Ibutop gel
Poland
Table of Contents
Patient Information Leaflet
Ibutop Gel
50 mg/g, gel
Ibuprofenum
Please read the following information 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
your doctor or pharmacist.
- Keep this leaflet for future reference.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If symptoms do not improve after 10 days, or if they worsen, consult your doctor.
Table of Contents:
- What Ibutop Gel is and what it is used for
- Important information before using Ibutop Gel
- How to use Ibutop Gel
- Possible side effects
- How to store Ibutop Gel
- Contents of the pack and other information
1. What Ibutop Gel is and what it is used for
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen has analgesic and anti-inflammatory properties. Its action is based on inhibition of 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, lower back pain, and traumatic injuries related to sports activities or accidents (e.g. bruises, sprains).
2. Important information before using Ibutop Gel
When not to use Ibutop Gel
- if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
- if the patient has hypersensitivity (allergy) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs); if the patient previously experienced: urticaria, allergic rhinitis, asthma after administration of acetylsalicylic acid or other NSAIDs;
- if the patient is in the last three months of pregnancy.
Warnings and precautions
Before starting treatment with Ibutop Gel, consult a doctor or pharmacist.
Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Treatment with Ibutop Gel should be discontinued and immediate medical advice sought if any of the symptoms associated with severe skin reactions described in section 4 occur.
Ibutop Gel should not be applied to open wounds, mucous membranes, or near the eyes.
Ibutop Gel should be used with caution in patients with gastric or duodenal ulcer disease, renal insufficiency, bronchial asthma, or intolerance to acetylsalicylic acid, ibuprofen, or other NSAIDs taken orally.
During treatment with Ibutop Gel, avoid exposing the treated areas of skin to sunlight, as this may lead to photosensitivity reactions.
If a rash develops, discontinue use of the medicine.
If there is no need to treat the hands for therapeutic purposes, hands should be washed after each application of the medicine.
Children and adolescents
Ibutop Gel is not indicated for the treatment of children under 14 years of age.
Ibutop Gel and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
There are currently no known interactions between topically applied ibuprofen and other medicines. Concurrent 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 have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not use Ibutop Gel during the last three months of pregnancy. Ibutop Gel should not be used during the first six months of pregnancy unless clearly necessary and recommended by a doctor. If treatment during this period is necessary, the lowest effective dose for the shortest possible duration should be used.
Oral formulations (e.g. tablets) may cause adverse effects in the unborn child. It is not known whether the same risk applies to Ibutop Gel when applied to the skin.
Breastfeeding
Do not use Ibutop Gel during breastfeeding.
Fertility
No effect on fertility has been observed at this level of exposure.
Driving and operating machinery
No adverse effects affecting the ability to drive or operate machinery are known.
Ibutop Gel contains fragrance substances: benzyl alcohol, benzyl benzoate, citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene / d-limonene, linalool.
This medicine may cause allergic reactions.
3. How to use Ibutop Gel
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 a doctor or pharmacist.
For use in adults and adolescents aged 14 years and older.
For topical application to the skin.
Unless otherwise directed by a doctor, apply 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) to the skin and rub in 3 to 4 times daily.
If necessary, the medicine may be used more frequently, but not more often than every 4 hours.
This medicine is not intended for use under occlusive dressings.
Absorption of the active substance through the skin is increased during iontophoresis procedures (a special form of electrotherapy). Ibutop Gel is applied under the cathode (negative pole).
Typically, a current intensity of 0.1 to 0.5 mA per 5 cm² of electrode surface area is used, and the duration of treatment should not exceed 15 minutes.
The duration of treatment is determined by the doctor. If symptoms have not improved or worsen after 10 days of treatment, the patient should consult a doctor.
The daily dose should not exceed 12 g of gel (600 mg of ibuprofen).
Use of a higher than recommended dose of Ibutop Gel
Due to the low systemic absorption through the skin—compared to oral administration—no cases of poisoning have been observed following topical application of Ibutop Gel.
Oral ingestion of 8 g to 12 g of ibuprofen in adults may lead to dizziness, loss of consciousness, and decreased blood pressure.
In children aged 1.5 to 2 years, ingestion of 3 g to 4 g of ibuprofen may result in apnea and cyanosis. With controlled ventilation and intensive supportive care, respiratory function normalizes within 12 hours.
In cases of poisoning due to improper use of Ibutop Gel, treatment is symptomatic. There is no specific antidote known for ibuprofen poisoning. If a potentially toxic amount of Ibutop Gel has been ingested within the past hour, seek immediate medical attention.
Missed dose of Ibutop Gel
Do not use a double dose to make up for a missed dose.
If in doubt about using this medicine, consult a doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You must stop using Ibutop Gel and seek immediate medical help if any of the following symptoms occur:
- Reddish, flat or circular raised patches on the trunk, often with blisters in the centre, peeling skin, mouth, throat, nose, genital or 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) [Very rare – less than 1 in 10,000 patients]
- Widespread rash, high fever and swollen lymph nodes (DRESS syndrome) [Frequency not known]
- Widespread red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised exanthematous pustulosis) [Frequency not known]
Other possible side effects include:
Common (may affect up to 1 in 10 people):
- Various types of skin rash, itching, urticaria, angioedema, purpura.
Very rare (affecting less than 1 in 10,000 patients), adverse reactions related to the local application of ibuprofen may occur. If any of the following adverse effects occur, discontinue the medicine:
- Non-specific allergic and anaphylactic reactions, shock;
- Skin disorders (e.g. redness, tingling at the site of application);
- Asthma, worsening of asthma, bronchospasm or dyspnoea;
- Bullous skin diseases (epidermal necrolysis, erythema multiforme);
- Renal failure in patients with kidney disease;
- Abdominal pain, indigestion.
Frequency not known:
- Skin becomes sensitive to light.
Additional side effects may occur with long-term treatment.
If any of the side effects worsen or if any side effects not listed in this leaflet occur, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.
5. How to store Ibutop Gel
Keep this medicine out of sight and reach of children.
Store below 25°C.
Do not use Ibutop Gel after the expiry date stated on the label.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater (for example, toilets or sinks).
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 Ibutop 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 saturated triglycerides (Miglyol 812), lavender oil, orange oil, purified water.
What Ibutop Gel looks like and contents of the pack
Ibutop Gel is a clear, colourless to slightly opalescent gel.
Aluminium tube with a white HDPE screw cap, in a cardboard box. Pack sizes: 20 g, 50 g, 100 g, and 150 g.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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