Olfen Max

Package Leaflet: Information for the Patient

Olfen Max, 20 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 this package leaflet or as directed by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or you feel worse after 7 days, consult your doctor.

Table of Contents of the Package Leaflet:

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

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

Olfen Max contains the active substance diclofenac, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). The medicine is intended for topical use.
Olfen Max is used to relieve pain, reduce inflammation, and reduce swelling in painful conditions of the muscles and joints.
Olfen Max is indicated for use in adults and adolescents from 14 years of age.

Adults and Adolescents from 14 Years of Age

Olfen Max is used for short-term, topical treatment of symptomatic relief of acute pain, inflammation, and swelling in cases of soft tissue injuries, such as post-traumatic tendonitis, ligament sprains, muscle and joint strains caused by twisting, spraining, or bruising (e.g., sports injuries).

Adults

Olfen Max is intended for topical, symptomatic treatment of pain and inflammation in the course of:

• soft tissue injuries, post-traumatic conditions, tendon, ligament, muscle, and joint injuries resulting from, for example, twisting, spraining, or bruising (injuries related to sports training);
• back pain (resulting from sports injuries). After consulting a doctor in case of:
• local forms of soft tissue rheumatism, e.g., tennis elbow, bursitis, and periarticular inflammation (periartropathies);
• local forms of degenerative rheumatism, including peripheral joint disease and knee joint disease.

2. Important Information Before Using Olfen Max

When Not to Use Olfen Max

• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if you have ever had breathing difficulties (asthma, bronchospasm), hives, runny nose, or face 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;
• during the last trimester of pregnancy (last three months); see section "Pregnancy".

Warnings and Precautions

Before starting to use Olfen Max, discuss it with your doctor if you have a higher than average risk of asthma attacks (so-called analgesic asthma), local skin swelling or mucous membrane swelling (so-called Quincke's edema), or hives; if you have asthma, hay fever, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections (especially those associated with symptoms typical of hay fever) or if you are allergic to other painkillers and various anti-rheumatic drugs.
Olfen Max may only be used in these patients with certain precautions (be prepared for sudden reactions) and under direct medical supervision. The same applies to patients with allergies to other substances, e.g., those manifesting as skin reactions, itching, or hives.
When Olfen Max is used on large areas of skin or for a long time, it cannot be ruled out that systemic side effects may occur.
Olfen Max should only be used on intact, undamaged, non-diseased skin. Avoid contact with eyes and mucous membranes of the mouth.
Olfen Max is intended for external use only. The gel must not be taken 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 non-breathable occlusive dressings.
If symptoms worsen or do not improve within 7 days of use, consult your doctor.
If a skin rash occurs, treatment with Olfen Max should be discontinued.
During the use of this medicine, avoid exposure to sunlight, including sunlamps.
Measures should be taken to prevent the skin to which the gel has been applied from coming into contact with a child.

Children and Adolescents

Olfen Max is not intended for use in children and adolescents under 14 years of age.

Olfen Max 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.
No interactions have been found so far when Olfen Max is used topically as recommended.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not useOlfen Max during the last trimester of pregnancy (last three months) as it may harm the fetus or cause difficulties during delivery. During the first and second trimesters of pregnancy (first six months), Olfen Max should only be used after consulting a doctor. In such cases, the dose should be as low as possible, and the treatment duration as short as possible.
Breastfeeding
Olfen Max 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 breasts of nursing women or to large areas of skin or used for extended periods.

Driving and Operating Machines

Using Olfen Max does not affect or slightly affects the ability to drive and operate machines.

Olfen Max Contains Propylene Glycol (E1520)

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

Olfen Max Contains Butylhydroxytoluene (E321)

Butylhydroxytoluene may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.

Olfen Max Contains Fragrances

This medicine contains a fragrance composition, which includes 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 mild, local skin irritation.

3. How to Use Olfen Max

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and Adolescents from 14 Years of Age

Olfen Max should be used 2 times a day (optimally in the morning and evening) on the treated area.
The pain-relieving effect of the medicine may last up to 12 hours after a single dose.
Depending on the size of the treated area, 2 g to 4 g of gel is required, which corresponds to the size of a cherry to a walnut.
The maximum daily dose is 8 g of gel.

Elderly Patients

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

Renal or Hepatic Impairment

Dose reduction is not required.

Use in Children and Adolescents Under 14 Years of Age

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

Before First Use:

• 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 package leaflet. If the ring is broken, do not use the gel.

How to Use the Medicine

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

Treatment Duration

The treatment duration depends on the symptoms and underlying disease.

Adults

• In cases of muscle and joint injuries (e.g., sprains, strains, bruises) or back pain, the medicine should not be used for more than 2 weeks. The doctor will decide whether to continue treatment. If pain or swelling does not improve within 7 days of starting treatment or worsens, consult your doctor.
• In the treatment of pain associated with rheumatic diseases (soft tissue rheumatism, degenerative joint disease), this medicine can only be used after a doctor's recommendation, who will determine the duration of treatment.

Adolescents from 14 to 18 Years of Age

• This medicine should not be used for more than 7 days without consulting a doctor.

Overdose of Olfen Max

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

Missed Application of Olfen Max

If you forget to apply Olfen Max at the right time, apply the gel as soon as you remember, and then continue treatment according to the schedule.
Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Olfen Max can cause side effects, although not everybody gets them.

Some side effects are rare or very rare and may be serious.

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

• Blisters; hives (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 less than 1 in 10 people):
skin rash, itching, redness, eczema, skin inflammation, including contact dermatitis.
Uncommon side effects(may occur in less than 1 in 100 people):
skin peeling, skin dryness, swelling.
Very rare side effects(may occur in less than 1 in 10,000 people)
nodular rash, gastrointestinal disorders, hypersensitivity reactions (including hives), hypersensitivity to light with skin reactions after exposure to sunlight.
Frequency not known(frequency cannot be estimated from available data)
burning sensation at the application site, skin dryness.
When Olfen Max is used 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 those not listed in this package leaflet, tell your doctor or pharmacist. Side effects can be reported to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Olfen Max

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after "Expiry Date" or "EXP". The expiry date refers to the last day of the month stated.
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 Package and Other Information

What Olfen Max Contains

• The active substance is diclofenac.
• 1 g contains 23.2 mg of diclofenac diethylammonium, which corresponds to 20 mg of diclofenac sodium.
• The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), cetearyl olivate, liquid paraffin, carbomer, cetomacrogol ether, diethylamine, oleic acid, butylhydroxytoluene (E 321), fragrance (containing citronellol, geraniol, benzyl alcohol, linalool, limonene, citral, farnesol, coumarin, and eugenol), purified water

What Olfen Max Looks Like and Contents of the Package

Olfen Max 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 30 g, 50 g, 60 g, 100 g, 150 g, 180 g.
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

This Medicinal Product is Authorized in the Member States of the EEA Under the Following Names:

Czech Republic: Olfen Neo Forte
Hungary: Diclofenac ratiopharm 20mg/g gel
Croatia: Olfen 20 mg/g gel
Poland: Olfen MAX
Date of Last Revision of the Package Leaflet:July 2021