DICLOZIAJA 11.6 mg/g Gel

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Dicloziaja 11.6 mg/g gel
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Dicloziaja and what is it used for
   1. Indications
4. Important information before using Dicloziaja
   1. When not to use Dicloziaja
   2. Warnings and precautions
   3. Dicloziaja and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
   6. Dicloziaja contains propylene glycol (E 1520)
   7. Dicloziaja contains a fragrant substance
5. How to use Dicloziaja
   1. Using a higher dose of Dicloziaja than recommended
   2. Missing a dose of Dicloziaja
6. Possible side effects
   1. Some side effects are rare or very rare but can be serious.
   2. If the patient experiences any of the following side effects, they should stop using the medicine and consult their doctor:
   3. Other side effects in order of frequency
   4. Reporting side effects
7. How to store Dicloziaja
8. Contents of the packaging and other information
   1. What Dicloziaja contains
   2. What Dicloziaja looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: patient information

Dicloziaja 11.6 mg/g gel

Diclofenac diethylammonium

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 this 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Dicloziaja and what is it used for

Dicloziaja is a gel containing diclofenac diethylammonium, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) with analgesic and anti-inflammatory effects. Due to its water-alcohol base, the gel also has a soothing and cooling effect.

Indications

Adolescents over 14 years of age – short-term treatment

• local symptomatic treatment of pain in sprains, strains, or bruises caused by blunt trauma.

Adults

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints resulting from sprains, strains, or bruises,
• back pain,
• limited inflammatory conditions of soft tissues, such as tendonitis or tennis elbow,
• limited and mild forms of degenerative joint disease.

If after 7 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Dicloziaja

When not to use Dicloziaja

• if the patient is hypersensitive to diclofenac or any of the other ingredients of this medicine (listed in section 6),
• in patients who have experienced asthma attacks, hives, or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• in children and adolescents under 14 years of age,
• during the last three months of pregnancy.

Warnings and precautions

Before starting to use Dicloziaja, the patient should discuss it with their doctor or pharmacist:

• if the patient has impaired renal, cardiac, or hepatic function,
• if the patient has active peptic ulcer disease,
• if the patient is taking other NSAID medicines,
• if the patient is elderly, as the risk of side effects is higher,
• if the patient is exposed to direct sunlight or artificial UV radiation (solarium). During treatment and for two weeks after its completion, the patient should avoid sunlight and artificial light (solarium).

This medicine should only be used on intact skin surfaces (not on diseased, damaged, or wounded skin). The medicine can be used with breathable, non-occlusive dressings, but not with occlusive, non-breathable dressings. The patient should avoid contact with the eyes and mucous membranes and not swallow the medicine. The patient should stop using Dicloziaja if a rash appears.

Dicloziaja and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The systemic availability of diclofenac (the amount of diclofenac in the blood) after topical application is low, so the likelihood of interactions with other medicines is small. The patient should avoid using other products on the treated skin surface at the same time.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Pregnancy: This medicine is not recommended for use in pregnant women. During the last three months of pregnancy, this medicine should not be used due to the potential risk of fetal harm or difficulties during delivery. Breastfeeding: This medicine is not recommended during breastfeeding.

Driving and using machines

Dicloziaja has no effect on the ability to drive or operate machines.

Dicloziaja contains propylene glycol (E 1520)

This medicine contains 50 mg of propylene glycol (E 1520) per gram of gel. Propylene glycol may cause skin irritation.

Dicloziaja contains a fragrant substance

This medicine contains a fragrant substance, including: benzyl alcohol (0.048 mg per gram of gel), 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amylcinnamaldehyde, pentylcinnamaldehyde, anise alcohol, benzyl benzoate, cinnamyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, hexylcinnamaldehyde, hydroxycitronellal, hydroxymenthylpentylcyclohexenecarboxaldehyde, isoeguenol, lilial, linalool, methylheptinocarboxylate, oakmoss, treemoss. These substances may cause allergic reactions. Additionally, the medicine may cause mild, local skin irritation.

