5% gel
ibuprofen
What Ibumetin is and what it is used for
Ibuprofen, the active substance in Ibumetin gel, belongs to the group of non-steroidal anti-inflammatory drugs ( NSAIDs ) and relieves pain and reduces inflammation where the damage has occurred.
You can use Ibumetin gel to treat mild to moderate pain associated with muscle and joint injuries, such as sports injuries.
2. What you need to know before using Ibumetin
Do not use Ibumetin
- if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
- if you have had allergic symptoms (eg difficulty breathing, nasal congestion, rash) while taking acetylsalicylic acid or similar medicines for inflammation .
- if you have previously had skin reactions after treatment with medicines containing ibuprofen or any of the other ingredients in gel en or if you have eczema , acne , infections or open sores in the treatment area, gel en should not be used.
Warnings and cautions
Talk to your doctor or pharmacist before using Ibumetin.
- Ibumetin gel should not be used by children and adolescents under 16 years of age.
- For chickenpox, Ibumetin should not be used.
- Do not use if you are hypersensitive (eg if you have asthma ) to acetylsalicylic acid . If you have stomach ulcers , you should consult a doctor before using Ibumetin.
- Before treatment with Ibumetin, you should consult a doctor if you have or have had diseases of the kidneys, heart or liver function.
- Do not use on damaged or infected skin.
- The gel must not come into contact with mucous membranes or eyes.
- Do not use Ibumetin gel under tight-fitting dressings.
- Avoid direct sunlight, including solarium, on treated area during treatment and at least two weeks after treatment.
- The risk of side effects increases with treatment time. Therefore, the treatment should not exceed 1 week.
- Ibumetin, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to conceive and is therefore not recommended for women who want to become pregnant. The effect is temporary, ie ceases when you stop using these types of drugs.
Other medicines and Ibumetin
Never use several different painkillers at the same time without consulting a doctor or pharmacist.
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not use Ibumetin during the last three months of pregnancy. The use of Ibumetin should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Ibuprofen passes into breast milk but is unlikely to affect breastfed infants. Talk to your doctor if you need more than the temporary use of Ibumetin gel during breastfeeding.
Treatment with ibuprofen may affect the ability to conceive. This effect is temporary and ceases if the medication is stopped. Ibuprofen is not recommended for women who want to become pregnant or undergo infertility tests.
Driving and using machines
No effects on the ability to drive or use machines have been observed.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Ibumetin
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Ibumetin gel should only be used topically.
Adults and children from 16 years:
Apply a layer of gel on the painful area up to three times a day. Then massage gently until the gel has entered the skin. Wash hands after use if they have not been treated. Do not use more gel than necessary to cover the damaged area. The normal dosage is 9-10 grams of gel per day (10 g corresponds to an approximately 17 cm long gel strand). Do not use more than 15 grams per day. The duration of treatment should not exceed one week.
Contact a doctor if symptoms worsen or do not improve within 7 days.
If you use more Ibumetin than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ibumetin and contact a doctor immediately if you get any of the following symptoms ( angioedema ):
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing
Treatment should be stopped and a doctor consulted if a rash or other side effect occurs.
Uncommon (may affect up to 1 in 100 people ): Reddening of the skin, itching, eczema.
Rare ( may affect up to 1 in 1,000 people ): Blisters, hives.
Very rare ( may affect up to 1 in 10,000 people): Swelling of the face, lips, tongue, and/or throat, sometimes with shortness of breath or difficulty swallowing – so-called angioedema.
In some cases, allergy-like reactions have symptoms such as difficulty breathing, skin rash, swelling, and sometimes drops in blood pressure have been reported. Isolated cases of renal impairment have been reported.
Has been reported (occurs in an unknown number of users): The skin becomes photosensitive.
In rare cases, severe skin infections are associated with chickenpox.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ibumetin
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 carton after “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Empty drug packages are sorted at the source according to local regulations.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
– The active substance is ibuprofen 5%. 1 g of gel contains 50 mg of ibuprofen .
– The other ingredients are denatured spirits, carbomers, propylene glycol, diethylamine, and water.
What the medicine looks like and contents of the pack
Ibumetin is a clear to translucent gel.
Non-prescription package sizes: Aluminum tube 30 g, 50 g, and 100 g gel.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Takeda Pharma AB
Vasagatan 7, 6 tr
111 20 Stockholm
Tel: 08-731 28 00
Email: infosweden@takeda.com
Manufacturer:
Fleet Laboratories Limited
94 Rickmansworth Road
Watford, Herts
WD18 7JJ, England
tel +44 19 23 22 92 51
fax +44 19 23 22 07 28