Harpagomed coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
HarpagoMed coated tablets
Extract (as dry extract) of root of Harpagophytum procumbens DC.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for taking this medicine contained in this leaflet or those provided by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 4 weeks.
Contents of the leaflet
- What HarpagoMed is and what it is used for
- What you need to know before taking HarpagoMed
- How to take HarpagoMed
- Possible adverse effects
- How to store HarpagoMed
- Contents of the pack and other information
1. What HarpagoMed is and what it is used for
HarpagoMed is a traditional herbal medicinal product used for the treatment of mild joint pain.
Its use is based solely on its traditional use.
2. What you need to know before starting to take HarpagoMed
Do not take HarpagoMed:
- if you are allergic to harpagophytum (also known as devil's claw) or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take HarpagoMed.
Do not exceed the recommended dose.
If symptoms worsen or there is no improvement after 4 weeks of treatment, or if any adverse reaction not mentioned in this leaflet occurs, consult your doctor.
Use with caution if you have gastric or duodenal ulcer or cardiovascular problems.
If pain is accompanied by joint swelling, redness, or fever, you must consult a doctor.
Patients with gallstones should consult their doctor before using devil's claw.
Children and adolescents
Not recommended for children and adolescents under 18 years of age. Sufficient data are lacking.
Other medicines and HarpagoMed
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
There is no evidence that taking HarpagoMed interferes with other medications.
Taking HarpagoMed with food and drink
It is recommended to take HarpagoMed immediately after a meal.
Food and drinks do not influence this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor. Use of HarpagoMed is not recommended during pregnancy.
The safety of this medicine during breastfeeding is unknown; therefore, administration is not recommended.
Driving and using machines
In very rare cases, HarpagoMed may cause dizziness. If this happens to you, do not drive or operate machinery.
HarpagoMed contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take HarpagoMed
Follow exactly the instructions for use provided in this leaflet or as directed by your physician or pharmacist. If in doubt, consult your physician or pharmacist.
The recommended dose is:
Adults and elderly: 1–2 tablets, twice daily immediately after meals.
HarpagoMed is for oral use only. Do not exceed the recommended dose.
Use in children
Do not use in individuals under 18 years of age without consulting a physician.
If you take more HarpagoMed than you should
If you take more HarpagoMed than prescribed and feel unwell, contact your physician immediately.
In case of overdose or accidental ingestion, contact your physician or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take HarpagoMed
Do not take a double dose to make up for missed doses.
Take HarpagoMed as directed by the recommended dosage.
If you stop taking HarpagoMed
You may discontinue taking HarpagoMed at any time without any problems.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse reactions of unknown frequency (frequency cannot be estimated from the available data):
The following adverse reactions may occur when using HarpagoMed:
Nervous system disorders: headache, dizziness.
Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain.
Skin and subcutaneous tissue disorders: allergic skin reactions.
Stop treatment and consult your doctor or pharmacist if any of these symptoms occur.
If you consider any of the effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 HarpagoMed
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use HarpagoMed if you notice any change in colour. The tablets should be white.
Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of HarpagoMed
- The active substance is extract from the root of Harpagophytum procumbens DC. (devil's claw) and/or Harpagophytum zeyheri Decne.
One coated tablet of HarpagoMed contains:
480 mg of dry extract from devil's claw root (Harpagophytum procumbens DC. and/or H. zeyheri Decne.), equivalent to 720–1440 mg of devil's claw root.
Extraction solvent: ethanol 60% (v/v)
- Other components are: lactose, corn starch, microcrystalline cellulose, precipitated silica, colloidal silica, magnesium stearate (of vegetable origin)
The coating layer contains: talc, titanium dioxide, Macrogol and hydroxymethylcellulose.
Appearance of the medicinal product and contents of the container
HarpagoMed is available as white oval tablets, packed in glass bottles containing 30, 60 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bioforce España A.Vogel, S.A.
Platón 6,
08021-Barcelona
Spain
Tel. 93 201 99 22
Fax 93 209 03 19
Manufacturer
- VOGEL B.V.
J.P. Broekhovenstraat 16, Elburg
The Netherlands
Date of the most recent revision of this leaflet: January 2020
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/