LOSARTAN MYLAN GENERICS

Package leaflet: Information for the patient

Losartan Mylan Generics 12.5 mg film-coated tablets, 50 mg film-coated tablets

Losartan potassium
Generic medicine
Please read this leaflet carefully before using 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 only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losartan Mylan Generics is and what it is used for

Losartan Mylan Generics contains the active substance losartan, which belongs to a family of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that binds to specific receptors in the 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 the blood vessels and a consequent reduction in blood pressure. Losartan slows the progression of renal insufficiency in hypertensive patients with type 2 diabetes.

Losartan Mylan Generics is used:

• for the treatment of patients with high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• to preserve kidney function in hypertensive patients with type 2 diabetes whose laboratory tests show impaired kidney function with proteinuria ≥ 0.5 g/day (a condition in which the urine contains an abnormally high amount of protein).
• for the treatment of patients with chronic heart failure when the doctor considers unsuitable a therapy based on specific medicines known as angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower blood pressure). If your heart failure has been stabilized with an ACE inhibitor, you should not switch to Losartan Mylan Generics.
• In patients with high blood pressure and left ventricular hypertrophy, treatment with Losartan Mylan Generics has been shown to reduce the risk of heart attack (Study “LIFE Indication”).

2. What you should know before taking Losartan Mylan Generics

Do not take Losartan Mylan Generics:

• if you are allergic (hypersensitive) to losartan or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe impairment of liver function
• if you are more than 3 months pregnant (Losartan Mylan Generics should also be avoided in early pregnancy – see section “Pregnancy”)
• 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 Mylan Generics:

• if you have previously experienced episodes of angioedema (swelling of the face, lips, throat and/or tongue) (see also section “Possible side effects”);
• if you have had excessive vomiting or diarrhoea leading to significant fluid and/or salt loss from your body;
• if you are being treated with diuretics (medicines that increase the amount of fluid eliminated through the kidneys) or are on a low-salt diet causing substantial fluid and salt loss (see section 3 “Dosage in specific patient groups”);
• if you know you have narrowing or blockage of the blood vessels to the kidneys or have recently undergone a kidney transplant;
• if you have impaired liver function (see sections 2 “Do not take Losartan Mylan Generics” and 3 “Dosage in specific patient groups”);
• if you have 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 or heart muscle disorders;
• if you suffer from coronary (caused by reduced blood flow in the heart’s blood vessels) 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 structural abnormalities of 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 monitor your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals.
See also the section “Do not take Losartan Mylan Generics”.
You must inform your doctor if you think you are pregnant (or could become pregnant). Losartan Mylan Generics is not recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause severe harm to your unborn baby when used at this stage (see section on pregnancy).

Children and adolescents
Losartan has been studied in children. For further information, consult your doctor. Losartan Mylan Generics is not recommended in children with kidney or liver problems, as data in this patient group are limited.
Losartan Mylan Generics is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.

Other medicines and Losartan Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise particular caution if you are taking the following medicines while being treated with Losartan Mylan Generics:

• other antihypertensive medicines, as these may further lower 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-containing supplements or 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 antihypertensive effect of losartan.

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 sections “Do not take Losartan Mylan Generics” 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 must not be taken in combination with losartan without close monitoring by your doctor. Appropriate precautionary measures may be required (e.g. blood tests).

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will advise you to stop taking Losartan Mylan Generics before starting pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Losartan Mylan Generics is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to your unborn baby if used beyond the first trimester.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Losartan Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
No studies have been conducted on the effects on the ability to drive or operate machinery. It is unlikely that Losartan Mylan Generics affects this ability. However, like many other medicines used to treat hypertension, Losartan Mylan Generics may cause dizziness or drowsiness in some individuals.
If you experience dizziness or drowsiness, consult your doctor before engaging in such activities.
Inform your doctor before performing these activities.

Losartan Mylan Generics contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to use Losartan Mylan Generics

