Losartan and hydrochlorothiazide HCS

Package leaflet: Information for the user

Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets

losartan potassium/hydrochlorothiazide
Generic medicine
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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Losartan and Hydrochlorothiazide HCS is and what it is used for

Losartan and Hydrochlorothiazide HCS 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 the blood vessels 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 a consequent reduction in blood pressure. Hydrochlorothiazide
works by increasing the amount of water and salt excreted by the kidneys. This also helps to lower
blood pressure.
Losartan and Hydrochlorothiazide HCS is indicated for the treatment of essential hypertension (high
blood pressure).

2. What you should know before taking Losartan and Hydrochlorothiazide HCS

Do not take Losartan and Hydrochlorothiazide HCS

• if you are allergic to losartan and/or hydrochlorothiazide or to any of the other excipients of this medicine (listed in section 6);
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial drugs such as co-trimoxazole; ask your doctor if you are unsure);
• if you are more than 3 months pregnant (Losartan and Hydrochlorothiazide HCS should also be avoided in early pregnancy – see "Pregnancy and breastfeeding");
• if you have severe liver dysfunction; cholestasis or obstructive biliary disorders;
• if you have severe renal impairment (i.e. creatinine clearance <30 ml/min);
• if your kidneys are not producing urine;
• if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected with treatment;
• if you suffer from gout;
• if 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 HCS:

• if you have previously experienced swelling of the face, lips, throat, or tongue (angioedema),
• if you are taking diuretics,
• if you are on a low-salt diet,
• if you have or have had vomiting and/or diarrhoea,
• if you have heart failure,
• if you have impaired liver function (see section 2 “Do not take Losartan and Hydrochlorothiazide HCS”),
• if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant,
• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function),
• if you have “mitral or aortic valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a condition causing thickening of the heart muscle),
• if you are diabetic,
• if you have had gout,
• if you have or have had an allergic condition, asthma, or a condition causing joint pain, skin rash, and fever (systemic lupus erythematosus),
• if you have high calcium levels or low potassium levels, or are on a low-potassium diet,
• if you need to undergo anaesthesia (even by a dentist) or surgery, or if you are scheduled for a test to assess parathyroid function, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased aldosterone secretion by the adrenal gland due to an abnormality within the gland),
• if you are taking medicines that may increase serum potassium levels (see section 2 “Other medicines and Losartan and Hydrochlorothiazide HCS”),
• if you have previously had skin cancer or develop an unexpected skin lesion 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 sun exposure and UV radiation while taking Losartan and Hydrochlorothiazide HCS,
• if you have previously experienced respiratory or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Losartan and Hydrochlorothiazide HCS, consult a doctor immediately,
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after starting Losartan and Hydrochlorothiazide HCS. If left untreated, this may lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamides, you have a higher risk of developing this condition,
• if you are taking any of the following medicines for 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 the heading "Do not take Losartan and Hydrochlorothiazide HCS".
Contact your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Losartan and Hydrochlorothiazide HCS. Your doctor will decide whether treatment should continue. Do not stop taking Losartan and Hydrochlorothiazide HCS on your own.
Inform your doctor if you think you are (or might become) pregnant. Losartan and Hydrochlorothiazide HCS is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see section "Pregnancy and breastfeeding").

Other medicines and Losartan and Hydrochlorothiazide HCS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Losartan and Hydrochlorothiazide HCS is not recommended.
Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide HCS can interact with other medicines. Lithium-containing preparations should not be taken with Losartan and Hydrochlorothiazide HCS without close medical supervision. Special precautions (e.g. blood tests) may be necessary if you are taking other diuretics (“medicines that increase fluid excretion through the kidneys”), 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 blood pressure-lowering medicines, steroids, cancer medicines, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, opioids such as morphine, “pressor amines” such as adrenaline or similar agents, oral antidiabetic medicines, 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 sections "Do not take Losartan and Hydrochlorothiazide HCS" and “Warnings and precautions”).

Inform your doctor that you are taking Losartan and Hydrochlorothiazide HCS if you are scheduled for X-rays or are to receive iodinated contrast agents.

Losartan and Hydrochlorothiazide HCS with food, drinks and alcohol
Losartan and Hydrochlorothiazide HCS can be taken with or without food.
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and Hydrochlorothiazide HCS tablets may increase each other's effects.
A diet particularly high in salt may reduce the effectiveness of Losartan and Hydrochlorothiazide HCS tablets.
Grapefruit juice should be avoided during treatment with Losartan and Hydrochlorothiazide HCS.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will generally advise you to stop taking Losartan and Hydrochlorothiazide HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan and Hydrochlorothiazide HCS is not recommended during early pregnancy and must not be taken after the first 3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Use in children and adolescents
There is no experience with the use of Losartan and Hydrochlorothiazide HCS in children. Therefore, Losartan and Hydrochlorothiazide HCS should not be given to children.

Use in elderly patients
Losartan and Hydrochlorothiazide HCS works the same way and is equally well tolerated in most elderly and younger adult patients. Most elderly patients require the same dosage as younger patients.

Driving and use of machines
When starting treatment with this medicine, do not perform tasks requiring particular alertness (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartan and Hydrochlorothiazide HCS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Losartan and Hydrochlorothiazide HCS

Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide HCS based on your condition and any other medicines you may be taking. It is important to continue taking Losartan and Hydrochlorothiazide HCS for the full duration prescribed by your doctor, as this will help maintain stable control of your high blood pressure.

High blood pressure
The usual dose of Losartan and Hydrochlorothiazide HCS for most patients with high blood pressure is 1 tablet of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg once daily, to control blood pressure over 24 hours. This dose may be increased to 2 tablets once daily of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets or adjusted to 1 tablet once daily of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets (a higher dose) per day.

The maximum daily dose is 2 tablets of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets or 1 tablet of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets.

If you take more Losartan and Hydrochlorothiazide HCS 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, disturbances in blood electrolytes, and dehydration.

If you forget to take Losartan and Hydrochlorothiazide HCS
Try to take Losartan and Hydrochlorothiazide HCS once daily as prescribed. However, if you miss a dose, do not take a double dose. Continue with your regular dosing schedule.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience the following side effect, stop taking Losartan and Hydrochlorothiazide HCS 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 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 intervention or hospitalization is required.

The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, disorders of the nasal bone cavities,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Increased potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels,
• Changes in kidney function including renal failure,
• Low blood sugar levels (hypoglycaemia).

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

• Anaemia, red or brownish spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, reduction in white blood cells, coagulation disorders and reduction in platelet count,

• Loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels,

• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, insomnia, memory disturbances,

• Tingling sensation or feeling like needles or pins, pain in extremities, tremor, migraine, fainting,

• Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things yellowish,

• Sensation of hearing sound, ringing, buzzing or clicking noises in the ears, vertigo,

• Low blood pressure, which may be associated with changes in posture (light-headedness or weakness when standing up), angina (chest pain), abnormal heartbeat, stroke (TIA, "mini-stroke"), heart attack, palpitations,

• Inflammation of blood vessels, often associated with skin redness and bruising,

• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion,

• Constipation, obstinate constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of the salivary glands, toothache,

• Jaundice (yellowing of eyes and skin), inflammation of the pancreas,

• Urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, hot flushes, sweating, hair loss,

• Pain in arms, shoulders, hips, knees and other joints, joint swelling, numbness, muscle weakness,

• Frequent urination including at night, abnormal kidney function including kidney inflammation,
  urinary tract infection, sugar in urine,

• Decreased sexual desire, impotence,

• Facial swelling, localized swelling (oedema), fever.

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

• Hepatitis (inflammation of the liver), changes in liver function tests,
• Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from available data):

• Influenza-like symptoms,
• Low sodium levels in the blood (hyponatraemia),
• General feeling of being unwell (malaise),
• Skin and lip cancer (non-melanoma skin cancer),
• Unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• Taste disturbance (dysgeusia),
• Decreased vision or eye pain due to increased eye pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 Losartan and Hydrochlorothiazide HCS

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 after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.
HDPE tablet container:
Use within 100 days after first opening the medicine.

