Losartan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan DOC 12.5 mg film-coated tablets, 50 mg film-coated tablets, 100 mg film-coated tablets

Generic Medicine
Please read all of this leaflet carefully before you start taking 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, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losartan DOC 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 by 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, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Losartan slows down the decline in kidney function in patients with hypertension and type 2 diabetes.

Losartan DOC is used:

• for the treatment of patients with high blood pressure (hypertension) in adults and children and adolescents aged 6–18 years
• to protect the kidneys in hypertensive patients with type 2 diabetes who have laboratory evidence of impaired kidney function and proteinuria ≥ 0.5 g per day (a condition in which the urine contains an abnormally high amount of protein)
• for the treatment of patients with chronic heart failure when therapy with specific medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors, drugs used to lower blood pressure) is not considered appropriate by the physician. If heart failure has been stabilized with an ACE inhibitor, treatment should not be switched to losartan
• in patients with high blood pressure and left ventricular hypertrophy, Losartan DOC has been shown to reduce the risk of stroke (“LIFE indication”).

2. What you need to know before taking Losartan DOC

Do not take Losartan DOC

• if you are allergic to losartan or to any of the other ingredients of this medicine (listed in section 6),
• if you have severely impaired liver function,
• if you are more than three months pregnant (it is better to avoid Losartan DOC even in the early stages of 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 DOC.
You must tell your doctor if you think you are (or think you might become) pregnant. Losartan DOC 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 when used during this period (see section Pregnancy).
It is important that you inform your doctor before taking Losartan DOC:

• if you have previously had angioedema (swelling of the face, lips, throat and/or tongue) (see also section 4 “Possible side effects”),
• if you are experiencing severe vomiting or diarrhoea, resulting in extreme loss of fluids and/or salts from the body,
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet, leading to extreme loss of fluids and salts in the body (see section 3 “Dosage in particular patient groups”),
• if you have been told that you have narrowing or blockage of the blood vessels leading to the kidneys or have recently undergone kidney transplantation,
• if your liver function is impaired (see section 2 “Do not take Losartan DOC” and section 3 “Dosage in particular patient groups”),
• if you suffer from heart failure, with or without impaired kidney function, or have concomitant life-threatening arrhythmias. Particular caution is required if you are being treated concomitantly with 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 vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain),
• if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal glands due to an abnormality within these glands),
• 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 check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under the heading “Do not take Losartan DOC”.
Children and adolescents
Losartan DOC has been studied in children. Please consult your doctor for further information.
Losartan is not recommended for use in children with kidney or liver problems, as available data in these patient groups are limited. Losartan 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 DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, herbal medicines, or natural products. Pay particular attention if you are taking any of the following medicines during treatment with Losartan DOC:

• other antihypertensive medicines, as they may further lower blood pressure. Blood pressure may also be reduced 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 (NSAIDs), for example 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 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 unless under strict medical supervision. Special 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 the sections “Do not take Losartan DOC” and “Warnings and precautions”).

Losartan DOC with food and drink
Losartan DOC may 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 are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan DOC before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine instead of Losartan DOC.
Losartan DOC 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 taken beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or intend to start breastfeeding. Losartan DOC is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
No studies on the ability to drive vehicles or use machines have been conducted. It is unlikely that Losartan DOC affects such abilities. However, as with other medicines used to treat hypertension, losartan may cause dizziness or drowsiness in some people. If dizziness or drowsiness occurs, consult your doctor before engaging in such activities.
Losartan DOC contains lactose
Losartan DOC contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take Losartan DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor. Your doctor will determine the appropriate dose of Losartan DOC based on your condition and any other medicines you may be taking. It is important to continue taking Losartan DOC for the entire duration prescribed by your doctor in order to maintain consistent blood pressure control.

Adult patients with high blood pressure
Treatment is usually started with 50 mg of losartan (one 50 mg Losartan DOC tablet) once daily. Maximum antihypertensive effect should be achieved within 3 to 6 weeks after starting treatment. In some patients, the dose may subsequently be increased to 100 mg of losartan (two 50 mg Losartan DOC tablets) once daily. If you feel that the effect of losartan is too weak or too strong, consult your doctor or pharmacist.

Use in children and adolescents
Children under 6 years of age
Losartan is not recommended for use in children under 6 years of age, as it has not been shown to be effective in this age group.

Children 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, administered once daily (up to a maximum of 25 mg of losartan). Your doctor may increase the dose if blood pressure is not adequately controlled.
Another formulation 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 with 50 mg of losartan (one 50 mg Losartan DOC tablet) once daily. The dose may then be increased to 100 mg of losartan (two 50 mg Losartan DOC tablets) once daily, depending on blood pressure response.
Losartan DOC may be administered together with other medicines that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting antihypertensives), as well as insulin and other commonly used glucose-lowering medicines (e.g., sulfonylureas, glitazones, and glucosidase inhibitors).

Adult patients with heart failure
Treatment is usually started with 12.5 mg of losartan (one 12.5 mg Losartan DOC tablet) once daily.
Generally, the dose should be gradually increased each week (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week) up to the usual maintenance dose of 50 mg of losartan (one 50 mg Losartan DOC tablet) once daily, depending on your condition.
In the treatment of heart failure, losartan is usually given in combination with a diuretic (a medicine that increases the amount of water excreted 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 at the beginning of treatment, for certain patients such as those treated with 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 2 “Do not take Losartan DOC”).

Administration
The 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 to continue taking Losartan DOC unless otherwise instructed by your doctor.

