Zovencal 50mg Tablets

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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 Howto 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 p-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 Henoch-Schonlein 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 30°C.

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 WA16OPF 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