Primofenac Emulsion Gel 1% Tb 50g

What is Primofenac Emulsions Gel and when is it used?

Primofenac Emulsions Gel contains the active ingredient diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (painkillers and anti-inflammatory drugs). Primofenac emulsion gel has analgesic and anti-inflammatory properties and, thanks to the aqueous-alcoholic base, has a soothing, cooling effect.Primofenac emulsion 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 accidentlocalized forms of soft tissue rheumatism, such as tendinitis (tennis elbow), shoulder-hand syndrome, bursitis, periarthropathiesand 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 intended for use in adults and adolescents from the age of 12 years.

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 analgesic, anti-inflammatory and fever-reducing 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 section "What does Primofenac Emulsion Gel contain?"). Such hypersensitivity manifests itself, for example, in 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 Do you have to be careful when using Primofenac Emulsions-Gel?

• Primofenac Emulsions-Gel must not be applied to open skin wounds (e.g. after abrasions, cuts) or to damaged skin (e.g. eczema, skin rashes).Stop treatment immediately if a skin rash occurs after using the preparation.Primofenac Emulsions- Gel should not be applied to large areas over a long period of time 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 Emulsions Gel?»).Due to the ingredients contained in Primofenac, local skin irritations may occur in some patients.The preparation contains cetyl alcohol, methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate: Cetyl alcohol can cause localized skin irritations (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).

Inform your doctor, pharmacist or pharmacist if you have previously had allergic symptoms after using similar preparations («Rheu masalben») if you

• suffer from other diseases,Have allergies orUse other medicines (including those you bought yourself!).

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

During the 1st and 2nd trimester of pregnancy and while breastfeeding, Primofenac Emulsions-Gel must not be used unless specifically prescribed by a doctor.In the last 3 months of pregnancy, Prim ofenac Emulsions-Gel should not be used, as it can harm the unborn child or cause problems during birth.If you are planning a pregnancy, you should ask your doctor, pharmacist or druggist for advice before use.

How do you use Primofenac Emulsions-Gel?

The preparation is only intended for external use.

Adults and adolescents from 12 years

Depending on the size of the painful or swollen areas or areas to be treated, apply 2-4 g Primofenac emulsion gel (amount the size of a cherry to a walnut) 3 to 4 times a day, rub in lightly or massage in for muscle pain.

After use:

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

If you have forgotten to treat yourself with Primofenac Emulsions-Gel, do so as soon as possible. Do not apply double the amount to make up for the missed treatment.Inform your doctor if symptoms worsen or if 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, do not apply more than necessary.

Children under 12 years

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

If you or your child have (accidentally) swallowed Primofenac Emulsions-Gel, contact your doctor immediately.

Keep to the dosage given in the package insert or prescribed by the doctor.

If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist tin, 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, hiveswheezing, shortness of breath or a tight chest (asthma)swelling of the face, lips, tongue and throat.

Following 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 user in 10,000): increased sensitivity to sunlight. Signs of this are sunburn with itching, swelling and blistering.

If you get any side effects, talk to your ADoctor, pharmacist or druggist or 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 taken into account?

The medicine may only be used up to the date marked «EXP» on the container.Do not dispose of medicines via the wastewater (e.g. not down the toilet or sink). This helps to 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 technical information.

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/1 00 g), propyl 4-hydroxybenzoate (E 216, 6 mg/100 g); 2-propanol, glycerol (E422), polyacrylic acid, medium-chain triglycerides, macrogolcetylstearyl ether, purified water.

Authorization number

50191 (Swissmedic).

Where can you get Primofenac Emulsions-Gel? Which packs are available?

In pharmacies and drugstores without a doctor's prescription.

Tubes of 50 g and 100 g.

Authorization holder

Streuli Pharma AG, 8730 Uznach.

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