6. Package contents and other information

What Losartan and Hydrochlorothiazide HCS contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 50 mg of losartan potassium, equivalent to 45.76 mg of losartan, and 12.5 mg of hydrochlorothiazide.
• The other components are:

pregelatinized maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate
in the core; hypromellose, macrogol 4000, quinoline yellow (E104), talc, titanium dioxide (E171)
in the coating.
See section 2 “Losartan and Hydrochlorothiazide HCS contains lactose”. Description of the appearance of Losartan and Hydrochlorothiazide HCS and package contents
The tablets of Losartan and Hydrochlorothiazide HCS are yellow, oval, moderately biconvex, film-coated, with a break line to divide them in half, tablet size is 6 mm x 12 mm (oval shape), thickness 3.8 - 4.7 mm. The dividing line is intended only to facilitate breaking the tablet for easier administration and is not intended to divide the tablet into equal doses.

The tablets are supplied in packages containing:

• 10, 14, 28, 30, 56, 60, 84, 90, 98 and 112 film-coated tablets in transparent Al/PVC/PVDC blisters.
• 100 film-coated tablets in a white plastic tablet container with white tamper-evident screw cap.

Not all pack sizes may be marketed.
Marketing Authorization Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. - Italy
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Package leaflet: Information for the user

Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets

losartan potassium/hydrochlorothiazide
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist (see section 4).

Contents of this leaflet:

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

1. What Losartan and Hydrochlorothiazide HCS is and what it is used for

Losartan and Hydrochlorothiazide HCS 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 the blood vessels 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 a consequent reduction in blood pressure.
Hydrochlorothiazide works by increasing the amount of water and salt excreted by the kidneys. This also helps to lower blood pressure.
Losartan and Hydrochlorothiazide HCS is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking Losartan and Hydrochlorothiazide HCS

Do not take Losartan and Hydrochlorothiazide HCS

• if you are allergic to losartan and/or hydrochlorothiazide or to any of the other excipients of this medicine (listed in section 6);
• if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial drugs such as co-trimoxazole; ask your doctor if you are unsure);
• if you are more than 3 months pregnant (Losartan and Hydrochlorothiazide HCS is best avoided even in early pregnancy – see "Pregnancy and breastfeeding");
• if you have severe impairment of liver function; cholestasis or obstructive biliary disorders;
• if you have severe impairment of kidney function (i.e. creatinine clearance <30 ml/min);
• if your kidneys are not producing urine;
• if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected with treatment;
• if you suffer from gout;
• if 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 HCS:

• if you have previously experienced swelling of the face, lips, throat, or tongue;
• if you have taken diuretics;
• if you are on a low-salt diet;
• if you have or have had vomiting and/or diarrhoea;
• if you suffer from heart failure;
• if you have impaired liver function (see section 2 “Do not take Losartan and Hydrochlorothiazide HCS”);
• if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
• if you have "mitral or aortic valve stenosis" (narrowing of heart valves) or "hypertrophic cardiomyopathy" (a condition causing thickening of the heart muscle);
• if you are diabetic;
• if you have had gout;
• if you have or have had an allergic condition, asthma, or a condition causing joint pain, skin rash, and fever (systemic lupus erythematosus);
• if you have high calcium levels or low potassium levels, or are on a low-potassium diet;
• if you need to take an anaesthetic (even from the dentist) or before undergoing surgery, or if you are scheduled for a test to monitor parathyroid function, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased aldosterone secretion by the adrenal gland due to an abnormality within the gland);
• if you are taking medicines that may increase serum potassium (see section 2 “Other medicines and Losartan and Hydrochlorothiazide HCS”);
• if 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 sun and UV exposure while taking Losartan and Hydrochlorothiazide HCS;
• if you have had respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe breathing difficulties after taking Losartan and Hydrochlorothiazide HCS, consult a doctor immediately;
• if you experience a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur from a few hours to several weeks after taking Losartan and Hydrochlorothiazide HCS. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you have a higher risk of developing this condition;
• if you are taking any of the following medicines for high blood pressure:
  • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the information under the section "Do not take Losartan and Hydrochlorothiazide HCS".
Contact your doctor if, after taking Losartan and Hydrochlorothiazide HCS, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Losartan and Hydrochlorothiazide HCS on your own.
You must inform your doctor if you think you are (or could become) pregnant. Losartan and Hydrochlorothiazide HCS is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used during this period (see section "Pregnancy and breastfeeding").

