Diclogel

Leaflet attached to the packaging: patient information

Diclogel, 10 mg/g, gel

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 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 you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of contents of the leaflet

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

1. What is Diclogel and what is it used for

Diclogel is a gel containing 10 mg of diclofenac sodium per gram of gel.
Diclofenac is a derivative of phenylacetic acid and belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Its action is based on the inhibition of cyclooxygenase activity, and subsequently the inhibition of prostaglandin and other inflammatory mediator synthesis.
Diclofenac has anti-inflammatory and analgesic effects in the treatment of:

• mild to moderate muscle pain
• injuries
• post-traumatic pain.

Diclogel is intended for use in adults and adolescents over 14 years of age.

2. Important information before using Diclogel

When not to use Diclogel

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), which manifests as asthma, hives, or other allergic reactions, if angioedema is caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• in children under 14 years of age;
• in the last three months of pregnancy (see also "Pregnancy and breastfeeding");
• if the patient has kidney function disorders.

Warnings and precautions

Before starting treatment with Diclogel, consult a doctor or pharmacist.
The occurrence of systemic side effects after local application of diclofenac is less frequent compared to the frequency of side effects during oral administration of diclofenac.
There is a possibility of absorption of Diclogel through the skin, therefore, it cannot be excluded that systemic symptoms may occur. The risk of these symptoms depends, among other things, on the factors of the exposed skin surface, the amount used, and the duration of exposure.
Safety of using NSAIDs on the skin: Very rarely, severe skin reactions, some of them fatal, have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis associated with NSAID administration. The risk of side effects is higher at the beginning of treatment, and in most cases, symptoms appear within the first month of treatment. Treatment with Diclogel should be discontinued when the first signs of a rash, mucous membrane changes, or other symptoms of hypersensitivity appear.
Diclogel should be used with caution in patients with a history of asthma and stomach ulcers.
Diclogel should only be applied to intact skin surfaces. Contact with the eye and mucous membranes (e.g., in the mouth) should be avoided. The medicine should not be swallowed.
Exposure of the skin treated with Diclogel to sunlight is not recommended.

Children and adolescents

Since the data on the efficacy and safety of use in children and adolescents under 14 years of age are insufficient, Diclogel should not be used in this age group.

Diclogel and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Non-steroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with kidney function disorders (e.g., dehydrated patients or elderly patients with kidney function disorders), concomitant administration of an ACE inhibitor or angiotensin II antagonist (medicines used to treat hypertension or heart failure) and a cyclooxygenase inhibitor (e.g., diclofenac) may cause worsening of kidney function, including the possibility of acute kidney failure, which is usually reversible. The occurrence of these interactions should be considered in patients using diclofenac, especially if it is used on large skin areas for a long time, in combination with an ACE inhibitor or angiotensin II antagonist (medicines used to treat hypertension or heart failure). Therefore, this combination of medicines should be used with particular caution in elderly patients. Patients should be properly hydrated, and the need for kidney function monitoring should be analyzed after starting concomitant treatment and then periodically. Since the systemic absorption of diclofenac from the application site is very low, such interactions are very unlikely.

Diclogel with food and drink

Interactions between Diclogel and food and/or drink are not known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Diclogel during the last three months of pregnancy. During the first six months of pregnancy, do not use Diclogel unless it is necessary and recommended by a doctor.
If use is necessary, the smallest dose should be administered for the shortest possible time.
After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known if the same risk applies to Diclogel when used on the skin.
Breastfeeding
Diclogel passes into breast milk in small amounts. The medicine should be used during breastfeeding only after consulting a doctor. In such cases, Diclogel should not be applied to the breasts of nursing women, as well as to large skin areas or for a long time.
If you need further information on the use of this medicine in pregnant or breastfeeding women, consult your doctor or pharmacist.

Driving and using machines

Using the medicine does not affect the ability to drive and use machines.

Diclogel contains propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218).

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

Diclogel contains 80 mg of propylene glycol in each gram.

Propylene glycol may cause skin irritation.

