BEZALIP MONO 400 MG TABLETS - patient leaflet, side effects, dosage

Patient leaflet - BEZALIP MONO 400 MG TABLETS

Bezalip Mono

(bezafibrate)

Your medicine is known by the above name, but will be referred to as Bezalip Mono throughout this leaflet.

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, pharmacist or nurse.
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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Bezalip Mono is and what it is used for
2.What you need to know before you take Bezalip Mono
3.How to take Bezalip Mono
4.Possible side effects
5.How to store Bezalip Mono
6.Contents of the pack and other information

1. what bezalip mono is and what it is used for

Bezalip Mono 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.

Bezalip Mono 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.

2. what you need to know before you take bezalip mono

Do not take Bezalip Mono:

if you are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6).
if you are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines.
if you are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
– impaired kidney function
– an underactive thyroid (hypothyroidism)
– severe infection
- trauma
- surgery
– a change in the levels of hormones or chemicals in your body (seen in a blood test)
– a high alcohol intake.

if you are having dialysis.
if you have liver disease.
if you have gall bladder disease.
if you have nephrotic syndrome (a kidney disorder).
if you have impaired kidney function.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Bezalip Mono:

if you have an abnormal level of fats (lipids) in your blood caused by:
– uncontrolled type 2 diabetes mellitus
– an underactive thyroid (hypothyroidism)
– nephrotic syndrome (a kidney disorder)
– an abnormal protein content in the blood
– obstructive liver disease
– medication

if you have an alcohol addiction.
if you have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
– impaired kidney function
– an underactive thyroid (hypothyroidism)
– severe infection
– trauma
– surgery
– a change in the levels of hormones or chemicals in your body (seen in a blood test)
– a high alcohol intake
– are elderly (over 65 years old)
– have a family history of muscle disease.

Children and adolescents

Bezalip Mono should not be used in children.

Other medicines and Bezalip Mono

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines. Especially:

coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting).
antidiabetic medicines such as insulin (used in diabetes).
ciclosporin (used to suppress the immune system).
anion exchange resins such as colestyramine (used to lower cholesterol). Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.
statins e.g. atorvastatin (used to lower cholesterol).
monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression).
oestrogen or medicines which contain oestrogen.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Bezalip Mono may make you feel dizzy. Make sure you are not affected before you drive or operate machinery.

Tests

If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests.

Important information about some of the ingredients of Bezalip Mono

This medicine contains lactose. If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take bezalip mono

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

LACK

Swallow the tablets whole with water, after food in the morning or evening.

Bezalip Mono and an anion exchange resin should not be taken within 2 hours of each other.

The recommended dose is:

Adults: One tablet a day (400mg bezafibrate a day).

Elderly: Y our doctor may reduce the dose depending on how well your kidneys are working.

Children: Not recommended.

Impaired kidney function: Do not take Bezalip Mono if you have impaired kidney function or are having dialysis.

If you take more Bezalip Mono than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis).

If you forget to take Bezalip Mono

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you notice signs of:

an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing.
gallstones: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice).
abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling.
severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome)
severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Common (may affect up to 1 in 10 people):

decreased appetite
stomach disorders.

Uncommon (may affect up to 1 in 100 people):

dizziness
headache
bloated feeling
feeling sick
diarrhoea
stomach pain
constipation
indigestion
blocked bile flow (cholestasis)
itching
pale or red irregular raised patches with severe itching (hives)
rash
sensitivity to sunlight or artificial light (e.g. sun beds)
hair loss (alopecia)
muscle weakness, cramps or pain (myalgia)
acute kidney failure
erection problems
changes in the levels of certain enzymes within the body (seen in a blood test)
increased blood levels of creatinine.

Rare (may affect up to 1 in 1000 people):

damage to nerve endings causing tingling, pins and needles
inflammation of the pancreas (pancreatitis)
depression
difficulty sleeping.

Very rare (may affect up to 1 in 10,000 people):

inflammation in the lungs (interstitial lung disease)
decreased levels of platelets in the blood causing a disorder characterised by blood spots
bruising and discolouring to the skin (thrombocytopenic purpura)
decreased levels of the red blood pigment haemoglobin
increased levels of certain enzymes within the body (seen in a blood test)
circular, irregular red patches on the skin of the hands and arms (erythema multiforme)
changes in the numbers and types of your blood cells.

If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

Reporting of side 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 the Yellow Card Scheme website at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store bezalip mono

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Bezalip Mono after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

6. contents of the pack and other information

What Bezalip Mono contains

The active substance (the ingredient that makes the tablets work) is bezafibrate.

Each tablet contains 400mg bezafibrate.

Also includes lactose monohydrate, povidone K25, sodium laurilsulfate, hypromellose 100 mPas, colloidal hydrated silica, magnesium stearate, polymethacrylic acid esters, hypromellose 3 mPas, macrogol 10,000, talc, titanium dioxide, polysorbate 80, sodium citrate.

What Bezalip Mono looks like and contents of the pack

Each round, white round film-coated modified release tablet is marked ‘D9’ on one side, plain on the reverse.

Bezalip Mono are available in blister packs of 30.

Manufactured by Cenexi,52, Rue Marcel et Jacques Gaucher, 94120 Fontenay-Sous-Bois, France. Procured from within the EU and repackaged by Product Licence Holder Uni Health Distribution Limited, Unit G4 Riverside Industrial Estate, Riverside Way, Dartford, Kent, DA1 5BS.

PL 45396/0193 |POM|

Leaflet date: 30 March 2021 Ref: Bez400/UT1

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Bezalip Mono is a registered trademark of Actavis Group PTC ehf.