Package leaflet: Information for the user
TRAULEN 4% gel
Diclofenac sodium

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 pharmacist have told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

 

What is in this leaflet:

  1. What Traulen is and what it is used for
  2. What you need to know before you use Traulen
  3. How to use Traulen
  4. Possible side effects
  5. How to store Traulen
  6. Contents of the pack and other information

Traulen contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is used to relieve pain and inflammation.

Traulen is used locally to treat rheumatic or traumatic pain and inflammation affecting joints, muscles, tendons and ligaments.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

Do not use Traulen

  • If you are allergic to diclofenac or any of the other ingredients in this medicine (listed in section 6).
  • If you experienced attacks of asthma, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • After the sixth month of pregnancy (see section “Pregnancy and lactation”).
  • Children and adolescents aged less than 14 years.

 

Warnings and precautions
Ask your doctor or pharmacist for advice before using Traulen.

If the product is used on extended skin areas and over a longer period, the possibility of systemic side effects (i.e. effects that may affect different parts of the body) cannot be ruled out (see section 4 “Possible Side Effects”).

Discontinue the treatment immediately and consult your doctor if you experience a rash after applying the gel.

 

Children and adolescents
There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age. Therefore, do not use Traulen in children below 14 years of age.

 

Other medicines and Traulen
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Since systemic absorption of diclofenac following a topical application is very low, interactions with other medicines are very unlikely.


Pregnancy and breast-feeding
Do not use Traulen after the sixth month of pregnancy.  The use of Traulen should be avoided even during the early stages of pregnancy.

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


Driving and using machines
Cutaneous application of diclofenac has no influence on the ability to drive and use machines.


Traulen contains propylene glycol (E1520)
This medicinal product contains 3.75 g propylene glycol per bottle.

 

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


Adults (over 18 years of age)
The recommended dose is three to four applications, according to the extent of the area to be treated, three times daily.

Use in children and adolescents (from 14 to 18 years old)
Three to four applications, according to the extent of the area to be treated, three times daily.

ATTENTION: Use Traulen just for short-term treatment.
If you need to use Traulen for more than 7 days for pain relief or if symptoms worsen, consult your doctor.

Elderly patients:
The usual adult dosage may be used.

Children under 14 years of age
There are insufficient data on efficacy and safety available for children and adolescents below 14 years of age. Therefore, do not use Traulen in children below 14 years of age.

 

How to use the medicine:


Clean and dry carefully the painful area

Apply on the area to be treated

Massage gently in order to favour product absorption.
  • After application, the hands should be washed or they would result to be treated with the gel.
  • DO NOT USE on diseased skin, skin wounds or open lesions.
  • Avoid contact with eyes or mucous membranes.
  • Do not swallow
  • Do not use an airtight occlusive dressing

 

If you use more Traulen than you should
In case of accidental ingestion of an overdose of Traulen contact your doctor immediately or go to the nearest hospital emergency room.

 

If you forget to use Traulen
Do not use a double dose to make up for a forgotten dose.

If you have further questions about this medicine, ask your doctor or pharmacist.

 

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

If the product is used on extended skin areas and over a longer period, the possibility of systemic side effects (i.e. effects that may affect different parts of the body) such as nausea, indigestion, heartburn, excitement, altered taste, conjunctivitis, cannot be ruled out; should any of these symptoms occur, discontinue the treatment and consult your doctor.

 

Common undesirable effects (may affect up to 1 of 10 patients)

  • Skin rash
  • Itching

 

Uncommon undesirable effects (may affect up to 1 of 100 patients):

  • Redness and burning of the skin
  • Skin rash with blistering and vesicles
  • Peeling skin
  • Tingling sensation
  • Involuntary muscle contractions.

 

Very rare undesirable effects (may affect up to 1 of 10,000 patients)

  • Allergic reactions (hypersensitivity, including urticaria)
  • Fast swelling of skin and mucosa
  • Increased skin sensitivity to sunlight
  • Asthma

 

Unknown undesirable effects (frequency cannot be estimated based on available data)

  • Burning sensation at the application site
  • Dry skin

 

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system under https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

 

Store 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 bottle after EXP. The expiry date refers to the last day of that month.

Shelf life after first opening of the bottle is 6 months.

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.

What Traulen contains

  • The active substance is diclofenac sodium. Each 100 g gel contain 4 g diclofenac sodium.
  • The other ingredients are: propylene glycol (E1520), isopropyl alcohol, ethanol, soya lecithin, disodium phosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, ascorbyl palmitate, peppermint oil, purified water.

What Traulen looks like and contents of the pack
Traulen is a gel for cutaneous use. It is available in packs containing a 25 g bottle with dispenser.

MARKETING AUTHORIZATION HOLDER
OP Pharma S.r.l. Via Monte Rosa, 61 – 20149 Milan

Manufacturer
Pharbil Waltrop GmbH Im Wirrigen, 25 – Waltrop (Germany)
Doppel Farmaceutici S.r.l. Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

This package leaflet was last revised in 7th December 2019
 Through QRCode on carton, package leaflet or at the address https://oppharma-products.com/traulen you can access detailed and updated information about this medicinal product.

E’ un medicinale senza obbligo di prescrizione (SOP) che può essere consegnato solo dal farmacista. E’ un medicinale a base di diclofenac sodico che può avere effetti indesiderati anche gravi. Non utilizzare nei bambini e negli adolescenti al di sotto dei 14 anni di età. Leggere attentamente il foglio illustrativo.