LOJUXTA 5 мг Капсулы твердые

Содержание инструкции

1. Lojuxta 5 mg hard capsules, 10 mg hard capsules, 20 mg hard capsules
   1. What Lojuxta is and what it is used for
   2. What you need to know before taking Lojuxta
   3. How to take Lojuxta
   4. Possible side effects
   5. How to store Lojuxta
   6. Contents of the pack and other information
2. Lojuxta 30 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules
   1. What Lojuxta is and what it is used for
   2. What you need to know before taking Lojuxta
   3. How to take Lojuxta
   4. Possible side effects
   5. How to store Lojuxta
   6. Package Contents and Other Information

Lojuxta 5 mg hard capsules, 10 mg hard capsules, 20 mg hard capsules

lomitapide
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

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 their symptoms are the same as yours, 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 Lojuxta is and what it is used for
• 2. What you need to know before you take Lojuxta
• 3. How to take Lojuxta
• 4. Possible side effects
• 5. How to store Lojuxta
• 6. Contents of the pack and other information

1. What Lojuxta is and what it is used for

Lojuxta contains the active substance lomitapide. Lomitapide is a “lipid-modifying agent”, which works by blocking the action of the “microsomal triglyceride transport protein”.
This protein is found inside the cells of the liver and intestine, where it is involved
in the assembly of fats into larger particles that are then released into the
bloodstream. By blocking this protein, the medicine reduces the levels of fats and cholesterol
(lipids) in the blood.
Lojuxta is used to treat adult patients with very high cholesterol due to a disease present
in their families (homozygous familial hypercholesterolemia or HoFH). This disease is
usually passed on by both the father and the mother, who also have high cholesterol, passed on
to them by their parents. The patient’s “bad” cholesterol level is very high from a young age. “Bad”
cholesterol can cause heart attacks, strokes, or other events at a young age. Lojuxta is used
to reduce cholesterol levels along with a low-fat diet and other treatments that
lower lipids.
Lojuxta can lower blood levels of:

• LDL cholesterol (low-density lipoproteins, or “bad” cholesterol)
• total cholesterol
• apolipoprotein B, a protein that carries “bad” cholesterol in the blood
• triglycerides (fats carried in the blood)

2. What you need to know before taking Lojuxta

Do not take Lojuxta

• if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems or unexplained abnormal liver tests
• if you have problems with your intestines or are unable to absorb food from your intestines
• if you are taking more than 40 mg of simvastatin per day (another medicine used to lower cholesterol, see section “Other medicines and Lojuxta”)
• if you are taking any of these medicines that affect the way lomitapide is broken down in the body: itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) or telithromycin, clarithromycin, erythromycin (for bacterial infections) or indinavir, nelfinavir, saquinavir, ritonavir (for HIV infection) or diltiazem, verapamil (for high blood pressure or angina) and dronedarone (to regulate heart rhythm)
• if you are pregnant, suspect you may be pregnant or are planning a pregnancy (see section 2, “Pregnancy and breastfeeding”).

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

• you have had liver problems, even while taking other medicines. These capsules can cause side effects that can also be symptoms of liver problems. These side effects are listed in section 4 and you must inform your doctor immediatelyif you experience any of these signs and symptoms as they may be caused by liver damage. Your doctor will prescribe blood tests to check your liver function before you start taking these capsules, if the dose is increased and regularly during treatment. These blood tests will help your doctor adjust the dose. If the tests show liver problems, your doctor may decide to reduce the dose or stop treatment.

In some circumstances you may experience fluid loss/dehydration, for example in case of
vomiting, nausea and diarrhoea. It is important to avoid dehydration by drinking enough
fluids (see section 4).

Children and adolescents
Studies have not been conducted on children and adolescents under 18 years of age. Therefore, the use of this
medicine is not recommended in children and adolescents.

