ENALAPRIL 20 mg /12.5 Mg Коированная Таблетка

Содержание инструкции

1. Enalapril Hydrochlorothiazide ratiopharm 20 mg/12.5 mg tablets
   1. What is Enalapril Idroclorotiazide ratiopharm and what is it used for?
   2. What you need to know before you use enalapril Idroclorotiazide ratiopharm
   3. How to use Enalapril Idroclorotiazide ratiopharm
   4. Possible side effects
   5. How to store Enalapril Idroclorotiazide ratiopharm
   6. Package contents and other information

Enalapril Hydrochlorothiazide ratiopharm 20 mg/12.5 mg tablets

enalapril/hydrochlorothiazide
Generic medicine

important information for you.

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effect occurs, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Enalapril Idroclorotiazide ratiopharm and what is it used for?

This medicine is an antihypertensive that combines a diuretic: hydrochlorothiazide and an angiotensin converting enzyme inhibitor: enalapril.
It is indicated in the treatment of hypertension, in cases of insufficient control with treatment with a single medicine (angiotensin converting enzyme inhibitor).

2. What you need to know before you use enalapril Idroclorotiazide ratiopharm

Do not use Enalapril Idroclorotiazide ratiopharm

• if you are allergic to enalapril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from allergy to sulfonamides or their derivatives (ask your doctor for explanations regarding the term sulfonamides if you have doubts)
• in case of a history of allergic reactions with swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing, whether related to treatment with a medicine belonging to the same group as enalapril (angiotensin converting enzyme inhibitor), or if this type of reaction is hereditary or of unknown cause
• 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 this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat)
• if you suffer from severe kidney failure
• if you do not urinate
• if you have exceeded the first trimester of pregnancy. (It is actually preferable to avoid taking Enalapril Idroclorotiazide ratiopharm even in the early stages of pregnancy; see the section dedicated to pregnancy)
• if you suffer from severe liver failure/hepatic encephalopathy (neurological disease that manifests during severe liver disease)
• 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.

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Unless otherwise indicated by your doctor, this medicine is GENERALLY NOT

RECOMMENDED in the following cases:

• in combination with lithium, other antihypertensive drugs (e.g. prazosin, trimazosin, urapidil, nitrates), potassium-sparing diuretics, potassium salts,
• stenosis (narrowing) of the renal artery,
• hyperkalemia (high level of potassium in the blood).

If you have doubts, consult your doctor or pharmacist.

Warnings and precautions

• If you experience a dry cough during treatment, consult your doctor, who will decide whether the treatment should be continued or discontinued.
• Risk of allergic reactions and facial edema or adverse reactions of the skin and mucous membranes. ACE inhibitors cause a higher percentage of angioedema in patients with black skin compared to patients with white skin.
• Risk of particularly low levels of some white blood cells in the blood in immunodepressed patients.
• This medicine may induce a risk of allergic reactions in patients undergoing hemodialysis. Tell your doctor if you need to be treated with hemodialysis.
• Possibility of neurological alterations in patients with liver disease.

Talk to your doctor before taking Enalapril Idroclorotiazide ratiopharm if you suffer from:

• kidney failure or heart failure, atherosclerosis, renal artery stenosis, kidney transplant, liver disease,
• hypotension or strict salt-free diet,
• alterations in fluid and electrolyte levels (relating to water and mineral salts in the body),
• aortic or mitral stenosis, heart muscle disease,
• LDL apheresis (collection and separation of part of the blood),
• desensitization to bites from some insects,
• hemodialysis,
• diabetes,
• increased levels of potassium in the serum and/or abnormalities in blood tests (electrolytes) and/or high levels of uric acid in the blood,
• if you are to undergo surgery, inform the anesthesiologist that you are taking this medicine, you must inform the doctor 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), 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 reported in the section: “Do not use Enalapril Idroclorotiazide ratiopharm”. If you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased: drugs used to prevent organ transplant rejection and to treat cancer (e.g. sirolimus, everolimus, temsirolimus) and other drugs belonging to the class of mTOR inhibitors racecadotril, a medicine used to treat diarrhea vildagliptin, a medicine used to treat diabetes If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use

with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays during taking Enalapril Idroclorotiazide ratiopharm.
If you have a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye, which can occur within a period ranging from a few hours to weeks after taking Enalapril Idroclorotiazide ratiopharm.This condition, if left untreated, can lead to permanent vision loss. If you have had episodes of allergy to penicillin or sulfonamide in the past, you may be at greater risk of developing this condition.