Other medicines and Losartan and Hydrochlorothiazide HCS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Losartan and Hydrochlorothiazide HCS is not recommended.
Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide HCS may interact with other medicines. Lithium preparations must not be taken with Losartan and Hydrochlorothiazide HCS without close medical supervision. Special precautions (e.g. blood tests) may be appropriate if you are taking other diuretics (“medicines that increase fluid excretion through the kidneys”), certain laxatives, gout medications, medicines to control heart rhythm, or diabetes medicines (oral medications or insulin). It is also important for your doctor to know if you are taking other blood pressure-lowering medicines, steroids, cancer medicines, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, opioids such as morphine, "pressor amines" such as adrenaline or similar drugs, oral antidiabetic medicines, or insulin.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:

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

Inform your doctor that you are taking Losartan and Hydrochlorothiazide HCS if you are scheduled for X-ray examinations or if iodinated contrast agents are to be used.

Losartan and Hydrochlorothiazide HCS with food, drinks and alcohol
Losartan and Hydrochlorothiazide HCS may be taken with or without food.
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and Hydrochlorothiazide HCS tablets may increase each other's effects.
A diet particularly rich in salt may counteract the effect of Losartan and Hydrochlorothiazide HCS tablets.
Grapefruit juice should be avoided during treatment with Losartan and Hydrochlorothiazide HCS.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you are (or could become) pregnant. Your doctor will generally advise you to stop taking Losartan and Hydrochlorothiazide HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan and Hydrochlorothiazide HCS is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Use in children and adolescents
There is no experience with the use of Losartan and Hydrochlorothiazide HCS in children. Therefore, Losartan and Hydrochlorothiazide HCS must not be given to children.

Use in elderly patients
Losartan and Hydrochlorothiazide HCS works in the same way and is equally well tolerated in most elderly patients as in younger adults. Most elderly patients require the same dosage as younger patients.

Driving and using machines
When starting treatment with this medicine, do not perform activities requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartan and Hydrochlorothiazide HCS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Losartan and Hydrochlorothiazide HCS

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide HCS based on your condition and any other medicines you may be taking. It is important to continue taking Losartan and Hydrochlorothiazide HCS for the entire duration prescribed by your doctor, as this will help maintain consistent control of your high blood pressure.

High blood pressure
The usual dose of Losartan and Hydrochlorothiazide HCS for most patients with high blood pressure is 1 tablet of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg once daily, to control blood pressure over 24 hours. This dose may be increased to 2 tablets once daily of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets or changed to 1 tablet once daily of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets (a higher dose) per day.

The maximum daily dose is 2 tablets of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets or 1 tablet of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets.

If you take more Losartan and Hydrochlorothiazide HCS than you should
In case of overdose, contact your doctor immediately to receive immediate medical treatment. Overdose may cause low blood pressure, palpitations, slow pulse rate, disturbances in blood electrolytes, and dehydration.

If you forget to take Losartan and Hydrochlorothiazide HCS
Try to take Losartan and Hydrochlorothiazide HCS once daily as prescribed. However, if you miss a dose, do not take a double dose. Continue with your regular dosing schedule.

If you have any 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 will experience them.
If you experience the following side effect, stop taking Losartan and Hydrochlorothiazide HCS tablets and contact your doctor immediately or go to the Emergency Department of the nearest hospital:
A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty 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 intervention or hospitalization is required.

The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus bone disorders,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Increased potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels,
• Changes in kidney function including kidney failure,
• Low blood sugar levels (hypoglycaemia).

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

• Loss of appetite, increased levels of uric acid or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, insomnia, memory impairment,
• Tingling sensation or pins and needles, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• Sensation of hearing sound, ringing, buzzing or clicking noises in the ears, dizziness,
• Low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up), angina (chest pain), abnormal heartbeat, stroke (TIA, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels, often associated with skin redness and bruising,
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion,
• Constipation, persistent constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of the salivary glands, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, hot flushes, sweating, hair loss,
• Pain in arms, shoulders, hips, knees and other joints, joint swelling, numbness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Facial swelling, localized swelling (oedema), fever.

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

• Hepatitis (liver inflammation), changes in liver function tests,
• Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

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

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion).

