Olfen Forte 23.2 mg/g gel

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olfen Forte 23.2 mg/g gel

diclofenac (as diethylamine salt)

For adults and adolescents over 14 years of age

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 3–5 days.

Leaflet contents:

1. What Olfen Forte is and what it is used for
2. What you need to know before using Olfen Forte
3. How to use Olfen Forte
4. Possible adverse effects
5. How to store Olfen Forte
6. Contents of the pack and other information

1. What Olfen Forte is and what it is used for

Olfen Forte contains the active substance diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

For adults and adolescents over 14 years of age

For local, short-term symptomatic treatment of mild to moderate pain in sprains, strains, or contusions following acute closed trauma.

2. What you need to know before using Olfen Forte

Do not use Olfen Forte

• if you are allergic to diclofenac or to any of the other ingredients of this medicine listed in section 6,
• if you have ever developed respiratory problems (asthma, bronchospasm), skin reactions (urticaria), nasal discharge, or swelling of the face or tongue after taking/using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g., ibuprofen),
• on open wounds, inflamed or infected skin areas, eczema, or mucous membranes,
• during the last three months of pregnancy (“see Pregnancy”),
• in children and adolescents under 14 years of age.

Warnings and precautions

Consult your doctor or pharmacist before using this medicine.

You may be more likely than other patients to experience asthma attacks (known as analgesic intolerance/analgesic-induced asthma), local skin or mucosal swelling (so-called Quincke's edema), or urticaria if you have asthma, allergic rhinitis, nasal mucosa inflammation (nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with symptoms resembling allergic rhinitis), or hypersensitivity to other analgesics and anti-rheumatic drugs of any kind.

In such patients, this medicine should be used only under certain precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances, for example, those with skin reactions, itching, or urticaria.

When this medicine is applied over a large area of skin and for prolonged periods, systemic adverse effects cannot be ruled out. These side effects are similar to those that may occur with oral medications containing diclofenac. Therefore, the gel should be used with caution in patients with impaired renal function, impaired cardiac function, or impaired hepatic function, as well as in patients with active peptic ulceration of the stomach or duodenum.

Apply this medicine only on intact, healthy, and undamaged skin. Avoid contact with eyes and mucous membranes. The gel must not be taken orally.

After applying the gel to the skin, you may use a permeable (non-occlusive) dressing, but allow the gel to dry on the skin for a few minutes first. Do not use it with an occlusive, airtight dressing.

If symptoms worsen or do not improve within 3–5 days, consult a doctor.

Discontinue use of this medicine if you develop a skin rash.

Exposure to direct sunlight or artificial UV light may cause skin reactions. You should avoid sunlight or artificial tanning during treatment and for two weeks after stopping treatment.

Precautions should be taken to prevent children from touching the area where the gel has been applied.

Children and adolescents

This medicine is contraindicated in children and adolescents under 14 years of age.

Other medicines and Olfen Forte

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

No interactions have been reported to date with the intended topical use of this medicine.

Pregnancy and breastfeeding

If you are pregnant, 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 trimester of pregnancy, as it may harm the fetus or cause complications during delivery. During the first and second trimesters of pregnancy, this medicine should be used only after consulting your doctor. If treatment is required during this time, the lowest effective dose for the shortest possible duration should be used.

Breastfeeding

Use this medicine only as directed by your doctor, since diclofenac passes into breast milk in small amounts. This medicine should not be applied to the breast area or to large areas of skin for prolonged periods if you are breastfeeding.

Driving and using machines

This medicine has no or negligible influence on your ability to drive or operate machinery.

Olfen Forte contains propylene glycol (E1520)

This medicine contains 54 mg of propylene glycol in 1 gram of gel.

Olfen Forte contains butylated hydroxytoluene (E321)

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

Olfen Forte contains fragrances

This medicine contains fragrances including benzyl alcohol (0.15 mg/g gel), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalool, which may cause allergic reactions.

In addition, benzyl alcohol may cause mild local irritation.

3. How to use Olfen Forte

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 14 years of age

This medicine is used twice daily (preferably in the morning and at night).

Depending on the size of the affected area to be treated, apply an amount the size of a cherry or a walnut, corresponding to 1–4 g of gel.

The maximum daily dose is 8 grams of gel.

If symptoms worsen or do not improve within 3–5 days, you must consult a doctor.

Elderly patients

No special dose adjustment is required. If you are elderly, you should pay particular attention to any adverse effects, and if necessary, consult your doctor or pharmacist.

Impaired renal or hepatic function

Dose reduction is not necessary.

Use in children and adolescents (under 14 years of age)

There is insufficient data on safety and efficacy in children and adolescents under 14 years of age (see section 2 "Do not use Olfen Forte").

Use in adolescents (14 years of age and older)

For adolescents aged 14 years and older, the patient/caregiver should consult a doctor if the medicine is needed for more than 7 days to relieve pain or if symptoms worsen.

Before first use, open as follows:

1. Unscrew the cap from the tube. To open the tube's safety seal, invert the cap and press it onto the nozzle. Do not use scissors or other sharp objects.
2. Twist and remove the plastic seal from the tube. Use the gel as described in this leaflet. Do not use if the seal is broken.

How to apply:

This medicine is for cutaneous use only.

Apply the gel to the affected areas of the body in a thin layer and gently rub in until absorbed into the skin. Afterwards, wipe hands with a paper towel and then wash them, unless the hands are the area being treated.

If too much gel is accidentally applied, wipe off the excess with a paper towel.

Dispose of the used paper towel in household waste to prevent unused product from entering aquatic environments.

Allow the gel to dry for a few minutes on the skin before applying a dressing.

Duration of treatment:

The duration of use depends on the symptoms and underlying condition.

This medicine should not be used for longer than 1 week without medical advice.

If you use more Olfen Forte than you should

An overdose is unlikely if more gel is used than recommended, since absorption into the bloodstream is low when applied to the skin.

If this medicine is accidentally ingested, contact your doctor, who will determine the appropriate measures.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Olfen Forte

Do not apply 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, this medicine can cause adverse effects, although not everyone will experience them.

Some rare and very rare adverse effects can be serious.

If you experience any of the following signs of allergy, stop using this medicine and consult your doctor or pharmacist immediately.

• Skin rash with blisters; hives (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath, or tightness in the chest (asthma) (may affect up to 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (may affect up to 1 in 10,000 people).

Other adverse effects are possible:

Frequent (may affect up to 1 in 10 people)

Skin rash, itching, redness, eczema, dermatitis (inflammation of the skin), including contact dermatitis.

Uncommon (may affect up to 1 in 100 people)

Peeling, skin dehydration, swelling (edema).

Very rare (may affect up to 1 in 10,000 people)

Pustular rash, gastrointestinal discomfort, hypersensitivity reactions (including hives), photosensitivity with skin reactions appearing after exposure to sunlight.

Not known (frequency cannot be estimated from available data)

Burning sensation at the application site, dry skin.

When this medicine is applied over a wide area of skin and for a prolonged period, the possibility of systemic adverse effects (e.g., renal, hepatic, or gastrointestinal adverse effects, systemic hypersensitivity reactions) cannot be completely ruled out, such as those possibly occurring after systemic administration of medicines containing diclofenac.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olfen Forte

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and tube, following the abbreviation CAD or EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olfen Forte

• The active substance is diclofenac.
• 1 gram contains 23.2 mg of diethylamine diclofenac, equivalent to 20 mg of sodium diclofenac.
• The other ingredients are carbomer, cocoil caprilcaprate, macrogol cetearyl ether, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), oleic acid (E570), butylhydroxytoluene (E321), fragrance (containing benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool), purified water.

Appearance of Olfen Forte and contents of the pack

White or almost white, homogeneous gel, packed in laminated aluminium tubes closed with a PE seal and polypropylene screw caps, in pack sizes: 30 grams, 50 grams, 60 grams, 100 grams, 150 grams, 180 grams per tube.

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer

Merckle GmbH

Graf Arco Strasse 3

89079 Ulm (Germany)

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas 28108

Madrid (Spain)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Diclofenac AbZ Schmerzgel
France: DICLOFENAC TEVA SANTE CONSEIL 2%, gel
Spain: Olfen Forte 23.2 mg/g gel
Sweden: Diklofenak Teva
United Kingdom (Northern Ireland): Diclofenac diethylamine 2.32 % w/w gel

Date of the most recent review of this leaflet: October 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es