ZESTORETIC 20 mg /12.5 Mg Коированная Таблетка

Содержание инструкции

1. ZESTORETIC 20 mg + 12,5 mg tablets
   1. What is Zestoretic and what it is used for
   2. What you need to know before taking Zestoretic
   3. How to take Zestoretic
   4. Possible side effects
   5. How to store Zestoretic
   6. Contents of the pack and other information

ZESTORETIC 20 mg + 12,5 mg tablets

Lisinopril + Hydrochlorothiazide
Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Zestoretic and what it is used for

Zestoretic contains the active ingredients: lisinopril and hydrochlorothiazide.
Lisinopril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors), which work by reducing blood pressure by dilating blood
vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics, which work by promoting the
production and elimination of urine, which causes a lowering of blood pressure.
Zestoretic is indicated for the treatment of high blood pressure (primary arterial hypertension)
in adults, when it is not possible to control it with lisinopril or hydrochlorothiazide monotherapy alone.
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Zestoretic

Do not take Zestoretic:

• if you are allergic to lisinopril or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to drugs similar to Zestoretic (other ACE inhibitors or sulfonamide-derived medicines)
• if you do not urinate (anuria)
• if in the past you have suffered from itching, hives, sudden drop in blood pressure, swelling of hands, feet, ankles, face, lips, tongue and/or throat (angioedema) caused by a previous treatment with ACE inhibitors
• if someone in your family has had a severe allergic reaction of unknown cause. This may indicate a condition called hereditary angioedema and may make you more susceptible to the symptoms described above
• if you suffer from idiopathic angioedema (without an obvious cause)
• if you suffer from severe kidney problems (creatinine clearance < 30 ml/min)
• if you suffer from severe liver problems
• if you are pregnant for more than 3 months (see section “Pregnancy and breastfeeding”)
• if you are taking medicines containing aliskiren (to treat high blood pressure) and suffer from diabetes or have reduced kidney function (see section “Other medicines and Zestoretic”).

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

• if you suffer from a narrowing (stenosis) of the aortic valve (an artery of the heart) or of the kidney artery
• if you suffer from hypertrophic cardiomyopathy (a condition characterized by an increase in the thickness of the heart muscle) or if the heart valves have a narrowing (mitral valve), or if there are other obstructions to the outflow from your left ventricle
• if you suffer from problems with diarrhea or vomiting
• if you suffer from gout (a disease that causes joint pain)
• if you suffer from liver problems
• if you suffer from kidney problems
• if you are undergoing dialysis (medical treatment to clean the blood when you suffer from severe kidney disease)
• if you have had a kidney transplant
• if you are on a low-salt diet
• if you are taking medicines to treat allergies, for example for insect bites
• if you or someone in your family has had allergic reactions in the past with swelling of the hands, feet or ankles, face, lips, tongue and/or throat with difficulty breathing (see section “Possible side effects”)
• if you need to undergo apheresis (a procedure with which some components of the blood are separated)
• if you suffer from hypotension (low blood pressure that can manifest as a feeling of weakness or dizziness)
• if you have reduced sugar tolerance or if you suffer from diabetes
• if you are taking one of the following medicines used to treat high blood pressure: o 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 or Aliskiren
• if you are taking medicines for the treatment of breast cancer called mTOR inhibitors (for example temsirolimus, everolimus, sirolimus) or medicines containing NEP inhibitors (for example racecadotril) as they may increase the risk of angioedema. Symptoms of angioedema include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing
• 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 while taking Zestoretic
• If you 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 Zestoretic. This can lead to permanent vision loss if not

treated. If you have previously experienced an allergy to penicillins or sulfonamides, you may be at a higher
risk of developing it

• If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Zestoretic, 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:

• if changes occur in the number of blood cells (white blood cells, red blood cells and platelets) during treatment with Zestoretic
• if you have a significant decrease in certain types of white blood cells with the development of susceptibility to infections and severe general symptoms (agranulocytosis)

Changes in blood salt levels (electrolyte imbalance)
Due to the diuretic present in Zestoretic, levels of sodium and potassium in the blood may decrease. This
can cause dry mouth, thirst, weakness, drowsiness, irritability, fatigue or muscle pain,
hypotension, nausea, rapid heartbeat and stomach and/or intestinal disorders.
The diuretic may also cause a decrease in the levels of chloride and magnesium; while
it may cause an increase in calcium levels.
The doctor may therefore prescribe blood tests to check your salt levels.