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

• Flu-like symptoms,
• Low sodium levels in the blood (hyponatraemia),
• General feeling of being unwell (malaise),
• Skin and lip cancer (non-melanoma skin cancer),
• Unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• Taste disturbances (dysgeusia),
• Decreased vision or eye pain due to increased eye pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma).

Reporting of side effects
If you experience any side effect, 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 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 Losartan and Hydrochlorothiazide HCS

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 after
EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
HDPE tablet container:
Use within 100 days after first opening the medicine.
Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine 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 HCS contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of hydrochlorothiazide.
• The other components are: pregelatinized maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate in the core; and hypromellose, polyethylene glycol 4000, quinoline yellow (E104), talc, titanium dioxide (E171) in the coating. See section 2 “Losartan and Hydrochlorothiazide HCS contains lactose”.

Description of the appearance of Losartan and Hydrochlorothiazide HCS and package contents
Losartan and Hydrochlorothiazide HCS 100 mg/25 mg: yellow, oval, slightly biconvex film-coated tablets,
with tablet dimensions of 8 mm x 15 mm, thickness of 5.1 – 6.1 mm.

• The tablets are available in cardboard boxes containing: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 112 film-coated tablets in transparent Al/PVC/PVDC blisters.
• 100 film-coated tablets in a white plastic container with white tamper-evident screw cap.

Not all pack sizes may be marketed.
Marketing Authorization Holder
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. - Italy
This medicinal product is authorized in the European Economic Area and in the
United Kingdom (Northern Ireland) under the following names:

Package leaflet: Information for the user

Losartan and Hydrochlorothiazide HCS 100 mg/12.5 mg film-coated tablets

losartan potassium/hydrochlorothiazide
Please read this leaflet carefully before using 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist (see section 4).

Contents of this leaflet:

1. What Losartan and Hydrochlorothiazide HCS is and what it is used for
2. What you need to know before taking Losartan and Hydrochlorothiazide HCS
3. How to take Losartan and Hydrochlorothiazide HCS
4. Possible side effects
5. How to store Losartan and Hydrochlorothiazide HCS
6. Package contents and other information

2. What Losartan and Hydrochlorothiazide HCS is and what it is used for

Losartan and Hydrochlorothiazide HCS 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 blocks angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels, which in turn lowers blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salt through the kidneys. This also helps to reduce blood pressure.
Losartan and Hydrochlorothiazide HCS is indicated for the treatment of essential hypertension (high blood pressure).

4. What you need to know before taking Losartan and Hydrochlorothiazide HCS

Do not take Losartan and Hydrochlorothiazide HCS

• if you are allergic to losartan, hydrochlorothiazide, or any of the other excipients of this medicine (listed in section 6);
• if 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);
• if you have severely impaired liver function;
• if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment;
• if you suffer from gout;
• if you are more than 3 months pregnant (Losartan and Hydrochlorothiazide HCS should also be avoided in early pregnancy – see section "Pregnancy");
• if you have severely impaired kidney function;
• if your kidneys do not produce urine;
• if 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 HCS.
You must inform your doctor if you think you are (or might become) pregnant. Losartan and Hydrochlorothiazide HCS
is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant,
as it may cause serious harm to your baby if used at this stage (see section "Pregnancy").
It is important to inform your doctor before taking Losartan and Hydrochlorothiazide HCS:

