Losartan and hydrochlorothiazide Sandoz: detailed information

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

LOSARTAN HYDROCHLOROTHIAZIDE Sandoz 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 others, even if they have the same symptoms as you, because it could 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 HYDROCHLOROTHIAZIDE Sandoz is and what it is used for
What you need to know before taking LOSARTAN HYDROCHLOROTHIAZIDE Sandoz
How to take LOSARTAN HYDROCHLOROTHIAZIDE Sandoz
Possible side effects
How to store LOSARTAN HYDROCHLOROTHIAZIDE Sandoz
Package contents and other information

1. WHAT LOSARTAN HYDROCHLOROTHIAZIDE SANDOZ IS AND WHAT IT IS USED FOR

Losartan potassium belongs to a group of medicines called angiotensin II receptor antagonists.
This causes relaxation of blood vessels, resulting in a reduction of blood pressure.
Hydrochlorothiazide belongs to a group of medicines called diuretics.
Hydrochlorothiazide works by increasing the excretion of water and salt through the kidneys. This also helps reduce blood pressure.
Losartan Hydrochlorothiazide Sandoz 50 mg/12.5 mg film-coated tablets
These tablets are used for the treatment of high blood pressure. The combination of losartan and hydrochlorothiazide provides a suitable alternative for patients who would otherwise be treated with separate losartan potassium and hydrochlorothiazide therapy.
Losartan Hydrochlorothiazide Sandoz 100 mg/25 mg film-coated tablets
These tablets are used to treat high blood pressure in patients who have not responded adequately to treatment with Losartan Hydrochlorothiazide Sandoz 50 mg/12.5 mg film-coated tablets.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LOSARTAN HYDROCHLOROTHIAZIDE SANDOZ

Do not take Losartan Hydrochlorothiazide Sandoz if

you are allergic to losartan, to hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6)
you are allergic to other sulfonamide-derived substances (for example, other thiazides, certain antibacterial medicines such as co-trimoxazole; if in doubt, consult your doctor)
you are more than 3 months pregnant (Losartan Hydrochlorothiazide Sandoz should also be avoided during early pregnancy – see section “Pregnancy”)
you have severe impairment of liver function
you have severe impairment of kidney function or your kidneys are not producing urine

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you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment
you suffer from gout
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of the conditions listed above apply to you, inform your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan Hydrochlorothiazide Sandoz.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Losartan Hydrochlorothiazide Sandoz 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 the unborn baby when used during this period (see section “Pregnancy”).
It is important to inform your doctor before taking Losartan Hydrochlorothiazide Sandoz:

if you have a history of swelling of the face, lips, tongue, or throat (angioedema)
if you are taking diuretics
if you are on a low-salt diet
if you have or have had severe vomiting and/or severe diarrhoea
if you have heart failure
if you have impaired liver function (see section 2 “Do not take Losartan Hydrochlorothiazide Sandoz”)
if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant
if you are on haemodialysis
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 had an allergic condition, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus)
if you have had respiratory or lung problems (including lung inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe breathing difficulties after taking Losartan Hydrochlorothiazide Sandoz, seek immediate medical attention
if you have high calcium levels or low potassium levels, or if you are on a diet low in potassium
if you need to take an anaesthetic (even from a dentist) or before undergoing surgery, or if you are scheduled for tests to assess your parathyroid function – inform your doctor or healthcare provider that you are taking Losartan Hydrochlorothiazide Sandoz tablets
if you have primary hyperaldosteronism (a syndrome associated with increased aldosterone secretion by the adrenal gland due to an abnormality within the gland)
if you have previously had skin cancer or develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV radiation while taking Losartan Hydrochlorothiazide Sandoz
if you experience vision loss or eye pain. These could 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 taking Losartan Hydrochlorothiazide Sandoz. If left untreated, this may lead to permanent vision loss. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms. FI_LOSARTAN_HCT_SANDOZ_2603-16
if 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 the section "Do not take Losartan Hydrochlorothiazide Sandoz".
Contact your doctor if, after taking Losartan Hydrochlorothiazide Sandoz, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Losartan Hydrochlorothiazide Sandoz on your own.
Children and adolescents
The safety and efficacy of Losartan Hydrochlorothiazide Sandoz in children and adolescents under 18 years of age have not been established. Losartan Hydrochlorothiazide Sandoz must not be administered to children or adolescents.
If you are an athlete about to undergo doping tests, inform your doctor, as Losartan Hydrochlorothiazide Sandoz contains an active substance that may lead to a positive doping test result.
Other medicines and Losartan Hydrochlorothiazide Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust the dose and/or take additional precautions if you are taking:

lithium (a medicine used for the treatment of mania or depression)
potassium supplements
potassium-containing salt substitutes
potassium-sparing medicines
other diuretics
certain laxatives
medicines used to treat gout
medicines used to control heart rhythm
medicines for diabetes (oral agents or insulin)
medicines used to lower blood pressure
steroids
medicines used for cancer treatment
analgesics
medicines used for arthritis treatment
medicines used to treat fungal infections
resins used to treat high cholesterol (e.g., cholestyramine)
medicines to relax muscles
sleeping pills
opioid medicines (e.g., morphine)
medicines called vasopressor amines (e.g., adrenaline)
glycyrrhizin (found in liquorice)
an ACE inhibitor or aliskiren (see also the sections: "Do not take Losartan Hydrochlorothiazide Sandoz" and "Warnings and precautions").

