Dolgit
Poland
Table of Contents
Patient Information Leaflet
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Dolgit (Dolgit - Creme), 50 mg/g, cream
(Ibuprofenum)
Dolgit and Dolgit - Creme are different trade names for the same medicine.
Please read this 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 so that you can read it again if necessary.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 10 days, or if your condition worsens, consult your doctor.
Table of contents:
- What Dolgit is and what it is used for
- What you need to know before using Dolgit
- How to use Dolgit
- Possible side effects
- How to store Dolgit
- Contents of the pack and other information
1. What Dolgit is and what it is used for
Ibuprofen, the active substance in Dolgit, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen exerts analgesic and anti-inflammatory effects by inhibiting prostaglandin synthesis in inflamed tissue.
Indications:
- Local treatment of muscle pain;
- Treatment of pain associated with degenerative joint diseases, rheumatic disorders 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, lumbar back pain, and inflammatory sports-related or traumatic injuries (e.g. contusions, sprains).
If there is no improvement after 10 days, or if your condition worsens, consult your doctor.
2. Important information before using Dolgit
When not to use Dolgit
- if the patient is allergic to ibuprofen, the preservative sodium methyl parahydroxybenzoate (E 219), propylene glycol, benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene / d-limonene, linalool, or any of the other ingredients of this medicine (listed in section 6);
- if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if the patient has previously experienced urticaria, allergic rhinitis, or asthma after taking acetylsalicylic acid or other NSAIDs.
Warnings and precautions
Before starting to use Dolgit, consult your doctor or pharmacist.
Dolgit cream must not be applied to open wounds, mucous membranes, or near the eyes.
Use Dolgit with caution in patients with gastric or duodenal ulcer disease, renal impairment, bronchial asthma, or intolerance to acetylsalicylic acid, ibuprofen, or other NSAIDs taken orally.
If a rash occurs, discontinue use of the medicine.
If there is no need to treat the hands therapeutically, wash hands thoroughly after each application.
Children and adolescents
Dolgit cream is not recommended for use in children under 14 years of age.
Dolgit and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
No interactions between topically applied ibuprofen and other medicines are currently known. However, concomitant use of acetylsalicylic acid and other non-steroidal anti-inflammatory drugs may increase the frequency of adverse effects.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Dolgit during the third trimester of pregnancy is contraindicated. During the first and second trimesters, Dolgit should not be used over large skin areas or for prolonged periods.
Dolgit should not be used during breastfeeding.
Driving and operating machinery
No adverse effects affecting the ability to drive or operate machinery are known.
Dolgit contains propylene glycol and sodium methyl parahydroxybenzoate (E 219).
This medicine contains 50 mg of propylene glycol per 1 g.
Propylene glycol may cause skin irritation.
Sodium methyl parahydroxybenzoate (E 219) may cause allergic reactions (including delayed-type reactions).
Dolgit contains fragrance ingredients: benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene / d-limonene, linalool.
This medicine may cause allergic reactions.
3. How to use Dolgit medicine
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For use in adults and adolescents aged 14 years and older.
For topical application to the skin.
Recommended dosage:
Unless otherwise advised by a doctor, apply and gently rub into the skin 3 to 4 times daily 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).
If necessary, the medicine may be used more frequently, but not more often than every 4 hours.
In cases of extensive bruising or sprains, the cream may initially be applied under an occlusive dressing.
Absorption of the active ingredient through the skin is increased during ionophoresis (a type of electrotherapy). Dolgit cream should be applied under the cathode (negative pole). The usual current intensity is 0.1 to 0.5 mA per 5 cm² of electrode surface area, and the duration of treatment should not exceed 15 minutes. The duration of such treatment is determined by the physician.
If symptoms persist or worsen after 10 days of treatment, consult a doctor.
The daily dose should not exceed 12 g of cream (600 mg of ibuprofen).
Use of a higher than recommended dose of Dolgit
Due to the low systemic absorption through the skin compared to oral administration of ibuprofen, no cases of poisoning have been observed following topical application of Dolgit cream.
Oral ingestion of 8 g to 12 g of ibuprofen in adult patients may lead to dizziness, loss of consciousness, and hypotension.
Ingestion of 3 g to 4 g of ibuprofen in children aged 1.5 to 2 years may result in apnea and cyanosis. With controlled ventilation and intensive supportive care, respiratory function typically normalizes within 12 hours.
In cases of poisoning due to improper use of Dolgit, treatment depends on the symptoms presented. There is no specific antidote known for ibuprofen poisoning.
If a potentially toxic amount of Dolgit has been ingested within the past hour, seek immediate medical attention.
Missed dose of Dolgit
Do not use a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
Dolgit contains propylene glycol and sodium methylparahydroxybenzoate (E 219)
This medicine may cause skin irritation and allergic reactions (delayed-type reactions possible).
4. Possible adverse reactions
Like all medicines, this medicine may cause adverse reactions, although not everyone will experience them.
Very rare (in less than 1 in 10,000 patients), adverse reactions related to the local application of ibuprofen may occur. If any of the following adverse reactions occur, discontinue use of the medicine:
- non-specific allergic and anaphylactic reactions, shock;
- skin disorders (e.g. redness, tingling at the application site);
- asthma, worsening of asthmatic condition, bronchospasm or dyspnoea;
- various types of rashes, pruritus, urticaria, angioedema, purpura;
- blistering skin diseases (epidermal necrolysis, erythema multiforme);
- renal failure in patients with kidney disease;
- abdominal pain, dyspepsia.
Frequency unknown
- skin becomes sensitive to light.
Additional adverse reactions may occur during prolonged treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Dolgit
Keep the medicine out of sight and reach of children.
Do not store above 25°C.
Period of validity after first opening of the tube – 12 months.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system (for example, in toilets or sinks). Ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.
6. Contents of the package and other information
What Dolgit contains
- The active substance is ibuprofen. 100 g of cream contains 5 g of ibuprofen.
- The other ingredients are: medium-chain triglycerides, glycerol monostearate 40-55, polyglycerol-30-glycerol monostearate, polyglycerol-100-glycerol monostearate, propylene glycol, sodium methylparaben (E 219), xanthan gum, lavender essential oil, bitter orange flower essential oil, purified water.
What Dolgit looks like and contents of the pack
Aluminium tube with a polyethylene cap, packed in a cardboard box. Pack size: 100 g.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in Austria, the country of export: 1-19151
Parallel import authorisation number: 191/25