Ibuprofen Alkaloid-int

Leaflet accompanying the packaging: patient information

Ibuprofen Alkaloid-INT, 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Ibuprofen Alkaloid-INT and what is it used for
• 2. Important information before using Ibuprofen Alkaloid-INT
• 3. How to use Ibuprofen Alkaloid-INT
• 4. Possible side effects
• 5. How to store Ibuprofen Alkaloid-INT
• 6. Package contents and other information

1. What is Ibuprofen Alkaloid-INT and what is it used for

Ibuprofen Alkaloid-INT contains the active substance ibuprofen, which belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs) and is intended to relieve pain and reduce inflammation.
This medicine is used externally in adults and adolescents over 14 years of age as a supportive, symptomatic treatment of pain in the following cases:

• swelling or inflammation of soft tissues around the joints (e.g., bursae, tendons, tendon sheaths, ligaments, and joint capsules),
• acute sprains, strains, or bruises on the limbs resulting from blunt trauma, such as sports injuries.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Ibuprofen Alkaloid-INT

When not to use Ibuprofen Alkaloid-INT:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had breathing problems (asthma, bronchospasm), hives, hay fever, or face or tongue swelling after taking or using acetylsalicylic acid or another nonsteroidal anti-inflammatory drug (NSAID);
• on open wounds, inflamed skin, or infected skin, as well as on eczema or mucous membranes;
• if the patient is in the last three months of pregnancy.

Warnings and precautions

Before starting to use Ibuprofen Alkaloid-INT, the patient should discuss it with their doctor or pharmacist.

• If the patient has or has had asthma or another allergic disease, as bronchospasm may occur.
• In patients with asthma, hay fever, nasal polyps, or chronic obstructive pulmonary disease (COPD) or chronic respiratory infections (especially when symptoms similar to those of hay fever occur), the risk of asthma attacks (so-called intolerance to painkillers or asthma caused by painkillers), local skin and mucous membrane swelling (so-called Quincke's edema), or hives after using Ibuprofen Alkaloid-INT is higher than in other patients. In these patients, Ibuprofen Alkaloid-INT can only be used with certain precautions and under the direct supervision of a doctor. The same recommendations apply to patients allergic to other substances, e.g., those who experience skin reactions, itching, or hives.
• If the patient has kidney, heart, or liver disorders or if they currently have or have had stomach or duodenal ulcers, enteritis, or a tendency to bleeding.
• Ibuprofen Alkaloid-INT should not be used for a long time or on large areas of skin.
• Side effects can be reduced by using the smallest effective dose for the shortest possible time necessary to relieve symptoms.
• Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions, they should stop using Ibuprofen Alkaloid-INT and seek medical attention immediately.
• If a skin rash occurs during treatment with Ibuprofen Alkaloid-INT, treatment should be discontinued immediately.
• The treated skin area should be avoided from strong natural or artificial light exposure during treatment and for one day after its discontinuation to reduce the risk of photosensitivity reactions.
• Children should be kept from touching the skin area where the medicine has been applied.

Elderly patients

In elderly patients, nonsteroidal anti-inflammatory drugs should be used with caution.
With age, the risk of side effects increases.

Children and adolescents

Ibuprofen Alkaloid-INT should not be used in children and adolescents under 14 years of age,
due to the lack of sufficient data on efficacy and safety in this age group.

Ibuprofen Alkaloid-INT and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This is especially important if the patient is taking any of the following medicines:

• blood pressure-lowering medicines
• blood-thinning medicines, e.g., warfarin
• acetylsalicylic acid or other NSAIDs - used to treat inflammation and pain

Ibuprofen Alkaloid-INT should not be used simultaneously on the same skin area with other topical medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
Pregnancy
The patient should inform their doctor if they become pregnant during treatment with Ibuprofen Alkaloid-INT.
This medicine should not be used during the last three months of pregnancy, as it may cause heart and kidney damage to the unborn child. Use of this medicine in late pregnancy may increase the risk of bleeding in the mother and child and prolong labor. Therefore, this medicine should not be used during the last three months of pregnancy due to the high risk of complications in the mother and child.
This medicine should not be used during the first six months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is necessary during this period, the smallest dose should be used for the shortest possible time.
Oral
forms
of
ibuprofen
may
cause
side
effects
in
the
unborn
child.
It is not known if the risk is the same when ibuprofen is used on the skin.
Breastfeeding
Only small amounts of the active substance ibuprofen and its metabolites pass into human milk.
No harmful effects on breastfed children have been reported to date, so in the case of short-term use of Ibuprofen Alkaloid-INT in the recommended doses, breastfeeding does not usually need to be discontinued.
However, as a precautionary measure, Ibuprofen Alkaloid-INT should not be applied directly to the breast area in breastfeeding women.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen Alkaloid-INT has no influence on the ability to drive vehicles and operate machines in the case of single administration or short-term use.

