LOSARTAN 50 mg /12,5 Mg Film-Coated Tablets

Зміст інструкції

1. Losartan and Hydrochlorothiazide Zentiva Italia 50 mg/12.5 mg film-coated tablets
   1. What is Losartan and Hydrochlorothiazide Zentiva Italia and what it is used for
   2. What you need to know before taking Losartan and Hydrochlorothiazide Zentiva Italia
   3. How to take Losartan and Hydrochlorothiazide Zentiva Italia
   4. Possible side effects
   5. How to store Losartan and Idroclorotiazide Zentiva Italia
   6. Package contents and other information

Losartan and Hydrochlorothiazide Zentiva Italia 50 mg/12.5 mg film-coated tablets

Losartan and Hydrochlorothiazide Zentiva Italia 100 mg/25 mg film-coated tablets
Generic medicine
Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not 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 Losartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
• 2. What you need to know before you take Losartan and Hydrochlorothiazide Zentiva Italia
• 3. How to take Losartan and Hydrochlorothiazide Zentiva Italia
• 4. Possible side effects
• 5. How to store Losartan and Hydrochlorothiazide Zentiva Italia
• 6. Contents of the pack and other information

1. What is Losartan and Hydrochlorothiazide Zentiva Italia and what it is used for

Losartan and Hydrochlorothiazide Zentiva Italia is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide). Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing relaxation of the blood vessels with a consequent lowering of blood pressure. Hydrochlorothiazide works by causing the kidneys to eliminate a greater quantity of water and salt. This also helps to reduce blood pressure.
Losartan and Hydrochlorothiazide Zentiva Italia is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan and Hydrochlorothiazide Zentiva Italia

Do not take Losartan and Hydrochlorothiazide Zentiva Italia if

• you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6);
• you are allergic to other sulfonamide-derived substances (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure);
• you have a severe impairment of liver function;
• you have low levels of potassium, low levels of sodium or high levels of calcium that cannot be corrected by treatment;
• you suffer from gout;
• you are pregnant for more than 3 months (it is also preferable to avoid the use of Losartan and Hydrochlorothiazide Zentiva Italia in the early period of pregnancy - see section “Pregnancy”);
• you have a severe impairment of kidney function or if your kidneys do not produce urine;
• 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
Talk to your doctor or pharmacist before taking Losartan and Hydrochlorothiazide Zentiva Italia.
You must tell your doctor if you think you are (or may become) pregnant. Losartan and
Hydrochlorothiazide Zentiva Italia is not recommended in the first period of pregnancy, and should not
be taken if you are pregnant for more than 3 months, because it can cause serious harm to your
baby if used during this period (see section “Pregnancy”).
It is important to inform your doctor before taking Losartan and Hydrochlorothiazide Zentiva Italia if:

• you have previously suffered from swelling of the face, lips, tongue or throat.
• you are taking diuretics (medicines that help you to urinate).
• you are following a low-salt diet.
• you have or have had severe vomiting and/or diarrhea.
• you have heart failure.
• you have impaired liver function (see section 2 “Do not take Losartan and Hydrochlorothiazide Zentiva Italia”).
• you have a narrowing of the renal arteries (renal artery stenosis) or if you have only one functioning kidney, or if you have recently had a kidney transplant.
• you have a narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function).
• you have “mitral or aortic valve stenosis” (narrowing of the heart valves) or “hypertrophic cardiomyopathy” (a condition that causes thickening of the heart muscle).
• you have diabetes.
• you have had gout.
• 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 radiation while taking Losartan and Hydrochlorothiazide Zentiva Italia.
• if you have blurred 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 and can occur within hours to weeks after taking Losartan and Hydrochlorothiazide Zentiva Italia. If left untreated, this condition can lead to permanent vision loss. If you have previously had episodes of allergy to penicillin or sulfonamides, you may be at greater risk of

developing this condition

• you have or have had an allergic condition, asthma or a condition that causes joint pain, skin redness and fever (systemic lupus erythematosus).
• you have high levels of calcium or low levels of potassium or are following a low-potassium diet;
• you need to have an anesthetic (even from the dentist) or before surgery, or if you are about to undergo tests to assess parathyroid function, you must tell your doctor or medical staff that you are taking Losartan and Hydrochlorothiazide Zentiva Italia.
• you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality thereof) .
• if you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), 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 stated in the section "Do not take Losartan and Hydrochlorothiazide Zentiva Italia”.

Children and adolescents
There is no experience with the use of Losartan and Hydrochlorothiazide Zentiva Italia in children and adolescents
(<18 years). therefore losartan and hydrochlorothiazide zentiva italia should not be given to
children and adolescents.

Elderly patients
Losartan and Hydrochlorothiazide Zentiva Italia works just as well and is just as well tolerated
by most elderly patients and younger adult patients. Most elderly patients
require the same dose as younger patients.

Other medicines and Losartan and Hydrochlorothiazide Zentiva Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide Zentiva Italia can
interact with other medicines.
Lithium preparations must not be taken with Losartan and Hydrochlorothiazide Zentiva
Italia without close medical supervision.
Special precautions (e.g. blood tests) may be appropriate if you are taking
potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (“medicines that help you to urinate”), some laxatives, medicines for the
treatment of gout, medicines for controlling heart rhythm or for diabetes (oral medicines
or insulins).