Children and Adolescents
Use in children is not recommended.
Athletes
WARNING: this medicine contains an active substance, hydrochlorothiazide, which can induce, in some patients, a positive response to doping tests.

Other medicines and Enalapril Idroclorotiazide ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you inform your doctor if you are using any of the following medicines:
potassium-sparing diuretics (“water pills”), such as spironolactone, triamterene or amiloride, potassium supplements (including salt substitutes) and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection; and heparin, a medicine used to thin the blood) or calcium supplements or calcium-containing food supplements or saline solutions. The association with these preparations may cause dangerously high levels of potassium or calcium in the blood
other antihypertensive agents or diuretics at high doses (“water pills”). This association may cause a dangerous drop in blood pressure
angiotensin II receptor antagonists (AIIRAs) or aliskiren (anti-hypertensive agent): the doctor may need to adjust the dose and/or take other precautions if you are taking angiotensin II receptor antagonists (AIIRAs) or aliskiren (see also what is reported in the section “Do not use Enalapril Idroclorotiazide ratiopharm” and“Warnings

and Precautions”)
cytostatic agents (cancer drugs)
lithium (medicine used to treat mental health problems). This association may cause an excessive accumulation of lithium in the body, increasing the risk of side effects
antipsychotic drugs, some medicines used to treat depression (tricyclic antidepressants) or medicines that stimulate the central nervous system
some anesthetic drugs, barbiturates or strong painkillers. This association may cause dizziness when getting up
anti-inflammatory drugs (NSAIDs)
carbenoxolone (used to relieve ulcer discomfort), corticotropin (ACTH, used to treat epilepsy) or stimulant laxatives. This association may cause abnormal levels of water and minerals in the body, in particular potassium deficiency
cardiac glycosides (such as digoxin) or tubocurarine (a muscle relaxant). The effect of these medicines may be potentiated
insulin or oral antidiabetic medicines such as vildagliptin
cholestyramine or colestipol (medicines that bind cholesterol)
medicines that act on the autonomic nervous system (sympathomimetic drugs), for example ephedrine, pseudoephedrine and salbutamol
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injectable medicines containing gold, for example sodium aurothiomalate
medicines used to treat irregular heartbeat (antiarrhythmic medicines, for example quinidine, procainamide, amiodarone and sotalol)
pressor amines, for example norepinephrine, epinephrine
drugs commonly used to prevent organ rejection and to treat cancer (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of mTOR inhibitors). See paragraph “Warnings and precautions”
racecadotril (a medicine used to treat diarrhea). See paragraph “Warnings and precautions”
do not take Enalapril Idroclorotiazide ratiopharm with sacubitril /valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults. See paragraph 2 "Do not take Enalapril Idroclorotiazide ratiopharm".
Enalapril Idroclorotiazide ratiopharm with food, drinks and alcohol
Enalapril Idroclorotiazide ratiopharm can be taken with liquids both on an empty stomach and with food.
You should always remember that drinking alcohol can enhance the effect of this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Your doctor will generally advise you to stop taking Enalapril Idroclorotiazide ratiopharm before becoming pregnant or as soon as you find out you are pregnant, and will suggest taking another medicine instead of Enalapril Idroclorotiazide ratiopharm.
Taking Enalapril Idroclorotiazide ratiopharm is not recommended during pregnancy, and should be avoided after the first trimester of pregnancy, as it can cause serious harm to the baby if used after that period.
Breastfeeding
Enalapril Idroclorotiazide ratiopharm is not recommended in breastfeeding mothers, especially if your baby was born prematurely and is less than a week old.

