VASORETIC 20 мг/12,5 мг Таблетки

Содержание инструкции

1. Vasoretic 20 mg + 12,5 mg tablets
   1. What Vasoretic is and what it is used for
   2. What you need to know before taking Vasoretic
2. Vasoretic may experience severe shortness of breath or difficulty breathing, consult
   1. How to take Vasoretic
   2. Possible side effects
   3. How to store Vasoretic
   4. Package Contents and Other Information

Vasoretic 20 mg + 12,5 mg tablets

enalapril maleate + hydrochlorothiazide

Read this leaflet carefully before you start taking this medicine as 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 Vasoretic is and what it is used for
• 2. What you need to know before you take Vasoretic
• 3. How to take Vasoretic
• 4. Possible side effects
• 5. How to store Vasoretic
• 6. Contents of the pack and other information

1. What Vasoretic is and what it is used for

Vasoretic contains two active ingredients: enalapril maleate and hydrochlorothiazide.
Enalapril maleate belongs to a group of medicines known as angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work by causing
relaxation of the blood vessels, and therefore facilitating the passage of blood through
them. ACE inhibitors are used for the treatment of high blood pressure
(hypertension).
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It works
by stimulating the kidneys to produce a greater quantity of urine (diuretic action) and thereby
reducing blood pressure (antihypertensive action).
Vasoretic is used for the treatment of high blood pressure and is indicated in patients whose
blood pressure is not adequately controlled with enalapril maleate or
hydrochlorothiazide administered alone.

2. What you need to know before taking Vasoretic

Do not take Vasoretic:

• if you are allergic to the active ingredients (enalapril maleate and hydrochlorothiazide) or to other medicines derived from sulfonamides (a chemically related substance to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction that caused swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with

consequent difficulty in swallowing or breathing (angioedema) after taking ACE-
inhibitors;

• if you suffer from hereditary angioedema (due to a family history);
• if you suffer from idiopathic angioedema, that is, angioedema whose cause is unknown;
• if you suffer from severe kidney problems (severe renal failure);
• if you are unable to urinate (anuria);
• if you are in the second or third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if you suffer from severe liver problems (severe hepatic failure);
• 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 (see section “Other medicines and Vasoretic”);
• 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 increased

Warnings and precautions
Talk to your doctor or pharmacist before taking Vasoretic.
In particular, talk to your doctor or pharmacist before taking Vasoretic if:

• you are taking medicines that increase urine production (diuretics), are following a low-salt diet, or if you have had vomiting or diarrhea. In these cases you are at risk of an excessive drop in blood pressure (hypotension) which may manifest with a feeling of weakness or dizziness. Your doctor will prescribe you to measure the amount of electrolytes present in the blood regularly.
• you have had disorders of blood flow to the heart (ischemic heart disease) or brain (ischemic cerebrovascular disease), or other heart problems associated with or without kidney problems. In these cases, an excessive drop in blood pressure can be particularly dangerous. If you experience symptoms of hypotension during treatment with Vasoretic, lie down and contact your doctor;
• 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 while taking Vasoretic. If you are taking any of the following medicines, the risk of angioedema may be increased:
• 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.
• tell your 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. If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If after taking

Vasoretic may experience severe shortness of breath or difficulty breathing, consult

a doctor immediately. 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 paragraph “Do not take Vasoretic”;

