The active substance is ibuprofen 5 g.
Excipients/Inactive Ingredients: The other ingredients are isopropyl alcohol, hydroxyethyl cellulose, sodium hydroxide, benzyl alcohol, purified water q.s. ad 100 g.
Extrapan gel is a non-steroidal analgesic anti-inflammatory medication. These medicines have a painkilling and anti-inflammatory effect.
Extrapan gel may provide some relief of pain in musculoskeletal conditions and joint disorders such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis including juvenile idiopathic arthritis, peri-articular disorders such as bursitis and tenosynovitis, and soft-tissue disorders such as sprains and strains.
Extrapan gel should always be used exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if not sure.
The usual dose for adults: Apply adequate quantity of gel to the affected area, 3 to 4 times a day and rub lightly.
If the patient forgets to use Extrapan gel: No special precautions needed.
If the patient stops using Extrapan gel: No special precautions needed.
If the prescribed quantity is followed properly, poisoning is highly unlikely because relatively little active ingredient is absorbed via the skin (minor local percutaneous resorption) compared with administration via the circulation (systemic).
Should the patient ingest Extrapan gel, patients must be advised to immediately get in touch with the doctor or pharmacist.
Extrapan gel should not used: If the patient is allergic (hypersensitive) to ibuprofen or any of the other ingredients of Extrapan gel; If the patient is allergic to other drugs of the same category or to Ibuprofen; On mucous membranes and eyes; With babies and children except on the advice of a doctor; On inflamed skin or on wounds; The third trimester of pregnancy, because of risks of premature closure of the ductus arteriosus, and prolonged parturition.
Special care should be taken with Extrapan gel: If the patient has an allergic reaction to anti-inflammatory medications that are not derived from cortisone.
In case of skin rash, the treatment should be stopped.
If the patient is using other drugs as well. Also, read "Using other medicines" under Interactions.
Patients must be advised to inform the doctor if any of these previously mentioned warnings apply, or if this has been the case in the past.
Driving and using machines: Extrapan gel does not influence the ability to drive or to use machines.
Patients must be advised before taking/using any medicine.
The use of Extrapan gel is not advisable during pregnancy and breast-feeding.
Ibuprofen are contraindicated for use during the third trimester of pregnancy because of risks of premature closure of the ductus arteriosus and the potential to prolong parturition. Caution is recommended in prescribing Ibuprofen during the first and second trimester of pregnancy, particularly from the middle to end of the second trimester of pregnancy (onset at approximately 20 weeks) due to possible fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment or failure.
Ibuprofen should not be used during the first two trimesters of pregnancy unless the expected benefits to the mother outweigh the risk to the fetus.
Published studies and postmarketing reports describe maternal Non-Steroidal Anti-Inflammatory Drug (NSAID) use at approximately 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment or failure. NSAIDs were shown to cause significant reduction in fetal urine production prior to reduction of amniotic fluid volume. There have also been a limited number of case reports of maternal NSAID use and neonatal renal dysfunction and renal impairment without oligohydramnios, some of which were irreversible, even after treatment discontinuation.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Complications of prolonged oligohydramnios may for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If after careful consideration of the benefit-risk, NSAID treatment is considered necessary to be administered anywhere from the middle (onset at approximately 20 weeks) to the end of the second trimester of pregnancy, the use should be limited to the lowest effective dose and shortest duration possible. It is also recommended that ultrasound monitoring of amniotic fluid be considered if Ibuprofen treatment extends beyond 48 hours and that NSAIDs treatment be discontinued if oligohydramnios occurs, followed by appropriate medical follow up.
Like all medicines, Extrapan gel can cause side effects, although not everybody gets them.
Skin rashes, urticaria, bronchoconstriction and anaphylactic shock may occur. In this case, this medicine should be stopped.
If any of the side effects get serious, or if there are any side effects noticed not listed in this monograph, patients must be advised to inform the doctor or pharmacist.
Using other medicines: Caution should be exercised in case of taking or having recently taken any other medicines, including medicines obtained without a prescription. Interactions between Extrapan gel and other drugs have never occurred up to now.
Using Extrapan gel with food and drink: Interactions between Extrapan gel and nutrition have never occurred up to now.
Important information about some of the ingredients of Extrapan gel: Not applicable.
M02AA13 - ibuprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Extrapan topical gel 5% w/w
100 g x 1's;50 g x 1's
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