Losartan PensA

Patient Information Leaflet: Information for the patient

LOSARTAN PENSA 12.5 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If you notice any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What LOSARTAN PENSA 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 an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Losartan slows the decline in kidney function in patients with high blood pressure and type 2 diabetes.

Losartan is used:

• to treat patients with high blood pressure (hypertension) in adults, children and adolescents aged between 6 and 18 years.
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory test results showing impaired kidney function and proteinuria ≥ 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 treatment 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 an ACE inhibitor, you should not switch to treatment with losartan.
• in patients with high blood pressure and left ventricular hypertrophy, losartan has been shown to reduce the risk of stroke (“LIFE study indication”).

The losartan contained in LOSARTAN PENSA is also authorized to treat 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 LOSARTAN PENSA

Do not take LOSARTAN PENSA

• if you are allergic to losartan potassium 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 better to avoid LOSARTAN PENSA even in early pregnancy – see 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 PENSA.
You must inform your doctor if you think you are pregnant (or if you might become pregnant). LOSARTAN
PENSA 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 baby (see section on pregnancy).
Before taking LOSARTAN PENSA, 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 have excessive vomiting or diarrhoea causing significant fluid and/or salt loss from the body,
• if you are taking diuretics (medicines that increase the amount of water eliminated through the kidneys) or are on a low-salt diet causing significant fluid and salt loss (see section 3 “Dosage in specific 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 PENSA” and 3 “Dosage in specific patient groups”),
• if you suffer from heart failure with or without impaired kidney function or life-threatening cardiac arrhythmias. Pay special attention if you are also being treated with a beta-blocker,
• if you have heart valve or heart muscle problems,
• 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 adrenal gland abnormality),
• 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 LOSARTAN PENSA".
Children and adolescents
Losartan has been studied for use in children. For further information, consult your doctor.
Administration of losartan is not recommended in children with kidney or liver problems or in children
under 6 years of age, as data available for these patient groups are limited.
Other medicines and LOSARTAN PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicine, including those without a prescription, herbal preparations or natural products.
Pay particular attention if you are taking any of the following medicines while being treated with
LOSARTAN PENSA:

• 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.

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 together with losartan without close monitoring by your
doctor. Appropriate precautionary measures may be required (e.g. blood tests).
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 LOSARTAN PENSA" and
"Warnings and precautions").
LOSARTAN PENSA with food and drink
LOSARTAN PENSA can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby,
please consult your doctor or pharmacist before taking this medicine.
Generally, your doctor will advise you to stop taking LOSARTAN PENSA before becoming
pregnant or as soon as you find out you are pregnant and will recommend an alternative medicine
instead of LOSARTAN PENSA. LOSARTAN PENSA is not recommended during early
pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to
your unborn baby if used after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to start breastfeeding. LOSARTAN PENSA is
not recommended for breastfeeding women and your doctor may choose another treatment for you if
you wish to breastfeed, especially if your baby is newborn or premature.
Consult your doctor or pharmacist before taking any medicine.
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 will affect 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 should consult your doctor
before engaging in these activities.
LOSARTAN PENSA contains lactose monohydrate
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.
LOSARTAN PENSA contains sodium This medicine contains less than 1 mmol (23 mg) of sodium
per tablet, i.e. essentially ‘sodium-free’.

3. How to take LOSARTAN PENSA

Always take this medicine exactly as instructed by your doctor or pharmacist.
If you are unsure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of LOSARTAN PENSA based on your condition and any other medicines you may be taking. It is important to continue taking LOSARTAN PENSA for the entire duration prescribed by your doctor in order to keep your blood pressure under control.

Adult patients with high blood pressure
Treatment is usually started at a dose of 50 mg of losartan (one tablet of LOSARTAN PENSA 50 mg) once daily. The maximum blood pressure-lowering effect is reached 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 PENSA 50 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 of age
The use of LOSARTAN PENSA is not recommended in children under 6 years of age, as its effectiveness has not been demonstrated in this age group.

Use in children and adolescents aged 6 to 18 years
The recommended starting dose for patients weighing between 20 and 50 kg is 0.7 mg of losartan per kg of body weight, given once daily (up to a maximum of 25 mg of LOSARTAN PENSA). Your doctor may increase the dose if blood pressure is not adequately controlled.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Adult patients with high blood pressure and type 2 diabetes
Treatment is usually started at a dose of 50 mg of losartan (one tablet of LOSARTAN PENSA 50 mg) once daily. The dose may subsequently be increased to 100 mg of losartan (two tablets of LOSARTAN PENSA 50 mg) once daily, depending on your blood pressure response to therapy.
Losartan 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 glucosidase inhibitors).

