OLFEN PATCH

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Olfen Patch (Olfen)
140 mg, medicated patch
Diclofenacum natricum
Olfen Patch and Olfen are different trade names of the same medicine.
Please 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 leaflet or according to
the instructions provided by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in the leaflet, inform your doctor or pharmacist. See section 4. If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.

Leaflet Contents:

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

Olfen Patch is a medicine that relieves pain. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Olfen Patch is used locally in short-term treatment to relieve pain associated with sudden strains, sprains, or contusions of the hands and feet resulting from blunt injuries.

2. Important information before using Olfen Patch

When not to use Olfen Patch

• if the patient is allergic to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to any other non-steroidal anti-inflammatory drug (NSAID), e.g. acetylsalicylic acid, ibuprofen,
• if taking acetylsalicylic acid or another NSAID has previously triggered asthma attacks, skin swelling, or swelling and irritation inside the nose,
• if the patient has active gastric or duodenal ulcer,
• on wounds or open skin lesions (e.g. abrasions, cuts, burns), in case of skin infections or eczema,
• during the last three months of pregnancy.

Warnings and precautions
Before starting treatment with Olfen Patch, discuss with your doctor or pharmacist:

• if the patient has or has had asthma or allergies, as bronchospasm may occur, causing breathing difficulties,
• if a rash appears; in such case, the patch should be removed immediately and treatment discontinued,
• if the patient has impaired kidney, heart or liver function, or has a tendency to gastrointestinal ulcers, intestinal inflammation, or bleeding.

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

• If symptoms do not improve within 3 days, consult a doctor.
• Do not apply the medicinal patch near the eyes or mucous membranes. Avoid contact with eyes and mucous membranes.

The patch should be applied only to intact skin. It should not be worn during bathing.
After removing the medicinal patch, avoid exposing the treated areas to direct sunlight or solarium for approximately one day after removal of Olfen Patch to reduce the risk of photosensitivity.
Do not simultaneously use topical or systemic medications containing diclofenac or other NSAIDs.

Olfen Patch and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use. When Olfen Patch is used correctly, only a very small amount of diclofenac is absorbed into the body, so interactions that may occur with oral administration of the drug are unlikely.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Olfen Patch should be used during the first six months of pregnancy only after consultation with a doctor.
Olfen Patch must not be used during the last three months of pregnancy due to increased risk of complications for mother and child (see "When not to use Olfen Patch").

Fertility
Olfen Patch should not be used in women who are trying to become pregnant, have difficulties conceiving, or are undergoing fertility investigations.

Breastfeeding
Before using any medicine, consult your doctor or pharmacist.
Only small amounts of diclofenac pass into breast milk. Short-term use of Olfen Patch patches does not require interruption of breastfeeding, as no adverse effects in the infant have been observed.
However, Olfen Patch patches should not be applied to the breast area.

Driving and operating machinery
Olfen Patch has no effect or negligible effect on the ability to drive and operate machinery.

Olfen Patch contains propylene glycol and butylhydroxytoluene (E 321).
The medicine contains 1400 mg of propylene glycol per patch. Propylene glycol may cause skin irritation.
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Olfen Patch

This medicine should always be used as directed by a physician. If in doubt, consult your doctor or pharmacist.
Typical dosage:
Apply the medicated patch to the painful area twice daily, in the morning and evening. No more than two medicated patches should be used per day, even if injuries occur in several areas. Only one painful area should be treated at a time.
Olfen Patch should only be applied to intact, disease-free skin.
Elderly patients
Elderly patients should use Olfen Patch with particular caution, as they are more susceptible to adverse reactions.
Patients with kidney, heart or liver disorders
Olfen Patch should be used with special caution in patients with kidney, heart or liver disorders.
Children and adolescents under 16 years of age
There is insufficient data on the efficacy and safety of use in children and adolescents under 16 years of age.
Method of application:
For topical use only. Do not swallow!