• are at risk of an increase in blood potassium levels (hyperkalemia) due to:
• kidney failure, worsening kidney function, diabetes, dehydration, acute heart failure due to which the heart does not pump blood adequately throughout the body, increased amount of acids in the blood (metabolic acidosis);
• concomitant use of medications that facilitate urine excretion while preserving potassium (potassium-sparing diuretics, for example spironolactone, eplerenone, triamterene or amiloride), potassium supplements, salt substitutes containing potassium, or if you are taking other medications that can increase potassium in the blood (e.g., heparin [a medication used to prevent blood clots], products containing trimethoprim such as cotrimoxazole [medications used to treat infections]) (see paragraph “Other medicines and Vasoretic”). In such cases, the doctor will frequently monitor the potassium level in the blood;
• suffer from a narrowing (stenosis) of the aortic artery or have a thickening of the heart walls (hypertrophic cardiomyopathy);
• suffer from severe heart problems (severe heart failure);
• have kidney problems, such as a narrowing (stenosis) of one or both renal arteries, as there is an increased risk of hypotension and kidney failure. In this case, the doctor will keep you under close observation by monitoring your kidney function;
• have recently undergone a kidney transplant. In this case, the use of this medicine is not recommended;
• are undergoing dialysis (blood purification therapy) due to kidney failure. In this case, the doctor will consider alternative treatment (see paragraph “Do not take Vasoretic”);
• have liver problems or suffer from a disease that could lead to destruction of liver cells (progressive liver disease) (see paragraphs “Do not take Vasoretic” and “Stop taking Vasoretic and tell your doctor if”);
• have a chronic and degenerative liver disease (liver cirrhosis), present a marked production of urine, do not take an adequate amount of electrolytes orally, are being treated with corticosteroids or adrenocorticotropic hormone (hormonal medicines). In such cases, the risk of a lowering of the blood potassium level (hypokalemia) is maximum;
• suffer from a connective tissue disease involving blood vessels, are taking medications that suppress the immune defenses (immunosuppressants), suffer from gout or are taking allopurinol (used in the treatment of gout) or procainamide (used to treat heart rhythm abnormalities), or have a combination of these risk factors, especially if you also have kidney problems. In this case, serious infections may occur that may not respond to antibiotic therapy. If you need to take Vasoretic in the presence of these conditions, the doctor will prescribe you specific blood tests. Report to the doctor any sign or symptom of infection;
• have diabetes and are taking oral or insulin antidiabetic medications. In this case, the doctor will tell you to perform blood tests to check the glucose level, especially during the first month of treatment with Vasoretic and assess the need to adjust the dose of antidiabetic medications;
• are taking lithium (medicine for the treatment of mood disorders) (see paragraph “Other medicines and Vasoretic”);
• are of black race. Vasoretic may in fact be less effective in lowering blood pressure in black patients compared to non-black patients. In addition, you may have an increased risk of developing angioedema;
• have developed a persistent dry cough for a long time after starting treatment with an ACE inhibitor;
• if you have a history of allergies or bronchial asthma, as sensitivity reactions may occur with the use of Vasoretic;
• if you suffer from a disorder called systemic lupus erythematosus (an autoimmune disease), which may occur or worsen with the use of Vasoretic;
• have decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and can occur within a period ranging from a few hours to weeks after taking Vasoretic. This can lead to permanent vision loss if left untreated. If you have had an allergy to penicillin or sulfonamide in the past, you may be at greater risk of developing these symptoms. If you are about to undergo any of the following procedures, tell your doctor that you aretaking Vasoretic:
• any surgical intervention or if you are to undergo anesthetic therapy;
• a treatment called LDL (low-density lipoprotein) apheresis with dextran sulfate, to remove cholesterol from the blood using machinery. The doctor may interrupt the treatment with Vasoretic to prevent a possible allergic reaction;
• a treatment to reduce the effects of an allergy, resulting for example from an insect bite (desensitization treatment). If you are taking Vasoretic while undergoing this treatment, you may experience a severe allergic reaction, so it is advisable to temporarily interrupt the therapy;
• you need to perform tests to check the function of the parathyroid glands. Consult the doctor who will tell you to suspend the intake of Vasoretic before performing this test. Stop taking Vasoretic and tell your doctor if you experience:
• swelling of the hands, feet, ankles, or even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema);
• yellowing of the skin and the whites of the eyes (jaundice), which indicate liver problems or an increase in liver enzyme (transaminase) levels in the blood;
• increased levels of nitrogen and creatinine in the blood, this circumstance could suggest the possibility of a stenosis of the renal artery;
• increased calcium levels in the blood (hypercalcemia). During treatment with Vasoretic, an electrolyte imbalance may occur which manifests with signs and symptoms that may include:
• dry mouth, thirst, weakness, pathological deep sleep (lethargy), drowsiness, agitation, muscle pain or cramps, muscle fatigue, lowering of blood pressure, reduced urine production, increased heart rate (tachycardia) and gastrointestinal disorders, such as nausea and vomiting. In these cases, promptly inform your doctor. The use of this medicine must take place under regular medical supervision. Therefore, scrupulously follow the examinations and laboratory tests according to the doctor's prescriptions.