Inform your doctor that you are taking Losartan Hydrochlorothiazide Sandoz if you are scheduled for an X-ray involving iodinated contrast agents.
Losartan Hydrochlorothiazide Sandoz with food and drinks
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You are advised not to consume alcohol with these tablets: alcohol and Losartan Hydrochlorothiazide Sandoz may enhance each other's effects.
Excessive dietary salt intake may counteract the effects of Losartan Hydrochlorothiazide Sandoz.
Losartan Hydrochlorothiazide Sandoz may be taken with or without food.
Grapefruit juice should be avoided during treatment with Losartan Hydrochlorothiazide Sandoz.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan Hydrochlorothiazide Sandoz before starting a pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Losartan Hydrochlorothiazide Sandoz is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the first trimester.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan Hydrochlorothiazide Sandoz is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
Ask your doctor or pharmacist for advice before taking any medicine.
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 Hydrochlorothiazide Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE LOSARTAN HYDROCHLOROTHIAZIDE SANDOZ

Take Losartan Hydrochlorothiazide Sandoz exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan Hydrochlorothiazide Sandoz based on your condition and whether you are taking other medications. It is important to continue taking Losartan Hydrochlorothiazide Sandoz for as long as prescribed by your doctor in order to maintain blood pressure under easy control.
Take the tablets with a glass of water, with or without food.

Use in adults
Losartan Hydrochlorothiazide Sandoz 50 mg/12.5 mg film-coated tablets
The usual dose is one tablet once daily. If necessary, your doctor may increase the dose up to a maximum of two tablets once daily or one tablet of Losartan Hydrochlorothiazide Sandoz 100 mg/25 mg film-coated tablets once daily.

Losartan Hydrochlorothiazide Sandoz 100 mg/25 mg film-coated tablets
The usual dose is one tablet once daily.
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Use in the elderly
Dose adjustment is normally not required in elderly patients.

Use in patients with impaired renal function and on haemodialysis
Dose adjustment is generally not necessary in cases of mild to moderate renal impairment. However, do not take Losartan Hydrochlorothiazide Sandoz if you have severely impaired renal function.
Losartan Hydrochlorothiazide Sandoz is not recommended for patients on haemodialysis.

Use in patients with impaired hepatic function
Losartan Hydrochlorothiazide Sandoz should be used with caution in patients with a history of mild to moderate hepatic impairment. However, do not take Losartan Hydrochlorothiazide Sandoz if you have severely impaired liver function (see section 2 “Do not take Losartan Hydrochlorothiazide Sandoz”).

Use in children and adolescents
Losartan Hydrochlorothiazide Sandoz must not be administered to children and adolescents under 18 years of age.

Use in Black patients:
Dose adjustment may be necessary, as Losartan Hydrochlorothiazide Sandoz may be less effective in Black patients compared to non-Black patients.

If you take more Losartan Hydrochlorothiazide Sandoz than you should
In case of overdose, contact your doctor immediately to receive prompt medical assistance. Overdose may cause a drop in blood pressure, palpitations, slowed heartbeat, changes in blood composition, and dehydration.

If you forget to take Losartan Hydrochlorothiazide Sandoz
Do not take a double dose to make up for a missed dose. Simply take the next dose at your usual time.

If you stop taking Losartan Hydrochlorothiazide Sandoz
If you wish to stop treatment, always consult your doctor first: you may need to continue therapy even if you feel well.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, stop taking Losartan Hydrochlorothiazide Sandoz 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 severe but rare side effect, affecting more than 1 in 10,000 patients but fewer than 1 in 1,000. It may require urgent medical attention or hospitalization.

Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness and confusion),
this is a very rare side effect (may affect up to 1 in 10,000 people).
The following side effects have also been reported:

Common (may affect up to 1 in 10 people):
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cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal sinus disorders
diarrhoea, abdominal pain, nausea, indigestion
muscle pain or cramps, leg and back pain
insomnia, headache, dizziness
weakness, fatigue, chest pain
increased potassium levels in the blood (which may cause heart rhythm abnormalities), decreased haemoglobin levels
impaired 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 especially on feet, legs, arms and buttocks, associated with joint pain, swelling of hands and feet and stomach pain), bruising, reduced white blood cell count, coagulation disorders, reduced platelet count
loss of appetite, increased uric acid levels or clinical signs of gout, increased blood sugar levels, abnormal blood electrolyte levels
anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, drowsiness, memory impairment
tingling or similar sensations, limb pain, tremor, migraine, fainting
blurred vision, burning/stinging sensation in the eyes, conjunctivitis, worsening of vision, seeing things in yellow
ringing, buzzing, noise or clicking in the ears, vertigo
low blood pressure, which may be associated with changes in posture (dizziness or weakness when standing up), angina (chest pain), heart rhythm abnormalities, cerebrovascular accident (TIA, “mini-stroke”), heart attack, palpitations
inflammation of blood vessels, often associated with rash or bruising
sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion
constipation, obstipation, flatulence, gastric disturbances, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
jaundice (yellowing of the eyes and skin), inflammation of the pancreas
urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, Lyell’s syndrome (skin appears burnt and peels off), dry skin, flushing, sweating, hair loss
pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness
frequent urination, including at night, abnormal kidney function, including kidney inflammation, urinary tract infection, presence of sugar in urine
decreased sexual desire, impotence
facial swelling, localized swelling (oedema), fever

