Cerdelga - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Cerdelga 84 mg hard capsules

eliglustat

V This medicine is subject to additional monitoring. This will allow quick identification of new safetyinformation. You canhelp by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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.

• – 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Cerdelga is and what it is used for

• 2. What you need to know before you take Cerdelga

• 3. How to take Cerdelga

• 4. Possible side effects

• 5. How to store Cerdelga

• 6. Contents of the pack and other information

1. What Cerdelga is and what it is used for

Cerdelga contains the active substance eliglustat and is used for the long term treatment of adult patients with Gaucher disease type 1.

Gaucher disease type 1 is a rare, inherited condition in which a substance called glucosylceramide is not effectively broken down by your body. As a result glucosylceramide builds up in your spleen, liver and bones. The build-up prevents these organs from working properly. Cerdelga contains the active substance eliglustat which decreases the production of glucosylceramide, thereby preventing its buildup. In turn this helps your affected organs to work better.

People differ in the speed that their body breaks down this medicine. As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond. Cerdelga is meant to be used in patients whose body breaks down this medicine at normal speed (known as intermediate metabolisers and extensive metabolisers) or slow speed (known as poor metabolisers). Your doctor will determine if Cerdelga is suitable for you before you start taking it, using a simple laboratory test.

Gaucher disease type 1 is a lifelong condition and you must continue to take this medicine as prescribed by your doctor to gain the maximum benefit from your medicine.

2. What you need to know before you take Cerdelga

Do not take Cerdelga

• – If you are allergic to eliglustat or any of the other ingredients of this medicine (listed in section 6).

• – If you are an intermediate or extensive metaboliser and use medicines known as strong or moderate CYP2D6 inhibitors (examples are quinidine and terbinafine) used in combination with strong or moderate CYP3A inhibitors (examples are erythromycin and itraconazole). The combination of these medicines will interfere with your body’s ability to break down Cerdelga and this can result in higher levels of the active substance in your blood (see the section ‘ Other medicines and Cerdelga’ for an expanded list of medicines).

• – If you are a poor metaboliser and use medicines known as strong CYP3A inhibitors (for example itraconazole). Medicines of this type will interfere with your body’s abilty to break down Cerdelga and this can result in higher levels of the active substance in your blood (see the section ‘Other medicines and Cerdelga’ for an expanded list of medicines).

• – If you are an extensive metaboliser and you have severely reduced liver function.

• – If you are an extensive metaboliser and you have mildly or moderately reduced liver function

while taking a strong or moderate CYP2D6 inhibitor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cerdelga, if you:

• are currently treated, or about to start treatment with any of the medicines listed in section ‘Other medicines and Cerdelga.’
• have had a heart attack or heart failure.
• have a slow heart rate.
• have an irregular, or abnormal heart beat, inluding a heart condition called long QT syndrome.
• have any other heart problems.
• are taking an antiarrhythmic medicine (used to treat irregular heart beat) like quinidine, amiodarone or sotalol.
• are an extensive metaboliser and you have moderately reduced liver function.
• are an intermediate or poor metaboliser and you have any level of reduced liver function.
• are an intermediate or poor metaboliser and you have reduced kidney function.
• are an end stage renal disease (ESRD) patient.

Children and adolescents

Cerdelga has not been tested in children and adolescents under 18 years of age. Do not give this medicine to children or adolescents.

Other medicines and Cerdelga

Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.

Medicines that must not be taken in combination with each other and Cerdelga

Cerdelga must not be used with certain type of medicines. These medicines can interfere with your body’s ability to break down Cerdelga and this can result in higher levels of Cerdelga in your blood. These medicines are known as strong or moderate CYP2D6 inhibitors and strong or moderate CYP3A inhibitors. There are many medicines in these categories and depending on how your body breaks down Cerdelga the effects may differ from person to person. Please speak to your doctor regarding these medicines before you start taking Cerdelga. Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.

Medicines that may increase the level of Cerdelga in the blood such as:

• paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide – antidepressants (used to treat depression)
• dronedarone, quinidine, verapamil – antiarrhythmic medicines (used to treat irregular heartbeat)
• ciprofloxacin, clarithromycin, erythromycin, telithromycin – antibiotics (used to treat

infections)

• terbinafine, itraconazole, fluconazole, posaconazole, voriconazole – antifungals (used to treat fungal infections)
• mirabegron – used to treat overactive bladders
• cinacalcet – calcimimetic (used in some dialysis patients and specific cancers)
• atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir -antiretrovirals (used to treat HIV)
• cobicistat – used to improve the effects of antiretrovirals (used to treat HIV)
• aprepitant – antiemetic (used to reduce vomiting)
• diltiazem – antihypertensive (used to increase blood flow and decrease heart rate)
• conivaptan – diuretic (used to increase low blood sodium levels)
• boceprevir, telaprevir – antiviral (used to treat Hepatitis C)
• imatinib – anticancer (used to treat cancer)
• amlopidine, ranolazine – used to treat angina pectoris
• cilostazol – used to treat cramp-like pain in your legs when you walk caused by insufficient

blood supply in your legs

• isoniazid – used to treat tuberculosis.
• cimetidine, ranitidine – antacids (used to treat indigestion)
• goldenseal – (also known as Hydrastis canadensis) a herbal preparation obtained without a prescription, used as a digestive aid.

