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You may be given Eprosartan on its own or with another medicine used to treat high blood pressure. Using both medicines together will lower your blood pressure more than one on its own.

The active ingredient in this medicine is eprosartan mesilate. This is the new name for eprosartan mesylate. The active ingredient itself has not changed.

2. What you need to know before you take Eprosartan Do not take Eprosartan:

•    if you are allergic to Eprosartan or any of the other ingredients ofthis medicine (listed in section 6);

> ifyou have severe liver problems;

•    if you are more than 3 months pregnant (it is better to avoid Eprosartan in early pregnancy - see "pregnancy and breastfeeding" section)

. If you have significant narrowing of the blood vessels leading to your kidneys especially if you have one kidney « If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, talk to your doctor before you start taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Eprosartan if: « You have heart, kidney or liver problems, especially severe heart failure, narrowing ofthe heart valves, thickening of heart muscle (obstructive cardiomyopathy)

. You have narrowing or a blockage of the blood vessels leading to your kidneys or if you only have one kidney « You have recently been sick or had diarrhoea

•    You are taking water tablets (diuretics) and they make you feel dizzy when you stand up

•    You are taking water tablets or potassium supplements and you also have a kidney problem. Your doctor might sometimes checkyour blood to make sure that Eprosartan is not affecting the amount of potassium in your blood

•    You suffer from lactose intolerance (see section 'Important information about some of the ingredients of Eprosartan')

•    Youthink you are (or might become) pregnant. Eprosartan 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)

•    If you have been told you have Conn's syndrome (primary hyperaldosteronism) i.e. your body is making too much of the hormone aldosterone. Eprosartan may notwork, so check with your doctor.

•    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 ifyou 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 Eprosartan". If you are not sureif any of the above apply to you, talk toyour doctor or pharmacist before taking Eprosartan.

Other medicines and Eprosartan

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicine. This includes medicines obtained without a prescription, including herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any ofthe following medicines:

•    Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Non-steroidal anti-inflammatory medicines)

•    Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes

•    Watertablets (Diuretics) such as hydrochlorothiazide and calcium channell blocker such as nifedipine which may be used to help loweryour blood pressure

•    Aspirin (more than 3 g per day) used for pain, fever and to prevent blood clotting

« Lithium used for mental problems.

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

Ifyou are taking an ACE-inhibitor or aliskiren (see also information underthe headings "Do nottake Eprosartan" and "Warnings and precautions").

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Eprosartan.

Pregnancy, breast-feeding and fertility

Pregnancy

You must tell your doctor ifyou thinkyou are (or might become) pregnant.

« Your doctor will normally advise you to stop taking Eprosartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Eprosartan. Eprosartan 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.

Breast-feeding

•    Tell your doctor if you are breast-feeding or about to start breast-feeding.

Eprosartan is not recommended for mothers who are breastfeeding, 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.

If you stop taking Eprosartan

Keep taking this medicine until your doctor tells you to stop. Do not stop taking Eprosartan just because you feel better.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Stop taking Eprosartan and see a doctor straight away if you develop any of the following symptoms - you may need urgent medical treatment:

•    Sudden swelling ofyourface, lips ortongue and breathing problems. These may be signs of a severe allergic reaction and may be life threatening. This side effect is uncommon (may affectmore than 1 in 100 people).

A list of possible side effects reported in clinical studies with eprosartan is given below:

Very common side effects ((may affect more than 1 in 10 peopley.y.

•    Headache

Common side effects (may affect more than 1 in 10 people):

•    Skinrashesoritching

•    Weakness or lack of strength

•    Feeling dizzy

•    Feelingsick(nauseaorvomiting)

« Diarrhoea

•    Joint pain

•    Runnynose « Flatulence

Uncommon (mayaffectmore than 1 in 100people)

> Low blood pressure (hypotension)

•    Sudden swelling ofyourface, lips ortongue and breathing problems. These may be signs of a severe allergic reactions and may be life threatening.

Undesirable effects have been reported since Eprosartan has been marketed but the frequency is not known

•    Changes in kidney function including kidney failure in patients with existing kidney problems.

Reporting ofside effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety ofthis medicine.

Blood tests

Ifyou need a blood sample taking fortesting, you should remind your doctor that you are taking Eprosartan, as it may affect the result.

5.    How to store Eprosartan

Keep this medicine outofthe sightand reach of children Do not use Eprosartan after the expiry date which is stated on the label and carton EXP (month,year). The expiry date refers to the last day of that month.

Do not use Eprosartan if you notice any visible signs of deterioration.

Do notthrow away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer ue. These measures will help protect the environment.

6.    Contents of the pack and other information What Eprosartan contains:

The active substance is eprosartan (as mesilate). Each tablet contains 300mg, 400mg or 600mg of eprosartan. The other ingredients are: lactose, microcrystalline cellulose (E460), magnesium stearate (E572), croscarmellose sodium, hydroxypropylcelluse, hypromellose, titanium dioxide (E171), polysorbate 80 (E433) and macrogol 400

•    The 300 mg and 600 mg tablets also opadry white

•    The 400 mg tablets also contain iron oxides (E172) and opadry pink

What Eprosartan looks like and contents of the pack

300 mg: White to off white, oval shaped, biconvex film-coated tablets debossed with 'I' on one side and '120' on other side.

400 mg: Pink, oval shaped, biconvex film-coated tablets debossed with 'I' on one side and '121' on other side.

600 mg: White to off-white, modified capsule shaped, biconvex film-coated tablets debossed with 'H' on one side and '188' on other side.

Eprosartan is available in blister packs containing 28 or 56 tablets.

Marketing Authorisation Holder Hetero Europe S.L.

Viladecans Business Park, Catalunya 83-85- Edificio Brasil, 08840, Viladecans-Barcelona, Spain.

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000 Malta

This leaflet was last approved in October 2014.

Size: 180x230 mm