iMeds.se

Helaflex

Information för alternativet: Helaflex Filmdragerad Tablett, visa andra alternativ
Document: Helaflex film-coated tablet ENG OTC PL change

Package leaflet: Information for the user


Helaflex film-coated tablets

Extract of Devil´s claw


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


Always use this medicine exactly as described in this leaflet or as your doctor or other health care professionals have told you.


What is in this leaflet

1. What Helaflexis and what it is used for

2. What you need to know before you use Helaflex

3. How to use Helaflex

4. Possible side effects

How to store Helaflex

6. Contents of the pack and other information


What Helaflex is and what it is used for


Helaflex is a traditional herbal medicinal product used for relief of pain in mild joint abrasion (osteoarthritis).


The product is a traditional herbal medicinal product for use in the specified indication exclusively based on long-standing use.


What you need to know before you use Helaflex


Do not use Helaflex

- if you are allergic to Devil´s claw or any of the other ingredients of this medicine (listed in section 6).

- if you ever had or have stomach ulcer or duodenal ulcer.

- if you are pregnant or breastfeeding.


Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Helaflex, if you have gallstone problems or cardiovascular disease.


If your joint pain is accompanied by swelling of joints, severe motion pain, redness or fever, you should be examined by a doctor.


Children and adolescents

Helaflex is not recommended for children and adolescents under 18 years of age.


Other medicines and Helaflex

The effects of concomitant administration of other medicines are not studied.


Tell your doctor or other health care professionals if you are taking or have recently taken this non-prescription medicine.


Pregnancy, breast-feeding and fertility

In the absence of sufficient data, Helaflex should not be used by pregnant or breast-feeding women.

The medicinal products potential impact on fertility has not been studied. It is not known if Devil´s claw extract is excreted to breast milk. Safety for the fetus or infant has not been confirmed.


Driving and using machines

In rare cases this product may cause dizziness. If this happens to you, do not drive or use machines.


You alone are responsible to decide if you are in a fit condition to drive a motor vehicle or perform other tasks that demand increased concentration. Because of their effects or undesirable effects, one of the factors that can reduce your ability to do these things safely is your use of medicines.

Descriptions of these effects can be found in other sections. Therefore, read all the information in this leaflet for guidance. Discuss with your doctor, nurse or pharmacist if you are unsure about anything.


Helaflex contains lactose

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.


How to use Helaflex


Always use this medicine exactly as described in this leaflet or as health care professionals have told you. Check with your doctor or pharmacist if you are not sure.


The recommended dose is: 1 tablet morning and evening. Should be taken with food and preferably with ½ glass of water. The tablets should be swallowed whole.

You should talk to a doctor if the symptoms worsen or do not improve within 4 weeks.


Helaflex is not recommended for children and adolescents under 18 years of age.


If you use more Helaflex than you should

If you have taken too much of the medicine, or if a child has taken the medicine by accident, always contact a doctor or hospital for risk assessment and advice.


If you forget to take Helaflex

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


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


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


Diarrhoea, nausea, vomiting and abdominal pain have been reported, as well as dizziness, headache and allergic skin reactions.


Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Helaflex


Do not store above 25ºC.


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 after Exp.date. The expiry date refers to the last day of that month.


Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6. Contents of the pack and other information


What Helaflex contains



What Helaflex looks like and contents of the pack


Beige to light-brown oblong tablet

Dimensions:

Length: 19.1 - 19.3 mm

Width: 8.1 - 8.3 mm

Height: 6.0 - 6.2 mm


Pack sizes: 50 and 100 tablets in PVC/PVdC/Al-blisters.

Not all pack sizes may be marketed.


Registration Holder and Manufacturer

<To be completed nationally>


<For any further information about this medicine, please contact the local representative of the Registration Holder:>


<To be completed nationally>


This medicinal product is registered in the Member States of the EEA under the following names:


Denmark: Helaflex

Finland: Helaflex

Norway: flexiLoges®

Sweden: Helaflex



This leaflet was last revised in 04 May 2016.


3