Eprosartan 400 Mg Film-Coated Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER Eprosartan 300mg, 400mg and 600mg film-coated tablets
eprosartan mesilate
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.
■ This medicine has been prescribed for you. 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).
In this leaflet:
1. What Eprosartan is and what it is used for
2. What you need to know before you take Eprosartan
3. How to take Eprosartan
4. Possible side effects
5. How to store Eprosartan
6. Contents of the pack and other information
1. What Eprosartan is and what it is used for Eprosartan 300mg, 400mg and 600mg film-coated tablets contains a medicine called Eprosartan mesilate. This belongs to a group of medicines called 'angiotensin II receptor antagonists'.
This medicine is used to treat high blood pressure, also called hypertension.
The main cause of high blood pressure is narrowing of the blood vessels. This increases the amount of work your heart must do to pump blood around your body. You may not feel unwell, but if high blood pressure is not treated, it can lead to heart disease and stroke.
How Eprosartan works:
■ Angiotensin II is a chemical found in the body which makes your blood vessels contract. This makes it more difficult for blood to pass through them
■ This causes your blood pressure to rise
■ Eprosartan works by preventing the chemical, angiotensin II, from causing your blood vessels to contract. This has the effect of lowering your blood pressure.
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 of this medicine (listed in section 6);
■ if you have severe liver problems;
■ if you are more than 3 months pregnant (it is better to avoid Eprosartan in early pregnancy - see "pregnancy and breast-feeding" 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 of the 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 check your 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')
■ You think 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 not work, 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 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 Eprosartan".
If you are not sure if any of the above apply to you, talk to your 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 of the following medicines: Medicines for pain and inflammation such as ibuprofen, diclofenac, celecoxib, etoricoxib or lumiracoxib (Nonsteroidal anti-inflammatory medicines)
■ Potassium supplements, potassium-sparing agents or potassium-containing salt substitutes
■ Water tablets (Diuretics) such as hydrochlorothiazide and calcium channel blocker such as nifedipine which may be used to help lower your blood pressure
■ Aspirin (more than 3g 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/or take other precautions:
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings "Do not take 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 if you think you 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.
Driving and using machines
You may feel tired or dizzy when you start taking Eprosartan.
If this happens, do not drive or use any tools or machines until these effects wear off.
(continued overleaf)
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WIP URN |
V |
251114-GEP01-PIL-03 |
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APPROVED URN |
N/A | |
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Job |
Eprosartan PIL - Side 1 | |
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Size |
180 x 230mm | |
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Date |
25 November 2014 | |
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BOH Approval Date | ||
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Saved as |
14131/03 PIL S1.ai M1 |
Prints
1 Colour - Black