Olfen gel

Patient Information Leaflet

Olfen gel, 10 mg/g, gel
Diclofenacum natricum
(in the form of Diclofenacum diethylammonium)
Please read this leaflet carefully before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please contact your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should consult your doctor.

Table of Contents:

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 non-steroidal anti-inflammatory drugs (NSAIDs).
Olfen gel is used to relieve pain, reduce inflammation and swelling in painful muscular and joint conditions.
Olfen gel is indicated for use in adults and adolescents aged 14 years and older.

Adults
Olfen gel is intended for local, symptomatic treatment of pain and inflammation in:

• Soft tissue injuries such as traumatic inflammation of tendons, ligaments, muscles and joints caused by sprains, strains and contusions (sports injuries),
• Acute muscular pain, e.g. in the back area.

After consultation with a doctor, also indicated for:

• Local forms of soft tissue rheumatism, e.g. tennis elbow, bursitis, periarthritis,
• Local forms of degenerative rheumatism, e.g. osteoarthritis of peripheral joints and knees.

Adolescents aged 14 years and older
Olfen gel is intended for short-term, local, symptomatic treatment of acute pain, inflammation and swelling associated with soft tissue injuries such as traumatic inflammation of tendons, ligaments, muscles and joints caused by sprains, strains or contusions (sports injuries).

2. Important information before using Olfen gel

When NOT to use Olfen gel

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever previously experienced breathing difficulties (asthma, bronchospasm), skin reactions (urticaria), rhinitis, or facial or tongue swelling after taking/using medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen);
• during the last three months of pregnancy (see section "Pregnancy");
• in children and adolescents under 14 years of age.

Warnings and precautions
Before starting to use Olfen gel, discuss this with your doctor or pharmacist.
If the patient suffers from asthma, hay fever, nasal mucosa swelling (nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (especially associated with symptoms typical of hay fever), or if the patient has hypersensitivity to other painkillers and various anti-rheumatic drugs, there is a higher risk than in other patients of experiencing asthma attacks (so-called analgesic intolerance / analgesic-induced asthma), local skin or mucosal swelling (so-called Quincke's oedema), or urticaria.
In such patients, Olfen gel may be used only with appropriate precautions (be prepared for possible sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, manifesting as skin reactions, itching, or urticaria.
When Olfen gel is applied over large skin areas or for prolonged periods, systemic adverse effects cannot be ruled out.
Olfen gel should be applied only to intact, undamaged, and non-diseased skin. Do not apply to open wounds, inflamed or infected skin areas, or to eczema. Avoid contact of the gel with eyes and mucous membranes. If Olfen gel gets into the eyes, rinse thoroughly with water. The gel must not be taken orally.
After applying the gel to the skin, a breathable (non-occlusive) dressing may be used, but wait several minutes until the gel has dried on the skin. Do not use air-tight (occlusive) dressings.
Consult a doctor if the gel is used for acute medical conditions associated with severe redness, swelling, or overheating of joints, prolonged joint pain, or severe back pain radiating to the legs and/or associated with neurological disturbances (e.g. numbness, tingling).
Discontinue use of Olfen gel if a skin rash occurs.
During treatment with this medicine, avoid exposure to sunlight, including solarium use.
Take measures to prevent children from touching skin areas where 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
Inform your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
When Olfen gel is applied to the skin as recommended, no interactions have been observed so far.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do NOT use Olfen gel during the last three months of pregnancy, as it may harm the unborn child or cause difficulties during childbirth. Olfen gel should not be used during the first 6 months of pregnancy unless absolutely necessary and specifically advised by a doctor. If treatment during this period is necessary, the lowest possible dose should be used for the shortest possible duration.
Oral formulations (e.g. tablets) of diclofenac may cause adverse effects in the unborn child. It is unknown whether the same risk applies when Olfen gel is used topically.

Breastfeeding
During breastfeeding, Olfen gel may be used only on medical advice, as diclofenac passes into breast milk in small amounts. Olfen gel should not be applied to breast areas in breastfeeding women, nor to large skin areas or for prolonged periods.

Driving and operating machinery
The use of Olfen gel has no effect or only a negligible effect on the ability to drive and operate machinery.

Olfen gel contains propylene glycol (E1520)
This medicine contains 50 mg of propylene glycol per 1 g of gel.

Olfen gel contains fragrance substances
This medicine contains a fragrance composition including benzyl alcohol (0.15 mg/g gel), citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene, and linalool – these substances may cause allergic reactions. In addition, benzyl alcohol may cause mild, local irritation.

