LISINOPRIL 20 мг/12,5 мг Таблетки

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

Lisinopril Hydrochlorothiazide Sandoz 20 mg/ 12,5 mg tablets

Lisinopril and hydrochlorothiazide

Generic medicine

Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 Lisinopril Hydrochlorothiazide Sandoz is and what it is used for
• 2. What you need to know before you take Lisinopril Hydrochlorothiazide Sandoz
• 3. How to take Lisinopril Hydrochlorothiazide Sandoz
• 4. Possible side effects
• 5. How to store Lisinopril Hydrochlorothiazide Sandoz
• 6. Contents of the pack and other information

1. What is Lisinopril Hydrochlorothiazide Sandoz and what is it used for

Lisinopril, which belongs to a group of medicines called “angiotensin converting enzyme inhibitors” (ACE inhibitors), lowers blood pressure by widening blood vessels.

Hydrochlorothiazide, which belongs to a group of medicines called diuretics, lowers blood pressure by increasing urine production.
Lisinopril Hydrochlorothiazide Sandoz contains a combination of lisinopril and hydrochlorothiazide and is used as treatment for high blood pressure when treatment with lisinopril alone has proven insufficient.
The doctor may also prescribe Lisinopril Hydrochlorothiazide Sandoz instead of identical, but separate, dosages of lisinopril and hydrochlorothiazide. The fixed-dose combination is not suitable for initiating therapy.

2. What you need to know before taking Lisinopril Hydrochlorothiazide Sandoz

DO NOT take Lisinopril Hydrochlorothiazide Sandoz

• if you are allergic to lisinopril, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other ACE inhibitors, for example ramipril, or to medicines derived from sulfonamide (mainly antibiotics, such as sulfamethoxazole)
• if in the past you have suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) when you received other medicines belonging to a class of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors), such as ramipril
• if in the past you have suffered from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema) in any other circumstance
• if you are taking or have taken 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 anyone in your family has suffered in the past from swelling of the extremities, face, lips, throat, mouth or tongue (angioedema)
• if you suffer from severe kidney disorders
• if you suffer from severe liver disorders
• if you suffer from inability to pass urine (anuria)
• if you are pregnant for more than 3 months (it is better to avoid Lisinopril Hydrochlorothiazide Sandoz in the early stages of pregnancy - see the paragraph “Pregnancy and breastfeeding”).
• 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.

Warnings and precautions
Tell your doctor or pharmacist before taking Lisinopril Hydrochlorothiazide Sandoz:

• if you suffer from narrowing of the arteries (atherosclerosis), cerebrovascular disorders, such as a stroke or transient ischemic attack (TIA, the so-called “mini-stroke”)
• if you suffer from heart failure
• if you have low blood pressure, follow a low-salt diet or are taking diuretics
• if you have abnormal organic levels of water and minerals (water/electrolyte imbalance)
• if you suffer from a disease of the heart muscle (hypertrophic cardiomyopathy), a narrowing of the aorta, the main artery that carries blood from the heart (aortic stenosis), or another form of heart disorder called outflow obstruction
• if you are to undergo LDL apheresis (removal of cholesterol from the blood using a machine)
• if you are to undergo desensitization therapy for some insect venoms, such as bees and wasps
• if you suffer from diabetes
• 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 Your 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 under “Do not take Lisinopril Hydrochlorothiazide Sandoz”.
• If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased:
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as, temsirolimus, sirolimus, everolimus);
• racecadotril, a medicine used to treat diarrhea;
• vildagliptin, a medicine used to treat diabetes.
• if you suffer from gout, have high levels of uric acid in your blood or are being treated with allopurinol
• if you are to receive an anesthetic
• if you have recently suffered from severe and prolonged vomiting and/or severe diarrhea
• if you are about to undergo tests to check parathyroid function
• if you suffer from or have suffered from liver or kidney disorders, a narrowing of the arteries to the kidneys (renal artery stenosis) or have only one functioning kidney, or are to undergo hemodialysis
• if you suffer from collagen vascular diseases, such as systemic lupus erythematosus (SLE) or scleroderma, which may be associated with skin rashes, joint pain and fever
• 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 Lisinopril Hydrochlorothiazide Sandoz
• if you have allergy problems or asthma
• if you are taking lithium, used to treat some mental illnesses
• if you believe you are (or may be) pregnant. Lisinopril Hydrochlorothiazide Sandoz is not recommended in early pregnancy and should not be taken after the first 3 months of pregnancy, as it can cause serious harm to the baby if taken during this period (see the paragraph “Pregnancy”)
• if you are being treated with other diuretics. The other treatment should be stopped 2-3 days before starting treatment with Lisinopril Hydrochlorothiazide Sandoz

Lisinopril Hydrochlorothiazide Sandoz is not generally recommended in the following cases; therefore consult your
doctor before starting to take this medicine:

• if you have recently had a kidney transplant
• if you have high levels of potassium in your blood.

Also refer to the section “Other medicines and Lisinopril Hydrochlorothiazide Sandoz” below.
If you are an athlete about to take a doping test, consult your doctor, as Lisinopril Hydrochlorothiazide
Sandoz contains an active substance that may result in positive doping test results.
Elderly or malnourished patients should pay particular attention when using Lisinopril Hydrochlorothiazide
Sandoz.
Lisinopril Hydrochlorothiazide Sandoz may be less effective in patients of African descent.

Children
The use of this medicine is not recommended in children.
During treatment with Lisinopril Hydrochlorothiazide Sandoz
If you develop any of the following symptoms you should immediately inform medical personnel:

• Feeling dizzy after the first dose. Some people react to the first dose or an increase in dosage with a feeling of dizziness, weakness, fainting and nausea
• Sudden swelling of lips, face and neck, possibly also of hands and feet, or shortness of breath and hoarseness. This condition is called angioedema and can occur at any time during treatment. ACE inhibitors cause a higher incidence of angioedema in black patients compared to non-black patients
• High temperature, sore throat or ulcers in the mouth (these may be symptoms of an infection caused by a reduction in the number of white blood cells)
• Yellowing of the skin and whites of the eyes (jaundice), which may be a sign of liver disease.
• Dry cough that persists for a long time. Cough has been reported with the use of ACE inhibitors, but it may also be a symptom of other diseases of the upper airways.
• Myopathy or glaucoma.

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

Other medicines and Lisinopril Hydrochlorothiazide Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
This particularly applies to:

• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, a medicine

immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine
used to thin the blood and prevent the formation of clots)

• other medicines used to treat high blood pressure Your doctor may need to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also what is reported under “Do not take Lisinopril Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
• anesthetics and medicines used for mental disorders or depression, medicines for the treatment of psychoses, tricyclic antidepressants, or sedatives
• lithium, a medicine for depression
• pain relievers and anti-inflammatory drugs, such as acetylsalicylic acid (>3000 mg/day) or indometacin
• sodium aurothiomalate (gold), an injectable medicine against rheumatoid arthritis
• sympathomimetic medicines, such as ephedrine, norepinephrine or adrenaline, used for the treatment of hypotension, shock, heart failure, asthma or allergies
• hypoglycemic medicines, such as insulin or those taken orally
• cholestyramine and colestipol resins, active substances used to lower lipid levels in the blood
• corticosteroids, anti-inflammatory substances similar to hormones
• ACTH, used to check the correct functioning of the adrenal glands
• muscle relaxants (such as tubocurarine chloride), medicines used to relax muscles during surgical operations
• allopurinol, a medicine used to treat gout
• medicines used to treat cancer, such as cyclophosphamide or methotrexate
• medicines that inhibit the immune system, medicines that prevent rejection reactions after organ or bone marrow transplants
• cardiac glycosides (such as digoxin), medicines used to strengthen the heart
• medicines that, as a side effect, cause abnormalities in the conduction of cardiac stimulation, such as those used for heart rhythm disorders, some medicines for psychoses and other medicines, such as those used to treat bacterial infections
• calcium salts, used to increase calcium levels in the blood
• amphotericin B, a medicine used against fungal infections
• laxatives, medicines used to stimulate defecation
• carbenoxolone, a medicine used to treat gastrointestinal diseases
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the mTOR inhibitors class). See section “Warnings and precautions”
• lovastatin, a medicine used to treat high cholesterol
• sotalol (a beta-blocker): increases the risk of arrhythmia

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you believe you are (or may be) pregnant you should tell your doctor. The latter will usually advise you to stop taking Lisinopril Hydrochlorothiazide Sandoz before becoming pregnant
or as soon as pregnancy has been diagnosed and to take another medicine instead of Lisinopril
Hydrochlorothiazide Sandoz. Lisinopril Hydrochlorothiazide Sandoz is not recommended during pregnancy and should not
be taken after the first 3 months of pregnancy, as it can cause serious harm to the baby if used after the third
month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Lisinopril Hydrochlorothiazide Sandoz
is not recommended in women who are breastfeeding and, if you wish to breastfeed, your doctor may choose another
treatment.

Driving and using machines
People taking Lisinopril Hydrochlorothiazide Sandoz have reported dizziness and fatigue. If
you experience any of these effects, do not drive vehicles or use machines (see section 4,
“Possible side effects”).

3. How to take Lisinopril Hydrochlorothiazide Sandoz

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is one tablet once a day.
The maximum daily dose is 40 mg of lisinopril and 25 mg of hydrochlorothiazide.

Use in children
Safety and efficacy in children and adolescents have not been established.

