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SECALIP SUPRA 160MG TABLETS

Active substance(s): FENOFIBRATE / FENOFIBRATE / FENOFIBRATE

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Ref: 0831/230617/1/F

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Supralip 160mg Tablets / Secalip Supra 160mg Tablets
(fenofibrate)
Patient Information 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, or 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, or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
Your medicine is called Supralip 160mg Tablets / Secalip Supra 160mg
Tablets and will be referred to as Supralip throughout the leaflet.
What is in this leaflet:
1 What Supralip is and what it is used for
2 What you need to know before you take Supralip
3 How to take Supralip
4 Possible side effects
5 How to store Supralip
6 Contents of the pack and other information

1

What Supralip is and what it is used for

Supralip 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.
Supralip 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.
Supralip 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

What you need to know before you take Supralip

Do not take Supralip if:
• you are allergic to fenofibrate or any of the other ingredients of this
medicine (listed in Section 6: Contents of the pack and other further
information)
• you are allergic to peanut or arachis oil or soya lecithin or related products
• while taking other medicines (such as other fibrates or an
anti-inflammatory medicine called ‘ketoprofen’) you have had an allergic
reaction or skin damage from sunlight or UV light
• you have severe liver, kidney or gallbladder problems
• you have pancreatitis (an inflamed pancreas which causes abdominal
pain) which is not caused by high levels of fat in the blood
Do not take Supralip if any of the above apply to you. If you are not sure,
talk to your doctor or pharmacist before taking Supralip.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Supralip 160 mg if:
• you have any liver or kidney problems
• you may have an inflamed liver (hepatitis) - signs include yellowing of the
skin and the whites of the eyes (jaundice), an increase in liver enzymes
(shown in blood tests), stomach pain and itching
• you have an under-active thyroid gland (hypo-thyroidism)
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Supralip.
Supralip and effects on muscles
Stop taking Supralip and see a doctor straight away if you get
- unexplained cramps
- painful, tender or weak muscles
This is because this medicine may cause muscle problems, which may be
serious. These problems are rare but include muscle inflammation
breakdown. This can cause kidney damage or even death.

Your doctor may do a blood test to check your muscles before and after
starting treatment.
The risk of muscle breakdown is higher in some patients. In particular, tell
your doctor if:
• you are over 70 years old
• you have kidney problems
• you have thyroid problems
• you or a close family member has muscle problem which runs in the family
• you drink large amounts of alcohol
• you are taking medicines called statins to lower cholesterol (such as
simvastatin, atorvastatin, pravastatin, rosuvastatin or fluvastatin)
• you have ever had muscle problems during treatment with statins or
fibrates (such as fenofibrate, bezafibrate or gemfibrozil).
If any of the above apply to you (or you are not sure), talk to your doctor
before taking Supralip.
Other medicines and Supralip
Tell your doctor or pharmacist if you are taking have recently taken or might
take any other medicines.
In particular tell your doctor or pharmacist if you are taking any of the
following medicines:
• anti-coagulants to thin your blood (such as warfarin)
• other medicines to control levels of fat in the blood (such as, statins or
fibrates). This is because taking statin or another fibrate in addition to
Supralip may increase the risk of muscle problems
• a particular class of medicines to treat diabetes (such as rosiglitazone
or pioglitazone)
• ciclosporin (an immunosuppressant)
If any of the above apply to you (or you are not sure), talk to your doctor
or pharmacist before taking Supralip.
Pregnancy, breast-feeding and fertility
• Tell your doctor if you are pregnant, think you may be pregnant or are
planning to have a baby. This is because it is not know how Supralip may
affect your unborn baby. You should only use Supralip if your doctor tells
you to.
• Do not use Supralip if you are breast feeding or planning to breast-feed
your baby. This is because it is not known whether Supralip passes into
human milk
Driving and using machines
This medicine will not affect you being able to drive or use tools or
machines.
Supralip contains lactose, sucrose and soya oil
- Supralip contains sugars called lactose. If you have been told by your
doctor that you cannot tolerate or digest some sugars (have an
intolernace), talk to your doctor before taking this medicine.
- Supralip contains soya oil. If you are allergic to peanuts, arachis oil or
soya, do not take this medicine.

3

How to take Supralip

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the appropriate strength for you, depending on
your condition, your current treatment and your personal risk status.
Taking this medicine
Take the tablet with food - it will work as well if your stomach is empty.
- Swallow the tablet with a glass of water.
- Do not crush or chew the tablet.
Remember that as well as taking Supralip, it is also important that you:
- have low fat diet
- take regular exercise
How much to take
The recommended dose is one tablet a day. If you are already taking one
capsule of Lipantil Micro 200 mg, you can change to one tablet of Supralip
160 mg. You will still receive the same amount of medicine.
People with kidney problems
If you have kidney problems, your doctor may tell you to take a lower dose.
Ask your doctor or pharmacist about this.
Use in children and adolescents
The use of Supralip is not recommended in children and young people under
18 years old.