Cough
During treatment you may have a dry and persistent cough.
This cough resolves with discontinuation of treatment.
If you need to undergo tests to assess respiratory function during treatment, inform your
doctor that you are taking Zestoretic.

Sudden drop in blood pressure
The initial dose may cause a sudden drop in blood pressure, greater than that which
occurs subsequently with continued treatment. You may therefore experience a
feeling of weakness or dizziness; in these cases, lying down may help. If symptoms persist,
consult your doctor.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
Zestoretic and, in particular, the anesthesiologist (the doctor responsible for the anesthesia) in case of
surgery. It will also be appropriate to inform your dentist if an anesthetic is administered for
dental care.

Ethnicity
If you are of black origin, you may be more likely to experience "angioedema" (characterized by swelling of the face,
lips, tongue, throat or sudden difficulty breathing).

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

Children and adolescents
The safety and efficacy of Zestoretic in children and adolescents has not been established, therefore this
medicine is not recommended for children and adolescents.

Other medicines and Zestoretic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
In particular, before starting treatment with Zestoretic, tell your doctor if you are taking:

• other diuretic medicines (including a type of diuretics called “potassium-sparing”), as if taken at the same time as Zestoretic they may increase the effect of this medicine
• other antihypertensive medicines (for the treatment of high blood pressure) known as sartans(e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems or have diabetes
• other antihypertensive medicines (for the treatment of high blood pressure), including those containing aliskiren(for the treatment of high blood pressure), as if taken at the same time as Zestoretic they may increase the effect of this medicine In particular, do not take Zestoretic if you are taking aliskiren and have kidney problems or diabetes (see section “Do not take Zestoretic”)
• indometacin(painkiller, medicine for pain and inflammation) or other medicines for the treatment of joint inflammation or muscle pain
• lithium(used to treat mental illness)
• goldinjectable (for the treatment of rheumatoid arthritis, a chronic inflammation of the joints)
• NSAIDs(Non-Steroidal Anti-Inflammatory Drugs, medicines for pain and inflammation), as if taken at the same time as Zestoretic they may decrease the effect of this medicine. Furthermore, if you suffer from reduced kidney function, these medicines may cause a further reduction in your kidney function
• allopurinol(for the treatment of gout, a disease that causes joint pain), as if taken together with Zestoretic it may increase the risk of leucopenia (reduction in the number of white blood cells in the blood)
• cytostatic agents(used to reduce tumor growth) e.g. cyclophosphamide, methotrexate, everolimus and medicines used to prevent organ rejection after transplantation, such as kidney or liver (e.g. temsirolimus, sirolimus) as if taken together with Zestoretic they may increase the risk of leucopenia
• racecadotrilused to treat diarrhea
• tissue plasminogen activator (TPA), used to dissolve blood clots that have formed in blood vessels
• immunosuppressants (medicines that reduce the immune response), which if taken together with Zestoretic may increase the risk of leucopenia
• procainamideand sotalol(medicines against heart rhythm abnormalities, antiarrhythmics)
• medicinesto treat diabetes(including insulin), as if you suffer from diabetes, your doctor may need to adjust the dose of the medicine you are taking
• potassiumsupplements or salt substitutes containing potassium or other drugs that increase potassium levels in the blood (e.g. heparin, cotrimoxazole)
• salicylic acid derivatives, used in the treatment of various forms of pain (e.g.: headache, menstrual pain, muscle or bone pain), to lower fever and in the treatment of inflammatory diseases
• calcium or vitamin Dsupplements
• vasodilators, nitroglycerin and other nitrates(used to lower blood pressure and/or treat heart problems)
• medicinesto relax musclesin case of general anesthesia and in intensive care (including tubocurarine chloride and anesthetics)
• medicinesto treat mood disorders, such as tricyclic antidepressants and antipsychotics
• sympathomimetics(medicines that act primarily on the sympathetic nervous system, the system that controls the internal organs, mainly blood circulation and heart)
• amphotericin B(administered intravenously), for the treatment of fungal infections
• carbenoxolone(for the treatment of ulcers or inflammation of the esophagus or around the mouth)
• corticotropin(a hormone)
• stimulant laxatives(medicines to treat constipation)
• digoxin(for the treatment of heart problems, including heart rhythm problems)
• medicinesto treat high cholesterollevels such as colestyramine and colestipol
• trimethoprim, for the treatment of bacterial infections
• medicines to prevent rejectionof organs after transplantation such as cyclosporine
• medicines with anti-inflammatory activity (corticosteroids), as they increase the elimination of some salts normally dissolved in the blood and fluids of the body, in particular potassium
• medicines such as adrenaline(a medicine that stimulates the heart), as their effect may decrease
• barbituratesand narcotics(substances that reduce brain activity), as they may cause an excessive decrease in blood pressure when in an upright position
• diazoxide(used to treat low blood sugar levels)
• amantadine(used to treat viral infections), as there is an increase in drug toxicity

Zestoretic with alcohol
The use of alcohol together with Zestoretic may cause an excessive decrease in blood pressure
when in an upright position.