1. Open the package containing the medicated patch by cutting along the marked line.

2. Remove the patch and tightly close the packaging by carefully pressing the edges together.

3. Remove the protective liner from the adhesive surface of the patch.

4. Apply the patch to the painful area.

If necessary, a knitted bandage may be used to secure the patch in place.
Do not apply the medicated patch under an occlusive (airtight) dressing.
Do not cut the patch 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.
Do not use Olfen Patch for longer than 3 days without consulting a doctor.
Therapeutic benefits of using the patch for longer than 7 days have not been confirmed.
In adolescents aged 16 years and adults, if use beyond 7 days is necessary to relieve pain or if symptoms worsen, parents or patients should consult a doctor.
Use of a higher than recommended dose of Olfen Patch
If severe adverse symptoms occur due to accidental overdose (e.g., by children) or improper use of Olfen Patch, contact a doctor immediately. Based on the assessment of the degree of intoxication, the doctor will decide what corrective actions are necessary.
Missed dose of Olfen Patch
Do not apply a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Olfen Patch may cause adverse reactions, although not everyone will experience them.
You should stop using the patch and immediately consult a doctor if you notice any of the following symptoms:
sudden itchy rash (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty breathing, sudden drop in blood pressure or feeling of weakness.

The following adverse reactions may occur:
Common (may affect up to 1 to 10 patients in 100)
Reactions at the application site, rash, skin eruption, redness, skin inflammation (including allergic and contact dermatitis), skin swelling, itching, burning sensation.

Uncommon (may affect up to 1 in 100 patients)
Generalized skin rash, allergic reactions (including urticaria), swelling of the skin and mucous membranes, anaphylactic reactions, photosensitivity.

Rare (may affect up to 1 to 10 in 1,000 patients)
Skin blisters, dry skin

Very rare (may affect up to 1 in 10,000 patients)
Asthmatic attack, severe rash, pustular rash, ulcerative rash

Frequency not known (frequency cannot be estimated from the available data)
Bruising at the application site

Systemic absorption of diclofenac after topical application is very low, resulting in very low plasma concentrations of diclofenac compared to oral administration. Therefore, the likelihood of systemic adverse effects (such as gastrointestinal disorders, liver or kidney dysfunction, bronchospasm) is negligible compared to the risk associated with oral diclofenac. However, if diclofenac is used for too long on large areas of skin, systemic adverse reactions may occur.

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, you should inform your doctor or pharmacist.

Reporting of adverse reactions
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C 02-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Olfen Patch

The medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light and drying out.
Keep the sachet tightly closed to protect from drying out.
Shelf-life after first opening of the sachet: 4 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information
What Olfen Patch contains
The active substance is: sodium diclofenac. Each medicated patch contains 140 mg of sodium diclofenac.
The other ingredients are: macrogol lauryl ether, diisopropyl adipate, glycerol, propylene glycol, liquid sorbitol crystallising (E 420), sodium polyacrylate, sodium carmellose, basic butyl methacrylate copolymer, anhydrous colloidal silica, light natural kaolin, sodium sulfite (E 221), disodium edetate, butylhydroxytoluene (E 321), alum, tartaric acid, levomenthol, purified water, polyester backing layer, polypropylene protective film.

What Olfen Patch looks like and contents of the pack
Olfen Patch is a medicated patch measuring 10 cm x 14 cm, with a uniform adhesive layer applied on a dressing, ranging in colour from white to light brown, protected by a release liner.
Olfen Patch is available in packs containing 5 or 10 medicated patches in resealable sachets.
For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Portugal, country of export:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer:
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
Sofarimex – Indústria Química e Farmacêutica, S.A.
Avenida das Indústrias, Alto de Colaride – Agualva
2735-213 Cacém
Portugal
Mepha Polska Sp. z o.o.
ul. Wojciechowska 9B
20-704, Lublin
Poland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Portugal, country of export, Marketing Authorisation Number: 5128723
Parallel Import Authorisation Number: 223/25

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
France: VoltarenPlast 1%
Germany: Olfen Patch
Poland: Olfen Patch
Portugal: Olfen