DOLGIT 50 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.
3. Dolgit (Dolgit - Cream), 50 mg/g, Cream
   1. It is Necessary to Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
4. What is Dolgit and What is it Used for
5. Important Information Before Using Dolgit
   1. When Not to Use Dolgit
   2. Warnings and Precautions
   3. Children and Adolescents
   4. Dolgit and Other Medications
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Operating Machines
   7. Dolgit Contains Propylene Glycol and Methyl Parahydroxybenzoate Sodium (E 219)
6. How to Use Dolgit
   1. Using a Higher Dose of Dolgit than Recommended
   2. Missing a Dose of Dolgit
   3. Dolgit Contains Propylene Glycol and Methyl Parahydroxybenzoate Sodium (E 219)
7. Possible Undesirable Effects
   1. Frequency Not Known
   2. Reporting Undesirable Effects
8. How to Store Dolgit
9. Package Contents and Other Information
   1. What Dolgit Contains
   2. What Dolgit Looks Like and What the Package Contains
   3. Marketing Authorization Holder in Austria, the Country of Export:
   4. Manufacturer:
   5. Parallel Importer:
   6. Repackaged by:
   7. Parallel Import License Number: 191/25
   8. Date of Approval of the Leaflet: 27.05.2025

Package Leaflet: Information for the User

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Dolgit (Dolgit - Cream), 50 mg/g, Cream

(Ibuprofen)
Dolgit and Dolgit - Cream are different trade names for the same drug.

It is Necessary to Carefully Read the Contents of the Leaflet Before Using the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Used Exactly as Described in this Patient Leaflet or as Directed by a Doctor or Pharmacist.

• The Leaflet Should be Kept in Case it Needs to be Read Again.
• If Advice or Additional Information is Needed, a Pharmacist Should be Consulted.
• If the Patient Experiences any Undesirable Effects, Including any Possible Undesirable Effects not Listed in this Leaflet, the Doctor or Pharmacist Should be Informed. See Section 4.
• If There is no Improvement or the Patient Feels Worse after 10 Days, the Doctor Should be Contacted.

Table of Contents of the Leaflet:

• 1. What is Dolgit and What is it Used for
• 2. Important Information Before Using Dolgit
• 3. How to Use Dolgit
• 4. Possible Undesirable Effects
• 5. How to Store Dolgit
• 6. Package Contents and Other Information

1. What is Dolgit and What is it Used for

Ibuprofen, the Active Substance of Dolgit, Belongs to the Group of Non-Steroidal Anti-Inflammatory Drugs.
Ibuprofen has an Analgesic and Anti-Inflammatory Effect by Inhibiting the Synthesis of Prostaglandins in Inflamed Tissue.
Indications for Use :

• Local Treatment of Muscle Pains;
• Treatment of Pains in the Course of Degenerative Joint Diseases, Rheumatic Diseases of the Peripheral Joints and Spine;
• Treatment of Inflammatory Changes in the Tissues Around the Joints (e.g., Bursae, Tendons, Tendon Sheaths, Ligaments, and Joint Capsules);
• Treatment of Painful Stiffness of the Shoulder, Lower Back Pain, Post-Traumatic Changes Related to Sports or Accidents (e.g., Bruises, Sprains).

If There is no Improvement or the Patient Feels Worse after 10 Days, the Doctor Should be Consulted.

2. Important Information Before Using Dolgit

When Not to Use Dolgit

• If the Patient is Allergic to Ibuprofen, the Preservative - Methyl Parahydroxybenzoate Sodium (E
• 219), Propylene Glycol, Benzyl Alcohol, Benzyl Benzoate, Citral, Citronellol, Coumarin, Eugenol, Farnesol, Geraniol, Limonene / D-Limonene, Linalol, or any of the Other Components of this Medication (Listed in Section 6);
• If the Patient is Allergic to Acetylsalicylic Acid or Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs);
• If the Patient has Experienced in the Past: Urticaria, Allergic Rhinitis, Asthma after Using Acetylsalicylic Acid or Other NSAIDs.

Warnings and Precautions

Before Starting to Use Dolgit, the Doctor or Pharmacist Should be Consulted.
Dolgit Cream Should not be Used on Open Wounds, Mucous Membranes, and in the Eye Area.
The Medication Should be Used with Caution in Patients with Gastric and (or) Duodenal Ulcer Disease, Renal Insufficiency, Bronchial Asthma, and Intolerance to Acetylsalicylic Acid, Ibuprofen, or Other NSAIDs Taken Orally.
If a Rash Occurs, the Medication Should be Discontinued.
If There is no Need to Apply the Medication 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 Medications

The Doctor or Pharmacist Should be Informed about all Medications Currently or Recently Taken by the Patient, as well as any Medications Planned to be Taken, Including those Available Without a Prescription.
So far, there are no Known Interactions Between Topically Applied Ibuprofen and Other Medications. Concurrent Use of Acetylsalicylic Acid and Other Non-Steroidal Anti-Inflammatory Drugs may Increase the Frequency of Undesirable Effects.

