What is LIXIM PATCH and when is it used?

LIXIM PATCH is a medicated patch containing the active ingredient etofenamate, a substance from the group of non-steroidal anti-inflammatory drugs (NSAIDs) with analgesic, anti-inflammatory and decongestant properties. Etofenamate penetrates the skin and reaches the diseased tissue areas.

LIXIM PATCH is used for the short-term symptomatic treatment of acute, uncomplicated ankle injuries in adults.

When is LIXIM PATCH not to be used?

LIXIM PATCH is not to be used:

•if you are hypersensitive to other non-steroidal anti-inflammatory drugs (NSAIDs);

•for broken skin of varying degrees: weeping rash, eczema, infected lesion, burn or open wound;

•in the last trimester of pregnancy;

•during lactation;

•in infants and young children;

•If you are allergic to the active substance or an auxiliary substance according to the composition (see «What does LIXIM PATCH contain?»).

When is caution required when using LIXIM PATCH?

It is recommended to choose the shortest possible duration of use in order to minimize the occurrence of undesirable effects.

Stop treatment immediately if a rash occurs after applying the patch.

Only apply the patch to intact, healthy skin. The patch must not be placed on broken skin or open injuries.

The patch should not come into contact with mucous membranes or eyes.

Bronchospasm or rhinitis may occur in patients with asthma, allergic rhinitis, or nasal polyps. Allergic reactions are possible in patients with chronic nettle fever (urticaria).

The absorption of etofenamate into the body when applied externally in the form of a patch is very low, which is why the risk of a clinically relevant drug interaction is negligible.

Because the plaster still contains a relevant amount of the active substance after use, care must be taken to ensure that it is disposed of properly (see also the information under «What else needs to be taken into account»). Small children and pets should under no circumstances come into contact with the used patches. However, a relevant overdose by sucking or chewing used patches is unlikely.

Due to the route of administration and the low systemic availability of the active ingredient, LIXIM PATCH is not expected to affect the ability to drive or use machines.

Itell your doctor, pharmacist or druggist if you

▪suffer from other diseases,

▪ Have allergies or

•Take other medicines (including those you bought yourself!) or use them externally!

Can LIXIM PATCH be used during pregnancy or breastfeeding?

This medicine must not be used in the last three months of pregnancy.

LIXIM PATCH should not be used during the first and second trimester unless clearly necessary.

LIXIM PATCH must not be used in nursing mothers.

In any case, consult your doctor, pharmacist or druggist or your doctor, pharmacist or druggist in case of long-term use.

In general, as a precautionary measure, you should avoid taking medicines during pregnancy and breastfeeding or ask your doctor, pharmacist or druggist for advice.

How do you use LIXIM PATCH?

Unless otherwise prescribed, 1 patch is applied to the area of ​​skin to be treated with slight pressure every 24 hours (see also the instructions under «Application »).

If there is no improvement after 7 days or if the symptoms worsen, you should consult a doctor.

Only one patch should be used per injured area.

The use and safety of LIXIM PATCH in children and adolescents has not yet been tested and should therefore not be used in these age groups.

For small children under 2 years of age, only use if prescribed by a doctor.

LIXIM PATCH must not be used on babies and small children.

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.

Application

See «How to use LIXIM PATCH» at the end of this patient information sheet.

What side effects can LIXIM PATCH have?

The following side effects can occur when using LIXIM PATCH. In these cases, stop the treatment and inform your doctor, pharmacist or druggist immediately.

Uncommon (affects 1 to 10 users in 1000)

Local skin reactions such as redness, itching, burning sensation, swelling of the skin or wheezing.

Rare (affects 1 to 10 users in 10,000)

Hypersensitivity reactions or local allergic reactions such as skin rash, hives, sudden swelling around the eyes, tightness in the chest with difficulty breathing or swallowing.

If you get any side effects, talk to 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.

Disposal

Used patches always contain residues of the active ingredient. After use, the patch should be folded sticky side in and discarded in a safe place, out of the reach of children. The used plaster can be disposed of with the household waste together with the protective film of the new plaster. Wash your hands afterwards.

Use by after opening

Repeated opening of the packaging does not affect the product quality.

Storage Instructions

Do not store above 30°C. Close the bag tightly again after removal. Keep out of reach of CHILDREN.

Further Notes

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

What is in LIXIM PATCH?

Active ingredients

70 mg etofenamate per medicated patch (10×14 cm).

Excipients

Self-Adhesive Layer: Trimethylsilylated Polysilicate Alpha-Hydro-Omega-Hydroxypoly(dimethylsiloxane) Polycondensate, Dimethicone, Macrogol 400, Olive Oil;

Cover fabric: Bi-elastic polyester fabric;

Release liner: Fluoropolymer coated polyester film.

Approval number

67494 (Swissmedic).

Where can you get LIXIM PATCH? What packs are available?

In pharmacies and drugstores, without a doctor's prescription.

Packs of 7 patches and 2×7 patches.

Authorization holder

Drossapharm AG, Basel.

This leaflet was last checked by the Medicines Agency (Swissmedic) in July 2022.

How to use LIXIM PATCH

Use the patch on dry, smooth skin. Sweat or a lot of hair at the application site can affect the adhesive strength of the patch.

First the protective strip in the middle of the patch (A) is removed. This part of the patch is pressed directly onto the skin.

Do not touch the sticky side of the patch with your fingers.

The center of the patch (A) is held with one hand and the next outer protective film (B) is pulled outwards from the center of the patch with the other hand. The released adhesive surface is pressed along the skin with slight pressure.

Remove the other outer protective film (C) in the same way. The adhesive surface that is released is also pressed gently along the skin.

The patch should then be pressed firmly onto the skin for at least 30 seconds to achieve optimal adhesion.

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.

If you have overdosed on LIXIM PATCH, or if a child has accidentally used this medicine, contact your doctor, pharmacist or druggist immediately.

Do not apply a duplicate number of patches to make up for a missed application.