Children and adolescents
The use of Vasoretic is not recommended in children, due to the lack of data on
safety and efficacy.

Other medicines and Vasoretic
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
In particular, consult your doctor or pharmacist if you are taking:

• an angiotensin II receptor blocker (AIIRA) or aliskiren (see also what is reported in the paragraph “Do not take Vasoretic” and “Warnings and precautions”). The doctor may consider it necessary to modify the dose and/or take other precautions;
• other medicines that lower blood pressure (antihypertensives), including vasodilators, nitroglycerin and other nitrates, because an excessive reduction in blood pressure may occur;
• lithium, used to treat some mood disorders, because an excessive increase in lithium concentration in the blood and subsequent lithium toxicity may occur; Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in the blood (e.g. trimethoprim and cotrimoxazole for infections caused by bacteria; cyclosporine, an immunosuppressant used to prevent organ rejection;

heparin, a medicine used to thin the blood to prevent the formation of
clots). See also the information in the paragraph “Warnings and precautions”;

• diuretics, such as thiazides or loop diuretics, because they may cause a reduction in blood pressure;
• anesthetics, antipsychotics and tricyclic antidepressants (used to treat mental disorders) because a further reduction in blood pressure may occur;
• medicines that act on the autonomic nervous system (sympathomimetics) such as ephedrine, pseudoephedrine, salbutamol found in some nasal decongestants, medicines for cough and cold, for asthma, for the treatment of low blood pressure and for the treatment of heart problems. These medicines can reduce the antihypertensive effects of Vasoretic;
• insulin or other antidiabetic medicines taken orally. The glucose level in the blood must be carefully monitored, especially in the first weeks of treatment with Vasoretic and in patients with kidney problems;
• medicines used to treat stiffness and inflammation associated with painful conditions, in particular those affecting muscles, bones and joints, including:
• medicines containing gold administered by injection, for example sodium aurothiomalate, because they can cause flushing of the face, feeling unwell (nausea), vomiting and low blood pressure, if taken with Vasoretic;
• non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, because they can reduce the effectiveness of Vasoretic, increase potassium levels in the blood and worsen kidney function;
• carbenoxolone (medicine used to treat stomach problems such as ulcers), kaliuretic diuretics (for example furosemide) or excessive use of laxatives. The use of Vasoretic with these medicines may further reduce the levels of potassium and/or magnesium in the blood;
• tubocurarine, used to relax muscles during surgery (muscle relaxant), because Vasoretic can increase its effects;
• barbiturates, which have a sedative effect on the central nervous system, used for example to treat epilepsy, or opioid analgesics, medicines used to reduce pain. These medicines can worsen the feeling of dizziness when getting up, due to a lowering of blood pressure (orthostatic hypotension);
• medicines used to reduce the amount of fats in the blood, such as cholestyramine or colestipol resins because they can reduce the absorption of Vasoretic;
• medicines used to treat irregular heartbeat (antiarrhythmics such as quinidine, procainamide, amiodarone, sotalol) because they can cause heart rhythm problems (torsade de pointes);
• medicines used to treat heart failure (digitalis medicines);
• corticosteroids (which modulate anti-inflammatory reactions) and adrenocorticotropic hormone ACTH (used to verify if the adrenal glands are functioning

correctly) because they can further reduce the levels of salts in the blood, in
particular potassium (hypokalemia);

• pressor amines (e.g. norepinephrine) because Vasoretic can decrease their effects;
• medicines for the treatment of cancer such as cyclophosphamide or methotrexate because Vasoretic can increase their toxicity;
• medicines for the treatment of gout, such as allopurinol (see paragraph “Warnings and precautions”);
• medicines that suppress the immune defenses (immunosuppressants);
• mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus) as concomitant administration may increase the risk of an allergic reaction called angioedema (see the paragraph “Stop taking Vasoretic and tell your doctor if”),
• a medicine containing a neprilysin inhibitor such as sacubitril (available as a fixed-dose combination with valsartan), racecadotril or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) may be increased. See also the information contained in the paragraphs “Do not take VASORETIC” and “Warnings and precautions”.

