Leaflet: information for the user

ESPINO ALBAR ARKOPHARMA

Hard capsules

Crataegus monogynaJacq. (Lindm.) andC. laevigata(Poiret) D.C. (C. oxyacanthoidesThuill.)

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

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

• 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 or doctor,even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 14 days.

1. What isESPINO ALBAR ARKOPHARMAand what it is used for

2. What you need to know before takingESPINO ALBAR ARKOPHARMA

3. How to takeESPINO ALBAR ARKOPHARMA

4. Possible side effects

5. Storage ofESPINO ALBAR ARKOPHARMA

6. Contents of the pack and additional information

Traditional medication based on plants to relieve nervousness with an exaggerated perception of heartbeats (palpitations) and in case of difficulty sleeping, based exclusively on its traditional use.

Do not take ESPINO ALBAR ARKOPHARMA

- If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).

- If you are under 18 years old.

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 medications

No known interactions with other medications.

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

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

Taking ESPINO ALBAR ARKOPHARMA with food and drinks

No influence of food and drinks on the effect of the medication has been described.

Pregnancy and breastfeeding:

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your pharmacist or doctor before using this medication. There is no clinical information available to demonstrate the safe use of the medication during pregnancy and breastfeeding, so it is not recommended for use in these circumstances.

Driving and operating machinery

No effect on the ability to drive and operate machinery has been registered.

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 for:

Nervousness:

Adults: Take 1 capsule in the morning, noon, and evening with a glass of water.

Difficulty sleeping:

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

This medication is taken orally.

The recommended treatment is for 4 weeks, however, if you observe that the symptoms do not improve or worsen after 2 weeks or if swelling in the legs occurs, you should consult with your pharmacist or doctor.

Use in children and adolescents

It is not recommended for administration to individuals under 18 years old.

If you take moreESPINO ALBAR ARKOPHARMA than you should

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 takeESPINO ALBAR ARKOPHARMA

In case of forgotten 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 forgotten dose and wait for the next one. Never take a double dose to compensate for the forgotten dose.

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

At the recommended doses of ESPINO ALBAR ARKOPHARMA, no adverse effects are presented.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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.Disposeof the packaging and medications you no longer need at the SIGRE collection pointofyour pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need.This will help protect the environment.

Composition of ESPINO ALBAR ARKOPHARMA:

Each capsule contains as active ingredient: 350 mg of cryomilled flower tops ofCrataegus monogynaJacq. (Lindm.) andC. laevigata(Poiret) D.C. (C. oxyacanthoidesThuill.) (White thorn).

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

Appearance of the product and contents of the packaging:

They are capsules that are presented in bottles containing 48 and 84 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Arkopharma LABORATORIES, S.A.U.

C/ Amaltea N°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 ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.