Camilina Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CAMILINA ARKOPHARMA

hard capsules

Camellia sinensis L.

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

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

• 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 reactions, consult your pharmacist, doctor, or nurse, even if they are adverse reactions not listed in this leaflet.
• You should consult a doctor if your condition worsens or if you do not improve after 30 days.

Contents of the leaflet

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

1. What CAMILINA ARKOPHARMA is and what it is used for

A traditional herbal medicinal product used in adults and adolescents over 12 years of age as a supplement in weight control diets to aid the elimination of fluids from the body in individuals with overweight, based exclusively on its traditional use.

Consult a doctor if symptoms worsen or do not improve after 1 month.

2. What you need to know before starting to take CAMILINA ARKOPHARMA

Do not take CAMILINA ARKOPHARMA

If you are allergic to the active substance or to any of the other components of this medicine.

If you have hepatic insufficiency.

Warnings and precautions

Consult your pharmacist or doctor before starting to take CAMILINA ARKOPHARMA. This medicine is recommended as a complement to dietary measures in overweight individuals with a Body Mass Index (BMI) between 25–29.9. BMI is a way of determining whether you have a healthy weight or overweight, taking into account your height.

Its use is not recommended in cases of edema associated with cardiac or renal insufficiency.

Children

Administration of this medicine is not recommended for children under 12 years of age.

Taking CAMILINA ARKOPHARMA with other medicines

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

Taking CAMILINA ARKOPHARMA with food and drink

Food and beverages do not influence the effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your pharmacist or doctor before using this medicine. No studies have been conducted to establish the safety of using this medicine during pregnancy or breastfeeding; therefore, its administration is not recommended under these circumstances.

Driving and using machines

No effects on the ability to drive or use machines have been reported.

3. How to take CAMILINA ARKOPHARMA

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

The recommended dose is:

Adults and adolescents over 12 years of age: take 3 capsules at breakfast and 3 capsules at lunchtime, with a glass of water.

This medicine is for oral use.

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

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

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

Use in children

Administration of this medicine is not recommended for children under 12 years of age.

If you take more CAMILINA ARKOPHARMA than you should

Cases of overdose with CAMILINA ARKOPHARMA have not been reported.

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

If you forget to take CAMILINA ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if it is almost time for the next dose, it is better not to take the missed dose and wait until the next scheduled dose. Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

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

Due to its caffeine content, it may increase nervousness, make sleep difficult, or cause changes in blood pressure levels.

Reporting of 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CAMILINA ARKOPHARMA

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging, following the abbreviation "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Each capsule contains as the active substance: 300 mg of cryomilled leaves of Camellia sinensis L. (Green tea).

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

Appearance of the product and contents of the pack:

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturer

Arkopharma

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

Date of the most recent review of this leaflet: September 2016

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.gob.es/