Diky 4%

Package leaflet: Information for the user

DIKY 4%, 40 mg/g, cutaneous spray, solution
(Diclofenacum natricum)
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Leaflet contents:

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

DIKY 4% contains the active substance called sodium diclofenac, which belongs to a 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 joints and surrounding tissues following acute blunt injury.
DIKY 4% is indicated for short-term local treatment.
DIKY 4% is intended for use in adults and adolescents above the age of 14 years.

2. Important information before using DIKY 4%

When not to use DIKY 4%

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

Warnings and precautions
Before using DIKY 4%, discuss it with your doctor or pharmacist if:

• You have or have ever had a stomach ulcer, liver or kidney problems, a tendency to bleeding, or inflammatory bowel disease.
• You have or have ever 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 prolonged periods unless directed by a doctor. Follow the dosing instructions and do not exceed the maximum treatment duration.
• Do not apply near the eyes, nose, or mouth. If the spray gets into the eyes, rinse thoroughly with water and contact your doctor.
• This medicine is for external use only. Do not use the product in the mouth and do not swallow it.
• Avoid exposure to sunlight, including sunbeds, while using this medicine. If skin reactions occur, discontinue use of this product.
• Discontinue use of DIKY 4% if a skin rash develops.
• Do not cover the area where the medicine has been applied with occlusive dressings (waterproof or air-tight) or plasters.
• Wash your hands after use, unless the hands are the area being treated.

If in doubt, contact your 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 your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Talk to your doctor before using DIKY 4% if:

• You are taking tablets, capsules, or suppositories for pain relief containing sodium diclofenac, acetylsalicylic acid, or any other anti-inflammatory medicine, such as ibuprofen. Using another NSAID (including acetylsalicylic acid or ibuprofen) together with DIKY 4% may increase the risk of adverse effects.

Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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, DIKY 4% should not be used unless necessary and recommended by a doctor. If use is necessary, the lowest dose for the shortest possible duration should be administered.
DIKY 4% may be used by breastfeeding women only after consultation with a doctor, as diclofenac passes into breast milk in small amounts. However, DIKY 4% should not be applied to the breasts of breastfeeding women or to large skin areas for prolonged periods.
Driving and operating machinery
DIKY 4% has no influence on the ability to drive or operate machinery.
DIKY 4% contains soy lecithin, propylene glycol, and alcohol (ethanol)
This medicine contains soy (in the form of soy lecithin). If you are allergic to peanuts or soy, do 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 alcohol (ethanol) in each gram of solution. It may cause stinging on damaged skin.

3. How to use DIKY 4%

This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist. If in doubt, consult your doctor or pharmacist.
DIKY 4% is for external use only.
In adults and adolescents above 14 years of age, the recommended dose is 4 to 5 sprays of DIKY 4% applied to the skin at the painful site, three times daily. The number of sprays depends on the size of the area being treated. 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 your hands unless the hands are the area being treated.
• After applying the medicine, wait several minutes before applying a dressing or bandage to allow the treated area to dry. Be cautious, as wet medicine may stain clothing.

Duration of use:

• Discontinue treatment once symptoms (pain and swelling) have subsided.
• Do not use the medicine for longer than 7–8 days without consulting a doctor.
• If there is no improvement after 3 days of treatment or if symptoms worsen, consult your doctor.
• In adolescents aged 14 years and older, if use of this medicine for pain relief is required for longer than 7 days or if symptoms worsen, the patient/parents should consult a doctor.

Use of more than the recommended dose of DIKY 4%

• If more than the recommended dose is used, wipe off the excess DIKY 4% with a tissue.
• If you or your child swallows the medicine, contact your doctor immediately or go to the nearest hospital, taking the medicine bottle and this leaflet with you.

Missed dose of DIKY 4%

• Apply the medicine as soon as you remember, but do not use a double dose to make up for a missed one. Resume your regular dosing schedule.
• Do not use a double dose to compensate for a missed dose.

If you have any doubts about how to use 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.

• If the following symptoms of allergy occur, DISCONTINUE USE of DIKY 4% and IMMEDIATELY CONTACT a doctor or pharmacist:
• Skin rash with blisters, urticaria (affects no more than 1 in 1,000 people)
• Wheezing, shortness of breath, feeling of tightness in the chest (asthma) (affects no more than 1 in 10,000 people)
• Swelling of the face, lips, tongue, or throat (affects no more than 1 in 10,000 people).
• Discontinue use of DIKY 4% if a skin rash occurs. Following topical application (on the skin) of medicines containing diclofenac, reactions at the application site have been frequently observed. These included rash, itching, redness, burning sensation, or skin peeling.
  • Common adverse reactions (affects no more than 1 in 10 people): Skin rash, itching, redness, or burning of the skin.
  • Very rare adverse reactions (affects no more than 1 in 10,000 people): Skin may become more sensitive to sunlight. Possible symptoms include sunburn with itching, swelling, and blisters.
  • Adverse reactions of unknown frequency (frequency cannot be estimated from available data): Reactions at the application site, dry skin, burning sensation. If the medicine is used long-term (longer than three weeks) and/or over large areas of skin, systemic adverse reactions may occur, such as stomach pain and disturbances, heartburn, and kidney problems.

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 of Adverse Drug Reactions at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store DIKY 4%

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

6. Contents of the package and other information

What DIKY 4% contains

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

What DIKY 4% looks like and contents of the pack
DIKY 4% is a golden-yellow, transparent solution which, when sprayed onto the skin, turns into a gel-like consistency.
Pack sizes: Each bottle contains 12.5 g or 25 g of cutaneous aerosol solution.
Marketing Authorisation Holder
CYATHUS Exquirere PharmaforschungsGmbH
Beim Mauthaus 6
2100 Korneuburg
Austria
Manufacturer
Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop, Germany
This medicinal product is authorised for sale in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: