Package leaflet: Information for the user

Lipsin 200 mg hard capsules

Fenofibrate
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lipsin is and what it is used for
What you need to know before taking Lipsin
How to take Lipsin
Possible side effects
How to store Lipsin
Contents of the pack and other information

1. What Lipsin is and what it is used for

Lipsin contains the active substance fenofibrate and belongs to a group of medicines commonly known as "fibrates". These medicines are used to lower the level of fats (lipids) in the blood, such as fats known as triglycerides.
Lipsin is used together with a low-fat diet and other non-pharmacological treatments such as exercise and weight loss, to reduce blood fat levels.
Additionally, Lipsin may be used:

in combination with other medicines called "statins" when blood fat levels are not controlled by statins alone;
when treatment with statins is not possible (e.g. not tolerated or allergic to such medicines).

2. What you should know before taking Lipsin

Do not take Lipsin if:

you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6);
while taking other medicines, you have experienced an allergic reaction or skin damage caused by sunlight or UV rays (these medicines include other fibrates and an anti-inflammatory drug called "Ketoprofen");
you have severe liver or kidney problems, or gallbladder disease;
you have pancreatitis (inflammation of the pancreas causing abdominal pain and poor digestion) not caused by high levels of fats in the blood;
you are breastfeeding;
you are under 18 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lipsin if:

you have liver or kidney problems;
you have liver inflammation (hepatitis), which manifests as yellowing of the skin and eyes (jaundice) or increased liver enzymes in the blood. In such cases, your doctor will assess whether treatment with Lipsin should be discontinued;
you have low levels of protein in the blood (dysproteinemia);
you drink large amounts of alcohol;
you have diabetes;
you have a stomach or duodenal ulcer;
you have reduced thyroid function (hypothyroidism).

Effects on muscles
Stop taking Lipsin and consult your doctor if you experience widespread muscle pain, weakness, or cramps during treatment with this medicine.

This is because Lipsin may cause muscle problems, even serious ones.
These problems may be signs of muscle inflammation (myositis) and breakdown (rhabdomyolysis); rarely, they may also cause kidney damage. Your doctor may decide to perform a blood test to monitor muscle health before and after starting treatment.

The risk of muscle damage is higher in certain patients. Remember to inform your doctor if:

you are over 70 years old;
you have low levels of albumin in the blood;
you have or have had muscle problems, or if a family member has had muscle problems;
you have kidney problems;
you have reduced thyroid function (hypothyroidism);
you drink large amounts of alcohol;
you are taking other medicines belonging to the class of "fibrates";
you are taking drugs called statins, used to lower blood fat levels, such as simvastatin or atorvastatin.

Other medicines and Lipsin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
This is particularly important if you are taking:

other medicines used to lower blood fat levels (such as statins or other fibrates). Taking any of these medicines with Lipsin increases the risk of muscle problems (see "Effects on muscles");
glitazones, medicines used in diabetes;
blood-thinning medicines (such as warfarin);
cyclosporine, a medicine used to suppress the immune system;
estrogens or contraceptives containing estrogens.

Lipsin and food
It is important that you take the capsule with food.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Lipsin if you are breastfeeding.
Driving and using machines
Lipsin does not affect the ability to drive or operate machinery.
Lipsin contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".

3. How to take Lipsin

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will determine the appropriate dose for you, depending on your condition,
your current treatment, and your individual risk factors.
Dose
The usual dose is 1 capsule (200 mg) daily.
Please remember that in addition to taking Lipsin, it is important to:

follow a low-fat diet;
exercise regularly.

If after 3–6 months of treatment your blood fat levels have not decreased, your doctor will
evaluate whether to modify your therapy.
Method of administration
Take this medicine by mouth (oral use), during meals. Swallow the capsule whole with
a glass of water.
Patients with liver or kidney problems
If you have liver or kidney problems, your doctor may advise you to take a lower dose
than those indicated above.
Children and adolescents
The use of Lipsin is not recommended in children and adolescents under 18 years of age.
If you take more Lipsin than you should
If you take more Lipsin than you should, inform your doctor or go to the nearest hospital.
If you forget to take Lipsin
If you forget to take a dose of this medicine, take the next dose at the following meal.
Do not take a double dose to make up for a missed dose.
If you stop taking Lipsin
Do not stop taking Lipsin and follow the treatment duration prescribed by your doctor. This is
important because abnormal levels of fats in the blood need to be treated over a long period
of time.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Lipsin immediately and contact your doctor if you experience any of the following serious conditions:

allergic reactions showing as swelling of the face, eyes, lips, tongue or throat, possibly causing breathing difficulties, increased heart rate and possibly a sudden drop in blood pressure;
widespread muscle pain, weakness or cramps. These symptoms may indicate muscle inflammation (myositis) and muscle breakdown (rhabdomyolysis); in rare cases, this can also lead to kidney damage;
yellowing of the skin or eyes (jaundice) or increased liver enzymes in the blood, which may be signs of liver inflammation (hepatitis);
severe skin rashes with redness, blistering and skin peeling, or mouth, lip and skin ulcers (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor if, during treatment with Lipsin, you notice:
Common side effects (may affect up to 1 in 10 people)

stomach or intestinal problems such as abdominal pain, nausea, vomiting, diarrhoea, or excess gas in the intestines (flatulence);
increased transaminases in the blood;
increased homocysteine levels (elevated levels of this amino acid in the blood have been associated with a higher risk of coronary heart disease, stroke and peripheral vascular disease, although a causal relationship has not been established).

Uncommon side effects (may affect up to 1 in 100 people)

headache;
chest pain and shortness of breath, possible signs of a blood clot in the lung (pulmonary embolism);
pain, redness or swelling in the legs, possible signs of a blood clot in the leg (deep vein thrombosis);
abdominal pain and indigestion, possible signs of inflammation of the pancreas (pancreatitis);
gallstones;
skin rashes, itching or hives (due to allergy);
sexual problems;
increased creatinine (a substance used to assess kidney function) in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

blood disorders such as: decreased haemoglobin (the substance that carries oxygen in the blood) and white blood cells, increased urea (a substance used to assess kidney function) in the blood;
hair loss (alopecia);
increased sensitivity of the skin to sunlight or sunbeds (photosensitivity).

Other side effects (frequency cannot be estimated from the available data)

changes in heart rhythm;
changes in kidney function such as: difficulty urinating (dysuria), reduced urine output (oliguria), presence of blood (haematuria) or protein (proteinuria) in the urine;
increased appetite (polyphagia) and weight gain;
lung problems (interstitial lung disease);
complications of gallstones, for example inflammation of the gallbladder (cholecystitis, cholangitis) or abdominal pain (biliary colic);
feeling exhausted (fatigue).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lipsin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack.
The expiry date refers to the last day of that month.
Store below 30°C and in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lipsin contains

The active substance is: fenofibrate. Each Lipsin capsule contains: 200 mg of fenofibrate.
The other components are: lactose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, crospovidone. Capsule shell: titanium dioxide (E171), yellow iron oxide, erythrosine (E127), gelatin.

Description of the appearance of Lipsin and contents of the pack
Lipsin is available in packs of 20 capsules.
Marketing Authorization Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)
Manufacturer
Astrea Fontaine SAS Rue des Prés Potets - 21121 Fontaine lès Dijon (France)