Driving and using machines
Particular caution is required for drivers and machine operators due to the risk of dizziness and fatigue.

Enalapril Idroclorotiazide ratiopharm contains lactose and sodium
This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
For those who play sports: the use of the drug without therapeutic need constitutes doping and may still result in positive doping tests.

3. How to use Enalapril Idroclorotiazide ratiopharm

Use Enalapril Idroclorotiazide ratiopharm following always exactly the instructions of the doctor or the
pharmacist. If you have doubts, consult the doctor or the pharmacist.
The usual dose is one tablet, to be taken once a day. Swallow the tablet with a
glass of water.
The tablet can be divided into equal doses.
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If you feel that the effect of Enalapril Idroclorotiazide ratiopharm is too strong or too
weak, talk to your doctor or pharmacist.
It is particularly important that you carry out the treatment for the entire duration of time indicated by your
doctor. Do not forget that, in order to be effective, this medicine must be taken with
extreme regularity and for all the time that the doctor has indicated to you, as it introduces a new
balance in your body that can only be maintained through treatment.

If you take moreEnalapril Idroclorotiazide ratiopharmthan you should
The most likely event in case of overdose is hypotension. Severe hypotension can be
treated by lying down with your legs raised. If this discomfort should continue,
inform your doctor immediately.
If you accidentally take more tablets than the prescribed dose, inform your doctor.

If you forget to take Enalapril Idroclorotiazide ratiopharm
Do not take a double dose to make up for the missed tablet/dose.
Take the next dose at the usual time. If you have forgotten several doses, ask your
doctor for advice.

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 everyone will experience them.

Stop taking this medicine and consult your doctor immediately if you experience symptoms of angioedema during treatment, such as:
allergic reaction accompanied by swelling of the hands, feet, ankles, or face, lips, tongue and/or throat with resulting difficulty swallowing or breathing
The following side effects have been reported:

Very common (may affect more than 1 in 10 people)
Blurred vision;
Dizziness;
Cough;
Nausea;
Loss of strength (asthenia).

Common (may affect up to 1 in 10 people)
Reduction of potassium levels in the blood (hypokalaemia) or increase of potassium levels
(hyperkalaemia), cholesterol, triglycerides, uric acid (hyperuricemia) and creatinine in the
blood
Headache, depression, temporary loss of consciousness (syncope), altered
taste
Reduction of blood pressure (hypotension), decrease in blood pressure
following a sudden change from a sitting or lying position to an upright position (orthostatic
hypotension), changes in heart rhythm, chest pain accompanied by a sensation of
constriction and oppression in the chest (angina pectoris), rapid heartbeat (tachycardia)
Difficulty breathing (dyspnea)
Diarrhea, abdominal pain
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Skin rash (exanthema)
Involuntary muscle contractions (muscle cramps)
Chest pain, fatigue.

Uncommon (may affect up to 1 in 100 people)
Decrease in the number of red blood cells (anemia, including aplastic and hemolytic anemia)
Decrease in blood sugar (hypoglycemia), decrease in magnesium levels in the
blood (hypomagnesemia), pain and swelling in the joints (gout)
Confusion, drowsiness, insomnia, nervousness, tingling sensation in the legs, arms or
other parts of the body (paresthesia), feeling of dizziness (vertigo)
Decreased sexual desire, impotence
Annoying sensation of sounds or whistling in the ears (tinnitus)
Redness and sensation of warmth mainly on the face (flushing), perception of irregular or reinforced
heartbeat (palpitations), heart attack (myocardial infarction) or stroke
(cerebrovascular accident), possibly secondary to a drastic drop in blood pressure in
high-risk patients (see section “Warnings and precautions”)
Runny nose (rhinorrhea), sore throat and hoarseness, feeling of tightness in the chest that makes
breathing difficult and noisy (bronchospasm/asthma)
Reduction of intestinal movements (ileus), inflammation of the pancreas (pancreatitis),
vomiting, difficulty digesting food (dyspepsia), constipation, loss of appetite (anorexia),
stomach irritation, dry mouth, stomach lesions (peptic ulcer), increased
production of intestinal gas (flatulence)
Increased sweating (diaphoresis), itching, hives, hair loss (alopecia)
Joint pain (arthralgia)
Impaired kidney function, kidney failure, presence of protein in the urine
(proteinuria)
Feeling unwell, fever
Increased urea levels in the blood (uremia), low sodium concentration in the blood
(hyponatremia).

