Leaflet: information for the user

HARPAGOFITO ARKOPHARMAhard capsules

Harpagophytum procumbensDC.

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 doctor or pharmacist.

• 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 doctor or pharmacist, 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 28 days.

1. What isHARPAGOFITO ARKOPHARMAand what it is used for

2. What you need to know before takingHARPAGOFITO ARKOPHARMA

3. How to takeHARPAGOFITO ARKOPHARMA

4. Possible side effects

5. Storage ofHARPAGOFITO ARKOPHARMA

6. Contents of the pack and additional information

Traditional medication based on plants used in the treatment of mild joint pains, based exclusively on its traditional use.

Do not takeHARPAGOFITO ARKOPHARMA

If you are allergic to the active ingredient or to any of the other components of HARPAGOFITO ARKOPHARMA..

Be especially careful with HARPAGOFITO ARKOPHARMA

If you have a gastric or duodenal ulcer or cardiovascular problems.

If you experience possible joint inflammation, redness, or fever.

Use of other medications

Inform your pharmacist or doctor if you are using or have recently used other medications, including those purchased without a prescription.

Taking HARPAGOFITO ARKOPHARMAwith food and beverages

Foods and beverages have no influence on the effect of the medication.

Pregnancy and breastfeeding

There are no adequate and well-controlled studies in pregnant women or breastfeeding women, so its administration is not recommended.

IMPORTANT FOR WOMEN

If you are pregnant or believe you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machines

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

Follow these instructions unless your doctor has given you different instructions.

Consult your pharmacist or doctor if you have any doubts.

The usual dose is:

Adults: take 1 capsule in the morning, at lunch, and at dinner with a glass of water.

This medication is taken orally.

Use for a period of 4 weeks, as needed.

Use in children

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

If you take more HARPAGOFITO ARKOPHARMAthan you should

No cases of overdosing with HARPAGOFITO 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 HARPAGOFITO 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. Never take a double dose to compensate for the missed dose.

Like all medications, HARPAGOFITO ARKOPHARMAmay cause adverse effects, although not all people will experience them.

Adverse gastrointestinal disorders such as: diarrhea, nausea, vomiting, and abdominal pain; central nervous system disorders such as: headache or dizziness may appear.

In rare cases, skin allergic reactions may appear. Frequency is unknown.

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 out of reach and sight of children.

Do not store at a temperature above 25°C.

Expiration Date:

Do not use HARPAGOFITO ARKOPHARMAafter 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 medicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of HARPAGOFITO ARKOPHARMA:

Each capsule contains as active ingredient: 435 mg of cryomolded roots ofHarpagophytum procumbensDC.(Harpagofito).

The other components are the excipients: hypromellose (capsule coating), hydrated colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package:

There are 3 presentations in bottles containing 48, 50, 84, and 168 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Arkopharma LABORATORIES, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturing responsible parties

ARKOPHARMA

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS Cedex - FRANCE

This leaflet was approved in:November 2016

“Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices(AEMPS)”