• if you have previously experienced swelling of the face, lips, throat, or tongue,
• if you are taking diuretics ("water pills"),
• if you are on a low-salt diet,
• if you have had or currently have severe episodes of vomiting and/or diarrhoea,
• if you suffer from heart failure,
• if your liver function is impaired (see section 2 “Do not take Losartan and Hydrochlorothiazide HCS”),
• if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant,
• if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function),
• if you have 'mitral or aortic valve stenosis' (narrowing of heart valves) or 'hypertrophic cardiomyopathy' (a condition causing thickening of the heart muscle),
• if you are diabetic,
• if you have had gout,
• if you have or have had allergic conditions, asthma, or conditions causing joint pain, skin rashes, and fever (systemic lupus erythematosus),
• if you have high calcium levels or low potassium levels, or are on a low-potassium diet,
• if you require anaesthesia (even by a dentist) or before undergoing surgery, or if you are scheduled for a test to assess parathyroid function, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased aldosterone secretion from the adrenal gland due to an abnormality within the gland),
• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan and Hydrochlorothiazide HCS”),
• if you have previously had skin cancer or develop an unexpected skin lesion 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 radiation while taking Losartan and Hydrochlorothiazide HCS.
• if you have had respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe breathing difficulties after taking Losartan and Hydrochlorothiazide HCS, consult a doctor immediately.
• if you experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to several weeks after starting Losartan and Hydrochlorothiazide HCS. If untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you have a higher risk of developing this condition,
• if you are taking any of the following medicines for 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 the heading "Do not take Losartan and Hydrochlorothiazide HCS".
Contact your doctor if, after taking Losartan and Hydrochlorothiazide HCS, you experience abdominal pain,
nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not
stop taking Losartan and Hydrochlorothiazide HCS on your own.
Children and adolescents
There is no experience with the use of Losartan and Hydrochlorothiazide HCS in children. Therefore, Losartan and
Hydrochlorothiazide HCS must not be given to children.
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Other medicines and Losartan and Hydrochlorothiazide HCS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Losartan and Hydrochlorothiazide HCS is not recommended.
Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide HCS may interact with
other medicines. Lithium-containing preparations must not be taken with Losartan and Hydrochlorothiazide
HCS without close medical supervision. Special precautionary measures (e.g. blood tests) may be appropriate if you are taking other diuretics (“medicines that increase fluid excretion through the kidneys”), certain laxatives, gout treatments, medicines to control heart rhythm, or diabetes medicines (oral agents or insulin).
It is also important for your doctor to know if you are taking:

• other medicines to lower blood pressure;
• steroids;
• cancer treatments;
• painkillers;
• antifungal medicines;
• arthritis treatments;
• cholesterol-lowering resins such as cholestyramine;
• muscle relaxants;
• sleeping pills;
• opioid medicines such as morphine;
• "pressor amines" such as adrenaline or other medicines in the same group;
• oral antidiabetic medicines or insulin.

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

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

Inform your doctor that you are taking Losartan and Hydrochlorothiazide HCS if you know you will undergo a
radiographic procedure involving iodinated contrast agents.
Losartan and Hydrochlorothiazide HCS with food, drinks, and alcohol
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and
Hydrochlorothiazide HCS tablets may increase each other's effects.
A diet particularly rich in salt may counteract the effect of Losartan and Hydrochlorothiazide HCS
tablets. Losartan and Hydrochlorothiazide HCS may be taken regardless of meals.
Pregnancy and breastfeeding
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
You must inform your doctor if you think you are (or might become) pregnant. Your doctor will generally advise you to stop taking Losartan and Hydrochlorothiazide HCS before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan and Hydrochlorothiazide HCS is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby if used beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
Use in elderly patients
Losartan and Hydrochlorothiazide HCS works in the same way and is equally well tolerated in most elderly and younger adult patients. Most elderly patients require the same dosage as younger adults.
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 react to the medicine.
Losartan and Hydrochlorothiazide HCS contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

5. How to take Losartan and Hydrochlorothiazide HCS

Take this medicine exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions.
If you have any doubts, consult your doctor.
Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide HCS based on your condition
and any other medicines you may be taking. It is important to continue taking Losartan and Hydrochlorothiazide HCS
for the entire duration prescribed by your doctor, as this will maintain stable control of high blood pressure.

Losartan and Hydrochlorothiazide HCS is available in three strengths:
Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets,
Losartan and Hydrochlorothiazide HCS 100 mg/12.5 mg film-coated tablets,
Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets.

High blood pressure
The usual dose of Losartan and Hydrochlorothiazide HCS for most patients with high blood pressure is
1 tablet of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg once daily to control blood pressure over a 24-hour period.
The dose may be increased to two tablets of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets once daily,
or switched to 1 tablet of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg (higher strength) film-coated tablets once daily.
The maximum dose is 2 tablets of Losartan and Hydrochlorothiazide HCS 50 mg/12.5 mg film-coated tablets once daily,
or 1 tablet of Losartan and Hydrochlorothiazide HCS 100 mg/25 mg film-coated tablets daily.