It is also important for the doctor to know if you are taking:

• Other medicines to reduce blood pressure.
• Steroids.
• Medicines for cancer.
• Painkillers.
• Medicines for treating fungal infections.
• Medicines for treating arthritis.
• Cholesterol-lowering resins, such as colestyramine.
• Medicines to relax muscles.
• Antidepressants.
• Sleeping pills.
• Opioids such as morphine.
• “Pressor amines” such as adrenaline or other drugs of the same kind.
• Carbamazepine used for the treatment of epilepsy.
• Oral diabetes medicines or insulins.

Your doctor may need to adjust the dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Losartan and Hydrochlorothiazide Zentiva Italia" and "Warnings and precautions”).

Also inform your doctor if you are taking Losartan and Hydrochlorothiazide Zentiva Italia and will
be undergoing an X-ray procedure involving the administration of iodinated contrast media.

Losartan and Hydrochlorothiazide Zentiva Italia with food and drink and alcohol
It is recommended not to drink alcoholic beverages while taking these tablets: alcohol and Losartan
and Hydrochlorothiazide Zentiva Italia tablets can increase each other’s effect. Losartan and
Hydrochlorothiazide Zentiva Italia should not be taken with liquorice as it can cause a
lowering of potassium levels in the blood.
A diet particularly rich in salt can counteract the effect of Losartan and Hydrochlorothiazide
Zentiva Italia tablets.

Pregnancy, breastfeeding and fertility
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
If you think you are pregnant (or might become pregnant) you should tell your doctor. Normally,
your doctor will advise you to stop taking Losartan and Hydrochlorothiazide Zentiva Italia
before becoming pregnant or as soon as you find out you are pregnant and will advise you to take
another medicine instead of Losartan and Hydrochlorothiazide Zentiva Italia. Losartan and Hydrochlorothiazide
Zentiva Italia is not recommended during pregnancy, and should not be taken if you are pregnant for
more than 3 months, as it could seriously harm your baby if taken after the 3
month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding.
Losartan and Hydrochlorothiazide Zentiva Italia is not recommended for use in women who are
breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed.

Driving and using machines
When you start treatment with this medicine, you should not undertake activities that require
particular attention (e.g. driving a car or using dangerous machinery) until
you know how you tolerate the medicine.

Losartan and Hydrochlorothiazide Zentiva Italia contains lactose monohydrate and sodium
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is
essentially ‘sodium-free’.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in
positive doping tests.

3. How to take Losartan and Hydrochlorothiazide Zentiva Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist. The doctor will establish the appropriate dose of Losartan and
Hydrochlorothiazide Zentiva Italia depending on your condition and any other medicines you
are taking. It is important to continue taking Losartan and Hydrochlorothiazide Zentiva Italia for
the time prescribed by your doctor in order to maintain regular blood pressure
control.

High blood pressure
The usual dose of Losartan and Hydrochlorothiazide Zentiva Italia for most patients with
high blood pressure is 1 tablet of Losartan and Hydrochlorothiazide Zentiva Italia 50 mg / 12.5
mg per day to maintain blood pressure control over 24 hours. The dose may be increased to 2
tablets of Losartan and Hydrochlorothiazide Zentiva Italia 50 mg / 12.5 mg film-coated tablets
once a day or modified to 1 tablet per day of Losartan and Hydrochlorothiazide
Zentiva Italia 100 mg / 25 mg film-coated tablets (a higher concentration).
The maximum daily dose is 2 tablets of Losartan and Hydrochlorothiazide Zentiva Italia 50 mg /
12.5 mg film-coated tablets per day or 1 tablet per day of Losartan and
Hydrochlorothiazide Zentiva Italia 100 mg / 25 mg film-coated tablets.
The tablets of Losartan and Hydrochlorothiazide Zentiva Italia can be taken with or without food .

If you take more Losartan and Hydrochlorothiazide Zentiva Italia than you should
In case of overdose, contact your doctor immediately, in order to receive immediate medical
care. Overdose may cause a lowering of blood pressure, palpitations,
slow pulse rate, alterations in blood composition and dehydration.

If you forget to take Losartan and Hydrochlorothiazide Zentiva Italia
Try to take Losartan and Hydrochlorothiazide Zentiva Italia once a day as prescribed.
Do not take a double dose to make up for the missed dose. Just resume the usual
dosing schedule.

If you stop taking Losartan and Hydrochlorothiazide Zentiva Italia
It is important to continue taking Losartan and Hydrochlorothiazide Zentiva Italia for the time
prescribed by your doctor in order to maintain regular blood pressure control.
If you have further questions on 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 everybody gets them.
If you experience the following side effect, stop taking Losartan and
Idroclorotiazide Zentiva Italia tablets and contact your doctor immediately or go to the nearest hospital emergency room:

• A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat that can cause difficulty swallowing or breathing). This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but in less than 1 in 1,000 patients. It may require immediate medical attention or hospitalization.