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 taking this medicine.

Pregnancy
The use of Zestoretic is not recommended during the first 3 months of pregnancy.
Do not take Zestoretic after the first 3 months of pregnancy (see section “Do not take Zestoretic”).
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Therapy with Zestoretic should not be started during pregnancy.
As a rule, your doctor will advise you to stop taking Zestoretic before becoming pregnant or as soon as you find out that you are pregnant and will advise you to take another medicine unless it is considered essential to continue therapy with an ACE inhibitor.
Zestoretic is not recommended at the beginning of pregnancy, as there is a slight increase in the risk of toxicity to the fetus.
Zestoretic should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the third month of pregnancy (see section “Do not take Zestoretic”).
If you are exposed to an ACE inhibitor after the first trimester of pregnancy, your doctor will recommend an ultrasound check of kidney function and the fetal skull, and will subsequently monitor the newborn for the risk of hypotension (low blood pressure).

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
Breastfeeding of newborns (first weeks after birth) and especially premature babies is not recommended while taking Zestoretic. The doctor will assess the benefits for you and the risks for the newborn related to taking Zestoretic during breastfeeding, and may advise you on alternative treatment if you wish to breastfeed.

Driving and operating machinery
During treatment with Zestoretic you may experience dizziness or fatigue.
Therefore, avoid driving vehicles or using machinery that requires particular attention, at least until your tolerance to this medicine is known.

3. How to take Zestoretic

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

Adults and the elderly
The recommended dose is 1 tablet once a day. In general, if after 2-4 weeks you do not
obtain the desired effect, your doctor may increase the dosage up to 2 tablets to be taken
simultaneously in a single daily dose.

If you have reduced kidney function (renal insufficiency)
If you suffer from renal insufficiency, your doctor, after evaluating your kidney function, may not
prescribe Zestoretic in the initial treatment of hypertension, as this medicine may
be ineffective. When used alone, the recommended initial dose of lisinopril in
renal insufficiency is 5-10 mg.

In case of previous treatment with diuretics(medicines that work by increasing the amount of urine
produced by the kidneys)
If, before treatment with Zestoretic, you have undergone therapy with diuretics, at the beginning of therapy with
Zestoretic you may experience symptomatic hypotension (reduction of blood pressure that manifests
with symptoms such as nausea, weakness, headache, drowsiness, mental confusion). This
may happen especially if you are in a condition where you have a reduced blood volume
(hypovolemia) and/or have a reduced amount of sodium in the blood caused by previous therapy with
diuretics.
If you are taking diuretics, your doctor will suspend the diuretic therapy you are taking for 2-3 days,
before starting therapy with Zestoretic. If this is not possible, your doctor will start treatment with
lisinopril alone at a dose of 5 mg.

Use in children and adolescents
The safety and efficacy of Zestoretic in children and adolescents have not been established, therefore this
medicine is not recommended for children and adolescents.

How
Take the tablets with some water at the same time of day, preferably early in the morning.

If you use more Zestoretic than you should
In case of accidental intake of doses higher than those recommended, immediately contact
your doctor or the nearest hospital.
In case of taking an excessive dose of the medicine, you may experience the following symptoms: reduction of
blood pressure, syncope (fainting), alterations of the electrolyte balance (amount of sodium, potassium
and others in the blood), kidney problems, rapid and deep breathing, accelerated heartbeat,
perception of heartbeats, slowed heartbeat, dizziness, anxiety, cough, increased diuresis,
convulsions, paralysis, irregular heartbeats and serious kidney problems.