Other medicines and Lojuxta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Other medicines can affect the way Lojuxta works. Do not take any of the following
medicines together with Lojuxta:

• some medicines for bacterial, fungal or HIV infections (see section 2, “Do not take Lojuxta”)
• some medicines for high blood pressure, angina or to regulate heart rhythm (see section 2, “Do not take Lojuxta”)

You should also tell your doctor or pharmacist if you are taking any of the following medicines,
as they may need to adjust the dose of Lojuxta:

• medicines that lower cholesterol (such as atorvastatin)
• combined oral contraceptives (such as ethinylestradiol, norgestimate)
• glucocorticoids (such as beclometasone, prednisolone), steroid medicines used to treat inflammation in conditions such as severe asthma or arthritis
• medicines to treat cancer (such as bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or to treat nausea/vomiting in cancer therapy (such as fosaprepitant)
• medicines to reduce the activity of the immune system (such as cyclosporine, tacrolimus)
• medicines to treat bacterial or fungal infections (such as nafcillin, azithromycin, roxithromycin, clotrimazole)
• medicines to treat and prevent blood clots (such as cilostazol, ticagrelor)
• medicines to treat angina, chest pain caused by the heart (such as ranolazine)
• medicines to lower blood pressure (such as amlodipine, lacidipine)
• medicines to regulate heart rhythm (such as amiodarone)
• medicines to treat epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines to treat diabetes (such as pioglitazone, linagliptin)
• medicines to treat tuberculosis (such as isoniazid, rifampicin)
• tetracycline antibiotics to treat infections such as urinary tract infections
• medicines to treat anxiety and depression (such as alprazolam, fluoxetine, fluvoxamine)
• antacids (such as ranitidine, cimetidine)
• aminoglutethimide, a medicine used to treat Cushing's syndrome
• medicines to treat severe acne (such as isotretinoin)
• paracetamol, to treat pain
• medicines to treat cystic fibrosis (such as ivacaftor)
• medicines to treat urinary incontinence (such as propiverine)
• medicines to treat low sodium levels in the blood (such as tolvaptan)
• medicines to treat excessive daytime sleepiness (such as modafinil)
• some herbal medicines: St. John's wort (for depression) or ginkgo (to improve memory) or goldenseal (for inflammation and infections)

Lojuxta can affect the mechanism of action of other medicines. Tell your doctor or pharmacist
if you are taking any of the following medicines:

• oral contraceptives (see section 2, “Pregnancy and breastfeeding”)
• other medicines used to lower cholesterol such as statins like simvastatin. The risk of liver damage increases when this medicine is used together with statins. Muscle pain or muscle weakness may also occur. Seek immediate medical attention if you experience unexplained muscle pain, tenderness or weakness. When using Lojuxta you should not take more than 40 mg of simvastatin (see section 2, “Do not take Lojuxta”)
• coumarin anticoagulants to thin the blood (such as warfarin)
• medicines to treat cancer (such as everolimus, imatinib, lapatinib, nilotinib, topotecan)
• medicines to reduce the activity of the immune system (such as sirolimus)
• medicines to treat HIV (such as maraviroc)
• medicines to treat and prevent blood clots (such as dabigatran etexilate)
• medicines to treat angina, chest pain caused by the heart (such as ranolazine)
• medicines to lower blood pressure (such as talinolol, aliskiren, ambrisentan)
• medicines to regulate heart rhythm (such as digoxin)
• medicines to treat diabetes (such as saxagliptin, sitagliptin)
• medicines to treat gout (such as colchicine)
• medicines to treat low sodium levels in the blood (such as tolvaptan)
• antihistamines to treat hay fever (such as fexofenadine)

Lojuxta with food, drinks and alcohol

• Do not drink grapefruit juice of any kind.
• Drinking alcohol while taking Lojuxta is not recommended.
• The dose of Lojuxta may need to be adjusted if you consume peppermint oil or bitter orange oil.
• To reduce the possibility of stomach problems, you should follow a low-fat diet while taking this medicine. Talk to a dietitian to find out what you can eat while taking Lojuxta.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant or are planning a
pregnancy, as it may be harmful to the fetus. If you become pregnant while taking
this medicine, contact your doctor immediately and stop taking the capsules.
Pregnancy

• Before starting treatment, you must confirm that you are not pregnant and that you will use effective contraceptive measures, as recommended by your doctor. If you use contraceptive pills and experience an episode of diarrhoea or vomiting lasting more than 2 days, you should use an alternative method of contraception (condoms, diaphragm) for 7 days after the symptoms resolve.
• If, after starting treatment with Lojuxta, you decide that you want to become pregnant, tell your doctor as the treatment will need to be changed.