Vasoretic and alcohol
Vasoretic should not be taken with alcohol, as an excessive
lowering of blood pressure may occur.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy
Vasoretic is not recommended during pregnancy, and should not be taken if you are
pregnant for more than 3 months, as it can cause serious harm to the baby if taken
after the third month of pregnancy (see section “Do not take Vasoretic”).
You should inform your doctor if you think you may be pregnant (or if you are planning
a pregnancy). Your doctor will tell you to stop taking Vasoretic
immediately before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Vasoretic.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to breastfeed your baby with
breast milk. Vasoretic is not recommended in women who are breastfeeding, particularly
if your baby was born prematurely and in the first few weeks after delivery.

Driving and using machines
Vasoretic can cause side effects that may affect your ability to drive
vehicles and use machines, such as dizziness or fatigue that may occur
occasionally.
Therefore, be cautious when driving and using machines.

Vasoretic contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking this medicine.

Vasoretic contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is
essentially
‘sodium-free’.

For athletes
The use of the medicine without therapeutic necessity constitutes doping and may still result in a positive doping test.

3. How to take Vasoretic

Take this medicine following exactly the instructions of your doctor. If you have
doubts, consult your doctor.
The recommended dose is 1 tablet per day. If necessary, your doctor may increase the
dose up to a maximum of 2 tablets to be taken 1 time a day.
At the beginning of treatment, it is advisable to start with half the dosage (10 mg of enalapril and
6.25 mg of hydrochlorothiazide).
Since the tablet cannot be divided into two equal parts, the doctor may consider
using the individual components at the above doses or other medicines
(with the same combination of active ingredients and dosage) available in divisible tablets.
The doctor will determine the dose based on your condition and until control is achieved
of blood pressure.

Previous diuretic therapy
If you are already taking another medicine that promotes diuresis, the use of enalapril,
contained in Vasoretic, may determine an excessive reduction in blood
pressure. In such cases, if the doctor still deems the use of Vasoretic necessary, he will tell you
to suspend the diuretic a few days before taking Vasoretic. If this is not
possible, the doctor will decide to start therapy with lower doses of enalapril, i.e. with
separate tablets of the same active ingredients as Vasoretic (enalapril and hydrochlorothiazide).
Vasoretic can then be used later, when the doctor has established for you the
need to take the dose of enalapril and hydrochlorothiazide present in the tablet of
Vasoretic.

Patients with kidney problems (renal insufficiency)
You should not use Vasoretic if you suffer from severe kidney problems (see section “Do not take
Vasoretic”).
If you have kidney problems, your doctor will check your kidney function and decide the
appropriate dose of Vasoretic.

Use in children and adolescents
The use of Vasoretic is not recommended in children.

Use in the elderly
No dosage adjustment is necessary in elderly patients.

If you take more Vasoretic than you should
In case of accidental intake of an excessive dose of Vasoretic, immediately inform
your doctor or go to the nearest hospital and stop treatment.
The symptoms of an overdose may include: feeling of emptiness or dizziness,
due to excessive lowering of blood pressure, serious circulation problems (circulatory shock), renal failure, hyperventilation, increased
heart rate (tachycardia), palpitations, decreased heart rate (bradycardia), anxiety, cough, electrolyte disturbances such as low
level of potassium (hypokalemia), chlorine (hypochloremia) and sodium (hyponatremia) in the blood,
dehydration due to excessive diuresis.

If you forget to take Vasoretic
Do not take a double dose to make up for the forgotten tablet. If in
doubt, contact your doctor.

