Voltaren Emulgel Forte

Active Ingredients

Active ingredient and its quantity in a dose unit:

Diclofenac diethylamine 2.32%

(Corresponds to Diclofenac sodium 2.0%)

Indications

Therapeutic class:

Voltaren Emulgel Forte contains the active ingredient diclofenac, which belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs). It has a special formulation which enables it to be rubbed into the skin.

Voltaren Emulgel Forte is intended for use without a doctor’s order for the following indications:

Local treatment of pain, inflammation and swelling in adults and adolescents over 12 years of age, in the following cases: trauma of the tendons, ligaments, muscles and joints due to sprain, strain, bruise and/or back pain (e.g., sports injuries). Local soft tissue rheumatic diseases, such as tendonitis (e.g., tennis elbow) and bursitis. According to a doctor’s order, the medicine is intended for treatment of pain due to osteoarthritis of the joints, such as the knee or fingers.

Instructions

Do not swallow. The preparation is intended for external use only.

Rub a small amount of Voltaren Emulgel Forte into the skin in the painful/swollen area. The amount of emulgel depends on the size of the injured area. You may feel a slightly cold sensation while rubbing the emulgel. Following use, wipe any leftover gel from the pull-out cap as necessary using a cotton cloth or paper towel, until it appears clean and dry. Close the pull-out cap until you hear a “click”. Hold the tube upright when opening or closing the pull-out cap to prevent the gel from leaking. Wash your hands after using Voltaren Emulgel Forte, unless your hands are the treated area.

The generally accepted dosage for children, adolescents over 12 years of age and adults is:

Apply the preparation twice daily (morning and evening) to the painful area, which will relieve the pain for up to 12 hours.

Do not exceed the recommended dose.

Voltaren Emulgel Forte may be used for up to 14 days; further use should be according to a doctor’s recommendation only.

If no improvement in your condition is felt within 7 days or if it is worsening, contact the doctor.

If you forgot to apply this medicine at the required time, apply it when you remember and apply the next dose at the regular time. Do not apply it more than twice daily. Do not apply a double dose.

Warnings

Do not use Voltaren Emulgel Forte if you are sensitive (allergic) to the active ingredient (diclofenac diethylamine) or to other medicines for treatment of pain, fever or inflammation, such as ibuprofen or aspirin (a medicine used to treat blood coagulation), or to any of the additional components the medicine contains. Symptoms of an allergic reaction may manifest as shortness of breath or wheezing while breathing (asthma), skin rash with blisters or urticaria, swelling of the face or tongue, runny nose.

Do not use this medicine if you have recently been suffering from severe joint pains that are not related to an injury or in times of excessive use.

Do not use this medicine if you feel unwell, you have a fever or another symptom alongside the pain.

Do not use this medicine if you are in the last trimester of pregnancy.

Do not use the preparation in children under the age of 12.

Do not apply the emulgel on a rash or eczema, cuts or open wounds. Stop the treatment if a skin rash appears following application of the medicine.

Avoid application on large skin areas and for a prolonged period of time, unless the doctor recommends it.

Care should be taken while sunbathing or when using tanning lamps, as your skin may be more sensitive to sunlight.

Avoid contact of Voltaren Emulgel Forte with the eyes. If this happens, wash your eyes thoroughly with clean water. If the discomfort continues, speak to the doctor or pharmacist.

Due to increased risk of side effects, care should be taken when taking other medicines that contain analgesics (NSAIDs), such as aspirin or ibuprofen.

A splint or wound dressing may be used, but do not apply the emulgel under an air-tight dressing (plastic).

If you are suffering or have previously suffered from a gastric or a duodenal ulcer, tell your doctor or pharmacist before using the emulgel.

If you are suffering or have previously suffered from asthma, tell your doctor or pharmacist before using the emulgel.

Do not go near an open fire or smoke in its vicinity - there is a risk for severe burns. Fabric (clothes, bed linen, dressings etc.) that was in contact with the medicine will burn more easily and is a serious fire hazard. Washing clothes and bed linen can decrease the accumulation of the material, but not remove it completely.

Do not use Voltaren Emulgel Forte if you are in the last trimester of pregnancy, since the preparation may harm the fetus or cause problems during delivery. Do not use the preparation during the first six months of pregnancy unless the doctor orders it; the lowest dosage should be used for the shortest period of time possible. This preparation has a possible side effect of kidney impairment in the fetus and low amniotic fluid levels starting from the 20th week of pregnancy. It is recommended to avoid using preparations from the NSAIDs family starting from the 20th week of pregnancy and to consult a healthcare professional if necessary.

Do not use Voltaren Emulgel Forte if you are breastfeeding unless a doctor orders it, since diclofenac passes into breastmilk in small amounts. Breastfeeding women should not apply Voltaren Emulgel Forte on their breasts, nor on large areas or for a prolonged period of time.

If you are pregnant or breastfeeding, consult the doctor or pharmacist for more information.

Please do not consider this information as an alternative to consulting your physician or pharmacist.

For further information on instructions for use, risks and side effects, please read the patient package insert and consult your doctor or pharmacist.
Read the patient package insert carefully before starting to take any medication.