Dolgit

Package Leaflet: Information for the User

Dolgit, 50 mg/g, Cream

(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 directed by a doctor or pharmacist.

• Keep this package 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 any possible side effects not listed in this package 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 Package Leaflet:

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

1. What is Dolgit and what is it used for

Ibuprofen, the active substance of Dolgit, belongs to the group of nonsteroidal anti-inflammatory drugs.
Ibuprofen has analgesic and anti-inflammatory effects by inhibiting the synthesis of prostaglandins
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).

If after 10 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Dolgit

When not to use Dolgit

• if the patient is hypersensitive to ibuprofen, preservative - methyl parahydroxybenzoate sodium, propylene glycol, 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 is hypersensitive to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if the patient has experienced: hives, allergic rhinitis, asthma after using acetylsalicylic acid or other NSAIDs.

Warnings and precautions

Before starting to use Dolgit, the patient should discuss it with their doctor or pharmacist.
Dolgit cream should not be applied to open wounds, mucous membranes, and the eye area.
The medicine should be used with caution in patients with gastric and duodenal ulcers, renal failure, asthma, and hypersensitivity to acetylsalicylic acid, ibuprofen, or other NSAIDs taken orally.
If a rash occurs, 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 cream is not indicated for the treatment of children under 14 years of age.

Dolgit 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, including those available without a prescription.
So far, no interactions between topically applied ibuprofen and other medicines have been reported.
Concomitant 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.
Using Dolgit in the third trimester of pregnancy is contraindicated. In the first and second trimesters, the medicine should not be applied to large areas of skin and for a long time.
Dolgit should not be used during breastfeeding.

Driving and using machines

No adverse reactions to the medicine that could affect the ability to drive vehicles or operate machinery have been reported.

Dolgit contains propylene glycol and methyl parahydroxybenzoate sodium.

This medicine contains 50 mg of propylene glycol per 1 g.
Propylene glycol may cause skin irritation.
Methyl parahydroxybenzoate sodium may cause allergic reactions (possible late reactions).
Dolgit 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

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
For use by adults and adolescents from 14 years of age.
For topical use, on the skin.
Recommended dose:
If the doctor has not recommended otherwise, usually apply and rub into the skin 3 to 4 times
a day a strip of cream 4 to 10 cm long (2 g to 5 g of cream, which corresponds to 100 mg to 250 mg
of ibuprofen).
If necessary, the medicine can be used more frequently, but not more than every 4 hours.
In the case of extensive bruises and sprains, the cream can be used under an occlusive dressing at the beginning of treatment.
Absorption of the active substance through the skin is greater during iontophoresis procedures (a type of electrotherapy). Dolgit cream is applied under the cathode (negative pole). The usual current intensity is 0.1 to 0.5 mA per 5 cm of electrode surface, and the treatment time is a maximum of 15 minutes. The duration of such treatment is determined by the doctor.
If after 10 days of using the medicine the symptoms do not disappear or worsen, the patient should consult their doctor.
The daily dose should not exceed 12 g of cream (600 mg of ibuprofen).

Using a higher dose of Dolgit than recommended

Due to the low absorption through the skin compared to oral absorption of ibuprofen, no cases of poisoning have been observed after topical application of Dolgit cream.
Oral administration of 8 g to 12 g of ibuprofen in adults leads to dizziness, loss of consciousness, and decreased blood pressure.
As a result of taking 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, treatment depends on the symptoms. A specific antidote for ibuprofen poisoning is not known.
If the patient has ingested a potentially toxic amount of Dolgit within an hour, they should immediately consult their doctor.

Missing a dose of Dolgit

A double dose should not be used to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

Dolgit contains propylene glycol and methyl parahydroxybenzoate sodium

The medicine may cause skin irritation and allergic reactions (possible late reactions).

4. Possible side effects

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

• non-specific allergic and anaphylactic reactions, shock;
• skin disorders (e.g. redness, tingling at the site of application);
• asthma, worsening of asthma, bronchospasm or shortness of breath;
• rashes of various types, itching, hives, angioedema, purpura;
• bullous skin diseases (toxic epidermal necrolysis, erythema multiforme);
• renal failure in patients with kidney disease;
• abdominal pain, nausea.

Frequency not known

• The skin becomes sensitive to light.

Additional side effects may occur during long-term treatment.

Reporting side effects

If any side effects occur, including any side effects not listed in the package leaflet, the patient should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 allow for more information to be collected on the safety of the medicine.

5. How to store Dolgit

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and label after:
“Expiry date” or “EXP”. 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 patient should ask their pharmacist 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 contains

• The active substance of the medicine is ibuprofen.
• The other ingredients are: triglycerides of saturated fatty acids of medium chain length, glycerol monostearate, macrogol-30-glycerol monostearate, macrogol-100-glycerol monostearate (E 471), propylene glycol (E 1520), methyl parahydroxybenzoate sodium (E 219), xanthan gum (E 415), lavender oil, orange oil, purified water.

What Dolgit looks like and contents of the pack

Aluminum tube with HDPE cap in a cardboard box. Pack sizes: 20 g, 50 g, 100 g, or 150 g.

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
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder.
Natur Produkt Zdrovit Sp. z o.o.
ul. Nocznickiego 31
01-918 Warsaw
Tel. 22 569 82 00
Date of last revision of the package leaflet:August 2023