Ref: 0831/230617/1/B

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Supralip 160mg Tablets / Secalip Supra 160mg Tablets
(fenofibrate)
Patient Information Leaflet (continued)
If you take more Supralip than you should
If you take more Supralip than you should or if someone else has taken your
medicine, tell your doctor or contact your nearest hospital.
If




you forget to take Supralip
If you forget to take a dose, take the next dose with your next meal.
Then take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose

If you are worried about this talk to your doctor.
If you stop taking Supralip
Do not stop taking Supralip unless your doctor tells you to, or the tablets
make you feel unwell. This is because you require long-term treatment. If
your doctor stops your medicine, do not keep any leftover tablets unless
your doctor tells you to.

Not known: it is not known how often these happen:
• muscle breakdown
• complications of gallbladder stones
• feeling exhausted (fatigue)
Tell your doctor or pharmacist if you notice any of the side effects listed
above.
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.
By reporting side effects you can help provide more information on the
safety of this medicine.

If you have any further qiestions on the use of this medicine, ask your doctor
or pharmacist.
5
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking Supralip and see a doctor straight away, if you notice any
of the following serious side effects – you may need urgent medical
treatment:
Uncommon: may affect up to 1 in 100 people
- cramps or painful, tender or weak muscles - these may be signs of muscle
inflammation or breakdown, which can cuase kidney damage or even
death
- stomach pain - this may be a sign that your pancreas is inflamed
(pancreatitis)
- chest pain and feeling breathless - these may be signs of a blood clot in
the lung (pulmonary embolism)
- pain, redness or swelling in the legs - these may be signs of a blood clot in
the leg (deep vein thrombosis)

How to store Supralip

• Do not store above 30°C. Store in original package.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use this medicine after the expiry date shown on the carton label
or
blister strip. If your doctor tells you to stop taking this medicine, return any
unused medicine to your pharmacist for safe disposal. Only keep this
medicine, if your doctor tells you to. If your medicine becomes discoloured
or shows any other signs of deterioration, consult your pharmacist who will
tell you what to do.
• Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to anyone, it may harm them, even if their symptoms
are the same as yours. This leaflet does not tell you everything about this
medicine. If you have any questions or are not sure about anything then
ask your doctor or pharmacist.

6

Contents of the pack and other information

Rare: may affect up to 1 in 1,000 people
- allergic reaction - the signs may include swelling of the face, lips, tounge
or throat, which may cause difficulty in breathing
- yellowing of the skin and whites of the eyes (janudice), or an increase in
liver enzymes - these may be signs of an inflamed liver (hepatitis)

What this medicine contains:
Each film-coated tablet contains 160mg fenofibrate as the active ingredient.
Your medicine also contains the following inactive ingredients: sodium
laurilsulfate, lactose monohydrate, povidone, crospovidone, microcrystalline
cellulose, silica colloidal anhydrous, sodium stearyl fumarate, polyvinyl
alcohol, titanium dioxide (E171), talc, soybean lecithin and xanthan gum.

Not known: it is not known how often these happen
- severe skin rash which reddens, peels and swells and looks like a severe
burn
- long-trem lung problems

What this medicine looks like and contents of the pack
Supralip are white, oblong, film-coated tablets engraved with “160” on one
side and “Fournier logo” on the other side. Each blister strip contains 10
tablets. They are available in packs of 30 tablets

Stop taking Supralip and see a doctor straight away, if you notice any of the
side effects above.

Manufacturer and Licence Holder
This medicine is manufactured by Recipharm Fontaine, Rue des
Prés-Potets, 21121 Fontaine Les Dijon, France and is procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.

Other side effects include:
Common may affect up to 1 in 10 people:
• diarrhoea
• stomach pain
• wind (flatulence)
• feeling sick (nausea)
• being sick (vomiting)
• raised levels of liver enzymes in the blood - shown in tests
• increased in homocysteine (too much of this amino acid in the blood has
been associated to a higher risk of coronary heart disease, stroke and
peripheral vascular disease, although a causal link has not been
established)
Uncommon may affect up to 1 in 100 people:
• headache
• gallstones
• reduced sex drive
• rash, itching or red patches on the skin
• increase in creatinine (produced by the kidneys) - shown in tests
Rare may affect up to 1 in 1,000 people:
• hair loss
• increase in urea (produced by the kidneys) -shown in tests
• skin is more sensitive to sunlight, sun lamps and sunbeds
• drops in haemoglobin (that carries oxygen in the blood and white blood
cells - shown in tests

If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0831

Supralip 160mg Tablets

Supralip and Secalip are registered trademarks of Fournier Industrie et
Sante.
Revision date: 23/06/17

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 to obtain the leaflet
in a format suitable for you

Expand Transcript

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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