Diclotica

Package Leaflet: Information for the Patient

Diclotica, 10 mg/g, Gel

Diclofenac Sodium

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet

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

1. What is Diclotica and what is it used for

Diclotica contains the active substance diclofenac sodium, which has anti-inflammatory and analgesic effects.
Indications:
Diclotica is used for local treatment of:

Adults and adolescents over 14 years of age:

• post-traumatic inflammatory conditions of tendons, ligaments, muscles, and joints (e.g., due to sprains, strains, or bruises);
• back pain;
• limited inflammatory conditions of soft tissues, such as tendonitis, tennis elbow, bursitis, and periarthritis.

Adults (over 18 years of age)

• limited and mild forms of osteoarthritis.

2. Important information before using Diclotica

When not to use Diclotica

• - If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had an allergic reaction (e.g., rash, difficulty breathing, or coughing fit) after using medicines containing acetylsalicylic acid (also used as an anti-coagulant), ibuprofen, or other medicines used to treat joint and muscle pain, fever, and inflammation.
• In the third trimester of pregnancy.
• In children under 14 years of age.

Warnings and precautions

Before starting to use Diclotica, discuss it with your doctor or pharmacist.
Do not apply the medicine to damaged skin, open wounds, or eczema. The surface to which Diclotica gel is applied must not be exposed to sunlight.
Stop using the medicine if a rash or other signs of hypersensitivity occur.

• Avoid using the medicine on large areas of skin or for a long period if not advised by a doctor. The medicine may cause severe skin reactions
• Diclotica is intended for topical use, on the skin. Do not use it on mucous membranes, in the mouth, or swallow it. After use, wash your hands. Avoid contact with the eyes. If the medicine gets into the eyes, rinse them with clean water and contact a doctor or pharmacist.
• Use with caution in patients with asthma and a history of peptic ulcer disease.
• The medicine may be used under bandages or dressings normally used for sprains, but do not use it under dressings that prevent air from reaching the skin.

Children and adolescents

There is insufficient data on the efficacy and safety of using the product in children and adolescents under 14 years of age.
In adolescents over 14 years of age, if the product needs to be used for more than 7 days to treat pain or if symptoms worsen, the patient should contact a doctor.

Diclotica and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Be aware of the possibility of interactions when using diclofenac, especially if the product is used on large areas of skin and for a long time, in combination with ACE inhibitors (angiotensin-converting enzyme inhibitors) or ARBs (angiotensin receptor blockers).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Do not use Diclotica during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery.
During the first six months of pregnancy, Diclotica should only be used on the advice of a doctor, with the lowest possible dose and for the shortest possible duration.
Breastfeeding
Diclofenac passes into breast milk. It is not recommended to use Diclotica during breastfeeding.
If you have any further questions on the use of Diclotica in pregnant or breastfeeding women, ask your doctor or pharmacist.

Driving and using machines

Diclotica has no effect on the ability to drive or use machines.

Diclotica contains propyl hydroxybenzoate (E 216) and methyl hydroxybenzoate (E 218).

The medicine may cause allergic reactions (possible late reactions).

Diclotica contains propylene glycol

Propylene glycol may cause skin irritation.

3. How to use Diclotica

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Adults and adolescents over 14 years of age

Apply a thin layer of Diclotica gel to the affected area, 3 to 4 times a day as needed, from 2 g to 4 g of the medicine, which is approximately 2.0-2.5 cm and is sufficient to cover an area of about 400 cm to 800 cm.
Treatment duration depends on the indications and response to treatment. If using the medicine without consulting a doctor, do not use it for more than 14 days for post-traumatic inflammatory conditions and soft tissue rheumatism, and not more than 4 weeks for osteoarthritis. Consult a doctor after 7 days of treatment if there is no improvement or if symptoms worsen.

Use in children under 14 years of age

There is insufficient data on the efficacy and safety of using the medicine in children and adolescents under 14 years of age.

Use in elderly patients (over 65 years of age)

Use as for other adults.
After using the medicine, wash your hands unless they are the ones being treated.
Diclotica may be used as an adjunct to oral non-steroidal anti-inflammatory drugs.

Using more than the recommended dose of Diclotica

Diclofenac is absorbed into the bloodstream in very small amounts, so overdose after topical use is unlikely.

Missing a dose of Diclotica

Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diclotica can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, which may be signs of an allergic reaction, stop using the medicine and contact your doctor or go to the nearest hospital emergency department:
Rare (affect up to 1 in 1000 people using the medicine):

• Bullous dermatitis. Very rare (affect up to 1 in 10,000 people using the medicine):
• Asthma, wheezing, shortness of breath, or feeling of tightness in the chest (asthma), swelling of the face, lips, tongue, or throat, and reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Other side effects

Other side effects that may occur when using Diclotica are usually mild, harmless, and temporary:
Very rare (affect up to 1 in 10,000 people using the medicine):

• Papular rash, itching, redness, or local or generalized skin eruptions. Reactions to light, increased skin sensitivity to sunlight. Symptoms of hypersensitivity are sunburn with itching, swelling, and blisters. Common (affect up to 1 in 10 people using the medicine):
• Blistering skin rash, urticaria, itching, redness, or burning of the skin, skin inflammation (including contact dermatitis).

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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 Diclotica

Keep out of the sight and reach of children.
Store in the original package to protect from light. Store at a temperature below 25°C.
Do not store in the refrigerator or freeze.
Shelf life after first opening the immediate packaging: 6 months.
Do not use this medicine if you notice signs of deterioration.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
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. Contents of the pack and other information

What Diclotica contains

The active substance is diclofenac sodium. One gram of gel contains 10 mg of diclofenac sodium.
The other ingredients are: propylene glycol, sodium hydroxide, medium-chain triglycerides, carbomer, hydroxyethylcellulose, propyl hydroxybenzoate (E 216), methyl hydroxybenzoate (E 218), and purified water.

What Diclotica looks like and contents of the pack

White or almost white, gentle, homogeneous gel, with a creamy consistency.
Aluminum tube with a membrane, internally coated with epoxy-phenolic lacquer, with a polyethylene cap and a piercer, in a cardboard box, containing 100 g of gel.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tactica Pharmaceuticals Sp. z o.o.
ul. Bankowa 4
44-100 Gliwice
tel.: +48 889 388 53
{logo of the marketing authorization holder}

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal

Date of last revision of the leaflet: