PATIENT INFORMATION LEAFLET

Olfen 140 mg Adhesive Medicinal Plasters

Diclofenac Sodium

Read this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-For advice on any side effects, consult your pharmacist.

-For advice on any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

1. What Olfen is and what it is used for

2. What you need to know before using Olfen

3. How to use Olfen

4. Possible side effects

5. Storage of Olfen

6. Contents of the pack and additional information

Olfenis a medication that reduces pain. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).

For adults and adolescents 16 years of age and older:

This medication is used for short-term treatment of local symptomatic relief of acute pain associated with sprains, strains, or bruises in arms and legs resulting from injuries, for example, sports injuries.

Do not use Olfen

• if you are allergic to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other components of this medication (listed in section 6),
• if you are allergic to any other nonsteroidal anti-inflammatory drug (NSAID, for example, acetylsalicylic acid, ibuprofen)
• if you developed asthma, skin rash, or inflammation and irritation inside the nose after taking acetylsalicylic acid or any other NSAID,
• if you have an active peptic ulcer,
• if you have open skin wounds (for example, skin abrasions, cuts, burns), skin infections, or eczema,
• in the last three months of pregnancy.
• in children and adolescents under 16 years old

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication

• if you have or have had bronchial asthma or allergies, you may experience bronchospasm, which manifests with difficulty breathing,
• if you observe a skin rash, remove the adhesive medicated patch immediately and suspend treatment,
• if you have kidney, heart, or liver disorders or if you have had or have previously had gastrointestinal ulcers, intestinal inflammation, or a tendency to bleed.

The adverse effects may be reduced by using the minimum effective dose for the shortest possible period.

IMPORTANT PRECAUTIONS:

• If symptoms persist for more than 3 days or worsen, you should consult your doctor,

Do not use the medicated adhesive patch on the eyes or mucous membranes or allow it to come into contact with them

After removing the adhesive medicated patch, avoid direct exposure of the treated area to sunlight or other sources of ultraviolet radiation (such as a solarium) for at least one day to reduce the risk of photosensitivity.

Do not use simultaneously, either topically or systemically, any medication containing diclofenac or other NSAIDs

Older patients

Older patients should use this medication with caution, as they are more prone to experiencing adverse effects.

Children and adolescents

This medication should not be used in children and adolescents under 16 years old due to lack of experience.

Using Olfen with other medications

Inform your doctor or pharmacist if you are using/taking, have used recently, or may need to use/take any other medication.

As long as the medication is used correctly, the absorption of diclofenac by the body is very small, so the interactions described when diclofenac is administered orally are unlikely to occur.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

During the first six months of pregnancy, you can only use Olfen adhesive medicated patches after consulting your doctor.

During the last trimester of pregnancy, you should not use Olfen, as there is an increased risk of complications for the mother and child (see "Do not use Olfen").

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Very small amounts of diclofenac are excreted in breast milk. As no adverse effects have been known in children, it is generally not necessary to interrupt breastfeeding during the use of Olfen. However, the patch should not be applied directly to the breast area.

Driving and operating machinery:

This medication has no or insignificant influence on your ability to drive and operate machinery.

Olfen contains propylene glycol and butylhydroxytoluene,

This medication contains 1,400 mg of propylene glycol in each adhesive. Propylene glycol may cause skin irritation.

Butylhydroxytoluene may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Apply a medicated adhesive patch to the painful area twice a day, in the morning and at night. The maximum total daily dose is 2 medicated patches, even if there are multiple injured areas to be treated. Treat only one painful area at a time.

Use in children and adolescents

There are not enough data on efficacy and safety in children or adolescents under 16 years old.

Administration method

Only for topical use. Do not ingest!

1. Cut the package containing the medicated adhesive patch along the mark.

2. Remove the medicated adhesive patch and close the package tightly by pressing the closure.

3. Remove the protective film from the surface of the medicated adhesive patch.

4. Place the medicated adhesive patch on the painful area.

If necessary, the medicated adhesive patch can be adhered using an elastic mesh bandage.

