Losartan and hydrochlorothiazide Aurobindo

Patient Information Leaflet: Information for the User

Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated tablets, 100 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Losartan and Hydrochlorothiazide Aurobindo is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to narrow. This leads to an increase in blood pressure.
Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of blood vessels and a consequent reduction in blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salt through the kidneys. This mechanism also helps lower blood pressure.
Losartan and Hydrochlorothiazide Aurobindo is indicated for the treatment of essential hypertension (high blood pressure).

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

Do not take Losartan and Hydrochlorothiazide Aurobindo

• if you are allergic to losartan, hydrochlorothiazide, or any of the excipients of this medicine (listed in section 6);
• if you are allergic (hypersensitive) 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. It is better to avoid Losartan and Hydrochlorothiazide Aurobindo even during the first months of pregnancy (see also 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 or pharmacist before taking Losartan and Hydrochlorothiazide Aurobindo:

• if you have previously had skin cancer or if you 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 exposure to sunlight and UV radiation while taking Losartan and Hydrochlorothiazide Aurobindo.

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

• if you have previously experienced swelling of the face, lips, throat, or tongue;
• if you are taking diuretics;
• 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 your liver function is reduced (see section 2 “Do not take Losartan and Hydrochlorothiazide Aurobindo”);
• if you have narrowing of the renal arteries (renal artery stenosis), only one functioning kidney, or have recently received a kidney transplant;
• if you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
• if you have mitral valve stenosis or aortic 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 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 your dentist) or before surgery, or if you are about to undergo tests to evaluate 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 secretion of the hormone aldosterone 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; or aliskiren.

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 information under “Do not take Losartan and Hydrochlorothiazide Aurobindo”.
For athletes: Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
There is no experience regarding the use of Losartan and Hydrochlorothiazide Aurobindo in children.
Therefore, Losartan and Hydrochlorothiazide Aurobindo must not be given to children.
Other medicines and Losartan and Hydrochlorothiazide Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics such as hydrochlorothiazide contained in Losartan and Hydrochlorothiazide Aurobindo can interact with other medicines.
Lithium-containing preparations must not be taken with Losartan and Hydrochlorothiazide Aurobindo 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, certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).
It is also important for your doctor to know if you are taking:

• other medicines to lower blood pressure;
• steroids;
• cancer medicines;
• painkillers;
• medicines for fungal infections;
• medicines for arthritis;
• resins used for high cholesterol, such as cholestyramine;
• medicines to relax muscles;
• sleeping pills;
• opioids such as morphine;
• pressor amines such as adrenaline or similar medicines;
• oral antidiabetic agents or insulin;
• carbamazepine;
• calcium salts;
• antipsychotics, antidepressants;
• intravenous erythromycin, intravenous vincamine, halofantrine, pentamidine;
• mizolastine, terfenadine;
• cyclosporine;
• methyldopa;
• anticholinergic agents (e.g. atropine, biperiden);
• ACTH;
• glycyrrhizin (found in liquorice).

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 “Do not take Losartan and Hydrochlorothiazide Aurobindo” and “Warnings and precautions”).
Inform your doctor that you are taking Losartan and Hydrochlorothiazide Aurobindo, especially if you are scheduled to receive iodinated contrast agents.
Losartan and Hydrochlorothiazide Aurobindo with food, drinks, and alcohol
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and Hydrochlorothiazide Aurobindo tablets may enhance each other’s effects.
A diet particularly rich in salt may counteract the effect of Losartan and Hydrochlorothiazide Aurobindo tablets. Losartan and Hydrochlorothiazide Aurobindo tablets can be taken with or without food.
Pregnancy, breastfeeding, and fertility
Pregnancy
Inform your doctor if you think you may be pregnant (or if you might become pregnant). Your doctor will usually advise you to stop taking Losartan and Hydrochlorothiazide Aurobindo before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Losartan and Hydrochlorothiazide Aurobindo 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 unborn child if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and Hydrochlorothiazide Aurobindo 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 Aurobindo 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 attention (e.g. driving a car or operating dangerous machinery) until you know how you tolerate the medicine.
Losartan and Hydrochlorothiazide Aurobindo contains lactose
Losartan and Hydrochlorothiazide Aurobindo contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Losartan and Hydrochlorothiazide Aurobindo

Take Losartan and Hydrochlorothiazide Aurobindo exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide Aurobindo based on your condition and any other medications you may be taking. It is important to continue taking Losartan and Hydrochlorothiazide Aurobindo for the full duration prescribed by your doctor in order to maintain stable blood pressure control.
This medicine is available in three strengths: 50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg.
High blood pressure
The usual dose of Losartan and Hydrochlorothiazide Aurobindo for most patients with high blood pressure is 1 tablet of Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg once daily to maintain blood pressure control over 24 hours. The dose may be increased to 2 tablets of Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated tablets once daily or changed to 1 tablet of Losartan and Hydrochlorothiazide Aurobindo 100 mg/25 mg film-coated tablets (a higher strength) once daily. The maximum daily dose is 2 tablets of Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg film-coated tablets per day or 1 tablet per day of Losartan and Hydrochlorothiazide Aurobindo 100 mg/25 mg film-coated tablets.
The Losartan and Hydrochlorothiazide Aurobindo 100 mg/12.5 mg dosage is available for patients previously titrated to 100 mg of losartan who require additional blood pressure control.
If you take more Losartan and Hydrochlorothiazide Aurobindo than you should
In case of overdose, contact your doctor immediately to receive prompt medical treatment. Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood composition, and dehydration.
If you forget to take Losartan and Hydrochlorothiazide Aurobindo
Try to take Losartan and Hydrochlorothiazide Aurobindo once daily as prescribed. However, if you miss a dose, do not take a double dose. Resume your regular dosing schedule.
If you have any questions 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 gets them.
If you experience any of the following side effects, stop taking Losartan and Hydrochlorothiazide Aurobindo tablets and contact your doctor immediately or go to the nearest hospital Emergency Department:
Common (may affect up to 1 in 10 people):

• renal failure.

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

• reduction in the number of white blood cells, making infections more likely; problems with blood clotting and reduction in the number of platelets, causing an increased risk of bleeding or bruising;
• abnormal heartbeat, stroke (TIA, "mini-stroke"), heart attack;
• fluid in the lungs (causing difficulty breathing);
• inflammation of the pancreas which may cause abdominal and back pain;
• widespread skin rash with blisters and peeling of the skin over large areas of the body (toxic epidermal necrolysis).

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

• severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing). Immediate medical attention or hospitalization may be required;
• hepatitis (inflammation of the liver).

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

• unexplained muscle pain, with dark urine (tea-coloured) (rhabdomyolysis).

The following side effects have also been reported:
Common (may affect more than 1 in 10 people):

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus problems;
• 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 an abnormal heart rhythm), decreased haemoglobin levels;
• changes in kidney function;
• 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 feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and stomach pain), bruising;
• 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, dream abnormalities, sleep disturbances, insomnia, memory impairment;
• tingling sensation, pins and needles, pain in the extremities, tremor, migraine, fainting;
• blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, seeing things tinted yellow;
• sensation of hearing sound, ringing, buzzing or clicking noises in the ears, vertigo;
• low blood pressure, which may be associated with postural changes, feeling light-headed or weak when standing up, angina (chest pain), palpitations;
• inflammation of blood vessels, often associated with skin rash or bruising;
• sore throat, shortness of breath, bronchitis, pneumonia, nosebleeds, runny nose, congestion;
• constipation, difficulty passing stools, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of the salivary glands, toothache;
• jaundice (yellowing of the eyes and skin);
• urticaria, itching, skin inflammation, rash, skin redness, photosensitivity, dry skin, hot flushes, 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):

• changes in liver function tests.

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;
• altered taste (dysgeusia);
• skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan and Hydrochlorothiazide Aurobindo

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton/label. The expiry date refers to the last day of that month.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Losartan and Hydrochlorothiazide Aurobindo contains
The active substances are losartan potassium and hydrochlorothiazide.
Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as active substances.
Losartan and Hydrochlorothiazide Aurobindo 100 mg/12.5 mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as active substances.
Losartan and Hydrochlorothiazide Aurobindo 100 mg/25 mg contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as active substances.
The excipients are: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, anhydrous colloidal silica, magnesium stearate.
Tablet coating: hydroxypropylcellulose (E463), hypromellose 6cp (E464), titanium dioxide (E171), quinoline yellow aluminium lake (E104) [only in 50 mg/12.5 mg and 100 mg/25 mg tablets].

Description of the appearance of Losartan and Hydrochlorothiazide Aurobindo and contents of the pack
Film-coated tablets.
Losartan and Hydrochlorothiazide Aurobindo 50 mg/12.5 mg
Yellow, oval-shaped, bevelled-edge, biconvex, film-coated tablets, printed with 'E' on one side and '48' on the other side.
Losartan and Hydrochlorothiazide Aurobindo 100 mg/12.5 mg
White, oval-shaped, bevelled-edge, biconvex, film-coated tablets, printed with 'F' on one side and '74' on the other side.
Losartan and Hydrochlorothiazide Aurobindo 100 mg/25 mg
Yellow, oval-shaped, bevelled-edge, biconvex, film-coated tablets, printed with 'E' on one side and '49' on the other side.
Losartan and Hydrochlorothiazide Aurobindo is available in PVC/PE/PVDC-aluminum foil blister packs and in HDPE bottles.
Pack sizes:
Blister packs: 14, 28, 30, 50, 56, 60, 90, 98, 100, 280 and 500 film-coated tablets.
Bottle: 14, 30 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
France: LOSARTAN + HYDROCHLOROTHIAZIDE ARROW LAB 50 mg/12.5 mg, 100 mg/12.5 mg & 100 mg/25 mg, comprimé pelliculé
Germany: Losartan-Kalium/Hydrochlorothiazid Aurobindo 50 mg/12.5 mg, 100 mg/12.5 mg & 100 mg/25 mg Filmtabletten
Italy: Losartan e Idroclorotiazide Aurobindo
Netherlands: Kaliumlosartan/Hydrochlorothiazide Aurobindo 50/12.5 mg, 100/12.5 mg & 100/25 mg, filmomhulde tabletten
Portugal: Losartan + Hidroclorotiazida Aurobindo
United Kingdom: Losartan potassium/Hydrochlorothiazide 50 mg/12.5 mg, 100 mg/12.5 mg & 100 mg/25 mg film-coated tablets

This leaflet was last approved on