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BEZALIP RETARD 400MG TABLETS

Active substance(s): BEZAFIBRATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

BEZALIP® RETARD 400mg TABLETS
BEZALIP® MONO 400mg TABLETS
(Bezafibrate)
Patient Information Leaflet

27mm

This medicine is known as the above names but will be referred to as Bezalip Mono throughout this leaflet.

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.

DATE:

Pregnancy and breast-feeding
Speak to your doctor before taking Bezalip Mono during pregnancy or breast-feeding.

TVT CHECKED

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

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

11/03/14
DATE OF PROOF:

CODE:

6464/0299D

DATE:

DT
PRODUCT:

Bezalip retard 400mg tabs

ARTWORKER:

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. 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 cholestyramine (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.

Q.A.
APPROVED:

CUSTOMER
APPROVED:

Check with your doctor or pharmacist before taking Bezalip Mono 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.

05-0440
PRE-PRESS NO.:
Waymade
CUSTOMER:

WARNING!

2. Before you take
Do not take Bezalip Mono and tell your doctor if you:
• are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section
6).
• are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light
(e.g. sunbeds) when taking these medicines.
• 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.
• are having dialysis.
• have liver disease.
• have gall bladder disease.
• have nephrotic syndrome (a kidney disorder).
• have impaired kidney function.

Sugar intolerance
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.
Tests
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out tests
3. How to take
Always take Bezalip Mono exactly as your doctor has told you. If you are not sure, check with your doctor or
pharmacist.
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.
Doses:
Adults: One tablet a day (400mg bezafibrate a day).
Elderly: Your 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 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 the tablets
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.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
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CRESTOR 6464/2069 2070

Index
1. What Bezalip Mono is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information

PROOF HISTORY:
v.1 - waymade - 11/03/14

«PAdBì

Leaflet Flat Size = 148 x 400

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 symptoms are the same as yours.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000D

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

4. Possible side effects
Like all medicine, Bezalip Mono 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.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
• Common (occurs in less than 1 in 10 users):
decreased appetite, stomach disorders.

• Very rare (occurs in less than 1 in 10,000 users):
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), 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), 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.
If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or
pharmacist.
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 at:
www.mhra.gov.uk/yellowcard.




DATE:

CUSTOMER
APPROVED:




5. How to Store
There are no special storage conditions for Bezalip Retard 400mg Tablets/Bezalip Mono 400mg
Tablets.
Do not use after the expiry date printed on the carton, label or blister strip. The expiry date refers to
the last day of that month.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If the tablets become discoloured or show any other signs of deterioration, you should ask your
doctor or pharmacist before taking them.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
Your medicine is called Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets. Each modified release
tablet contains 400mg of the active ingredient, bezafibrate.
The tablet is round, white, film-coated and marked ‘BM’ on one side and ‘D9' on the other side or the tablet is
round, white, film-coated and marked ‘D9’ on one side and plain on the reverse.
Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets also contain the following:
lactose, povidone K25, polymethacrylic acid esters, macrogol 10000, hypromellose, talc, polysorbate 80,
titanium dioxide (E171), sodium citrate dihydrate, colloidal silica anhydrous, sodium lauryl sulphate and
magnesium stearate.

DATE:

DT

11/03/14

ARTWORKER:

DATE OF PROOF:

POM

PL No: 6464/0299

This product is manufactured by Patheon Italia S.p.A., Monza, Milan, Italy, and/or, Cenexi 52, Rue Marcel et
Jaques Gaucher, 94120 Fontenay-Sous-Bois, France and procured from within the EU and repackaged by
the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 11.03.2014
BEZALIP is a registered trademark of HOFFMANN-LA-ROCHE AG

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

TVT CHECKED
6464/0299D

CODE:

PRODUCT:

Bezalip retard 400mg tabs

Q.A.
APPROVED:
PRE-PRESS NO.:
CUSTOMER:

Waymade

05-0440

Bezalip Retard 400mg Tablets/Bezalip Mono 400mg Tablets are available as blister packs of 30 tablets.

Colour
Swatch

Black

000-0000D

WARNING!



WARNING!

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

• Rare (occurs in less than 1 in 1,000 users):
damage to nerve endings causing tingling, pins and needles, inflammation of the pancreas (pancreatitis),
depression, difficulty sleeping.

PROOF HISTORY:
v.1 - waymade - 11/03/14

«PAdBì

Leaflet Flat Size = 148 x 400

• Uncommon (occurs in less than 1 in 100 users):
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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