Do not use the medicated adhesive patch with an occlusive bandage.

Do not divide the medicated adhesive patch.

The used medicated adhesive patch must be folded in half, with the adhesive side facing inward.

Duration of use

Do not use Olfen for more than 3 days without consulting your doctor. The use of this medication for a longer period should be consulted with your doctor and should not exceed 7 days.

If you use more Olfen than you should

If you have used more Olfen than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service (Tel: 91 562 04 20).

Inform your doctor if severe adverse effects occur after incorrect use of the medication or accidental overdose (e.g. in children). Your doctor will advise you on the necessary measures, depending on the severity of the poisoning.

If you forgot to use Olfen

Do not use a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication can produce adverse effects, although not all people will experience them.

Consult your doctor immediately and discontinue use of the medicated adhesive patch if you notice any of the following:

Sudden skin rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing, drop in blood pressure, or weakness.

You may experience the following adverse effects:

Frequent (may affect up to 1 in 10 people)

Local skin reactions, such as skin redness, burning sensation, itching, inflamed skin redness, skin rash, sometimes with pustules or papules.

Rare (may affect up to 1 in 100 people)

Contact dermatitis or local allergic reactions (hypersensitivity reactions).

Unknown frequency (cannot be estimated from available data)

Dry skin

In patients who have used topically active substances belonging to the same group of medications as diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions, such as skin swelling and mucous membrane swelling, and anaphylactic reactions with acute circulatory disorders and light sensitivity have been reported.

The absorption of diclofenac into the body through the skin is very low compared to the concentration of the active substance in the blood after oral ingestion of diclofenac. The probability of adverse effects in the body (such as renal or gastrointestinal alterations or breathing difficulties) is very low.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of the medication.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Store in the original packaging to protect it from light and desiccation.

Store the sealed envelope to protect it from desiccation.

This medication can be stored for 4 months after the first opening of the envelope.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Olfen

The active ingredient is: diclofenac sodium. Each medicated adhesive plaster contains 140 mg of diclofenac sodium.

The other components are: glycerol, propylene glycol (E1520), diisopropyl adipate, crystallizable liquid sorbitol (E-420), sodium caramel, sodium acrylate, butyl methacrylate copolymer base, disodium edetate, sodium sulfite (E-221), butylhydroxytoluene (E-321), anhydrous aluminum potassium sulfate, anhydrous colloidal silica, light kaolin (natural), macrogol lauryl ether (9 EO units), levomenthol, tartaric acid, purified water, polyester non-woven support, polypropylene protective film.

Appearance of the product and contents of the package:

Olfen are medicated adhesive plasters 10 x 14 cm with a uniform white to light brown paste evenly spread as a uniform base on a non-woven support and with a disposable protective film.

Olfen is available in packages with 2, 5, 10 or 14 medicated adhesive plasters in self-sealing envelopes containing 2 or 5 medicated plasters.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio

Albatros B 1st floor 28108

Alcobendas, Madrid (Spain)

Responsible manufacturer

Merckle GmbH

Ludwing-Merckle-Strabe 3

89143 Blaubeuren, (Germany)

This medicinal product is authorized in the Member States of the EEA with the followingnames:

Austria: Dolostrip 140 mg medicated plaster

Belgium: Kinespir Patch 140 mg plaster

Czech Republic: Olfen 140 mg medicated plaster

Denmark: Diclofenac ratiopharm

Germany: Diclofenac-ratiopharm pain plaster

Hungary: Algoplast-ratiopharm 140 mg medicated patch

Italy: Diclofenac Pharmentis 140mg medicated plasters

Slovakia: Diclobene 140 mg

Spain: Olfen 140 mg medicated adhesive plasters

United Kingdom: ALGOPAIN-Eze 140 mg medicated plaster

Last review date of this leaflet:October 2019

Other sources of information

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es