Harpagophytum Arkopharma hard capsules
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
HARPAGOFITO ARKOPHARMA hard capsules
Harpagophytum procumbens DC.
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- 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 doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if there is no improvement after 28 days.
- What HARPAGOFITO ARKOPHARMA is and what it is used for
- What you need to know before taking HARPAGOFITO ARKOPHARMA
- How to take HARPAGOFITO ARKOPHARMA
- Possible side effects
- How to store HARPAGOFITO ARKOPHARMA
- Contents of the pack and other information
1. What HARPAGOFITO ARKOPHARMA is and what it is used for
A traditional herbal medicinal product used for the treatment of mild joint pain, based solely on long-standing use.
2. BEFORE TAKING HARPAGOFITO ARKOPHARMA
Do not take HARPAGOFITO ARKOPHARMA
If you are allergic to the active substance or to any of the other components of HARPAGOFITO ARKOPHARMA.
Take special care with HARPAGOFITO ARKOPHARMA
If you suffer from gastric or duodenal ulcer or cardiovascular problems.
If a possible joint inflammation, redness, or fever occurs.
Use of other medicines
Inform your pharmacist or doctor if you are using or have recently used any other medicines, including those obtained without a prescription.
Taking HARPAGOFITO ARKOPHARMA with food and drink
Food and drink do not affect the medicine's action.
Pregnancy and breastfeeding
There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, administration is not recommended.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be, consult your doctor before taking this medicine. Taking medicines during pregnancy may 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 or use machines have been reported.
3. How to take HARPAGOFITO ARKOPHARMA
Follow these instructions unless your doctor has given you different ones.
Consult your pharmacist or doctor if you have any doubts.
Recommended dose:
Adults: take 1 capsule at breakfast, lunch, and dinner with a glass of water.
This medicine is for oral use.
Use for a period of 4 weeks, as needed.
Use in children
Administration is not recommended for individuals 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 at telephone number 91 562 04 20, indicating the product and the amount ingested.
If you forget to take HARPAGOFITO ARKOPHARMA
If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and simply wait for the next scheduled dose. Never take a double dose to make up for the missed one.
4. Possible adverse effects
Like all medicines, HARPAGOFITO ARKOPHARMA may produce adverse effects, although not everyone will experience them.
Gastrointestinal disorders may occur, such as: diarrhoea, nausea, vomiting, and abdominal pain; disorders of the central nervous system such as: headache or dizziness.
In rare cases, skin allergic reactions may occur. Frequency is unknown.
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 may 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 HARPAGOFITO ARKOPHARMA
Keep out of the reach and sight of children.
Do not store above 25°C.
Expiry date:
Do not use HARPAGOFITO ARKOPHARMA 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.
6. Additional information
Composition of HARPAGOFITO ARKOPHARMA:
Each capsule contains as the active substance: 435 mg of cryo-ground roots of Harpagophytum procumbens DC. (Harpagophytum).
The other components are excipients: hypromellose (capsule coating), colloidal hydrated silica and magnesium stearate.
Appearance of the product and contents of the container:
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 summary of product characteristics was approved in: November 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/”