhea),
• medicines used to prevent organ transplant rejection and for cancer (e.g., temsirolimus, sirolimus, everolimus and other mTOR inhibitors),
• vildagliptin (a medicine used to treat diabetes).

• you have diabetes and are taking antidiabetic medicines, including insulin to control your diabetes (you should monitor low blood glucose levels, especially during the first month of treatment),
• you are taking potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicines that may increase potassium levels in the blood such as (e.g., trimetoprima or cotrimoxazol, medicines used to treat bacterial infections; ciclosporinas, an immunosuppressant used to prevent organ transplant rejection; heparin, a medicine used to prevent blood clots),
• you are taking lithium, used to treat certain psychiatric disorders,
• you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor antagonist (ARA) (also known as “sartanes”, e.g., valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes,
• aliskirén.

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

See also the information under the section “Do not take Enalapril Sandoz”.

• your doctor has told you that you have intolerance to certain sugars.

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

• jaundice (yellowing of the skin and white of the eyes),
• dry cough persisting for a long time.

If you are about to be in any of the following situations, inform your doctor that you are taking Enalapril Sandoz:

• any surgery or are to receive anesthesia (even at the dentist),
• an LDL apheresis treatment, to remove cholesterol from your blood using a machine,
• desensitization treatment, to reduce the effect of an allergy or bee stings.

Routine tests

When you start taking Enalapril Sandoz, your doctor will check your blood pressure frequently to ensure that you have been given the right dose. In some patients, the doctor may require some tests to measure potassium, creatinine, and liver enzymes.

Pregnancy

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. Enalapril is not recommended at the beginning of pregnancy, and 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 phase (see section “Pregnancy”).

Children and adolescents

The information on the use of Enalapril Sandoz in children over 6 years old with high blood pressure is limited, but for children with heart problems, there is no information. Enalapril Sandoz should not be used in babies or children with kidney problems.

Other medicines and Enalapril Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Some medicines may affect the action of the other.

• potassium-sparing diureticssuch as spironolactone, eplerenone, triamterene, or amiloride, potassium supplements (including salt substitutes) or other medicines that may increase potassium levels in the blood (e.g.,

trimetoprimaandcotrimoxazolalso known as trimetoprima/sulfametoxazol for bacterial infections; ciclosporinas, an immunosuppressant used to prevent organ transplant rejection; andheparina, a medicine used to prevent blood clots).Enalapril Sandoz may increase potassium levels in the blood, leading to high potassium levels. This produces few symptoms and is usually detected by a test,

• diureticssuch as thiazides, furosemide, and bumetamida,
• medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimusand other mTOR inhibitors). See also the section “Warnings and precautions”,
• otherblood pressure medicines, such as nitroglycerin, nitrates, and vasodilators,
• litio, used to treat psychiatric disorders. Enalapril should not be taken with this medicine,
• tricyclic antidepressantssuch as amitriptilina, used for depression, antipsychotics such as phenothiazines, used for severe anxiety,
• analgesicssuch as morphine and anesthetics, as your blood pressure may drop too low,
• medicines used for torticollis and inflammationassociated with painful conditions, particularly those affecting your muscles, bones, and joints:
• • includinggold treatmentwhich may cause flushing of the face, feeling of dizziness (nausea), vomiting, and low blood pressure when taking Enalapril Sandoz, and
  • nonsteroidal anti-inflammatory drugs (NSAIDs)(e.g., diflunisal or diclofenaco), including COX-2 inhibitors. These may prevent your blood pressure from being well controlled and may increase potassium levels in the blood,
• aspirin(used to reduce pain),
• medicines such asefedrina, used in some cough and cold remedies, ornoradrenalina and adrenalinaused for low blood pressure, shock, heart failure, asthma, or allergies. If used with Enalapril Sandoz, these medicines may keep your blood pressure high,
• alopurinol(used to treat gout),
• procainamida(used to treat heart rhythm disorders),
• antidiabetic medicinessuch as insulin, Enalapril Sandoz may cause blood glucose levels to drop even further if taken with antidiabetic medicines.

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

If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the sections “Do not take Enalapril Sandoz” and “Be careful with Enalapril Sandoz”).

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before taking Enalapril Sandoz.

Enalapril Sandoz and alcohol

If you drink alcohol during treatment with Enalapril Sandoz, it may cause your blood pressure to drop too low and you may experience dizziness, drowsiness, or fainting. You should reduce your alcohol intake to a minimum.

Pregnancy

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. Enalapril Sandoz is not recommended at the beginning of pregnancy and 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 phase.

Lactation

Inform your doctor if you are breastfeeding or are about to start. While taking Enalapril Sandoz, breastfeeding is not recommended in newborns (first weeks after birth), and especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Enalapril Sandoz, compared to other treatments, while breastfeeding.

Driving and operating machines

Certain side effects such as dizziness or fatigue with Enalapril Sandoz may affect your ability to drive or operate machines.

Enalapril Sandoz contains lactose

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

Enalapril Sandoz contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Administration of this medication

• Take this medication orally,
• The number of tablets you should take each day will depend on your condition,
• You can take Enalapril Sandoz with or without food

Dosage for high blood pressure

The initial dose is 5 mg per day up to 20 mg depending on your blood pressure. In patients with slightly elevated blood pressure levels, the recommended dose is 5 to 10 mg per day. For patients with kidney problems, heart problems, low salt levels, and/or fluid levels, start with a dose of 5 mg or less.

If you are currently taking high doses of diuretics, your doctor may instruct you to stop treatment for 2 to 3 days before taking Enalapril Sandoz. It is recommended to start with an initial dose of 5 mg or less.

Once your blood pressure is controlled, the normal maintenance dose is 20 mg per day up to a maximum of 40 mg per day.

Dosage for heart conditions

In patients with heart problems, Enalapril Sandoz is used in addition to diuretics and when appropriate, with digitalis (a medication used in congestive heart failure or irregular heart rhythm) or beta-blockers (medications used to treat high blood pressure, angina, and heart problems). The initial dose is 2.5 mg and should be gradually increased over a period of 2 to 4 weeks, up to the usual maintenance dose of 20 mg administered in a single dose or divided into two doses. The maximum daily dose is 40 mg per day divided into two doses.

Reduced renal function

In patients with kidney problems, the dose adjustment of enalapril depends on the functioning of their kidneys. Renal function is calculated by measuring the amount of creatinine (a waste product) in their urine and also by taking a blood sample. If you are undergoing dialysis treatment, your dose will vary daily. Your doctor will indicate the necessary dose.

Use in the elderly

Your doctor will decide your dose, and it will be based on the functioning of your kidneys.

Use in children and adolescents

The experience in the use of Enalapril Sandoz in children with high blood pressure is limited. If the child can swallow the tablets, the dose will be determined based on the child's weight and blood pressure response. The recommended initial dose is 2.5 mg in children weighing 20 kg to less than 50 kg and 5 mg in children weighing 50 kg or more. Enalapril Sandoz is administered once a day. The dose can be adjusted according to the child's needs up to a maximum of 20 mg per day in children weighing 20 kg to less than 50 kg and 40 mg per day in children weighing 50 kg or more.

Newborns and children with kidney problems

Enalapril Sandoz should not be used in newborns or children with kidney problems.

If you take more Enalapril Sandoz than you should

If you take more Enalapril Sandoz than you should, consult your doctor or pharmacist immediately. The most likely symptoms of overdose are a drop in blood pressure, stupor (a state of almost total loss of consciousness). Other symptoms may include dizziness or fainting due to low blood pressure, rapid and strong heartbeats, rapid pulse, anxiety, cough, renal failure, rapid breathing.

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 forget to take Enalapril Sandoz

If you forget to take a tablet, skip the missed dose.

Take the next dose as prescribed.

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

If you interrupt treatment with Enalapril Sandoz

Do not stop treatment with your medication unless your doctor has instructed you to do so. If you do, your blood pressure may increase. If your blood pressure becomes very high, it may affect your heart and kidneys.

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

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

The following side effects may occur with this medicine:

It is vital to stop taking this medicine and seek medical attention immediately if you experience the following symptoms:

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

Stop taking Enalapril Sandoz immediately and visit your doctor if you experience any of the following side effects:

• severe dizziness, fainting, especially at the beginning of treatment or when increasing the dose or standing up, excessive skin redness, blisters, skin peeling.

Other possible side effects

Very common(may affect more than 1 in 10 people)

• blurred vision, cough, sensation of dizziness (nausea), weakness.

Common(may affect up to 1 in 10 people)

• headache, depression, decreased blood pressure, fainting,
• chest pain, changes in heart rhythm, angina, rapid heart rate, shortness of breath,
• diarrhea, abdominal pain around the stomach area, changes in taste, feeling tired,
• skin rash, allergic reactions with swelling of arms and legs, face, lips, tongue, or throat with difficulty swallowing or breathing,
• increased potassium levels in the blood, increased serum creatinine (both usually detected by a blood test).

