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Losartan 25mg Film-Coated Tablets

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Document: leaflet MAH GENERIC_PL 20417-0112 change

PATIENT INFORMATION LEAFLET LOSARTAN POTASSIUM 25, 50 & 100 mg FILM-COATED TABLETS

The name of this medicine is Losartan Potassium 25, 50 & 100 mg Film-coated Tablets

which will be referred to as Losartan Tablets throughout this leaflet.

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 further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others.

It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist this includes any possible side effects not listed in this leaflet..

What is in this in this leaflet:

1.    What Losartan Tablets are and what they are used for.

2.    What you need to know before you take Losartan Tablets.

3.    How to take Losartan Tablets.

4.    Possible side effects.

5.    How to Store Losartan Tablets.

6.    Contents of the pack and other information..


1. WHAT LOSARTAN TABLETS ARE AND WHAT THEY ARE USED FOR


Losartan Tablets belong to a group of medicines known as angiotensin-II receptor blockers

(ARBs). Losartan can reduce blood

pressure and improve the ability of the heart to pump blood.

Losartan is used

•    to lower blood pressure in people with high blood pressure (hypertension)

•    to protect the kidney in type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria > 0.5 g per

day (a condition in which urine contains an abnormal amount of protein).

•    to treat patients with chronic heart failure when therapy with specific medicines called angiotension-converting-enzyme

inhibitors (ACE inhibitors) is not considered suitable by your doctor. If your heart failure has

been stabilized with an ACE

inhibitor you should not be switched to losartan.

•    in patients with high blood pressure and thickened heart muscle, losartan has been shown to decrease the risk of stroke.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOSARTAN TABLETS Do not take Losartan Tablets if you:

•    are allergic (hypersensitive) to losartan or any of the other ingredients in the tablets (these are listed in Section 6, Further

Information),

•    are pregnant, think you may be pregnant or are planning to become pregnant, (see also "Pregnancy, breast-feeding and fertility”),

•    are breast-feeding

•    have severe liver problems

• If you have diabetes or impared kidney function and you are treated with a blood pressure lowering medicine contacting aliskiren

Warnings and precautions

Talk to your doctor or pharmacist before taking Losartan Tablets if you:

•    have ever had a history of angioedema (swelling of the face, lips, throat, and/or tongue) (see also section 4 "Possible side effects”),

•    suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,

•    receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction,

•    are known to have narrowing or blockage of the blood vessels leading to your kidneys or if you have received a kidney transplant,

•    if you have heart problems - caution is needed if you are treated with medicines known as beta-blockers

•    If you have ever had a stroke,

•    suffer from primary hyperaldosteronism (a hormone imbalance),

•    have liver problems.

- If you are taking any of the following medicines used to treat high blood pressure:

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes related kidney problems.

- aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not losartan tablets’

Other medicines and Losartan Tablets

Talk to your doctor or pharmacist or nurse before taking any other medicines, including medicines obtained without a prescription or herbal medicines and natural products.

Take particular care if you are taking the following medicines while under treatment with Losartan Tablets:

•    other blood pressure lowering medicines as they may additionally reduce your blood pressure. This list of medicines includes

baclofen, amifostine and medicines used for mental health such as amitriptyline and chlorpromazine,

•    medicines that affect potassium e.g. potassium supplements or certain diuretics ("water pills”) such as amiloride, triamterene,

spirinolactone or medicines containing potassium such as heparin,

•    pain relieving medicines such as indomethacin and medicines known as "Cox-2-inhibitors” because they may reduce the blood

pressure lowering effect of losartan,

If you already have kidney problems then using these medicines together with losartan may worsen your kidney function.

•    lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor.

Special precautionary measures (e.g. blood tests) may be appropriate.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not losartan ” and “Warnings and precautions”)

Losartan Tablets with food and drink

Losartan Tablets can be taken with or without food.

Pregnancy, breast-feeding and fertility

You should not take losartan in the first 12 weeks of pregnancy and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby.

If you become pregnant while on losartan, tell your doctor immediately so that an alternative medicine may be taken instead. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.

You must not take losartan if you are breast-feeding.

Losartan is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is new born, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Children and adolescents

Losartan may be prescribed for children and adolescents. For more information, talk to your doctor.

Driving and using machines

Losartan may cause dizziness or drowsiness in some people and so may affect the ability to drive or use machines. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities.

Losartan contains Lactose:

These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE LOSARTAN TABLETS


Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not

sure. Your doctor will decide on the appropriate dose of Losartan Tablets depending on your condition and whether you are taking

other medicines. It is important to continue taking the tablets for as long as your doctor prescribes it in order to maintain smooth control of your blood pressure.

PATIENTS WITH HIGH BLOOD PRESSURE

Treatment usually starts with one 50 mg tablet once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to 100 mg losartan (two 50 tablets mg) once daily.

If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.

PATIENTS WITH HIGH BLOOD PRESSURE AND TYPE 2 DIABETES

Treatment usually starts with 50 mg losartan (one 50 mg tablet) once a day. The dose may

later be increased to 100 mg losartan

(two 50 mg tablets) once daily depending on your blood pressure response.

Losartan Tablets may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers,

alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the

level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors). ADULT PATIENTS WITH HEART FAILURE

Treatment usually starts with 12.5 mg losartan once a day. Generally, the dose should be increased weekly step-by-step (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 losartan (one 50 mg tablet) once daily, according to your condition.

In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you

pass out through your kidneys) and/or digitalis (medicine that helps to make the heart

stronger and more efficient) and/or a

beta-blocker.

Dosage in special patient groups

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in

high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in

patients with severe hepatic impairment (see section "Do not take Losartan Tablets”). Administration

The tablets should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is

important that you continue to take the tablets until your doctor tells you otherwise.

For the 50mg tablet there is a score line which allows the tablet to be divided into equal doses.

If you take more Losartan Tablets than you should

If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or tell your

doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and

symptoms of overdose are a fall in blood pressure (causing dizziness and light headedness) accompanied by either a fast or slow heart rate.

If you forget to take Losartan Tablets

It is important that you take your medicine every day. However, if you forget to take one or more doses, take your next dose when

it is due and then go on as prescribed. Do not take a double dose to make up for a forgotten dose.

If you have any further questions about this product ask your doctor or pharmacist.

Note: This product is not available as a 12.5mg dose. Your doctor will prescribe an alternative if necessary.

4. POSSIBLE SIDE EFFECTS_

Like all medicines, Losartan Tablets can cause side effects, although not everybody gets them.

The following side effects are important and will require immediate action if you experience them. You should stop taking Losartan

Tablets and tell your doctor immediately or go to the casualty department of your nearest hospital if the following symptoms occur:

A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause difficulty in swallowing or breathing).

Rare side effects affecting fewer than 1 in 1,000 patients:

•    swelling of the face, tongue and windpipe which can cause great difficulty in breathing

•    a sudden allergic reaction with shortness of breath, rash, wheezing and drop of blood pressure

•    stroke

Uncommon, (may affect up to 1 in 100 people):

•    angina (heart pain)

The following side effects have also been reported:

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

•    dizziness, sensation of spinning

•    weakness, lassitude

•    low blood pressure,

•    low blood sugar (hypoglycaemia),

•    changes in blood test results that show how the liver and kidneys are working. Too much potassium in the blood

(hyperkalaemia).

Uncommon (may affect up to 1 in 100 people):

•    sleepiness or other sleep disturbance

•    skin rash, itch, hives

•    headache,

•    palpitations

•    fainting on standing (caused by low blood pressure)

•    low blood pressure (especially after excessive loss of water from the body from within blood vessels e.g. in patients with

severe heart failure or under treatment with high dose diuretics).

•    breathlessness or difficulty breathing

•    diarrhoea, nausea, vomiting, constipation, abdominal pain

•    fluid retention (causing, for example, swollen ankles)

Rare (may affect up to 1 in 1000 people):

•    tingling sensation in the skin

•    fainting (syncope)

•    allergic reactions

•    inflammation of the small blood vessels

•    liver problems

•    stroke

•    very rapid and irregular heart beat (atrial fibrillation)

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

•    anaemia causing shortness of breath or looking pale

•    bleeding or bruising more easily than normal

•    back pain

•    urinary infection

•    flu-like symptoms

•    migraine

•    kidney problems (more common in those known to be at risk of kidney problems)

•    muscle pains, joint pains

•    Distorted sense of taste,

•    sensitive to sunlight,

•    erectile dysfunction/impotence,

•    depression,

•    ringing in the ear

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LOSARTAN TABLETS


Keep your tablets out of the reach and sight of children.

Store in the original package in order to protect from light and moisture. Do not store above 25°C.

Do not use this medicine if you notice any signs of deterioration in the packaging or if the tablets do not match description given in section 6. (Contents of the pack and other information)

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you are no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION


What Losartan Tablets contain:

The active ingredient is losartan potassium. Each tablet contains 25, 50 or 100 mg of losartan potassium, equivalent to 22.9 mg, 45.8 mg or 91.6 mg of losartan.

Tablet core: Microcrystalline cellulose, dibasic calcium phosphate, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate.

Film-coating: Opadry White 31F58914*

*consists of Hypromellose (E464), lactose monohydrate, titanium dioxide (E171), polyethylene glycol 4000, sodium citrate dihydrate (E331).

What Losartan Tablets look like and the contents of the pack:

Losartan Potassium 25 mg Film-coated Tablets are white, round-shaped, film-coated tablets plain on both sides.

Losartan Potassium 50 mg Film-coated Tablets are white, oval-shaped, film-coated tablets with a central break line on one side and plain on the other.

Losartan Potassium 100 mg Film-coated Tablets are white, oval-shaped, film-coated tablets plain on both sides.

Losartan Potassium Film-coated Tablets are supplied in blister packs containing 28 tablets. Marketing Authorisation Holder:

Fannin (UK) Ltd., 42-46 Booth Drive, Park Farm South, Wellingborough, Northhamptonshire, NN86GT

Manufacture responsible for batch release is Fannin (UK) Ltd., 42-46 Booth Drive, Park

Farm South, Wellingborough, Northhamptonshire, NN8 6GT

This information is available in alternative formats upon request.

This leaflet was last approved in Jan 214