Losartan and Hydrochlorothiazide HCS 100 mg/12.5 mg (losartan 100 mg/hydrochlorothiazide 12.5 mg)
film-coated tablets are available for patients already titrated to 100 mg of losartan who require additional blood pressure control.

Administration
The tablets should be swallowed whole with a glass of water.

If you take more Losartan and Hydrochlorothiazide HCS 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 electrolytes, and dehydration.

If you forget to take Losartan and Hydrochlorothiazide HCS
Try to take Losartan and Hydrochlorothiazide HCS once daily as prescribed. However, if you miss a dose,
do not take a double dose. Continue with your regular dosing schedule.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience the following side effect, stop taking Losartan and Hydrochlorothiazide HCS tablets and contact your doctor immediately or go to the nearest hospital emergency department:
if you experience a severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).
This is a serious but rare side effect, affecting up to 1 in 10,000 patients. You may require urgent medical treatment or hospitalization.
Acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).
This is a serious but very rare side effect, affecting up to 1 in 10,000 patients. You may require urgent medical treatment or hospitalization.

The following side effects have been reported:

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

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus bone cavity disorders,
• Diarrhoea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Increased potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels,
• Changes in kidney function including kidney failure,
• Blood sugar levels too low (hypoglycaemia).

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

• Anaemia, red or brownish spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain),
• Bruising, reduced white blood cells, blood clotting problems, reduced platelet count,
• Loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, insomnia, memory impairment,
• Tingling sensation or pins and needles, pain in the extremities, tremor, migraine, fainting,
• Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things yellowish in colour,
• Sensation of hearing a sound, ringing, buzzing or clicking noises in the ears, dizziness,
• Low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up), angina (chest pain), abnormal heartbeat, stroke (TIA, "mini-stroke"), heart attack, palpitations,
• Inflammation of blood vessels, often associated with skin redness and bruising,
• Sore throat, breathlessness, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion,
• Constipation, obstinate constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of the salivary glands, toothache,
• Jaundice (yellowing of the eyes and skin), inflammation of the pancreas,
• Urticaria, itching, skin inflammation, irritation, skin redness, photosensitivity, dry skin, hot flushes, sweating, hair loss,
• Pain in arms, shoulders, hips, knees and other joints, joint swelling, numbness, muscle weakness,
• Frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• Decreased sexual desire, impotence,
• Facial swelling, localised swelling (oedema), fever.

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

• Hepatitis (liver inflammation), changes in liver function tests.
• Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Not known (frequency cannot be estimated from the available data):
Skin and lip cancer (non-melanoma skin cancer)
Flu-like symptoms;
Unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis);
Low sodium levels in the blood (hyponatraemia);
General feeling of being unwell (malaise);
Taste disturbances (dysgeusia);
Decreased vision or eye pain due to increased eye pressure (possible symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or angle-closure glaucoma).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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 Losartan and Hydrochlorothiazide HCS

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 after EXP.
The expiry date refers to the last day of that month.
Do not store above 30 °C.
Store in the original packaging to protect the medicine from moisture.
HDPE tablet container:
Use within 100 days after first opening of the container.
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 HCS contains

• The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 12.5 mg of hydrochlorothiazide.
• The other components are: pregelatinized maize starch, microcrystalline cellulose, monohydrate lactose, magnesium stearate in the core and coating, hypromellose, macrogol 4000, talc, titanium dioxide (E171). See section 2. Losartan and Hydrochlorothiazide HCS contains lactose.

Description of the appearance of Losartan and Hydrochlorothiazide HCS and the contents of the pack
The film-coated tablets of Losartan and Hydrochlorothiazide HCS are white, oval, biconvex.
Tablet size: 13 mm x 8 mm.
The tablets are supplied in packs containing:

• 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 112 film-coated tablets in PVC/PVDC/Al blisters.
• 100 film-coated tablets in a white plastic container with a white tamper-evident screw cap.

Not all pack sizes may be marketed.
Marketing Authorization Holder:
HCS BV, H. Kennisstraat 53, B 2650 Edegem, Belgium
Responsible for batch release:
KRKA d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Local representative in Italy:
KRKA Farmaceutici Milano S.r.l. - Italy
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: