DOLGIT 50 mg /G Cream

Зміст інструкції

1. Dolgit 50 mg/g cream
   1. What is Dolgit and what is it used for
   2. What you need to know 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

Dolgit 50 mg/g cream

For adults and adolescents aged 14 years and over
Ibuprofen
Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet:

• 1. What Dolgit is and what it is used for
• 2. What you need to know 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

The active ingredient is ibuprofen. Ibuprofen is a pain reliever and anti-inflammatory drug (non-steroidal anti-inflammatory drug, NSAID).
Dolgit is used for local treatment only or as supportive therapy in cases of

• painful degenerative joint diseases (osteoarthritis), diagnosed by a doctor
• swelling and inflammation of soft tissues near the joints (e.g. bursae, tendons, tendon sheaths, ligaments and joint capsules),
• shoulder stiffness, lower back pain, lumbago,
• sports injuries and injuries such as bruises, sprains, strains.

Dolgit is indicated for adults and adolescents aged 14 years and over.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

2. What you need to know before using Dolgit

Do not use Dolgit

• if you are allergic to ibuprofen, other analgesics or anti-rheumatic drugs or to any of the other ingredients of this medicine (listed in section 6);
• on open wounds, inflammation or skin infections as well as on eczema or mucous membranes;
• if you are in the last 3 months of pregnancy. Warnings and precautions

Consult your doctor or pharmacist before using Dolgit.
Adverse effects can be reduced by using the minimum effective dose for the shortest time possible needed to control the symptoms.
In patients who suffer from or have suffered in the past from bronchial asthma or allergies and who use ibuprofen, bronchospasm may occur.
During treatment with Dolgit, patients affected by asthma, hay fever, nasal mucosal swelling (nasal polyps), chronic obstructive bronchopneumonia or chronic respiratory tract infections (especially if associated with symptoms similar to those of hay fever) are more predisposed to asthmatic attacks (analgesic/asthma intolerance asthma), local skin and mucous membrane swelling (Quincke's edema) or urticaria compared to other patients.
In these patients, Dolgit can only be used by taking certain precautions and under direct medical supervision. The same applies to patients allergic to other substances, e.g. with skin reactions, itching or urticaria.
Take appropriate precautions to prevent children from touching the skin areas treated with the medicine.
If a rash develops, treatment with Dolgit should be discontinued.
Do not expose the treated area to sources of intense natural and/or artificial light (e.g. tanning lamps) during treatment and on the day following the end of treatment, to reduce the risk of photosensitization.
Even when used locally, effects on the whole body by ibuprofen cannot be completely excluded, and the simultaneous use of ibuprofen in cream form with other NSAIDs may lead to an increase in adverse reactions.
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (PEAG) have been reported in association with treatment with ibuprofen. Stop using Dolgit and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

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

Other medicines and Dolgit
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When used as directed, no interactions with Dolgit have been reported; therefore, interactions reported with oral ibuprofen are unlikely to occur.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Dolgit if you are in the last 3 months of pregnancy. Do not use Dolgit during the first 6 months of pregnancy unless strictly necessary and under the advice of your doctor. If treatment is necessary during this period, the lowest dose should be used for the shortest possible time.
Oral forms (e.g. tablets) of Dolgit can cause adverse effects in the fetus.
It is not known whether the same risk applies when Dolgit is used on the skin.
No harmful effects are known due to the use of this medicine during breastfeeding. However, as a precaution, the cream should not be applied directly to the breast during breastfeeding.
Ibuprofen belongs to a group of medicines (NSAIDs) that can impair female fertility. This effect is reversible after stopping treatment.

Driving and using machines
Dolgit does not impair the ability to drive and use machines in case of single or short-term use.

This medicine contains sodium methyl parahydroxybenzoate (E 219), propylene glycol (E 1520) and fragrances with allergens.
Sodium methyl parahydroxybenzoate may cause allergic reactions (even delayed).
This medicine contains 50 mg of propylene glycol per g. Propylene glycol can cause skin irritation.
This medicine contains fragrances with benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene/d-limonene, linalool, which may cause allergic reactions.

3. How to use Dolgit

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults and adolescents aged 14 years and over:
Apply Dolgit 3-4 times a day. Depending on the size of the painful area to be treated, a strip of cream 4-10 cm long will be required, corresponding to 2-5 g of cream (100-250 mg of
ibuprofen). The maximum daily dose is 20 g of cream, corresponding to 1,000 mg of ibuprofen.
Consult a doctor if symptoms worsen or do not improve after 3 days.
Method of administration
Cutaneous use.
Apply Dolgit to the skin, massaging lightly. In case of severe bruises and sprains, it may be useful to apply an occlusive dressing at the beginning of the treatment. The penetration of the
active ingredient into the skin can be enhanced by iontophoresis (a particular form of
electrotherapy). Apply Dolgit under the cathode (negative pole). The amperage should be
0.1-0.5 mA per 5 cm² of electrode surface and the duration of treatment up to about
10 minutes.
After applying the cream to the skin, wash your hands after cleaning them with a paper towel, unless your hands are the area to be treated. Dispose of the paper towel with non-recyclable waste. Before showering or bathing, wait for the active ingredient to be absorbed.
For short-term use.
The duration of use depends on the symptoms and the underlying disease. Do not use Dolgit for more than
2-3 weeks. The therapeutic benefit of longer use has not been demonstrated.

If you use more Dolgit than you should
If a larger amount than the recommended dose is applied to the skin, the cream should be removed (e.g. with a paper towel) and washed off with water. Contact your doctor if the cream has been
applied in large excess or in case of accidental ingestion of Dolgit.
There is no specific antidote.

If you forget to use Dolgit
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): local skin reactions such as erythema, itching,
burning, rash, even with pustules or hives
Uncommon (may affect up to 1 in 100 people): hypersensitivity reactions, e.g. local allergic
reactions (contact dermatitis)
Very rare (may affect up to 1 in 10,000): angioedema, narrowing of the airways
(bronchospasm)
Not known (frequency cannot be estimated from available data): skin sensitization to light
If Dolgit is applied to extensive skin areas and for prolonged periods, side effects affecting a
specific organ system or the entire organism cannot be excluded, such as those that may occur
following systemic use of medicines containing ibuprofen.

Stop treatment with ibuprofen and consult your doctor immediately if you notice any of the
following symptoms:

• reddish, non-raised patches, target-shaped or circular on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red and scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly through the national reporting system.
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Dolgit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack and the tube after
“Exp.” The expiry date refers to the last day of that month.
Do not store above 25 °C.
The period of validity after first opening of Dolgit is 1 year.
Do not dispose of any medicine in waste water . Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dolgit contains:

• The active ingredient is ibuprofen. 1 g of cream contains 50 mg of ibuprofen.
• The other components are: Medium chain triglycerides Glycerol monostearate 40-55 Macrogol stearate 1 500 Macrogol stearate 5 000 Propylene glycol (E 1520) Sodium methyl parahydroxybenzoate (E 219) Xanthan gum Lavender oil (contains benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene, linalool) Neroli oil (contains citral, geraniol, citronellol, farnesol, limonene/d-limonene, linalool) Purified water.

Description of the appearance of Dolgit and contents of the pack:
Soft, smooth cream, of white or cream color.
Dolgit is available in tubes of 20 g, 40 g, 50 g, 60 g, 100 g, 120 g and 150 g of cream.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Dolorgiet GmbH & Co. KG
Otto-von-Guericke Strasse 1
53757 Sankt Augustin
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Germany: Dolgit Creme 50 mg/g
Croatia: Dolgit 50 mg/g krema
Italy: Dolgit, 50 mg/g crema
Lithuania: Ibutop 50 mg/g kremas
Latvia: Ibutop 50 mg/g krēms
Romania: Ibutop 50 mg/g cremă
Slovenia: Dolgit 50 mg/ krema