Losartan and hydrochlorothiazide Zentiva Italia: detailed information

PATIENT INFORMATION LEAFLET

Losartan and Hydrochlorothiazide Zentiva Italia 50 mg/12.5 mg film-coated tablets, 100 mg/25 mg film-coated tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Losartan and Hydrochlorothiazide Zentiva Italia is and what it is used for
What you need to know before taking Losartan and Hydrochlorothiazide Zentiva Italia
How to take Losartan and Hydrochlorothiazide Zentiva Italia
Possible side effects
How to store Losartan and Hydrochlorothiazide Zentiva Italia
Contents of the pack and other information

1. What Losartan and Hydrochlorothiazide Zentiva Italia is 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 narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Hydrochlorothiazide works by increasing the elimination of water and salt through the kidneys. This also helps reduce blood pressure.
Losartan and Hydrochlorothiazide Zentiva Italia is indicated for the treatment of essential hypertension (high blood pressure).

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

Do not take Losartan and Hydrochlorothiazide Zentiva Italia if

you are allergic to losartan, hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure);
you have severe impairment of liver function;
you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment;
you suffer from gout;
you are more than 3 months pregnant (it is also advisable to avoid the use of Losartan and Hydrochlorothiazide Zentiva Italia during early pregnancy – see section “Pregnancy”);
you have severe impairment of kidney function or your kidneys do not produce urine;
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan and Hydrochlorothiazide Zentiva Italia.
You must inform your doctor if you think you are (or might become) pregnant. Losartan and
Hydrochlorothiazide Zentiva Italia is not recommended during early pregnancy and must not
be taken if you are more than 3 months pregnant, as it may seriously harm your baby if used at
this stage (see section “Pregnancy”).
It is important to inform your doctor before taking Losartan and Hydrochlorothiazide Zentiva Italia if:

you have previously experienced swelling of the face, lips, throat, or tongue.
you are taking diuretics (medicines that help you urinate).
you are on a low-salt diet.
you have or have had severe vomiting and/or diarrhoea.
you have heart failure.
you have impaired liver function (see section 2 “Do not take Losartan and Hydrochlorothiazide Zentiva Italia”).
you have narrowing of the renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant.
you have narrowing of arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function).
you have “mitral or aortic valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a condition causing thickening of the heart muscle).
you have diabetes.
you have had gout.
you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Losartan and Hydrochlorothiazide Zentiva Italia.
you experience vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye, which may occur from a few hours to several weeks after starting Losartan and Hydrochlorothiazide Zentiva Italia. If untreated, this condition may lead to permanent vision loss. If you have previously had allergic reactions to penicillin or sulfonamides, you may be at higher risk of developing this condition.
you have or have had allergic conditions, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus).
you have high calcium levels or low potassium levels, or are on a low-potassium diet;
you need to undergo anaesthesia (even by a dentist) or before surgery, or if you are scheduled for tests assessing parathyroid function, you must inform 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 due to an abnormality).
you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under “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 must not be administered to children and adolescents.
Elderly patients
Losartan and Hydrochlorothiazide Zentiva Italia works equally well and is equally well tolerated by most elderly patients as by younger adults. Most elderly patients require the same dosage as younger patients.
Other medicines and Losartan and Hydrochlorothiazide Zentiva Italia
Inform 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-containing preparations must not be taken with Losartan and Hydrochlorothiazide Zentiva Italia without close medical supervision.
Special precautionary measures (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 urinate”), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).
It is also important for your doctor to know if you are taking:

Other medicines to lower blood pressure.
Steroids.
Medicines for cancer.
Painkillers.
Medicines for fungal infections.
Medicines for arthritis.
Cholesterol-lowering resins, such as cholestyramine.
Medicines to relax muscles.
Antidepressants.
Sleeping pills.
Opioids such as morphine.
"Pressor amines" such as adrenaline or similar medicines.
Carbamazepine used for epilepsy.
Oral medicines for diabetes or insulin.

Your doctor may consider it necessary to adjust the dose and/or take additional precautions:

If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Losartan and Hydrochlorothiazide Zentiva Italia” and “Warnings and precautions”).

Inform your doctor if you are taking Losartan and Hydrochlorothiazide Zentiva Italia and are scheduled for a radiographic procedure involving iodinated contrast agents.
Losartan and Hydrochlorothiazide Zentiva Italia with food, drinks, and alcohol
It is recommended not to drink alcoholic beverages while taking these tablets: alcohol and Losartan and Hydrochlorothiazide Zentiva Italia tablets may increase each other's effects. Losartan and Hydrochlorothiazide Zentiva Italia must not be taken with liquorice, as it may cause a decrease in blood potassium levels.
A diet particularly rich in salt may counteract the effect of Losartan and Hydrochlorothiazide Zentiva Italia tablets.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
If you think you are pregnant (or might become pregnant), inform your doctor. Usually, your doctor will advise you to stop taking Losartan and Hydrochlorothiazide Zentiva Italia before becoming pregnant or as soon as you learn you are pregnant, and will recommend an alternative medicine. Losartan and Hydrochlorothiazide Zentiva Italia is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may seriously harm your baby if used after the third month of pregnancy.
Breastfeeding
Inform 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 an alternative treatment if you wish to breastfeed.
Driving and using machines
When starting treatment with this medicine, do not perform activities requiring particular alertness (e.g. driving a car or operating dangerous machinery) until you know how you tolerate the medicine.
Losartan and Hydrochlorothiazide Zentiva Italia contains lactose monohydrate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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 those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Losartan and Hydrochlorothiazide Zentiva Italia