Ibuprofen Alkaloid-INT contains the fragrance substance linalool, d-limonene,

citral, citronellol,which may cause allergic reactions.

3. How to use Ibuprofen Alkaloid-INT

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 14 years of age
Apply Ibuprofen Alkaloid-INT 3 to 4 times a day. Depending on the size of the painful area to be treated, apply a strip of gel 4 to 10 cm long, which corresponds to 2 g to 5 g of gel (100 to 250 mg of ibuprofen). The maximum daily dose is 20 g of gel, which corresponds to 1000 mg of ibuprofen.
The gel should be used in the smallest effective dose for the shortest possible time necessary to relieve symptoms.
Method of administration
For external use only.
Ibuprofen Alkaloid-INT should be applied to the skin and gently rubbed in.
After applying the gel to the skin, hands should be wiped with a paper towel and then washed, unless the hands are the area being treated. The paper towel should be disposed of in a waste container. Before taking a shower or bath, wait until the gel has dried on the skin.
The medicine should not be used under an occlusive dressing (e.g., a waterproof or tight bandage or plaster).
The use of iontophoresis (a special form of electrotherapy performed by medical personnel) may increase the absorption of the active substance through the skin. In this case, Ibuprofen Alkaloid-INT should be applied under the cathode (negative electrode). The current intensity should be between 0.1 and 0.5 mA per 5 cm of electrode surface. The current should be passed for a maximum of about 10 minutes.
Duration of treatment
The medicine is intended for short-term use.
The treatment duration depends on the symptoms and the underlying disease for which the medicine is used. The treatment duration should not exceed 1 to 2 weeks. No therapeutic benefits have been proven for using the medicine for a longer period.
If after 3 days the symptoms worsen or there is no improvement, the patient should contact their doctor.
If the patient feels that the effect of Ibuprofen Alkaloid-INT is too strong or too weak, they should consult their doctor or pharmacist.

Using a higher dose of Ibuprofen Alkaloid-INT than recommended

If the gel is applied to the skin as recommended, overdose is unlikely.
In case of applying a dose larger than recommended to the skin, the gel should be removed (e.g., with a paper towel) and the skin washed with water. If the amount applied is significantly larger than recommended or in case of accidental ingestion of ibuprofen in the form of a gel, the patient should inform their doctor.
There is no specific antidote.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should stop using Ibuprofen Alkaloid-INT and seek medical attention immediately if they experience any of the following symptoms:

• red, non-raised, 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] [very rare: may occur in up to 1 in 10,000 people].
• widespread rash, high body temperature, swollen lymph nodes [DRESS syndrome] [frequency not known: cannot be estimated from the available data].
• red, peeling, widespread rash with nodules under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known: cannot be estimated from the available data].

If the patient experiences any of the following side effects, they should inform their doctor immediately:

Common: may occur in up to 1 in 10 people

• local skin reactions, such as redness (erythema), itching, burning, rash, including the formation of pustules or hives.

Uncommon: may occur in up to 1 in 100 people

• allergic reactions or local allergic reactions.

Rare: may occur in up to 1 in 10,000 people

• angioedema (sudden swelling of the face, tongue, hands, feet, or other parts of the body);
• breathing difficulties caused by bronchospasm;
• gastrointestinal disorders

Frequency not known: cannot be estimated from the available data

• skin sensitivity to light.

In case of applying Ibuprofen Alkaloid-INT to large skin areas and using it for a long time, it cannot be excluded that side effects related to specific organs or even the whole body may occur, which may be associated with the use of ibuprofen-containing medicines administered systemically.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of 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 this medicine.

5. How to store Ibuprofen Alkaloid-INT

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after "EXP". The expiry date refers to the last day of the month.
Do not store above 25°C.
Shelf life after first opening the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Ibuprofen Alkaloid-INT contains

The active substance of the medicine is ibuprofen; 1 g of gel contains 50 mg of ibuprofen.
The other ingredients are: poloxamer type 407, isopropylidene glycerol, isopropyl alcohol, medium-chain triglycerides, lavender oil (contains linalool, d-limonene), orange oil (contains d-limonene, citral, citronellol), and purified water.

What Ibuprofen Alkaloid-INT looks like and contents of the pack

Tube with a screw cap, containing 50 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing authorization holder and importer

Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana-Črnuče
Slovenia
Tel.: + 386 1 300 42 90
Fax: + 386 1 300 42 91
email: [email protected]

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: