Cystine 250 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cystine 250 mg Tablets

L-cystine

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 15–30 days.

Contents of the 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. Storage of Cystine Tablets

6. Contents of the pack and other information

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

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

Cystine is indicated for: Treatment of cystine deficiency (a component of keratin), which may manifest as hair loss and/or brittle nails, caused by unbalanced or restrictive diets (weight-loss diets, vegetarian diets, etc.).

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

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

Do not take Cistina:

• 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 (a hereditary disease with possible formation of kidney stones).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Cistina.

You should exercise caution if you have disorders affecting cystine absorption or excretion.

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

Children

Do not give 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

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No drug interaction studies have been conducted with cystine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As a precautionary measure, Cistina should not be taken during pregnancy or breastfeeding.

Driving and using machines

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

Cistina Tablets contain corn starch (gluten-free) and sucrose

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him or her before taking this medicine.

3. How to take Cystine Tablets

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dosage:

• Adults and adolescents over 14 years of age:

Oral use.

It is recommended to take 4 to 6 tablets per day, divided among 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, you must stop treatment and consult your doctor.

If you take more Cystine than you should

No information on cases of poisoning is available.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

No adverse effects have been reported with the use of Cystine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be handed in at the Sigre collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Cystine

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

Appearance of the product and contents of the container

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

Each container 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 most recent review of this leaflet: September 2013.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es