CRECIL 500 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Crecil 500 mg Hard Capsules

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.
• You should consult a doctor if it worsens or does not improve after 30 days.

Contents of the Package Leaflet

1. What Crecil 500 mg Hard Capsules are and what they are used for
2. What you need to know before taking Crecil 500 mg Hard Capsules
3. How to take Crecil 500 mg Hard Capsules
4. Possible side effects
5. Storage of Crecil 500 mg Hard Capsules
6. Package Contents and Additional Information

1. What Crecil 500 mg Hard Capsules are and what they are used for

They contain an amino acid (a component of proteins) that contains sulfur and is part of a protein (keratin) that makes up hair and nails.

Crecil is indicated for the treatment of cystine deficiency (a component of keratin), which may manifest as hair loss and/or nail fragility, caused by unbalanced or restrictive diets (weight loss, vegetarian, etc.)

Crecil is indicated for adults and adolescents over 14 years of age.

2. What you need to know before taking Crecil 500 mg Hard Capsules

Do not take Crecil Capsules

• if you are allergic to cystine or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Crecil.

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

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 Crecil Capsules with other Medicines

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

Pregnancy and Breastfeeding

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

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

Driving and Using Machines

Crecil does not affect the ability to drive vehicles or use machines.

3. How to Take Crecil 500 mg Hard Capsules

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in 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 2 to 3 capsules per day, coinciding with meals.

The capsules should be taken with a sufficient amount of water.

If symptoms do not improve or worsen after a month of treatment, it should be discontinued and the doctor consulted.

If you take more Crecil Capsules 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 Crecil Capsules

Do not take a double dose to make up for forgotten 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 Crecil 500 mg Hard Capsules.

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 Surveillance System for Human Use. www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Crecil 500 mg Hard Capsules

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 stated on the package 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 packages and medicines you no longer need at the Sigre Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Crecil 500 mg Hard Capsules

• The active ingredient is Cystine. Each capsule contains 500 mg of cystine.
• The other ingredients (excipients) are: talc, magnesium stearate, and sodium lauryl sulfate. Excipients of the hard gelatin capsule: gelatin, erythrosine (E-127), titanium dioxide (E-171), indigo carmine (E-132), and water.

Appearance of the Product and Package Contents

Crecil is presented in hard gelatin capsules of red color in packages of 40 capsules.

Marketing Authorization Holder

Laboratorios Viñas, S.A.

Provenza, 386

08025 Barcelona

Manufacturer

Laboratorios Viñas, S.A.

Torrente Vidalet, 29 Barcelona 08012 SPAIN

Date of the Last Revision of this Package Leaflet:April 2013.

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