Diki 4%

Leaflet attached to the packaging: information for the user

DIKY 4%, 40 mg/g, skin spray, solution

(Diclofenac sodium)

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

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is DIKY 4% and what is it used for

DIKY 4% contains the active substance diclofenac sodium, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
DIKY 4% is used to relieve mild to moderate acute pain and swelling of small and medium-sized joints and surrounding tissues after blunt trauma.
DIKY 4% is indicated for short-term local treatment.
DIKY 4% is intended for use in adults and adolescents over 14 years of age.

2. Important information before using DIKY 4%

When not to use DIKY 4%

• If the patient is hypersensitive (allergic) to diclofenac, peanuts, soy, or any of the other ingredients of the medicine (listed in section 6).
• If the patient has ever had an allergic reaction to acetylsalicylic acid, ibuprofen, or any other NSAID (medicines used to treat pain, fever, or inflammation). Symptoms of an allergic reaction may include difficulty breathing, rash, and rhinitis.
• If the patient is in the last three months of pregnancy (see the section on pregnancy and breastfeeding).
• In children and adolescents under 14 years of age.

Warnings and precautions

Before using DIKY 4%, the patient should discuss it with their doctor or pharmacist.

• If the patient has or has had stomach ulcers, liver or kidney problems, a tendency to bleed, or inflammatory bowel disease.
• If the patient has or has had asthma or allergies.
• Do not apply this medicine to damaged skin, open wounds, or infected skin.
• Do not use this medicine on large areas of skin or for a longer period, unless advised by a doctor. Follow the instructions for dosage and do not exceed the maximum treatment duration.
• Do not use near the eyes, nose, and mouth. If the spray gets into the eyes, rinse them thoroughly with water and consult a doctor.
• This medicine is for external use only. Do not use the product in the mouth or swallow it.
• Avoid exposure to sunlight, including sunlamps, while using this medicine. If skin reactions occur, discontinue use of this product.
• Discontinue use of DIKY 4% if a skin rash occurs.
• Do not cover the treated area with occlusive dressings (waterproof or airtight) or bandages.
• Wash hands after use, unless the hands are being treated.

In case of doubts, consult a doctor or pharmacist before starting to use this medicine.

Children and adolescents

Do not use this medicine in children and adolescents under 14 years of age.

DIKY 4% and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take.
Consult a doctor before using DIKY 4%:

• If the patient is taking pain-relieving tablets, capsules, or suppositories containing diclofenac sodium, acetylsalicylic acid, or any other anti-inflammatory medicine, such as ibuprofen. Using another NSAID (including acetylsalicylic acid or ibuprofen) at the same time as DIKY 4% may increase the risk of side effects.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Do not use DIKY 4% during the last three months of pregnancy. During the first six months of pregnancy, do not use DIKY 4% unless it is necessary and advised by a doctor. If use is necessary, the smallest dose should be used for the shortest possible time.
DIKY 4% can be used by breastfeeding women only after consulting a doctor, as diclofenac passes into breast milk in small amounts. However, DIKY 4% should not be applied to the breast or large areas of skin for a long time.

Driving and using machines

DIKY 4% has no effect on the ability to drive or use machines.

DIKY 4% contains soybean lecithin, propylene glycol, and ethanol

This medicine contains soy (in the form of soybean lecithin). If the patient is allergic to peanuts or soy, they should not use this medicinal product.

• This medicine contains 150 mg of propylene glycol in each gram of solution. Propylene glycol may cause skin irritation.
• This medicine contains 33.3 mg of ethanol in each gram of solution. It may cause a burning sensation on damaged skin.

3. How to use DIKY 4%

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
DIKY 4% is for external use only.
In adults and adolescents over 14 years, the recommended dose is 4 to 5 sprays of DIKY 4% on the skin at the painful site, 3 times a day. The number of sprays depends on the size of the treated area. The maximum single dose should not exceed 5 sprays. The maximum daily dose is 15 sprays.

How to use DIKY 4%

• Remove the cap.
• Spray the appropriate amount of DIKY 4% onto the painful or swollen area, holding the bottle upright.
• Gently rub DIKY 4% into the skin, then wash hands, unless the hands are being treated.
• Before applying a dressing or bandage after using the medicine, let the treated area dry for a few minutes. Be careful, as the wet medicine may stain clothing.

Duration of use:

• After the symptoms (pain and swelling) have subsided, treatment should be discontinued.
• The medicine should not be used for more than 7-8 days without consulting a doctor.
• If there is no improvement after 3 days of using the medicine or if the symptoms worsen, the patient should consult a doctor.
• In adolescents over 14 years, if the use of this medicine is required for more than 7 days or if the symptoms worsen, the patient/parent should consult a doctor.

Using more than the recommended dose of DIKY 4%

• In case of using more than the recommended dose, wipe off the excess DIKY 4% with a cloth.
• If the medicine is swallowed by you or your child, immediately inform a doctor or go to the nearest hospital, taking the medicine bottle and this leaflet with you.

Missing a dose of DIKY 4%

• The patient should use the medicine as soon as they remember, but should not use a double dose to make up for the missed dose.
• Do not use a double dose to make up for a missed dose.

In case of doubts about using the medicine, consult a doctor or pharmacist.

4. Possible side effects

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

• If the following symptoms of an allergic reaction occur, STOP USING DIKY 4% and consult a doctor or pharmacist immediately:
• Skin rash with blisters, hives ( affects less than 1 in 1000 people)
• Wheezing, shortness of breath, feeling of tightness in the chest (asthma) ( affects less than 1 in 10,000 people)
• Swelling of the face, lips, tongue, or throat ( affects less than 1 in 10,000 people).
• Discontinue use of DIKY 4% if a skin rash occurs. After local application (on the skin) of diclofenac-containing medicines, common reactions at the application site have been observed. These were rash, itching, redness, burning sensation, or skin peeling.
• Common side effects(affects less than 1 in 10 people): Skin rash, itching, redness, or burning sensation.
• Very rare side effects(affects less than 1 in 10,000 people): The skin may be more sensitive to sunlight. Possible symptoms are sunburn with itching, swelling, and blisters.
• Side effects of unknown frequency(frequency cannot be estimated from available data): Reactions at the application site, dry skin, burning sensation. If the medicine is used for a long time (more than three weeks) and/or on large areas of skin, systemic side effects may occur, such as stomach pain and disorders, heartburn, and kidney problems.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products.
Jerozolimskie Avenue 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store DIKY 4%

This medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, outer packaging, and immediate packaging. The expiry date refers to the last day of the month.
Store in the original packaging.
Do not use DIKY 4% after 6 months from the first opening.
Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What DIKY 4% contains

• The active substance of the medicine is diclofenac sodium. Each gram of solution contains 40 mg of diclofenac sodium.
• The other ingredients of the medicine are: propylene glycol (E 1520), isopropyl alcohol, NAT 8539: soybean lecithin 76% and anhydrous ethanol, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, disodium edetate, peppermint oil, ascorbyl palmitate, purified water, 10% hydrochloric acid, and 10% sodium hydroxide (to adjust pH).

What DIKY 4% looks like and contents of the pack

DIKY 4% is a gold-yellow, clear solution that becomes gel-like when sprayed onto the skin.
Pack sizes: Each bottle contains 12.5 g or 25 g of skin spray, solution.

Marketing authorization holder

CYATHUS Exquirere PharmaforschungsGmbH
Beim Mauthaus 6
2100 Korneuburg
Austria

Manufacturer

Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop, Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: November 2024