Breastfeeding

• It is not known whether Lojuxta is excreted in breast milk. Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor may advise you to stop taking Lojuxta or stop breastfeeding.

Driving and using machines
Treatment may affect your ability to drive or operate machines. If you experience
dizziness during treatment, do not drive or operate machines until you feel better.

Lojuxta contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Lojuxta

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. These capsules must be prescribed by a doctor
experienced in the treatment of lipid metabolism disorders, who will regularly monitor you.
The recommended starting dose is one 5 mg capsule per day. Your doctor may slowly increase the
dose over time, up to a maximum of 60 mg per day. Your doctor will tell you:

• what dose to take and for how long
• when to increase or decrease the dose. Do not change the dose on your own.
• Take this medicine once a day with a glass of water before bedtime, at least 2 hours after your evening meal (see section 2, “Lojuxta with food, drinks and alcohol”).
• Do not take this medicine with food, as this may otherwise cause stomach problems (see section 2, “Lojuxta with food, drinks and alcohol”).
• If you are taking another medicine that lowers cholesterol by binding to bile acids, such as colesevelam or colestyramine, take the latter at least 4 hours before or 4 hours aftertaking Lojuxta.

Due to the possibility of interaction with other medicines, your doctor may change the time you
take your medicines. Alternatively, your doctor may decrease the dose of Lojuxta. Tell your
doctor about any changes in the medicines you are taking.
While taking this medicine, you must also take vitamin E and essential fatty acid (omega-3 and omega-6) supplements every day. The dose you will usually need is indicated below.
Ask your doctor or dietitian how to obtain these supplements. See section 2, “Lojuxta with
food, drinks and alcohol”.

Daily amount
Vitamin E
400 IU*

Omega-3Approximately
EPA 110 mg *
DHA 80 mg
ALA 210 mg

Omega-6
Linoleic acid 200 mg
*IU: international units, mg: milligrams

If you take more Lojuxta than you should
Contact your doctor or pharmacist immediately.

If you forget to take Lojuxta
Take the normal dose at the usual time the next day. Do not take a double dose to
make up for a missed dose.

If you stop taking Lojuxta
If you stop taking this medicine, your cholesterol may increase again. Contact
your doctor before stopping treatment with this medicine.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects:

• altered blood tests regarding liver function have been reported commonly (may affect up to 1 in 10 people). Signs and symptoms of liver problems include:

o nausea
o vomiting
o stomach pain
o muscle pain
o fever
o yellowish discoloration of the skin or whites of the eyes
o feeling more tired than usual
o flu-like feeling

Tell your doctor immediatelyif you experience any of these symptoms as they
may decide to stop treatment.
The following other side effects have also been reported:

Very common (may affect more than 1 in 10 people):

• diarrhoea
• nausea and vomiting
• stomach pain or discomfort or stomach bloating
• decreased appetite
• indigestion
• flatulence (gas)
• constipation
• weight loss

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

• inflammation of the stomach and intestines resulting in diarrhoea and vomiting
• regurgitation (bringing up of food)
• hiccups
• feeling of incomplete bowel movement (intestinal movement), urgent need to defecate
• bleeding from the rectum or blood in the stool
• dizziness, headache, migraine
• fatigue, lack of energy or generalized weakness
• enlarged, damaged or fatty liver
• purple discoloration of the skin, solid bumps on the skin, skin rash, yellowish bumps on the skin
• changes in blood clotting tests
• changes in the number of blood cells
• reduction in levels of potassium, carotene, vitamin E and vitamin K in the blood
• muscle spasms

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

• flu or cold, fever, sinus inflammation, cough
• low number of red blood cells (anaemia)
• dehydration, dry mouth
• increased appetite
• burning or tingling of the skin
• swelling of the eyes
• sore throat or ulcer in the throat
• vomiting blood
• dry skin
• blisters
• excessive sweating
• joint pain or swelling, pain in hands or feet
• muscle pain
• blood or protein in urine
• chest pain
• changes in walking (gait)
• altered liver function tests