3. How to use Olfen gel

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults and adolescents aged 14 years and older
Olfen gel should be applied 3 to 4 times daily.
Depending on the size of the affected area, apply 2 g to 4 g of gel, corresponding to the size of a cherry to a walnut.
The maximum daily dose is 16 g of gel.
Elderly patients
No special dose adjustment is necessary. Elderly patients should pay particular attention to possible adverse 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").
How to open the tube for the first time

1. Unscrew the cap from the tube. To remove the protective membrane sealing 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 for topical use only. Do not swallow!
Apply a thin layer of gel to the affected area of the skin and gently massage it in. After application, wipe your hands with a paper towel and then wash them, unless the hands are the treated area.
If too much gel has been applied by accident, wipe off the excess with a paper towel. The paper towel should be disposed of in household waste to prevent unused medicine from entering the aquatic environment.
Do not apply the gel shortly before taking a shower or bath.
Wait several minutes after application to allow the gel to dry before applying a dressing.
Duration of treatment
The duration of treatment depends on the symptoms and underlying condition. Do not use more Olfen gel than necessary and use it only for the shortest time possible.
Adults

• In case of muscle or joint injuries (e.g. sprains, strains, contusions) or acute muscle pain, e.g. in the back, do not use the medicine for longer than 2 weeks. A doctor will decide whether treatment should be continued. If pain or swelling does not improve within 7 days of starting treatment, or if symptoms worsen, consult a doctor.
• For pain associated with rheumatic diseases (soft tissue rheumatism, osteoarthritis), this medicine should be used only as directed by a doctor, who will determine the duration of treatment.

Adolescents aged 14 years and older

• Do not use the medicine for longer than 7 days without consulting a doctor.

Accidental overdose of Olfen gel
Overdose of Olfen gel is unlikely due to its low systemic absorption when used topically. If the recommended dose is significantly exceeded, remove the gel from the skin and wash the area with water.
In case of accidental ingestion of Olfen gel, contact a doctor immediately for appropriate advice.
If a dose of Olfen gel is missed
If a patient forgets to apply Olfen gel at the scheduled time, apply it as soon as remembered, then continue treatment according to the prescribed schedule. Do not apply a double dose to make up for a missed dose.
If in doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions occurring rarely or very rarely may be serious.
If any of the symptoms listed below, which may be signs of hypersensitivity, occur, stop using Olfen gel immediately and contact your doctor or pharmacist without delay.

• Skin rash with blisters; urticaria (may occur in no more than 1 in 1,000 people).
• Wheezing, shortness of breath, or feeling of tightness in the chest (asthma) (may occur in no more than 1 in 10,000 people).
• Swelling of the face, lips, tongue, or throat (may occur in no more than 1 in 10,000 people).

Other possible adverse reactions:
Common adverse reactions (may occur in no more than 1 in 10 people):
Skin rash, itching, redness, eczema, dermatitis, including contact dermatitis.
Uncommon adverse reactions (may occur in no more than 1 in 100 people):
Skin peeling, skin dehydration, swelling.
Very rare adverse reactions (may occur in no more than 1 in 10,000 people):
Nodular rash, gastrointestinal disorders, hypersensitivity reactions (including urticaria), photosensitivity with skin reactions occurring after exposure to sunlight.
Frequency not known (frequency cannot be estimated from available data):
Burning sensation at the application site, dry skin.
When Olfen gel is used over a large surface area of the skin or for prolonged periods, systemic adverse reactions (e.g. adverse effects on the gastrointestinal system, liver or kidneys, systemic hypersensitivity reactions) cannot be excluded, which may occur following systemic use of medicines containing diclofenac.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported via the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Olfen gel

This medicine should be stored in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and tube under "Expiry date (EXP)" or "EXP". The expiry date refers to the last day of the stated month.
Store in the original tube to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olfen gel contains

• The active substance is diclofenac.
• Each gram of gel contains 11.6 mg of diethylammonium diclofenac, equivalent to 10 mg of sodium diclofenac.
• The other ingredients are: carbomer, cococaprylocaprate, cetostearyl macrogol ether, liquid paraffin, diethanolamine, isopropyl alcohol, propylene glycol (E1520), fragrance (containing benzyl alcohol, citral, citronellol, coumarin, eugenol, farnesol, geraniol, d-limonene and linalool), purified water.

What Olfen gel looks like and contents of the pack
Olfen gel is a homogeneous gel, white to almost white, packed in aluminium laminated tubes with PE sealing rings and PP caps, placed in a cardboard box.
Pack sizes: tubes of 30 g, 50 g, 60 g, 100 g, 120 g, 150 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
Merckle GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

For further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.