Losartan and hydrochlorothiazide Tecnigen

Package leaflet: Information for the user

Losartan and Hydrochlorothiazide TecniGen 50/12.5 mg film-coated tablets, 100/12.5 mg film-coated tablets

Losartan and Hydrochlorothiazide TecniGen 100/25 mg film-coated tablets
Generic medicine
Please read all of 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful. If you experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

Losartan and Hydrochlorothiazide TecniGen 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 results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, causing blood vessels to relax and thereby lowering blood pressure. Hydrochlorothiazide works by increasing the amount of water and salts excreted by the kidneys. This also helps reduce blood pressure.
Losartan and Hydrochlorothiazide TecniGen is indicated for the treatment of essential hypertension (high blood pressure).

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

Do not take Losartan and Hydrochlorothiazide TecniGen

• if you are allergic to losartan, hydrochlorothiazide, or 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 drugs 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 TecniGen should also be avoided during the first trimester of pregnancy – see section “Pregnancy”);
• if you have severe kidney dysfunction 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.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Losartan and Hydrochlorothiazide TecniGen.

• 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 TecniGen.

You should speak with your doctor if you are pregnant or think you might become pregnant. Losartan and Hydrochlorothiazide TecniGen 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 during this period (see section “Pregnancy”).
It is important that you speak with your doctor before taking Losartan and Hydrochlorothiazide TecniGen:

• if you have a history of facial swelling, swelling of the 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 had or currently have severe vomiting and/or diarrhea;
• if you have heart failure;
• if your liver function is impaired (see section 2 “Do not take Losartan and Hydrochlorothiazide TecniGen”);
• if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently received 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 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 receive an anesthetic (including 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 secretion of the hormone aldosterone by the adrenal gland due to glandular abnormality);
• 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;
• if you experience vision changes 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 TecniGen. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may have an increased risk of developing this condition.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.
See also information under the section "Do not take Losartan and Hydrochlorothiazide TecniGen".

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

Other medicines and Losartan and Hydrochlorothiazide TecniGen
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 TecniGen can interact with other medicines. Lithium-containing preparations must not be taken with Losartan and Hydrochlorothiazide TecniGen without close medical supervision. Special precautions (e.g., blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes, or 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 medications 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 drugs.

Inform your doctor that you are taking Losartan and Hydrochlorothiazide TecniGen if you are scheduled for a radiographic procedure involving iodinated contrast agents.
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 TecniGen" and "Warnings and precautions").

Losartan and Hydrochlorothiazide TecniGen with food, drinks, and alcohol
You are advised not to drink alcoholic beverages while taking the tablets: alcohol and Losartan and Hydrochlorothiazide TecniGen tablets may enhance each other's effects.
A diet particularly rich in salt may reduce the effectiveness of Losartan and Hydrochlorothiazide TecniGen tablets.
Losartan and Hydrochlorothiazide TecniGen can be taken with or without food.

Pregnancy, breastfeeding, and fertility
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 pregnant or could become pregnant. Your doctor will usually advise you to stop taking Losartan and Hydrochlorothiazide TecniGen before becoming pregnant or as soon as you know you are pregnant, and will prescribe an alternative medicine. Losartan and Hydrochlorothiazide TecniGen is not recommended during pregnancy and must not be taken after the third month, as it may cause serious harm to the baby if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan and Hydrochlorothiazide TecniGen is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you intend to breastfeed.

Use in elderly patients
Losartan and Hydrochlorothiazide TecniGen 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 TecniGen contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, talk to your doctor 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 TecniGen

