LOSARTAN POTASSIUM LICONSA 50 MG FILM-COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Losartan potassium Liconsa 25 mg / 50 mg / 100 mg film-coated tablets
Losartan potassium
Read all of this leaflet carefully before taking this medicine.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Losartan potassium Liconsa is and what it is used for
Before you take Losartan potassium Liconsa
How to take Losartan potassium Liconsa
Possible side effects
How to store Losartan potassium Liconsa
Further information

1.

WHAT Losartan potassium Liconsa 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 which binds to receptors in blood vessels,
causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding
of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the
blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure
and type 2 diabetes.
Losartan potassium Liconsa is used

to treat patients with high blood pressure (hypertension)

to protect the kidney in hypertensive 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
angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood
pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an
ACE inhibitor you should not be switched to losartan.

in patients with high blood pressure and a thickening of the left ventricle, Losartan potassium
Liconsa has been shown to decrease the risk of stroke (“LIFE indication”).

2.

BEFORE YOU TAKE Losartan potassium Liconsa

Do not take Losartan potassium Liconsa






if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
if your liver function is severely impaired,
if you are, think you may be or are planning to become pregnant (see also “Pregnancy and
breast-feeding”),
If you are more than 3 months pregnant. (It is also better to avoid Losartan potassium Liconsa
in early pregnancy – see pregnancy section.)


Take special care with Losartan potassium Liconsa
You must tell your doctor if you think you are (or might become) pregnant. Losartan potassium
Liconsa is not recommended in early pregnancy, and must not be taken if you are more than
3months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy
section).
It is important to tell your doctor before taking Losartan potassium Liconsa :

if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue)
(see also section 4 ‘Possible side effects’),

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

if you receive diuretics (medicines that increase the amount of water that you pass out
through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and
salt in your body (see section 3 ‘Dosage in special patient groups’),

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

if your liver function is impaired (see sections 2 "Do not take Losartan" and 3 ‘Dosage in
special patient groups’),

if you suffer from heart failure with or without renal impairment or concomitant severe life
threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker
concomitantly,

if you have problems with your heart valves or heart muscle,

if you suffer from coronary heart disease (caused by a reduced blood flow in the blood
vessels of the heart) or from cerebrovascular disease (caused by a 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 gland, caused by an abnormality within the
gland).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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 potassium Liconsa :

other blood pressure lowering medicines as they may additionally reduce your blood pressure.
Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic
antidepressants, antipsychotics, baclofene, amifostine,


medicines which retain potassium or may increase potassium levels (e.g. potassium
supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain
diuretics [amiloride, triamteren, spironolactone] or heparine),

non-steroidal anti-inflammatory drugs such as indomethacin, including cox-2-inhibitors
(medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the
blood lowering effect of losartan.
If your kidney function is impaired, the concomitant use of these medicines may lead to a
worsening of the 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.
Taking Losartan potassium Liconsa with food and drink
Losartan potassium Liconsa may be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will
normally advise you to stop taking Losartan potassium Liconsa before you become pregnant or as
soon as you know you are pregnant and will advise you to take another medicine instead of
Losartan potassium Liconsa . Losartan potassium Liconsa is not recommended in early pregnancy,
and must not be taken when more than 3 months pregnant, as it may cause serious harm to your
baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan potassium
Liconsa 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 newborn, or was
born prematurely.
Use in children and adolescents
Losartan potassium Liconsa has been studied in children. For more information, talk to your doctor.
Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.
Losartan potassium Liconsa is unlikely to affect your ability to drive or use machines. However, as
with many other medicines used to treat high blood pressure, losartan may cause dizziness or
drowsiness in some people. If you experience dizziness or drowsiness, you should consult your
doctor before attempting such activities.
Important information about some of the ingredients of Losartan potassium Liconsa
Losartan potassium Liconsa contains lactose monohydrate. If you have been told by your doctor
that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.

HOW TO TAKE Losartan potassium Liconsa

Always take Losartan potassium Liconsa exactly as your doctor has instructed you. Your doctor
will decide on the appropriate dose of Losartan potassium Liconsa , depending on your condition
and whether you are taking other medicines. It is important to continue taking Losartan potassium
Liconsa for as long as your doctor prescribes it in order to maintain smooth control of your blood
pressure.
Adult patients with High Blood Pressure
Treatment usually starts with 50 mg losartan 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 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.
Use in children or adolescent (6 to 18 years old)
The recommended dose in patients who weigh between 20 and 50kg is 25mg administered once a
day. The doctor may increase the dose if blood pressure is not controlled
The recommended dose in patients who weigh above 50 kg is 50 mg administered once a day. The
doctor may increase the dose if blood pressure is not controlled
Adults patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan once a day. The dose may later be increased to 100 mg
losartan 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).
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 once daily, according to your condition.
This medicine does not allow to take the 12.5 mg dose. In those cases in which losartan 12.5 mg is
prescribed your doctor will have to choose another product.
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 potassium Liconsa ").

