Losartic

Package Leaflet: Information for the User

Losartic, 50 mg, Film-Coated Tablets

Losartan Potassium

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• -Keep this package leaflet. You may need to read it again.
• -If you have any further questions, ask your doctor or pharmacist.
• -This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• -If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

1. What is Losartic and what is it used for

Losartic contains the active substance losartan, which belongs to a group of medicines called angiotensin II receptor antagonists. It is used to lower high blood pressure and to protect the kidneys in patients with type 2 diabetes and high blood pressure.

• Losartic is used to treat high blood pressure.
• Losartic is used to protect the kidneys in patients with type 2 diabetes and high blood pressure.
• Losartic is used to treat patients with chronic heart failure.
• Losartic is used to reduce the risk of stroke in patients with high blood pressure and left ventricular hypertrophy.

2. Important information before taking Losartic

When not to take Losartic

• If you are allergic to losartan or any of the other ingredients of this medicine.
• If you have severe liver disease.
• If you are pregnant after the third month.
• If you have diabetes or kidney disease and are treated with aliskiren.

Warnings and precautions

You should inform your doctor if you think you might be pregnant or if you are planning to become pregnant. Losartic should not be used during the first trimester of pregnancy and should not be used after the third month of pregnancy, as it may harm the baby.

• If you have had angioedema (swelling of the face, lips, throat, and/or tongue) in the past.
• If you have had severe vomiting or diarrhea, which may lead to excessive loss of water and electrolytes.
• If you are taking diuretics or are on a low-salt diet, which may lead to excessive loss of water and electrolytes.
• If you have narrowing or blockage of the blood vessels supplying the kidneys or have recently had a kidney transplant.
• If you have liver disease (see also section "When not to take Losartic" and section "How to take Losartic").
• If you have heart failure with kidney problems or life-threatening irregular heartbeats. Special care should be taken when taking beta-blockers.
• If you have problems with your heart valves or heart muscle.
• If you have coronary heart disease (caused by reduced blood flow in the coronary arteries) or cerebrovascular disease (caused by reduced blood flow in the brain).
• If you have primary hyperaldosteronism (a condition where the adrenal glands produce too much aldosterone).
• If you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems due to diabetes.
• Aliskiren. Your doctor may monitor your kidney function, blood pressure, and electrolyte levels regularly. See also section "When not to take Losartic" and section "Warnings and precautions".

Children and adolescents

Losartan has been studied in children. Your doctor will provide more information.

Other medicines and Losartic

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, and about any medicines you plan to take.

• Other medicines that lower blood pressure, as they may increase the blood pressure-lowering effect. Your blood pressure may also be lowered by one of the following medicines/types of medicines: tricyclic antidepressants, antipsychotics, baclofen, amifostine.
• Your doctor may need to change the dose and/or take other precautions if you are taking an ACE inhibitor or aliskiren (see also section "When not to take Losartic" and section "Warnings and precautions").
• Medicines that increase potassium levels (e.g., potassium supplements, potassium-sparing diuretics, heparin).
• Non-steroidal anti-inflammatory medicines (e.g., indomethacin), including COX-2 inhibitors (medicines that reduce inflammation and are used to relieve pain), as they may reduce the blood pressure-lowering effect of Losartic. If you have kidney problems, taking these medicines together may worsen your kidney problems. Lithium should not be taken with Losartic without close monitoring by your doctor. Special precautions may be taken (e.g., blood tests).

Losartic with food and drink

Losartic can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, ask your doctor for advice before taking this medicine.
Your doctor will normally advise you to stop taking Losartic before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartic. Losartic should not be used during the first trimester of pregnancy and should not be used after the third month of pregnancy, as it may harm the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Losartic should not be used during breastfeeding, especially during breastfeeding of newborns or premature babies. Your doctor may advise you to take another medicine.

Driving and using machines

No studies have been performed on the effects of Losartic on the ability to drive or use machines.
The effect of Losartic on the ability to drive or use machines is unlikely.
However, as with other medicines used to treat high blood pressure, Losartic may cause dizziness or fatigue in some patients. If you experience dizziness or fatigue, consult your doctor before driving or using machines.
Losartic contains lactose and sodium.
Lactose
If you have been told that you have an intolerance to some sugars, contact your doctor before taking Losartic.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is essentially sodium-free.

3. How to take Losartic

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Losartic should not be used in the initial treatment of heart failure. Since there are no Losartic tablets available with a strength less than 25 mg, Losartic cannot be used in indications where the recommended dose is less than 25 mg losartan potassium.
Always take Losartic as directed by your doctor. Your doctor will decide on the appropriate dose of Losartic, depending on your condition and any other medicines you are taking.
It is important to continue taking Losartic for as long as your doctor prescribes it to maintain even blood pressure control.

Patients with high blood pressure

Treatment usually starts with 50 mg losartan (one 50 mg Losartic tablet) once daily. The maximum blood pressure-lowering effect is achieved within 3-6 weeks of starting treatment. In some patients, the dose may be increased to 100 mg losartan (two 50 mg Losartic tablets) once daily.
If you feel that the effect of Losartic is too strong or too weak, talk to your doctor or pharmacist.
Use in children and adolescents (6-18 years old)
The recommended starting dose for patients weighing between 20 kg and 50 kg is 25 mg Losartic once daily. For patients weighing more than 50 kg, the usual dose is 50 mg once daily. Your doctor may increase the dose depending on the change in blood pressure in response to the medicine.
Losartic should not be used in children under 6 years old due to limited experience in this age group.
Losartic should not be used in children with acute kidney injury or liver disease.

