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Document: leaflet MAH BRAND_THR 12297-0013 change

N-ARKOCAPS UK 200X130:N-ARKOCAPS UK 200X130 15/04/09 11:

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Product not currently marketed under this name - change to distributor as per submission 0004 required prior to marketing

6 - FURTHER INFORMATION


HARPADOL, capsules


Devil's Claw Root 435 mg *


What HARPADOL contains

-    Each hard capsule contains 435 mg Devil’s Claw Root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne).

-    The other ingredients are magnesium stearate (vegetable origin), silica colloidal hydrated and hypromellose (capsule shell).

What HARPADOL looks like and contents of the pack

Each pack contains 45 or 150 hard capsules Not all pack sizes may be marketed.

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.

Traditional Herbal Registration Holder and Manufacturer

LABORATOIRES ARKOPHARMA

LID de Carros Le Broc - 1er avenue, 2709 m

06510 CARROS - France

Tel.: (+33) (0) 4 93 29 11 28 - Fax: (+33) (0) 4 93 29 11 62 Distributed in UK by

Cedar health

BBI Healthcare Ltd, Unit 1 Pencoed Technology Park Pencoed CF35 5HZ Tel: (+44) (0) 161 483 1235

This leaflet was last approved in December 2008

Traditional Herbal Registration Number

THR 12297/0013    |

For a large print, call 161 483 1235 or email to info@bbihealthcare.com °

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Read all of this leaflet carefully before you start taking this medicine.

It contains important information your treatment.

This medicine is available without prescription. However, you still need to use HARPADOL carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What HARPADOL is and what it is used for

2.    Before you take HARPADOL

3.    How to take HARPADOL

4.    Possible side effects

5.    How to store HARPADOL

6.    Further information

1 - WHAT HARPADOL IS AND WHAT IT IS USED FOR

HARPADOL is a traditional herbal medicinal product used for the relief of:

•    Rheumatic or muscular pain

•    General aches and pains in the muscles and joints

•    Backache

This is based on traditional use only.


2    - BEFORE YOU TAKE HARPADOL D0N0JTAKE HARPADOL IF

-    you are allergic (hypersensitive) to the active substance or to any of the other ingredients of HARPADOL (see Section 6 Further Information).

-    you are under 18 years old.

TAKE SPECIAL CARE WITH HARPADOL

-    Do not take more than the recommended dose.

-    Tell your doctor or a healthcare practitioner:

•    If your symptoms worsen or persist for more than 8 weeks;

•    If you have heart problems and want to take Harpadol;

•    If side-effects not mentioned in this leaflet occur;

•    If your joint pain is accompanied by swelling of the joint, redness or fever;

-    If you have an ulcer (either a gastric and/or duodenal ulcer), you should not use HARPADOL.

TAKING OTHER MEDICINES

You can use HARPADOL with other medicines.

PREGNANCY & BREAST FEEDING:

Do not use if you are pregnant or breast-feeding.

DRIVING AND USING MACHINES

In rare cases some patients have experienced dizziness while taking Devil’s claw. If this happens to you, do not drive or use machines.

3    - HOW TO TAKE HARPADOL Adults and the elderly:

Take 1 capsule morning, noon and evening during meals with a large glass of water.

If your symptoms worsen or do not improve after 8 weeks, consult your doctor or a qualified health care practitioner.

Not for use in children or those under 18 years. For oral use only.

Don’t take more than the recommended dose.

IF YOU TAKE MORE HARPADOL THAN YOU SHOULD

If you take too much and feel ill, talk to your doctor.

Taking too much is unlikely to be harmful.

IF YOU FORGET TO TAKE HARPADOL

Do not take a double dose to make up for a forgotten dose.

IF YOU STOP TAKING HARPADOL You can stop taking Harpadol at any time.

4    - POSSIBLE SIDE EFFECTS

Like all medicines, Harpadol can have side effects, although not everybody gets them.

MINOR SIDE EFFECTS

The following minor side effects can occur when using Harpadol:

•    Digestive symptoms: diarrhoea, feeling sick, vomiting, abdominal pain.

•    Central nervous system symptoms: headache, dizziness.

Discontinue use if you find these symptoms are troubling you.

Talk to a doctor, pharmacist or other healthcare practitioner

if you are concerned.

•Allergic skin reactions: rash, itching.

Stop taking Harpadol if you experience any allergic skin reaction.

If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

5    - HOW TO STORE HARPADOL

Keep out of the reach and sight of children.

Do not use HARPADOL after the expiry date which is stated on the bottle after “Exp”. The expiry date refers to the last day of that month.

Store in the original package. Store below 25°C.