Rare (may affect up to 1 in 1,000 people)
Decrease in the number of certain white blood cells (neutropenia, leukopenia and agranulocytosis),
of hemoglobin, of the total volume of red blood cells (low hematocrit), of platelets
(thrombocytopenia) or of all different types of blood cells (pancytopenia), bone marrow depression (when the bone marrow fails to produce a sufficient number of cells
for the blood), swelling of glands called lymph nodes (lymphadenopathy), diseases of the
immune system (autoimmune diseases)
Increased blood sugar levels
Abnormal dreams, sleep disorders, partial reduction of motility (paresis due to
hypokalaemia)
Reduced blood flow to the fingers of hands and feet causing redness and pain (Raynaud's phenomenon)
Lung problems including lung infiltrates, severe respiratory failure (acute respiratory distress syndrome), inflammation (pneumonia) and fluid accumulation in the lungs (pulmonary
edema), allergic reaction (hypersensitivity) in the lungs (allergic alveolitis), eosinophilic pneumonia (lung disease)
Irritation or inflammation of the nose (rhinitis)
Inflammation of the oral mucosa (stomatitis) with ulcerations or sores, inflammation of the
tongue (glossitis)
Liver problems, for example liver failure, liver damage (necrotic hepatitis,
potentially fatal), inflammation of the liver or bile ducts (hepatocellular or
cholestatic hepatitis), yellowing of the skin and whites of the eyes (jaundice),
inflammation of the gallbladder (cholecystitis, especially in patients with pre-existing gallstones)
Severe skin diseases with blister formation, redness and scaling, including
erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal
necrolysis, purpura, cutaneous lupus erythematosus (an autoimmune disease that causes skin inflammation), pemphigus and erythrodermia (redness of the skin)
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Decreased urine output (oliguria), kidney disease (interstitial nephritis)
Breast enlargement in men (gynecomastia)
Increased liver enzymes, increased bilirubin levels in the blood (bilirubinemia).

Very rare (may affect up to 1 in 10,000 people)
Increased calcium levels in the blood (hypercalcemia)
Swelling of the intestinal mucosa (intestinal angioedema).

Not known (frequency cannot be estimated from available data)
Skin and lip cancer (non-melanoma skin cancer)

• Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• Decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). Other side effectsA complex disorder including one or more of the following symptoms has been reported, with unknown frequency: fever, serositis (inflammation of the membranes lining the body cavities, such as chest and abdomen), vasculitis (inflammation of blood vessels), muscle pain or muscle inflammation (myalgia/myositis), joint pain or inflammation (arthralgia/arthritis), positive test for the presence of antinuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leukocytosis), skin rash, skin sensitivity to light (photosensitivity) and other skin problems.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Idroclorotiazide ratiopharm

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 the outer packaging
after ”Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Idroclorotiazide ratiopharm contains
The active ingredients are enalapril maleate and hydrochlorothiazide.
Each tablet contains 20 mg of enalapril (as maleate) and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
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Lactose monohydrate, corn starch, sodium bicarbonate, pregelatinized starch, talc, magnesium
stearate.

Description of the appearance of Enalapril Idroclorotiazide ratiopharm and package contents
This medicine is presented in tablet form. The tablets are round, white, flat with
a fracture line on one side and beveled edges.
Packs of 14, 28, 30, 84, 90 tablets.

Marketing authorisation holder and manufacturer
ratiopharm GmbH, Graf-Arco Strasse 3 - 89079 Ulm (Germany)

Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3 - 89143 Blaubeuren (Germany)
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