If you stop taking Vasoretic
Do not stop treatment with Vasoretic unless your doctor tells you to. If you have
any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

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

Stop taking Vasoretic 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 even the face, lips, tongue and/or throat with resulting difficulty swallowing or breathing (angioedema). The side effects observed with the use of Vasoretic were: 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)
• lowering of the level of potassium in the blood (hypokalaemia) or increase of the level of potassium in the blood (hyperkalaemia), increase of the level of cholesterol, triglycerides, uric acid (hyperuricemia) and creatinine in the blood;
• headache, depression, temporary loss of consciousness (syncope), altered taste;
• lowering of blood pressure (hypotension), decrease in blood pressure following the sudden transition from a sitting or lying position to an upright position (orthostatic hypotension), alterations in heart rhythm, pain accompanied by a feeling of constriction and oppression in the chest (angina pectoris), increased heart rate (tachycardia);
• difficulty breathing (dyspnoea);
• diarrhoea, abdominal pain;
• 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 (anaemia, including aplastic and hemolytic anaemia);
• decrease in blood sugar (hypoglycaemia), decrease in the level of magnesium in the blood (hypomagnesaemia), 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);
• reduced sexual desire, impotence;
• annoying sensation of sounds or whistling in the ears (tinnitus);
• redness and sensation of heat mainly on the face (hot flushes), 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 (laryngodynia) 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 in digestion (dyspepsia), constipation (stipsi), loss of appetite (anorexia), irritation of the stomach, dry mouth, lesions in the stomach (peptic ulcer), increased production of intestinal gas (flatulence);
• increased sweating (diaphoresis), itching, hives, hair loss (alopecia);
• joint pain (arthralgia);
• alteration of renal function, renal failure, presence of protein in the urine (proteinuria);
• malaise, fever;
• increased level of urea 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 some white blood cells (neutropenia, leucopenia and agranulocytosis), the amount of hemoglobin, the total volume of red blood cells (low hematocrit), platelets (thrombocytopenia) or all different types of blood cells (pancytopenia), depression of the bone marrow (when the bone

marrow fails to produce a sufficient number of cells found in the
blood), swelling of glands called lymph nodes (lymphadenopathy), diseases of the
immune system (autoimmune diseases);

• increase in 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);
• problems with the lungs including lung infiltrates, severe respiratory failure (acute respiratory distress syndrome), inflammation (pneumonia) and accumulation of fluid in the lungs (pulmonary edema), allergic reaction (hypersensitivity) in the lungs (allergic alveolitis), lung disease (eosinophilic pneumonia);
• irritation or inflammation of the nose (rhinitis);
• inflammation of the oral mucosa (stomatitis) with ulcerations or sores, inflammation of the tongue (glossitis);
• problems with the liver such as liver failure, liver damage (necrotic hepatitis, potentially fatal), inflammation of the liver or bile ducts (hepatocellular or cholestatic hepatitis), yellowing of the skin and the 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);
• decreased urine output (oliguria), kidney disease (interstitial nephritis);
• growth of breast tissue in men (gynecomastia);
• increased liver enzymes, increased level of bilirubin in the blood (bilirubinemia). Very rare (may affect up to 1 in 10,000 people)
• increased level of calcium in the blood (hypercalcemia);
• swelling of the intestinal mucosa (intestinal angioedema) acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion). Not known (frequency cannot be estimated on the basis of available data):
• inappropriate secretion syndrome of antidiuretic hormone, SIADH;
• rapid onset of distance vision impairment (acute myopia), 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);
• skin and lip cancer (non-melanoma skin cancer). 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), positivity to the test for the presence of anti-nuclear antibodies, increased erythrocyte sedimentation rate (ESR), increased number of white blood cells (eosinophilia, leucocytosis), skin rash, skin sensitivity to light (photosensitivity) and other problems affecting the skin.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet,
please inform your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
https://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 Vasoretic

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 package and on the blister
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 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 Vasoretic contains

• The active ingredients are enalapril maleate and hydrochlorothiazide. Each tablet contains 20 mg of enalapril maleate and 12.5 mg of hydrochlorothiazide.
• The other excipients are: sodium bicarbonate, lactose monohydrate, yellow iron oxide, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Vasoretic and package contents
Vasoretic is available in the form of tablets contained in an aluminum blister.
Each pack contains 14 or 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN – Haarlem, Netherlands
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, 2220, Belgium