Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zavesca

Document Subject

Generated Narrative: MedicinalProductDefinition mp94a02a9d12dc7fffcfe59cdd0b624e87

identifier: http://ema.europa.eu/identifier/EU/1/02/238/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zavesca 100 mg capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-94a02a9d12dc7fffcfe59cdd0b624e87

identifier: http://ema.europa.eu/identifier/EU/1/02/238/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zavesca

Attesters

What is in this leaflet

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

Zavesca contains the active substance miglustat which belongs to a group of medicines that affect metabolism. It is used to treat two conditions:

Zavesca is used to treat mild to moderate type 1 Gaucher disease in adults. In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body. It starts to build up in certain cells of the body s immune system. This can result in liver and spleen enlargement, changes in the blood, and bone disease. The usual treatment for type 1 Gaucher disease is enzyme replacement therapy. Zavesca is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.

Zavesca is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children. If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain. This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures. Zavesca works by inhibiting the enzyme called glucosylceramide synthase which is responsible for the first step in the synthesis of most glycosphingolipids.

Do not take Zavesca

if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor or pharmacist before taking Zavesca

if you suffer from kidney disease

if you suffer from liver disease Your doctor will perform the following tests before treatment and during treatment with Zavesca:

an examination to check the nerves in your arms and legs

measurement of vitamin B12 levels

monitoring growth if you are a child or adolescent with Niemann-Pick type C disease

monitoring of blood platelet counts The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Zavesca. The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Zavesca (see section 4 for further details). If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Zavesca together with food, or to temporarily reduce your dose. In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide. If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor. In such case, your doctor may decide to conduct further investigations. Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment. Children and adolescents Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease. Other medicines and Zavesca Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Zavesca. They may lower the amount of Zavesca in your body. Pregnancy, breast-feeding and fertility You should not take Zavesca if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information. You must use effective birth control while taking Zavesca. Do not breast-feed while you are taking Zavesca. Male patients should use reliable birth control methods during their treatment with Zavesca, and for 3 months after finishing treatment. If you are pregnant, breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Zavesca may make you feel dizzy. Do not drive or use any tools or machines if you feel dizzy. Zavesca contains sodium This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially sodium-free .

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

For type 1 Gaucher disease: For adults, the usual dose is one capsule (100 mg) three times a day (morning, afternoon and evening). This means a daily maximum of three capsules (300 mg).

For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening). This means a daily maximum of six capsules (600 mg). For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease. If you have a problem with your kidneys you may receive a lower starting dose. Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Zavesca (see section 4). Your doctor will tell you how long your treatment will last. To remove the capsule:

1. Separate at perforations
2. Peel back paper at arrows
3. Push product through foil Zavesca can be taken with or without food. You should swallow the whole capsule with a glass of water. If you take more Zavesca than you should If you take more capsules than you were told to, consult your doctor immediately. Zavesca has been used in clinical trials at doses up to 3000 mg: this caused decreases in white blood cells and other side effects similar to those described in section 4. If you forget to take Zavesca 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 Zavesca Don t stop taking Zavesca without talking to your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most serious side effects: Some patients have had tingling or numbness in the hands and feet (seen commonly). They could be signs of peripheral neuropathy, due to side effects of Zavesca or they could be due to existing conditions. Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2). If you do get any of these effects, please seek medical advice from your doctor as soon as possible. If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible. The tremor often disappears without needing to stop the treatment. Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor. Very common: (may affect more than 1 in 10 people) The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite. If you do lose some weight when you start treatment with Zavesca don t worry. People usually stop losing weight as treatment goes on. Common: (may affect up to 1 in 10 people) Common side effects of treatment include headache, dizziness, paraesthesia (tingling or numbness), abnormal coordination, hypoaesthesia (reduced sensation to touch), dyspepsia (heartburn), nausea (feeling sick), constipation and vomiting, swelling or discomfort in the abdomen (stomach) and thrombocytopenia (reduced levels of blood platelets).The neurological symptoms and thrombocytopenia could be due to the underlying disease. Other possible side effects are muscular spasms or weakness, fatigue chills and malaise, depression, difficulty sleeping, forgetfulness, and less libido. Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment. Most cases are mild and disappear quite quickly. If any of these side effects cause problems, consult your doctor. He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects. 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date which is stated on the carton after EXP . The expiry date refers to the last day of that month. Do not store above 30 C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer take. These measures will help protect the environment.

What Zavesca contains The active substance is miglustat 100 mg. The other ingredients are: Sodium starch glycollate, Povidone (K30), Magnesium stearate. Gelatin, Titanium dioxide (E171). Black iron oxide (E172), Shellac. What Zavesca looks like and contents of the pack Zavesca is a white 100 mg capsule with OGT 918 printed in black on the cap and 100 printed in black on the body. Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules. Marketing Authorisation Holder: Janssen-Cilag International NV Turnhoutseweg B-2340 Beerse Belgium Manufacturer: Janssen Pharmaceutica NV Turnhoutseweg B-2340 Beerse Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien Janssen-Cilag NV Tel/T l: +32 14 64 94 janssen@jacbe.jnj.com Lietuva UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 lt@its.jnj.com

&
.: +359 2 489 94 jjsafety@its.jnj.com Luxembourg/Luxemburg Janssen-Cilag NV T l/Tel: +32 14 64 94 janssen@jacbe.jnj.com esk republika Janssen-Cilag s.r.o. Tel: +420 227 012 Magyarorsz g Janssen-Cilag Kft. Tel.: +36 1 884 2janssenhu@its.jnj.com Danmark Janssen-Cilag A/S Tlf: +45 4594 8jacdk@its.jnj.com Malta AM MANGION LTD Tel: +356 2397 6Deutschland Janssen-Cilag GmbH Tel: +49 2137 955 jancil@its.jnj.com Nederland Janssen-Cilag B.V. Tel: +31 76 711 1janssen@jacnl.jnj.com Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7ee@its.jnj.com Norge Janssen-Cilag AS Tlf: +47 24 12 65 jacno@its.jnj.com

Janssen-Cilag . . . . T : +30 210 80 90 sterreich Janssen-Cilag Pharma GmbH Tel: +43 1 610 Espa a Janssen-Cilag, S.A. Tel: +34 91 722 81 contacto@its.jnj.com Polska Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 France Janssen-Cilag T l: 0 800 25 50 75 / +33 1 55 00 40 medisource@its.jnj.com Portugal Janssen-Cilag Farmac utica, Lda. Tel: +351 214 368 Hrvatska Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 jjsafety@JNJCR.JNJ.com Rom nia Johnson & Johnson Rom nia SRL Tel: +40 21 207 1Ireland Janssen Sciences Ireland UC Tel: +353 1 800 709 Slovenija Johnson & Johnson d.o.o. Tel: +386 1 401 18 Janssen_safety_slo@its.jnj.com sland Janssen-Cilag AB c/o Vistor hf. S mi: +354 535 7janssen@vistor.is Slovensk republika Johnson & Johnson, s.r.o. Tel: +421 232 408 Italia Janssen-Cilag SpA Tel: 800.688.777 / +39 02 2510 1 janssenita@its.jnj.com Suomi/Finland Janssen-Cilag Oy Puh/Tel: +358 207 531 jacfi@its.jnj.com

: +357 22 207 Sverige Janssen-Cilag AB Tfn: +46 8 626 50 jacse@its.jnj.com Latvija UAB "JOHNSON & JOHNSON" fili le Latvij Tel: +371 678 93lv@its.jnj.com United Kingdom (Northern Ireland) Janssen Sciences Ireland UC Tel: +44 1 494 567 This leaflet was last revised in: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.