CISTINE 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cystine 250 mg Tablets

L-cystine

Read the package leaflet carefully before starting to take this medicine because it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 15-30 days.

Contents of the Package Leaflet

1. What Cystine Tablets are and what they are used for
2. What you need to know before taking Cystine Tablets
3. How to take Cystine Tablets
4. Possible side effects

5 Conservation of Cystine Tablets

1. Contents of the pack and additional information

1. What Cystine Tablets are and what they are used for

They contain an amino acid (component of proteins) that is part of keratin. Keratin is a fundamental constituent protein of the skin, hair, and nails.

Cystine is indicated in: Treatment of cystine deficiency (constituent of keratin), which could manifest with hair loss and/or nail fragility, caused by unbalanced or restrictive diets (weight loss, vegetarian, etc.).

Cystine Tablets are indicated in adults and adolescents over 14 years of age.

2. What you need to know before taking Cystine Tablets

Do not take Cystine:

• if you are allergic to L-cystine or to any of the other components of this medicine (listed in section 6).
• if you have cystinosis (hereditary disease with possible kidney stone formation).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cystine.

You should be cautious if you have disorders in the absorption or elimination of cystine.

Interference with analytical tests: If you are going to undergo any diagnostic test (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Children

Do not administer this medicine to children under 14 years of age, as its safety and efficacy have not been established in children.

Taking Cystine with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken, or may need to take any other medicine.

No drug interaction studies have been conducted with cystine.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

As a precautionary measure, do not take Cystine during pregnancy or breastfeeding.

Driving and using machines

Cystine Tablets do not affect the ability to drive or operate machines.

Cystine Tablets contain cornstarch (gluten-free) and sucrose

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

3. How to take Cystine Tablets

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents over 14 years of age:

Oral route.

It is recommended to take 4 to 6 tablets a day, divided into the three main meals.

The tablets should be taken during meals with a glass of water.

If the symptoms do not improve or worsen after 15-30 days of treatment, you should stop it and consult your doctor.

If you take more Cystine than you should

There is no information on cases of intoxication.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested (or go to a medical center).

If you forget to take Cystine

Do not take a double dose to make up for the missed doses.

If you have any other doubts 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 everyone gets them.

No side effects have been described with the use of Cystine.

Reporting side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Cystine Tablets

No special storage conditions are required.

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Cystine

• The active ingredient is L-cystine. Each tablet contains 250 mg of L-cystine.
• The other components (excipients) are: Cornstarch (gluten-free), sucrose, and talc.

Appearance of the product and contents of the pack

Cystine is presented in tablets; they are white and biconvex.

Each pack contains 40 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

LA QUÍMICA MÉDICA, S.A.

Avda. de Sarriá, 146-148

08017 Barcelona

Tel. 93 203 21 51

Manufacturer

Noucor Health, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona)

Date of the last revision of this package leaflet: September 2013.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.es