Patients with high blood pressure and type 2 diabetes

Treatment usually starts with 50 mg losartan (one 50 mg Losartic tablet) once daily. The dose may be increased to 100 mg losartan (two 50 mg Losartic tablets) once daily, depending on blood pressure values.
Losartic can be used with other medicines that lower blood pressure (e.g., diuretics, calcium channel blockers, alpha- and beta-blockers) and with insulin and other commonly used medicines that lower blood sugar levels (e.g., sulfonylureas, glitazones, glucosidase inhibitors).

Patients with heart failure

Treatment usually starts with 12.5 mg losartan once daily. The dose is usually increased weekly (12.5 mg once daily during the first week, 25 mg once daily during the second week, 50 mg once daily during the third week) to the usual maintenance dose of 50 mg losartan once daily, depending on the patient's condition.
In the treatment of heart failure, Losartic is usually used in combination with diuretics (medicines that increase urine production) and/or digitalis glycosides (medicines that improve the heart's pumping efficiency) and/or beta-blockers.

Dosing in special patient groups

Your doctor may prescribe a lower dose, especially when starting treatment in certain patients, such as those taking high doses of diuretics, patients with liver disease, or patients over 75 years old. Losartan should not be used in patients with severe liver disease (see section "When not to take Losartic").

Administration

Swallow the tablets with a glass of water. The daily dose should be taken at about the same time each day. It is important to continue taking Losartic as long as your doctor prescribes it.

Overdose

If you have taken too many tablets or if a child has taken some, contact your doctor immediately. Symptoms of overdose are: low blood pressure, fast heartbeat, and slow heartbeat.

Missed dose

If you miss a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.

4. Possible side effects

Like all medicines, Losartic can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking Losartic and contact your doctor or go to the emergency department immediately:

Severe allergic reaction (rash, itching, swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing or breathing).
This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical attention or hospitalization may be required.
The frequency of side effects is defined as follows:

Very common:occurs in more than 1 in 10 patients
Common:occurs in 1 to 10 patients in 100
Uncommon:occurs in 1 to 10 patients in 1,000
Rare:occurs in 1 to 10 patients in 10,000
Very rare:occurs in less than 1 in 10,000 patients
Frequency not known(frequency cannot be estimated from the available data)
The following side effects have been reported with Losartic:

Common:

• dizziness,
• low blood pressure,
• weakness,
• fatigue,
• low blood sugar (hypoglycemia),
• reduced red blood cell count (anemia),
• low blood pressure,
• kidney problems, including kidney failure,
• increased levels of urea, creatinine, and potassium in the blood in patients with heart failure,
• high levels of potassium in the blood (hyperkalemia).

Uncommon:

• sleepiness,
• headache,
• sleep disorders,
• fast heartbeat (palpitations),
• severe chest pain (angina pectoris),
• low blood pressure (especially after excessive loss of water and electrolytes, e.g., in patients with severe heart failure or those treated with high doses of diuretics),
• orthostatic effects (dose-dependent) such as low blood pressure when standing up from a lying or sitting position,
• shortness of breath (dyspnea),
• abdominal pain,
• cough,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• localized swelling.

Rare:

• blood vessel inflammation (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very fast and irregular heartbeat (atrial fibrillation), stroke,
• liver inflammation,
• increased levels of alanine aminotransferase (ALT), usually resolving after stopping treatment.

Frequency not known:

• reduced red blood cell count (anemia),
• reduced platelet count,
• migraine,
• taste disorders,
• liver problems,
• increased sensitivity to sunlight,
• muscle and joint pain,
• unexplained muscle pain with dark urine (rhabdomyolysis),
• kidney problems (which may resolve after stopping treatment), including kidney failure,
• flu-like symptoms,
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general feeling of being unwell,
• ringing in the ears (tinnitus),
• back pain and urinary tract infections.

Side effects in children are similar to those in adults.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products)
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Losartic

Keep this medicine out of the sight and reach of children.
Store in a cool, dry place, below 25°C. Protect from moisture.
Do not use this medicine after the expiry date stated on the carton after "Expiry date" or "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Losartic contains

• The active substance is losartan potassium. Each tablet contains 50 mg losartan potassium. The other ingredients are: microcrystalline cellulose, calcium phosphate dihydrate, colloidal silicon dioxide, sodium croscarmellose, talc, magnesium stearate, and the film coating Opadry II 32K54870 pink (hypromellose, lactose monohydrate, titanium dioxide (E 171), glycerol triacetate, iron oxide red (E 172)).

What Losartic looks like and contents of the pack

Pink, round, biconvex film-coated tablets with a score line on one side.
Pack sizes: 28 tablets (2 blisters of 14 tablets) in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipovića 25, 10000 Zagreb
Croatia

Date of last revision of the package leaflet: