Diclofenac dr. max

Package leaflet: Information for the user

Diclofenac Dr. Max, 23.2 mg/g, gel
Diclofenacum diethylammonium
Please read the entire 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 patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Table of contents:

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

1. What Diclofenac Dr. Max is and what it is used for

Diclofenac Dr. Max contains the active substance diclofenac. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is intended for topical application to the skin.
Diclofenac Dr. Max is used to relieve pain, reduce inflammation and swelling in painful musculoskeletal conditions.

Diclofenac Dr. Max is used in the treatment of the following conditions:

Adolescents over 14 years of age:
Short-term, local, symptomatic treatment of acute pain, inflammation and swelling in:

• soft tissue injuries, such as traumatic inflammation of tendons, ligaments, muscles and joints, caused for example by sprains, strains and contusions (sports injuries).

Adults (over 18 years of age):
Local, symptomatic treatment of pain, inflammation and swelling in:

• soft tissue injuries, such as traumatic inflammation of tendons, ligaments, muscles and joints, caused for example by sprains, strains and contusions (sports injuries);
• back pain (sports injuries);
• following consultation with a doctor, in the following conditions:
• localized forms of soft tissue rheumatism, such as tendon sheath inflammation (tennis elbow), bursitis and periarticular inflammation;
• localized forms of degenerative rheumatism, such as osteoarthritis of peripheral joints and knees.

2. Important information before using Diclofenac Dr. Max

When not to use Diclofenac Dr. Max

• 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 experienced an allergic reaction such as wheezing or shortness of breath (asthma), blistering skin rash or hives, facial or tongue swelling, or nasal congestion after taking medicines containing acetylsalicylic acid, ibuprofen, or other non-steroidal anti-inflammatory drugs (medicines used to treat pain, fever, or inflammation);
• if the patient is in the last three months of pregnancy;
• in children and adolescents under 14 years of age.

If any of the above situations apply, do not use Diclofenac Dr. Max.
Warnings and precautions
Before starting to use Diclofenac Dr. Max, discuss this with your doctor or pharmacist:

• if the patient suffers from asthma, hay fever, nasal mucosal swelling (so-called nasal polyps), or chronic obstructive pulmonary disease and chronic respiratory infections (especially those associated with hay fever-like symptoms).
• Do not apply Diclofenac Dr. Max to damaged skin or open wounds. Do not use on skin with rash or eruption.
• Do not use over large areas of skin or for prolonged periods.
• Diclofenac Dr. Max gel is for external use only. Do not swallow or apply inside the mouth. The medicine must not come into contact with the eyes or mucous membranes. If the medicine gets into the eyes, rinse thoroughly with clean water.
• A support or non-occlusive (air-permeable) bandage commonly used for injuries such as sprains may be applied, but do not use airtight (plastic) dressings.
• Avoid exposure to sunlight, including sunbeds, while using this medicine. If photosensitivity reactions occur, discontinue use.
• If a rash appears after application to the skin, stop treatment.
• Take measures to prevent children from touching skin to which the gel has been applied.

If you have any further doubts regarding the use of Diclofenac Dr. Max,
consult your doctor or pharmacist.
Children and adolescents
There is insufficient data on the safety and efficacy of Diclofenac Dr. Max in children and
adolescents under 14 years of age (see section "When not to use Diclofenac Dr. Max").
Diclofenac Dr. Max and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not use Diclofenac Dr. Max during the last three months of pregnancy, as it may harm the unborn child or cause delivery complications.
During the first six months of pregnancy, Diclofenac Dr. Max should not be used unless absolutely necessary and only as prescribed by a doctor. If use is necessary, the dose should be as low as possible and the duration of treatment as short as possible.
During breastfeeding, Diclofenac Dr. Max should only be used after consulting a doctor, as diclofenac passes into human milk in small amounts. However, Diclofenac Dr. Max must not be applied to the breasts of breastfeeding mothers, over large skin areas, or for prolonged periods.
Adverse effects on the unborn child have been reported after oral forms of diclofenac (e.g. tablets). It is unknown whether the same risk applies to Diclofenac Dr. Max when applied to the skin.
Driving and operating machinery
Diclofenac Dr. Max has no effect or negligible effect on the ability to drive and operate machinery.
Diclofenac Dr. Max contains:

• Propylene glycol (E 1520): This medicine contains 54 mg of propylene glycol in each gram of gel.
• Butylated hydroxytoluene (E 321): May cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
• Fragrances containing allergens (benzyl alcohol, citral, coumarin, eugenol, farnesol, geraniol, limonene, citronellol and linalool). Allergens may cause allergic reactions.
• This medicine contains 0.15 mg of benzyl alcohol in each gram of gel. Benzyl alcohol may cause mild local irritation.