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Mylan Generics based on your condition and any other
medicines you may be taking. It is important to continue taking Losartan Mylan Generics for the
period prescribed by your doctor in order to maintain easy control of your blood pressure.
Adult patients with high blood pressure
The usual starting dose is 50 mg of losartan once daily (one tablet of Losartan Mylan
Generics 50 mg). The maximum effect on blood pressure will be achieved within 3–6 weeks after starting
treatment. In some patients, the dose may later be increased up to 100 mg of losartan (two
tablets of Losartan Mylan Generics 50 mg) once daily.
If you feel that the effect of this medicine is too strong or too weak, discuss it with your
doctor or pharmacist.
Use in children and adolescents
Children under 6 years of age
Use of Losartan Mylan Generics is not recommended in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Children between 6 and 18 years of age
The recommended starting dose of losartan in patients weighing between 20 and 50 kg is 25 mg
once daily (up to a maximum of 50 mg of losartan once daily). Your doctor may increase
the dose if blood pressure is not controlled.
Other formulations of this medicine may be more suitable for use in children; please consult your
doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
The usual starting dose is 50 mg of losartan once daily (one tablet of Losartan Mylan
Generics 50 mg). The dose may later be increased up to 100 mg of losartan (two tablets of
Losartan Mylan Generics 50 mg) once daily, depending on the response of blood pressure.
Losartan Mylan Generics may be administered together with other antihypertensive medicines (e.g.
diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents), as well as
with insulin and other medicines commonly used to lower blood glucose levels (e.g.
sulfonylureas, glitazones, and glucosidase inhibitors).
Adult patients with heart failure
The starting dose is 12.5 mg of losartan (one tablet of Losartan Mylan Generics 12.5 mg) once daily.
Typically, the dose is increased weekly in steps (i.e. 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) until the maintenance dose established by the doctor is reached. A maximum dose of 150 mg of losartan (for example,
three tablets of Losartan Mylan Generics 50 mg) once daily may be used.
In the treatment of heart failure, losartan is usually administered in combination with a
diuretic (a medicine that increases the amount of fluid excreted by the kidneys) and/or digitalis
(a medicine that makes the heart stronger and more efficient) and/or a beta-blocker.
Dosing in specific patient groups
Your doctor may recommend a lower dose, especially at the beginning of 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 Mylan Generics”).
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 Mylan Generics unless your doctor tells you otherwise.
Losartan may be taken with or without food.
If you take more Losartan Mylan Generics than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor immediately. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.
If you forget to take Losartan Mylan Generics
If you accidentally miss your daily dose, take the next dose as usual. Do not take a double
dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following side effects, stop taking the tablets and immediately contact your doctor,
or go immediately to the nearest hospital emergency department:

• skin rash, itching, swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing. These may be signs of a severe allergic reaction, including angioedema. This is
• a serious side effect, although rare, which may affect up to 1 in 1,000 people.
• unexplained muscle pain with dark urine (tea-coloured). These may be signs of muscle problems (rhabdomyolysis). This is a serious side effect, but its frequency is unknown (cannot be estimated from the available data).

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

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

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

• drowsiness
• headache
• sleep disorders
• sensation of increased heart rate (palpitations)
• a feeling of tightness in the chest or severe chest pain (angina pectoris)
• shortness of breath (dyspnoea)
• cough
• abdominal pain
• constipation
• diarrhoea
• nausea
• vomiting
• urticaria
• itching (pruritus)
• skin rashes
• localized swelling (oedema)

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

• hypersensitivity
• inflammation of blood vessels (vasculitis, including Henoch-Schönlein purpura)
• sensation of numbness or tingling (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (atrial fibrillation)
• cerebral ischaemia (stroke)
• inflammation of the liver (hepatitis), which may cause yellowing of the skin and eyes (jaundice)
• elevated levels of alanine aminotransferase (ALT) in the blood, usually reversible after discontinuation of treatment.

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

• reduction in the number of platelets
• ringing in the ears (tinnitus)
• abnormalities in liver function
• increased sensitivity to sunlight (photosensitivity)
• migraine
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis)
• altered taste
• erectile dysfunction, impotence
• depression
• inflammation of the pancreas (pancreatitis) causing severe abdominal pain
• muscle and joint pain
• low sodium levels in the blood (hyponatraemia), which can be detected by blood tests
• flu-like symptoms
• feeling of general malaise (malaise)
• back pain and urinary tract infection. The 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, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.
Store in the original packaging.
Do not open the blister pack until it is time to take the medicine.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Losartan Mylan Generics contains
The active substance is potassium losartan.
Each tablet contains either 12.5 mg or 50 mg of potassium losartan, equivalent to 11.44 mg or 45.76 mg of losartan.
The other components are monohydrate lactose (see section 2 "Losartan Mylan Generics contains lactose"), pregelatinized starch, microcrystalline cellulose, magnesium stearate. The coating includes hydroxypropylcellulose, hypromellose, titanium dioxide [E171], and Brilliant Blue FCF aluminium lake [E133] (only in the 12.5 mg tablets).

Description of the appearance of Losartan Mylan Generics and package contents
The film-coated tablets are round in shape.
The 12.5 mg tablets are blue.
The 50 mg tablets are white.
Losartan Mylan Generics is available in blisters containing 7, 10, 14, 20, 21, 28, 28 (calendar pack), 30, 50x1, 56, 60, 84, 90, 98, 98 (calendar pack), 100, 210, 250, 280, 500 tablets.
HDPE bottles containing 100 and 250* tablets.
*Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A
Via Vittor Pisani, 20
20124 Milan
(Italy)

Manufacturers responsible for batch release
Liconsa
Avenida Miralcampo n. 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

McDermott Laboratories t/a Gerard Laboratories
Industrial Estate, Grange Road, Dublin 13
Ireland

This medicinal product is authorized in the European Economic Area countries under the following names:
Belgium LosartanMylan 12.5mg, 25mg, 50mg and 100mg film-coated tablets
Italy LosartanMylanGenerics 12.5 mg and 50mg
Czech Republic Losagen 25mg and 50mg
Sweden Losartan Mylan 12.5mg, 25mg, 50mg and 100mg