IBUFLEX gel 5% 50g
IBUFLEX 5% gel
ibuprofen
IBUFLEX 5% gel
ibuprofen
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better after 3-5 days or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What IBUFLEX is and what it is used for
2. What you need to know before you use IBUFLEX
3. How to use IBUFLEX
4. Possible side effects
5. How to store IBUFLEX
6. Contents of the pack and other information
1. What IBUFLEX is and what it is used for
IBUFLEX gel contains ibuprofen, which suppresses pain, reduces swelling and limits inflammation. It belongs to the group of non-steroidal anti-inflammatory drugs.
It is intended for application to the skin, and the other ingredients contained in the gel ensure and support the penetration of ibuprofen into deep tissues in concentrations necessary to control inflammation and relieve pain. Application to the skin reduces the risk of developing adverse reactions that are observed when taking drugs from this group by mouth.
IBUFLEX gel is used in adults and adolescents over 14 years of age to manage mild or moderate muscle and bone and joint pain associated with injuries (sprains, dislocations, growths, various sports injuries), inflammation and pain in the joints, tendons and muscles, stiffness and pain in the neck, back, waist, etc.
If you do not feel better after 3-5 days or your condition worsens, you should consult your doctor.
2. What you need to know before you use IBUFLEX
Do not use IBUFLEX if:
· you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
· you suffer from asthma, allergic rhinitis associated with taking ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
· you have had skin rashes, redness, itching or other symptoms related to taking ibuprofen in the past;
· you have skin diseases such as acne or eczema, open skin wounds, skin infections;
· you are in the last three months of pregnancy.
This medicine should not be used in children under 14 years of age.
The gel should not be applied to the area around the eyes, genitals, anus, or under a tight bandage.
Warnings and precautions
Talk to your doctor or pharmacist before using IBUFLEX.
During treatment with this medicine, you need to know the following:
· prolonged use of medications intended for application to the skin may lead to sensitization (increased sensitivity) and local irritation;
· treatment should be discontinued immediately if any skin reaction or rash, shortness of breath or other signs of allergy develop after administration;
· in people with asthma, allergic rhinitis, chronic sinusitis and/or nasal polyps there is a higher risk of allergy to aspirin and/or nonsteroidal anti-inflammatory drugs, including ibuprofen;
· exposure to the sun and ultraviolet rays (e.g. solarium) on skin areas in contact with the product may cause photosensitivity;
· the gel should not be applied to the genital and anal areas, as well as other mucous membranes. It should not come into contact with the eyes;
· this medication should not be applied under compressive bandages;
· application of large amounts of gel may lead to significant penetration of ibuprofen through the skin, which may cause some adverse reactions, such as asthma attacks or allergic reactions;
· the drug should be used with caution in people with kidney disease, those with stomach ulcers or gastritis.
The safety and efficacy of ibuprofen-containing gel in children and adolescents under 14 years of age have not been established, therefore the use of the product in this age group is not recommended.
You should seek medical attention if symptoms worsen or persist despite the use of the product.
Other medicines and IBUFLEX
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The risk of allergic reactions or other adverse reactions is higher if you are currently taking other fever-reducing, pain-relieving and anti-inflammatory medications, therefore simultaneous use should be avoided.
Interactions with other drugs are unlikely, since the concentrations of ibuprofen in the blood after topical application are low. However, it is necessary to inform your doctor or pharmacist if you are taking blood thinners (aspirin, warfarin, ticlopidine, etc.), blood pressure lowering drugs, other non-steroidal anti-inflammatory drugs, corticosteroids.
IBUFLEX with food, drink and alcohol
There are no restrictions.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The use of this medicine during the first and second trimester of pregnancy should be avoided. The available data on the use of ibuprofen during the first months of pregnancy are limited. In certain cases, when there are no other treatment options, short-term use of the product is possible only after consultation with a doctor or pharmacist and after careful consideration of the benefits and risks for the mother and the fetus.
You should not use IBUFLEX during the last three months of pregnancy due to an increased risk of complications for the mother and child (see What you need to know before using IBUFLEX).
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk. Since no negative effects on the child are known to date, it is not necessary to interrupt breastfeeding during short-term therapy.
However, the daily dose of 5 g gel should not be exceeded and discontinuation of breastfeeding should be considered if long-term therapy is necessary.
