Enalapril Doc Generici: detailed information

Patient Information Leaflet: Information for the User

ENALAPRIL DOC 5 mg, 20 mg tablets

Generic Medicine
Please read this entire 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ENALAPRIL DOC is and what it is used for
What you need to know before taking ENALAPRIL DOC
How to take ENALAPRIL DOC
Possible side effects
How to store ENALAPRIL DOC
Contents of the pack and other information

1. What ENALAPRIL DOC is and what it is used for

ENALAPRIL DOC contains an active substance called enalapril maleate. This active substance
belongs to a group of medicines known as ACE inhibitors (angiotensin-converting enzyme inhibitors).
ENALAPRIL DOC is used:

to treat high blood pressure (hypertension)
to treat heart failure (weakening of heart function). It may reduce the need for hospitalisation and may help some patients live longer
to prevent signs of heart failure. These signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

This medicine works by dilating the blood vessels. This lowers blood pressure. The medicine
usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require
several weeks of treatment before the full effect on blood pressure is seen.

2. What you need to know before taking ENALAPRIL DOC

Do not take ENALAPRIL DOC

if you are allergic to enalapril maleate or to any of the other ingredients of this medicine (listed in section 6).
if you previously had an allergic reaction to a medicine of the same type as this one, called an ACE inhibitor.
if you previously had swelling of the face, lips, mouth, tongue, or throat causing difficulty in swallowing or breathing (angioedema) of unknown or hereditary origin.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you are more than three months pregnant. ENALAPRIL DOC should also be avoided in the early stages of pregnancy (see section Pregnancy).
if you are taking or have taken sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat).

The risk of angioedema may be increased if you are taking any of the following medicines:

Racecadotril, a medicine used to treat diarrhoea.
Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
Vildagliptin, a medicine used to treat diabetes.

Do not take this medicine if you have any of the conditions listed above. If you are in doubt, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

if you have a heart condition.
if you have a condition affecting the blood vessels in the brain.
if you have a blood disorder such as low number or absence of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or reduced number of red blood cells (anaemia).
if you have a liver problem.
if you are taking any 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), particularly if you have kidney problems related to diabetes.
- aliskiren.
if you have a kidney problem (including kidney transplant). This may lead to increased potassium levels in the blood, which can be serious. Your doctor may need to adjust the dose of ENALAPRIL DOC or monitor your blood potassium levels.
if you are on dialysis.
if you have recently experienced excessive vomiting or severe diarrhoea.
if you are on a low-salt diet, taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes.
if you are over 70 years of age.
if you have diabetes. Close monitoring for low blood glucose levels is necessary, especially during the first month of treatment. Blood potassium levels may also be higher.
if you have previously had an allergic reaction with swelling of the face, lips, tongue, or throat causing difficulty in swallowing or breathing. Note that black patients have a higher risk of such reactions to ACE inhibitors.
if you have low blood pressure (you may feel faint or dizzy, especially when standing up).
if you have a collagen vascular disease (e.g. systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are undergoing immunosuppressive therapy, or are taking allopurinol, procainamide, or their combinations. Your doctor may periodically check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
This medicine is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child (see section Pregnancy).
Please note that in black patients, this medicine is less effective in lowering blood pressure compared to non-black patients.
If you are unsure whether any of the conditions listed above apply to you, consult your doctor or pharmacist before taking this medicine.
See also the information under "Do not take ENALAPRIL DOC".

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking ENALAPRIL DOC:

any type of surgery or anaesthesia (including dental procedures).
a treatment to remove cholesterol from the blood called "LDL apheresis".
desensitisation treatment to reduce the effects of an allergy to bee or wasp stings.

If any of the above conditions apply to you, speak with your doctor or dentist before the procedure.

Other medicines and ENALAPRIL DOC

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines. This is because ENALAPRIL DOC may interfere with the action of certain medicines, and some other medicines may interfere with the action of ENALAPRIL DOC.

Your doctor may consider it necessary to adjust the dose and/or take other precautions:

if you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "Do not take ENALAPRIL DOC" and "Warnings and precautions").

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

other medicines that lower blood pressure, such as beta-blockers, diuretics.
medicines for diabetes (including oral antidiabetics and insulin).
lithium (a medicine used to treat certain types of depression).
antidepressant medicines called "tricyclic antidepressants".
medicines for mental disorders called "antipsychotics".
some cough and cold medicines and weight-reducing medicines containing a so-called "sympathomimetic agent".
some medicines for pain or arthritis, including gold salts therapy.
non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).
aspirin (acetylsalicylic acid).
medicines used to dissolve blood clots (thrombolytics).
alcohol.
potassium supplements (including potassium-containing salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (such as trimethoprim and cotrimoxazole used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent clot formation).

If you are unsure whether any of the above conditions apply to you, speak with your doctor or pharmacist before taking ENALAPRIL DOC.

ENALAPRIL DOC with food, drinks, and alcohol

ENALAPRIL DOC tablets can be taken regardless of meals, but should be taken with sufficient liquid.

Alcohol enhances the effect of ENALAPRIL DOC on high blood pressure.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Your doctor will usually advise you to stop taking ENALAPRIL DOC before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.

ENALAPRIL DOC is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn child after the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed.

Breastfeeding of newborns (first weeks after birth), and especially of premature infants, is not recommended while taking ENALAPRIL DOC.

For older infants, your doctor will advise you on the benefits and risks of taking ENALAPRIL DOC during breastfeeding compared to other treatments.

Driving and using machines

When driving or operating machinery, consider the possibility of occasional dizziness or weakness. If this occurs, do not drive or operate any tools or machines.

ENALAPRIL DOC contains lactose

Lactose is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

ENALAPRIL DOC contains sodium

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

3. How to take ENALAPRIL DOC

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The daily dose is usually taken as a single dose in the morning; however, it may also be divided into two doses, one in the morning and one in the evening.

It is very important to continue taking this medicine for as long as your doctor prescribes it.
Do not take more tablets than prescribed.

For the treatment of high blood pressure

The usual initial dose ranges from 5 to 20 mg once daily.
Some patients may need to start treatment with a lower dose.
The usual maintenance dose is 20 mg once daily.
The maximum maintenance dose is 40 mg once daily.

Patients with heart failure

The usual initial dose is 2.5 mg once daily.
Your doctor will gradually increase the dose until the appropriate dose for you is reached.
The usual maintenance dose is 20 mg per day, taken as a single dose or divided into two doses.
The maximum maintenance dose is 40 mg per day, divided into two doses.

Patients with kidney problems
The dose of the medicine will depend on how well your kidneys are functioning:

moderate kidney problems - 5 to 10 mg per day.
severe kidney problems - 2.5 mg per day.
if you are on dialysis - 2.5 mg per day. On days when you are not undergoing dialysis, the dose may be adjusted according to your blood pressure.

Elderly patients
The dose will be determined by your doctor and will be based on the degree of your kidney function.
Use in children
Experience with the use of ENALAPRIL DOC in children with high blood pressure is limited. If the child is able to swallow tablets, the dose will be based on the child's weight and blood pressure. The usual initial doses are:

weight between 20 kg and 50 kg - 2.5 mg per day.
weight above 50 kg - 5 mg per day. The dose may be adjusted according to the child's needs:
a maximum dose of 20 mg per day may be used in children weighing between 20 kg and 50 kg.
a maximum dose of 40 mg per day may be used in children weighing more than 50 kg.

This medicine is not recommended for newborns (first weeks of life) and children with kidney problems.
If you feel that the effect of ENALAPRIL DOC is too strong or too weak, consult your doctor or pharmacist.
If you take more ENALAPRIL DOC than you should
If you accidentally take too many tablets, contact your doctor immediately.
Limited data on overdose in humans are available. Symptoms of overdose may include extremely low blood pressure and kidney failure.
If you forget to take ENALAPRIL DOC
If you accidentally miss a dose, skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking ENALAPRIL DOC
Do not stop taking this medicine unless your doctor tells you to. Usually, there is no rebound effect (return or worsening of symptoms) when treatment with ENALAPRIL DOC tablets is discontinued.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Stop taking ENALAPRIL DOC and contact a doctor immediately if you notice
any of the following symptoms:

swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing.
swelling of the hands, feet or ankles.
development of a skin rash with raised red patches (urticaria).

You should know that black patients have a higher risk of developing these types of reactions. If you notice any of these symptoms, stop taking ENALAPRIL DOC and contact a doctor immediately.
When you start taking this medicine, you may feel faint or dizzy. If this happens, it may help to lie down. This is caused by a drop in blood pressure. The symptoms should improve as you continue taking the medicine. If you are concerned, please contact your doctor.