Elderly
No particular dose adjustment is necessary.

Kidney problems
Do not take this medicine if your kidney function is severely impaired. If you suffer from a
kidney disease, your doctor must prescribe the lowest possible dose and monitor kidney function.

Previous treatment with diuretics
If you switch from a treatment with diuretics to Lisinopril Hydrochlorothiazide Sandoz, you must stop taking
the diuretics 2-3 days before starting to take this medicine.

How to take the tablets
Take the tablet or half tablet with a large amount of water. Try to take the
medicine at the same time each day.

Tablet division
Place the tablet on a rigid, flat surface, with the fracture line facing upwards. Press
with a finger in the centre of the tablet and it will break into two parts.

If you take more Lisinopril Hydrochlorothiazide Sandoz than you should
If you (or someone else) have swallowed an excessive number of tablets all at once, or if you believe that a
child has swallowed any number of tablets, consult a doctor immediately.
An overdose is likely to cause hypotension, circulatory shock, electrolyte disturbances, renal
failure, hyperventilation (rapid breathing, nausea and vomiting), excessively fast or
slow heartbeat, palpitations (feeling of a fast or irregular heartbeat), dizziness, anxiety and
cough. Bring with you to hospital or to the doctor this leaflet, any remaining tablets and the
container, so that medical staff know which tablets have been taken.

If you forget to take Lisinopril Hydrochlorothiazide Sandoz
Do not take a double dose to make up for a missed tablet; take the next dose
at the usual time.

If you stop taking Lisinopril Hydrochlorothiazide Sandoz
Treatment of hypertension is a long-term treatment and interruption of treatment must be
discussed with your doctor. Discontinuation or suspension of therapy may cause an increase in
blood pressure.
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 gets them.
manifest them.

If you experience the effects listed below, stop taking this
medicine immediately and inform your doctor or go to the nearest hospital emergency room:

• a severe allergic reaction called angioedema (skin rash, itching, swelling of the extremities, face, lips, mouth or throat, which can cause difficulty swallowing or breathing). This is a serious and rareside effect (may affect up to 1 in 1,000 people). You may need urgent medical attention or hospitalisation
• jaundice (yellowing of the skin and whites of the eyes). This is a potentially serious but very rareside effect (may affect up to 1 in 10,000 people), indicative of liver inflammation. You may need urgent medical attention or hospitalisation
• You do not urinate (low urine output) which can also occur with a high temperature (fever), nausea, fatigue, flank pain, swelling of the legs, ankles, feet, face and hands, or blood in the urine. These are due to kidney problems. This is a serious and rareside effect (may affect up to 1 in 1000) due to a severe kidney problem (acute renal failure). Lisinopril Hydrochlorothiazide Sandoz commonly(may affect up to 1 in 10 people) causes a decrease in blood pressure, which may be associated with feelings of dizziness and weakness. In some patients this may occur after the first dose or when the dosage is increased. If you experience these symptoms, you should contact your doctor immediately.

Lisinopril Hydrochlorothiazide Sandoz can cause a decrease in the number of white blood cells, due to
which resistance to infections may decrease. If you experience an infection with symptoms such as fever and
severe deterioration of general condition, or fever with symptoms of local infection, such as sore
throat/pharynx/mouth or urinary problems, consult your doctor immediately. They will prescribe a blood test
to check for a possible decrease in white blood cells (agranulocytosis). It is important that you inform your
doctor that you are taking this medicine.
With the use of Lisinopril Hydrochlorothiazide Sandoz and other ACE inhibitors, a dry cough has been reported commonly(may
affect up to 1 in 10 people), which may persist for a long time, but which may also be
a symptom of another upper respiratory tract disease. If you develop this symptom you should
consult your doctor.
The following side effects have also been reported

Common (may affect up to 1 in 10 people)

• dizziness, headache, sudden loss of consciousness
• low blood pressure associated with changes in posture (such as feeling lightheaded or weak when getting up from lying down)
• cough (see the beginning of this paragraph)
• diarrhoea, vomiting
• kidney problems.

Uncommon (may affect up to 1 in 100 people)

• mood changes
• sensation of tingling or numbness, vertigo, changes in taste, difficulty sleeping
• heart attack or stroke (“mini-stroke”) (mainly in patients suffering from low blood pressure)
• palpitations (feeling of a fast or particularly strong or irregular heartbeat)
• excessively fast heartbeat (tachycardia)
• Raynaud's syndrome, a disorder of the blood vessels that can cause tingling of the fingers of the hands and feet, followed by whitening, bluish and finally reddish discoloration
• inflammation of the nasal lining, causing a runny nose (rhinitis)
• nausea, abdominal pain and indigestion
• increased amount of enzymes and waste products produced by the liver
• skin rashes and/or itching
• impotence
• fatigue, general weakness
• increased amount of urea in the blood
• high levels of potassium in the blood, which can cause an abnormal heart rhythm; increased amount of creatinine in the blood.