3. How to use Diclogel

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Adults and adolescents over 14 years of age
Apply a thin layer of Diclogel to the affected areas 3 to 4 times a day, as needed (about 2 to 4 grams, an amount corresponding to the size of a cherry to the size of a walnut), and gently rub in.
The treatment period depends on the indications and the patient's response to treatment. It is recommended to assess the treatment after 7 days from the start.
If pain and swelling do not subside within 7 days or symptoms worsen, contact your doctor.
Do not use Diclogel for more than 7 days without consulting a doctor.
Diclogel may be used as additional treatment during oral administration of non-steroidal anti-inflammatory drugs.
Children and adolescents under 14 years of age
Do not use Diclogel in children under 14 years of age, as there are no data on the safety and efficacy of use in this patient group (see section 2. When not to use Diclogel).
Liver and kidney function disorders
No dose adjustment is necessary in patients with liver function disorders.
Diclogel is contraindicated in patients with kidney function disorders.
Use in elderly patients
Use the same dosage as in adults.

Method of administration

Apply to the skin.
After application, wash your hands unless they are being treated.
Apply only to healthy skin.

In case of accidental contact with Diclogel

In case of contact with the eyes, mucous membranes (e.g., in the mouth), or damaged skin areas, rinse the affected area with running water. If irritation persists, consult a doctor or pharmacist.

In case of accidental ingestion of Diclogel

In case of accidental ingestion of Diclogel, immediately contact a doctor or go to the hospital. Remember to take the medicine packaging with you.

Using a higher dose of Diclogel than recommended

Diclofenac is very poorly absorbed into the bloodstream, so overdose is unlikely. In case of excessive use of Diclogel, collect the excess.

Missing a dose of Diclogel

If you miss a dose, use the medicine as soon as you remember, and then continue with the recommended dosage. Do not use a double dose to make up for the missed dose.

Stopping treatment with Diclogel

Treatment with Diclogel can be discontinued at any time without consulting a specialist. However, there is a possibility of recurrence of pain or swelling in the treated area.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop using Diclogel and immediately contact your doctor if you experience the following side effects (occurring in less than 1 in 10,000 people)

• hypersensitivity, which is a type of allergic reaction characterized by a skin rash with or without blisters (skin eruptions with redness), hives, shortness of breath, and difficulty swallowing;
• wheezing, shortness of breath, or feeling of pressure in the chest (asthma);
• swelling, especially of the face, lips, and throat (angioedema).

The risk of these reactions is higher at the beginning of treatment.
Common (occurring in less than 1 in 10 people)

• skin rash
• skin disorders (eczema)
• redness of the skin (erythema)
• skin inflammation at the application site, characterized by a rash, swelling, or nodules (skin inflammation, contact dermatitis)
• itching of the skin (pruritus)

Rare (occurring in less than 1 in 1,000 people)

• widespread skin changes with redness, peeling, and large blisters (bullous dermatitis)

Very rare (occurring in less than 1 in 10,000 people)

• skin rash with pus-filled blisters (pustular rash)
• increased skin sensitivity to sunlight (photosensitivity reaction)

Frequency not known

• burning sensation at the application site
• dry skin

Prolonged use of Diclogel on a large body surface area may cause side effects in other areas of the body beyond the skin, such as:

• nausea
• vomiting
• diarrhea
• abdominal pain

Reporting side effects

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

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Do not store in the refrigerator or freeze.
Do not use this medicine if signs of deterioration are visible.
Shelf life after first opening the tube:
6 months for 100 g size,
2 months for 60 g size.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Diclogel contains

The active substance of Diclogel is diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium.
The other ingredients are: propylene glycol, sodium hydroxide (for pH adjustment), medium-chain triglycerides, carbomer 980, hydroxyethyl cellulose, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), and purified water.

What Diclogel looks like and what the packaging contains

Diclogel is a white, gentle, homogeneous gel with a mild characteristic odor.
Diclogel is packaged in an aluminum tube with an internal sealing membrane coated with an epoxy-phenolic lacquer, with an HDPE cap with a piercer, which is placed in a cardboard box. The tube contains 60 g or 100 g of gel.

Marketing authorization holder

Fortis Pharmaceuticals Sp. z o.o.
ul. Mickiewicza 29
40-085 Katowice
e-mail: kontakt@fortispharmaceuticals.pl

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: