Ibuprofen alkaloid-int

Patient Information Leaflet

Ibuprofen Alkaloid-INT, 50 mg/g, gel
Ibuprofenum
Please read this 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 the physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your physician or pharmacist. See section 4.
• If there is no improvement after 3 days, or if symptoms worsen, consult your physician.

Table of contents

1. What Ibuprofen Alkaloid-INT is and what it is 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. 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 intended to relieve pain and reduce inflammation.
This medicine is for topical use in adults and adolescents over 14 years of age, for symptomatic, supportive treatment of pain associated with:

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

If there is no improvement after 3 days, or if symptoms worsen, consult your physician.

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 experienced breathing problems (asthma, bronchospasm), urticaria, rhinitis, or swelling of the face or tongue after taking or using acetylsalicylic acid or any other non-steroidal anti-inflammatory drug (NSAID);
• on open wounds, inflamed or infected skin, rashes, or mucous membranes;
• if the patient is in the last three months of pregnancy.

Warnings and precautions
Before starting to use Ibuprofen Alkaloid-INT, discuss this with your doctor or pharmacist.

• If the patient has or has ever had asthma or any other allergic condition, bronchospasm may occur.
• In patients with asthma, hay fever, nasal mucosal swelling (so-called nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections (especially if symptoms resemble hay fever), the risk of asthma attacks (so-called analgesic intolerance or drug-induced asthma), local skin and mucous membrane swelling (so-called Quincke's edema), or urticaria after using Ibuprofen Alkaloid-INT is higher than in other patients. In such patients, Ibuprofen Alkaloid-INT should be used only with specific precautions and under direct medical supervision. The same recommendations apply to patients allergic to other substances, for example those who experience skin reactions, itching, or urticaria.
• If the patient has impaired kidney, heart, or liver function, or if the patient currently has or has previously had peptic ulcer disease of the stomach and/or duodenum, intestinal inflammation, or a tendency to bleeding.
• Do not use Ibuprofen Alkaloid-INT for prolonged periods or over large areas of skin.
• The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to relieve symptoms.
• Serious 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 develops any of the symptoms associated with these serious skin reactions described in section 4, Ibuprofen Alkaloid-INT must be discontinued immediately and medical help should be sought.
• If a skin rash occurs during treatment with Ibuprofen Alkaloid-INT, treatment must be discontinued immediately.
• Avoid exposing the treated skin area to strong natural and/or artificial light (e.g. solarium) during treatment and for one day after stopping treatment, to reduce the risk of photosensitivity reactions.
• Take care to prevent children from touching skin areas to which the medicine has been applied.

Elderly patients
Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients.
The risk of adverse effects increases with age.

Children and adolescents
Do not use Ibuprofen Alkaloid-INT in children and adolescents under 14 years of age due to insufficient data on efficacy and safety in this age group.

Ibuprofen Alkaloid-INT and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
This is particularly important if the patient is using any of the following medicines:

• medicines that lower blood pressure
• anticoagulants, e.g. warfarin
• acetylsalicylic acid or other NSAIDs – used to treat inflammation and pain

Do not apply Ibuprofen Alkaloid-INT simultaneously to the same skin area as other topical medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a baby, she should consult her 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 heart and kidney damage in the unborn child. Use during late pregnancy may increase the risk of bleeding in both mother and child and may delay or prolong labor. Therefore, this medicine must not be used during the last three months of pregnancy due to the high risk of complications for both mother and child.
Do not use Ibuprofen Alkaloid-INT during the first six months of pregnancy unless absolutely necessary and recommended by a 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 effects in the unborn child.
It is not known whether the risk is the same when ibuprofen is applied to the skin.

Breastfeeding
Only small amounts of the active substance ibuprofen and its metabolites pass into human milk.
No harmful effects have been observed in breastfed infants so far; therefore, interruption of breastfeeding is usually not necessary when Ibuprofen Alkaloid-INT is used short-term at recommended doses.
However, as a precaution, do not apply Ibuprofen Alkaloid-INT directly to the breast area of breastfeeding women.