If you forget to use Zestoretic
In case you forget to take a dose, it is advisable to take it as soon as possible. Two doses must not
be taken simultaneously.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking Zestoretic
Improvement of health status should not lead to interruption of treatment, unless
requested by your doctor.
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.
Zestoretic is generally well tolerated.
If you experience the following side effects during treatment with Zestoretic, contact your doctor immediately, who will STOPtreatment with Zestoretic:

• allergic reactions. Signs may include: swelling of the face, hands, feet, ankles, lips, tongue and/or throat (angioedema) (see section “Warnings and precautions”);
• jaundice (yellowing of the skin and the whites of the eyes);
• marked increase in liver enzymes (evaluated with a blood test). Increased liver enzyme levels are symptoms of impaired liver function: hepatitis (inflammation of the liver), liver failure (severe liver disease).

If you experience the following side effect during treatment, contact your doctor immediately:

• severe eye pain accompanied by redness and sudden blurred vision. If left untreated, this condition may cause permanent vision loss.

In addition, the following side effects have been observed and reported during treatment with Zestoretic
with the following frequencies:

Common (may affect up to 1 in 10 people):

• dizziness
• headache
• paresthesia (tingling)
• orthostatic effects, including hypotension (reduction in blood pressure when standing up accompanied by symptoms such as dizziness/lightheadedness)
• syncope (fainting)
• cough
• diarrhea
• nausea
• vomiting
• rash (skin eruptions)
• muscle cramps
• inability to achieve an erection (impotence)
• fatigue
• asthenia (weakness)
• changes in blood tests to check kidney function (increased urea and creatinine)
• changes in blood tests to check liver function (increased liver enzymes)
• changes in blood tests to assess hemoglobin (decreased hemoglobin).

Uncommon (may affect up to 1 in 100 people):

• gout (disease that causes joint pain)
• depressive symptoms
• palpitations (feeling of increased heartbeat)
• dry mouth
• feeling of chest tightness
• change in a laboratory test: decreased hematocrit (test that measures the amount of red blood cells in the blood).

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

• anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• inadequate production of a hormone that reduces the amount of urine produced by the kidneys, called “antidiuretic hormone”
• increased blood sugar levels (hyperglycemia)
• decreased potassium levels in the blood (hypokalemia)
• increased uric acid levels in the blood (hyperuricemia)
• increased potassium levels in the blood (hyperkalemia)
• taste disturbances
• pancreatitis (inflammation of the pancreas, a gland located near the stomach)
• muscle weakness
• increased bilirubin (a substance produced by the body whose increase may be due to a liver disorder) in the blood.

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

• myelodysplasia (reduced activity of the bone marrow, where blood cells are produced)
• hemolytic anemia (disease due to the destruction of some blood cells, red blood cells)
• thrombocytopenia (reduction in the number of platelets in the blood)
• leukopenia (reduction in the number of white blood cells in the blood)
• agranulocytosis (increased number of granulocytes in the blood, a type of blood cell)
• intestinal angioedema (swelling of the intestinal walls that can cause severe abdominal pain, with vomiting and diarrhea)
• cutaneous pseudolymphoma (disease that manifests with a complex symptomatology that may include one or more of the following effects: fever, vasculitis (inflammation of blood vessels), myalgia (muscle pain), arthralgia/arthritis (joint pain/inflammation), positive laboratory values for measuring certain immune reactions (positive antinuclear antibodies, ANA), increased erythrocyte sedimentation rate (ESR, high laboratory value for measuring inflammation), eosinophilia and leukocytosis (increase in the blood of eosinophils and leukocytes, two types of blood cells), rash (skin eruptions), photosensitivity (sensitivity to sunlight) and other manifestations concerning the skin)
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known (frequency cannot be estimated based on available data)

• Severe allergic reactions
• Skin and lip cancer (non-melanoma skin cancer)

Other side effects that have been reported with other medicines containing the same active ingredients as
Zestoretic (hydrochlorothiazide and lisinopril), and which therefore may be potential side effects of
Zestoretic.

Possible side effects with hydrochlorothiazide
Frequency not known (frequency cannot be estimated based on available data)

