Olfen patch

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Olfen Patch (Olfen)
140 mg, medicated patch
Diclofenacum natricum
Olfen Patch and Olfen are different trade names for the same medicine.
Please read carefully the information in this leaflet 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
physician or pharmacist.

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

Contents of the leaflet:

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 a doctor or pharmacist:

• if the patient has or has had asthma or allergies, bronchospasm with breathing difficulties may occur,
• if a rash appears; in such case, remove the patch immediately and discontinue treatment,
• 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 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 medicinal 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 or recently taken, as well as any medicines planned for use. When Olfen Patch is used correctly, only a minimal 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 might be pregnant, or is planning to have a baby, she should consult a 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 planning pregnancy, experiencing difficulties in becoming pregnant, or undergoing fertility investigations.

Breastfeeding
Before using any medicine, consult a doctor or pharmacist.
Only small amounts of diclofenac pass into breast milk. With short-term use of Olfen Patch patches, interruption of breastfeeding is not necessary, 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 or negligible influence on the ability to drive and operate machinery.

Olfen Patch contains propylene glycol and butylhydroxytoluene.
This medicine contains 1400 mg of propylene glycol in each 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 the physician. In case of doubts, consult a
doctor or pharmacist.
Usual 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 at a time to a single painful site.
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 reactions.
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 topical use only. Do not swallow!

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

2. Remove the patch and tightly close the package by pressing the edges together firmly.

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

4. Apply the patch to the painful area.

If necessary, a tubular bandage may be used to secure the patch in place.
Do not use the medicated patch under an occlusive dressing (i.e. one that does not allow air
passage).
Do not cut the patch into parts.
Used patches should be folded in half with the adhesive side turned inwards.
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.
The therapeutic benefit of using the patch for longer than 7 days has not been confirmed.
In adolescents aged 16 years and adults, if treatment longer than 7 days is required for pain relief,
or if symptoms worsen, parents or patients should consult a doctor.
Use of a higher than recommended dose of Olfen Patch
In case of severe adverse symptoms due to accidental overdose (e.g. by children) or incorrect use
of Olfen Patch patches, contact a doctor. Based on the assessment of the degree of intoxication,
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 questions about 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.
Discontinue use of the patch and consult a doctor immediately if any of the following symptoms occur:
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 patients)
Reactions at the application site, rash, eczema, 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 in 1,000 patients)
Skin blisters, dry skin

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

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

Systemic absorption of diclofenac after topical application is very low, resulting in significantly lower plasma concentrations compared to oral administration. Therefore, the likelihood of systemic adverse effects (such as gastrointestinal disorders, liver or kidney function disturbances, bronchospasm) is considerably lower than with oral diclofenac. However, if diclofenac is applied for too long on large skin areas, 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 or pharmacist. 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 sight and reach of children.
Do not use Olfen Patch after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
After first opening the packaging, the medicine may be stored for up to 4 months.
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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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.

Other ingredients include: macrogol lauryl ether, diisopropyl adipate, glycerol, propylene glycol (E 1520), liquid sorbitol, crystallizing (E 420), sodium polyacrylate, sodium carboxymethylcellulose, basic butyl methacrylate copolymer, colloidal anhydrous silica, natural light kaolin, sodium sulfite (E 221), disodium edetate, butylated hydroxytoluene (E 321), potassium aluminium sulphate, tartaric acid, levo-menthol, purified water, polyester support 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 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 sachet or 10 medicated patches in 2 resealable sachets of 5 patches each.

For further 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
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Sofarimex-Indústria Química e Farmacêutica, SA
Avenida das Indústrias, Alto de Colaride - Agualva
2735-213 Cacem
Portugal
Glaxosmithkline Santé Grand Public
23 rue Francois Jacob
92500 Rueil Malmaison
France

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Portugal, country of export, Marketing Authorisation Number: 5128723
Parallel Import Authorisation Number: 186/23

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