Adult patients with heart failure
Treatment is usually started at a dose of 12.5 mg of losartan (one tablet of LOSARTAN PENSA 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 determined by your doctor. A maximum daily dose of 150 mg of losartan (three tablets of LOSARTAN PENSA 50 mg) may be used.
In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases the amount of fluid excreted by the kidneys) and/or digitalis (a medicine that helps make the heart stronger and more efficient) and/or beta-blockers.

Doses in specific patient groups
Your doctor may recommend lower doses, especially at the beginning of treatment, for certain patients such as those receiving high-dose diuretics, patients with impaired liver function, or patients aged over 75 years. The use of losartan is not recommended in patients with severe impairment of liver function (see section "Do not take LOSARTAN PENSA").

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 that you continue taking LOSARTAN PENSA until your doctor tells you otherwise.

If you take more LOSARTAN PENSA 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, or possibly decreased heart rate.

If you forget to take LOSARTAN PENSA
If you accidentally miss a dose, take your next dose at the usual time.
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 everybody gets them.
If you experience the following side effect, 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 but less than 1 in 1,000 patients. It may require urgent medical treatment or hospitalisation.
The following side effects have been reported with losartan:
Common (may affect from 1 to 10 people):

• dizziness,
• low blood pressure (especially after excessive loss of fluid from the blood vessels, 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 rising from a lying or sitting position,
• weakness,
• fatigue,
• low blood sugar levels (hypoglycaemia),
• high potassium levels in the blood (hyperkalaemia),
• renal function abnormalities including renal failure,
• reduction in the number of red blood cells in the blood (anaemia),
• increased blood urea, serum creatinine and serum potassium levels in patients with heart failure.

Uncommon (may affect from 1 to 100 people):

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

Rare (may affect from 1 to 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 the blood, usually reversible upon discontinuation of treatment.

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

• reduction in platelet count,
• migraine,
• liver function abnormalities,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infection,
• increased sensitivity to sunlight (photosensitivity),
• unexplained muscle pain with dark urine (tea-coloured) (rhabdomyolysis),
• impotence,
• inflammation of the pancreas (pancreatitis),
• low sodium levels in the blood (hyponatraemia),
• depression,
• general feeling of malaise,
• ringing, buzzing, pulsating or clicking sounds in the ears (tinnitus),
• taste disturbances (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 LOSARTAN PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 any 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 PENSA contains

• The active substance is potassium losartan.
  Each 12.5 mg LOSARTAN PENSA tablet contains 12.5 mg of potassium losartan, equivalent to 11.44 mg of losartan.
  Each 50 mg LOSARTAN PENSA tablet contains 50 mg of potassium losartan, equivalent to 45.8 mg of losartan.
  Each 100 mg LOSARTAN PENSA tablet contains 100 mg of potassium losartan, equivalent to 91.6 mg of losartan.

The other components are microcrystalline cellulose (E460), monohydrate lactose, pregelatinized maize starch [of botanical origin (maize)], sodium starch glycolate type A, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171).

Description of the appearance of LOSARTAN PENSA and package contents
LOSARTAN PENSA 12.5 mg film-coated tablets are white, round, biconvex, film-coated tablets with a diameter of approximately 5.1 mm.
LOSARTAN PENSA 50 mg film-coated tablets are white, round, biconvex, film-coated tablets with a diameter of approximately 7.6 mm, with a score line on one side. The tablet can be divided into two equal parts.
LOSARTAN PENSA 100 mg film-coated tablets are white, round, biconvex, film-coated tablets with a diameter of approximately 9.1 mm, with a score line on one side. The tablet can be divided into two equal parts.
The tablets are supplied in PVC/PE/PVDC/Aluminum blisters.
Pack sizes:
12.5 mg: 21 film-coated tablets
50 mg and 100 mg: 28 film-coated tablets

Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milan, Italy

Manufacturer
Specifar S.A.
1, 28 Octovriou str.
123 51 Ag. Varvara
Athens, Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Losartan Pensa 12.5 mg film-coated tablets
Losartan Pensa 50 mg film-coated tablets
Losartan Pensa 100 mg film-coated tablets