Medicines that may decrease the level of Cerdelga in the blood:

• rifampicin, rifabutin – antibiotics (used to treat infections)
• carbamazepine, phenobarbital, phenytoin -anti-epileptics (used to treat epilepsy and seizures)
• St. John’s wort – (also known as Hypericum perforatum) a herbal preparation obtained without a prescription, used to treat depression and other conditions

Cerdelga may increase the level of the following types of medicines in the blood:

• dabigatran – anticoagulant (used to thin the blood)
• phenytoin – anti-epileptic (used to treat epilepsy and seizures)
• nortryptyline, amitriptyline, imipramine, desipramine – antidepressants (used to treat depression)
• phenothiazines – antipsychotics (used to treat schizophrenia and psychosis)
• digoxin -used to treat heart failure and atrial fibrillation
• colchicine – used to treat gout
• metoprolol – used to lower blood pressure and/or reduce heart rate
• dextromethorphan – cough medicine
• atomoxetine – used to treat attention deficit hyperactivity disorder (ADHD)
• pravastatin – used to lower cholesterol and prevent heart disease

Taking Cerdelga with food and drink

Avoid consumption of grapefruit or grapefruit juice since it may increase the level of Cerdelga in your blood.

Pregnancy, breast-feeding and fertility

If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.

The active substance in this medicine has been shown to pass in trace amounts into breast milk in animals. Breast-feeding is not recommended during treatment with this medicine. Tell your doctor if you are breast-feeding.

There are no known effects on fertility at normal doses.

Driving and using machines

Cerdelga has negligible or no influence on the ability to drive and use machines.

Cerdelga contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Cerdelga

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you are an intermediate metaboliser or extensive metaboliser:

Swallow one 84 mg capsule whole twice a day with water. It may be taken with or without food. Take one capsule in the morning and one capsule at night.

If you are a poor metaboliser:

Swallow one 84 mg capsule whole once a day with water. It may be taken with or without food. Take one capsule at the same time every day.

Do not open, crush, dissolve, or chew the capsule before swallowing it. If you cannot swallow the capsule whole, tell your doctor.

Continue taking Cerdelga every day for as long as your doctor tells you.

How to pull the blister/wallet from the sleeve

While pressing your thumb and finger together at one end of the sleeve (1) gently pull the ___

blister/wallet out to open the sleeve (2).

If you take more Cerdelga than you should

If you take more capsules than you were told to, consult your doctor immediately. You may experience dizziness marked by loss of balance, slow heart rate, nausea, vomiting and lightheadedness.

If you forget to take Cerdelga

Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Cerdelga

Do not stop taking Cerdelga without talking to your doctor.

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.

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

• Headache
• Dizziness
• Change in taste (dysgeusia)
• Palpitations
• Throat irritation
• Heartburn (dyspepsia)
• Feeling sick (nausea)
• Diarrhoea
• Constipation
• Abdominal pain
• Stomach ache (upper abdominal pain)
• Acid reflux disease (gastrooesophageal reflux disease)
• Bloating (abdominal distension)
• Inflammation of the stomach (gastritis)
• Difficulty swallowing (dysphagia)
• Vomiting
• Dry mouth
• Gas (flatulence)
• Dry skin
• Hives (urticaria)
• Joint pain (arthalagia)
• Pain in arms, legs or back
• Tiredness (fatigue)

Reporting of side effects

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

5. How to store Cerdelga

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 carton, sleeve and blister after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Cerdelga contains

• The active substance is eliglustat (as tartrate). Each capsule contains 84 mg eliglustat.
• The other ingredients are:

What Cerdelga looks like and contents of the pack

Cerdelga capsules have a pearl blue-green opaque cap and a pearl white opaque body with “GZ02” printed in black on the capsule.

Pack sizes of 14 hard capsules in 1 blister wallet, 56 hard capsules in 4 blister wallets of 14 capsules each or 196 hard capsules in 14 blister wallets of 14 capsules each

Not all packs may be marketed in your country.

Marketing Authorisation Holder

Genzyme Europe B.V.

Paasheuvelweg 25

1105 BP Amsterdam

The Netherlands

Manufacturer

Genzyme Ireland Ltd IDA Industrial Park Old Kilmeaden Road Waterford

Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien/ Luxembourg/Lu­xemburg Sanofi Belgium

Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40

Tél/Tel: + 32 2 710 54 00

Etnrapua Swixx Biopharma EOOD Ten.: +359 (0)2 4942 480	Magyarorszag SANOFI-AVENTIS Zrt. Tel: +36 1 505 0050
Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111	Malta Sanofi S.r.l. Tel: +39 02 39394275
Danmark Sanofi A/S Tlf: +45 45 16 70 00	Nederland Genzyme Europe B.V. Tel: +31 20 245 4000
Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 04 36 996 Tel. aus dem Ausland: +49 69 305 70 13	Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 00

Eesti Swixx Biopharma OÜ Tel: +372 640 10 30	Österreich sanofi-aventis GmbH Tel: + 43 1 80 185 – 0
EMáóa sanofi-aventis AEBE Tql: +30 210 900 1600	Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
España sanofi-aventis, S.A. Tel: +34 93 485 94 00	Portugal Sanofi – Produtos Farmacéuticos, Lda. Tel: +351 21 35 89 400
France sanofi-aventis France Tél: 0 800 222 555 Appel depuis l’étranger: +33 1 57 63 23 23	Romania Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 500

Slovenija Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +353 (0) 1 403 56 00

Suomi/Finland

Sanofi Oy

Puh/Tel: + 358 201 200 300

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI

Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: There are also links to other websites about rare diseases and treatments.

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