Take this medicine exactly as your doctor or pharmacist has instructed you. If you have
any doubts, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan and Hydrochlorothiazide
TecniGen based on your condition and any other medicines you may be taking. It is important
to continue taking Losartan and Hydrochlorothiazide TecniGen for the entire duration prescribed by your doctor, as this
will help maintain consistent control of your high blood pressure.
High blood pressure
The recommended dose for most patients with high blood pressure is 1 tablet of Losartan and
Hydrochlorothiazide TecniGen 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 once
daily or adjusted to 1 tablet daily of Losartan/Hydrochlorothiazide 100 mg/25 mg (a higher
strength). The maximum daily dose is 2 tablets of Losartan/Hydrochlorothiazide 50 mg/12.5 mg per day or 1 tablet per day of Losartan/Hydrochlorothiazide 100 mg/25 mg.
The breakline on Losartan and Hydrochlorothiazide TecniGen 50 mg/12.5 mg tablets and on Losartan and
Hydrochlorothiazide TecniGen 100 mg/25 mg tablets is intended to facilitate breaking the tablet if you have
difficulty swallowing it whole, and is not intended for dividing the tablet into equal parts.
If you take more Losartan and Hydrochlorothiazide TecniGen 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 Losartan and Hydrochlorothiazide TecniGen
Try to take Losartan and Hydrochlorothiazide TecniGen once daily as prescribed. However, if
you miss a dose, do not take a double dose. Skip the missed tablet and take the next
tablet at the usual time on the following day.
For any further questions about the use of this medicine, please 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 TecniGen tablets and contact your doctor immediately or go to the nearest hospital Emergency Department:
A severe allergic reaction (redness, 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 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 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 haemoglobin levels.
Changes in kidney function including kidney 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 the 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 and 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 feeling like needles or pins, pain in the extremities, tremor, migraine, fainting,
Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things as yellow-coloured,
Sensation of hearing a sound, ringing, buzzing or clicking in the ears, dizziness,
Low blood pressure, which may be associated with changes in posture (feeling of 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, breathlessness, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties),
Nosebleeds, runny nose, congestion,
Constipation, obstipation, 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, light sensitivity, 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.

Not known (frequency cannot be estimated from the available data):
Flu-like symptoms,
Unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
Low sodium levels in the blood (hyponatraemia),
General feeling of being unwell (malaise),
Taste disturbances (dysgeusia),
Skin and lip cancer (non-melanoma skin cancer).
Reduced 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)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. 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 TecniGen

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.
Losartan and Hydrochlorothiazide TecniGen 50 mg/12.5 mg and Losartan and Hydrochlorothiazide TecniGen 100 mg/25 mg
Do not store above 30°C.
Losartan and Hydrochlorothiazide TecniGen 100 mg/12.5 mg
Do not store above 25°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. Pack contents and other information

What Losartan and Hydrochlorothiazide TecniGen contains
Losartan and Hydrochlorothiazide TecniGen 50 mg/12.5 mg

• The active substances are potassium losartan and hydrochlorothiazide. Each film-coated tablet contains 50 mg of potassium losartan and 12.5 mg of hydrochlorothiazide.
• The excipients are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (tablet core), and hypromellose, macrogol 400 and titanium dioxide (E171) (tablet coating).

Losartan and Hydrochlorothiazide TecniGen 100 mg/12.5 mg

• The active substances are potassium losartan and hydrochlorothiazide. Each film-coated tablet contains 100 mg of potassium losartan and 12.5 mg of hydrochlorothiazide.
• The excipients are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (tablet core), and hypromellose, macrogol 400 and titanium dioxide (E171) (tablet coating).

Losartan and Hydrochlorothiazide TecniGen 100 mg/25 mg

• The active substances are potassium losartan and hydrochlorothiazide. Each film-coated tablet contains 100 mg of potassium losartan and 25 mg of hydrochlorothiazide.
• The excipients are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (tablet core), and hypromellose, macrogol 400 and titanium dioxide (E171) (tablet coating).

Description of the appearance of Losartan and Hydrochlorothiazide TecniGen and pack contents
Losartan and Hydrochlorothiazide TecniGen 50 mg/12.5 mg is supplied as white, oblong, film-coated, scored tablets.
Losartan and Hydrochlorothiazide TecniGen 100 mg/12.5 mg is supplied as white, oblong, film-coated tablets.
Losartan and Hydrochlorothiazide TecniGen 100 mg/25 mg is supplied as white, oblong, film-coated, scored tablets.
Losartan and Hydrochlorothiazide TecniGen is available in the following pack sizes:
Losartan and Hydrochlorothiazide TecniGen 50 mg/12.5 mg – Boxes containing PVC/aluminum blisters in packs of 14, 28, 30 or 56 tablets.
Losartan and Hydrochlorothiazide TecniGen 100 mg/25 mg – Boxes containing PVC/aluminum blisters in packs of 14, 28, 30 or 56 tablets.
Losartan and Hydrochlorothiazide TecniGen 100 mg/12.5 mg – Boxes containing PVC/aluminum blisters in packs of 14, 28, 30 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
TECNIMEDE – Sociedade Técnico-Medicinal, S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra, Portugal

Supplier responsible for distribution
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Losartan and Hydrochlorothiazide TecniGen
Portugal: Losartan + Hidroclorotiazida Tecnigen