Package leaflet: Information for the user

Losartan Teva 25, 50 and 100 mg film-coated tablets

Losartan potassium
Generic medicine
Please read all of this leaflet carefully before you start 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 or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

1. What Losartan Teva 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 them to narrow. This leads to increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of blood vessels and a consequent lowering of blood pressure.

Losartan Teva is used:

to treat patients with high blood pressure (hypertension) in adults and in children and adolescents aged between 6 and 18 years.
to protect the kidneys in hypertensive patients with type 2 diabetes who have impaired kidney function, as shown by laboratory tests, and with proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein).
to treat chronic heart failure in adults, when treatment with specific medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to lower high blood pressure) is not considered appropriate by the doctor. If heart failure has been stabilised with an ACE inhibitor, you must not switch to treatment with losartan.
in patients with high blood pressure and left ventricular hypertrophy, Losartan Teva has been shown to be effective in reducing the risk of stroke (LIFE study).

2. What you need to know before taking Losartan Teva

Do not take Losartan Teva

if you are allergic 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 three months pregnant. (It is advisable to avoid Losartan Teva even in the early stages of pregnancy – see section 2: Pregnancy and breastfeeding),
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 Teva.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant).
Losartan Teva is not recommended during early 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 during this period (see section 2: Pregnancy and breastfeeding).
Before taking Losartan Teva, it is important that you inform your doctor:

if you have a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see section 4: 'Possible side effects'),
if you have excessive vomiting or diarrhoea causing significant loss of body fluids and/or salts,
if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet causing significant loss of body fluids and salts (see section 3: 'Dosage in particular patient groups'),
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 Teva" and 3 'Dosage in particular 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 taking 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 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 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 need to check your kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium) at regular intervals.
See also the information in the section "Do not take Losartan Teva".
Children and adolescents
Losartan Teva has been studied in children. For further information, consult your doctor.
Losartan Teva is not recommended for use in children with kidney or liver problems, as data are limited in these patient groups.
Losartan Teva is not recommended for use in children under 6 years of age, as efficacy has not been demonstrated in this age group.
Other medicines and Losartan Teva
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 being treated with Losartan Teva:

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,
your doctor may consider it necessary to adjust the dose and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also information in the sections: "Do not take Losartan Teva" and "Warnings and precautions"),
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. If your kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.

Medicines containing lithium should not be taken concomitantly with losartan without close medical monitoring. Appropriate precautionary measures (e.g. blood tests) may be required.
Losartan Teva with food and drink
Losartan Teva can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning 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 may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan Teva before starting pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartan Teva is not recommended during early 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.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Losartan Teva is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
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 Teva has any effect on 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, consult your doctor before engaging in these activities.
Losartan Teva contains lactose monohydrate
Losartan Teva contains lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.

3. How to take Losartan Teva

Your doctor will decide the appropriate dosage of Losartan Teva based on your condition and any other
medicines you may be taking. It is important to continue taking Losartan Teva for the entire duration
prescribed by your doctor, as this will help maintain stable blood pressure control. Take this medicine
exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adult patients with high blood pressure
Treatment usually starts with 50 mg of losartan (one tablet of Losartan Teva 50 mg) once daily. The
maximum effect in lowering blood pressure is achieved 3 to 6 weeks after starting treatment. In some
patients, the dose may later be increased to 100 mg of losartan (two tablets of Losartan Teva 50 mg or
one tablet of Losartan Teva 100 mg) once daily.
If you feel that the effect of losartan is too strong or too weak, contact your doctor or pharmacist.
Adult patients with high blood pressure and type 2 diabetes
The usual starting dose is 50 mg once daily (one 50 mg tablet). The dose may later be increased to
100 mg of losartan once daily (two tablets of Losartan Teva 50 mg or one tablet of Losartan Teva
100 mg), depending on the response in terms of arterial pressure.
Losartan Teva may be administered concomitantly with other antihypertensive agents (e.g. diuretics,
calcium channel blockers, α- or β-blockers, and centrally acting agents), as well as with insulin and
other agents commonly used to reduce blood glucose levels (e.g. sulfonylureas, glitazones, and
glucosidase inhibitors).
Adult patients with heart failure
The recommended initial dose is 12.5 mg of losartan once daily.
Generally, the dose should be gradually increased each week (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.
A maximum dose of 150 mg of losartan (e.g., three tablets of Losartan Teva 50 mg or one tablet each
of Losartan Teva 100 mg and Losartan Teva 50 mg) once daily may be used.
In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases
the amount of water passing through the kidneys) and/or digitalis (a medicine that helps make the heart
stronger and more efficient) and/or a beta-blocker.
Dosage in specific patient groups
Your doctor may recommend a lower dose, especially when starting treatment in certain patients such
as those treated with 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 impairment of liver function
(see section 2: "Do not take Losartan Teva").
Use in children and adolescents
Children under 6 years of age
Losartan Teva film-coated tablets are not recommended for use in children under 6 years of age, as
effectiveness has not been demonstrated in this age group.
Children from 6 to 18 years of age
The recommended initial dose in patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg
of body weight, taken once daily (up to 25 mg of Losartan Teva film-coated tablets). Your doctor may
increase the dose if blood pressure is not controlled.
Other formulations of this medicine may be more suitable for children; please consult your doctor or
pharmacist.
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 Teva
unless your doctor tells you otherwise.
If you take more Losartan Teva than you should
If you accidentally take too many tablets, or if a child takes any, contact your doctor immediately.
Symptoms of overdose may include low blood pressure, increased heart rate, or possibly decreased
heart rate.
If you forget to take Losartan Teva
If you accidentally miss a daily dose, take the next tablet at the usual time the following day. Do not
take a double dose to make up for the missed tablet. If you have any questions about how to use this
product, consult your doctor or pharmacist.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking losartan tablets and contact your doctor immediately or go to the nearest hospital emergency department.
A severe allergic reaction (skin 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 hospitalization.

