What is Primofenac emulsion gel and when is it used?

Primofenac Emulsions-Gel is used for the external treatment of pain, inflammation and swelling in:

• Injuries to tendons, ligaments, muscles and joints, e.g. sprains, bruises, strains or back pain after sport or an accident
• localized forms of soft tissue rheumatism, such as tendinitis (tennis elbow), shoulder-hand syndrome, bursitis, periarthropathies
• and for the symptomatic therapy of arthrosis of small and medium-sized joints that are close to the skin, such as finger joints or knees.

Primofenac Emulsions-Gel is for Intended for use in adults and adolescents from 12 years of age.

When should Primofenac Emulsions-Gel not be used?

Primofenac Emulsions-Gel should not be used if there is a known hypersensitivity to the active ingredient diclofenac or other pain, anti-inflammatory and antipyretic agents Substances (in particular acetylsalicylic acid/aspirin and ibuprofen) and hypersensitivity to one of the excipients (e.g. isopropanol; for a full list of excipients, see the “What does Primofenac Emulsions-Gel contain?” section). Such hypersensitivity is manifested, for example, by wheezing or shortness of breath (asthma), breathing difficulties, skin rash with blistering, hives, swelling of the face and tongue, runny nose.

In the last 3 months of pregnancy, Primofenac Emulsions-Gel must not be used (see also «Can Primofenac Emulsions-Gel be used during pregnancy or while breastfeeding?»).

When is caution required when using Primofenac emulsion gel?

• Primofenac emulsion gel must not be applied to open skin wounds (e.g. after abrasions, cuts) or on damaged skin (e.g. eczema, skin rashes).
• Stop treatment immediately if a skin rash occurs after using the product.
• Primofenac Emulsions-Gel should not be used for a long time applied to large areas unless prescribed by a doctor.
• Eyes and mucous membranes should not come into contact with the preparation. If this does happen, rinse your eyes thoroughly with tap water and inform your doctor if the symptoms persist.
• Do not take the medicine. Wash hands after use, except when treating the finger joints (see also «How do you use Primofenac Emulsion Gel?»)
• Due to the ingredients contained in Primofenac, local skin irritations may occur in some patients.
• The preparation contains cetyl alcohol, methyl parahydroxybenzoate and propyl parahydroxybenzoate: cetyl alcohol can cause localized skin irritation (e.g. contact dermatitis). Methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate can trigger allergic reactions, including delayed reactions.
• Primofenac emulsion gel must not be used with an airtight bandage (occlusive bandage).

• suffer from other diseases,
• have allergies or
• use other medicines (including those you bought yourself!).

Can Primofenac Emulsions-Gel be used during pregnancy or while breastfeeding?

Primofenac Emulsions-Gel must not be used during the 1st and 2nd trimester of pregnancy or while breastfeeding , unless specifically prescribed by a doctor.

Primofenac Emulsions-Gel must not be used during the last 3 months of pregnancy as it may harm the unborn child or cause problems during delivery.

If you are planning to become pregnant, you should ask your doctor, pharmacist or druggist for advice before use.

How do you use Primofenac Emulsion Gel?

The preparation is intended for external use only.

Adults and adolescents from the age of 12

Depending on the size of the painful or swollen areas or areas to be treated, an amount of 2-4 g Primofenac emulsion gel (amount the size of a cherry to a walnut) applied, rubbed in lightly or massaged in for muscle pain.

After application:

• Wipe hands with a dry paper towel, then wash hands well, except when treating fingers. Dispose of the paper towel with the household waste.
• You should wait until the gel has dried on your skin before showering or bathing.

You should consider a treatment with Primofenac Emulsions - Gel, make up for it as soon as possible. Do not apply double the amount to make up for the forgotten treatment.

Tell your doctor if your symptoms get worse or if your symptoms have not improved after a week. Primofenac Emulsions-Gel should not be used for more than 2 weeks without a doctor's prescription. Use the preparation for the shortest time necessary, applying no more than necessary.

Children under the age of 12

The use and safety of Primofenac Emulsions-Gel in children under the age of 12 have not yet been systematically tested. Its use is therefore not recommended.

If you or your child swallow Primofenac emulsion gel (accidentally), contact your doctor immediately.

Stick to the dosage given in the package leaflet or as prescribed by your doctor.

If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Primofenac Emulsions Gel have?

The following side effects can occur when using Primofenac Emulsions Gel: Some rare or very rare side effects can be serious. If any of the following side effects occur, stop treatment with Primofenac Emulsions-Gel and tell your doctor immediately:

• rash with blisters, hives
• wheezing, shortness of breath, or a tightness in the chest (asthma)
• swelling of the face, lips, tongue and of the throat.

These other side effects are usually mild and temporary:

• Common (affects 1 to 10 users in 100): rash, itching, redness burning sensation of the skin.
• Very rare (affects less than 1 in 10,000 users): increased sensitivity to sunlight. Signs of this are sunburn with itching, swelling and blistering.

If you notice any side effects, contact your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What else needs to be considered?

The medicinal product may only be used up to the date marked «EXP» on the container.

Do not throw away any medicines via wastewater (e.g. not down the toilet or sink). This helps protect the environment.

Storage Instructions

Store at room temperature (15-25 °C).

Keep out of the reach of children.

Further information

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Primofenac emulsion gel contain?

100 g emulsion gel contains

Active ingredients

1 g diclofenac sodium.

Excipients

cetyl alcohol (250 mg/100 g), methyl 4-hydroxybenzoate (E 218, 14 mg/100 g), propyl 4-hydroxybenzoate (E 216.6mg/100g); 2-Propanol, Glycerol (E422), Polyacrylic Acid, Medium Chain Triglycerides, Macrogolcetyl Stearyl Ether, Purified Water.

Approval number

50191 (Swissmedic).

Where can you get Primofenac Emulsion Gel? What packs are available?

In pharmacies and drugstores without a doctor's prescription.

50g and 100g tubes.

Authorization holder

Streuli Pharma AG, 8730 Uznach.

This leaflet was last checked by the drug authority (Swissmedic) in October 2020.