film-coated tablets
Extract from devil’s claw root

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.
  • You should consult a doctor if you do not feel better or if you feel worse after 2 weeks of treatment (mild indigestion) or 4 weeks of treatment (mild joint pain). See section 3.

In this leaflet:
1. What Harpatinum is and what it is used for
2. What you need to know before you use Harpatinum
3. How to use Harpatinum
4. Possible side effects
5. How to store Harpatinum
6. Contents of the packaging and other information

1. What Harpatinum is and what it is used for

Harpatinum is a traditional herbal medicine used to:

  • relieve mild joint pain
  • relieve mild indigestion (such as bloating and gas and temporary loss of appetite)

The indications for traditional herbal medicine are based solely on experience with long-term use.

Harpatinum contains a dry extract from the devil’s claw root.

2. What you need to know before you use Harpatinum

Do not use Harpatinum

  • If you are allergic to devil’s claw (also called harpago herb and Harpagophytum ), peanuts, soy or any of the other ingredients of this medicine (listed in section 6).
  • If you have ulcers in your stomach or intestines.

Warnings and cautions

Talk to your doctor before using Harpatinum, if you have:

  • joint pain along with joint swelling, redness or fever;
  • gallstone problems.

If symptoms worsen with the use of this medicine, you should consult a doctor.

Children and young people

This medicine is not recommended for children and adolescents under 18 years of age due to insufficient information.

Other medicines and Harpatinum

Possible effects of concomitant use of other drugs have not been studied.

In case of contact with a doctor or other healthcare professional, remember to tell them that you are taking or have recently taken Harpatinum.

Harpatinum with food, drink and alcohol

There are no known effects of concomitant consumption of food, drink, or alcohol.

Pregnancy, breastfeeding and fertility

In the absence of adequate information, the use of Harpatinum during pregnancy and lactation is not recommended. The potential effect of the drug on fertility has not been studied.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Harpatinum has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or other healthcare professional.

Harpatinum contains lactose (milk sugar)

Do not use this medicine if you are allergic to peanuts or soy.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Harpatinum.

3. How to use Harpatinum

Always take this medicine exactly as described in this leaflet or as directed by your doctor or other healthcare professional. If you are not sure, talk to your doctor, healthcare professional, or pharmacist.

Adults:

The recommended dose is 2 capsules twice a day.

Daily maximum dose: 4 capsules.

Swallow the capsules together with a glass of water.

Contact a doctor or other healthcare professional if symptoms persist for more than 4 weeks when using Harpatinum to relieve mild joint pain or for longer than 2 weeks to relieve mild indigestion.

If you use more Harpatinum than you should 

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Harpatinum

Do not take a double dose to make up for a forgotten dose . Take the next dose as usual.

If you stop using Harpatinum

You can stop taking this medicine at any time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them. The following side effects have been reported:

  • Stomach and intestine: diarrhea, nausea, vomiting, abdominal pain.
  • Central nervous system: headache, dizziness.
  • Allergic reactions: rash, hives, swelling of the face.

The frequency of these side effects is not known.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Harpatinum

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is dry extract from the root of devil’s claw.
    Each capsule contains 225 mg of extract (as a dry extract) from Harpagophytum procumbens DC. and / or Harpagophytum zeyheri Decne. (devil’s claw), radix, corresponding to 990-1125 mg dried root of devil’s claw. Extractant: 60% ethanol (v / v).
  • The other ingredients are: lactose monohydrate , hydrated colloidal silica, refined soybean oil, refined coconut oil, fractionated palm kernel oil, yellow wax, purified soybean phospholipids (lecithin), milk fat, gelatin, glycerol (E4) and liquid sorbitol (e4).

What the medicine looks like and contents of the pack

Oval (15×10 mm), light brown, soft capsules. The capsule contents are dark brown.

Harpatinum is available in packs of 30, 60, 90 and 120 capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Florealis ehf.

Síðumúla 25

108 Reykjavík

Iceland

Email info@florealis.com

Manufacturer

Swiss Caps GmbH

Grassingerstraße 9

D-83043 Bad Aibling

Germany

Muhammad Nadeem

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