LOSARTAN POTASSIUM 100MG FILM COATED TABLETS

Active substance: LOSARTAN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan potassium 25 mg, 50 mg, 100 mg
Film-coated Tablets

• if you have ever had a stroke
• if you suffer from “primary hyperaldosteronism”
(a hormone imbalance)

(Losartan Potassium)

Read all of this leaflet carefully before you start taking
this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.

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.

- 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.

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

- 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.

• 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

In this leaflet
1. What Losartan is and what it is used for
2. Before you take Losartan
3. How to take Losartan
4. Possible side effects
5. How to store Losartan
6. Further information
The name of your medicine is Losartan potassium 25 mg,50 mg
or 100 mg film-coated tablets.(referred to as Losartan in this
leaflet)
1. WHAT LOSARTAN IS AND WHAT IT IS USED FOR
Losartan belongs 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.

• Medicines that affect potassium e.g. potassium supplements
or certain diuretics (“water pills”) such as amiloride,
triamterene, spironolactone or medicines containing
potassium such as heparin
• Pain-relieving medicines such as indometacin and medicines
known as “cox-2-inhibitors” because they may reduce the
blood 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
Taking Losartan with food and drink

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 until your
doctor tells you otherwise.
If you take more Losartan 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 and either a fast or slow
pulse rate.
If you forget to take Losartan
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 Losartan
tablets then ask your doctor or pharmacist.

• to treat patients with chronic heart failure when therapy with
specific medicines called ACE inhibitors is not considered
suitable by your doctor.
You should not be switched to losartan if your heart failure
has been stabilised with an ACE inhibitor
• to lower blood pressure in people who have high blood
pressure
If you have high blood pressure AND you have diabetes
(treated by tablets or diet) and kidney problems THEN
losartan will help protect your kidneys.

Like all medicines, Losartan 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 Lorsatan and see your doctor immediately if the following symptoms occur:
Rare side effects affecting fewer than 1 in 1,000 patients:

If you have high blood pressure AND you have been shown to
have thickened heart muscle THEN losartan has been shown
to reduce your risk of stroke.

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

Pregnancy and breast feeding

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

Breast feeding
Tell your doctor if you are breast-feeding or about to start
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 newborn, or was born prematurely.
Use in children and adolescents

2. BEFORE YOU TAKE LOSARTAN
Do not take Losartan :
• if you are allergic (hypersensitive) to losartan or to any
of its other ingredients
• if you have severe liver problems
• if you are more than 3 months pregnant. (It is also better
to avoid Losartan in early pregnancy-see pregnancy
section.)
Take special care with Losartan
You must tell your doctor if you think you are (or might
become) pregnant. Losartan is not recommended in early
pregnancy, and must not be taken if you are more than 3
months 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:
• if you have ever had swelling of the face, lips, throat,
and/or tongue (also known as “angioedema”)
• if you lose fluid through vomiting or diarrhoea
• if you are prescribed diuretics (medicines that increase
the amount of water that you pass out through your
kidneys) or are under dietary salt restriction
• 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
• if you have liver problems

Driving and using machines
Losartan may cause side effects such as dizziness or drowsiness in some people and so may affect
the ability to drive or use machines. If you experience side
effects, you should consult your doctor before attempting such
activities.
Important information about some of the ingredients of
Losartan Tablets
Losartan contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.

Uncommon, affecting fewer than 1 in 100 people:
• Angina (heart pain)
The following side effects have also been reported:
Common, affecting up to 1 in 10 people:
• Dizziness, sensation of spinning
• Weakness, lassitude

Always take Losartan Tablets exactly as your doctor has
instructed you. Your doctor will decide on the appropriate
dose of Losartan, depending on your condition and whether
you are taking other medicines.It is important to continue
taking Losartan for as long as your doctor prescribes it in
order to maintain control of your blood pressure
Dosage in special patient groups
The doctor may advise a low dose of losartan especially when
starting treatment in people with
liver problems or people over the age of 75 years.
The use of losartan is not recommended in patients with
severe liver problems

- Do not use Losartan Tablets after the expiry date which is
stated on the carton after “Exp”. The expiry date refers to
the last day of that month.
- Do not store your tablets above 25˚C. Keep them in the
original package in order to protect from light.
- Do 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.

What Losartan Tablets contain
- The active substance is Losartan potassium
- The other ingredients are microcrystalline cellulose (E460),
dibasic calcium phosphate, colloidal anhydrous silica,
croscarmellose sodium, talc, magnesium stearate
The film-coat contains hypromellose (E464), lactose
monohydrate, titanium dioxide (E171), polyethylene glycol
4000 and sodium citrate dihydrate.
Each Losartan potassium 25 mg tablet contains 25 mg of
losartan (as potassium salt)
Each Losartan potassium 50 mg tablet contains 50 mg of
losartan (as potassium salt)
Each Losartan potassium 100 mg tablet contains 100 mg of
losartan (as potassium salt)
What Losartan looks like and contents of the pack
Losartan potassium 25 mg tablets are white, round shaped
film-coated tablets debossed with L25 on one side and plain
on other side.
Losartan potassium 50 mg tablets are white, oval shaped
film- coated tablets with central break line on one side and
L50 on the other side.

• Low blood sugar

Losartan potassium 100 mg tablets are white, oval shaped
film- coated tablets debossed with L100 on one side and plain
on other side.

• Changes in blood test results that show how the liver and
kidneys are working

Losartan tablets are supplied in the following pack sizes:

• low blood pressure

Uncommon, affecting fewer than 1 in 100 people:
• sleepiness or other sleep disturbance
• skin rash, itch, hives
• headache
• palpitations
• fainting on standing (caused by low blood pressure)
• Breathlessness or difficulty breathing
• diarrhoea, nausea, vomiting, constipation
• fluid retention (causing, for example, swollen ankles)
Rare, affecting fewer than 1 in 1000 people:
• tingling sensation in the skin
• fainting
• allergic reactions
• inflammation of the small blood vessels

3. HOW TO TAKE LOSARTAN

Losartan potassium
25 mg, 50 mg, 100 mg
Film-coated Tablets

Losartan potassium
25 mg, 50 mg, 100 mg
Film-coated Tablets

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

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

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

6. FURTHER INFORMATION

Losartan may be taken with or without food.

You must tell your doctor if you think you are (or might
become) pregnant. Your doctor will normally advice you to
stop taking Losartan before you become pregnant or as soon
as you know you are pregnant and will advise you to take
another medicine instead of Losartan. Losartan 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.

5. HOW TO STORE LOSARTAN TABLETS

4. POSSIBLE SIDE EFFECTS

Pregnancy

Losartan is used:

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.

• liver problems
Not known (cannot be estimated from the available data):
• anaemia causing shortness of breath or looking pale

Losartan 25 mg tablets are presented in a blister pack of
7 or 28 tablets.
Losartan 50 mg tablets are presented in a blister pack of
7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 280 or 500 mg tablets.
Losartan 100 mg tablets are presented in a blister pack of
7, 10, 14, 15, 20, 28, 30, 50, 56, 90, 98 or 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Cipla (EU) Ltd,
Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, C.P. House, 97- 109 Uxbridge Road, Ealing,
London W5 5TL
Distributed By:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, C.P. House, 97- 109 Uxbridge Road, Ealing,
London W5 5TL

• bleeding or bruising more easily than normal
• back pain

This leaflet was last revised in 06/2012

• urinary infection
• flu-like symptoms
• migraine
• kidney problems (more common in those known to be at
risk of kidney problems)
• muscle pains, joint pains

XXXXX

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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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