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Ketoflex gel 5% 50 g.

Product Code: Ketoflex gel 5% 50 g.
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What KetoFLEX is and what it is used for
KetoFLEX wire contains ketoprofen - a non-steroidal anti-inflammatory drug that has a pronounced anti-inflammatory and analgesic effect.

This drug is intended for application to the skin, as the composition of the gel provides and promotes the penetration of ketoprofen through the skin to deep tissues in concentrations sufficient to control inflammation and pain. Topical application to the skin reduces the risk of side effects that occur when taking this group of drugs by mouth.

KetoFLEX GSL is used to control moderate or severe muscle and bone and joint pain associated with injuries (sprains, sprains, muscle and tendon sprains), low back pain, neck stiffness and more.

2. What you need to know before you use KetoFLEX
Do not use KetoFLEX if:
you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
you suffer from asthma, allergic rhinitis associated with ketoprofen, fenofibrate, tiaprofen and acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
you have had skin rashes and redness, itching or other manifestations related to ketoprofen, fenofibrate, tiaprofenic acid or the use of octacrylene-containing cosmetics or hygiene products (shampoos, aftershaves, bath gels and showers, skin creams) , lipsticks, make-up cleaning products, etc.);
you have skin conditions such as acne or eczema, open skin wounds, skin infections;
there is a risk or you are about to be exposed to sunlight, incl. indirect or solarium light;
you are pregnant in the last three months of pregnancy.
This medicine should not be used in children under 15 years of age.

This medicine should not be used around the eyes, genitals, anus, or under an occlusive dressing.

Warnings and precautions
Talk to your doctor before using KetoFLEX.

During treatment with this drug you need to know the following:

prolonged use of drugs on the skin can lead to sensitization and local irritation;
treatment should be discontinued immediately if any skin reaction develops after administration;
People with asthma, chronic rhinitis, chronic sinusitis and / or nasal polyps have a higher risk of allergy to aspirin and / or non-steroidal anti-inflammatory drugs, incl. ketoprofen;
Exposure to the sun (even indirectly) and ultraviolet rays (such as a tanning bed) on skin areas that come in contact with the product can cause potentially serious skin reactions (photosensitivity), therefore, to avoid such:
treated areas should be protected by covering with clothing during treatment and 2 weeks after its termination;
hands should be washed thoroughly after each administration of the drug.
the drug should not be applied to the genital and anal area, as well as on mucous membranes. It must not come into contact with the eyes;
should not be used under occlusive dressings;
application of large amounts of gel can lead to significant penetration of ketoprofen through the skin, which can cause some side effects, such as asthma attacks or allergic reactions;
the drug should be used with caution in persons with heart, liver and kidney disease.
Other medicines and KetoFLEX
You should tell your doctor if you are taking, have recently taken or might take any other medicines.

The risk of allergic reactions is higher when taken with other antipyretics, painkillers and anti-inflammatory drugs, so it should be avoided.

Interactions with other drugs are unlikely, as concentrations of ketoprofen in the blood after topical administration are low. However, careful monitoring of patients taking coumarins (blood thinners) is needed.

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 KetoFLEX.

The available data on the use of ketoprofen in the first months of pregnancy are limited, but do not show harmful effects on the embryo and fetus. In certain cases, when there are no other treatment options, only after consultation with a doctor or pharmacist and after careful consideration of the benefits and risks, the use of the product is possible. However, the use of this drug in the first and second trimesters of pregnancy should generally be avoided.

You should not use KetoFLEX during the last three months of pregnancy due to an increased risk of complications for mother and child (see section "What you need to know before you use KetoFLEX").

It is not known whether ketoprofen is excreted in human milk, which is why the use of this doctor
Driving and using machines
KetoFLEX does not affect the ability to drive and use machines.

KetoFLEX contains ethanol and methyl parahydroxybenzoate
The gel should not be in contact with open wounds, mucous membranes and eyes due to the alcohol content in it.

Methyl parahydroxybenzoate may cause allergic reactions.

3. How to use KetoFLEX
Always use KetoFLEX exactly as your doctor has told you. If you are not sure about anything, ask your doctor.

The recommended doses are as follows:
Adults and children over 15 years
Depending on the surface of the lesion, 3-5 cm of gel is applied to the skin of the affected area 1 or 2 times a day. It is recommended to apply with light massage / rubbing in order to facilitate penetration.

Children under 15 years
Experience with the use of ketoprofen for topical use in children under 15 years is limited, therefore the use of the product in this age group is not recommended.

Elderly people
There are no specific dosing recommendations.

Method and duration of application
This medicine is for use on the skin. Applying to the skin with a light massage / rubbing facilitates penetration.

The duration of treatment depends on the type and severity of the disease and is determined by your doctor.

If you use more KetoFLEX than you should
The risk of overdose is minimal due to the low plasma concentrations that occur after topical application of ketoprofen to the skin. Frequent use of the product on large skin areas may result in some systemic side effects.

If you forget to take the required dose of KetoFLEX
Do not take a double dose to make up for a forgotten dose. Apply the dose as soon as you remember. If it is time for your next dose, go back to your regular dosing schedule.
If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following side effects while taking KetoFLEX, stop treatment immediately and tell your doctor or visit the nearest hospital:
swelling of the face, tongue or throat, which can also lead to difficulty breathing, rapid heartbeat, sudden and rapid drop in blood pressure;
shortness of breath and wheezing, drop in blood pressure;
appearance of skin rashes, redness, severe itching and irritation, scaling, spread of the rash and skin changes throughout the body.
The frequency listed below is the frequency with which adverse reactions have been reported.

Uncommon (affects less than 100 in every 100 patients)
redness of the skin, itching, skin rash, burning;
photosensitivity, urticaria (hives).
Rare (affects less than 1 user in 1,000)
skin rashes with blisters and blisters.
Very rare (affects less than 1 patient in 10,000)
contact dermatitis;
exacerbation of pre-existing renal failure.
Not known (cannot be estimated from the available data)
anaphylactic shock (severe allergic reaction, manifested by shortness of breath and wheezing, drop in blood pressure and dizziness);
angioedema (swelling of the face, tongue or throat, which can lead to difficulty breathing, rapid heartbeat, sudden and rapid drop in blood pressure).
Elderly patients are at higher risk of side effects because they are more sensitive to the action of non-steroidal anti-inflammatory drugs.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly by:

Executive Agency for Medicines
str., Damyan Gruev "№ 8,
1303 Sofia,

By reporting side effects, you can help to obtain more information about the safety of this medicine.

5. How to store KetoFLEX
Keep out of reach of children.
At temperatures below 25 ° C.
Shelf life after first opening the aluminum tube: 28 days.
Do not use this medicine after the expiry date which is stated on the carton [Exp. .........]. The expiry date refers to the last day of that month.

Do not use this medicine if you notice changes in the appearance of the gel.

Do not dispose of medicines in the sewage system in the household waste container. 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 contains
The active substance in 1 gram of gel is ketoprofen 50 mg.
The other ingredients (excipients) are: carbomer, ethanol (96 per cent), trolamine, methyl parahydroxybenzoate, purified water.
What KetoFLEX looks like and contents of the pack
Colorless, homogeneous, transparent to almost transparent gel, with a specific odor of ethanol.

Available in an aluminum tube or in a pressure pack of 50 g.
One tube or pressure pack in a cardboard box, together with patient information.
Not all pack sizes may be marketed.


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