Olfen 140 mg medicated adhesive patches
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Olfen 140 mg medicated adhesive patches
For adolescents from 16 years of age and adults
sodium diclofenac
Read this entire leaflet carefully before you start using the medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet:
- What Olfen is and what it is used for
- What you need to know before using Olfen
- How to use Olfen
- Possible adverse effects
- How to store Olfen
- Contents of the pack and other information
1. What Olfen is and what it is used for
Olfen is a medication that reduces pain. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used for the local and short-term symptomatic treatment of acute pain associated with sprains, strains or bruises in arms and legs resulting from injuries, for example, sports injuries in adolescents aged 16 years and older, and adults.
2. What you need to know before using Olfen
Do not use Olfen
- if you are allergic to diclofenac, propylene glycol, butylhydroxytoluene, or any of the other ingredients of this medicine (listed in section 6),
- if you are allergic to any other non-steroidal anti-inflammatory drug (NSAID), for example, acetylsalicylic acid or ibuprofen,
- if you have ever experienced asthma attacks, hives, skin and mucosal swelling, or inflammation and irritation inside the nose after taking acetylsalicylic acid or any other NSAID,
- if you have active stomach or duodenal ulcer,
- if you are in the last three months of pregnancy,
- if you are a child or adolescent under 16 years of age,
- on damaged skin (e.g., skin abrasions, cuts, burns), infected skin, or skin affected by exudative dermatitis or eczema.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if:
- you suffer or have previously suffered from bronchial asthma or allergies, as you may experience bronchial muscle spasms (bronchospasm), which make breathing difficult,
- you notice a skin rash developing after applying the medicated patch. If this occurs, remove the medicated patch immediately and discontinue treatment,
- you have kidney, heart, or liver disorders, or if you currently have or have previously had stomach or intestinal ulcers, intestinal inflammation, or a tendency to bleeding.
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Important precautions:
- Do not apply the medicated adhesive patch to the eyes or mucous membranes, or allow it to come into contact with them.
- Avoid exposing the treated area directly to sunlight or sunbed lamps after removing the medicated patch, to reduce the risk of photosensitivity.
- Do not use simultaneously, either topically or systemically, any medication containing diclofenac or other NSAIDs.
Elderly patients
Elderly patients should use this medicine with caution, as they are more likely to experience adverse effects.
Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age, as adequate experience in this age group is lacking.
Other medicines and Olfen
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
When used correctly, only a small amount of diclofenac is absorbed into the body, so interactions described with orally administered diclofenac-containing medicines are unlikely to occur.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use this medicine during the last three months of pregnancy. You should not use Olfen during the first six months of pregnancy unless clearly necessary and advised by your doctor. If treatment is required during this period, the lowest dose for the shortest possible time should be used.
Oral forms (e.g., tablets) of this medicine may cause adverse effects on the fetus. It is unknown whether the same risk applies to this medicine when used on the skin.
Breastfeeding
Consult your doctor or pharmacist before using any medicine.
Very small amounts of diclofenac are excreted in breast milk. As adverse effects in infants are not known, breastfeeding generally does not need to be interrupted during use of Olfen. However, this medicine must not be applied directly to the breast area.
Driving and using machines:
This medicine has no or negligible influence on your ability to drive or operate machinery.
Olfen contains propylene glycol and butylhydroxytoluene
This medicine contains 1,400 mg of propylene glycol in each patch. Propylene glycol may cause skin irritation.
Butylhydroxytoluene may cause local skin reactions (such as contact dermatitis) or irritation of the eyes and mucous membranes.
3. How to use Olfen
Follow exactly the instructions for use provided in this leaflet or those given 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. The total maximum daily dose is 2 medicated patches, even if more than one injured area is to be treated. Treat only one painful area at a time.
Use in children and adolescents
This medicine must not be used in children and adolescents under 16 years of age. There are insufficient data on efficacy and safety in children and adolescents under 16 years of age.
Method of administration
For cutaneous use only (topical use)
- Cut the pouch containing the medicated patch along the marked line.
- Remove the medicated patch and carefully reseal the pouch by pressing the closure together.
- Remove the protective film from the surface of the medicated patch.
- Apply the medicated patch to the painful area.
Use the medicated patch only on intact, non-diseased skin.
If necessary, the medicated patch may be secured using an elastic mesh bandage.
Do not use the medicated patch together with an occlusive dressing.
Do not wear the patch while bathing or showering.
Do not cut the medicated patch.
Used medicated patches should be folded in half with the adhesive side facing inward.
Duration of use
Do not use this medicine for more than 7 days.
If symptoms worsen or persist for more than 3 days, consult a doctor.
If you feel the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
If you use more Olfen than you should
If you have used more of the medicine than recommended, contact your doctor, pharmacist, or the Poison Information Service immediately (Tel: 91 562 04 20).
Inform your doctor if significant adverse effects occur following incorrect use of the medicine or after accidental overdose (e.g., in children). Your doctor will advise you on any necessary measures.
If you forget to use Olfen
Do not use a double dose to make up for missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
Consult your doctor immediately and stop using the medicated patch if you notice any of the following:
Sudden itchy skin rash (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, including allergic and contact dermatitis, such as redness of the skin, burning sensation, itching, redness of inflamed skin, skin rash, sometimes with pustules or papules.
Rare (may affect up to 1 in 1,000 people)
Blisters on the skin, dry skin
Very rare (may affect up to 1 in 10,000 people)
Hypersensitivity reactions
(including urticaria), angioneurotic edema, anaphylactoid reaction
Asthma
Photosensitivity
In patients using topical medicines containing the same active substance, diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions such as swelling of the skin and mucous membranes, anaphylactoid-type reactions with acute circulatory disturbances, and photosensitivity 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 intake of diclofenac. Therefore, the likelihood of systemic adverse effects (such as renal, hepatic or gastrointestinal disturbances or breathing difficulties) is very low.
However, when the medicated patch is used over a large area of skin and for a prolonged period, systemic side effects may occur.
Reporting of adverse effects:
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olfen
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation CAD. The expiry date refers to the last day of the month indicated.
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.
May be stored for 4 months after first opening of the sachet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Olfen
The active substance is: sodium diclofenac. Each medicated adhesive patch contains 140 mg of sodium diclofenac.
The other components are: glycerol, propylene glycol (E1520), diisopropyl adipate, crystallizable liquid sorbitol (E-420), sodium carboxymethylcellulose, sodium polyacrylate, butyl methacrylate-based copolymer, disodium edetate, sodium sulfite (E-221), butylated hydroxytoluene (E-321), dry potassium aluminium sulfate, anhydrous colloidal silica, light (natural) kaolin, macrogol lauryl ether (9 EO units), levomenthol, tartaric acid, purified water, non-woven polyester support, polypropylene protective film.
Appearance of the product and contents of the pack:
Olfen consists of 10 x 14 cm patches with a uniformly spread, white to light brown paste applied as a uniform layer on a non-woven support, and a disposable protective film.
It is available in packs containing 2, 5, 10 or 14 medicated adhesive patches, in resealable pouches containing either 2 or 5 medicated patches.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio
Albatros B, 1st floor, 28108
Alcobendas, Madrid (Spain)
Manufacturer
Merckle GmbH
Ludwing-Merckle-Strabe 3
89143 Blaubeuren, (Germany)
This medicinal product is authorized in the EEA Member States under the following names:
Germany: Diclofenac-ratiopharm Schmerzpflaster
Belgium: Kinespir Patch 140 mg pleister
Slovakia: Olfen 140 mg
Spain: Olfen 140 mg medicated adhesive patches
Hungary: Algoplast-ratiopharm 140 mg gyógyszeres tapasz
Czech Republic: Olfen
Date of the latest revision of this leaflet: June 2025
Other sources of information
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70307/P_70307.html