Rare (may affect up to 1 in 1000 people)

• decrease in haemoglobin (red pigment of the blood) and number of red blood cells (haematocrit)
• mental confusion
• dry mouth
• hypersensitivity/angioedema (see the beginning of the paragraph), itchy skin rash, hair loss, reddish/silvery raised spots on the skin
• kidney problems
• enlargement of the breasts in men
• low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures or coma, and even dehydration and low blood pressure, resulting in dizziness when getting up.
• Syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Symptoms of this include weight gain, nausea, vomiting, muscle cramps, confusion and convulsions.

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

• reduction in the number of white blood cells, which makes infections more likely, reduction in the number of other blood cells, poor production of bone marrow, diseases of the lymph nodes, autoimmune disease, due to which the body attacks itself
• reduction in the number of red blood cells, which can cause pale skin and cause weakness or shortness of breath (anaemia)
• hypoglycaemia (low blood sugar levels) (see “Warnings and precautions” in paragraph 2)
• difficulty breathing, shortness of breath
• inflammation of the sinuses
• lung problems, including pneumonia
• inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)
• intestinal bloating
• liver problems*
• excessive sweating (diaphoresis), severe skin disorders, including Stevens-Johnson syndrome and clusters of mature or abnormally appearing lymphocytes in the dermis (cutaneous pseudolymphoma)**
• absence of urge to go to the bathroom or going to the bathroom less often (low urine production)

* Very rarely, it has been reported that in some patients the undesirable development of hepatitis has deteriorated into
liver failure. Patients treated with lisinopril/hydrochlorothiazide combination who develop jaundice or
marked increases in liver enzymes should discontinue the lisinopril/hydrochlorothiazide combination and
receive appropriate follow-up.
** A complex of symptoms has been reported that may include one or more of the following: fever,
inflammation of a blood vessel (vasculitis), muscle pain (myalgia), joint pain
(arthralgia) and joint inflammation (arthritis), increased amount of antibodies (ANA), increased
erythrocyte sedimentation rate, rash and increased number of white blood cells (eosinophilia and
leukocytosis), skin rash, photosensitivity or other skin reactions.

Not known (frequency cannot be estimated from available data)

• skin and lip cancer (non-melanoma skin cancer)
• inflammation of a salivary gland
• increased levels of sugar, fat (including cholesterol) or uric acid in the blood, painful and swollen joints (gout), sugar in the urine; low levels of potassium in the blood, which can cause muscle weakness, spasms or abnormal heart rhythm; decreased levels of magnesium and chlorine in the blood
• stomach irritation
• constipation
• loss of appetite
• restlessness
• shortness of breath due to fluid in the lungs
• visual disturbances
• inflammatory disease of the blood vessels (necrotizing vasculitis)
• skin sensitivity to light, skin disorders with scaly red patches on the nose and cheeks (lupus erythematosus) - this condition may be aggravated in patients who already suffer from it, severe allergic reactions
• muscle cramps, muscle weakness
• inflammation of the kidneys (interstitial nephritis)
• fever
• depression
• flushing

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, 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 Lisinopril Hydrochlorothiazide Sandoz

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 package after the wording
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special 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. Contents of the pack and other information

What Lisinopril Idroclorotiazide Sandoz contains
The active ingredientsare lisinopril and hydrochlorothiazide.
Each tablet contains 20 mg of lisinopril (as dihydrate) and 12.5 mg of hydrochlorothiazide.
The other ingredientsare: calcium hydrogen phosphate dihydrate, croscarmellose sodium, mannitol, maize starch, magnesium stearate and red iron oxide (E 172).

Description of the appearance of Lisinopril Idroclorotiazide Sandoz and contents of the pack
The tablets are pink, round, biconvex and have a fracture line on one side.
The tablets are packaged in PVC/aluminium blisters contained in a cardboard box.
Lisinopril Idroclorotiazide Sandoz is available in packs of 14, 28, 30, 50, 56, 98, 100 and 400 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 – 21040 Origgio (VA)

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
BE: Co-Lisinopril Sandoz 10 mg/12.5 mg tablets
Co-Lisinopril Sandoz 20 mg/12.5 mg tablets
IE: Lispril-Hydrochlorothiazide 10 mg/12.5 mg tablets
Lispril-Hydrochlorothiazide 20 mg/12.5 mg tablets
IT: Lisinopril Idroclorotiazide Sandoz
PT: Lisinopril + Hidroclorotiazida Sandoz 20 mg + 12,5 mg tablets
ES: Lisinoprilo Hidroclorotiazida Bexal 20/12,5 mg tablets EFG