Package Insert: Information for the User

Olfen Forte 23.2 mg/g Gel

diclofenac, dietilamine

Read this package insert carefully before starting to use the medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improveafter 3-5 days.

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

2. What you need to know before starting to use Olfen Forte

3. How to use Olfen Forte

4. Possible adverse effects

5. Storage of Olfen Forte

6. Contents of the package and additional information

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

For adults and adolescents over 14 years old

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

Do not use Olfen Forte

• If you are allergic to diclofenac or any of the other components of this medication listed in section 6,
• If you have ever developed respiratory problems (asthma, bronchospasm), urticaria, nasal secretion or swelling of the face or tongue after taking or using acetylsalicylic acid or another non-steroidal anti-inflammatory drug (e.g., ibuprofen),
• On open wounds, skin inflammation or infections, as well as on eczema or mucous membranes,
• In the last trimester of pregnancy (see Pregnancy),
• In children and adolescents under 14 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication.

You are more likely to suffer from asthma attacks (called analgesic-induced asthma), local skin swelling or mucous membrane swelling (called Quincke's edema) or urticaria than other patients.

If you have asthma, allergic rhinitis, nasal membrane inflammation (called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with symptoms similar to allergic rhinitis) or hypersensitivity to other analgesics and any type of anti-rheumatic medication.

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

When this medication is applied to a large area of the skin and for a prolonged period, the possibility of systemic adverse effects cannot be ruled out. The gel, therefore, should be used with caution in patients with reduced renal function, reduced cardiac function or reduced liver function, as well as in patients with active peptic ulcers in the stomach or duodenum.

Apply this medication only to intact, healthy, or unbroken skin. Avoid contact with the eyes and mucous membranes. The gel should not be taken orally.

After applying the gel to the skin, you can use a permeable (non-occlusive) dressing, but leave the gel to dry on the skin for a few minutes. Do not use it with a hermetic occlusive dressing.

If symptoms worsen or do not improve after 3 to 5 days, consult a doctor.

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

There is a risk of skin reactions when exposed to direct sunlight or artificial sunlight. Avoid direct sunlight or artificial sunlight during treatment and for two weeks after stopping treatment.

Take precautions to prevent children from touching the area where the gel is applied.

Children and adolescents

This medication should not be used in children and adolescents under 14 years old.

Other medications and Olfen Forte

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

No interactions have been known in the planned cutaneous use of this medication.

Pregnancy and breastfeeding

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

Pregnancy

Do not usethis medication during the last trimester of pregnancy as it may harm the fetus or cause problems during delivery. If you are planning a pregnancy or during the first and second trimesters, this medication should only be used after consulting your doctor.

Breastfeeding

Do not use this medication while breastfeeding, except as directed by your doctor, as diclofenac passes into breast milk in small amounts. Do not apply it directly to the breast area or to other areas, in extensive areas of the skin for prolonged periods of time.

Driving and operating machines

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

Olfen Forte contains propylenglycol (E1520)

This medication contains 54 mg of propylenglycol per 1 gram of gel.

Olfen Forte contains butylhydroxytoluene (E321)

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

Olfen Forte contains fragrances

This medication contains fragrances with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalol that may cause allergic reactions.

Additionally, benzyl alcohol may cause mild local irritation.

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

Adults and adolescents over 14 years old

This medication is used 2 times a day (preferably in the morning and at night).

Depending on the size of the affected area to be treated, a quantity the size of a cherry or a walnut, corresponding to 1 - 4 g of gel, is required.

The maximum daily dose is 8 grams of gel.

Older patients

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

Renal or hepatic function impairment

No dose reduction is necessary.

Use in children and adolescents (under 14 years old)

Do not use this medication in children and adolescents under 14 years old (see section 2 "Do not use Olfen Forte”).

Before using it for the first time, open as follows:

1. Unscrew the cap from the tube. To open the safety seal of the tube, invert the cap and attach it to the nozzle. Do not use scissors or other sharp objects.

2. Turn 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 medication is for topical use.

Apply the gel to the affected areas of the body in a thin layer and gently massage the skin. Unless the hands are the area to be treated, wash your hands after massaging the gel.

Treatment duration:

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

This medication should not be used for more than 1 week without medical advice.

If symptoms worsen or do not improve after 3-5 days, consult a doctor.

If you use more Olfen Forte than you should

It is unlikely that an overdose will occur if you use more Olfen Forte than you should, as absorption into the bloodstream is low when used on the skin. If you significantly exceed the recommended dose when used on the skin, remove the gel and wash it off with water.

If you accidentally ingest this medication, contact your doctor, who will decide on the necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Olfen Forte

Do not apply 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 may produce adverse effects, although not all people will experience them.

Some rare and very rare adverse effects may be severe.

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

• Skin rash with blisters; urticaria (may affect up to 1 in 1,000 people).
• Wheezing, shortness of breath, or feeling of chest tightness (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 (skin inflammation) including contact dermatitis.

Infrequent(may affect up to 1 in 100 people)

Peeling, skin dehydration, swelling (edema).

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

Pustular rash, gastrointestinal discomfort, hypersensitivity reactions (including urticaria), sensitivity to light with appearance of skin reactions after exposure to sunlight.

Unknown(frequency cannot be estimated from available data)

Burning sensation at the application site, dry skin.

When this medication is applied to a large area of the skin and for a prolonged period, it cannot be completely ruled out that systemic adverse effects (e.g., renal, hepatic, or gastrointestinal effects, systemic hypersensitivity reactions) may occur, as may possibly occur after systemic administration of diclofenac-containing medications.

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 and tube after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require special temperature conservation conditions.

Store in the original tube to protect it from light.

Medications should not be disposed of through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Olfen Forte

• The active principle is diclofenac.
• 1 gram contains 23.2 mg of diclofenac diethylamine equivalent to 20 mg of diclofenac sodium.
• The other ingredients are isopropyl alcohol, propylene glycol (E1520), caprylic-capric triglyceride, liquid paraffin, carbomer, cetostearyl macrogol ether, diethylamine, oleic acid (E570), butylhydroxytoluene (E321), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Appearance of the product and contents of the container

White or almost white, homogeneous gel, packaged in laminated aluminum tubes, closed with PE seal and PP screw caps, in container sizes: 30 grams, 50 grams, 60 grams, 100 grams, 150 grams, 180 grams per tube.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible for manufacturing

Merckle GmbH

Graf Arco Strasse 3

89079 Ulm (Germany)

You can request more information about this medication by contacting 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 medication is authorized in the EEA member states with the following names:

Germany:Diclofenac AbZ Gel

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

Last review date of this leaflet:November 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es