PACKAGE LEAFLET: INFORMATION FOR THE USER

LOZID

50mg/12.5mg film-coated tablets
100mg/25mg film-coated tablets
losartan potassium and hydrochlorothiazide
Generic medicine
Read this entire leaflet carefully before taking this medicine.

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. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What LOZID is and what it is used for
Before you take LOZID
How to take LOZID
Possible side effects
How to store LOZID
Further information

1. WHAT LOZID IS AND WHAT IT IS USED FOR

LOZID is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
LOZID is indicated for the treatment of essential hypertension (high blood pressure).

2. BEFORE TAKING LOZID

Do not take LOZID

if you are allergic (hypersensitive) to losartan, hydrochlorothiazide, or any of the other excipients of this medicine;
if you are allergic (hypersensitive) to other sulfonamide-derived substances (e.g., other thiazides, certain antibacterial agents such as co-trimoxazole; ask your doctor if you are unsure);
if you are more than 3 months pregnant (LOZID should also be avoided during the first months of pregnancy);
- See Pregnancy;
if you have severe impairment of liver function;
if you have severe impairment of kidney function or if your kidneys are not producing urine;
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment;
if you suffer from gout.

Take special care with LOZID

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 LOZID;
if you have a history of swelling of the face, lips, throat, and/or tongue;
if you are taking diuretics (medicines that increase the amount of fluid excreted by the kidneys);
if you are on a low-salt diet;
if you have or have recently had severe vomiting and/or diarrhoea;
if you have heart failure;
if you have impaired liver function (see section 2 “Do not take LOZID”);
if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
if you have 'mitral valve stenosis' or 'aortic valve stenosis' (narrowing of heart valves) or 'hypertrophic cardiomyopathy' (a condition causing thickening of the heart muscle);
if you have diabetes;
if you have previously had gout;
if you have or have had an allergic condition, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus);
if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet;
if you need to take an anaesthetic (even from a dentist) or before surgery, or if you are about to undergo tests 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 hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to an abnormality);
you must inform your doctor if you think you are (or might become) pregnant. LOZID is not recommended during the first months of pregnancy and must not be used if you are more than three months pregnant, as it may cause serious harm to your baby if used at this stage (see the section on Pregnancy);
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 and may occur within hours or weeks of starting LOZID. This may lead to permanent vision impairment if not treated. If you have previously been allergic to penicillins or sulfonamides, you may have a higher risk of developing this condition.
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
Aliskiren
- if you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking LOZID, consult a doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take LOZID".
Taking LOZID with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Diuretics such as hydrochlorothiazide contained in LOZID may interact with other medicines.
Lithium-containing preparations must not be taken with LOZID without close medical supervision. Special precautionary measures (e.g., blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics ("medicines that increase the amount of fluid excreted by the kidneys"), certain laxatives, gout treatments, medicines for controlling heart rhythm, or diabetes medicines (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, sedatives, opioids such as morphine, pressor amines such as adrenaline, or similar agents (oral antidiabetics or insulin).
Your doctor may consider it necessary to adjust your dose and/or take additional precautions:
if you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take LOZID" and "Take special care with LOZID").
For athletes: using LOZID without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Inform your doctor that you are taking LOZID when planning to use iodinated contrast agents.
Taking LOZID with food and drinks
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and LOZID tablets may enhance each other's effects.
A diet particularly high in salt may counteract the effect of LOZID tablets. LOZID tablets may be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop taking LOZID before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine to LOZID. LOZID is not recommended during 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. LOZID 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Use in children and adolescents
There is no experience with the use of LOZID in children. Therefore, LOZID must not be given to children.
Use in elderly patients
LOZID 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 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.
Important information about some excipients of LOZID
contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE LOZID

Always take LOZID exactly as directed by your doctor. Your doctor will determine the
appropriate dose of LOZID based on your condition and any other medications you may
be taking. It is important to continue taking LOZID for the full duration prescribed by your
doctor, as this will help maintain stable blood pressure control.

