IBUPROFENE 50 mg /G Gel

Зміст інструкції

1. Ibuprofene Alkaloid-INT 50 mg/g gel
   1. What is Ibuprofen Alkaloid-INT and what is it used for
   2. What you need to know before using Ibuprofen 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

Ibuprofene Alkaloid-INT 50 mg/g gel

ibuprofene

Indicated for adults and adolescents aged 14 years and over.

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 told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet

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

Ibuprofene Alkaloid-INT contains the active ingredient ibuprofen which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and is indicated to relieve pain and
reduce inflammation.
This medicine is used in adults and adolescents from 14 years of age for the symptomatic supportive external treatment in case of:

• swelling and inflammation of soft tissues near the joints (such as bursae, tendons, tendon sheaths, ligaments and joint capsule),
• acute sprains, strains or bruises in the area of the limbs following blunt traumatic injuries, such as sports injuries.

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

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

Do not use Ibuprofene 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), hives, 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, inflammation or skin infections, as well as on eczema or mucous membranes;
• if you are in the last three months of pregnancy.

Warnings and precautions
Consult your doctor or pharmacist before using Ibuprofene Alkaloid-INT

• If you suffer from 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 the nasal mucous membranes (so-called nasal polyps) or chronic obstructive bronchopneumopathy or chronic respiratory infections (in particular those connected to symptoms similar to allergic rhinitis) are at greater risk of asthma attacks (so-called analgesic intolerance/asthma from analgesics), local swelling of the skin and mucous membranes (so-called Quincke's edema) or hives compared to other patients when using Ibuprofeen Alkaloid-INT. In such patients, Ibuprofene Alkaloid-INT can only be used with particular precautions and direct medical supervision. The same applies to patients who are also allergic to other substances, e.g. with skin reactions, itching or hives.
• If you have problems with your kidneys, heart or liver, if you suffer from an active peptic ulcer, or have suffered from it in the past, from intestinal inflammation or a tendency to bleeding.
• Ibuprofene Alkaloid-INT must not be used for a prolonged period of time or on large areas.
• Adverse effects can be reduced by using the lowest effective dose for the shortest period necessary to control the symptoms.
• In association with treatment with ibuprofen, serious skin reactions have been reported, 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). Stop using Ibuprofene Alkaloid-INT and see your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• If you develop a rash during treatment with Ibuprofene Alkaloid-INT, immediately stop treatment.
• 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.
• Make sure that children do not touch the skin areas where the product is applied.

Elderly
Non-steroidal anti-inflammatory drugs must be used with caution in elderly patients because
the probability of developing adverse effects increases with advancing age.

Children and adolescents
Ibuprofene Alkaloid-INT must not be used in children and adolescents under 14 years of age
because there is not enough data on efficacy and safety in this age group.

Other medicines and Ibuprofene Alkaloid-INT:
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicine.
Especially if you are using any of the following:

• medicines that lower blood pressure
• medicines to thin the blood 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 are pregnant, are planning a pregnancy or are breastfeeding
ask your doctor for advice before using this medicine.
Pregnancy
Tell your doctor if you become pregnant while using Ibuprofene Alkaloid-INT.
Do not use this medicine during the last three months of pregnancy as it can cause damage to
the heart and kidneys of the unborn baby. If used in late pregnancy, this medicine can predispose
both the mother and the baby to bleeding and delay the onset of labour. Therefore, due to the high
risk of complications for the mother and the baby, this medicine should not be used in the
last three months of pregnancy.
You should not use ibuprofen in the first six months of pregnancy unless it is absolutely
necessary and recommended by your doctor. In such cases, treatment should be at the lowest
possible dose, for the shortest possible time.
Oral forms (e.g. tablets) of ibuprofen can cause adverse effects in the unborn baby.
It is not known whether the same risk applies when ibuprofen is used on the skin.
Breastfeeding
Only small amounts of the active ingredient ibuprofen and its metabolites pass into breast milk.
As no harmful effects on infants have been reported to date, it is generally not necessary to
interrupt breastfeeding during short-term treatment with Ibuprofene Alkaloid-INT at the
recommended dose.
However, as a precaution, you should not apply this medicine
directly to the breast during breastfeeding.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that can affect female fertility.
This effect is reversible by stopping the use of the medicine.

Driving and operating machinery
Ibuprofene Alkaloid-INT does not impair the ability to drive and operate machinery when
used singly or for a short period.

Ibuprofene Alkaloid-INT contains fragrances with linalool, d-limonene, citral and citronellol
which can cause allergic reactions.

3. How to use Ibuprofene Alkaloid-INT

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

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, 4 to 10 cm of gel should be used, equivalent to 2-5 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 and for the shortest duration necessary to control
the symptoms.
Method of administration
For external use (on the skin) only.
Apply Ibuprofene Alkaloid-INT to the skin and gently massage to allow it to penetrate the skin.
After applying the gel to the skin, your hands should be cleaned with a paper towel and then washed,
unless they are the area to be treated. The paper towel should be discarded in non-recyclable waste. You must wait for the gel to dry completely on the skin before showering
or bathing.
Do not use it with occlusive dressings (e.g. waterproof or airtight bandages or plasters).
The penetration of the active ingredient through the skin can be increased by iontophoresis (a
special form of electrotherapy performed by a healthcare professional). In this case Ibuprofene
Alkaloid-INT must be applied under the cathode (negative electrode). The amperage must be
between 0.1 and 0.5 mA per 5 cm of electrode surface and must be applied for approximately 10 minutes.
Duration of treatment
For short-term use.
The duration of use depends on the symptoms and the underlying condition. The duration of treatment should not
exceed 1-2 weeks. The therapeutic benefit of use beyond this period has not been proven.
If symptoms worsen or do not improve after 3 days, you should 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
towel) and washed off with water. If the amount applied is significantly greater than
should be, or if this medicine is accidentally ingested, you should inform your
doctor.
There is no specific antidote (cure).
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ibuprofene and see your doctor immediately if you notice any of the following
symptoms:
 flat, reddish-purple, target-shaped or circular patches on the trunk, often with
blisters in the centre, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These
severe skin reactions 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 temperature and swollen lymph nodes (DRESS syndrome) [not
known: frequency cannot be estimated based on the available data].
 a widespread rash with redness and flaking with swellings under the skin and
blisters accompanied by fever. The symptoms generally occur at the beginning of
treatment (acute generalized exanthematous pustulosis) [not known: frequency cannot
be estimated based on the available data].
Tell 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, rash - even with the
  formation of pustules or hives.

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 parts of the body);
• difficulty breathing due to narrowing of the airways (bronchospasm);
• gastrointestinal disorders

Not known: frequency cannot be estimated based on the available data

• the skin becomes sensitive to light.

If Ibuprofene Alkaloid-INT is applied to an extensive area of skin and for a prolonged
period, the occurrence of side effects affecting a particular system
organ or even the whole organism cannot be excluded, as can happen after systemic use of medicines
containing ibuprofen.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell 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 to 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 which is stated on the pack after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25  C.
Use within 3 months after first opening.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
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