IBUPROFENO GEISER 50 MG/G GEL

Introduction

Package Leaflet: Information for the User

Ibuprofen Geiser50 mg/g gel

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. - Keep this package leaflet, as you may need to read it again. - If you need advice or more information, consult your pharmacist. - If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4. - You should consult a doctor if it worsens or does not improve after 3 days of treatment.

Contents of the Package Leaflet

1. What is Ibuprofen Geiser and what is it used for 2. What you need to know before using Ibuprofen Geiser 3. How to use Ibuprofen Geiser 4. Possible side effects 5. Storage of Ibuprofeno Geiser 6. Contents of the pack and further information

1. What is Ibuprofeno Geiser and what is it used for

This medication is indicated for the local symptomatic short-term treatment of occasional muscle and joint pains such as those produced by minor bruises, blows, sprains, torticollis, or other contractures, mild sprains caused by a twist, and lumbago.

The active ingredient of this product is ibuprofen. It belongs to a group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). This group of medications is used to relieve pain and inflammation. This medication is for topical use.

This medication is intended for use in adults and adolescents 12 years of age and older.

2. What you need to know before using Ibuprofeno Geiser

Do not use Ibuprofeno Geiser:

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6)
• if you have experienced allergic reactions such as bronchospasm (muscle tension in the lungs with difficulty breathing), asthma, rhinitis, cold, sneezing, or urticaria (skin rash with itching), or angioedema (swelling under the skin) when taking acetylsalicylic acid or other NSAIDs.
• on damaged or diseased skin.
• during the last three months of pregnancy.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medication.

• You should avoid contact with mucous membranes (nose, mouth) and eyes. Do not ingest the product.
• Do not apply this medication to open skin wounds. This medication should only be applied to intact skin, without disease.
• Do not use with occlusive dressings (sealed or impermeable bandages or casts).
• Do not expose treated areas to the sun to reduce the risk of photosensitive reactions (skin lesions such as eczema, blisters, etc.). If skin reactions occur, stop using this product.
• Do not apply simultaneously with other topical products in the same area.

This medication should not be used on large areas of the skin or for extended periods, as this increases the likelihood of systemic side effects. Please follow the instructions on dosage and do not exceed the maximum treatment duration.

Side effects can be reduced by using the lowest effective dose for the shortest time necessary to control symptoms.

Bronchospasm may occur in patients using ibuprofen who have previously suffered from bronchial asthma or allergies.

Patients who suffer from asthma, hay fever, inflammation of the nasal mucous membranes (nasal polyps), or chronic obstructive pulmonary disease or chronic respiratory infections (especially those associated with symptoms similar to hay fever) are at greater risk of suffering from asthma attacks (analgic intolerance/asthma), local inflammation of the skin and mucous membranes (Quincke's edema), or urticaria when treated with this medication than other patients.

In these patients, this medication can only be used under certain precautions and direct medical supervision. The same applies to patients who are also allergic to other substances, for example, with skin reactions, itching, or urticaria.

Precautions should be taken to prevent children from touching the skin areas where the medication has been applied.

Although the systemic availability of topically applied ibuprofen is significantly lower than that of oral pharmaceutical forms, complications may occur in rare cases. For these reasons, patients with: altered renal, cardiac, or hepatic function; active peptic ulcer or history of peptic ulcer, intestinal inflammation, or bleeding tendency should consult a doctor before using this medication.

Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients, as they are more likely to experience side effects.

Severe skin reactions such as 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 in association with treatment with this medication. Discontinue treatment with Ibuprofeno Geiser and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Using Ibuprofeno Geiser with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Do not apply other topical preparations to the same area of skin where you are using this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

During the first six months of pregnancy, this medication should not be administered unless strictly necessary. Do not use this medication during the last three months of pregnancy. If treatment is needed during this period, the lowest dose should be used for the shortest possible time.

This medication should not be applied directly to the breast area of breastfeeding women.

Oral forms (e.g., tablets) of Ibuprofeno Geiser may cause adverse reactions in the fetus. It is unknown if the same risk applies to Ibuprofeno Geiser when used on the skin.

Driving and Using Machines

No effects on the ability to drive vehicles or use machinery have been described when used externally on the skin.

3. How to use Ibuprofeno Geiser

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Dosage for adults and adolescents (12 years of age and older):

Apply between 4 and 10 cm of gel (50-125 mg of ibuprofen) to the affected area and gently massage until absorbed. Repeat if necessary, up to a maximum of four times a day.

This medication is for external use only.

Apply a thin layer of gel to the affected parts of the body and rub gently until it penetrates the skin. Unless the treated area is the hands, wipe your hands with a paper towel before washing them after rubbing in the gel. The paper towel should be thrown away.

Before applying a bandage, the gel should be allowed to dry on the skin for a few minutes. Similarly, before showering or bathing, wait for the gel to dry on the skin.

This medication should be used at the lowest effective dose for the shortest time necessary to control symptoms. The gel is for short-term use only. Do not apply for more than 7 consecutive days (5 days in adolescents). If symptoms do not improve after 3 days, consult your doctor.

Use in children (under 12 years of age):

The safety and efficacy of this medication have not been established in children under 12 years of age.

If you use more Ibuprofeno Geiser than you should

Due to the topical use of this medication, it is unlikely that cases of overdose will occur.

If the recommended dose is significantly exceeded, the gel should be removed from the skin with a paper towel. The paper towel should be disposed of with waste.

In case of accidental ingestion of the gel

Symptoms will depend on the dose ingested and the time elapsed since ingestion. Symptoms may include nausea, vomiting, abdominal pain, drowsiness, and low blood pressure.

Consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The most common side effects are skin symptoms. The systemic availability of topical ibuprofen is low compared to oral NSAIDs. Adverse effects, especially those affecting the gastrointestinal tract, are less frequent with topical ibuprofen use. However, during prolonged treatment and/or when large areas are treated, there is a possibility of systemic adverse reactions. Reactions such as abdominal pain, dyspepsia, gastric disorders, and renal disorders may occur.

STOP USINGthis medication and contact your doctor immediately if you experience:

• Signs of allergic reaction such as asthma, unexplained wheezing, or difficulty breathing, itching, nasal discharge, or skin rashes.
• Signs of hypersensitivity and skin reactions such as redness, swelling, scaling, blisters, or peeling of the skin.
• Red patches, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Common side effects (may affect up to 1 in 10 people)

• Symptoms of irritation in the treated area
• Skin rash
• Itching
• Urticaria
• Redness
• Burning sensation
• Contact dermatitis

Uncommon side effects (may affect up to 1 in 100 people)

• Skin peeling
• Dry skin
• Edema

Rare side effects (may affect up to 1 in 1,000 people)

• Bullous dermatitis

Very rare side effects (may affect up to 1 in 10,000 people)

• Hypersensitivity reactions
• Angioedema (rapid swelling of the skin and mucous membranes or tissues underneath)
• Bronchospasm (symptom of hypersensitivity reaction)
• Abdominal discomfort

Not known (frequency cannot be estimated from available data)

• Photosensitivity (skin becomes sensitive to light)
• Pustular rash

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ibuprofeno Geiser

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Before opening the packaging for the first time:

This medication does not require special storage conditions.

Do not refrigerate or freeze.

Once the tube is opened:

Do not use after 30 days.

Store below 25°C. Do not refrigerate or freeze.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ibuprofeno Geiser

• The active ingredient is ibuprofen; each gram of this medication contains 50 mg of ibuprofen.

• The other ingredients are levomenthol, carbomer A, diisopropanolamine 90% (pH adjustment), isopropyl alcohol, glycerol (E-422), and purified water

Appearance of Ibuprofeno Geiser and contents of the pack

Transparent, colorless, or slightly yellowish gel with a mentholated odor (pH 6.7-7.4).

It is presented in an aluminum tube with a membrane, internally coated with an epoxiphenolic layer, with a threaded HDPE cap and a piercing device.

The tube may contain 50 g, 100 g, or 150 g.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Geiser Pharma, S.L.

Polígono Mutilva Calle E, 5 bajo

31192, Mutilva

Navarra, Spain

Manufacturer

Laboratorios Bohm, S.A.

Calle Molinaseca, 23, Poligono Industrial Cobo Calleja

28947, Fuenlabrada

Madrid, Spain

Industrial Farmacéutica Cantabria, S.A.

Barrio Solía nº 30

La Concha, Villaescusa

39690 Santander

Cantabria, Spain

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

Poland: Ibuprofen APTEO MED

Czech Republic: Ibuprofen Geiser

Germany: Ibubeta Schmerzgel 50 mg/g

Date of the last revision of this package leaflet: January 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/