Ibuprom Effect zhel

Package Leaflet: Information for the Patient

IBUPROM EFFECT GEL

50 mg/g, gel
Ibuprofen

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.
This medicine should always be used exactly as described in this leaflet for the patient or as advised by
the doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

• 1. What is IBUPROM EFFECT and what is it used for
• 2. Important information before using IBUPROM EFFECT
• 3. How to use IBUPROM EFFECT
• 4. Possible side effects
• 5. How to store IBUPROM EFFECT
• 6. Contents of the pack and other information

1. What is IBUPROM EFFECT and what is it used for

Ibuprofen belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen has analgesic and anti-inflammatory effects. Its action is based on the inhibition of
prostaglandin synthesis in inflamed tissue.
Indications for use of IBUPROM EFFECT:

• local treatment of muscle pain,
• treatment of pain in degenerative joint diseases, rheumatic diseases of peripheral joints and spine,
• treatment of inflammatory changes in periarticular tissues (e.g. bursae, tendons, tendon sheaths, ligaments and joint capsules),
• treatment of painful shoulder stiffness, lower back pain, post-traumatic changes related to sports or accidents (e.g. bruises, sprains).

IBUPROM EFFECT is indicated for use in adults and adolescents over 14 years of age.

2. Important information before using IBUPROM EFFECT

When not to use IBUPROM EFFECT

• If the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient has hypersensitivity (allergy) to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has experienced: hives, allergic rhinitis or asthma after using acetylsalicylic acid or other NSAIDs.

If the patient is in the last 3 months of pregnancy.

Warnings and precautions

Before starting treatment with IBUPROM EFFECT, discuss it with your doctor or
pharmacist.
IBUPROM EFFECT should not be used on open wounds, mucous membranes, and in the vicinity of
the eyes.
IBUPROM EFFECT should be used with caution in patients with gastric and (or) duodenal ulcer disease, renal failure, bronchial asthma, and intolerance to acetylsalicylic acid, ibuprofen or other NSAIDs taken orally.
Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ibuprofen use.
If the patient experiences any symptoms associated with these severe skin reactions described in section 4, IBUPROM EFFECT should be discontinued and medical help sought immediately.
During treatment with IBUPROM EFFECT, avoid exposing the treated skin area to sunlight, as this may cause photosensitivity reactions.
If a rash occurs, discontinue use of the medicine.
If there is no need to apply the medicine to the hands for therapeutic purposes, wash your hands after each application.

Children and adolescents

IBUPROM EFFECT is not indicated for use in children under 14 years of age.

IBUPROM EFFECT and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
No interactions between topically applied ibuprofen and other medicines are known.
Concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of adverse reactions.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using IBUPROM EFFECT.
Pregnancy
Do not use IBUPROM EFFECT in the last 3 months of pregnancy.
Do not use IBUPROM EFFECT during the first 6 months of pregnancy, unless absolutely necessary and advised by your doctor.
If treatment is necessary during this period, use the lowest dose for the shortest possible time.
Oral forms (e.g. tablets) of ibuprofen may cause adverse reactions in the unborn child.
It is not known whether the same risk applies to ibuprofen when used on the skin.
Breastfeeding
Do not use IBUPROM EFFECT during breastfeeding.

Driving and using machines

No data are available on the effects of the medicine on the ability to drive and use machines.

IBUPROM EFFECT contains alcohol (ethanol)

The medicine contains 200 mg of alcohol (ethanol) per 1 g of gel, which is equivalent to 400 mg to 1000 mg per dose unit.
This may cause a burning sensation on damaged skin.