3. How to use Dicloziaja

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Adults and adolescents over 14 years of age: The medicine should be applied topically to the skin three or four times a day, gently rubbing it in. The amount of medicine used should be adjusted to the size of the affected area. 2 g to 4 g (the amount of gel equivalent to the size of a cherry to the size of a walnut) is sufficient to cover a surface area of approximately 400 cm to 800 cm. After applying the medicine, the patient should wash their hands, unless they are treating their hands. The patient should avoid contact with the eyes and mouth. The medicine should not be used for more than 14 days without consulting a doctor. The patient should consult their doctor after 7 days of treatment if there is no improvement or if the symptoms worsen. In adolescents over 14 years of age, the medicine should not be used for more than 7 days. If it is necessary to use the product for more than 7 days to treat pain or if the symptoms worsen, the patient or their caregiver should consult their doctor. Use in children and adolescents under 14 years of age: This medicine is contraindicated in children and adolescents under 14 years of age - see "Important information before using Dicloziaja". Elderly patients (over 65 years): The patient should use the same dosage as for adults.

Using a higher dose of Dicloziaja than recommended

In case of accidental ingestion of the medicine or application of an excessive amount, the patient should consult their doctor. Overdose after topical application of this medicine is unlikely. The symptoms of overdose are similar to those of oral nonsteroidal anti-inflammatory drugs (headaches, dizziness, drowsiness, abdominal pain, nausea, vomiting).

Missing a dose of Dicloziaja

The patient should apply the next dose according to the previous schedule. The patient should not apply a double dose to make up for a missed dose. If the patient has any further doubts about using this medicine, they should consult their 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 the patient experiences any of the following side effects, they should stop using the medicine and consult their doctor:

• Rare (affects less than 1 in 1,000 people using the medicine): blistering skin rash (skin rash with blisters)
• Very rare (affects less than 1 in 10,000 people using the medicine): hives and other hypersensitivity reactions, asthma (breathing difficulties, shallow breathing), angioedema (swelling of the face, lips, tongue, throat, and larynx)

Other side effects in order of frequency

• Common (affects less than 1 in 10 people using the medicine): rash, eruption, redness, skin inflammation (including contact dermatitis), itching
• Very rare (affects less than 1 in 10,000 people using the medicine): photosensitivity reactions, papular rash

Systemic side effects (e.g., gastrointestinal disorders, such as stomach ulcers, or nervous system disorders, such as dizziness or headaches) cannot be ruled out when using the medicinal product on large skin surfaces or during prolonged use.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Dicloziaja

The medicine should be stored out of 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 below 25°C. Shelf life after first opening the tube: 2 years. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Dicloziaja contains

• The active substance of the medicine is diclofenac in the form of diclofenac diethylammonium. 1 g of Dicloziaja contains 11.6 mg of diclofenac diethylammonium, which corresponds to 10 mg of diclofenac sodium.
• Other ingredients are: carbomer 5984, diethylamine, cetostearyl ether of macrogol 20, capryloyl/capric triglyceride, isopropyl alcohol, propylene glycol (E 1520), light liquid paraffin, fragrant substance (3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one, amylcinnamaldehyde, pentylcinnamaldehyde, anise alcohol, benzyl alcohol, benzyl benzoate, cinnamyl benzoate, benzyl salicylate, cinnamaldehyde, cinnamyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, hexylcinnamaldehyde, hydroxycitronellal, hydroxymethylpentylcyclohexenecarboxaldehyde, isoeguenol, lilial, linalool, methylheptinocarboxylate, oakmoss, treemoss), purified water.

What Dicloziaja looks like and contents of the pack

Dicloziaja is a white or almost white, homogeneous gel with a characteristic odor, available in aluminum tubes of 40 g, 50 g, 100 g with a PE cap in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

ZIAJA Ltd Zakład Produkcji Leków sp. z o.o., ul. Jesienna 9, 80-298 Gdańsk, Poland, Tel.: +48 58 521 34 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland, Czech Republic: Dicloziaja

Date of last revision of the leaflet:02/2024