If you take more Losartan DOC than you should
If you accidentally take too many tablets, or if a child has ingested any tablets, contact your doctor immediately. Symptoms of overdose may include low blood pressure, increased heart rate, or possibly reduced heart rate.

If you forget to take Losartan DOC
If you accidentally miss a daily dose, take the next dose as usual. Do not take a double dose to make up for the missed tablet.

If you stop taking Losartan DOC
If you have any questions about using Losartan DOC, 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 the following effect, stop taking Losartan DOC and contact your doctor immediately or go to the nearest hospital emergency department:
Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty 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. Urgent medical treatment or hospitalization may be required.

The following side effects have been reported with Losartan DOC:

Common (may affect up to 1 in 10 people)

• dizziness
• low blood pressure (especially after excessive loss of fluid from the bloodstream, for example in patients with severe heart failure or those receiving high-dose diuretics)
• dose-related orthostatic effects such as drop in blood pressure upon standing up from lying or sitting position
• weakness
• fatigue
• abnormally low blood sugar level (hypoglycaemia)
• excess potassium in the blood (hyperkalaemia)
• reduced number of red blood cells (anaemia)
• changes in kidney function including kidney failure
• 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 increased heart rate (palpitations)
• severe chest pain (angina pectoris)
• shortness of breath (dyspnoea)
• abdominal pain
• persistent constipation
• diarrhoea
• nausea
• vomiting
• hives (urticaria)
• itching (pruritus)
• rash
• localized swelling (oedema)
• cough

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

• hypersensitivity
• angioedema
• inflammation of blood vessels (vasculitis, including Schönlein-Henoch purpura)
• numbness or tingling (paraesthesia)
• fainting (syncope)
• very rapid and irregular heartbeat (atrial fibrillation)
• stroke (cerebral infarction)
• inflammation of the liver (hepatitis)
• increased levels of alanine aminotransferase (ALT) in the blood, which usually resolves upon discontinuation of treatment

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

• reduced number of platelets
• migraine
• abnormalities in liver function
• muscle and joint pain
• flu-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 levels of sodium in the blood (hyponatraemia)
• depression
• general feeling of being unwell (malaise)
• ringing, buzzing, noise, clicking in the ear (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
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 DOC

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 that month.
This medicine does not require any special storage conditions. Do not open the blister pack until you are ready to take the medicine.
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. Contents of the pack and other information

What Losartan DOC contains
The active substance is losartan potassium.
Each 12.5 mg film-coated tablet of Losartan DOC contains 12.5 mg of losartan potassium.
Each 50 mg film-coated tablet of Losartan DOC contains 50 mg of losartan potassium.
Each 100 mg film-coated tablet of Losartan DOC contains 100 mg of losartan potassium.

The other components are:
microcrystalline cellulose (E460), monohydrate lactose, pregelatinized corn starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464).

Losartan DOC 12.5 mg, 50 mg and 100 mg contain potassium in the following amounts: 1.06 mg (0.027 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively.

Losartan DOC 12.5 mg film-coated tablets contain titanium dioxide (E171), Blue lake (E133, brilliant blue FCF).
Losartan DOC 50 mg film-coated tablets contain titanium dioxide (E171).
Losartan DOC 100 mg film-coated tablets contain titanium dioxide (E171).

Description of the appearance of Losartan DOC and pack sizes
Losartan DOC 12.5 mg is available as round, blue, film-coated tablets without a break line, containing 12.5 mg of losartan potassium.
Losartan DOC 50 mg is available as round, white, film-coated tablets without a break line, containing 50 mg of losartan potassium.
Losartan DOC 100 mg is available as round, white, film-coated tablets without a break line, containing 100 mg of losartan potassium.

Losartan DOC is available in the following pack sizes:
Losartan DOC 12.5 mg – PVC/PE/PVDC blisters with aluminium sealing foil in packs of 7, 10, 14, 15, 21, 28, 50, 56, 98, 100, 210 or 280 tablets.
Losartan DOC 50 mg – PVC/PE/PVDC blisters with aluminium sealing foil in packs of 7, 10, 14, 15, 21, 28, 50, 56, 98, 100, 210 or 280 tablets.
Losartan DOC 100 mg – PVC/PE/PVDC blisters with aluminium sealing foil in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 98, 100, 210 or 280 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC GENERICI S.r.l. - Via Turati, 40, 20121 Milano, Italy (IT).

Manufacturer
Laboratorios DOC
Avenida Miralcampo 7
Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

• Denmark: Losartan Medical Valley
• Finland: Losartan AGP 12,5/50/100 mg kalvopäällysteiset tabletit/filmdragerade tabletter
• Ireland: Losartan Potassium DOC 12.5/50/100 mg film-coated tablets
• Sweden: Losartan Medical Valley 12,5/50/100 mg filmdragerad tablett
• Portugal: Losartan Basi 12.5/50/100 mg comprimidos revestidos por película
• Czech Republic: Arionex 50/100 mg potahované tablety
• Estonia: Tarnasol 12,5/50/100 mg õhukese polümeerikattega tabletid
• Lithuania: Tarnasol 12,5/50/100 mg plėvele dengtos tabletės
• Slovenia: Tarnasol 12,5/50/100 mg filmsko obložene tablete
• Slovakia: Asortek 12,5/50/100 mg filmom obalené tablety
• Germany: Losartan Liconsa
• Norway: Losartan Medical Valley
• Iceland: Losartan Medical Valley
• Italy: Losartan DOC