HARPAGOPHYTUM ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

HARPAGOFITO ARKOPHARMAhard capsules

Harpagophytum procumbensDC.

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 28 days.

1. What HARPAGOFITO ARKOPHARMA is and what it is used for
2. What you need to know before taking HARPAGOFITO ARKOPHARMA
3. How to take HARPAGOFITO ARKOPHARMA
4. Possible side effects
5. Storage of HARPAGOFITO ARKOPHARMA
6. Package contents and additional information

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

Traditional herbal medicinal product used for the treatment of mild joint pain, based solely on its traditional use.

2. BEFORE TAKING HARPAGOFITO ARKOPHARMA

Do not takeHARPAGOFITO ARKOPHARMA

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

Be cautious with HARPAGOFITO ARKOPHARMA

If you have stomach or duodenal ulcers 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 ARKOPHARMA with food and beverages

Food and beverages do not affect the effect of the medication.

Pregnancy and breastfeeding

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

IMPORTANT FOR WOMEN

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

Driving and using machines

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

3. How to take HARPAGOFITO ARKOPHARMA

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

Consult your pharmacist or doctor if you have doubts.

The normal dose is:

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

This medication is for oral use.

Use for a period of 4 weeks, as needed.

Use in children

Its administration is not recommended for children under 18 years of age.

If you take more HARPAGOFITO ARKOPHARMA than you should

No cases of overdose with HARPAGOFITO ARKOPHARMA have been reported.

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

If you forget to take HARPAGOFITO ARKOPHARMA

In case of forgetting a dose, take the medication as soon as possible, continuing the 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. In no case should you take a double dose to compensate for the forgotten dose.

4. Possible side effects

Like all medications, HARPAGOFITO ARKOPHARMA can cause side effects, although not everyone experiences them.

Gastrointestinal disorders such as diarrhea, nausea, vomiting, and abdominal pain; central nervous system disorders such as headache or dizziness may occur.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of HARPAGOFITO ARKOPHARMA

Keep out of the reach and sight of children.

Do not store at a temperature above 25°C.

Expiry date:

Do not use HARPAGOFITO ARKOPHARMA after the expiry date stated on the packaging, after the abbreviation "CAD". The expiry date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of HARPAGOFITO ARKOPHARMA:

Each capsule contains as an active ingredient: 435 mg of cryomilled roots of Harpagophytum procumbensDC. (Harpagophytum).

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

Appearance of the product and package contents:

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

Marketing authorization holder and manufacturer:

Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturers

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

This package leaflet was approved in: November 2016

"Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"