Ficha técnica de Cistina 250 mg comprimidos – Espanha

Como usar Cistina 250 mg comprimidos

Introduction

Leaflet: information for the user

Cistina 250 mg Tablets

L-cystine

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-Conserve this leaflet, as you may need to read it again.

-If you need advice or more information, consult your pharmacist.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if you get worse or do not improve after 15-30 days.

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

2.What you need to knowbeforestarting totake Cistina Tablets

3.How to take Cistina Tablets

4.Possible side effects

5Storage of Cistina Tablets

6.Contents of the pack and additional information

1. What is Cistina Comprimidos and what is it used for

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

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

Cistina Comprimidos is indicated for adults and adolescents over 14 years old.

2. What you need to know before starting to take Cistina Tablets

Do not take Cistina:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cistina.

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

Interference with diagnostic tests:If you are to undergo any diagnostic test (including blood and urine tests, 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 Cistina with other medicines

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

No studies have been conducted on drug interactions with cystine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

As a precaution, do not take Cistina during pregnancy or breastfeeding.

Driving and operating machinery

Cistina Tablets do not affect the ability to drive or operate machinery.

Cistina Tabletscontains 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 Cistina Tablets

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

- Adults and adolescents over 14 years old:

Oral administration.

It is recommended to take4 to6 tablets per day, divided into the three main meals.

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

If symptoms do not improve or worsen after 15-30 days of treatment, discontinue and consult the doctor.

If you take more Cistina than you should

No information is available on cases of intoxication.

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

If you forgot to take Cistina

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

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

4. Possible Adverse Effects

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

No adverse effects have been described with the use of Cistina.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, even if it ispossibleadverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Cystine Tablets Storage

No special storage conditions are required.

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

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the Sigre Pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Cystine

- The active ingredient is L-cystine.Cada comprimido contains250 mgL-cystine.

- The other components (excipients)are: Cornstarch (gluten-free), sucrose and talc.

Appearance of the product and contents of the packaging

Cystineis presented intablets; they are white and biconvex.

Cada envase contains 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

LA QUÍMICA MÉDICA, S.A.

Avda. de Sarriá, 146-148

08017 Barcelona

Tel. 93 203 21 51

Responsible for manufacturing

Noucor Health, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Barcelona)

Date of the last review ofthis prospectus: September 2013.

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es