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AstraZeneca

Procysbi
mercaptamine

Package leaflet: Information for the user


PROCYSBI 25 mg gastro-resistant hard capsules PROCYSBI 75 mg gastro-resistant hard capsules


cysteamine (mercaptamine bitartrate)


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


If you take more PROCYSBI than you should

You should contact your doctor or the hospital emergency department immediately if you have taken more PROCYSBI than you should. You may become drowsy.


If you forget to take PROCYSBI

If you missed a dose of medicine, you should take it as soon as possible. However, if it is within 4 hours of the next dose, skip the missed dose and go back to the regular dosing schedule.


Do not take a double dose to make up for a forgotten dose.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

  1. Possible side effects


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


    Tell your doctor or nurse straight away if you notice any of the following side effects – you may need urgent medical treatment:

    • Severe allergic reaction (seen uncommonly): Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat.


      If any of the following side effects occur, please contact your doctor immediately. Since some of these side effects are serious, ask your doctor to explain their warning signs.


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

    • Skin rash: Tell the doctor right away if you get a skin rash. PROCYSBI may need to be temporarily stopped until the rash goes away. If the rash is severe, your doctor may discontinue cysteamine treatment.

    • Abnormal liver function on blood tests. Your doctor will monitor you for this.


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

    • Skin lesions, bone lesions, and joint problems: Treatment with high doses of cysteamine can cause skin lesions to develop. These include skin striae (which are like stretch marks), bone injuries (such as fractures), bone deformities, and joint problems. Examine your skin while taking this medicine. Report any changes to your doctor. Your doctor will monitor you for these problems.

    • Low white blood cell count. Your doctor will monitor you for this.

    • Central nervous system symptoms: Some patients taking cysteamine have developed seizures, depression, and become too sleepy (excessive sleepiness). Tell your doctor if you have these symptoms.

    • Stomach and intestinal (gastrointestinal) problems: Patients taking cysteamine have developed ulcers and bleeding. Tell your doctor right away if you get stomach ache, nausea, vomiting, loss of appetite, or throw up blood.

    • Benign intracranial hypertension, also called pseudotumor cerebri, has been reported with cysteamine use. This is a condition where there is high pressure in the fluid around the brain. Tell your doctor right away if you develop any of the following symptoms while taking PROCYSBI: headache, buzzing or "whooshing" sound in the ear, dizziness, nausea, double vision, blurry vision, loss of vision, pain behind the eye or pain with eye movement. Your doctor will monitor you with eye examinations to find and treat this problem early. This will help lessen the chance of loss of eyesight.


      The other side effects listed below are given with an estimation of the frequency with which they may occur with PROCYSBI.


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

    • diarrhoea

    • fever

    • sensation of sleep


      Common side effects:

    • unpleasant breath and body odour

    • heartburn

    • tiredness


      Uncommon side effects:

    • leg pain

    • scoliosis (deviation of the vertebral column)

    • bone fragility

    • hair discolouration

    • fits

    • nervousness

    • hallucination

    • effect on the kidney manifested by swelling of the extremities and weight gain


      Reporting of side effects

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      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.


  2. How to store PROCYSBI


    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 and the bottle label after EXP. The expiry date refers to the last day of that month.


    Do not take this medicine if the foil seal has been open for more than 30 days. Discard the open bottle and use a new bottle.


    Store in a refrigerator (2°C-8°C). Do not freeze. After opening do not store above 25°C. Keep the container tightly closed in order to protect from light and moisture.


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


  3. Contents of the pack and other information What PROCYSBI contains

Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A. Via Palermo 26/A

43122 Parma Italy


Manufacturer

Chiesi Farmaceutici S.p.A. Via San Leonardo 96 43122 Parma

Italy


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


België/Belgique/Belgien

Chiesi sa/nv

Tél/Tel: + 32 (0)2 788 42 00

Lietuva

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919


България

Chiesi Bulgaria EOOD

Teл.: + 359 29201205

Luxembourg/Luxemburg

Chiesi sa/nv

Tél/Tel: + 32 (0)2 788 42 00


Česká republika

Chiesi CZ s.r.o.

Tel: + 420 261221745

Magyarország Chiesi Hungary Kft. Tel.: + 36-1-429 1060


Danmark

Chiesi Pharma AB Tlf: + 46 8 753 35 20

Malta

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


Deutschland

Chiesi GmbH

Tel: + 49 40 89724-0

Nederland

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


Eesti

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

Norge

Chiesi Pharma AB Tlf: + 46 8 753 35 20


Ελλάδα

Chiesi Hellas AEBE

Τηλ: + 30 210 6179763

Österreich

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919


España

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

Polska

Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421


France

Chiesi S.A.S.

Tél: + 33 1 47688899

Portugal

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


Hrvatska

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

România

Chiesi Romania S.R.L. Tel: + 40 212023642

Ireland

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

Slovenija

Chiesi Slovenija d.o.o.

Tel: + 386-1-43 00 901


Ísland

Chiesi Pharma AB Sími: +46 8 753 35 20

Slovenská republika Chiesi Slovakia s.r.o. Tel: + 421 259300060


Italia

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

Suomi/Finland

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


Κύπρος

Chiesi Farmaceutici S.p.A.

Τηλ: + 39 0521 2791

Sverige

Chiesi Pharma AB Tel: +46 8 753 35 20


Latvija

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

United Kingdom (Northern Ireland)

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


This leaflet was last revised in


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