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 Losartan potassium Liconsa
until your doctor tells you otherwise.
If you take more Losartan potassium Liconsa than you should
If you accidentally take too many tablets, or a child swallows some, contact your doctor
immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly
decreased heartbeat.
If you forget to take Losartan potassium Liconsa
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to
make up for a forgotten tablet. If you have any further questions on the use of this product, ask your
doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Losartan potassium Liconsa can cause side effects, although not everybody gets
them.
If you experience the following, stop taking losartan tablets and tell your doctor immediately or go
to the casualty department of your nearest hospital:
A severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat that may cause
difficulty in swallowing or breathing).
This is a serious but rare side effect, which affects more than 1 out of 10,000 patients but fewer than
1 out of 1,000 patients. You may need urgent medical attention or hospitalisation.
The side effects of medicines are classified as follows:
very common: happening in more than 1 in 10 patients
common: happening in 1 in 100 to 1 in 10 patients
uncommon: happening in 1 in 1,000 to 1 in 100 patients
rare: happening in 1 in 10,000 to 1 in 1,000 patients
very rare: happening in less than 1 in 10,000 patients
not known: (cannot be estimated from the available data)
The following side effects have been reported with Losartan potassium Liconsa :
Common:

dizziness,

low blood pressure,

debility,

fatigue,

too less sugar in the blood (hypoglycaemia),

too much potassium in the blood (hyperkalaemia).




reduced number of red blood cells (anaemia),
changes in kidney function (may be reversible upon discontinuation of treatment) including
kidney failure




increase in blood urea, serum creatinine and serum potassium in patients with heart failure
vertigo

Uncommon:

somnolence,

headache,

sleep disorders,

feeling of increased heart rate (palpitations),

severe chest pain (angina pectoris),

low blood pressure (especially after excessive loss of water from the body within blood
vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),

dose-related orthostatic effects such as lowering of blood pressure appearing when rising
from a lying or sitting position,

shortness of breath (dyspnoea),

abdominal pain,

constipation,

diarrhoea,

nausea,

vomiting,

hives (urticaria),

itching (pruritus),

rash,

localised swelling (oedema).

cough

oedema (swelling)
Rare:







inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
numbness or tingling sensation (paraesthesia),
fainting (syncope),
very rapid and irregular heartbeat (artrial fibrillation) brain attack (stroke),
inflammation of the liver (hepatitis),
elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation
of treatment.

Not known.:

reduced number of thrombocytes,

migraine,

liver function abnormalities,

muscle and joint pain,

flu-like symptoms,

back pain and urinary track infection.

increased sensitivity to the sun (photosensitivity)









unexplained muscle pain with dark (tea-coloured)urine (rhabdomyolisis)
impotence
inflammation of the pancreas (pancreatitis)
low levels of sodium in the blood (hyponatraemia)
depression
generally feeling unwell (malaise)
ringing, buzzing, roaring, or clicking in the ears (tinnitus)

Side effects in children are similar to those seen in adults.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5.

HOW TO STORE Losartan potassium Liconsa

Keep out of the reach and sight of children.
Do not use Losartan potassium Liconsa after the expiry date which is stated on the carton after EXP.
The expiry date refers to the last day of that month.

No special storage conditions are requiredDo not open the blister pack until you are ready to
take the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Losartan potassium Liconsa contains
The active substance is losartan potassium.
Each Losartan potassium Liconsa 25 mg tablet contains 25 mg of losartan potassium.
Each Losartan potassium Liconsa 50 mg tablet contains 50 mg of losartan potassium.
Each Losartan potassium Liconsa 100 mg tablet contains 100 mg of losartan potassium.
The other ingredients are:
- Tablet core: lactose monohydrate, pregelatinised maize starch, microcrystalline cellulose and
magnesium stearate.
- Tablet coating: hyprolose, hypromellose and titanium dioxide.

What Losartan potassium Liconsa looks like and contents of the pack
Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 25
mg of losartan potassium.
Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 50
mg of losartan potassium.

Losartan potassium Liconsa is supplied as round white unscored film-coated tablets containing 100
mg of losartan potassium.
Losartan potassium Liconsa is supplied in the following pack sizes:
Losartan potassium Liconsa 25 mg - PVC/PE/PVDC blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28 25, 50, 56, 90, 98, 100, 210 or 280 tablets
Losartan potassium Liconsa 50 mg - PVC/PE/PVDC blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56,90, 98, 100, 210 or 280 tablets.
Losartan potassium Liconsa 100 mg - PVC/PE/PVDC blister packages with aluminium foil lidding
in packs of 7, 10, 14, 15, 21, 28, 30, 50, 56, 90, 98, 100, 210 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LABORATORIOS LICONSA, S.A.
Gran Vía Carlos III, 98, 7th floor, 08028 Barcelona

SPAIN
Manufacturer
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
SPAIN
This medicinal product is authorized in the Member States of the EEA under the following
names:
Member State

Invented name

-

Losartankalium “Liconsa” 25 mg / 50 mg / 100 mg filmovertrukket tablet
Losartan BGR 25 mg / 50 mg / 100 mg comprime pelliculé
Losanox 25 mg / 50 mg / 100 mg filmomhulde tablet
Losartan potassium Liconsa 25 mg / 50 mg / 100 mg film-coated tablets

Denmark:
France:
The Netherlands:
United Kingdom:

This leaflet was last approved in 01/2012.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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