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

dizziness, weakness or feeling unwell.
blurred vision.
cough.

Common (may affect up to 1 in 10 people)

low blood pressure, changes in heart rate, rapid heartbeat, angina pectoris or chest pain.
headache, fainting (syncope).
altered sense of taste, shortness of breath.
diarrhoea or abdominal pain, skin rash.
fatigue (tiredness), depression.
allergic reactions with swelling of the face, lips, tongue or throat, causing difficulty in breathing or swallowing.
increased potassium levels in the blood, increased creatinine levels in the blood (both are usually detected by laboratory tests).

Uncommon (may affect up to 1 in 100 people)

sudden drop in blood pressure.
rapid or irregular heartbeat (palpitations).
heart attack (possibly due to very low blood pressure in some high-risk patients, including those with circulatory problems affecting the heart or brain).
anaemia (including aplastic and haemolytic anaemia).
stroke (possibly due to very low blood pressure in high-risk patients).
confusion, insomnia or drowsiness, nervousness.
sensation of tingling or numbness of the skin.
dizziness.
ringing in the ears (tinnitus).
runny nose, sore throat and hoarseness.
asthma.
slowed movement of food through the intestine (intestinal obstruction), causing a feeling of bloating and painful cramps in the abdomen, inflammation of the pancreas.
vomiting, indigestion, constipation, loss of appetite.
irritated stomach (gastric irritation), dry mouth, ulcer, impaired kidney function, kidney failure.
increased sweating.
itching or urticaria.
hair loss.
muscle cramps, hot flushes, general feeling of malaise, high body temperature (fever), impotence.
high levels of protein in the urine (measured by laboratory test).
low blood sugar levels (with increased awareness or sensation of unsteadiness), low sodium levels in the blood, high urea levels in the blood (all measured by blood tests).

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

"Raynaud's phenomenon", in which hands and feet may become very cold and white due to reduced blood flow.
changes in blood test values such as reduced numbers of white blood cells and red blood cells, reduced haemoglobin, reduced platelet count.
bone marrow depression.
autoimmune diseases.
altered dreams or sleep disturbances.
pulmonary infiltrates.
inflammation of the nose.
pneumonia.
inflammation of cheeks, gums, tongue, lips, throat.
decreased amount of urine produced.
erythema multiforme.
“Stevens-Johnson syndrome”, a serious skin condition characterised by redness and peeling of the skin, blistering or exposed ulcers, or separation of the outer layer of skin from deeper layers.
liver problems such as reduced liver function, inflammation of the liver, jaundice (yellowing of the skin or eyes), increased liver enzymes or bilirubin (measured by blood tests).
enlargement of breast glands in men.

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

swelling in the intestine (intestinal angioedema).
Frequency not known (cannot be estimated from the available data)
Syndrome of inappropriate antidiuretic hormone secretion (SIADH), a condition in which the body retains excess water and has reduced sodium (salt) concentration, as a result of incorrect chemical signals. Patients with SIADH may become seriously ill or may have no symptoms at all.
A complex of symptoms has been reported, which may be associated with some or all of the following adverse effects: fever, inflammation of serous surfaces, inflammation of blood vessels, muscle and joint pains, inflammation of muscles and joints, and certain changes in laboratory values; skin rash, photosensitivity and other skin reactions may also occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ENALAPRIL DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C. Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What ENALAPRIL DOC contains

The active substance is 5 mg or 20 mg of enalapril maleate.
The other components are anhydrous colloidal silica, magnesium stearate, sodium hydroxide, povidone, talc, crospovidone, microcrystalline cellulose and monohydrate lactose.

Description of the appearance of ENALAPRIL DOC and package contents
The tablets are round, white or almost white, marked with "ED 5" (5 mg tablets) or "ED 20" (20 mg tablets) on one side and a score line on the other side.
The tablets are packaged in blisters (Alu/OPA-Alu-PVC).
Pack sizes of ENALAPRIL DOC 5 mg tablets: 28, 30, 50 or 100 tablets.
Pack sizes of ENALAPRIL DOC 20 mg tablets: 7, 14, 28, 30, 50 or 100 tablets.
However, it is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l.
Via Turati 40,
20121 Milan,
Italy

Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: ENALAPRIL DOC 5 mg tablets
Italy: ENALAPRIL DOC 20 mg tablets