Not known (frequency cannot be estimated from available data)

• hair loss (alopecia)
• muscle aches (myalgia)
• loss of fluids which may cause headache, dry mouth, dizziness, fatigue or loss of consciousness (dehydration)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lojuxta

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 label or the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
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. Contents of the pack and other information

What Lojuxta contains

• The active ingredient is lomitapide. Lojuxta 5 mg: each hard capsule contains lomitapide mesylate equivalent to 5 mg of lomitapide. Lojuxta 10 mg: each hard capsule contains lomitapide mesylate equivalent to 10 mg of lomitapide. Lojuxta 20 mg: each hard capsule contains lomitapide mesylate equivalent to 20 mg of lomitapide.
• The other ingredients are: pregelatinized starch, sodium starch glycolate (type A), microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silica and magnesium stearate (see section 2, “Lojuxta contains lactose and sodium”).

Capsule shell:

• The capsule shell of 5 mg and 10 mg capsules contains gelatin, titanium dioxide (E171) and red iron oxide (E172).
• The capsule shell of the 20 mg capsule contains gelatin and titanium dioxide (E171).
• All capsules are printed with a black edible ink.

Description of the appearance of Lojuxta and contents of the pack

• Lojuxta 5 mg is a hard capsule with an orange cap/orange body with “5 mg” printed on the body and “A733” printed on the cap in black ink.
• Lojuxta 10 mg is a hard capsule with an orange cap/white body with “10 mg” printed on the body and “A733” printed on the cap in black ink.
• Lojuxta 20 mg is a hard capsule with a white cap/white body with “20 mg” printed on the body and “A733” printed on the cap in black ink.

The pack sizes are:
28 capsules

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Diapharm GmbH & Co. KG
Am Mittelhafen 56
48155 Münster
Germany
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

Lietuva
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

България
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Тел.: +359 888 918 090
[email protected]

België/Belgique/Belgien
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Česká republika
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +420 724 321 774
[email protected]

Magyarország
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +36 20 399 4269
[email protected]

Danmark
Chiesi Pharma AB
Tlf.: + 46 8 753 35 20

Malta
Amryt Pharmaceuticals DAC
Tel: +44 1604 549952
[email protected]

Deutschland
Chiesi GmbH
Tel: + 49 40 89724-0

Nederland
Chiesi Pharmaceuticals B.V.
Tel: + 31 88 501 64 00

Eesti
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

Norge
Chiesi Pharma AB
Tlf: + 46 8 753 35 20

Ελλάδα
Amryt Pharmaceuticals DAC
Τηλ: +800 44 474447
Τηλ: +44 1604 549952
[email protected]

Österreich
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919

España
Chiesi España, S.A.U.
Tel: + 34 93 494 8000

Polska
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +48 502 188 023
[email protected]

France
Chiesi S.A.S.
Tél: + 33 1 47688899

Portugal
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791

Hrvatska
ExCEEd Orphan Distribution d.o.o.
Savska cesta 32, Zagreb, 100 00
Croatia
Tel: +385 99 320 0330
[email protected]

România
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +40 744 366 015
[email protected]

Ireland
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791

Slovenija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +386 30 210 050
[email protected]

Ísland
Chiesi Pharma AB
Sími: +46 8 753 35 20

Slovenská republika
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +420 608 076 274
[email protected]

Italia
Chiesi Italia S.p.A.
Tel: + 39 0521 2791

Suomi/Finland
Chiesi Pharma AB
Puh/Tel: +46 8 753 35 20

Κύπρος
Amryt Pharmaceuticals DAC
Τηλ: +800 44 474447
Τηλ: +44 1604 549952
[email protected]

Sverige
Chiesi Pharma AB
Tel: +46 8 753 35 20

Latvija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]
An authorisation for this medicinal product has been granted under “exceptional circumstances”. This means that
due to the rarity of the disease, complete information on this medicinal product has not been possible to obtain.
The European Medicines Agency will annually review any new information on this

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, https://www.ema.europa.eu/ .

Lojuxta 30 mg hard capsules, 40 mg hard capsules, 60 mg hard capsules

lomitapide
Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lojuxta is and what it is used for

Lojuxta contains the active substance lomitapide. Lomitapide is a “lipid-modifying agent”, which works by blocking the action of the “microsomal triglyceride transport protein”.
This protein is found inside the cells of the liver and intestine, where it is involved
in the assembly of fats into larger particles that are then released into the
bloodstream. By blocking this protein, the medicine reduces the levels of fats and cholesterol
(lipids) in the blood.
Lojuxta is used to treat adult patients with very high cholesterol due to a disease present
in their families (homozygous familial hypercholesterolemia or HoFH). This disease is
usually passed on by both the father and the mother, who also have high cholesterol, passed on
to them by their parents. The patient’s “bad” cholesterol level is very high from a young age. “Bad”
cholesterol can cause heart attacks, strokes or other events at a young age. Lojuxta is used
to reduce cholesterol levels along with a low-fat diet and other treatments that
lower lipids.
Lojuxta can lower blood levels of:

• LDL cholesterol (low-density lipoproteins, or “bad” cholesterol)
• total cholesterol
• apolipoprotein B, a protein that carries “bad” cholesterol in the blood
• triglycerides (fats transported in the blood)

2. What you need to know before taking Lojuxta

Do not take Lojuxta

• if you are allergic to lomitapide or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems or unexplained abnormal liver tests
• if you have problems with your intestines or are unable to absorb food from the intestines
• if you are taking more than 40 mg of simvastatin per day (another medicine used to lower cholesterol, see section “Other medicines and Lojuxta”)
• if you are taking any of these medicines that affect the way lomitapide is broken down in the body: itraconazole, ketoconazole, fluconazole, voriconazole, posaconazole (for fungal infections) or telithromycin, clarithromycin, erythromycin (for bacterial infections) or indinavir, nelfinavir, saquinavir, ritonavir (for HIV infection) or diltiazem, verapamil (for high blood pressure or angina) and dronedarone (to regulate heart rhythm)
• if you are pregnant, suspect you may be pregnant or are planning a pregnancy (see section 2, “Pregnancy and breastfeeding”).

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

• you have had liver problems, even while taking other medicines. These capsules can cause side effects that can also be symptoms of liver problems. These side effects are listed in section 4 and you must inform your doctor immediatelyif you experience any of these signs and symptoms as they may be caused by liver damage. Your doctor will prescribe blood tests to check the condition of your liver before you start taking these capsules, if the dose is increased and regularly during treatment. These blood tests will help your doctor adjust the dose. If the tests show liver problems, your doctor may decide to reduce the dose or stop treatment.

In some circumstances you may experience fluid loss/dehydration, for example in case of
vomiting, nausea and diarrhea. It is important to avoid dehydration by drinking enough
fluids (see section 4).

Children and adolescents
Studies have not been conducted on children and adolescents under 18 years of age. The use of this
medicine is therefore not recommended in children and adolescents.

Other medicines and Lojuxta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Other medicines can affect the way Lojuxta works. Do not take any of the following
medicines together with Lojuxta:

• some medicines for bacterial, fungal or HIV infections (see section 2, “Do not take Lojuxta”)
• some medicines for high blood pressure, angina or to regulate heart rhythm (see section 2, “Do not take Lojuxta”)

You should also tell your doctor or pharmacist if you are taking any of the following medicines,
as they may need to adjust the dose of Lojuxta:

• medicines that lower cholesterol (such as atorvastatin)
• combined oral contraceptives (such as ethinylestradiol, norgestimate)
• glucocorticoids (such as beclometasone, prednisolone), steroid medicines used to treat inflammation in conditions such as severe asthma or arthritis
• medicines to treat cancer (such as bicalutamide, lapatinib, methotrexate, nilotinib, pazopanib, tamoxifen) or to treat nausea/vomiting in cancer therapy (such as fosaprepitant)
• medicines to reduce the activity of the immune system (such as ciclosporin, tacrolimus)
• medicines to treat bacterial or fungal infections (such as nafcillin, azithromycin, roxithromycin, clotrimazole)
• medicines to treat and prevent blood clots (such as cilostazol, ticagrelor)
• medicines to treat angina, chest pain caused by the heart (such as ranolazine)
• medicines to lower blood pressure (such as amlodipine, lacidipine)
• medicines to regulate heart rhythm (such as amiodarone)
• medicines to treat epilepsy (such as phenobarbital, carbamazepine, phenytoin)
• medicines to treat diabetes (such as pioglitazone, linagliptin)
• medicines to treat tuberculosis (such as isoniazid, rifampicin)
• tetracycline antibiotics to treat infections such as urinary tract infections
• medicines to treat anxiety and depression (such as alprazolam, fluoxetine, fluvoxamine)
• antacids (such as ranitidine, cimetidine)
• aminoglutethimide, a medicine used to treat Cushing's syndrome
• medicines to treat severe acne (such as isotretinoin)
• paracetamol, to treat pain
• medicines to treat cystic fibrosis (such as ivacaftor)
• medicines to treat urinary incontinence (such as propiverine)
• medicines to treat low sodium levels in the blood (such as tolvaptan)
• medicines to treat excessive daytime sleepiness (such as modafinil)
• some herbal medicines: St. John's wort (for depression) or ginkgo (to improve memory) or goldenseal (for inflammation and infections)

Lojuxta can affect the mechanism of action of other medicines. Tell your doctor or pharmacist
if you are taking any of the following medicines:

• oral contraceptives (see section 2, “Pregnancy and breastfeeding”)
• other medicines used to lower cholesterol such as statins like simvastatin. The risk of liver damage increases when this medicine is used together with statins. Muscle pain or muscle weakness may also occur. Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. When using Lojuxta, you should not take more than 40 mg of simvastatin (see section 2, “Do not take Lojuxta”)
• coumarin anticoagulants to thin the blood (such as warfarin)
• medicines to treat cancer (such as everolimus, imatinib, lapatinib, nilotinib, topotecan)
• medicines to reduce the activity of the immune system (such as sirolimus)
• medicines to treat HIV (such as maraviroc)
• medicines to treat and prevent blood clots (such as dabigatran etexilate)
• medicines to treat angina, chest pain caused by the heart (such as ranolazine)
• medicines to lower blood pressure (such as talinolol, aliskiren, ambrisentan)
• medicines to regulate heart rhythm (such as digoxin)
• medicines to treat diabetes (such as saxagliptin, sitagliptin)
• medicines to treat gout (such as colchicine)
• medicines to treat low levels of sodium in the blood (such as tolvaptan)
• antihistamines to treat hay fever (such as fexofenadine)

Lojuxta with food, drinks and alcohol

• Do not drink grapefruit juice of any kind.
• Drinking alcohol during treatment with Lojuxta is not recommended.
• The dose of Lojuxta may need to be adjusted if you consume peppermint oil or bitter orange oil.
• To reduce the possibility of stomach problems, you should follow a low-fat diet while taking this medicine. Consult a dietitian to find out what you can eat while taking Lojuxta.

Pregnancy and breastfeeding
Do not take this medicine if you are pregnant, suspect you may be pregnant or are planning a
pregnancy, as it may be harmful to the fetus. If you become pregnant while taking
this medicine, contact your doctor immediately and stop taking the capsules.
Pregnancy

• Before starting treatment, you must confirm that you are not pregnant and that you will use effective contraceptive measures, as recommended by your doctor. If you are using birth control pills and experience an episode of diarrhea or vomiting lasting more than 2 days, you should use an alternative method of contraception (condoms, diaphragm) for 7 days after the symptoms resolve.
• If, after starting treatment with Lojuxta, you decide that you want to become pregnant, inform your doctor as the treatment will need to be changed.

Breastfeeding

• It is not known whether Lojuxta is excreted in breast milk. Tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor may advise you to stop taking Lojuxta or stop breastfeeding.

Driving and using machines
Treatment may affect your ability to drive or operate machinery. If you experience
dizziness during treatment, do not drive or operate machinery until you feel better.

Lojuxta contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your
doctor before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Lojuxta

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist. These capsules must be prescribed by a doctor
experienced in the treatment of lipid metabolism disorders, who will regularly monitor you.
The recommended starting dose is one 5 mg capsule per day. Your doctor may slowly increase the
dose over time, up to a maximum of 60 mg per day. Your doctor will tell you:

• what dose to take and for how long
• when to increase or decrease the dose. Do not change the dose on your own.
• Take this medicine once a day with a glass of water before bedtime, at least 2 hours after your evening meal (see section 2, “Lojuxta with food, drinks and alcohol”).
• Do not take this medicine with food, as this may otherwise cause stomach problems (see section 2, “Lojuxta with food, drinks and alcohol”).
• If you are taking another medicine that lowers cholesterol by binding to bile acids, such as colesevelam or colestiramina, take the latter at least 4 hours before or 4 hours aftertaking Lojuxta.

Due to the possibility of interaction with other medicines, your doctor may change the time at which
you take your medicines. Alternatively, your doctor may decrease the dose of Lojuxta. Tell your
doctor about any changes in the medicines you are taking.
While taking this medicine, you must also take vitamin E and essential fatty acid supplements (omega-3 and omega-6) every day. The dose you will usually need is indicated below.
Ask your doctor or dietitian how to obtain these supplements. See section 2, “Lojuxta with
food, drinks and alcohol”.

Daily amount
Vitamin E
400 IU*

Approximately
Omega-3
EPA 110 mg *
DHA 80 mg
ALA 210 mg

Omega-6
Linoleic acid 200 mg
*IU: international units, mg: milligrams

If you take more Lojuxta than you should
Contact your doctor or pharmacist immediately.

If you forget to take Lojuxta
Take the normal dose at the usual time the next day. Do not take a double dose to
make up for a missed dose.

If you stop taking Lojuxta
If you stop taking this medicine, your cholesterol may increase again. Contact
your doctor before stopping treatment with this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Serious side effects:

• altered blood tests regarding liver function have been reported commonly (may affect up to 1 in 10 people). Signs and symptoms of liver problems include: o nausea or vomiting o stomach pain o muscle pain o fever o yellowish discoloration of the skin or whites of the eyes o feeling more tired than usual or feeling flu-like

Tell your doctor immediatelyif you experience any of these symptoms as he/she
may decide to stop treatment.
The following other side effects have also been reported:

Very common (may affect more than 1 in 10 people):

• diarrhoea
• nausea and vomiting
• stomach pain or discomfort or stomach bloating
• decreased appetite
• indigestion
• flatulence (gas)
• constipation
• weight loss

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

• inflammation of the stomach and intestines resulting in diarrhoea and vomiting
• regurgitation (bringing food back up)
• hiccups
• feeling of incomplete bowel movement (intestinal movement), urgent need to defecate
• bleeding from the rectum or blood in the stools
• dizziness, headache, migraine
• fatigue, lack of energy or general weakness
• enlarged, damaged or fatty liver
• purple discoloration of the skin, solid bumps on the skin, skin rash, yellowish bumps on the skin
• changes in blood clotting tests
• changes in the number of blood cells
• reduction of potassium, carotene, vitamin E and vitamin K levels in the blood
• muscle spasms

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

• flu or cold, fever, sinus inflammation, cough
• low number of red blood cells (anaemia)
• dehydration, dry mouth
• increased appetite
• burning or tingling of the skin
• swelling of the eyes
• sore throat or ulcer in the throat
• vomiting blood
• dry skin
• blisters
• excessive sweating
• joint pain or swelling, pain in hands or feet
• muscle pain
• blood or protein in the urine
• chest pain
• changes in walking (gait)
• altered liver function tests

Not known (frequency cannot be estimated from available data)

• hair loss (alopecia)
• muscle aches (myalgia)
• loss of fluids which may cause headache, dry mouth, dizziness, fatigue or loss of consciousness (dehydration)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system listed in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lojuxta

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 label or the packaging after
“Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30 °C.
Keep the bottle tightly closed to protect the medicine from moisture.
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 Lojuxta contains

• The active ingredient is lomitapide. Lojuxta 30 mg: each hard capsule contains lomitapide mesylate equivalent to 30 mg of lomitapide. Lojuxta 40 mg: each hard capsule contains lomitapide mesylate equivalent to 40 mg of lomitapide. Lojuxta 60 mg: each hard capsule contains lomitapide mesylate equivalent to 60 mg of lomitapide.
• The other ingredients are: pregelatinized starch, sodium starch glycolate (type A), microcrystalline cellulose, lactose monohydrate, anhydrous colloidal silicon dioxide and magnesium stearate (see section 2, “Lojuxta contains lactose and sodium”).

Capsule shell:

• The shell of the 30 mg capsules contains gelatin, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
• The shell of the 40 mg capsules contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
• The shell of the 60 mg capsule contains gelatin, titanium dioxide (E171) and yellow iron oxide (E172).
• All capsules are printed with a black edible ink.

Description of the appearance of Lojuxta and package contents

• Lojuxta 30 mg is a hard capsule with an orange cap/yellow body with “30 mg” printed on the body and “A733” printed on the cap in black ink.
• Lojuxta 40 mg is a hard capsule with a yellow cap/white body with “40 mg” printed on the body and “A733” printed on the cap in black ink.
• Lojuxta 60 mg is a hard capsule with a yellow cap/yellow body with “60 mg” printed on the body and “A733” printed on the cap in black ink.

The package sizes are:
28 capsules

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
43122 Parma
Italy

Manufacturer
Diapharm GmbH & Co. KG
Am Mittelhafen 56
48155 Münster
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Lietuva
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

България
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Teл.: +359 888 918 090
[email protected]

Luxembourg/Luxemburg
Chiesi sa/nv
Tél/Tel: + 32 (0)2 788 42 00

Česká republika
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +420 724 321 774
[email protected]

Magyarország
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +36 20 399 4269
[email protected]

Danmark
Chiesi Pharma AB
Tlf.: + 46 8 753 35 20

Malta
Amryt Pharmaceuticals DAC
Tel: +44 1604 549952
[email protected]

Deutschland
Chiesi GmbH
Tel: + 49 40 89724-0

Nederland
Chiesi Pharmaceuticals B.V.
Tel: + 31 88 501 64 00

Eesti
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]

Norge
Chiesi Pharma AB
Tlf: + 46 8 753 35 20

Ελλάδα
Amryt Pharmaceuticals DAC
Tηλ: +800 44 474447
Tηλ: +44 1604 549952
[email protected]

Österreich
Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073919

España
Chiesi España, S.A.U.
Tel: + 34 93 494 8000

Polska
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +48 502 188 023
[email protected]

France
Chiesi S.A.S.
Tél: + 33 1 47688899

Portugal
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791

Hrvatska
ExCEEd Orphan Distribution d.o.o.
Savska cesta 32, Zagreb, 100 00
Croatia
Tel: +385 99 320 0330
[email protected]

România
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +40 744 366 015
[email protected]

Ireland
Chiesi Farmaceutici S.p.A.
Tel: + 39 0521 2791

Slovenija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +386 30 210 050
[email protected]

Ísland
Chiesi Pharma AB
Sími: +46 8 753 35 20

Slovenská republika
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel: +420 608 076 274
[email protected]

Italia
Chiesi Italia S.p.A.
Tel: + 39 0521 2791

Suomi/Finland
Chiesi Pharma AB
Puh/Tel: +46 8 753 35 20

Κύπρος
Amryt Pharmaceuticals DAC
Tηλ: +800 44 474447
Tηλ: +44 1604 549952
[email protected]

Sverige
Chiesi Pharma AB
Tel: +46 8 753 35 20

Latvija
ExCEEd Orphan s.r.o.
Bucharova 2657/12, Prague 5, 158 00
Czech republic
Tel.: +370 661 663 99
[email protected]
This medicine has been authorised under “exceptional circumstances”. This means that
due to the rarity of the disease, complete information on this medicine is not available.
The European Medicines Agency will review any new information annually on this

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency, https://www.ema.europa.eu .