LOSARTAN POTASSIUM 50 MG TABLETS

Active substance: LOSARTAN POTASSIUM

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Package Leaflet: Information for the user
Zovencal 25mg, 50mg and 100mg tablets
Losartan Potassium
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 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 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. See
section 4.
What is In This Leaflet:
1 What Zovencal 25mg, 50mg and 100mg Tablets are and what
they are used for.
2 What you need to know before you take Zovencal 25mg, 50mg
and 100mg Tablets.
3 How to take Zovencal 25mg, 50mg and 100mg Tablets.
4 Possible side effects.
5 How to store Zovencal 25mg, 50mg and 100mg Tablets.
6 Contents of the pack and other information.
1. WHAT ZOVENCAL 25mg, 50mg and 100mg TABLETS ARE AND
WHAT THEY ARE USED FOR
The active ingredient in Zovencal Tablets is Losartan Potassium.
This belongs to a group of medicines known as angiotensin-II
receptor antagonists. Angiotensin II is a chemical occurring in
the body, which tightens your blood vessels making it harder for
the blood to pass through them and causing your blood pressure
to increase. Zovencal Tablets blocks this effect of angiotensin
II, causing the blood vessels to relax, and so lowers your blood
pressure.
Your doctor has prescribed Zovencal Tablets because
• you have hypertension (high blood pressure)
Losartan Potassium which is contained in Zovencal Tablets may
also be authorised to treat other conditions which are not mentioned
in this leaflet. Ask your doctor or pharmacist if you have further
questions.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVENCAL
25mg, 50mg and 100mg TABLETS
Do not take Zovencal 25mg, 50mg and 100mg Tablets if:
• you are allergic to Losartan Potassium, or any of the other
ingredients of this medicine (listed in section 6.)
• you are more than 3 months pregnant. (It is also better to avoid
Losartan tablets in early pregnancy – see pregnancy section)
• you are planning to become pregnant
• your liver function is severely impaired
• if you have diabetes or impaired kidney function and you are
treated with a blood pressure lowering medicine containing
aliskiren.
If you think any of these apply to you, do not use any of the tablets.
Talk to your doctor first and follow the advice given to you.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Zovencal Tablets:
• think you are (or might become) pregnant. Losartan tablets are
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).







suffer from liver or kidney problems
have received a kidney transplant
have recently suffered from excessive vomiting and/or diarrhoea
have a condition called ‘aortic stenosis’ or ‘outflow obstruction’
are known to have narrowing or blockage of the blood vessels
leading to your kidneys
• receive diuretics (water tablets) or know that you have high levels
of potassium in your blood (hyperkalaemia) or you are on a low
potassium diet
• have had a history of angiooedema (swelling of the face, lips,
throat and/or tongue)
• suffer from heart failure with/without renal impairment or
concomitant severe life threatening cardiac arrhythmias. Special
caution is necessary when you are treated with a β-blocker
• 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)
• 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)
• 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 take Zovencal
Tablets’.
Other medicines and Zovencal Tablets
Tell your doctor if you are taking have recently taken or might take
any other medicines. 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 take Zovencal tablets’ and ‘Warnings
and precautions’). In addition you should tell your doctor if you are
taking any of the following medicines:
• Potassium supplements, potassium sparing agents, or
potassium-containing salt substitutes.
• rifampicin used in the treatment of tuberculosis (TB)
• fluconazole for the treatment of fungal infections such as thrush
• lithium, a drug used to treat certain mental disorders
• non-steroidal, anti-inflammatory painkillers (such as ibuprofen,
naproxen or diclofenac), COX-2 inhibitors (such as celecoxib,
etoricoxib or lumiracoxib) or more than 3 g of aspirin per day
• high doses of water-losing tablets (diuretics)
• 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 and
heparin
• other ACE inhibitors such as captopril and lisinopril. The addition
of other blood pressure lowering medicines by dual blockade will
require you to be closely monitored for kidney function.
Zovencal 25mg, 50mg and 100mg Tablets with food and drink
Zovencal Tablets does not usually interact with food therefore it can
be administered with or without food.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are pregnant, (or might
become) pregnant. Your doctor will normally advise you to stop
taking Losartan tablets before you become pregnant or as soon
as you know you are pregnant and will advise you to take another
medicine instead of Losartan tablets.
Losartan tablets are 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Losartan tablets are 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.
Children and Adolescents under the age of 18 years
Losartan has been studied in children. For information, talk to your
doctor.
Driving and Using Machines
Zovencal Tablets may have a minor or moderate effect on your
ability to drive and use machines. They may cause dizziness, feeling
of weakness and vertigo. If you experience any of these side effects
then you should not drive or use machines.
Zovencal 25mg, 50mg and 100mg Tablets contains lactose
These tablets contain lactose so if you suffer from rare hereditary
problems of galactose intolerance, the Lapp lactase deficiency or
glucose galactose malabsorption then you should not take this
medicine.
3. HOW TO TAKE ZOVENCAL 25mg, 50mg and 100mg TABLETS
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not
sure. Zovencal Tablets should be taken by mouth. You must keep
taking Zovencal Tablets every day and exactly as your doctor has
told you. It is important that you take Zovencal Tablets for as long,
as your doctor prescribes it, in order to keep your blood pressure
controlled and/or protect your kidneys from worsening damage. It is
recommended that you take your tablet at the same time each day.
Dose Instructions for Adults
Hypertension
The usual dose of Losartan Potassium Tablets for most adult
patients is one 50mg tablet once a day to control blood pressure
over the 24 hour period. However, in certain patients such as those
over 75 years of age or those with kidney or liver problems, the
doctor may prescribe a lower dose of 25 mg once a day.
Alternatively, the doctor may prescribe a higher dose (i.e. 100 mg).
Follow your doctor’s instructions exactly.
Use in Children
Hypertension in Children aged 6 to 16 years old
For children who can swallow tablets, and who weigh between 20
and 50 kg, the recommended dose is 25 mg once daily. The dose
can be increased to a maximum of 50 mg once daily.
For children who weigh 50 kg or over, the starting dose is 50 mg
once daily. The dose can be increased to a maximum of 100 mg
once daily.
The doctor will adjust the dosage according to the weight of the
child and their blood pressure response.

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.
If you take more Zovencal 25mg, 50mg and 100mg Tablets than
you should
If you take an overdose by mistake, contact your doctor immediately
or attend the nearest hospital casualty department.
If you forget to take Zovencal 25mg, 50mg and 100mg Tablets
Try to take Zovencal Tablets daily as prescribed. However, if you
miss a dose, just carry on with the next dose as normal. Do not take
an extra tablet to make up.
If you have any further questions about taking this product, ask
your doctor or pharmacist.
If you stop taking Zovencal 25mg, 50mg and 100mg Tablets
Always check with your doctor before you stop taking this medicine.
If you have any further questions on the use of this medicine ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine 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 hospitalization.
The following side effects have been reported with losartan tablets:
Common: may affect up to 1 in 10 people
• dizziness or spinning sensation
• low blood pressure,
• debility,
• fatigue,
• low sugar in the blood (hypoglycaemia),
• too much potassium in the blood (hyperkalaemia)
• reduced number of red blood cells (anaemia)
• increases in blood urea, serum creatinine and serum potassium
levels in patients with heart failure.
• changes in your kidney function (renal impairment, renal failure)
Uncommon: may affect up to 1 in 100 people
• sleepiness,
• headache,
• sleep problems,
• feeling of increased heart rate (palpitations),
• severe chest pain (angina),
• 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),
• cough,
• abdominal pain,

• severe constipation,
• diarrhoea,
• nausea,
• vomiting,
• hives (urticaria),
• itching (pruritus),
• rash,
• localised swelling (oedema).
Rare: may affect up to 1 in 1,000 people
• inflammation of blood vessels (vasculitis including HenochSchonlein purpura),
• numbness or tingling sensation (paraesthesia),
• fainting (syncope),
• very rapid and irregular heartbeat (atrial fibrillation) brain attack
(stroke),
• inflammation of the liver (hepatitis),
• elevated blood alanine aminotransferase (ALT Liver enzymes)
levels, usually resolved upon discontinuation of treatment.
not known: frequency cannot be estimated from the available data
• reduced number of red blood cells (anaemia),
• reduced number of platelets which may lead to easy bruising,
• ringing in the ears (tinnitus)
• migraine,
• cough,
• inflammation of the pancreas, which causes severe pain in the
abdomen and back (pancreatitis)
• liver function abnormalities,
• muscle and joint pain,
• changes in kidney function (may be reversible upon
discontinuation of treatment) including kidney failure,
• flu-like symptoms,
• back pain and urinary tract infection.
• sensitivity to light
• problems achieving and/or maintaining an erection (erectile
dysfunction / impotence)
• depression
• low sodium levels in the blood (hyponatreamia)
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
Website: 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 ZOVENCAL 25mg, 50mg and 100mg TABLETS
Keep this medicine out of the sight and reach of children.
Do not store above 30ºC.
Do not use Zovencal Tablets after the expiry date, which is stated
on the pack.
The expiry date refers to the last day of that month.
Disposal
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away any medicines you
no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zovencal 25mg, 50mg and 100mg Tablets contains
The active substance is Losartan Potassium

The other ingredients are:
Tablet Core
Cellulose microcrystalline (E460), Lactose anhydrous, Starch,
Pregelatinised
Silica, Colloidal anhydrous, Magnesium Stearate (E572)
Tablet Coating
Hydroxy propyl cellulose (E463), Hypromellose (E 464), Titanium
dioxide (E171)
Although Zovencal Tablets contain a very small amount of
potassium, they cannot replace potassium supplements. If your
doctor - has prescribed potassium supplements, continue to follow
his or her advice.
What Zovencal 25mg, 50mg and 100mg Tablets looks like and the
contents of the pack
Zovencal Tablets are available in three strengths.
• Zovencal 25mg Tablets are white capsule shaped, biconvex film
coated tablets, embossed with ‘25’ on one side and plain on the
other side and contain 25 mg of Losartan Potassium.
• Zovencal 50mg Tablets are white capsule shaped, biconvex film
coated tablets, embossed with ‘LUPIN’ on one side, ‘50’ and score
line on the other side and contain 50mg of Losartan Potassium.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
• Zovencal 100mg Tablets are white capsule shaped, biconvex film
coated tablets, embossed with ‘100’ on one side and ‘LUPIN’ on
the other side and contain 100mg of Losartan Potassium.
Zovencal Tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited,
Victoria Court,
Bexton Road,
Knutsford,
Cheshire
WA16 OPF
United Kingdom
Distributed by:
Discovery Pharmaceuticals
The Old Vicarage,
Market Place
Castle Donington
Derbyshire DE74 2JB,
England
This leaflet was last revised in September 2014
Code No. GO/DRUGS/654

ID#: 230678

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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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