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

hepatitis (liver inflammation), abnormalities 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 available data):

flu-like symptoms
unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis)
low sodium levels in the blood (hyponatraemia)
general feeling of being unwell (malaise)
taste disturbances (dysgeusia)
non-melanoma skin and lip cancer
myopia

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decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute 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 HYDROCHLOROTHIAZIDE SANDOZ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, bottle, or blister,
following the term EXP. The expiry date refers to the last day of that month.
50 mg/12.5 mg film-coated tablet:
Blister: Store below 30°C.
Bottle: Store below 30°C. Keep the bottle tightly closed to protect the medicine from moisture.
100 mg/25 mg film-coated tablet:
Alu/Alu blister: Store below 30°C.
Aclar/Alu blister: Store below 30°C.
Bottle: Keep the bottle tightly closed 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. PACKAGING CONTENTS AND OTHER INFORMATION

What Losartan Hydrochlorothiazide Sandoz contains
The active substances are losartan potassium and hydrochlorothiazide.
Each film-coated tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

The excipients are:
Tablet core: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch,
magnesium stearate, anhydrous colloidal silica.

50 mg/12.5 mg film-coated tablet:
Coating film: hypromellose, hydroxypropylcellulose, yellow iron oxide (E172), titanium dioxide (E171).

100 mg/25 mg film-coated tablet:
Coating film: hypromellose, hydroxypropylcellulose, yellow iron oxide (E172), titanium dioxide (E171),
macrogol (400), talc.

Description of the appearance of Losartan Hydrochlorothiazide Sandoz and packaging contents
50 mg/12.5 mg film-coated tablet
Round, biconvex, light yellow film-coated tablets with a diameter of 8 mm.
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100 mg/25 mg film-coated tablet
Round, biconvex, light yellow film-coated tablets with a diameter of 10 mm.

The film-coated tablets are packaged in aluminum blisters or in plastic bottles with or without child-resistant caps.
Blisters: 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets
Unit dose blisters: 50 film-coated tablets
Bottles: 100, 250 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Responsible for Batch Release
Lek Pharmaceuticals d.d., Verovskova 57, SI-1526 Ljubljana, Slovenia
Lek S.A., Ul. Domaniewska 50 C, 02-672 Warsaw, Poland
Salutas Pharma GmbH, Otto von Guericke Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d. Trimlini 2 D, 9220 Lendava, Slovenia

This medicinal product has been authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Losartan-HCT Sandoz 50 mg/12.5 mg - Filmtabletten
Belgium: Co-Losartan Sandoz 50 mg/12.5 mg filmomhulde tabletten
Czech Republic: Sangona COMBI 50mg/12.5 mg
Denmark: Losartan Comp
France: LOSARTAN/HYDROCHLOROTHIAZIDE Sandoz 50 mg/12.5 mg, comprimé pelliculé
Italy: LOSARTAN IDROCLOROTIAZIDE SANDOZ 50 mg + 12.5 mg compresse rivestite con film
Netherlands: Kaliumlosartan/Hydrochloorthiazide Sandoz 50/12.5 mg, filmomhulde tabletten
Portugal: Losartan + Hidroclorotiazida Normal, 50 mg + 12.5 mg Tablets
Slovenia: Lakea H 50 mg/12.5 mg filmsko obložene tablete
Spain: Losartan/Hidroclorotiazida Salutas 50 mg/12.5 mg comprimidos recubiertos con película EFG
United Kingdom: Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg Film-coated Tablets

Austria: Losartan-HCT Sandoz 100 mg/25 mg - Filmtabletten
Belgium: Co-Losartan Sandoz 100 mg/25 mg filmomhulde tabletten
Czech Republic: Sangona COMBI 100mg/25 mg
Denmark: Losartan Comp
France: LOSARTAN/HYDROCHLOROTHIAZIDE Sandoz 100 mg/25 mg, comprimé pelliculé
Italy: LOSARTAN IDROCLOROTIAZIDE SANDOZ 100 mg + 25 mg compresse rivestite con film
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Netherlands: Kaliumlosartan/Hydrochloorthiazide Sandoz 100/25 mg, filmomhulde tabletten
Portugal: Losartan + Hidroclorotiazida Normal, 100 mg + 25 mg Tablets
Slovenia: LAKEA 100 mg/25 mg filmsko obložene tablete
Spain: Losartan/Hidroclorotiazida Salutas 100 mg/25 mg comprimidos recubiertos con película EFG
United Kingdom: Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Film-coated Tablets
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