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide Zentiva Italia based on your condition and any other medicines you may be taking. It is important to continue taking Losartan and Hydrochlorothiazide Zentiva Italia for the length of time prescribed by your doctor in order to maintain consistent 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 once daily 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 daily, or adjusted to 1 tablet daily of Losartan and Hydrochlorothiazide Zentiva Italia 100 mg / 25 mg film-coated tablets (a higher strength).

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.

Losartan and Hydrochlorothiazide Zentiva Italia tablets 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 to receive prompt medical treatment. Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood composition, and dehydration.

If you forget to take Losartan and Hydrochlorothiazide Zentiva Italia
Try to take Losartan and Hydrochlorothiazide Zentiva Italia once daily as prescribed. Do not take a double dose to make up for a forgotten dose. Simply resume your regular dosing schedule.

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

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing). This is a serious but rare side effect occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical treatment or hospitalisation may be required.

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 (problems with the bony cavities inside the nose).
Abdominal pain, nausea, diarrhoea, indigestion.
Muscle pain or cramps, leg pain, back pain.
Changes in kidney function including kidney failure.
Weakness, fatigue, chest pain.
Increased potassium levels (which may cause abnormal heart rhythm), decreased haematocrit and haemoglobin levels, too little sugar in the blood (hypoglycaemia).

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

Anaemia (reduction in red blood cells), red or brownish spots on the skin (sometimes mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising, breakdown of red blood cells (haemolysis), reduction in white blood cells, blood clotting problems, reduced platelet count.
Loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels (hyperglycaemia); low potassium levels in the blood, low sodium levels in the blood.
Anxiety, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, drowsiness, memory impairment.
Restlessness, sensation of pins and needles or similar, pain in extremities, tremor, migraine, fainting.
Blurred vision, burning or pain in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
Dizziness, sensation of hearing a sound, ringing, buzzing or clicking 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 rash or bruising.
Sore throat, shortness of breath, bronchitis, nosebleed, runny nose, pneumonia, fluid in the lungs (causing breathing difficulties).
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, rash, dry skin, skin redness, flushing, urticaria, photosensitivity, itching, skin inflammation, sweating, skin blisters.
Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness.
Frequent urination, including at night, kidney function abnormalities including kidney inflammation, urinary tract infection, sugar in the urine.
Decreased sexual desire, impotence.
Facial swelling, localized swelling (oedema), fever.
Slight increase in blood urea and creatinine levels.

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

Hepatitis (inflammation of the liver), changes in 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 (an autoimmune inflammatory disease affecting the skin).
Flu-like symptoms, general feeling of being unwell (malaise).
Skin and lip cancer (non-melanoma skin cancer).
Decreased vision and/or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion), acute myopia or acute secondary angle-closure glaucoma).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Hydrochlorothiazide Zentiva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after
Exp. The expiry date refers to the last day of that month.
Store below 30°C in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via 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 Losartan and Hydrochlorothiazide Zentiva Italia contains
The active substances are potassium losartan and hydrochlorothiazide.
Losartan and Hydrochlorothiazide Zentiva Italia 50 mg/12.5 mg: Each tablet contains 50 mg of
potassium losartan, 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
potassium losartan, equivalent to 91.52 mg of losartan and 25 mg of hydrochlorothiazide.
The other components are: Tablet core: Microcrystalline cellulose, lactose monohydrate,
pregelatinized starch (maize), copovidone, sodium croscarmellose, magnesium stearate, colloidal
silicon dioxide.
Coating: Hypromellose, talc, macrogol 6000, titanium dioxide (E171), quinoline yellow aluminium
lake (E104).
Description of the appearance of Losartan and Hydrochlorothiazide Zentiva Italia and pack
contents
Losartan and Hydrochlorothiazide Zentiva 50 mg/12.5 mg
The film-coated tablets are yellow, oval-shaped 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-shaped 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 blisters with an
aluminum foil lid.
Pack sizes: 14, 28, 56, 90, 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia Srl
Viale Bodio n. 37/b – 20158 Milano
Italy
Manufacturer
Zentiva k.s.
U kabelovny 130
102 37 Praha 10 – Dolní Měcholupy
Czech Republic
This medicinal product is authorized in the European Economic Area countries under the
following names:
Country Name
Czech Republic Losartan/Hydrochlorothiazide Zentiva
France LOSARTAN HYDROCHLOROTHIAZIDE ZENTIVA LAB
Germany Losartan-HCT Zentiva
Italy Losartan and Hydrochlorothiazide Zentiva Italia
Portugal Losartan + Hydrochlorothiazide Zentiva