OLFEN FORTE 23.2 mg/g GEL

Introduction

Package Leaflet: Information for the User

Olfen Forte 23.2 mg/g Gel

diclofenac, diethylamine

Read the entire package leaflet carefully before starting to use the medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3-5 days.

Contents of the Package Leaflet:

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 side effects
5. Storage of Olfen Forte
6. Contents of the pack and further information

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

Olfen Forte contains the active substance diclofenac, which belongs to the 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 bruises after a closed trauma.

2. What you need to know before using Olfen Forte

DO NOT USE Olfen Forte

• if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6,
• if you have ever developed respiratory problems (asthma, bronchospasm), hives, nasal secretion, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory medicine (e.g., ibuprofen),
• on open wounds, skin inflammation, or infections, as well as on eczema or mucous membranes,
• during 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 medicine.

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

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

In these patients, this medicine may 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 hives.

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

Apply this medicine only to intact, healthy skin, not diseased or damaged 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 non-occlusive, permeable dressing, but let the gel dry on the skin for a few minutes. Do not use it with an occlusive, airtight dressing.

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

The use of this medicine should be discontinued if a skin rash develops.

If you are exposed to direct sunlight or artificial sunlight, there is a risk of skin reactions. You should avoid sunlight or artificial sunlight during treatment and for two weeks after discontinuation.

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

Children and Adolescents

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

Other Medicines and Olfen Forte

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions have been known so far in the intended cutaneous use of this medicine.

Pregnancy and Breastfeeding

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

Pregnancy

DO NOT USEthis medicine 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 trimester, this medicine should only be used after consulting your doctor.

Breastfeeding

During breastfeeding, do not use this medicine, except if your doctor has indicated it, as diclofenac passes into breast milk in small amounts. It should not be applied to the breast area or other large areas of skin for prolonged periods.

Driving and Using Machines

This medicine has a negligible influence on your ability to drive and use machines.

Olfen Forte contains Propylene Glycol (E1520)

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

Olfen Forte contains Butylhydroxytoluene (E321)

Butylhydroxytoluene may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation.

Olfen Forte contains Fragrances

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

In addition, benzyl alcohol may cause mild local irritation.

3. How to Use Olfen Forte

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and Adolescents over 14 years old

This medicine 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 is required, corresponding to 1-4 grams of gel.

The maximum daily dose is 8 grams of gel.

Elderly Patients

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

Impaired Renal or Hepatic Function

No dose reduction is necessary.

Use in Children and Adolescents (under 14 years old)

Do not use this medicine in children and adolescents under 14 years old (see section 2 "DO NOT USE Olfen Forte").

Before using for the first time, open as follows:

1. Unscrew the cap of the tube. To open the security seal of the tube, invert the cap and hook it onto 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 package leaflet. Do not use if the seal is broken.

How to Apply:

This medicine is for cutaneous use.

Apply the gel to the affected parts of the body in a thin layer and rub gently into the skin. Unless the hands are the area to be treated, wash your hands after rubbing in the gel.

Duration of Treatment:

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

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

If the symptoms worsen or do not improve after 3-5 days, you should 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, the gel should be removed and washed off with water.

If you accidentally ingest this medicine, 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 Toxicology Information Service, phone 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 forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some rare and very rare side effects can be serious.

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

• Blisters; hives (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 side effects are possible:

Common(may affect up to 1 in 10 people)

Skin rash, itching, redness, eczema, dermatitis (including contact dermatitis).

Uncommon(may affect up to 1 in 100 people)

Scaling, dry skin, swelling (edema).

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

Pustular rash, gastrointestinal disorders, hypersensitivity reactions (including hives), sensitivity to light with skin reactions after exposure to sunlight.

Not known(frequency cannot be estimated from the available data)

Burning sensation at the application site, dry skin.

When this medicine is applied to a large area of skin and for a prolonged period, the possibility of systemic side effects cannot be completely excluded (e.g., renal, hepatic, or gastrointestinal side effects, systemic hypersensitivity reactions), as may occur after systemic administration of medicines containing diclofenac.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olfen Forte

Keep this medicine out of the sight and reach of children.

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

This medicine does not require special temperature storage conditions.

Keep in the original tube to protect from light.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Olfen Forte

• The active substance 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), coco-caprylate, liquid paraffin, carbomer, macrogol cetostearyl ether, diethylamine, oleic acid (E570), butylhydroxytoluene (E321), fragrance (containing citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.

Appearance and Packaging

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Merckle GmbH

Graf Arco Strasse 3

89079 Ulm (Germany)

You can request more information about this medicine 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 medicine is authorized in the EEA Member States with 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 last revision of this package leaflet:November 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.