Dolgit Gel

Package Leaflet: Information for the Patient

Dolgit Gel

50 mg/g, gel
Ibuprofen

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 advised by
the doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

1. What is Dolgit Gel and what is it used for

Ibuprofen belongs to a group of nonsteroidal anti-inflammatory drugs.
Ibuprofen has analgesic and anti-inflammatory effects. Its action is based on the inhibition of
prostaglandin synthesis in inflamed tissue.
Indications for use:

• local treatment of muscle pain,
• treatment of pain in degenerative joint diseases, rheumatic diseases of peripheral joints and spine,
• treatment of inflammatory changes in periarticular tissues (e.g., bursae, tendons, tendon sheaths, ligaments, and joint capsules),
• treatment of painful shoulder stiffness, lower back pain, post-traumatic changes related to sports or accidents (e.g., bruises, sprains).

2. Important information before using Dolgit Gel

When not to use Dolgit Gel

If the patient is allergic to the active substance, benzyl alcohol, benzyl benzoate, citral,
citronellol, coumarin, eugenol, farnesol, geraniol, limonene / d-limonene, linalol, or any of the other ingredients of this medicine (listed in section 6).
If the patient has hypersensitivity (allergy) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).
If the patient has experienced in the past: hives, allergic rhinitis, asthma after using acetylsalicylic acid or other NSAIDs.

Warnings and precautions

Before starting to use Dolgit Gel, the patient should discuss it with their doctor or pharmacist.
Dolgit Gel should not be used on open wounds, mucous membranes, and around the eyes.
Dolgit Gel should be used with caution in patients with gastric and duodenal ulcer disease, renal failure, bronchial asthma, and intolerance to acetylsalicylic acid, ibuprofen, or other NSAIDs taken orally.
During the use of Dolgit Gel, the treated skin surface should be avoided from exposure to sunlight, as this may cause photosensitivity reactions.
In case of rash, the medicine should be discontinued.
If there is no need to apply the medicine to the hands for therapeutic purposes, the hands should be washed after each application.

Children and adolescents

Dolgit Gel is not indicated for the treatment of children under 14 years of age.

Dolgit Gel and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
So far, no interactions between topically applied ibuprofen and other medicines are known. Concurrent use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse reactions.

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 their doctor or pharmacist before using this medicine.
The use of Dolgit Gel in the third trimester of pregnancy is contraindicated; in the first and second trimesters, it should not be used on large skin surfaces and for a long time.
Dolgit Gel should not be used during breastfeeding.
No effect on fertility has been observed at this level of exposure.

Driving and using machines

No adverse reactions of the medicine that could affect the ability to drive vehicles or operate machinery are known.
Dolgit Gel contains fragrances: benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene / d-limonene, linalol.
This medicine may cause allergic reactions.

3. How to use Dolgit Gel

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by
the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
For use in adults and adolescents from 14 years of age.
For topical use, on the skin.
If the doctor has not recommended otherwise, usually a strip of gel 4 to 10 cm long (2 g to 5 g of gel, corresponding to 100 mg to 250 mg of ibuprofen) is applied and rubbed in 3 to 4 times a day.
If necessary, the medicine can be used more frequently, but not more often than every 4 hours.
The medicine is not intended for use under occlusive dressings.
Absorption of the active substance through the skin is increased during iontophoresis treatments (a special form of electrotherapy). Dolgit Gel is applied under the cathode (negative pole).
Usually, the current intensity is 0.1 to 0.5 mA per 5 cm2 of electrode surface, and the treatment time is up to 15 minutes.
The duration of treatment is determined by the doctor. If after 10 days of using the medicine the symptoms do not disappear or worsen, the patient should be advised to consult their doctor.
The daily dose should not exceed 12 g of gel (600 mg of ibuprofen).

Using a higher dose of Dolgit Gel than recommended

Due to the low absorption through the skin - compared to absorption after oral administration - no cases of poisoning have been observed after topical application of Dolgit Gel in the form of a gel.
Oral ingestion of 8 g to 12 g of ibuprofen in adults leads to dizziness, loss of consciousness, and decreased blood pressure.
As a result of ingesting 3 g to 4 g of ibuprofen in children aged 1.5 to 2 years, apnea and cyanosis occur. After controlled respiration and intensive care, normalization of respiration occurs within 12 hours.
In cases of poisoning caused by improper use of Dolgit Gel, treatment depends on the symptoms. A specific antidote is not known in cases of ibuprofen poisoning. If the patient has swallowed a potentially toxic amount of Dolgit Gel within an hour, they should immediately consult a doctor.

Missing a dose of Dolgit Gel

A double dose should not be used to make up for a missed dose.
In case of doubts related to the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very rare(in less than 1 in 10,000 patients) side effects related to the topical use of ibuprofen may occur.
If the following side effects occur, Dolgit Gel should be discontinued.
General disorders and administration site conditions:

• non-specific allergic reactions and anaphylaxis, shock,
• skin disorders (e.g., redness, tingling at the application site),

Respiratory, thoracic, and mediastinal disorders:

• asthma, worsening of asthma, bronchospasm, or dyspnea,

Skin and subcutaneous tissue disorders:

• rashes of various types, itching, hives, angioedema, purpura,
• bullous skin diseases (toxic epidermal necrolysis, erythema multiforme),

Renal and urinary disorders:

• renal failure in patients with kidney disease,

Gastrointestinal disorders:

• abdominal pain, nausea.

Frequency not known

• skin becomes sensitive to light.

During long-term treatment, additional side effects may occur.
If any of the side effects worsen or any side effects not listed in this leaflet occur, the doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be consulted.
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, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Dolgit Gel

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Dolgit Gel should not be used after the expiry date stated on the label.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater (e.g., down the toilet or sink).
The pharmacist should be asked 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 Dolgit Gel contains

The active substance is ibuprofen.
The other ingredients are: isopropyl alcohol, solketal (2,2-dimethyl-4-hydroxymethyl-1,3-dioxolane), poloxamer 407, medium-chain triglycerides (Miglyol 812), lavender oil, orange oil, purified water.

What Dolgit Gel looks like and contents of the pack

Dolgit Gel is a clear, colorless to slightly cloudy gel.
Aluminum tube with a white HDPE cap, in a cardboard box. Pack sizes: 20 g, 50 g, 100 g, and 150 g.

Marketing authorization holder and manufacturer

Marketing authorization holder

DOLORGIET GmbH & Co.KG
Otto-von-Guericke-Str. 1,
53757 Sankt Augustin, Germany

Manufacturer

DOLORGIET GmbH & Co. KG, Otto-von-Guericke-Str. 1, 53757 Sankt Augustin, Germany
Date of last revision of the leaflet: