Lastan

PACKAGE LEAFLET

LASTAN 12.5 mg film-coated tablets, 25 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Losartan potassium
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information.

• 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 personally. Never give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, inform your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

What is in this leaflet

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

1. WHAT LASTAN 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 the blood vessels,
causing them to narrow. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, allowing blood vessels to relax, thereby lowering blood pressure.
LASTAN is used:

• to treat patients with high blood pressure (hypertension) in adults, children and adolescents aged 6–18 years.
• to treat patients with chronic heart failure when treatment with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, medicines used to lower blood pressure) is not considered adequate by your doctor. If your heart failure has been stabilized with an ACE inhibitor, you should not switch to losartan. The losartan contained in LASTAN is also authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor or pharmacist if you have any further questions.

2. WHAT YOU NEED TO KNOW BEFORE TAKING LASTAN

DO NOT take LASTAN

• if you are allergic to losartan or to any of the excipients of this medicine (listed in section 6),
• if you are more than 3 months pregnant (it is better to avoid taking LASTAN even in early pregnancy - see the section on pregnancy),
• if you have severely impaired kidney function,
• if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Tell your doctor or pharmacist before taking LASTAN
Inform your doctor if you think you may be pregnant (or could become pregnant). LASTAN is not recommended during early
pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the
unborn baby if used at this stage (see the section on pregnancy).
Before taking LASTAN, 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 also section 4 "Possible side effects"),
• if you are experiencing excessive vomiting or diarrhoea leading to severe fluid and/or salt loss from your body,
• if you are taking diuretics (medicines that increase the amount of water excreted through the kidneys) or are on a low-salt diet, which may lead to severe fluid and salt loss from your body (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 kidney function (see sections 2 “Do not take LASTAN” and 3 “Dosage in specific patient populations”),
• if you have heart failure without renal impairment or severe life-threatening cardiac arrhythmias. Particular caution is required when concomitantly treated with a ß-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 monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading "Do not take LASTAN".
Children and Adolescents
LASTAN has been studied in children. For further information, please discuss with your doctor.
LASTAN is not recommended for use in children with kidney or liver problems, or in children under 6 years of age, due to limited available data in these patient groups.
Other medicines and LASTAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
During treatment with LASTAN, be particularly careful if you are taking any of the following medicines:

• other medicines that lower blood pressure, as they may further reduce your blood pressure. Blood pressure may also be lowered by any of the following drugs/classes of drugs: 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.

If you have impaired kidney function, concomitant use of these medicines may lead to worsening of kidney
function.
Lithium-containing medicines should not be taken together with losartan without close medical supervision. Appropriate precautionary measures may be required (e.g. blood tests).
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 information under "Do not take LASTAN" and "Warnings and Precautions").

LASTAN with food and drink
LASTAN can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must inform your doctor if you think you may be (or could become) pregnant. Normally, your doctor will
advise you to stop taking LASTAN before becoming pregnant or as soon as pregnancy is detected, and will
recommend an alternative medicine to LASTAN. LASTAN is not recommended during early 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.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. LASTAN is not recommended for
women who are breast-feeding, and if you wish to breast-feed, particularly if your baby is a newborn or was born prematurely, your doctor may choose an alternative treatment for you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies on the effects on the ability to drive or use machines have been performed.
It is unlikely that LASTAN will affect your ability to drive or use machines. However, as with other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, consult your doctor before engaging in such activities.
LASTAN contains lactose
LASTAN contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain
sugars, talk to your doctor before taking this medicine.

3. HOW TO TAKE LASTAN

Always take LASTAN exactly as directed by your doctor or pharmacist. Check with your
doctor or pharmacist if you are unsure.
Your doctor will decide the appropriate dose of LASTAN based on your condition and other medications you
are taking. It is important to continue taking LASTAN for the entire duration prescribed by your doctor to
maintain consistent blood pressure control.

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

Use in children and adolescents
Children under 6 years of age
LASTAN 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
In patients weighing between 20 and 50 kg, an initial dose of 0.7 mg of losartan per kg of body weight is recommended, given once daily (up to a maximum of 25 mg of LASTAN).
If blood pressure is not adequately controlled, your doctor may increase the dose.
Other formulations containing losartan may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with heart failure
Treatment usually starts with 12.5 mg of losartan (one tablet of LASTAN 12.5 mg) once daily.
Generally, 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 a maintenance dose as determined by your doctor. A maximum dose of 150 mg of losartan may be used once daily (for example, three 50 mg tablets of LASTAN, or one 100 mg tablet and one 50 mg tablet of LASTAN).
In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases the amount of water removed by the kidneys), and/or digitalis (a medicine that helps make the heart stronger and more efficient), and/or a beta-blocker.

Dosing 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 hepatic impairment, 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 LASTAN”).

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

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

If you forget to take LASTAN
If you accidentally miss a daily dose, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience any of the following effects, stop taking losartan tablets immediately and contact your doctor or go to the nearest emergency room:
a severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty breathing or swallowing). This is a serious but rare side effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. Medical assistance or hospitalization may be required.

The following side effects have been reported with LASTAN:

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

• dizziness,
• low blood pressure (particularly following excessive loss of fluid from blood vessels, e.g. in patients with severe heart failure or receiving high doses of diuretics),
• dose-dependent orthostatic effects such as drop in blood pressure upon standing up from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar (hypoglycaemia),
• high potassium levels in blood (hyperkalaemia),
• changes in kidney function including kidney failure,
• reduced number of red blood cells (anaemia),
• increased levels of urea, serum creatinine and serum potassium 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),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• skin rash,
• localized swelling (oedema),
• cough.

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

• 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 blood, usually reversible upon discontinuation of treatment.

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

• reduced platelet count,
• migraine,
• changes in liver function,
• muscle and joint pain,
• flu-like symptoms,
• back pain,
• urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-colored) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in blood (hyponatraemia),
• depression,
• general feeling of being unwell (malaise),
• ringing, buzzing, pulsating sounds in the ears (tinnitus),
• taste disturbances (dysgeusia).

Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist. This includes any side effect not listed in this leaflet. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.
Side effects in children are similar to those seen in adults.
If any of the side effects worsens, or if you notice a new side effect not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE LASTAN

Keep LASTAN out of the sight and reach of children.
Do not use LASTAN after the expiry date stated on the carton. The expiry date refers to the last day of the month.
This medicinal product 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. PACK CONTENTS AND OTHER INFORMATION

What LASTAN contains:
The active substance is Losartan potassium.
Each LASTAN 12.5 mg tablet contains 12.5 mg of losartan potassium.
Each LASTAN 25 mg tablet contains 25 mg of losartan potassium.
Each LASTAN 50 mg tablet contains 50 mg of losartan potassium.
Each LASTAN 100 mg tablet contains 100 mg of losartan potassium.
The other ingredients are microcrystalline cellulose (E460), monohydrate lactose, pregelatinized corn starch, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol, indigo carmine aluminum lake (E132) (only in LASTAN 25 mg film-coated tablets).
LASTAN 12.5 mg contains potassium in the following amounts: 1.1 mg (0.028 mEq)
LASTAN 25 mg contains potassium in the following amounts: 2.1 mg (0.053 mEq)
LASTAN 50 mg contains potassium in the following amounts: 4.24 mg (0.108 mEq)
LASTAN 100 mg contains potassium in the following amounts: 8.48 mg (0.215 mEq)

Description of the appearance of LASTAN and pack contents:
LASTAN 12.5 mg: white, round, film-coated tablets.
LASTAN 12.5 mg is supplied in the following pack sizes:
blister packs containing 7, 10, 14, 21, 28, 30, 50, 56, or 98 white, round, film-coated tablets.

LASTAN 25 mg tablets: blue, round, film-coated tablets, marked on one side. The tablets can be divided into two equal halves.
LASTAN 25 mg is supplied in the following pack sizes:
blister packs containing 7, 10, 14, 28, 30, 50, 56, or 98 blue, round, film-coated tablets, marked on one side.

LASTAN 50 mg tablets: white, round, film-coated tablets, marked on one side. The tablets can be divided into two equal halves.
LASTAN 50 mg is supplied in the following pack sizes:
blister packs containing 7, 10, 14, 28, 30, 50, 56, or 98 white, round, film-coated tablets, marked on one side.

LASTAN 100 mg tablets: white, oval, film-coated tablets, marked on one side. The tablets can be divided into two equal halves.
LASTAN 100 mg is supplied in the following pack sizes:
blister packs containing 7, 10, 14, 28, 30, 50, 56, or 98 white, oval, film-coated tablets, marked on one side.

Not all pack sizes may be marketed.

Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani 22 - 00040 Pomezia (RM), Italy

Manufacturer
Bluepharma Industria Farmacêutica, S.A. - S. Martinho do Bispo, 3045-016 Coimbra, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Losafox 12.5 mg Filmtabletten - Losafox 25 mg Filmtabletten - Losafox 50 mg Filmtabletten - Losafox 100 mg Filmtabletten
Italy: Lastan 12.5 mg film-coated tablet - Lastan 25 mg film-coated tablet - Lastan 50 mg film-coated tablet - Lastan 100 mg film-coated tablet
Netherlands: Losafox 12.5 mg - Losafox 25 mg - Losafox 50 mg - Losafox 100 mg

This Patient Information Leaflet was last approved on