Losaprex

Package leaflet: Information for the user

Losaprex film-coated tablets

losartan potassium
Please read all of this leaflet carefully before you take 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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losaprex is and what it is used for

Losaprex contains the active substance losartan, which belongs to a group of medicines known as
angiotensin II receptor antagonists.
Losaprex works by dilating blood vessels, thereby lowering blood pressure.
It also slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.
Losaprex is indicated:

• for the treatment of high blood pressure (hypertension) in adult patients, children and adolescents aged 6 to 18 years
• for the treatment of kidney disease in patients with high blood pressure and type 2 diabetes who have laboratory tests showing impaired kidney function, proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein)
• for the treatment of chronic heart failure in adult patients, when therapy with specific medicines (ACE inhibitors) is not considered appropriate by the physician
• to reduce the risk of stroke in patients with high blood pressure and thickening of the walls of the left ventricle (left ventricular hypertrophy).

2. What you should know before taking LOSAPREX

Do not take LOSAPREX:

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant (see section “Pregnancy and Breast-feeding”),
• 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 or pharmacist before taking Losaprex. Contact your doctor if, after taking Losaprex, you experience abdominal pain, nausea, vomiting or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking Losaprex on your own.
Inform your doctor before taking Losaprex:

• if you have previously had angioedema, a condition causing swelling of the face, lips, throat and/or tongue,
• if you have had or are experiencing vomiting and/or diarrhoea,
• if you are taking other medicines or supplements that retain potassium or that may increase potassium levels (see section “Other medicines and Losaprex”): e.g. diuretics (medicines that increase the amount of water and salts excreted by the kidneys), particularly potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes,
• if you are on a low-salt diet causing significant loss of body fluids and salt,
• if you have narrowing or blockage of blood vessels supplying blood to the kidneys (bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney),
• if you have recently undergone a kidney transplant,
• if you have impaired liver function,
• if you have heart failure, with or without kidney impairment or life-threatening cardiac arrhythmias. In particular, inform your doctor if you are also taking a medicine called a beta-blocker,
• if you have narrowing of heart valves (mitral or aortic valve stenosis) or a condition causing thickening of the heart muscle (hypertrophic cardiomyopathy),
• if you have a condition caused by reduced blood flow in the blood vessels of the heart (cardiovascular ischemic disease) or a condition caused by reduced blood circulation in the brain (cerebrovascular disease),
• if you have a syndrome associated with increased secretion of the hormone aldosterone (primary hyperaldosteronism),
• 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, or aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information under “Do not take Losaprex”,
• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and LOSAPREX”).

Children and adolescents
Do not give Losaprex to children with kidney or liver problems. Do not give Losaprex to children under 6 years of age.
Other medicines and Losaprex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium (e.g. heparin, medicines containing trimethoprim), as concomitant use with LOSAPREX is not recommended.
Inform your doctor if you are taking the following medicines:

• other medicines to lower blood pressure, as they may further reduce blood pressure, including:
• antidepressants (tricyclic antidepressants),
• medicines used in severe psychiatric disorders (antipsychotics),
• baclofen (a medicine to relax muscles),
• amifostine (a medicine used to reduce side effects of certain cancer treatments or radiotherapy),
• fluconazole (a medicine to treat fungal infections),
• rifampicin (an antibiotic),
• lithium (a medicine for mood disorders). In this case, your doctor will monitor you closely,
• non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid.

If kidney function is impaired, concomitant use of these medicines may lead to worsening of kidney function.
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 under “Do not take Losaprex” and “Warnings and precautions”).

Losaprex with food and drink
You may take Losaprex with or without food.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Inform your doctor if you think you are pregnant or are planning a pregnancy, as your doctor will prescribe another medicine instead of Losaprex.
Losaprex should not be taken during the first trimester of pregnancy unless your doctor considers losartan therapy essential, and must not be used during the second and third trimesters as it may cause harm to the unborn baby.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Losaprex must not be used during breast-feeding.
Your doctor may prescribe an alternative treatment to Losaprex, especially if your baby is a newborn or a premature infant.
Driving and using machines
Losaprex may cause dizziness or drowsiness, particularly at the beginning of treatment or when the dose is increased.
Do not drive or operate machinery if you experience dizziness or drowsiness. If you are giving the medicine to a child, take care if the child rides a bicycle or uses other vehicles.
Losaprex contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains potassium, less than 1 mmol (39 mg) per tablet, i.e. essentially “potassium-free”.

3. How to take Losaprex

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 dose of Losaprex based on your condition and any other medicines you may be taking.
It is important that you continue taking Losaprex for as long as your doctor has instructed, as this will keep your blood pressure under control.
Take the tablets with a glass of water. You may take the tablets with or without food.
Try to take your daily dose at the same time each day.
Continue taking Losaprex until your doctor tells you to stop treatment.

Use in adult patients
Adult patients with high blood pressure
The recommended starting dose is 50 mg of losartan (1 Losaprex 50 mg tablet) once daily, taken as a single dose.
The maximum blood pressure-lowering effect is achieved 3–6 weeks after starting treatment. If necessary, your doctor may increase your dose to 100 mg of losartan (2 Losaprex 50 mg tablets or 1 Losaprex 100 mg tablet) once daily, in the morning. Your doctor may also prescribe another medicine to be taken together with Losaprex.
If you feel that the effect of Losaprex is too strong or too weak, contact your doctor.

Adult patients with high blood pressure, type 2 diabetes, and proteinuria ≥ 0.5 g per day
The recommended starting dose is 50 mg of losartan (1 Losaprex 50 mg tablet) once daily, taken as a single dose.
The dose may subsequently be increased to 100 mg of losartan (2 Losaprex 50 mg tablets or 1 Losaprex 100 mg tablet) once daily, depending on your blood pressure response to therapy.
Losaprex may be administered together with other medicines to lower blood pressure, as well as with insulin or other medicines that reduce blood glucose levels.

Adult patients with heart failure
The recommended starting dose is 12.5 mg of losartan (1 Losaprex 12.5 mg tablet) once daily, taken as a single dose.
Your doctor will gradually increase your dose weekly (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) up to the maintenance dose of 150 mg of losartan (e.g., 3 Losaprex 50 mg tablets or 1 Losaprex 100 mg tablet and 1 Losaprex 50 mg tablet) once daily, taken as a single dose.
In the treatment of heart failure, losartan is usually combined with a diuretic (a medicine that increases the amount of fluid eliminated through the kidneys) and/or digitalis (a medicine that helps strengthen and improve heart efficiency) and/or beta-blockers.

Adult patients with high blood pressure and thickening of the left ventricular wall (left ventricular hypertrophy) to reduce the risk of stroke
The recommended starting dose is 50 mg of losartan (1 Losaprex 50 mg tablet) once daily, taken as a single dose. Your doctor may prescribe another medicine to be taken together with Losaprex or may increase the dose of Losaprex up to 100 mg daily, taken as a single dose.

Use in children and adolescents
Children under 6 years of age
Losaprex must not be used in children under 6 years of age.

Children and adolescents aged between 6 and 18 years
Children weighing between 20 and 50 kg: The recommended starting dose is 25 mg of Losaprex once daily, taken as a single dose. Your doctor may increase the dose if blood pressure is not controlled. For children unable to swallow tablets, another formulation of this medicine may be more suitable; consult your doctor for further information.
Children and adolescents weighing more than 50 kg: The recommended starting dose is 50 mg of Losaprex once daily, taken as a single dose. Your doctor may increase the dose if blood pressure is not controlled. For children unable to swallow tablets, another formulation of this medicine may be more suitable; consult your doctor for further information.

Children and adolescents with kidney or liver problems
Losaprex must not be used in children with impaired kidney or liver function.

Use in specific patient groups
Your doctor may prescribe a lower dose of Losaprex for patients with reduced blood volume (e.g., those receiving high-dose diuretic therapy), patients with impaired liver function, or patients over 75 years of age.
Losaprex must not be used in patients with severe impairment of liver function (see section "Do not take Losaprex").

If you take more Losaprex than you should
If you accidentally take too much Losaprex, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include low blood pressure and changes in heart rate.

If you forget to take Losaprex
If you accidentally miss a dose, skip the missed dose and 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 doubts about how to use this medicine, consult your doctor or pharmacist.

If you stop taking Losaprex
Do not stop treatment with this medicine unless your doctor tells you to.
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 gets them.
Stop taking Losaprex and consult your doctor immediately or go to the nearest emergency room if you experience symptoms of a severe allergic reaction, such as:

• skin rash
• itching
• swelling of the face, lips, mouth or throat, which may cause difficulty in swallowing or breathing

This is a serious side effect but occurs rarely, affecting up to 1 in 1,000 patients.

Common side effects (may affect up to 1 in 10 people)

• dizziness
• vertigo
• low blood pressure, particularly when standing up quickly
• weakness
• fatigue
• low blood sugar (hypoglycaemia)
• increased potassium levels in the blood (hyperkalaemia)
• changes in kidney function, including renal failure
• reduced number of red blood cells (anaemia)
• increased blood urea, serum creatinine and potassium levels

Uncommon side effects (may affect up to 1 in 100 people)

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

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

• allergic reactions, including severe reactions
• swelling of the skin or mucous membranes (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
• inflammation of the liver (hepatitis)
• elevated levels of alanine aminotransferase (ALT) in the blood, indicating liver damage; these values usually return to normal after stopping treatment
• intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea

Side effects with unknown frequency (frequency cannot be determined from available data)

• reduced number of platelets in the blood
• migraine
• liver function abnormalities
• muscle and joint pain
• muscle pain not explained by dark (tea-coloured) urine (rhabdomyolysis)
• flu-like symptoms
• back pain
• urinary tract infection
• appearance of spots or redness on the skin after exposure to sunlight or sunlamps (photosensitivity)
• erectile dysfunction/impotence
• inflammation of the pancreas (pancreatitis)
• low sodium levels in the blood (hyponatraemia)
• depression
• general feeling of being unwell (malaise)
• perception of ringing, buzzing, roaring or crackling sounds 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, talk to your doctor or pharmacist. 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 Losaprex

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from light and moisture.
Do not open the blister pack until the time when you are ready to take the tablet.
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 Losaprex contains

• The active substance is losartan potassium. Each film-coated tablet contains 12.5 mg or 50 mg or 100 mg of losartan potassium.
• The other ingredients are microcrystalline cellulose (E460), monohydrate lactose, pregelatinized corn starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), carnauba wax (E903), indigo carmine aluminium lake (E132 – only in Losaprex 12.5 mg).

Description of the appearance of Losaprex and package contents
Losaprex is supplied in blisters.
Each pack of Losaprex 12.5 mg film-coated tablets contains:
7 and 21 film-coated tablets
Each pack of Losaprex 50 mg film-coated, divisible tablets contains:
28 divisible film-coated tablets
Each pack of Losaprex 100 mg film-coated tablets contains:
28 film-coated tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Alfasigma S.p.A. – Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
Doppel Farmaceutici srl - Via Volturno, 48 - Quinto de’ Stampi - 20089 Rozzano (MI)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)