Prospect: information for the patient

Cerdelga 21mg hard capsules

Cerdelga 84mg hard capsules

eliglustat

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist,even if they are adverse effects that do not appear in this prospect. See section 4.

1.What is Cerdelga and what is it used for

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

3.How to take Cerdelga

4.Possible adverse effects

5.Storage of Cerdelga

1. Contents of the package and additional information

Cerdelga contains the active ingredient eliglustat and is used for the prolonged treatment of adults and children aged 6 years or older who weigh at least 15 kg with type 1 Gaucher's disease.1.

When used in children, Cerdelga is intended for those children whose disease is under control through enzyme replacement therapy. The doctor will determine if Cerdelga is suitable for you or your child before starting treatment through a simple laboratory test.

Type 1 Gaucher's disease is a rare inherited disorder in which the body does not break down a substance called glucosylceramide correctly. As a result, glucosylceramide accumulates in the spleen, liver, and bones. This accumulation prevents these organs from functioning properly. Cerdelga contains the active ingredient eliglustat, which reduces the production of glucosylceramide and thus prevents its accumulation. This, in turn, helps the affected organs to function better.

There are differences between individuals in the speed at which the body breaks down this medication. Therefore, the amount of medication in the blood may differ from one patient to another, which may affect how a patient responds to treatment. Cerdelga is intended for use in patients who break down the medication at a normal speed (known as intermediate metabolizers and rapid metabolizers) or at a low speed (known as slow metabolizers).

Type 1 Gaucher's disease is a lifelong condition, so you should continue taking this medication as instructed by your doctor to obtain the maximum benefit from treatment.

Do not take Cerdelga

• If you are allergic to eliglustat or any of the other ingredients in this medication (listed in section6).
• If you are a slow or rapid metabolizer and use medications called potent or moderate inhibitors of CYP2D6 (such as quinidine and terbinafine) in combination with potent or moderate inhibitors of CYP3A (such as erythromycin and itraconazole). The combination of these medications will interfere with your body's ability to break down Cerdelga and may produce higher levels of the active ingredient in the blood (seesection“Other medications and Cerdelga” for an expanded list of medications).
• If you are a slow metabolizer and use medications known as potent inhibitors of CYP3A (such as itraconazole). These medications will interfere with your body's ability to metabolize Cerdelga and may result in higher levels of active substance in your blood (see the section “Other medications and Cerdelga” for an expanded list of medications).
• If you are a rapid metabolizer and have severely decreased liver function.
• If you are a rapid metabolizer and have mildly or moderately decreased liver function while taking a potent or moderate inhibitor of CYP2D6.

Warnings and precautions

Consult your doctor or pharmacist before starting Cerdelga if:

• You are currently receiving treatment with any of the medications listed in the section “Other medications and Cerdelga” or are about to start treatment with them.
• You have had a heart attack or heart failure.
• You have a low heart rate.
• You have an irregular or abnormal heart rhythm, including a condition called long QT interval syndrome.
• You have other heart problems.
• You are taking an antiarrhythmic medication (used to treat irregular heart rhythms) such as quinidine, amiodarone, or sotalol.
• You are a rapid metabolizer and have moderately decreased liver function.
• You are a slow or intermediate metabolizer and have decreased liver function at any level.
• You are a slow or intermediate metabolizer and have decreased kidney function.
• You are a patient with end-stage renal disease (ESRD).

Children and adolescents

Cerdelga is not intended for use in children under 6 years of age or weighing less than 15 kg.

Other medications and Cerdelga

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Medications that should not be taken together and with Cerdelga

Cerdelga should not be used with certain types of medications. These medications may interfere with your body's ability to break down Cerdelga, which may result in higher levels of Cerdelga in the blood. These medications are known as potent or moderate inhibitors of CYP2D6 and CYP3A. There are many medications in these categories, and depending on how your body metabolizes Cerdelga, the effects may vary from person to person. Consult your doctor about these medications before starting Cerdelga. Your doctor will determine which medications you can use based on how quickly your body metabolizes eliglustat.

Medications that may increase the level of Cerdelga in the blood:

• paroxetine, fluoxetine, fluvoxamine, duloxetine, bupropion, moclobemide-antidepressants(used to treat depression)
• dronedarone, quinidine, verapamil-antiarrhythmics(used to treat irregular heart rhythms)
• 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 bladder
• cinacalcet-calcimimetic(used in some patients with dialysis and certain cancers)
• atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, ritonavir, saquinavir, tipranavir-antiretrovirals(used to treat HIV infection)
• cobicistat-used to enhance the effects of antiretrovirals (used to treat HIV)
• aprepitant-antiemetic(used to reduce vomiting)
• diltiazem-antihypertensive(used to increase blood flow and reduce heart rate)
• conivaptan-diuretic(used to elevate low sodium levels in the blood)
• boceprevir, telaprevir-antivirals(used to treat hepatitis C)
• imatinib-anticancer agent(used to treat cancer)
• amlodipine, ranolazineused to treat angina pectoris
• cilostazolused to treat intermittent claudication
• isoniazidused to treat tuberculosis
• cimetidine, ranitidine-antacids(used to treat indigestion)
• goldenseal(also known asHydrastis canadensis), a non-prescription herbal medication used to aid digestion.

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

• rifampicin, rifabutin-antibiotics(used to treat infections)
• carbamazepine, phenobarbital, phenytoin-antiepileptics(used to treat epilepsy and seizures)
• St. John's Wort(also known asHypericum perforatum)-a non-prescription herbal medication used to treatdepressionand other conditions.

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

• dabigatran-anticoagulant(used to thin the blood)
• phenytoin-antiepileptic(used to treat epilepsy and seizures)
• nortriptyline, amitriptyline, imipramine, desipramine-antidepressants(used to treat depression)
• phenothiazines-antipsychotics(used to treat schizophrenia and psychosis)
• digoxin-used to treatheart failure and atrial fibrillation
• colchicine-used to treatgout
• metoprolol-used toreduce blood pressure and/or heart rate
• dextromethorphan-cough suppressant
• atomoxetine-used to treatattention deficit hyperactivity disorder (ADHD)
• pravastatin-used toreduce cholesterol and prevent heart disease.

Taking Cerdelga with food and drinks

Avoid consuming grapefruit or grapefruit juice, as it may increase the level of Cerdelga in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor, who will tell you if you can take this medication during pregnancy.

It has been shown that the active ingredient of this medication passes into breast milk in small amounts in animals. It is not recommended to breastfeed during treatment with this medication. Inform your doctor if you are breastfeeding.

No effects on fertility have been known at normal doses.

Driving and operating machinery

Cerdelga may affect your ability to drive and operate machinery in patients who experience dizziness after administration.

Cerdelga contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Cerdelga is available in 2 different doses. The hard capsules containing 84 mg of eliglustat are blue-green and white, and the hard capsules containing 21 mg of eliglustat are completely white. When administering this medication to your child, ensure that they are taking the correct dose.

Cerdelga should be taken orally in children who can swallow the entire capsule.

The hard capsules of Cerdelga should be taken whole with water at the same time every day. They can be taken with or without food. Patients who take the dose twice a day should take one dose in the morning and another dose in the evening.

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

The mixing of the capsule content (eliglustat powder) with food or beverages has not been studied.

Recommended dose for adults

If you are an intermediate metabolizer or a rapid metabolizer:

Swallow one 84 mg capsule whole twice a day with water. It can be taken with or without food. Take one capsule in the morning and another in the evening.

If you are a slow metabolizer:

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

Recommended dose for children

The amount of this medication that your child takes depends on their body weight and how they metabolize the medication. The doctor will determine this before starting treatment.

Continue taking Cerdelga every day until your doctor tells you otherwise.

How to dispense the 21 mg hard capsule

Break the cover sheet with your thumb or index finger and push the capsule out.

How to remove the blister from the pouch for the 84 mg hard capsule

Press with your thumb and index finger together at one end of the pouch (1), and gently pull the blister to open the pouch (2).

If you take more Cerdelga than you should

If you take more capsules than you were told, consult your doctor immediately. You may experience dizziness with loss of balance, low heart rate, nausea, vomiting, and drowsiness.

If you forget to take Cerdelga

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

If you interrupt treatment with Cerdelga

Do not stop treatment with Cerdelga without telling your doctor.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

• Headache
• Dizziness
• Change in taste (dysgeusia)
• Palpitations
• Throat irritation
• Cough
• Heartburn (dyspepsia)
• Upper abdominal pain (dyspepsia)
• Diarrhea
• Nausea
• Constipation
• Abdominal pain
• Acid reflux disease (gastroesophageal reflux disease)
• Swelling (abdominal distension)
• Stomach inflammation (gastritis)
• Difficulty swallowing (dysphagia)
• Vomiting
• Dry mouth
• Gas (flatulence)
• Dry skin
• Hives (urticaria)
• Joint pain (arthralgia)
• Pain in arms, legs, or back
• Fatigue

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included intheAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, the outer cover, and the blister pack after “CAD”. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Cerdelga

The active ingredient is eliglustat (as tartrate).

Cerdelga 21 mg hard capsules

Each hard capsule contains 21 mg of eliglustat.

The other components are:

Cerdelga 84 mg hard capsules

Each hard capsule contains 84 mg of eliglustat.

The other components are:

Appearance of Cerdelga and contents of the pack

Cerdelga 21 mg hard capsules

Cerdelga 21 mg hard capsules have an opaque white mother-of-pearl cap and an opaque white mother-of-pearl body with the inscription “GZ04” printed in black on the capsule.

Size of the pack of 56 hard capsules in 4 blisters of 14 hard capsules each.

Cerdelga 84 mg hard capsules

Cerdelga 84 mg hard capsules have an opaque blue-green mother-of-pearl cap and an opaque white mother-of-pearl body with the inscription “GZ02” printed in black on the capsule.

Size of the pack of 14 hard capsules in 1 blister, 56 hard capsules in 4 blisters of 14 hard capsules each or 196 hard capsules in 14 blisters of 14 hard capsules each.

Only some pack sizes may be marketed.

Marketing authorisation holder

Sanofi B.V.

Paasheuvelweg 25
1105 BP Amsterdam

Netherlands

Responsible person for manufacturing

Cerdelga 21 mg hard capsule

Patheon France

40 Boulevard de Champaret

Bourgoin Jallieu

38300

France

Cerdelga 84 mg hard capsule

Sanofi Winthrop Industrie

30-36 avenue Gustave Eiffel

37100 Tours

France

Sanofi Winthrop Industrie

1 rue de la Vierge

Ambares et Lagrave

33565 Carbon Blanc cedex

France

Genzyme Ireland Ltd

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicinal products.