Losartan and hydrochlorothiazide Laboratori Alter: detailed information

Patient Information Leaflet

LOSARTAN AND HYDROCHLOROTHIAZIDE LABORATORI ALTER

50 mg/12.5 mg, film-coated tablets
(50 mg losartan potassium and 12.5 mg hydrochlorothiazide)
LOSARTAN AND HYDROCHLOROTHIAZIDE LABORATORI ALTER
100 mg/25 mg, film-coated tablets
(100 mg losartan potassium and 25 mg hydrochlorothiazide)
Generic medicine
Please read this leaflet carefully before taking 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, pharmacist, or nurse.
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, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Losartan and Hydrochlorothiazide Laboratori Alter is and what it is used for

Losartan and Hydrochlorothiazide Laboratori Alter 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 consequently lowering blood pressure.
Hydrochlorothiazide works by increasing the excretion of water and salt through the kidneys. This mechanism also helps reduce blood pressure.
Losartan and Hydrochlorothiazide Laboratori Alter is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan and Hydrochlorothiazide Laboratori Alter

Do not take Losartan and Hydrochlorothiazide Laboratori Alter

if you are allergic to losartan, hydrochlorothiazide, or to any of the other ingredients 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 severe liver dysfunction,
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 Laboratori Alter should also be avoided during early pregnancy – see section “Pregnancy”),
if you have severe kidney dysfunction or 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, pharmacist, or nurse before taking Losartan and Hydrochlorothiazide Laboratori Alter:

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 non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartan and Hydrochlorothiazide Laboratori Alter.
if you have previously experienced breathing or lung problems (including lung inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Losartan and Hydrochlorothiazide Laboratori Alter, consult a doctor immediately.

You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Losartan and Hydrochlorothiazide Laboratori Alter 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 child if taken during this period (see section “Pregnancy”). It is important to inform your doctor before using Losartan and Hydrochlorothiazide Laboratori Alter:

if you have a history of swelling of the face, lips, throat, and/or tongue
if you are taking diuretics (medicines that increase urine production)
if you are on a low-salt diet
if you have had or currently have severe vomiting and/or diarrhoea
if you have heart failure
if liver function is impaired (see section 2 “Do not take Losartan and Hydrochlorothiazide Laboratori Alter”)
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 have diabetes
if you have had gout
if you have or have had allergic conditions, 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 are on a low-potassium diet
if you need to take an anaesthetic (even from a dentist) or before undergoing surgery, or if you are scheduled for tests assessing 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 hormone secretion by the adrenal gland due to an abnormality)
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 experience decreased vision 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 and Hydrochlorothiazide Laboratori Alter. If left untreated, increased eye pressure may lead to permanent vision damage. If you have previously had an allergic reaction to penicillins or sulfonamides, you are at higher risk of developing these effects.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.
See also the section “Do not take Losartan and Hydrochlorothiazide Laboratori Alter”.

Children and adolescents
There is no experience regarding the use of Losartan and Hydrochlorothiazide Laboratori Alter in children and adolescents. Therefore, Losartan and Hydrochlorothiazide Laboratori Alter must not be administered to children and adolescents.

Other medicines and Losartan and Hydrochlorothiazide Laboratori Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 Losartan and Hydrochlorothiazide Laboratori Alter” and “Warnings and precautions”).

Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide Laboratori Alter may interact with other medicines.

Lithium-containing preparations must not be taken with Losartan and Hydrochlorothiazide Laboratori Alter without close medical supervision.

Special precautionary measures (e.g. blood tests) may be required if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics, certain laxatives, medicines for gout, medicines for controlling heart rhythm, or medicines for diabetes (oral agents or insulin).

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

other medicines to lower blood pressure
steroids
cancer medicines
painkillers
antifungal medicines
medicines for treating arthritis
cholesterol-lowering resins such as cholestyramine
muscle relaxants
sleeping pills
opioids such as morphine
pressor amines such as adrenaline or similar medicines
oral antidiabetics or insulin

Inform your doctor that you are taking Losartan and Hydrochlorothiazide Laboratori Alter if you are scheduled for a radiographic procedure involving iodinated contrast agents.

Losartan and Hydrochlorothiazide Laboratori Alter with food, drinks, and alcohol
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and Hydrochlorothiazide Laboratori Alter tablets may enhance each other's effects.

