Diclofenac Dr.max

Package Leaflet: Information for the User

Diclofenac Dr. Max, 23.2 mg/g, gel
Diclofenac diethylammonium

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

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

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

Package Leaflet Contents:

• 1. What is Diclofenac Dr. Max and what is it 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. Package contents and other information

1. What is Diclofenac Dr. Max and what is it 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 application to the skin. Diclofenac Dr. Max is used to relieve pain, reduce inflammation and swelling in painful conditions of the muscles and joints.

Diclofenac Dr. Max is used to treat 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 post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints, caused, for example, by sprains, strains, and bruises (sports injuries).

Adults (over 18 years of age):

Local, symptomatic treatment of pain, inflammation, and swelling in:

• soft tissue injuries, such as post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints, caused, for example, by sprains, strains, and bruises (sports injuries);
• back pain (sports injuries);
• after consulting a doctor in the following conditions:
• limited forms of soft tissue rheumatism, such as tendon sheath inflammation (tennis elbow), bursitis, and periarticular inflammation;
• limited forms of degenerative rheumatism, such as peripheral joint osteoarthritis and knee osteoarthritis.

2. Important information before using Diclofenac Dr. Max

When not to use Diclofenac Dr. 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 an allergic reaction, such as wheezing, shortness of breath (asthma), skin rash with blisters or hives, swelling of the face or tongue, or runny nose after using medicines containing acetylsalicylic acid, ibuprofen, or other non-steroidal anti-inflammatory drugs (medicines used to treat pain, fever, or inflammation);
• if you are in the last three months of pregnancy;
• in children and adolescents under 14 years of age.

If any of the above situations apply to you, do not use Diclofenac Dr. Max.

Warnings and precautions

Before starting to use Diclofenac Dr. Max, discuss it with your doctor or pharmacist

• if you have asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease and chronic respiratory infections (especially those associated with symptoms similar to hay fever).
• Do not apply Diclofenac Dr. Max to damaged skin or open wounds. Do not apply to skin with eczema or rash.
• Do not apply to large areas of skin and for a long time.
• Diclofenac Dr. Max gel is for external use only. Do not swallow or apply the medicine to the mouth. The medicine must not get into the eyes or mucous membranes. If the medicine gets into the eyes, rinse them thoroughly with clean water.
• You can apply an orthosis or a non-occlusive (air-permeable) bandage commonly used in the case of injuries such as sprains, but do not use hermetic (plastic) bandages.
• While using the medicine, avoid exposure to the sun, including solarium. If you experience light sensitivity reactions, stop using the medicine.
• If a rash appears on the skin after application, stop the treatment.
• Take measures to prevent children from touching the skin where the gel has been applied.

In case of any further doubts regarding the use of Diclofenac Dr. Max, consult a doctor or pharmacist.

Children and adolescents

There is no sufficient data on the safety and efficacy of using the medicine 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 taking now or recently, and about medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a 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 difficulties during delivery. During the first six months of pregnancy, do not use Diclofenac Dr. Max unless absolutely necessary and only as directed by a doctor. If necessary, the dose should be as low as possible and the duration of treatment as short as possible. During breastfeeding, Diclofenac Dr. Max should be used only after consulting a doctor, as diclofenac passes into human milk in small amounts. However, Diclofenac Dr. Max should not be applied to the breast of breastfeeding mothers, to large areas of skin, or for a long time. After oral administration of diclofenac (e.g., tablets), adverse reactions may occur in the unborn child. It is not known whether the same risk applies to Diclofenac Dr. Max when used on the skin.

Driving and using machines

Diclofenac Dr. Max has no or negligible influence on the ability to drive and use machines.

What Diclofenac Dr. Max contains

• -Propylene glycol (E 1520): This medicine contains 54 mg of propylene glycol in each gram of gel.
• -Butylhydroxytoluene (E 321): May cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
• -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 package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

Dosage for adults and adolescents over 14 years of age:

Diclofenac Dr. Max should be applied to the painful area on the skin twice a day (preferably in the morning and evening). Depending on the surface area to be treated, a single dose is an amount the size of a cherry to a walnut, corresponding to 2 to 4 grams of gel. The maximum daily dose is 8 grams of gel and should not be exceeded.

How to use Diclofenac Dr. Max

Diclofenac Dr. Max is for external use only.

• 1. To remove the seal, before the first use, unscrew and remove the cap. Remove the seal by inserting the opposite end of the cap and twisting it.
• 2. Apply the gel to the area of the body that needs treatment and gently rub it 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 to be treated.

In case of accidental application of too much gel, wipe off the excess with a paper towel. The paper towel should be disposed of in household waste to prevent the unused medicine from getting into the aquatic environment. Before applying a bandage, let the gel dry on the skin for a few minutes.

How long to use Diclofenac Dr. Max

Duration of treatment without consulting a doctor:

• adults
• in the case of muscle and joint injuries (e.g., sprains, strains, bruises) or back pain: do not use Diclofenac Dr. Max for more than 2 weeks; longer treatment must be decided by a doctor; if pain or swelling does not improve within 7 days of starting treatment or symptoms worsen, consult a doctor;
• in the treatment of pain associated with rheumatic diseases (soft tissue rheumatism, osteoarthritis), the medicine should be used only as directed by a doctor, who will determine the duration of treatment;
• adolescents 14-18 years old If the use of this medicine is required for more than 7 days to relieve pain or if symptoms worsen, it is recommended that the patient/parents of the adolescent consult a doctor.

Taking a higher dose of Diclofenac Dr. Max than recommended

In case of using an excessive amount of Diclofenac Dr. Max, wipe off the excess gel with a paper towel. In case of accidental ingestion of Diclofenac Dr. Max, contact a doctor immediately.

Missing a dose of Diclofenac Dr. Max

In case of forgetting to apply the medicine at the right time, apply it as soon as possible, and then continue treatment according to the schedule. Do not apply a double dose to make up for the missed dose. In case of any further doubts regarding 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 of an allergic reaction, STOP using Diclofenac Dr. Max and contact a doctor or pharmacist immediately:

• skin rash with blisters, hives (may affect up to 1 in 1,000 patients);
• wheezing, shortness of breath, or chest tightness (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 side effects that may occur are usually mild and temporary. If you experience any of these side effects, inform your doctor or pharmacist.
Common(may affect up to 1 in 10 patients):

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

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

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

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

• burning sensation at the application site, dry skin.

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 directly to the Department of Drug Safety Monitoring, 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 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 Diclofenac Dr. Max

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of the month. Store in the original package to protect from light. There are no special storage instructions for the medicine. Medicines should 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. Package contents and other information

What Diclofenac Dr. Max contains

• The active substance of the medicine is diclofenac diethylammonium. Each gram of gel contains 23.2 mg of diclofenac diethylammonium, which corresponds to 20 mg of diclofenac sodium.
• Other ingredients are: isopropyl alcohol, propylene glycol (E 1520), cetearyl glucoside, liquid paraffin, carbomer 974P, cetostearyl ether 22, diethylamine, fragrance (containing camphor, eucalyptol, ambrox, citronellol, benzyl alcohol, citral, coumarin, eugenol, farnesol, geraniol, limonene, linalool), oleic acid (E 570), butylhydroxytoluene (E 321), purified water.

What Diclofenac Dr. Max looks like and contents of the package

Diclofenac Dr. Max is a white to almost white, homogeneous gel with a creamy consistency. Package sizes: 30 g, 50 g, 60 g, 100 g, 150 g, 180 g of gel in a tube. Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medicine is authorized in the Member States of 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

Date of last revision of the package leaflet: