Diclac Max gel 50g.

1. What Diklak Max gel is and what it is used for

Diklak Max gel is a medicinal product with an analgesic and anti-inflammatory effect (non-steroidal anti-inflammatory drug - NSAID).

What is Diklak Max gel used for?

For local use in pain, inflammation and swelling in:

rheumatic diseases of soft tissues (inflammation of tendons and ligaments - tendinitis, tendovaginitis and bursitis, painful immobility of the shoulder, inflammation of muscles and joints);

degenerative joint diseases (arthrosis of large and small joints) of the limbs and in the area of ​​the spine;

sports and domestic injuries (sprains, contusions, sprains).

2. What you need to know before using Diklak Max gel

Do not use Diklak Max gel

if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).

on open wounds, damaged skin areas, inflammations and infections of the skin;

on mucous membranes;

if you get an allergic reaction to medicines used to treat pain, fever or inflammation such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (ibuprofen, etc.). Symptoms of an allergic reaction to these medicinal products may include asthma, wheezing, shortness of breath; skin rash or hives; swelling of the face or tongue; runny nose

in children and adolescents under 14 years of age;

during the last 3 months of pregnancy (see also the section on pregnancy and breastfeeding)

Warnings and precautions

Talk to your doctor or pharmacist before using Diclak Max gel,

if you suffer from asthma, hay fever, nasal polyps (swelling of the nasal mucosa), chronic lung disease or chronic respiratory system infections (hay fever-like symptoms);

if you are hypersensitive to anti-inflammatory products of all groups, there is a higher risk of asthma attacks (so-called intolerance to analgesics/analgesic asthma), local swelling of the skin and mucous membranes (so-called Quincke's edema) or urticaria when applying Diklak Max gel than in other patients. In these patients, Diclak Max gel can be applied only under the observance of certain precautions and follow-up by a doctor. The same applies to patients developing allergic reactions to other substances that manifest themselves with skin reactions, itching or urticaria.

Do not apply the gel if you have:

rash or eczema

cuts or open wounds

Stop treatment if you develop a skin rash after applying the product.

Care should be taken not to get the gel in contact with the eyes or mucous membranes and not to swallow it by mouth.

Avoid application to large areas of skin for an extended period of time unless directed by a physician.

Be careful when exposed to the sun or visiting a tanning bed, as your skin may be more sensitive to the sun while using Diklak Max.

Be careful when smoking or near fire due to risk of severe burns. Diclofenac gel contains paraffin, which is potentially flammable when it accumulates on fabric (clothing, bedding, bandages, etc.). Washing clothes and bedding can reduce product build-up, but not completely remove it.

Children and adolescents

Children and adolescents under 14 years of age should not apply Diclak Max gel, due to the lack of sufficient data on efficacy and safety in this age group.

If the product needs to be administered for more than 7 days in adolescents over 14 years of age for pain relief, or if symptoms worsen, patients or their parents should consult a doctor.

Children should be kept away from contact with the medicinal product with their hands or from rubbing it into the skin.

Other medicines and Diclak Max gel

It is unlikely that drug interactions will occur when applying Diklak Max gel. However, you should inform your doctor if you are taking or have recently taken other medicines.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine.

Women of childbearing age

There are no data to suggest recommendations in women of childbearing age.

Pregnancy

Since there are insufficient data on the safety of diclofenac gel in pregnant women, diclofenac gel should not be used during pregnancy.

Diclak Max Gel should not be used during the next 3 months of pregnancy, as it may harm your unborn child or cause complications at birth.

Do not apply Diklak Max gel during the first 6 months of pregnancy, except on a doctor's recommendation.

A risk of fetal kidney damage with subsequent reduction of the amniotic fluid that surrounds the baby (oligohydramnios) has been observed when NSAIDs (including diclofenac) are used from the 20th week

of pregnancy onwards.

Breastfeeding

The use of Diklak Max gel during breastfeeding is not recommended. If your doctor specifically recommends the use of Diklak Max gel during breastfeeding, application to the area around the breast and other large areas of the skin should be avoided and for a long period of time.

Fertility

There are no data on effects on human fertility.

Animal studies do not indicate any direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Driving in machine operation

Diklak Max gel used topically on the skin is not expected to have an effect on the ability to drive and operate machinery.

Important information about some of the ingredients of Diklak Max gel

Diclak Max 5% gel contains alcohol (isopropyl alcohol) and therefore should not be in contact with open wounds, mucous membranes or the eyes.

3. How to apply Diklak Max gel

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Diklak Max gel is applied in a thin layer to the relevant areas of the skin 3-4 times a day and rubbed in carefully. The amount required depends on the size of the painful area. For example, 2 to 4 g of diclofenac gel (an amount ranging from the size of a cherry to the size of a hazelnut) is sufficient to treat an area of ​​about 400 to 800 cm2. Duration of treatment depends on the indication and clinical response.

It is recommended that treatment be reviewed after 2 weeks.

Diklak Max gel is for external use only, on healthy skin. Do not take by mouth. Inform your doctor immediately in case of ingestion.

Be careful not to get gel in the eyes or on other mucous membranes.

Do not rub the gel on cuts, open wounds or other areas where the integrity of the skin is broken.

Hands should be wiped with absorbent paper (not wet wipes) and then washed, unless they are at the treatment site. Absorbent paper should be disposed of in the trash after use.

The patient should wait for diclofenac gel to dry before taking a shower/bath.

Diklak Max gel is applied in a thin layer to the affected part of the body and gently rubbed. Diklak Max should be allowed to soak in for a few minutes before dressing. The use of air-tight or occlusive dressings is not recommended. If dressing is required, the dressing should be loose and breathable.

Diklak Max gel is suitable for use during iontophoresis. This form of electrotherapy enhances penetration through the skin. Diklak Max gel should be applied to the negative pole (cathode).

The product can be applied from 3 to 7 days depending on the specific case.

If you have applied more than the required dose of Diclak Max gel

If the gel was applied in significantly larger quantities than recommended or was swallowed, the symptoms of overdose may be: dizziness, headache, impaired consciousness, impaired breathing, nausea, vomiting, abdominal pain, gastrointestinal bleeding, disorders of liver and kidney function, and seizures in children. Immediately inform your doctor, who will be guided by the clinical picture in the treatment of the overdose.

The gel should be removed and washed off with water if you have exceeded the recommended dose of application.

If you forget to use Diklak Max

If you forget to apply the product, continue to apply it regularly. Please consult your doctor if you are unsure about interrupting or pre-discontinuing therapy. Do not use a double dose to make up for a missed dose.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

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

Some rare and very rare side effects can be serious

If you experience any of the following signs of an acute allergic reaction, STOP using Diklak Max Gel and contact a doctor immediately:

skin rash with blisters, hives (bullous dermatitis) (rare: may affect up to 1 in 1,000 people)

swelling of the face, lips, tongue or throat (very rare: may affect up to 1 in 10,000 people)

sudden difficulty breathing and chest tightness with wheezing or coughing (asthma) (very rare: may affect up to 1 in 10,000 people)

Other side effects:

Common side effects (may affect up to 1 in 10 people)

skin rashes, itching, burning, redness or tingling

Very rare side effects (may affect up to 1 in 10,000 people):

hypersensitivity, including hives

blisters (pustules)

a reaction of increased sensitivity of the skin to sunlight. Possible signs are sunburn with itching, swelling and blisters. If a skin rash develops, stop using this medication.

local inflammation and edema of blood vessels

Not known (frequency cannot be estimated from the available data):

burning sensation at the site of application

dry skin

If Diklak Max gel is

applied to large areas of the skin and for a longer period of time, the occurrence of systemic adverse drug reactions affecting certain organs and systems or even the whole organism, similar to those that may occur with the use of diclofenac during mouth or by intramuscular or intravenous administration

In case of accidental ingestion resulting in a serious systemic adverse reaction, the usual therapeutic measures for the treatment of poisoning with non-steroidal anti-inflammatory drugs should be taken. Gastric lavage and activated charcoal may be considered, especially if soon after ingestion.

If any of the side effects become serious, or you notice other side effects not described in this leaflet, please tell your doctor or pharmacist.

5. How to store Diclak Max gel

To be stored at a temperature below 25 °C.

Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

The shelf life after first opening the tube is 12 months.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Diklak Max gel contains

The active substance is diclofenac sodium. 1 g of gel contains 50 mg of diclofenac sodium.

The other ingredients are: hypromellose, macrogol - 7 glycerol cocoate, isopropyl alcohol, purified water.

What Diklak Max looks like and contents of the pack

Packs containing 50 g, 100 g and 150 g of gel.

Not all types of packaging can be marketed.