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What KetoFLEX 2.5% gel is and what it is used for
How does KetoFLEX 2.5% gel work?
KetoFLEX 2.5% gel belongs to the group of non-steroidal anti-inflammatory and analgesic drugs. Relieves pain, inflammation and swelling in acute, painful musculoskeletal diseases by avoiding the typical side effects that are observed when taking non-steroidal anti-inflammatory drugs by mouth.
What is KetoFLEX 2.5% gel used for?
For symptomatic treatment of pain and swelling in inflammatory diseases and injuries of joints, ligaments, tendons and muscles (arthritis, periarthritis, tendinitis, bursitis, sprains, contusions, meniscus damage, neck cramps, lumbago).
2. What you need to know before using KetoFLEX 2.5% gel
Do not use KetoFLEX 2.5% gel
If you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6).
If you have a history of allergy to tiaprofenic acid, fenofibrate, UV blockers or perfumes.
Stop using KetoFLEX 2.5% gel immediately if any skin reaction occurs, including skin reactions after concomitant use of products containing octocrylene (octocrylene is one of the excipients of some cosmetic and hygiene products such as shampoos, products for after shave application, shower and bath gels, skin creams, lipsticks, anti-wrinkle creams, make-up removers, skin sprays to slow down photodegradation).
Do not expose treated areas to sunlight or UV rays from a tanning bed during treatment and for 2 weeks after discontinuation.
If you suffer from severe heart failure.
In children under 15 years of age.
Warnings and precautions
Exposure to the sun (even indirectly) or to UV rays in areas that come in contact with KetoFLEX 2.5% gel can cause potentially serious skin reactions (photosensitivity).
It is therefore necessary to:
protect the treated areas by covering them with clothing during treatment and for 2 weeks after discontinuation to avoid any risk of photosensitivity;
wash your hands thoroughly after each application of KetoFLEX 2.5% gel.
Treatment should be discontinued immediately if any skin reaction develops after administration of KetoFLEX 2.5% gel.
Other drugs and KetoFLEX 2.5% gel
Tell your doctor if you are taking, have recently taken or might take any other medicines.
No interactions with other drugs have been reported with ketoprofen. However, concomitant use of more than one NSAID medicinal product, including selective COX-2 inhibitors, should be avoided.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
The use of KetoFLEX 2.5% gel in pregnant and lactating women is not recommended, unless the benefits outweigh the risks to the fetus and only under medical supervision.
Driving and using machines
KetoFLEX 2.5% gel does not affect the ability to drive and use machines.
KetoFLEX 2.5% gel contains alcohol (ethanol 96%) and therefore should not be in contact with open wounds, mucous membranes or eyes.
KetoFLEX 2.5% gel contains methyl parahydroxybenzoate as an excipient that may cause allergic reactions (possibly delayed).
3. How to use KetoFLEX 2.5% gel
Always use KetoFLEX 2.5% gel exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Method of application: only externally, on the skin.
The gel is applied (3-5 cm or more depending on the damage) on the skin once or twice a day, with a light massage to facilitate penetration. It is applied externally for lubrication. Do not use for more than 5 days unless directed to do so.
Use in children and adolescents
Experience in children under 15 years is limited, therefore the use of KetoFLEX 2.5% gel is not recommended.
If you use more KetoFLEX 2.5% gel than you should
There is no danger of overdose when applied topically. Some systemic side effects may occur with frequent smearing of large surfaces. In case of accidental ingestion of large quantities, rinsing of the oral cavity and stomach is necessary, if necessary symptomatic treatment.
If you forget to use KetoFLEX 2.5% gel
Do not take a double dose to make up for a forgotten dose. Continue to apply the gel as prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, KetoFLEX 2.5% gel can cause side effects, although not everybody gets them.
In rare cases, local reactions at the application site may occur;
Allergic skin reactions.
Severe skin reaction during exposure to sunlight.
Rare cases of more severe skin reactions such as bullous or fliktenoid eczema have been reported, which may spread and become generalized.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bulgarian Medicines Agency, 8 Damyan Gruev Str .; 1303 Sofia; tel .: + 359 2 8903417; website: www.bda.bg. By reporting side effects, you can help to obtain more information about the safety of this medicine.
5. How to store KetoFLEX 2.5% gel
At temperatures below 25 ° C, away from fire and direct sunlight.
Keep out of reach of children!
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not throw away any medicines 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 package and additional information
What KetoFLEX 2.5% gel contains
The active substance is ketoprofen. 1 g of gel contains 25 mg of ketoprofen.
The other ingredients are: carbomer, ethanol 96%, trolamine, methyl parahydroxybenzoate (E218), purified water.
What KetoFLEX 2.5% gel looks like and contents of the pack
Colorless, homogeneous, transparent gel, in an aluminum tube of 50 g, with internal lacquer coating, placed in an individual cardboard box.
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