Ibuprofen Alkaloid-Int

Patient Information Leaflet

Ibuprofene Alkaloid-INT 50 mg/g gel

ibuprofen
For use in adults and adolescents aged 14 years and older.
Please read this leaflet carefully before using this medicine as it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you notice worsening of symptoms after 3 days.

Contents of this leaflet

1. What Ibuprofene Alkaloid-INT is and what it is used for
2. What you need to know before using Ibuprofene Alkaloid-INT
3. How to use Ibuprofene Alkaloid-INT
4. Possible side effects
5. How to store Ibuprofene Alkaloid-INT
6. Contents of the pack and other information

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

Ibuprofen Alkaloid-INT contains the active substance ibuprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), and is indicated to relieve pain and reduce inflammation.
This medicinal product is used in adults and adolescents from 14 years of age for the external symptomatic supportive treatment of:

• swelling and inflammation of soft tissues around the joints (such as bursae, tendons, tendon sheaths, ligaments and joint capsule),
• acute strains, sprains or bruises affecting the extremities following blunt trauma, such as sports injuries.

Consult a doctor if you do not notice improvement or if your symptoms worsen after 3 days.

2. What you need to know before using Ibuprofen Alkaloid-INT

Do not use Ibuprofen Alkaloid-INT

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you have ever developed breathing problems (asthma, bronchospasm), urticaria, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drug (NSAID);
• on open wounds, inflamed or infected skin areas, as well as on eczema or mucous membranes;
• if you are in the last three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Ibuprofen Alkaloid-INT

• If you currently suffer or have previously suffered from bronchial asthma or allergies, the use of ibuprofen may cause bronchospasm.
• Patients who suffer from asthma, allergic rhinitis, swelling of nasal mucous membranes (nasal polyps), chronic obstructive bronchopulmonary disease, or chronic respiratory infections (particularly associated with symptoms resembling allergic rhinitis) are at higher risk of asthma attacks (known as analgesic intolerance/analgesic-induced asthma), local skin and mucous membrane swelling (Quincke's edema), or urticaria compared to other patients when using Ibuprofen Alkaloid-INT. In such patients, Ibuprofen Alkaloid-INT should only be used with special precautions and under direct medical supervision. The same applies to patients who are allergic to other substances, e.g. those experiencing skin reactions, itching, or urticaria.
• If you have kidney, heart, or liver problems, if you currently have or have previously had a peptic ulcer, intestinal inflammation, or a tendency to bleeding.
• Ibuprofen Alkaloid-INT must not be used for prolonged periods or over large areas.
• Side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
• Serious skin reactions have been reported during treatment with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Discontinue use of Ibuprofen Alkaloid-INT and consult your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.
• If you develop a skin rash during treatment with Ibuprofen Alkaloid-INT, discontinue treatment immediately.
• To reduce the risk of photosensitization, avoid exposing the treated area to strong sources of natural and/or artificial light (e.g. tanning lamps) during treatment and for one day after stopping treatment.
• Ensure that children do not touch the skin areas where the product has been applied.

Elderly
Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as the likelihood of adverse effects increases with age.
Children and adolescents
Ibuprofen Alkaloid-INT must not be used in children and adolescents under 14 years of age due to insufficient data on efficacy and safety in this age group.
Other medicines and Ibuprofen Alkaloid-INT:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Especially if you are using any of the following:

• medicines that lower blood pressure;
• blood-thinning medicines such as warfarin;
• acetylsalicylic acid or other NSAIDs – used for inflammation and pain.

Do not use Ibuprofen Alkaloid-INT together with other topical medicines in the same area.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before using this medicine.
Pregnancy
Inform your doctor if you become pregnant while using Ibuprofen Alkaloid-INT.
Do not use this medicine during the last three months of pregnancy, as it may cause harm to the unborn baby's heart and kidneys. If used during late pregnancy, this medicine may increase the risk of bleeding in both mother and baby and delay the onset of labor. Therefore, due to the high risk of complications for both mother and baby, this medicine must not be used during the last three months of pregnancy.
Do not use ibuprofen during the first six months of pregnancy unless absolutely necessary and advised by your doctor. In such cases, treatment should be at the lowest possible dose and for the shortest possible duration.
Oral forms (e.g. tablets) of ibuprofen may cause adverse effects in the unborn child. It is not known whether the same risk applies when ibuprofen is used on the skin.
Breastfeeding
Only small amounts of the active substance ibuprofen and its metabolites pass into breast milk.
Since no harmful effects on newborns are currently known, it is generally not necessary to stop breastfeeding during short-term treatment with Ibuprofen Alkaloid-INT at the recommended dose.
However, as a precautionary measure, if you are breastfeeding, do not apply this medicine directly to the breast.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.
Driving and using machines
Ibuprofen Alkaloid-INT does not impair the ability to drive or operate machinery when used occasionally or for short periods.
Ibuprofen Alkaloid-INT contains fragrances with linalool, d-limonene, citral, and citronellol which may cause allergic reactions.

