Olfen patch

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Olfen Patch (Olfen)
140 mg, medicated patch
For use in adolescents aged 16 years and older and in adults
Diclofenacum natricum
Olfen Patch and Olfen are different brand names of the same medicine.
Please read the entire patient information 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If the patient experiences any adverse effects, including any possible adverse effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement or if the patient feels worse after 3 days, consult a doctor.

Table of 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 a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Olfen Patch is indicated for local, symptomatic and short-term treatment of pain associated with acute strains, sprains or contusions of arms and legs resulting from blunt injuries, such as sports injuries, in adolescents aged 16 years and older and in adults.

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 or ibuprofen,
• if taking acetylsalicylic acid or another NSAID has previously caused asthma attacks, urticaria, skin and mucosal swelling, or swelling and irritation inside the nose,
• if the patient has active gastric and/or duodenal ulcer,
• during the last three months of pregnancy,
• in children and adolescents under 16 years of age,
• on wounds or open skin lesions (e.g. abrasions, cuts, skin burns), infected skin, or skin affected by inflammatory conditions (exudative dermatitis) or rash.

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; bronchospasm (airway constriction) may occur, making breathing difficult,
• if the patient develops a skin rash after applying the medicated patch. In such a case, remove the patch immediately and discontinue treatment,
• if the patient has impaired kidney, heart, or liver function, or if the patient has or has previously had stomach or intestinal ulcers, inflammatory bowel disease, or a tendency to bleeding.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Important warnings:

• Do not apply the medicated patch near the eyes or mucous membranes. Avoid contact with eyes and mucous membranes.
• After removing the medicated patch, avoid exposing the treated area to direct sunlight or artificial UV radiation (e.g. sunbeds) to reduce the risk of photosensitivity reactions.
• Do not use simultaneously with other medicinal products containing diclofenac or other non-steroidal anti-inflammatory and analgesic drugs, regardless of whether they are applied topically, taken orally, or administered by injection.

Elderly patients
Elderly patients should use Olfen Patch with particular caution, as they are more susceptible to adverse effects.
Children and adolescents
Olfen Patch must not be used in children and adolescents under 16 years of age, due to insufficient data on safety and efficacy in this age group.
Olfen Patch and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
When Olfen Patch is used correctly, only a small amount of diclofenac is absorbed into the body, making drug interactions—commonly observed with oral diclofenac products—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 a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Olfen Patch during the last three months of pregnancy. During the first six months of pregnancy, Olfen Patch should not be used unless considered necessary and recommended by a doctor. If use is required, the lowest dose for the shortest possible time should be administered.
Adverse effects on the unborn child have been observed with oral forms of diclofenac (e.g. tablets). It is unknown whether the same risk applies to Olfen Patch when applied to the skin.
Breastfeeding
Consult a doctor or pharmacist before using Olfen Patch.
Small amounts of diclofenac pass into breast milk. Short-term use of Olfen Patch does not require discontinuation of breastfeeding, as no adverse effects on the infant have been observed.
Olfen Patch must not be applied directly to the breast area.
Fertility
Olfen Patch should not be used in women who are planning pregnancy, have difficulty becoming pregnant, or are undergoing fertility investigations.
Driving and operating machinery
Olfen Patch has no effect or has negligible effect on the ability to drive and operate machinery.
Olfen Patch contains propylene glycol and butylhydroxytoluene
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 exactly as described in this patient information leaflet or as
directed by your doctor or pharmacist. If in doubt, consult your doctor or
pharmacist.
The recommended dose is one medicated patch twice daily.
Apply one 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.
Use in children and adolescents
Olfen Patch must not be used in children and adolescents under 16 years of age. There is
insufficient data on the efficacy and safety of diclofenac in children and
adolescents under 16 years of age.
Method of administration:
For topical use only.

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

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

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

4. Apply the patch to the painful area.

The medicated patch should only be applied to intact, healthy skin without pathological changes.
If necessary, an elastic mesh 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 use the medicated patch while bathing or showering.
The patch must not be cut into pieces.
Used patches should be folded in half with the adhesive side facing inwards.
Duration of treatment
Do not use Olfen Patch for longer than 7 days.
If symptoms worsen or persist for more than 3 days, consult your doctor.
Contact your doctor or pharmacist if you feel the effect of Olfen
Patch is too strong or too weak.
Use of more than the recommended dose of Olfen Patch
Inform your doctor if serious adverse reactions occur as a result of improper use of this medicine or accidental overdose (e.g. by children).
Your doctor can provide advice on appropriate further management.
Missed dose of Olfen Patch
Do not apply a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
You must 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 effects may occur:

Common (may affect up to 1 in 10 people)
Local skin reactions (including allergic and contact dermatitis), such as redness of the skin, burning sensation, itching, redness and inflammation of the skin, skin rash, sometimes with pustules or urticarial blisters.

Uncommon (may affect up to 1 in 1,000 people)
Skin blisters, dry skin

Very rare (may affect up to 1 in 10,000 people)
Hypersensitivity reactions (including urticaria), angioedema, anaphylactic-type reactions, asthma attack, photosensitivity.

In patients using topical medicines from the same active substance group as diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions such as skin and mucosal swelling, anaphylactic-type reactions with acute circulatory disturbances, and photosensitivity have been reported.

Systemic absorption of diclofenac through the skin is very low compared to blood concentrations of the active substance achieved after oral administration of diclofenac. Therefore, the likelihood of systemic adverse effects (such as gastrointestinal disorders, liver or kidney function disturbances, or breathing difficulties) is very low. However, particularly when diclofenac is used for too long on large areas of skin, systemic adverse effects may occur.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 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.
After the first opening of the sachet, 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).
Store below 25°C.
Medicines must not be disposed of via the sewage system 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 packaging 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 (E 422), propylene
glycol (E 1520), liquid crystallizing sorbitol (E 420), sodium polyacrylate, sodium carboxymethylcellulose (E
466), basic butyl methacrylate copolymer (Eudragit E100), anhydrous colloidal silica, natural light kaolin,
sodium sulfite (E 221), disodium edetate, butylhydroxytoluene (E 321), dried potassium aluminium sulfate,
tartaric acid (E 334), levomenthol, purified water, and a base: 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 layer of adhesive mass applied on 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 (5 patches per sachet).
For further 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:
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

Marketing Authorisation Number in Latvia, country of export: 03-0519
Parallel Import Licence Number: 259/24

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