Crecil 500 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Crecil 500 mg hard capsules

Cystine

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

Follow exactly the instructions for administration of this medicine provided in this leaflet or those given 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 adverse effects not listed in this leaflet.
• You should consult a doctor if you worsen or do not improve after 30 days.

Contents of the leaflet

1. What Crecil 500 mg capsules is and what it is used for
2. What you need to know before taking Crecil 500 mg capsules
3. How to take Crecil 500 mg capsules
4. Possible side effects
5. How to store Crecil 500 mg capsules
6. Contents of the pack and other information

1. What Crecil 500 mg capsules is and what it is used for

Contains an amino acid (a component of proteins) that includes sulfur and is part of a protein (keratin) which constitutes hair and nails.

Crecil is indicated for the 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.).

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

2. What you need to know before starting to take Crecil 500 mg capsules

Do not take Crecil capsules

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Crecil.

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

Children

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

Taking Crecil capsules with other medicines

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

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, you should not take Crecil capsules during pregnancy or breastfeeding.

Driving and using machines

Crecil does not affect the ability to drive or operate machinery.

3. How to take Crecil 500 mg capsules

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

The recommended dose is:

• Adults and adolescents over 14 years of age:

Oral use.

It is recommended to take 2 to 3 capsules daily, taken with meals.

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

If symptoms do not improve or worsen after one month of treatment, treatment should be discontinued and you should consult your doctor.

If you take more Crecil capsules than you should

There is no information available on cases of poisoning.

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 medication 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 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 cause adverse effects, although not everyone will experience them.

No adverse effects have been reported with the use of Crecil 500 mg capsules.

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 Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Crecil 500 mg 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 expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Crecil 500 mg hard capsules

• The active substance is Cystine. Each capsule contains 500 mg of cystine.
• The other components (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 contents of the pack

Crecil is presented as red hard gelatin capsules in packs 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 most recent revision of this leaflet: April 2013.

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