The following side effects have been reported:

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

• Insomnia.
• Headache, dizziness.
• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders (disorders of the bony cavities inside the nose).
• Abdominal pain, nausea, diarrhea, indigestion.
• Muscle pain or cramps, leg pain, back pain.
• Changes in kidney function including renal failure.
• Weakness, fatigue, chest pain.
• Increased levels of potassium (which can cause an abnormal heart rhythm), decreased levels of hematocrit and hemoglobin, too little sugar in the blood (hypoglycemia).

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

• Anemia (reduction in red blood cells), red or brownish-purple spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, breakdown of red blood cells (hemolysis), reduced white blood cells, blood clotting problems, reduced number of platelets.
• Loss of appetite, increases in uric acid levels or gout clinically evident, increased blood sugar level (hyperglycemia); low potassium levels in the blood, low sodium levels in the blood.
• Anxiety, panic disorder (recurring panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment.
• Nervousness, tingling or pins and needles sensation, pain in the extremities, tremor, migraine, fainting.
• Blurred vision, burning or pain in the eyes, conjunctivitis, worsening of vision,

seeing things in yellow.

• Vertigo, sensation of hearing a sound, ringing, booming or similar snapping sound in the ears.
• Low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up), angina pectoris (chest pain), abnormal heartbeat, cerebrovascular event (TIA, "mini-stroke"), heart attack, palpitations.
• Inflammation of blood vessels, often associated with skin rash or bruising.
• Sore throat, shortness of breath, bronchitis, nosebleeds, runny nose, pneumonia, water in the lungs (causing difficulty breathing).
• Constipation, toothache, dry mouth, flatulence, stomach discomfort, stomach spasms, vomiting, inflammation of the salivary glands.
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas.
• Hair loss, skin rash, dry skin, skin redness, hot flushes, hives, sensitivity to light, itching, skin inflammation, sweating, blisters on the skin.
• Pain in the arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness.
• Frequent urination including at night, abnormalities in kidney function including kidney inflammation, urinary tract infection, sugar in the urine.
• Decreased sexual desire, impotence.
• Swelling of the face, localized swelling (edema), fever.
• Slightly increased levels of urea and creatinine in the serum.

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

• Hepatitis (inflammation of the liver), abnormal liver function tests.

Frequency not known(frequency cannot be estimated from the available data):

• Changes in taste (dysgeusia).
• Unexplained muscle pain with dark urine and fever (rhabdomyolysis).
• Cutaneous lupus erythematosus (autoimmune inflammatory disease affecting the skin).
• Flu-like symptoms, general feeling of being unwell (malaise).
• Skin and lip cancer (non-melanoma skin cancer).
• Impaired vision and/or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), acute myopia or acute angle-closure glaucoma).

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 Losartan and Idroclorotiazide Zentiva Italia

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 box and on the blister after
Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C in the original packaging to protect the medicine
from humidity.
Do not dispose of any medicine in the wastewater and 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 Losartan and Hydrochlorothiazide Zentiva Italia contains
The active ingredients are losartan potassium and hydrochlorothiazide.
Losartan and Hydrochlorothiazide Zentiva Italia 50 mg/12.5 mg: Each tablet contains 50 mg of
losartan potassium, equivalent to 45.76 mg of losartan and 12.5 mg of hydrochlorothiazide.
Losartan and Hydrochlorothiazide Zentiva Italia 100 mg/25 mg: Each tablet contains 100 mg of
losartan potassium, equivalent to 91.52 mg of losartan and 25 mg of hydrochlorothiazide.
The other ingredients are: Tablet core: Microcrystalline cellulose, lactose monohydrate,
pregelatinized starch (corn), copovidone, sodium croscarmellose, magnesium stearate, colloidal silicon
dioxide.
Coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), quinoline yellow on
aluminium hydrate (E104).

Description of the appearance of Losartan and Hydrochlorothiazide Zentiva Italia and contents of the
pack
Losartan and Hydrochlorothiazide Zentiva 50 mg/12.5 mg
The film-coated tablets are yellow, oval with dimensions 11.4 ± 0.4 mm x 6.2 ± 0.4 mm.
Losartan and Hydrochlorothiazide Zentiva Italia 100 mg/25 mg
The film-coated tablets are light yellow, oval with dimensions 15.6 ± 0.4 mm x 8.9 ± 0.4
mm.
Losartan and Hydrochlorothiazide Zentiva Italia is available in white PVC/PE/PVDC blister packs
and in aluminium foil.
Packs: 14, 28, 56, 90, 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia Srl
Viale Bodio n. 37/b – 20158 Milan
Italy

Manufacturer
Zentiva k.s.
U kabelovny 130
102 37 Prague 10 –DolníMěcholupy
Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Country Name
Czech Republic Losartan/Hydrochlorothiazide Zentiva
France LOSARTAN HYDROCHLOROTHIAZIDE ZENTIVA LAB
Germany Losartan-HCT Zentiva
Italy Losartan e Idroclorotiazide Zentiva Italia
Portugal Losartan + Hidroclorotiazida Zentiva