LIPSIN 200 mg Kapsułka Twarda

Treść ulotki

1. Lipsin 200 mg hard capsules
   1. What is Lipsin and what it is used for
   2. What you need to know before taking Lipsin
   3. How to take Lipsin
   4. Possible side effects
   5. How to store Lipsin
   6. Package Contents and Other Information

Lipsin 200 mg hard capsules

Fenofibrate

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lipsin and what it is used for

Lipsin contains the active ingredient fenofibrate and belongs to a group of medicines
commonly called “fibrates”. These medicines are used to lower the level of fats
(lipids) in the blood, for example 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 lower
blood fat levels.
In addition, Lipsin can be used:

• in addition to other medicines, called “statins” when blood fat levels are not controlled by the statin alone;
• when it is not possible to carry out treatment with statins (for example, it is not tolerated or you are allergic to these medicines).

2. What you need to know before taking Lipsin

Do not take Lipsin if:

• you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• while taking other medicines, you have had an allergic reaction or skin damage caused by sunlight or UV rays (these medicines include other fibrates and an anti-inflammatory drug called “Ketoprofene”);
• you have severe problems with your liver or kidneys, or diseases of the gallbladder;
• you have pancreatitis (an inflammation of the pancreas that causes abdominal pain and poor digestion), which is 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 problems with your liver or kidneys;
• you have inflammation of the liver (hepatitis) which manifests with yellowing of the skin and eyes (jaundice), increased liver enzymes in the blood. In such cases, the doctor will assess the possibility of stopping treatment with Lipsin;
• you have low levels of proteins in your 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 have widespread pain, weakness or cramps in the
muscles, during therapy with this medicine.

• This is because Lipsin can cause muscle problems, even serious ones.
• These problems are manifestations of inflammation (myositis) and breakdown (rhabdomyolysis) of the muscles; rarely they can also cause kidney damage. The doctor will assess whether to perform a blood test to check the muscles before and after starting treatment.

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

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

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

• other medicines used to lower fat levels in the blood (such as statins or other fibrates). Taking one of these medicines with Lipsin, the risk of having muscle problems is increased (see “Effects on muscles”);
• glitazones, medicines used in diabetes;
• medicines that thin the blood (such as warfarin);
• cyclosporine, a medicine used to suppress the immune system;
• oestrogens or contraceptives containing oestrogens.

LIPSIN and food
It is important that you take the capsule with food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.
Do not use Lipsin if you are breastfeeding

Driving and using machines
Lipsin does not impair the ability to drive or operate machinery.

Lipsin contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them 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 following exactly the instructions of your doctor. If you have
any doubts, consult your doctor or pharmacist.
The doctor will establish the appropriate dosage for you, depending on your condition, your
current treatment and your personal risk status.

Dosage
The usual dose is 1 capsule (200 mg) per day.
Remember that in addition to taking Lipsin it is important to:

• have a low-fat diet;
• do regular exercise.

If after 3 - 6 months of treatment the levels of fats in the blood have not decreased, the doctor
will evaluate the possibility of modifying the therapy.

Method of administration
Take this medicine by mouth (oral use), during meals. Swallow the capsule
whole with a glass of water.

People 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
next meal. Do not take a double dose to make up for the missed dose.

If you stop taking Lipsin
Do not stop taking Lipsin and respect the duration of the therapy established by your doctor. This is
important because abnormal levels of fats in the blood must be treated for a
long period of time.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• allergic reactions manifesting with swelling of the face, eyes, lips, tongue and throat with possible difficulty breathing, increased heart rate with possible sudden drop in blood pressure;
• widespread pain, weakness or muscle cramps. These problems are manifestations of inflammation (myositis) and breakdown (rhabdomyolysis) of the muscles; they can rarely also cause kidney damage;
• yellowing of the skin and eyes (jaundice) or an increase in liver enzymes in the blood, possible signs of liver inflammation (hepatitis);
• severe skin rashes with redness, blistering and peeling, ulcers of the mouth, lips and skin (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Inform your doctor if you notice the following during therapy with Lipsin:

Common side effects(may affect up to 1 in 10 people)

• problems with the stomach or intestines, such as abdominal pain, nausea, vomiting, diarrhea, presence of gas in the intestine (flatulence);
• increased transaminases in the blood;
• increased homocysteine (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 link 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 that assesses kidney function) in the blood.

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

• changes in blood counts such as: decrease in hemoglobin (a substance that carries oxygen in the blood) and white blood cells, increase in urea (a substance that assesses kidney function);
• hair loss (alopecia);
• increased sensitivity of the skin to sunlight or sunlamps (photosensitivity).

Other side effects(frequency cannot be estimated)

• irregular heartbeat;
• impaired kidney function such as: difficulty urinating (dysuria), decreased urine production (oliguria), presence of blood in the urine (hematuria) or protein (proteinuria);
• increased appetite (polyphagia) and weight;
• lung problems (interstitial lung disease);
• complications of gallstones, example inflammation of the gallbladder (cholecystitis, cholangitis) or abdominal pain (biliary colic);
• feeling exhausted (fatigue).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging.
The expiry date refers to the last day of that month.
Store at a temperature not exceeding 30°C and in the original packaging to
protect the medicine from humidity.
Do not dispose of any medicine in 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 ingredient is: fenofibrate. Each Lipsin capsule contains: 200 mg of fenofibrate.
• The other ingredients 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 package contents
Lipsin is available in packs of 20 capsules

Marketing Authorisation Holder
I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM)

Manufacturer
Recipharm Fountaine SAS - Rue des Prés Potets - 21121 Fontaine lès Dijon (France)