3. How to use IBUPROM EFFECT

This medicine should always be used exactly as described in this leaflet for the patient or as advised by
the doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
IBUPROM EFFECT is for topical use on the skin.
If the doctor has not recommended otherwise, usually apply a strip of gel 4 to 10 cm long (2 g to 5 g of gel, corresponding to 100 mg to 250 mg of ibuprofen) and rub in 3 to 4 times a day.
If necessary, the medicine can be used more frequently, but not more than every 4 hours.
Do not exceed the dose of 12 g of gel (600 mg of ibuprofen) per day.
The duration of treatment is determined by the doctor.
If after 10 days of treatment the symptoms have not improved or worsened, consult your doctor.
The medicine is not intended for use under occlusive dressings.
Absorption of the active substance through the skin is increased during iontophoresis treatments (a special form of electrotherapy).
IBUPROM EFFECT is applied under the cathode (negative pole).
Usually, a current intensity of 0.1 to 0.5 mA per 5 cm of electrode surface is used, and the treatment time is up to 15 minutes.
IBUPROM EFFECT is not indicated for use in children under 14 years of age.

Using a higher dose of IBUPROM EFFECT than recommended

Due to the low absorption through the skin (compared to oral administration), no cases of poisoning have been observed after topical use of IBUPROM EFFECT.
Oral ingestion of 8 g to 12 g of ibuprofen in adults can cause dizziness, loss of consciousness, and decreased blood pressure.
Ingestion of 3 g to 4 g of ibuprofen in children aged 1.5 to 2 years can cause apnea and cyanosis.
After controlled respiration and intensive care, normalization of respiration occurs within 12 hours.
In cases of poisoning caused by improper use of IBUPROM EFFECT, treatment depends on the symptoms.
No antidote is known for ibuprofen poisoning.
If the patient has ingested a potentially toxic amount of IBUPROM EFFECT within an hour, seek medical attention immediately.

Missing a dose of IBUPROM EFFECT

Do not use a double dose to make up for a missed dose.
In case of doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, IBUPROM EFFECT can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, do not take the medicine and contact your doctor immediately.

• non-specific allergic reactions and anaphylaxis, shock,
• asthma, worsening of asthma, bronchospasm or shortness of breath.
• red, flat, target-like or circular patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes.
  These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome)
• red, peeling rash with bumps under the skin and blisters, accompanied by fever.
  Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Side effects that occur very rarely (may affect up to 1 in 10,000 people):

• skin disorders (e.g. redness, tingling at the application site),
• rashes of various types, itching, hives, angioedema, purpura,
• renal failure in patients with kidney disease,
• abdominal pain, nausea.

Side effects with unknown frequency (frequency cannot be estimated from available data):

• skin becomes sensitive to light.

During long-term treatment, additional side effects may occur.
If any of the side effects worsen or any side effects not listed in this leaflet occur, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C

• 02 - 222 Warsaw Tel.: + 48 22 49 21 301 Fax: + 48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store IBUPROM EFFECT

Keep the medicine out of the sight and reach of children.
No special precautions for storage temperature are required.
Store in the original packaging to protect from light.
After first opening: Store below 25 ° C.
Store in the original packaging to protect from light.
Do not use IBUPROM EFFECT after the expiry date stated on the label.
The expiry date refers to the last day of the month.
After first opening, use the medicine within 3 months.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the pack and other information

What IBUPROM EFFECT contains

The active substance is ibuprofen.
The content of ibuprofen in 1 g of gel is 50 mg.
The other ingredients are: ethanol 96%, isopropyl alcohol, hydroxyethylcellulose, levomenthol, Reflex 12122 aroma (methyl salicylate), diethylene glycol monoethyl ether, macrogol caprylocapric glycerides (Macrogol 400), glycerol, sodium hydroxide (10% aqueous solution), purified water.

What IBUPROM EFFECT looks like and contents of the pack

Transparent, slightly yellowish gel with a characteristic odor.
Aluminum tube with an inner coating of epoxyphenolic resin, sealed with aluminum foil, closed with a polyethylene HDPE cap, containing 20 g, 60 g or 100 g of gel, placed in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław

Manufacturer

Farmasierra Manufacturing, S.L.
Ctra. Irún, Km. 26,200
San Sebastián de los Reyes, 28709 Madrid, Spain
To obtain more detailed information about this medicine, contact the representative of the marketing authorization holder:
USP Zdrowie Sp. z o.o.
ul. Poleczki 35, 02-822 Warsaw
tel. +48 (22) 543 60 00

Date of last revision of the leaflet: