Losartan Tecnigen

Package leaflet: Information for the user

LOSARTAN TECNIGEN 50 mg film-coated tablets, 100 mg film-coated tablets

Losartan potassium
Generic medicine
The name of this medicine is Losartan TecniGen 50 mg film-coated tablets or Losartan TecniGen
100 mg film-coated tablets. In the remainder of this leaflet, they will be referred to collectively as Losartan TecniGen.
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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to others. This medicine may be harmful to others, even if their symptoms are the same as yours.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

Losartan belongs to a group of medicines known as angiotensin II receptor antagonists. 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 a consequent reduction in blood pressure. Losartan slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.

Losartan TecniGen is used:

• to treat high blood pressure (hypertension) in adult patients and in adolescents aged 6 to 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory tests showing impaired kidney function and proteinuria greater than or equal to 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
• to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not considered appropriate by the physician. If your heart failure has been stabilized with ACE-inhibitor therapy, you should not be switched to losartan.
• in patients with high blood pressure and thickening of the walls of the left ventricle, Losartan TecniGen has been shown to reduce the risk of stroke (“LIFE study indication”).

2. What you should know before taking Losartan TecniGen

Do not take Losartan TecniGen

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (It is also advisable to avoid taking Losartan TecniGen during the early months of pregnancy – see Pregnancy)
• if you have severe impairment of liver function
• 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 TecniGen.
You must inform your doctor if you think you are (or might become) pregnant. Losartan TecniGen is not recommended during the early months of 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 on Pregnancy).
Before taking Losartan TecniGen, it is important that you tell your doctor:

• if you have a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 “Possible side effects”)
• if you are experiencing excessive vomiting or diarrhoea, leading to significant fluid and/or salt loss from the body
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet causing substantial fluid and salt loss (see section 3 “Dosage in specific patient populations”)
• if you know you have narrowing or blockage of the blood vessels supplying the kidneys, or if you have recently undergone a kidney transplant
• if you have impaired liver function (see sections 2 “Do not take Losartan” and 3 “Dosage in specific patient populations”)
• if you suffer from heart failure, with or without impaired kidney function, or life-threatening cardiac arrhythmias. Special caution is required if you are also being treated with a beta-blocker
• if you have heart valve problems or heart muscle disease
• if you suffer from coronary heart disease (caused by reduced blood flow in the blood vessels of the heart) or cerebrovascular disease (caused by reduced blood circulation in the brain)
• if you have primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to an abnormality within the gland)
• 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

Your doctor may periodically check your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also the section "Do not take Losartan TecniGen".

Children and adolescents
Losartan TecniGen has been studied in children. For further information, please consult your doctor.
Losartan TecniGen is not recommended in children with kidney or liver problems, or in children under 6 years of age, as available data in these patient groups are limited.

Other medicines and Losartan TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention if you are taking the following medicines while on treatment with Losartan TecniGen:

• other medicines to lower blood pressure, as they may further reduce your blood pressure. Blood pressure may also be lowered by any of the following medicines/classes of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine
• medicines that retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes, or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin)
• non-steroidal anti-inflammatory drugs such as indometacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan.

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 the sections: "Do not take Losartan TecniGen" and "Warnings and precautions").
If your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.
Lithium-containing medicines should not be taken in combination with losartan without close medical monitoring. Appropriate precautionary measures (e.g. blood tests) may be required.

Losartan TecniGen with food and drink
Losartan TecniGen can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Losartan TecniGen before you become pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Losartan TecniGen is not recommended during the early months of pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if used beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan TecniGen is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed. This is especially important if your baby is a newborn or a premature infant.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed. It is unlikely that Losartan TecniGen affects the ability to drive and use machines. However, as with other medicines that lower blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you must consult your doctor before engaging in these activities.

Losartan TecniGen contains monohydrate lactose. If your doctor has informed you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.

3. How to take Losartan TecniGen

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dosage of Losartan TecniGen based on your condition and any other medicines you are taking. It is important to continue taking Losartan TecniGen for the entire duration prescribed by your doctor, as this will help maintain stable blood pressure control.

Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (one tablet of Losartan TecniGen 50 mg) once daily. The maximum blood pressure-lowering effect is achieved 3–6 weeks after starting treatment. In some patients, the dosage may later be increased to 100 mg of losartan (two tablets of Losartan TecniGen 50 mg) or one tablet of Losartan TecniGen 100 mg once daily.
If you feel that the effect of losartan is too strong or too weak, contact your doctor or pharmacist.

Use in children and adolescents
Children under 6 years
Losartan TecniGen is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Children and adolescents aged 6 to 18 years
The recommended initial dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, taken once daily (up to a maximum of 25 mg of losartan). Your doctor may increase the dose if blood pressure is not adequately controlled.

Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg of losartan (one tablet of Losartan TecniGen 50 mg) once daily. The dosage may later be increased to 100 mg of losartan (two tablets of Losartan TecniGen 50 mg or one tablet of Losartan TecniGen 100 mg) once daily, depending on the blood pressure response to therapy.

Losartan tablets may be administered together with other antihypertensive medicines (e.g. diuretics, calcium antagonists, alpha or beta blockers, and centrally acting agents), as well as with insulin and other commonly used glucose-lowering medicines (e.g. sulfonylureas, glitazones, and alpha-glucosidase inhibitors).

Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan (one tablet of Losartan TecniGen 12.5 mg) once daily. The dose should be gradually increased on a weekly basis (e.g. 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, 100 mg daily during the fourth week, 150 mg daily during the fifth week), up to the maintenance dose established by your doctor. The maximum daily dose of losartan may be 150 mg (e.g. three tablets of Losartan 50 mg, or one tablet of Losartan TecniGen 100 mg and one tablet of Losartan TecniGen 50 mg) once daily.

In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases fluid excretion through the kidneys) and/or digitalis (a medicine that helps make the heart stronger and more efficient) and/or beta blockers.

Dosage in specific patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients, such as those receiving high-dose diuretics, patients with impaired liver function, or patients over 75 years of age. The use of losartan is not recommended in patients with severe hepatic impairment (see section “Do not take Losartan”).

Administration
The tablets should be swallowed with a glass of water. Try to take your daily dose at the same time each day. It is important to continue taking Losartan TecniGen unless your doctor tells you otherwise.

If you take more Losartan TecniGen than you should
If you accidentally take too many tablets, contact your doctor immediately. Symptoms of overdose may include low blood pressure, increased heart rate, and possibly decreased heart rate.

If you forget to take Losartan TecniGen
If you accidentally miss a dose, take the next tablet at your usual time the following day. Do not take a double dose to make up for the missed tablet.

If you have any questions about the use of 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 any of the following side effects, stop taking losartan tablets and consult 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 in swallowing or breathing).
This is a serious but rare side effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical treatment or hospitalisation.

The following side effects have been reported with losartan:

Common (may affect from 1 to 10 patients):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the bloodstream, e.g. in patients with severe heart failure or those treated with high doses of diuretics),
• dose-related orthostatic effects such as drop in blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• changes in kidney function, including kidney failure,
• reduction in the number of red blood cells (anaemia),
• increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

Uncommon (may affect from 1 to 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching,
• rash,
• localized swelling (oedema),
• cough.

Rare (may affect from 1 to 1,000 patients):

• hypersensitivity,
• angioedema,
• inflammation of blood vessels (vasculitis including Henoch–Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation),
• stroke (cerebrovascular accident),
• inflammation of the liver (hepatitis),
• elevated levels of alanine aminotransferase (ALT) in the blood, usually reversible upon discontinuation of treatment.

Frequency not known (cannot be estimated from the available data):

• reduction in the number of platelets,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• flu-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• perception of sounds, ringing, buzzing, crackling or other noises in the ears (tinnitus),
• altered taste (dysgeusia).

Side effects in children are similar to those observed in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Losartan 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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Losartan TecniGen contains
Losartan TecniGen 50 mg
The active substance is losartan potassium.
Each tablet contains 50 mg of losartan potassium.
The excipients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (tablet core), and hypromellose, macrogol 400 and titanium dioxide (E171) (tablet coating).
Losartan TecniGen 50 mg contains 4.24 mg (0.108 mEq) of potassium.

Losartan TecniGen 100 mg
The active substance is losartan potassium.
Each tablet contains 100 mg of losartan potassium.
The excipients are: microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose (tablet core), and hypromellose, macrogol 400 and titanium dioxide (E171) (tablet coating).
Losartan TecniGen 100 mg contains 8.48 mg (0.216 mEq) of potassium.

Description of the appearance of Losartan TecniGen and package contents
Losartan TecniGen 50 mg film-coated tablets are supplied as white, elongated, scored film-coated tablets containing 50 mg of losartan potassium.
Losartan TecniGen 100 mg film-coated tablets are supplied as white, elongated, scored film-coated tablets containing 100 mg of losartan potassium.

Losartan TecniGen is available in the following pack sizes:
• Losartan TecniGen 50 mg – Cartons containing PVC/Aluminium blisters with 14, 28 or 56 film-coated tablets.
• Losartan TecniGen 100 mg – Cartons containing PVC/Aluminium blisters with 14, 28 or 56 film-coated 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

Selling Licensee
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI), Italy

Manufacturer
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700-486 Amadora, Portugal
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 countries under the following names:
Italy – Losartan TecniGen
Portugal – Losartan Tecnigen