If you are breastfeeding you should not apply this medicine to your breasts to avoid your baby swallowing the medicine.
Driving and using machines
IBUFLEX does not affect the ability to drive or use machines.
IBUFLEX contains benzyl alcohol.
Benzyl alcohol may cause mild local irritation or allergic reactions.
3. How to use IBUFLEX
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended doses are as follows:
Adults and children over 14 years old
Apply 4-10 cm of gel (corresponding to 2-5 g of gel) to the affected area 3 or 4 times a day, depending on the surface area of the affected area. It is recommended to apply with a light massage to facilitate penetration. The maximum daily dose is 20 g of gel.
Children under 14 years old
Experience with the use of ibuprofen for topical application in children under 14 years of age is limited, therefore its use in this age group is not recommended.
Elderly people
There are no specific dosage recommendations.
Method and duration of administration
This medicine is intended for application to the skin. Application with gentle massaging/rubbing facilitates penetration.
It can be enhanced by iontophoresis (a type of electrical stimulation treatment used to deliver drugs through the skin to deeper tissues).
The duration of treatment depends on the type and severity of the disease, but short-term use (7 - 14 days) is recommended. Upon explicit prescription by a doctor, treatment may be extended.
If you use more IBUFLEX than you should
The risk of overdose is unlikely because the medicine is applied to the skin.
In case of exceeding the recommended dose, the gel should be removed and the treated area washed with water. In case of application of too large a quantity or accidental ingestion, it is necessary to contact a doctor.
If you forget to take the required dose of IBUFLEX
Do not take a double dose to make up for a forgotten dose. Take the dose as soon as you remember. If it is time for your next dose, continue as usual.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects while taking IBUFLEX, stop treatment immediately and tell your doctor or visit the nearest hospital:
· swelling of the face, tongue or throat, which may also lead to difficulty breathing, itching, a feeling of warmth on and under the tongue, palms and soles, skin rash, shortness of breath and wheezing in the chest, rapid pulse, sudden and rapid drop in blood pressure;
· appearance of skin rashes, redness, severe itching and irritation, peeling, spread of the rash and skin changes throughout the body.
The frequency listed below is the frequency with which the side effects have been reported.
Common (occurs in less than 1 in 10 patients)
· redness of the skin;
· skin rash with pus-filled pimples;
itching;
· burning sensation on the skin;
· urticaria (hives).
Uncommon (occurs in less than 1 in 100 patients)
· contact dermatitis (skin inflammatory reaction).
Very rare (occurs in less than 1 patient in every 10,000 patients)
· bronchospasm (difficulty breathing or wheezing).
Not known (frequency cannot be estimated from the available data)
· photosensitivity (increased sensitivity to ultraviolet rays).
In elderly patients, the risk of developing side effects is higher, as they are more sensitive to the effects of nonsteroidal anti-inflammatory drugs.
Reporting side effects
If you get any side effects, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via:
Executive Agency for Medicines
8 Damyan Gruev Street
1303 Sofia
tel.: +35 928903417
website: www.bda.bg
By reporting side effects, you can contribute to obtaining more information about the safety of this medicine.
5. How to store iBUFLEX
Keep out of the reach of children.
At a temperature below 25 °C.
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 any changes in the appearance of the gel.
Period of use after first opening the tube – 1 month.
Do not throw away medicines via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What IBUFLEX contains
- The active substance in one gram of gel is ibuprofen 50 mg.
- The other ingredients (excipients) are: isopropyl alcohol, benzyl alcohol, hydroxyethylcellulose, sodium hydroxide, lavender oil, purified water.
What IBUFLEX looks like and contents of the pack
Homogeneous, transparent to almost transparent colorless gel with a specific lavender odor.
Aluminum membrane tubes with sealing ring, internally varnished and externally varnished and lithographed, 50 g each. The tubes are closed with a polyethylene cap.
or
Pressurized packaging of 50 g - aerosol BOV actuator with cap and BOV bag.
Each tube/packaging is placed in cliched, foldable boxes.
Marketing Authorisation Holder
DANSON-BG Ltd.
26 Otets Paisii Street
2400 Radomir
Bulgaria
Manufacturer
VETPROM AD
26 Otets Paisii Street
2400 Radomir
Bulgaria
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
DANSON-BG Ltd.
26 Otets Paisii Street
2400 Radomir
Bulgaria
Date the leaflet was last revised
05/2023