The following side effects have been reported with Losartan Teva 25, 50, and 100 mg film-coated tablets:

Common (may affect up to 1 in 10 people):

dizziness
vertigo
low blood pressure (especially following excessive loss of fluid from the blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics)
dose-related orthostatic effects such as low blood pressure occurring when rising 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
reduced number of red blood cells (anaemia)
increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

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

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

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

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.

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

reduced number of platelets
migraine
changes in taste sensation
ringing, buzzing, roaring or clicking in the ears (tinnitus)
depression
general feeling of being unwell (malaise)
abnormal liver function
muscle and joint pain
unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis)
increased sensitivity to sunlight (photosensitisation)
impotence
inflammation of the pancreas (pancreatitis)
low sodium levels in the blood (hyponatraemia)
flu-like symptoms
back pain
urinary tract infection.

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.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store Losartan Teva

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 that 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 Teva Contains

Each film-coated tablet contains 25, 50, or 100 mg of the active substance, potassium losartan.
The excipients are:
Tablet core: monohydrate lactose, microcrystalline cellulose (E 460a), pregelatinized starch, magnesium stearate (E 572)
Film coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E 171), macrogol, talc.

Description of the Appearance of Losartan Teva and Package Contents
Losartan Teva 25 mg film-coated tablets are white, oval, slightly biconvex, film-coated tablets,
imprinted with “2”, a break line, and “5” on one side, and a break line on the other side.
Losartan Teva 50 mg film-coated tablets are white, oval, slightly biconvex,
film-coated tablets, imprinted with “50” on one side and a break line on the other side.
Losartan Teva 100 mg film-coated tablets are white, oval, slightly
biconvex, film-coated tablets, imprinted with “100” on one side and a break line on the other side.
The tablets are packaged in opaque white blisters made of PVC/PVdC/Al or in opaque white blisters made of PVC/PE/PVdC/Al or in blisters made of OPA/Alu/PVC/Al
and
HDPE bottles with tamper-evident closure made of polyethylene or tamper-evident/easy-open closure for elderly patients with desiccant insert.

Pack sizes:
Losartan Teva 25 mg film-coated tablets: 1, 14, 20, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets. Hospital packs of 50 (50 x 1) film-coated tablets and HDPE bottles with tamper-evident closure made of polypropylene with desiccant insert: 30, 100 and 250 film-coated tablets.
Losartan Teva 50 mg film-coated tablets: 1, 14, 20, 28, 30, 56, 60, 90, 98, 100, 105 and 120 film-coated tablets. Hospital packs of 50 (50 x 1) and 280 (10 x 28) film-coated tablets and HDPE bottles with tamper-evident closure made of polypropylene with desiccant insert: 30, 100 and 250 film-coated tablets.
Losartan Teva 100 mg film-coated tablets: 1, 14, 20, 28, 30, 56, 60, 90, 98, 100, 105 and 120 film-coated tablets. Hospital packs of 50 (50 x 1) and 280 (10 x 28) film-coated tablets and HDPE bottles with tamper-evident closure made of polypropylene with desiccant insert: 30, 100 and 250 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy
Manufacturers

Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park - BN 22 9AG Eastbourne - East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 - P.O. Box 552 - 2003 RN Haarlem (The Netherlands)