Informations for option: Fenofibrate 267mg Capsules, show other option

Select option:

1. Fenofibrate 267mg Capsules
2. Fenofibrate 267mg Capsules

Document: document 0 change

• document 0
• document 1

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

FENOFIBRATE 200 mg CAPSULES FENOFIBRATE 267 mg CAPSULES

In this leaflet:

1.    What Fenofibrate Capsules are and what they are used for

2.    Before you take Fenofibrate Capsules

3.    How to take Fenofibrate Capsules

4.    Possible side effects

5.    How to store Fenofibrate Capsules

6.    Further information

1. WHAT FENOFIBRATE CAPSULES ARE AND WHAT THEY ARE USED FOR

Fenofibrate belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides.

Fenofibrate is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.

Fenofibrate can be used in addition to other medicines [statins] in some circumstances when levels of fats in the blood are not controlled with a statin alone.

2. BEFORE YOU TAKE FENOFIBRATE CAPSULES

Do not take Fenofibrate Capsules if any of the following apply to you:

•    If you have previously had an allergic reaction to Fenofibrate or any of the ingredients listed in section 6 (an allergic reaction can include rashes, hives, itching, swelling of face/lips/hands/feet or breathing difficulties)

•    If you have been sensitive to or had an allergy to the sunlight whilst taking drugs such as fibrates or anti-inflammatory drugs (e.g. ketoprofen)

•    If you have severe kidney or liver problems (including biliary cirrhosis)

•    If you have a problem with your gallbladder

•    If you are pregnant, breast-feeding, or planning to get pregnant Take special care with Fenofibrate Capsules:

Please tell your doctor:

•    if you have kidney problems (your doctor may need to start you on a lower dose)

•    if you have pancreatitis (inflammation of the pancreas)

•    if you have hypothyroidism (low thyroid function)

•    if you have liver problems

•    if you or your family have had muscle problems

•    if you have problems with certain proteins in your blood

•    if are over 70 years of age

Please tell your doctor if any of the above was applicable to you in the past.

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.

You should especially be aware and notify your doctor if you:

•    are already taking drugs to lower your lipids (fats). Example drugs known as “statins” or other “fibrates”.

•    are taking oestrogens e.g. HRT or oral contraceptive pills

•    are taking anticoagulants (drugs that “thin” the blood) e.g. warfarin

•    are taking cyclosporine (an immunosuppressant)

Taking Fenofibrate Capsules with food and drink The capsules should be taken with or after food.

You should avoid drinking alcohol with Fenofibrate as this increases the risk of muscle problems.

Pregnancy and breast-feeding

Tell your doctor if you are, you think you might be or are planning to become pregnant. Fenofibrate Capsules must not be taken if you are pregnant or are breast feeding.

Askyour doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of Fenofibrate Your medicine contains an inactive ingredient called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Your medicine also contains small amounts of inactive ingredients called sunset yellow (E 110) and FD & C blue (E 132) which are found in the 200 mg and 267 mg capsules respectively. These are colouring agents and can cause allergic reactions.

3. HOW TO TAKE Fenofibrate Capsules

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage:

The usual doses for Fenofibrate are:

200mg and 267mg capsules: The recommended dose is one 200mg capsule taken once daily, with food. In patients with very high lipids your doctor may recommend an increased dose of 267mg daily.

Do not change your dose without instruction to do so by your doctor.

The response to treatment will be monitored by regular blood tests to check levels of fats in your blood. Your dose may be altered according to your response. Blood tests will also be done to check your liver function and, if necessary, your kidney function.

Use in children and adolescents

Safety and efficacy of this medicine in children and adolescents younger than 18 years has not been established. Therefore, the use is not recommended.

Methods and route of administration

•    Swallow the capsule(s) whole with a glass of water.

•    The capsules should be taken with or after food.

•    To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

If you have the impression that the effect of Fenofibrate Capsules is too strong or too weak, talk to your doctor or pharmacist.

If you take more Fenofibrate Capsules than you should

If you have taken more Fenofibrate Capsules than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet or some capsules with you

5095283] FENOFIBRATE Caps PIL (DWS-UK) Size : 122 x 384 mm RLL-DWS : 17.04.12nj, (85279)

Reflex Blue U

^ BLACKU