Olfen patch

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Olfen Patch (Olfen)
140 mg, medicinal patch
Diclofenacum natricum
Olfen Patch and Olfen are different trade names for 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 as directed by a doctor or pharmacist.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or further information.
• If any adverse effects occur, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4. If there is no improvement or if the patient feels worse after 3 days, 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 pain-relieving medicine. 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 arms and legs 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 caused asthma attacks, skin swelling, or swelling and irritation inside the nose,
• if the patient has active gastric or duodenal ulcer disease,
• 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 bronchial asthma or allergies, as bronchospasm causing breathing difficulties may occur,
• if a rash develops; in such case, remove the patch immediately and discontinue treatment,
• if the patient has impaired kidney, heart or liver function, or has a history of gastrointestinal ulcers, intestinal inflammation, or bleeding.

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

• If symptoms do not improve after 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 Olfen Patch, avoid exposing the treated areas to direct sunlight or solarium for approximately one day 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 taken, as well as any medicines planned for future use. When Olfen Patch is used correctly, only a very small amount of diclofenac is absorbed into the body, so drug interactions that may occur with oral administration of diclofenac are unlikely.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, 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 both mother and child (see "When not to use Olfen Patch").

Fertility
Olfen Patch should not be used in women who are planning pregnancy, have difficulties becoming pregnant, 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 have been observed in the infant.
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)
This 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 eyes and mucous membranes.

3. How to use Olfen Patch

This medicine should always be used as directed by the physician. In case of doubts, consult your
doctor or pharmacist.
Typically used dose:
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. Apply only
one patch to one painful area at a time.
Olfen Patch should be applied only to intact, healthy skin without pathological changes.
Elderly patients
Elderly patients should use Olfen Patch with particular caution, as they are more susceptible to
adverse effects.
Patients with kidney, heart or liver disorders
Olfen Patch should be used with particular 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 administration:
For external 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 package by carefully pressing the edges together.

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

4. Apply the patch to the painful area.

If necessary, a tubular elastic bandage may be used to secure the patch in place.
Do not use the medicated patch under an occlusive dressing (airtight).
Do not cut the patch into parts.
Used patches should be folded in half with the adhesive side inwards.
Duration of treatment
Due to limited data, 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 it is necessary to use the product for longer than 7 days
to relieve pain or if symptoms worsen, patients or parents should consult a doctor.
Use of a higher than recommended dose of Olfen Patch
If severe adverse symptoms occur as a result of accidental overdose (e.g., by children) or improper
use of Olfen Patch patches, contact a doctor. Based on the assessment of the degree of toxicity,
the doctor will decide on the necessary corrective actions.
Missed dose of Olfen Patch
Do not use 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 effects

Like all medicines, Olfen Patch may cause adverse effects, although not everyone experiences them.
You should stop using the patch and consult a doctor immediately 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 effects may occur:
Common (may affect up to 1 in 10 people)
Reactions at the application site, rash, skin eruptions, 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 urticaria), swelling of the skin and mucous membranes, anaphylactic reactions, photosensitivity.
Rare (may affect up to 1 in 1,000 people)
Skin blisters, dry skin.
Very rare (may affect up to 1 in 10,000 people)
Asthma attack, severe rash, pustular rash, ulcerative rash.
Frequency not known (frequency cannot be estimated from available data)
Bruising at the application site.
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 function disturbances, bronchospasm) is negligible compared to the risk associated with oral diclofenac. However, if diclofenac is applied for too long over large areas of skin, systemic adverse effects may occur.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Olfen Patch

Keep this medicine out of the sight and reach 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.
Store below 25°C.
After first opening the package, the medicine may be stored for 4 months in a tightly closed container at a temperature below 25°C, or for 6 months in a tightly closed container in the refrigerator (2°C–8°C).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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.
Other ingredients include: macrogol lauryl ether, diisopropyl adipate, glycerol, propylene glycol, liquid crystallizing sorbitol, sodium polyacrylate, sodium carmellose, basic butyl methacrylate copolymer (Eudragit E 100), anhydrous colloidal silica, natural light kaolin, sodium sulfite, disodium edetate, butylated hydroxytoluene, dried aluminium potassium sulfate, tartaric acid, levomenthol, purified water.
Base: polyester carrier 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 layer of adhesive mass applied to a dressing, ranging in colour from white to light brown, protected by a backing layer.
Olfen Patch is available in packs containing 5 medicated patches in 1 pouch, or 10 medicated patches in 2 resealable pouches of 5 patches each.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

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

Manufacturer:
Merckle GmbH, Ludwig-Merckle-Strasse 3, 89143 Blaubeuren, Germany
Mepha Pharma GmbH, Marie-Curie-Strasse 8, 79539 Lörrach, Germany

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Marketing Authorisation number in Latvia, country of export: 03-0519
Parallel Import Authorisation number: 229/24

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
France: VoltarenPlast 1%
Germany: Olfen Patch
Poland: Olfen Patch
Portugal: Olfen