High blood pressure
The usual dose of LOZID for most patients with high blood pressure is 1 tablet of LOZID 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/HCTZ 50 mg/12.5 mg film-coated tablets once daily or adjusted to 1 tablet daily of losartan/HCTZ 100 mg/25 mg film-coated tablets (a higher strength formulation).
The maximum daily dose is 2 tablets of losartan/HCTZ 50 mg/12.5 mg film-coated tablets per day or 1 tablet of losartan/HCTZ 100 mg/25 mg film-coated tablets per day.

If you take more LOZID 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, electrolyte disturbances in the blood, and dehydration.

If you forget to take LOZID
Try to take losartan/HCTZ once daily as prescribed. However, if you miss a dose, do not take a double dose. Continue with your regular dosing schedule.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, LOZID tablets can cause adverse reactions, although not everyone experiences them.
If you experience the following adverse reaction, stop taking LOZID tablets immediately and contact your doctor or go to the Emergency Department of the nearest hospital:
a severe allergic reaction (redness, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing).
This is a severe but rare adverse reaction, 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 adverse reactions have been reported:

Common (occur in less than 1 in 10 but more than 1 in 100 people):

Cough, upper respiratory tract infection, nasal congestion, sinusitis, disorders of the bony cavities within the nose;
Diarrhea, 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 hemoglobin levels.

Uncommon (occur in less than 1 in 100 but more than 1 in 1,000 people):

Anaemia, 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, reduced white blood cells, bleeding and bruising problems;
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, prickling or pins and needles, extremity pain, tremor, migraine, fainting;
Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things yellowed;
Sensation of hearing a sound, ringing, buzzing or clicking noises in the ears;
Low blood pressure, which may be associated with postural changes (feeling lightheaded or weak when standing up), angina (chest pain), irregular heartbeat, cerebrovascular accident (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, 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, 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 urine;
Decreased sexual desire, impotence;
Facial swelling, fever.

Rare (occur in less than 1 in 1,000 but more than 1 in 10,000 people):

Hepatitis (liver inflammation), changes in liver function tests.

Very rare (occur in less than 1 in 10,000 but more than 1 in 100,000 people):

Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

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

Sudden onset of reduced distance vision (acute myopia), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma). If sudden and painful redness of one eye occurs, inform your doctor immediately; treatment may be required to prevent permanent vision loss.
Altered taste.
Skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. This includes any possible adverse reaction not listed here. You can also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LOZID

Keep LOZID out of the reach and sight of children.
Do not use LOZID after the expiry date stated on the container. The expiry date refers to the last day of the month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What LOZID contains
The active substances are losartan potassium and hydrochlorothiazide.
Each tablet of LOZID 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of
hydrochlorothiazide as active substances.
Each tablet of LOZID 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of
hydrochlorothiazide as active substances.
The excipients are: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol, yellow iron oxide (E172), indigo carmine (E132).
LOZID 50 mg/12.5 mg contains potassium in the following amounts: 4.2 mg (0.107 mEq).
LOZID 100 mg/25 mg contains potassium in the following amounts: 8.4 mg (0.215 mEq).

Description of the appearance of LOZID and contents of the pack
LOZID 50 mg/12.5 mg is available in the following pack sizes:
Blister packs containing 7, 10, 14, 28, 30, 50, 56, or 98 film-coated tablets, yellow, round, with a score line on one side.
The score line on the tablet is intended to facilitate swallowing by making it easier to break the tablet and does not serve to divide the tablet into equal doses.

LOZID 100 mg/25 mg is available in the following pack sizes:
Blister packs containing 7, 10, 14, 28, 30, 50, 56, or 98 film-coated tablets, yellow, oval, with a score line on one side.
The tablet can be divided into two equal halves.

Not all pack sizes may be marketed.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00040 – Pomezia (Roma)
Italy

Responsible Manufacturer for batch release:
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy:
Lozid 50 mg/12.5 mg film-coated tablet
Lozid 100 mg/25 mg film-coated tablet

This patient information leaflet was last approved on