3. How to use Diclofenac Dr.Max

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Dosage for adults and adolescents over 14 years of age:
Apply Diclofenac Dr.Max to the painful area of skin twice daily (preferably in the morning and evening).
Depending on the size of the area being treated, apply an amount ranging from cherry-sized to walnut-sized, corresponding to 2 to 4 g of gel per single dose.
The maximum daily dose is 8 g of gel; this dose must not be exceeded.

How to use Diclofenac Dr.Max
Diclofenac Dr.Max is intended for topical use on the skin only.

1. To remove the seal, unscrew and remove the cap before first use. Insert the opposite end of the cap and twist to remove the seal.
2. Apply the gel to the affected area of the body and gently massage into the skin.
3. After applying the gel, wipe your hands with a paper towel and then wash them, unless your hands are the area being treated.

If too much gel is accidentally applied, wipe off the excess with a paper towel.
Dispose of the paper towel in household waste to prevent unused medicine from entering the aquatic environment.
Allow the gel to dry on the skin for several minutes before applying a bandage.

How long to use Diclofenac Dr.Max
Duration of treatment without consulting a doctor:

• Adults
  • For muscle and joint injuries (e.g. sprains, strains, bruises) or back pain: do not use Diclofenac Dr.Max for longer than 2 weeks; prolonged treatment must be decided by a doctor. 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): use the medicine strictly as directed by your doctor, who will determine the duration of treatment.
• Adolescents aged 14–18 years: If treatment with this medicine is required for longer than 7 days to relieve pain, or if symptoms worsen, the patient/parents should consult a doctor.

Accidental overdose of Diclofenac Dr.Max
If an excessive amount of Diclofenac Dr.Max has been applied, wipe off the excess gel with a tissue.
In case of accidental ingestion of Diclofenac Dr.Max, contact a doctor immediately.

Missed dose of Diclofenac Dr.Max
If you forget to apply Diclofenac Dr.Max at the scheduled time, apply it as soon as possible, then continue treatment according to the prescribed schedule. Do not apply a double dose to make up for a missed dose.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some adverse reactions occurring rarely or very rarely may be serious:
If any of the following signs of allergy occur, STOP using Diclofenac Dr.Max and contact your doctor or pharmacist immediately:

• Skin rash with blisters, urticaria (may affect up to 1 in 1,000 patients);
• Wheezing, shortness of breath, or tightness in the chest (asthma) (may affect up to 1 in 10,000 patients);
• Swelling of the face, lips, tongue, or throat (may affect up to 1 in 10,000 patients);

Other adverse reactions that may occur are usually mild and temporary. If any of these adverse reactions occur, inform your doctor or pharmacist.
Common (may affect up to 1 in 10 patients):

• Skin rash, itching, redness, or burning sensation of the skin.

Very rare (may affect up to 1 in 10,000 patients):

• Increased sensitivity of the skin to sunlight; possible symptoms include sunburn with itching, swelling, and blisters.

Frequency not known (cannot be estimated from available data):

• Burning sensation at the site of application, dry skin.

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 directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Diclofenac Dr.Max

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and tube
after: EXP. The expiry date refers to the last day of the stated month.
Store in the original outer packaging to protect from light. There are no special
requirements for the storage temperature of this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Diclofenac Dr. Max contains

• The active substance is diethylammonium diclofenac. Each gram of gel contains 23.2 mg of diethylammonium diclofenac, equivalent to 20 mg of sodium diclofenac.
• The other ingredients are: isopropyl alcohol, propylene glycol (E 1520), cocoyl caprylocaprate, liquid paraffin, carbomer 974P, cetostearyl ether of polyethylene glycol 22, diethanolamine, fragrance (containing camphor, eucalyptol, ambroxol, citronellol, benzyl alcohol, citral, coumarin, eugenol, farnesol, geraniol, limonene, linalool), oleic acid (E 570), butylated hydroxytoluene (E 321), purified water.

What Diclofenac Dr. Max looks like and contents of the pack
Diclofenac Dr. Max is a white to almost white, homogeneous gel with a creamy consistency.
Pack sizes: 30 g, 50 g, 60 g, 100 g, 150 g, 180 g gel in a tube.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
Tel.: (+420) 516 770 199

Manufacturer:
Merckle GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany

This medicinal product is authorised for sale in the European Economic Area under the following names:
Czech Republic: Diclofenac Dr. Max
Poland: Diclofenac Dr. Max
Slovakia: DICLOFENAC Dr. Max 20 mg/g gel