Effect on fertility
Ibuprofen belongs to a group of medicines (NSAIDs) which may affect female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
Ibuprofen Alkaloid-INT has no effect on the ability to drive or operate machinery when used as a single dose or short-term treatment.

Ibuprofen Alkaloid-INT contains a fragrance containing linalool, d-limonene, citral, and 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. If in doubt, consult a doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 14 years of age
Apply Ibuprofen Alkaloid-INT 3 to 4 times daily. Depending on the size of the painful area to be treated, apply a gel strip 4 to 10 cm long, corresponding to 2 g to 5 g of gel (100 to 250 mg of ibuprofen). The maximum daily dose is 20 g of gel, equivalent to 1000 mg of ibuprofen.
The gel should be used at the lowest effective dose for the shortest duration necessary to relieve symptoms.

Method of administration
For external use only.
Apply Ibuprofen Alkaloid-INT to the skin and gently rub in.
After applying the gel to the skin, wipe hands with a paper towel and then wash them, unless the hands are the area being treated. Dispose of the used paper towel in a waste container. Wait until the gel has dried on the skin before taking a shower or bath.
Do not use under an occlusive dressing (e.g. waterproof or airtight bandage or plaster).
Iontophoresis (a special form of electrotherapy performed by trained medical personnel) may increase the absorption of the active substance through the skin. In such cases, Ibuprofen Alkaloid-INT should be applied under the cathode (negative electrode). The current intensity should be 0.1 to 0.5 mA per 5 cm of electrode surface area. The current should be applied for no more than approximately 10 minutes.

Duration of treatment
This medicine is intended for short-term use only.
The duration of treatment depends on the symptoms and underlying condition for which the medicine is prescribed. Treatment should not exceed 1 to 2 weeks. Therapeutic benefit has not been demonstrated with longer use.
If symptoms worsen or do not improve after 3 days, consult a doctor.
If you feel that the effect of Ibuprofen Alkaloid-INT is too strong or too weak, consult a doctor or pharmacist.

Overdose of Ibuprofen Alkaloid-INT
If the gel is applied to the skin as recommended, overdose is unlikely.
If more than the recommended amount is applied to the skin, remove the excess gel (e.g. with a paper towel) and wash the skin with water. If significantly more than the recommended amount has been applied or if the gel is accidentally swallowed, contact a doctor.
There is no specific antidote available.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
You must immediately stop using Ibuprofen Alkaloid-INT and seek medical help if any of the following symptoms occur:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, and ulceration of the mouth, throat, nose, genital organs, 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, enlarged lymph nodes [DRESS syndrome] [frequency not known: cannot be estimated from available data].
• Red, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis) [frequency not known: cannot be estimated from available data].

If any of the following adverse reactions occur, you must immediately inform your doctor:
Common: may affect up to 1 in 10 people

• Local skin reactions such as redness (erythema), itching, burning, rash, including formation of blisters 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 caused by airway constriction (bronchospasm);
• Gastrointestinal disturbances.

Frequency not known: cannot be estimated from available data

• Skin photosensitivity.

When applying Ibuprofen Alkaloid-INT to large areas of skin and using it for prolonged periods, adverse reactions affecting specific organs or even the entire organism cannot be ruled out, which may occur after systemic administration of medicines containing ibuprofen.
Reporting of adverse reactions
If any adverse symptoms occur in the patient, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibuprofen Alkaloid-INT

Keep the medicine 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 specified month.
Do not store above 25 °C.
Period of use after first opening of the tube: 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen Alkaloid-INT contains
The active substance is ibuprofen; 1 g of gel contains 50 mg of ibuprofen.
The other ingredients are: poloxamer 407, glycerol isopropyldiene ether, 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
A tube with a screw cap containing 50 g or 100 g of gel.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names: