Dicloplast

Active Ingredients

Each patch contains:

180 mg Diclofenac Epolamine (equivalent to 140 mg Diclofenac Sodium)

Indications

Therapeutic group:

Non-steroidal anti-inflammatory drugs (NSAIDs).

Dicloplast patches are indicated for topical treatment of rheumatic diseases, pain and non-infectious inflammation.

Instructions

Do not swallow! For external use only.

Cut off the top of the inner sachet along the indicated line and open the seal.

Remove a patch from the sachet and close the sachet well, using the seal. Record the date on which the sachet was opened in the space provided. Remove the protective clear wrapping.

Apply the patch to the skin around the painful or swollen area. If necessary, secure the patch in place with an additional adhesive strip. Do not cover the patch with other dressings.

Dicloplast should be applied only to intact, undamaged skin and not to injured skin or open wounds, and should not be kept on when bathing.

Do not cut the patch.

The usual dosage is generally:

Place a patch on the affected area in the morning and in the evening (for up to 12 hours).

Do not exceed the recommended dose.

If there is no improvement in your condition within 7 days, refer to the doctor. The duration of treatment should not exceed 14 days.

Do not use this medicine frequently or for a prolonged period without consulting the doctor.

If you forgot to apply this medicine at the required time, do not apply an additional patch. Apply the next patch at the regular time.

The patches can be used within 3 months of opening the sachet.

Warnings

Do not use Dicloplast patches if you are hypersensitive (allergic) to the active ingredient Diclofenac or to any of the other ingredients contained in the medicine, to aspirin and salicylates, or to other NSAID preparations.

Do not use this medicine if you have breathing problems, asthma, skin rash or a runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs.

Do not use this medicine if you have entered or are beyond your sixth month of pregnancy.

Do not use this medicine if you have an active stomach ulcer (peptic ulcer).

Do not use this medicine if you have damaged skin, including discharge, infections, eczema, burns or wounds.

Do not use this medicine if you are a child or adolescent below the age of 16 years.

Before treatment with Dicloplast, tell the doctor if:

• You have heart disease
• You have kidney disease
• You have liver disease
• You have had stomach ulcers in the past
• You have an inflammatory bowel disease such as: Crohn’s disease or ulcerative colitis or you are susceptible to bleeding from your bowel
• You have asthma
• You have breathing problems, skin rash or a runny nose after taking acetylsalicylic acid (aspirin) or other NSAIDs
• You are taking Diclofenac or other NSAIDs, as an oral or topical preparation
• You regularly sunbathe or regularly use a sun-bed
• You are an elderly person who may be at higher risk for side effects.

Do not use Dicloplast on open wounds (abrasions, cuts).

Children and adolescents:

The medicine is not intended for children or adolescents below the age of 16 years.

If you are taking or have recently taken other medicines, including non-prescription medicines and nutritional supplements, tell the doctor or pharmacist. In particular if you are taking aspirin and salicylates and non-steroidal anti-inflammatory preparations.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult with the doctor or pharmacist before using the medicine. This preparation has a possible side effect of kidney damage in the fetus and a reduction in the amount of amniotic fluid starting from week 20 of pregnancy. It is recommended to refrain from using NSAIDs starting from Week 20 of pregnancy and to consult a healthcare practitioner if needed. Dicloplast must not be used if you have entered or are already beyond your sixth month of pregnancy, as it could harm your fetus or cause problems at delivery. Before the sixth month of pregnancy, use Dicloplast only after receiving medical advice. Keep the dose as low as possible and the duration of treatment as short as possible.

During breastfeeding Dicloplast should be used only after receiving medical advice, as the active ingredient, diclofenac, passes into breast milk in small amounts. It is important to avoid applying Dicloplast on the breasts of nursing mothers or elsewhere on large areas of skin or for a prolonged period of time.

Avoid contact of the Dicloplast with the eyes or mucosal tissues (e.g., nose and mouth), the genital and anal areas. If the patch comes into contact with these areas, wash the area well with water.

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.