HARPAGOMED Coated Tablets

Introduction

Leaflet: information for the user

HarpagoMed coated tablets

Extract (as dry extract) of root of Harpagophytum procumbensDC.

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

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 4 weeks.

Contents of the leaflet

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

1. What is HarpagoMed and what is it used for

HarpagoMed is a traditional herbal medicinal product used in the treatment of mild joint pain.

Its use is based exclusively on its traditional use.

2. What you need to know before taking HarpagoMed

Do not take HarpagoMed:

• if you are allergic to harpagophytum (also known as devil's claw) or any of the other components of this medication (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 do not improve after 4 weeks of treatment or if any adverse reaction occurs that is not mentioned in this leaflet, consult your doctor.

If you have a stomach or duodenal ulcer or cardiovascular problems, it should be used with caution.

If the pain is accompanied by swelling of the joint, redness, or fever, you should consult a doctor.

Patient with gallstones should consult their doctor before using devil's claw.

Children and adolescents

It is not recommended to administer to children and adolescents under 18 years of age. There is not enough data.

Other medications and HarpagoMed

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

There is no evidence that taking HarpagoMed interferes with the taking of other medications.

Taking HarpagoMed with food and drinks

It is recommended to take HarpagoMed immediately after a meal.

Food and drinks do not have an influence on this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

Taking medication during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor. The use of HarpagoMed is not recommended during pregnancy.

The safety of this medication during breastfeeding is not known, so its administration is not recommended.

Driving and using machines

In very rare cases, HarpagoMed can cause dizziness; if this happens to you, do not drive or use machinery.

HarpagoMed contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take HarpagoMed

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and elderly: 1-2 tablets, 2 times a day, immediately after meals.

HarpagoMed is exclusively for oral use. Do not take more than the recommended dose.

Use in children

Do not use in children under 18 years of age without consulting a doctor.

If you take more HarpagoMed than you should

If you take more HarpagoMed than you should and feel unwell, consult your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 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 forgotten doses.

Take HarpagoMed according to the recommended dose.

If you stop treatment with HarpagoMed

You can stop taking HarpagoMed whenever you want without any problems.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Adverse reactions of unknown frequency(frequency cannot be estimated from available data):

Using HarpagoMed, the following adverse reactions may occur:

Nervous system disorders: headache, dizziness.

Gastrointestinal disorders: diarrhea, nausea, vomiting, abdominal pain.

Disorders of the skin and subcutaneous tissue: allergic skin reactions.

Stop treatment and consult your doctor or pharmacist if any of these symptoms occur.

If you consider that any of the effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of HarpagoMed

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use HarpagoMed if you notice a change in color. The tablets should be white.

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

6. Package contents and additional information

Composition of HarpagoMed

• The active ingredient is the extract of 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 of devil's claw root (Harpagophytum procumbensDC. and/or H. zeyheriDecne.) equivalent to 720-1440 mg of devil's claw root.

Extraction solvent: ethanol 60% (v/v)

• The other components are: lactose, cornstarch, microcrystalline cellulose, precipitated silica, colloidal silica, magnesium stearate (of vegetable origin)

The coating of the tablet contains: talc, titanium dioxide, Macrogol, and hydroxypropylmethylcellulose.

Appearance of the product and package contents

HarpagoMed is presented in the form of white oval tablets, packaged in glass bottles with 30, 60, and 120 tablets.

Not all package 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

Netherlands

Date of the last revision of this leaflet: January 2020

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/

Comunication of side effects:

Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico o enfermero, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través del Sistema Español de Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.