Pregnancy, Breastfeeding, and Fertility

If the Patient is Pregnant or Breastfeeding, or Thinks she may be Pregnant or is Planning to have a Child, she Should Consult a Doctor or Pharmacist Before Using this Medication.
Using Dolgit in the Third Trimester of Pregnancy is Contraindicated. In the First and Second Trimesters, the Medication Should not be Used on Large Areas of Skin and for a Long Time.
Dolgit Should not be Used During Breastfeeding.

Driving and Operating Machines

There are no Known Undesirable Effects of the Medication that Could Affect the Ability to Drive Vehicles or Operate Machinery.

Dolgit Contains Propylene Glycol and Methyl Parahydroxybenzoate Sodium (E 219)

This Medication Contains 50 mg of Propylene Glycol per 1 g.
Propylene Glycol may Cause Skin Irritation.
Methyl Parahydroxybenzoate Sodium (E 219) 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 Medication may Cause Allergic Reactions.

3. How to Use Dolgit

This Medication Should Always be Used Exactly as Described in the Patient Leaflet or as Directed by a Doctor or Pharmacist. In Case of Doubt, the Doctor or Pharmacist Should be Consulted.
For Use in Adults and Adolescents Over 14 Years of Age.
For Topical Use, on the Skin.
Recommended Dose:
If the Doctor has not Prescribed Otherwise, a Strip of Cream 4 to 10 cm Long (2 g to 5 g of Cream, Corresponding to 100 mg to 250 mg of Ibuprofen) is Usually Applied and Rubbed into the Skin 3 to 4 Times a Day.
If Necessary, the Medication 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 Ionophoresis (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 up to 15 Minutes. The Duration of such Treatment is Determined by the Doctor.
If the Symptoms do not Improve or Worsen after 10 Days of Using the Medication, the Doctor Should be Consulted.
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 Use 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 Breathing and Intensive Care, Normalization of Breathing Occurs within 12 Hours.
In Cases of Poisoning Caused by Improper Use of Dolgit, Treatment Depends on the Occurring Symptoms. There is no Specific Antidote Known in Cases of Ibuprofen Poisoning.
If the Patient has Swallowed a Potentially Toxic Amount of Dolgit within an Hour, the Doctor Should be Consulted Immediately.

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 Regarding the Use of this Medication, the Doctor or Pharmacist Should be Consulted.

Dolgit Contains Propylene Glycol and Methyl Parahydroxybenzoate Sodium (E 219)

The Medication may Cause Skin Irritation and Allergic Reactions (Possible Late Reactions).

4. Possible Undesirable Effects

Like all Medications, this Medication can Cause Undesirable Effects, although not Everyone will Experience them.
Very Rarely(in Less than 1 in 10,000 Patients) Undesirable Effects Associated with Topical Use of Ibuprofen may Occur. If the Following Undesirable Effects Occur, the Medication Should be Discontinued:

• Non-Specific Allergic and Anaphylactic Reactions, Shock;
• Skin Disorders (e.g., Redness, Tingling at the Application Site);
• Asthma, Worsening of Asthmatic Condition, Bronchospasm, or Shortness of Breath;
• Rashes of Various Types, Itching, Urticaria, Angioedema, Purpura;
• Bullous Skin Diseases (Toxic Epidermal Necrolysis, Erythema Multiforme);
• Renal Failure in Patients with Kidney Diseases;
• Abdominal Pain, Nausea.

Frequency Not Known

• The Skin Becomes Sensitive to Light.

During Long-Term Treatment, Additional Undesirable Effects may Occur .

Reporting Undesirable Effects

If any Undesirable Effects Occur, Including any Undesirable Effects not Listed in the Leaflet, the Doctor or Pharmacist Should be Informed. Undesirable Effects can be Reported Directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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.
By Reporting Undesirable Effects, more Information can be Collected on the Safety of the Medication.

5. How to Store Dolgit

The Medication Should be Stored in a Place Out of Sight and Reach of Children.
Do not Store at a Temperature Above 25°C.
Shelf Life after First Opening the Tube - 12 Months.
Do not Use this Medication after the Expiration Date Stated on the Packaging. The Expiration Date Refers to the Last Day of the Specified Month.
Medications Should not be Disposed of in the Drainage System (e.g., Down the Toilet or Sink). The Pharmacist Should be Asked how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and Other Information

What Dolgit Contains

• The Active Substance of Dolgit is Ibuprofen. 100 g of Cream Contains 5 g of Ibuprofen.
• Other Ingredients are: Triglycerides of Fatty Acids of Medium Chain Length, Glycerol Monostearate 40-55, Macrogol-30-Glycerol Monostearate, Macrogol-100-Glycerol Monostearate, Propylene Glycol, Methyl Parahydroxybenzoate Sodium (E 219), Xanthan Gum

Lavender Essential Oil, Bitter Orange Flower Essential Oil, Purified Water.

What Dolgit Looks Like and What the Package Contains

Aluminum Tube with a Polyethylene Cap, in a Cardboard Box. Package Size 100 g.
For more Detailed Information, the Marketing Authorization Holder or Parallel Importer Should be Contacted.

Marketing Authorization Holder in Austria, the Country of Export:

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

Manufacturer:

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

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Austrian Export License Number:1-19151

Parallel Import License Number: 191/25

Date of Approval of the Leaflet: 27.05.2025

[Information about the Registered Trademark]