Leaflet: information for the user

CAMILINA ARKOPHARMA

Hard capsules

Camellia sinensisL.

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your pharmacist, doctor or nurse.

• Keep 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 pharmacist, doctor or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if you get worse or do not improve after 30 days.

1. What isCAMILINA ARKOPHARMAand what it is used for

2. What you need to know before starting to takeCAMILINA ARKOPHARMA

3. How to takeCAMILINA ARKOPHARMA

4. Possible side effects

5. Storage ofCAMILINA ARKOPHARMA

6. Contents of the pack and additional information

Traditional medication based on plants used in adults and adolescents over 12 years old as a complement in weight control diets to facilitate the elimination of liquids from the body, in people with overweight, based exclusively on its traditional use.

Consult a doctor if it worsens or does not improve after 1 month.

Do not take CAMILINA ARKOPHARMA

If you are allergic to the active ingredient or to any of the other components of this medication.

If you have liver insufficiency

Warnings and precautions

Consult your pharmacist or doctor before starting to take CAMILINA ARKOPHARMA. It is recommended to use this medication as a complement to dietary measures, in people with overweight with a Body Mass Index (BMI) between 25-29.9. The BMI is a way to know if you have a healthy weight or if you are overweight, taking into account your height.

It is not recommended in case of edema associated with heart or kidney insufficiency.

Children

This medication is not recommended for children under 12 years old.

Taking CAMILINA ARKOPHARMA with other medications

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

Taking CAMILINA ARKOPHARMA with food and drinks

Foods and drinks do not have an influence on the effect of the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant or intend to become pregnant, consult your pharmacist or doctor before using this medication. No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so it is not recommended to administer it in these circumstances.

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

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

The recommended dose is:

Adults and adolescents over 12 years old: take 3 capsules in the morning and 3 capsules with a meal with a glass of water.

This medication is used orally.

Due to its caffeine content, it is not recommended to take it at night.

Use for a period of 6 to 8 weeks, as needed.

If symptoms worsen or do not improve after 1 month of treatment, you must consult a healthcare professional.

Use in children

This medication is not recommended for children under 12 years old.

If you take more CAMILINA ARKOPHARMA than you should

No cases of overdose with CAMILINA ARKOPHARMA have been described.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to take CAMILINA ARKOPHARMA

If you forget a dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Do not take a double dose to compensate for the missed doses.

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

Due to the caffeine content, it may increase nervousness, make it difficult to sleep, or alter blood pressure levels.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Each capsule contains as active ingredient: 300 mg of cryomolded leaves ofCamellia sinensisL. (Green tea).

The other components are the excipients: gelatin (capsule coating).

Appearance of the product and contents of the packaging:

There are 3 presentations in bottles containing 50, 100, and 200 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Arkopharma LABORATORIES, S.A.U.

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing

Arkopharma

Laboratories Pharmaceutiques

BP 28 – 06511 CARROS Cedex - FRANCE

Date of the last review of this leaflet: September 2016

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.gob.es/