Olfen zhel

Package Leaflet: Information for the Patient

Olfen Gel, 10 mg/g, Gel

Diclofenac Sodium
(in the form of Diclofenac Diethylammonium)
For use in adults and adolescents from 14 years of age

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3-5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What Olfen Gel is and what it is used for
• 2. Important information before using Olfen Gel
• 3. How to use Olfen Gel
• 4. Possible side effects
• 5. How to store Olfen Gel
• 6. Contents of the pack and other information

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

Olfen Gel contains the active substance diclofenac, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
Olfen Gel is indicated for use in adults and adolescents from 14 years of age.

Adults

Local symptomatic treatment of pain:

• in acute strains, sprains or bruises caused by blunt trauma
• of soft tissues in the joint areas (e.g. capsules, tendons, tendon sheaths, ligaments, muscle attachments, and joint capsules) in degenerative joint disease of the knee and finger joints;
• in lateral epicondylitis of the humerus (inflammation of the tendon attachments in the elbow area, also known as tennis elbow or golfer's elbow);
• in acute muscle pain, e.g. back pain.

Adolescents from 14 years of age

For short-term treatment.
For local symptomatic treatment of pain in acute strains, sprains or bruises caused by blunt trauma.

2. Important information before using Olfen Gel

When not to use Olfen Gel

• if the patient is hypersensitive to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had breathing difficulties (asthma, bronchospasm), skin reactions (e.g. urticaria), hay fever or facial or tongue swelling after taking or using medicines containing acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (e.g. ibuprofen);
• on open wounds, inflammatory or infected skin, as well as on skin with eczema and mucous membranes;
• in the last trimester of pregnancy; see section "Pregnancy";
• in children and adolescents under 14 years of age.

Warnings and precautions

Before starting to use Olfen Gel, discuss it with your doctor or pharmacist:
if the patient has a higher than average risk of asthma attacks (so-called analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's edema) or urticaria if the patient has asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, chronic respiratory infections (especially those associated with symptoms typical of hay fever) or if the patient is hypersensitive to other painkillers and various anti-rheumatic drugs.
In these patients, Olfen Gel may only be used with certain precautions (be prepared for the possibility of sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, e.g. skin reactions, itching or urticaria.
If Olfen Gel is used on large areas of skin or for a long time, it cannot be ruled out that systemic side effects may occur.
Olfen Gel should only be used on intact, undamaged, non-diseased skin. Avoid contact with eyes and mucous membranes of the mouth. The gel must not be used orally.
After applying the gel to the skin, a breathable (non-occlusive) bandage can be applied, but you should wait a few minutes until the gel dries on the skin. Do not use occlusive dressings.
In case of use of the gel in acute conditions associated with severe redness, swelling or overheating of the joints, in cases of prolonged joint pain or severe back pain radiating to the legs and (or) associated with neurological disorders (e.g. numbness or tingling), consult a doctor.
In case of worsening symptoms or lack of improvement within 3-5 days of use, consult a doctor.
In case of skin rash, treatment with Olfen Gel should be discontinued.
During the use of this medicine, avoid exposure to sunlight, including sunbeds.
Measures should be taken to prevent children from coming into contact with the skin to which the gel has been applied.

Children and adolescents

Olfen Gel is contraindicated in children and adolescents under 14 years of age.

Olfen Gel and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
When using Olfen Gel locally as recommended, no interactions have been found so far.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not useOlfen Gel in the last trimester of pregnancy, as it may harm the fetus or cause difficulties during delivery. During the first and second trimesters of pregnancy, Olfen Gel should only be used after consulting a doctor.
Breastfeeding
Olfen Gel can be used during breastfeeding only on the advice of a doctor, as diclofenac passes into breast milk in small amounts. In such cases, the medicine should not be applied to the breast area in breastfeeding women or to large areas of skin or for extended periods.

Driving and using machines

Using Olfen Gel does not affect or has negligible effect on the ability to drive and use machines.

Olfen Gel contains propylene glycol (E1520)

This medicine contains 50 mg of propylene glycol in 1 g of gel.

Olfen Gel contains fragrances

This medicine contains a fragrance composition containing benzyl alcohol (0.15 mg/g), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalol - these substances may cause allergic reactions. Additionally, benzyl alcohol may cause local, mild irritation.

3. How to use Olfen Gel

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by the doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Adults and adolescents from 14 years of age

Olfen Gel should be used 3-4 times a day.
Depending on the surface area to be treated, apply from 1g to 4g of gel, i.e. in an amount corresponding to the size of a cherry to a walnut.
The maximum daily dose is 16g of gel.

Elderly patients

No special dose adjustment is necessary. Elderly patients should pay particular attention to side effects and, if necessary, consult a doctor or pharmacist.

Renal or hepatic impairment

Dose reduction is not required.

Use in children and adolescents under 14 years of age

Olfen Gel is contraindicated in children and adolescents under 14 years of age (see section 2 "When not to use Olfen Gel").

Before first use, open as follows

• 1. Unscrew the cap from the tube. To remove the protective membrane from the tube, pierce it with the reverse side of the cap. Do not use scissors or other sharp objects!
• 2. Twist and remove the plastic sealing ring from the tube. Use the gel as described in this leaflet. If the ring is broken, do not use the gel.

How to use the medicine

Olfen Gel is intended for use on the skin.
Apply a thin layer of gel to the affected area of the body and gently massage into the skin. Then wash your hands, unless they are the area being treated.

Treatment duration

The duration of treatment depends on the symptoms and underlying disease. Olfen Gel should not be used for more than 1 week without consulting a doctor.
In case of worsening symptoms or lack of improvement within 3-5 days of use, consult a doctor.

Using more than the recommended dose of Olfen Gel

Overdose of Olfen Gel is unlikely due to its low absorption into the bloodstream when used locally. If the recommended dose is significantly exceeded, the gel should be removed from the skin and rinsed with water.
In case of accidental ingestion of Olfen Gel, contact a doctor, who will recommend the appropriate course of action.

Missing a dose of Olfen Gel

Do not use a double dose to make up for a missed dose.
In case of doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

Some side effects are rare or very rare but can be serious.

If you experience any of the following symptoms, which may be signs of an allergic reaction, stop using Olfen Gel immediately and contact your doctor or pharmacist.

• Blisters on the skin; urticaria (may occur in less than 1 in 1,000 people).
• Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may occur in less than 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (may occur in less than 1 in 10,000 people).

Other possible side effects:
Common side effects(may occur in up to 1 in 10 people):
skin rash, itching, redness, eczema, skin inflammation, including contact dermatitis.
Uncommon side effects(may occur in up to 1 in 100 people):
peeling skin, dry skin, swelling.
Rare side effects(may occur in up to 1 in 10,000 people)
papular rash, gastrointestinal disorders, hypersensitivity reactions (including urticaria), hypersensitivity to light with skin reactions after exposure to sunlight.
Frequency not known(frequency cannot be estimated from the available data):
burning sensation at the application site, dry skin.
In case of use of Olfen Gel on large areas of skin or for a long time, it cannot be ruled out that systemic side effects may occur (e.g. unwanted effects on the gastrointestinal tract, liver, or kidneys, systemic hypersensitivity reactions), which may occur after systemic use of medicines containing diclofenac.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olfen Gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and tube after "EXP". The expiry date refers to the last day of that month.
Store in the original tube to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Do not use the gel shortly before bathing. This will help protect the environment.

6. Contents of the pack and other information

What Olfen Gel contains

• The active substance is diclofenac.
• 1g contains 11.6mg of diclofenac diethylammonium, which corresponds to 10mg of diclofenac sodium.
• The other ingredients are: carbomer, cetearyl caprate, cetomacrogol, liquid paraffin, diethylamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, and eugenol), purified water.

What Olfen Gel looks like and contents of the pack

Olfen Gel is a homogeneous gel, white to almost white in color, packaged in aluminum laminated tubes with PE sealing rings and PP caps, in a cardboard box.
Pack sizes: tubes of 30g, 50g, 60g, 100g, 120g, 150g.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Teva B.V.
Swensweg 5
2031GA Haarlem
Netherlands
Phone: (22) 345 93 00
Manufacturer
Merckle GmbH
Graf-Arco-Str.3
89079 Ulm
Germany

Date of last revision of the leaflet: