Package Leaflet: Information for the User

HarpagoMed Coated Tablets

Dried extract (as extractive) of root ofHarpagophytum procumbensDC.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of 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 have any doubts, consult your doctor or pharmacist.

- If you experience any adverse 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 worsen or do not improve after 4 weeks.

1. What is HarpagoMed and what it is used for

2. What you need to know before starting to take HarpagoMed

3. How to take HarpagoMed

4. Possible adverse effects

5. Storage of HarpagoMed

6. Contents of the pack and additional information

HarpagoMed is a traditional plant-based medication, used in the treatment of mild joint pains.

Its use is based exclusively on its traditional use.

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 there is no improvement after 4 weeks of treatment or any adverse reaction not mentioned in this prospectus occurs, consult your doctor.

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

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

Patients 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 old. There are not enough data.

Other medications and HarpagoMed

Inform your doctor or pharmacist if you are taking, have taken recently, or may have 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.

Foods and drinks have no influence on this medication.

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

In very rare cases, HarpagoMed may cause dizziness. If this occurs to you, do not drive or operate machinery.

HarpagoMed contains lactose

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 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 Toxicological 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 compensate for the missed doses.

Take HarpagoMed according to the recommended dose.

If you interrupt treatment with HarpagoMed

You can stop taking HarpagoMed at any time without any problems.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Unknown Frequency Adverse Reactions(frequency cannot be estimated from available data):

When using HarpagoMed, the following adverse reactions may occur:

Nervous System Disorders: headache, dizziness.

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

Skin and Subcutaneous Tissue Disorders: skin allergic reactions.

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

If you consider any of the effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Adverse Effect Reporting:

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

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

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 “CAD”. 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 perceive a change in color. The tablets should be white.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of HarpagoMed

- The active principle is the extract of the root ofHarpagophytum procumbensDC. (devil's claw) and/orHarpagophytum zeyheriDecne.

A coated HarpagoMed tablet contains:

480 mg of dry root extract of devil's claw (Harpagophytum procumbensDC. and/orH. 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 layer of the tablet contains: talc, titanium dioxide, Macrogol and hydroxypropylmethylcellulose.

Appearance of the product and content of the packaging

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

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel. 93 201 99 22

Fax 93 209 03 19

Responsible for manufacturing

A. VOGEL B.V.

J.P. Broekhovenstraat 16, Elburg

Netherlands

Last review date of this leaflet: January 2020

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