ESPINO ALBAR ARKOPHARMA HARD CAPSULES

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

WHITE HAWTHORN ARKOPHARMA

hard capsules

Crataegus monogyna Jacq. (Lindm.) and C. laevigata (Poiret) D.C. (C. oxyacanthoides Thuill.)

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as given by your pharmacist or doctor.

• 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 pharmacist or doctor, even if such effects are not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 14 days.

Contents of this leaflet:

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

1. What ESPINO ALBAR ARKOPHARMA is and what it is used for

A traditional herbal medicinal product used to relieve nervousness with exaggerated perception of heartbeats (palpitations) and in cases of difficulty sleeping, based solely on traditional use.

2. What you need to know before starting to take ESPINO ALBAR ARKOPHARMA

Do not take ESPINO ALBAR ARKOPHARMA

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you are under 18 years of age.

Warnings and precautions

Consult your pharmacist or doctor before starting to take ESPINO ALBAR ARKOPHARMA.

If symptoms do not improve or worsen after 2 weeks of treatment, consult your doctor.

Taking ESPINO ALBAR ARKOPHARMA with other medicines

No interactions with other medicines are known.

Consult your pharmacist or doctor before taking any medicine, especially if you have been diagnosed with any heart condition or suspect you may have one.

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

Taking ESPINO ALBAR ARKOPHARMA with food and drinks

The influence of food and drinks on the effect of the medicine has not been described.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your pharmacist or doctor before using this medicine. There is no demonstrative clinical information on the safe use of this medicine during pregnancy and breastfeeding; therefore, its use 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 ESPINO ALBAR ARKOPHARMA

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

The recommended dose is as follows:

Nervousness:

Adults: Take 1 capsule at breakfast, lunch, and dinner with a glass of water.

Difficulty sleeping:

Adults: Take 2 capsules in mid-afternoon and another 2 capsules before bedtime with a glass of water.

This medicine is for oral use.

The recommended treatment duration is 4 weeks. However, if you notice that symptoms do not improve or worsen after 2 weeks, or if leg swelling (edema) occurs, you should consult your pharmacist or doctor.

Use in children and adolescents

Administration is not recommended for individuals under 18 years of age.

If you take more ESPINO ALBAR ARKOPHARMA than you should

In case of overdose or accidental ingestion, contact 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 ESPINO ALBAR ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if it is almost time for the next dose, it is better to skip the missed dose and take the next one at the scheduled time. Never take a double dose to make up for a missed dose.

4. Possible adverse effects

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

At the recommended doses, ESPINO ALBAR ARKOPHARMA does not present adverse effects.

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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ESPINO ALBAR 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. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of ESPINO ALBAR ARKOPHARMA:

Each capsule contains as the active substance: 350 mg of cryomilled flowering tops of Crataegus monogyna Jacq. (Lindm.) and C. laevigata (Poiret) D.C. (C. oxyacanthoides Thuill.) (Hawthorn).

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

Appearance of the product and contents of the container:

Capsules presented in bottles containing 48 and 84 capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea No. 9

28045 MADRID

Manufacturer:

Arkopharma

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

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

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