A diet particularly high in salt may counteract the effect of Losartan and Hydrochlorothiazide Laboratori Alter tablets.

Losartan and Hydrochlorothiazide Laboratori Alter can be taken with or without food.

Pregnancy, breastfeeding, and fertility
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 and Hydrochlorothiazide Laboratori Alter before starting pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine.

Losartan and Hydrochlorothiazide Laboratori Alter is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Losartan and Hydrochlorothiazide Laboratori Alter is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment if you wish to breast-feed.

Use in elderly patients
Losartan and Hydrochlorothiazide Laboratori Alter 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 particular alertness (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

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

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Losartan and Hydrochlorothiazide Laboratori Alter

Take this medicine exactly as directed 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 Laboratori Alter based on your condition and any other medicines you are taking. It is important to continue taking Losartan and Hydrochlorothiazide Laboratori Alter for the entire duration prescribed by your doctor, as this will maintain stable control of your high blood pressure.

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

If you take more Losartan and Hydrochlorothiazide Laboratori Alter 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 Laboratori Alter
Try to take Losartan and Hydrochlorothiazide Laboratori Alter once daily as prescribed. However, if you miss a dose, do not take a double dose to make up for the missed dose. Skip the missed tablet and take the next tablet at your usual time on the following day.

If you stop taking Losartan and Hydrochlorothiazide Laboratori Alter
If you have any questions about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effect, stop taking Losartan and Hydrochlorothiazide Laboratori Alter 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 treatment or hospitalisation 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 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 renal failure
Low blood sugar (hypoglycaemia)

Uncommon (may affect up to 1 in 100 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, reduction in white blood cells, blood clotting problems, reduced platelet count
Loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels
Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disturbances, insomnia, memory impairment
Sensation of pins and needles or similar sensation, pain in extremities, tremor, migraine, fainting
Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things in yellow
Sensation of hearing a sound, ringing, buzzing or clicking noises in the ears, vertigo
Angina (chest pain), abnormal heartbeat, cerebrovascular accident (TIA, "mini-stroke"), heart attack, palpitations
Inflammation of blood vessels, often associated with rash and bruising
Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleed, runny nose, congestion
Constipation, persistent constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
Jaundice (yellowing of eyes and skin), inflammation of the pancreas
Urticaria, itching, skin inflammation, photosensitivity, 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, 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

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):

Thrombocytopenia (low platelet count in the blood)
Pancreatitis (inflammation of the pancreas)
Flu-like symptoms, general feeling of being unwell (malaise)
Abnormal liver function
Unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)
Low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up)
Low sodium levels in the blood (hyponatraemia)
Altered taste (dysgeusia)
Skin rash, redness of the skin
Skin and lip cancer (non-melanoma skin cancer)
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)
Rapid-onset decrease in distance vision (acute myopia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Losartan and Hydrochlorothiazide Laboratori Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of the month.
Store Losartan and Hydrochlorothiazide Laboratori Alter in the original packaging to protect it from light and moisture.
Store the package at a temperature not exceeding 30°C.
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. Contents of the pack and other information

What Losartan and Hydrochlorothiazide Laboratori Alter contains

The active substances are losartan potassium and hydrochlorothiazide.
Losartan and Hydrochlorothiazide Laboratori Alter 50 mg/12.5 mg: Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Losartan and Hydrochlorothiazide Laboratori Alter 100 mg/25 mg: Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
The other components are:
Tablet core: Lactose monohydrate, Microcrystalline cellulose, Hydroxypropylcellulose, Pregelatinized maize starch, Magnesium stearate
Coating: Hydroxypropylmethylcellulose 5cP, Titanium dioxide (E171), Macrogol 400 (OPADRY Y-1-7000 White).

Description of the appearance of Losartan and Hydrochlorothiazide Laboratori Alter and the contents of the pack
Losartan and Hydrochlorothiazide Laboratori Alter 50 mg/12.5 mg are white, elongated, biconvex tablets with a break line on both sides.
Losartan and Hydrochlorothiazide Laboratori Alter 100 mg/25 mg are white, elongated, biconvex tablets with a break line on both sides.
Losartan and Hydrochlorothiazide Laboratori Alter tablets are packaged in PVC/aluminum blisters.
Pack size: 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan, Italy

Manufacturer
Laboratorios Alter S.A.
c/Mateo Inurria 30
28036 Madrid, Spain

This patient information leaflet was last approved on