Uncommon(may affect up to 1 in 100 people)

• anemia, anxiety, sensation of increased consciousness or instability (caused by decreased blood sugar), confusion, feeling sleepy, difficulty sleeping, nervousness, tingling or numbness, sensation of spinning (vertigo),
• low blood pressure (which may make you feel dizzy when standing up), irregular heartbeats, heart attack or stroke (in high-risk patients),
• nasal secretion, sore throat, and hoarseness, difficulty breathing or asthma,
• intestinal blockage (ileus), pancreatitis, sensation of dizziness, indigestion, constipation, loss of appetite (anorexia), stomach irritation, dry mouth,
• burning, pain with a feeling of emptiness and hunger, particularly when the stomach is empty (caused by peptic ulcer), excessive sweating, pruritus, urticaria, hair loss, proteins in the urine (usually detected by a urine test),
• impotence, muscle cramps, redness, tinnitus, feeling lethargic, elevated temperature,
• renal function disorder,
• kidney failure, increased urea levels in the blood and decreased sodium levels in the blood (usually detected by a blood test).

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

• strange dreams, difficulty sleeping,
• decreased white blood cells, red blood cells, platelets, bone marrow depression (all usually detected by a blood test),
• swelling of the face and abnormality in lymph nodes (lymphadenopathy),
• decreased blood flow to the fingers and toes causing redness and pain (Raynaud), fluid in the lungs, nasal secretion or sore throat,
• increased immune response (autoimmune disease),
• eosinophilic pneumonia (symptoms may include cough, high temperature, and difficulty breathing),
• mouth pain, swelling, or ulcers, infection or pain and swelling of the tongue, renal problems such as reduced urine output,
• liver failure or hepatitis, which may cause yellowing of the skin (jaundice),
• excessive skin redness, blisters, skin peeling,
• development of breasts in men,
• increased enzymes or bilirubin in the blood (usually detected by a blood test), decreased blood glucose.

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

• intestinal angioedema. Symptoms may include abdominal pain, dizziness, vomiting, increased calcium levels in the blood.

Frequency not known(cannot be estimated from available data)

• feeling unwell, confused, or weak, sensation of dizziness (nausea), loss of appetite, feeling irritable. This may be known as syndrome of inappropriate antidiuretic hormone secretion (SIADH),
• also a complex adverse reaction has been reported that may include some of the following symptoms:
• • fever, inflammation of blood vessels, muscle and joint pain, and inflammation,
  • blood disorders affecting blood components (usually detected by a blood test),
  • skin rash, light sensitivity, and other skin effects.

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the carton packaging and blister/bottle after CAD/EXP. The expiration date is the last day of the month indicated.

Aluminum/OPA/Aluminum/PVC Blister

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture.

HDPE Bottle

Do not store at a temperature above 30 °C (expiration date after first opening: 6 months).

Keep the bottle perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Enalapril Sandoz 5 mg tablets:

• The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.
• The other components are: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, cornstarch, sodium hydrogen carbonate, and talc.

Composition of Enalapril Sandoz 20 mg tablets:

• The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.
• The other components are: lactose monohydrate, magnesium stearate, cornstarch, sodium hydrogen carbonate, iron oxide red (E 172), iron oxide yellow (E 172), and talc.

Appearance of the product and contents of the package:

Enalapril Sandoz 5 mg tablets are presented in the form of oval, biconvex, white, scored tablets on one side, and marked with “EN 5”, length: 10.9-11.5 mm.

The tablets are packaged in Aluminio/OPA/Aluminio/PVC blisters containing 10, 20, 28, 30, 50, 60, 98, 100, 100x1, 300, or 500 tablets.

Enalapril Sandoz 20 mg tablets are presented in the form of oval, biconvex, orange, scored tablets on one side, and marked with “EN 20”, mottled on the surface and inside the tablet, length: 10.9-11.5 mm.

The tablets are packaged in Aluminio/OPA/Aluminio/PVC blisters containing 10, 14, 28, 30, 50, 56, 60, 98, 100, 100x1, or 500 tablets.

The tablet can be divided into two equal halves.

HDPE bottle with PP cap, PP ring, and desiccant

Package sizes: 30, 100, 125, or 250 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

Lek Pharmaceuticals d.d.

Verovskova ulica 57

Ljubljana, 1526

Slovenia

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

Austria:Enalapril Sandoz 5 mg – Tablets

Enalapril Sandoz 20 mg - Tablets

Belgium:Enalapril Sandoz 5 mg tablets

Enalapril Sandoz 20 mg tablets

Denmark:Enalapril "Sandoz", tablets

Finland:Linatilsan 5 mg tablets

Linatilsan 20 mg tablets

Italy:Enalapril Sandoz

Norway:Enalapril Sandoz 5 mg tablets

Enalapril Sandoz 20 mg tablets

Portugal:Enalapril Sandoz

Sweden:Enalapril Sandoz 5 mg tablets

Enalapril Sandoz 20 mg tablets

Last review date of this leaflet: November 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