• anorexia (loss of appetite)
• gastric irritation (inflammation of the stomach)
• constipation
• sialoadenitis (inflammation of the glands that produce saliva)
• vertigo
• xanthopsia (visual disturbance consisting of seeing objects white as yellow)
• aplastic anemia (insufficient production of all types of blood cells by the bone marrow)
• purpura (disease in which the skin turns red due to abnormal accumulation of blood)
• photosensitivity (sensitivity to sunlight)
• urticaria (skin redness accompanied by itching)
• inflammation of blood vessels (necrotizing angiitis: vasculitis, cutaneous vasculitis)
• fever
• exanthem (skin eruption of pustules, vesicles and blisters, typical of some childhood diseases)
• difficulty breathing including pneumonia and pulmonary edema (increased fluid in the lungs)
• glycosuria (presence of sugars in the urine)
• electrolyte imbalances including hyponatremia (decrease in the amount of sodium in the blood), hypomagnesemia (decrease in the amount of magnesium in the blood)
• agitation, depression, dizziness, sleep disorders
• kidney disorders (renal dysfunction and interstitial nephritis)
• activation or increase of symptoms of lupus (an autoimmune disease that manifests with fatigue, joint pain, skin rashes, swelling, redness, weight gain or loss, etc.)
• toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin lesions characterized by irritation of the skin, blistering lesions with areas of skin detachment)
• hypochloremic alkalosis (loss of chlorine from the body)
• increased levels of cholesterol and triglycerides in the blood
• hypercalcemia (increased calcium in the blood); if you should have an increase in calcium in the blood, your doctor will prescribe tests to assess the presence of a disease called “hyperparathyroidism” (alteration in the production of a hormone that regulates the amount of calcium in the blood)
• cardiac arrhythmias (alteration of the heart rate, i.e. the number of beats per minute)
• rapid onset short-sightedness (myopia)
• acute angle-closure glaucoma (severe form of glaucoma, i.e. an eye disease caused by an increase in the pressure of the fluid contained inside the eye)
• decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)
• transient visual disturbances including transient blurred vision.

Possible side effects with lisinopril
Common (may affect up to 1 in 10 people):

• renal dysfunction.

Uncommon (may affect up to 1 in 100 people):

• taste alterations
• sleep disorders
• mood alterations
• myocardial infarction (heart attack) or cerebrovascular event (stroke), perhaps due to, in predisposed subjects, an excessive reduction in blood pressure
• tachycardia (increased heart rate)
• Raynaud's syndrome (pain in the fingers of hands and feet that become first white, then bluish and finally reddish)
• rhinitis (irritation or inflammation of the nasal mucosa)
• stomach pain (abdominal pain and indigestion)
• pruritus.

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

• mental confusion
• alopecia (hair loss)
• urticaria (skin redness accompanied by itching)
• psoriasis (chronic inflammatory skin disease, not infectious or contagious)
• uremia (presence of urea in the blood)
• acute renal failure (severe kidney disease)
• gynecomastia (development of breasts in men)
• low levels of sodium in the blood.

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

• lymphadenopathy (swelling of the lymph nodes - organs of the body's defense system)
• autoimmune disease (alteration of the body's defense system)
• low blood sugar levels (hypoglycemia)
• sinusitis (inflammation of the nose)
• bronchospasm (narrowing of the bronchi that causes severe difficulty breathing due to reduced air passage)
• difficulty breathing caused by an allergic reaction including allergic alveolitis/eosinophilic pneumonia
• severe skin alterations including pemphigus (a blistering skin disease), toxic epidermal necrolysis and Stevens-Johnson syndrome (severe skin lesions characterized by erythema, blistering lesions with areas of skin detachment) and erythema multiforme (a condition characterized by the appearance of red spots on the skin with a "bull's-eye" appearance associated with itching)
• diaphoresis (excessive sweating)
• oliguria/anuria (reduced/absent urine output).

Frequency not known (frequency cannot be estimated based on available data)

• hot flushes
• visual and/or auditory hallucinations (perception of things and/or voices that do not exist in reality).

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
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 Zestoretic

• Store in the original package to protect the medicine from light.
• 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 pack after SCAD. The expiry date refers to the last day of that month.
• 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. Contents of the pack and other information

• The active ingredients are: lisinopril dihydrate (each tablet contains 21.8 mg of lisinopril dihydrate, equivalent to 20 mg of anhydrous lisinopril), hydrochlorothiazide (each tablet contains 12.5 mg of hydrochlorothiazide)
• The other ingredients are: mannitol, dibasic calcium phosphate dihydrate, corn starch, pregelatinized starch, magnesium stearate.

Description of the appearance of Zestoretic and contents of the pack
Tablets packaged in blisters of 14 tablets, 28 tablets and 42 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Atnahs Pharma Netherlands B.V.
Copenhagen Towers, Ørestands Boulevard 108, 5.tv DK-2300, København S Denmark

Manufacturers
AstraZeneca Reims Production, Parc Industriel de la Pompelle, Chemin de Vrilly, 51100 Reims, France