3. How to use Ibuprofene Alkaloid-INT

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:
Adults and adolescents from 14 years of age
Apply Ibuprofene Alkaloid-INT 3–4 times a day. Depending on the size of the painful area to be treated, use 4 to 10 cm of gel, equivalent to 2–5 g of gel (100 to 250 mg of ibuprofen). The maximum daily dose is 20 g of gel, equivalent to 1,000 mg of ibuprofen.

The gel should be used at the lowest effective dose and for the shortest duration necessary to control symptoms.

Method of administration
For topical use only (on the skin).
Apply Ibuprofene Alkaloid-INT to the skin and rub it in gently with a light massage.
After applying the gel, clean your hands with a paper tissue and then wash them, unless your hands are the area being treated. The paper tissue must be disposed of in non-recyclable waste. Wait until the gel has completely dried on the skin before taking a shower or bath.

Do not use with occlusive dressings (e.g., waterproof or airtight bandages or plasters).
Skin penetration of the active substance may be enhanced by iontophoresis (a special form of electrotherapy performed by a healthcare professional). In such cases, Ibuprofene Alkaloid-INT should be applied under the cathode (negative electrode). The current should be between 0.1 and 0.5 mA per 5 cm² of electrode surface area and applied for approximately 10 minutes.

Duration of treatment
For short-term use only.
The duration of use depends on the symptoms and underlying condition. Treatment should not exceed 1–2 weeks. The therapeutic benefit of use beyond this period has not been demonstrated.
If symptoms worsen or do not improve within 3 days, consult a doctor.
Consult your doctor or pharmacist if you feel that the effect of Ibuprofene Alkaloid-INT is too strong or too weak.

If you use more Ibuprofene Alkaloid-INT than you should
Overdose is unlikely when the gel is applied to the skin as directed. If the recommended dose is exceeded, the gel should be removed from the skin (e.g., with a paper tissue) and washed off with water. If the amount applied is significantly higher than recommended, or if this medicine is accidentally ingested, inform your doctor.
There is no specific antidote (treatment) available.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking ibuprofen and contact your doctor immediately if you notice any of the following symptoms:
 red, flat, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) [very rare: may affect up to 1 in 10,000 people].
 widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome) [not known: frequency cannot be determined from available data].
 widespread rash with redness and peeling, accompanied by swellings under the skin and blisters, together with fever. Symptoms generally occur at the beginning of treatment (acute generalized exanthematous pustulosis) [not known: frequency cannot be determined from available data].

Inform your doctor as soon as possible if you notice any of the following side effects:

Common: may affect up to 1 in 10 people

• Local skin reactions such as redness (erythema), itching, burning sensation, rash – including pustule formation or urticaria.

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity reactions or local allergic reactions.

Very rare: may affect up to 1 in 10,000 people

• Angioedema (sudden swelling of the face, tongue, hands, feet, or other body parts);
• Breathing difficulties due to narrowing of the airways (bronchospasm);
• Gastrointestinal disturbances.

Not known: frequency cannot be determined from available data

• Skin becomes sensitive to light.

If Ibuprofene Alkaloid-INT is applied over a large area of skin and for a prolonged period, the occurrence of side effects affecting a specific organ system or even the whole organism cannot be excluded, as may occur following systemic use of medicines containing ibuprofen.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofene Alkaloid-INT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp. The
expiry date refers to the last day of that month.
Do not store above 25  C.
Use within 3 months after first opening.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

Description of the appearance of Ibuprofene Alkaloid-INT and contents of the pack
Tubes with screw cap containing 50 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
Ljubljana-Črnuče, 1231, Slovenia
email: [email protected]

This medicinal product is authorized in the European Economic Area countries under the following names:
Bulgaria BlokMAX 50 mg/g gel
Croatia BlokMAX 50 mg/g gel
Germany Ibuprofen ALKALOID-INT 50 mg/g Gel
Italy Ibuprofene Alkaloid-INT 50 mg/g gel
Poland Ibuprofen Alkaloid-INT
Portugal Ibuprofen Alkaloid-INT 50 mg/g gel
Czech Republic Ibuprofen Alkaloid-INT
Romania Ibuprofen Alkaloid-INT 50 mg/g gel
Slovakia Ibuprofén Alkaloid-INT 50 mg/g gél
Slovenia Ibuprofen Alkaloid-INT 50 mg/g gel
Hungary Ibuprofen Alkaloid-INT 50 mg/g gél