Olfen Path

Patient Information Leaflet: User Manual

Olfen Patch

140 mg, medicinal patch
(diclofenac sodium)

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in the patient information leaflet or as advised by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or more information.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4. If you do not feel better or feel worse after 3 days, consult a doctor.

Table of Contents:

1. What is Olfen Patch and what is it used for

2. Important information before using Olfen Patch

3. How to use Olfen Patch

4. Possible side effects

5. How to store Olfen Patch

6. Contents of the pack and other information

1. What is Olfen Patch and what is it used for

Olfen Patch is a pain-relieving medicine. It belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs).
Olfen Patch is used locally for short-term treatment to relieve pain associated with
sudden strains, sprains, or bruises in the arms and legs caused by blunt injuries.

2. Important information before using Olfen Patch

When not to use Olfen Patch

• if you are allergic to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID, e.g., acetylsalicylic acid, ibuprofen),
• if you have had asthma attacks, skin rash, or irritation of the nose when taking acetylsalicylic acid or other NSAIDs,
• if you have an active stomach or duodenal ulcer,
• on wounds or open skin damage (e.g., abrasions, cuts, burns), in case of skin infections or eczema,
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Olfen Patch, discuss with your doctor or pharmacist:

• if you have or have had asthma or allergies, you may experience bronchospasm, which is characterized by difficulty breathing,
• if a rash appears; then the patch should be removed immediately and treatment discontinued,
• if you have kidney, heart, or liver problems or have a tendency to gastrointestinal ulcers, enteritis, or bleeding.

Side effects can be reduced by using the lowest possible dose for the shortest duration.
Important warnings:

• If symptoms persist after 3 days, consult a doctor.
• Do not apply the medicinal patch to the eyes or mucous membranes. Avoid contact with eyes and mucous membranes.

The patch should only be applied to undamaged skin. It should not be worn during bathing.
After removing the medicinal patch, avoid exposing the treated area to direct sunlight and sunlamps for about one day after removing the Olfen Patch to minimize the risk of photosensitivity.
Do not use diclofenac-containing medicines or other NSAIDs at the same time, either locally or systemically.

Olfen Patch and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or recently, and about medicines you plan to use. If Olfen Patch is used correctly, only a small amount of diclofenac penetrates the body, so interactions that may occur with oral administration of the medicine are unlikely.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
In the first six months of pregnancy, Olfen Patch should only be used after consulting a doctor.
During the last three months of pregnancy, do not use Olfen Patch due to the increased risk of complications for the mother and child (see "When not to use Olfen Patch").
Fertility
Olfen Patch should not be used in women who are planning to become pregnant or have difficulty becoming pregnant, or are undergoing investigations to determine the cause of infertility.
Breastfeeding
Before using any medicine, consult your doctor or pharmacist.
Only small amounts of diclofenac pass into breast milk. For short-term use of Olfen Patch, it is not necessary to stop breastfeeding, as no adverse effects have been observed in the infant.
However, Olfen Patch should not be applied near the breast.

Driving and using machines

Olfen Patch has no or negligible influence on the ability to drive and use machines.
Olfen Patch contains propylene glycol and butylhydroxytoluene.
The medicine contains 1400 mg of propylene glycol in each patch. Propylene glycol may cause skin irritation.
Butylhydroxytoluene may cause a local skin reaction (e.g., contact dermatitis) or eye and mucous membrane irritation.

3. How to use Olfen Patch

This medicine should always be used exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.

Posology:

Apply one medicinal patch to the painful area twice a day, in the morning and evening. Do not use more than two medicinal patches per day, even if injuries occur in several places. Use only on one painful area at a time.
Olfen Patch should only be applied to undamaged, non-diseased skin.

Elderly patients

Elderly patients should use Olfen Patch with caution, as they are more likely to experience side effects.

Patients with kidney, heart, or liver problems

In patients with kidney, heart, or liver problems, Olfen Patch should be used with caution.

Children and adolescents under 16 years of age

There is a lack of sufficient data on the efficacy and safety of use in children and adolescents under 16 years of age.

Method of administration:

For cutaneous use only. Do not swallow!

• 1. Open the packaging containing the medicinal patch by cutting along the marked line.

• 2. Remove the patch and close the packaging tightly, carefully folding the edges.

• 3. Remove the protective layer from the adhesive surface of the patch.

• 4. Apply the patch to the painful area.

If necessary, a knitted bandage can be used to secure the patch in the desired position.
Do not use the medicinal patch under a non-permeable (occlusive) dressing.
Do not divide the patches into parts.
Used patches should be folded in half, with the adhesive side inward.

Duration of treatment

Due to limited data, only short-term therapy is recommended.
Olfen Patch should not be used for more than 3 days without consulting a doctor.
The therapeutic benefits of using the patch for more than 7 days have not been confirmed.
In the case of adolescents aged 16 and over and adults, if it is necessary to use the product for more than 7 days to relieve pain or if symptoms worsen, parents or patients should consult a doctor.

Overdose of Olfen Patch

In case of severe side effects due to accidental overdose (e.g., by children) or incorrect use of Olfen Patch, consult a doctor. Based on the assessment of the degree of poisoning, the doctor will decide what corrective actions to take.

Missed dose of Olfen Patch

Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olfen Patch can cause side effects, although not everybody gets them.

Stop using the patch and consult a doctor immediately if you notice any of the following symptoms:

sudden itchy rash (hives), swelling of hands, feet, ankles, face, lips, mouth, or throat, difficulty breathing, sudden drop in blood pressure, or feeling of weakness.

The following side effects may occur:

Common(may affect up to 1 in 10 people)
Reactions at the application site, rash, eruption, redness, skin inflammation (including allergic and contact dermatitis), skin swelling, itching, burning sensation.
Uncommon(may affect up to 1 in 100 people)
Generalized skin rash, allergic reactions (including hives), skin and mucous membrane swelling, anaphylactic reactions, photosensitivity.
Rare(may affect up to 1 in 1,000 people)
Blistering skin, dry skin
Very rare(may affect up to 1 in 10,000 people)
Asthma attack, severe skin eruption, pustular rash, rash with ulcers
Frequency not known(frequency cannot be estimated from the available data) Hematoma at the application site
The absorption of diclofenac after topical application is very low, resulting in very low plasma concentrations compared to oral administration. The likelihood of systemic side effects (such as gastrointestinal disorders, liver or kidney function disorders, bronchospasm) is therefore negligible compared to the likelihood of side effects after oral administration of diclofenac. However, if diclofenac is used for too long on large areas of skin, systemic side effects may occur.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olfen Patch

Keep the medicine out of the sight and reach of children.
Do not use Olfen Patch after the expiry date stated on the carton after the words "Expiry date" or "EXP".
The expiry date refers to the last day of that month. The batch number on the packaging is after the abbreviation "Lot".
Do not store above 25°C.
Store in the original packaging to protect from light and drying.
Store the sachet tightly closed to protect from drying.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olfen Patch contains

The active substance is: diclofenac sodium. Each medicinal patch contains 140 mg of diclofenac sodium.
The other ingredients are: macrogol lauryl ether (9EO), diisopropyl adipate, glycerol, propylene glycol, liquid crystallizing sorbitol (E 420), sodium polyacrylate, sodium carmellose, butyl methacrylate copolymer, anhydrous colloidal silica, light natural kaolin, sodium metabisulfite (E 221), disodium edetate, butylhydroxytoluene (E 321), aluminum potassium sulfate, tartaric acid, levomenthol, purified water, polyester backing layer (EL-8100S), protective polypropylene film.

What Olfen Patch looks like and contents of the pack

Olfen Patch is a medicinal patch with a size of 10 cm x 14 cm with a uniform adhesive layer applied to the dressing, white to light brown in color; protected by a protective layer.
Olfen Patch is available in packs containing 2 medicinal patches in one sachet, 5 medicinal patches in 1 sachet, or 10 medicinal patches in 2 sachets of 5 patches each with the possibility of reclosing.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Manufacturer
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren
Germany
Manufacturers/Importers
Sofarimex-Industria Química e Farmacêutica, SA
Av. Das Industrias
Alto De Colaride/ Algualva
2735-213 Cacem
Portugal
Haleon France
100 route de Versailles
78164 Marly-Le-Roi-Cedex
France
Teva Operations Poland Sp. z o.o
ul. Mogilska 80,
31-546 Kraków

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:
VoltarenPlast 1%
Germany:
Olfen Patch
Poland:
Olfen Patch
Portugal:
Olfen
Date of revision of the leaflet:August 2024