PATIENT INFORMATION LEAFLET

Read the entire leaflet carefully because it contains important information

for you.
This medicine can be bought without a prescription, for the treatment of

minor conditions without the intervention of a doctor. Nevertheless, you

should use IBUKEY 5% gel carefully to obtain the best results.

- Keep this leaflet. You may need to read it again.
- If you need advice or further information, please see your pharmacist.
- If symptoms worsen or persist after 7 days of treatment, consult your doctor.

In this leaflet:

1. What IBUKEY 5% gel is and what is used for.
2. Before you use IBUKEY 5% gel.
3. How to use IBUKEY 5% gel.
4. Possible side effects.
5. Preservation of IBUKEY 5% gel.


IBUKEY 5% GEL

- The active substance is ibuprofen. Each 100 g of gel contains 5 g of ibuprofen.
- The rest of components (excipients) are sodium hydroxide, isopropyl alcohol, hyetellose, benzyl alcohol, herbal perfume and purified water.


HOLDER: 
Pharminicio, S.L.
C/ Aribau 168-170
08036 Barcelona

COMPANY RESPONSIBLE FOR MANUFACTURING:
Laboratorios ALCALA FARMA, S.L.
Carretera M-300, Km 29,920
28802 Alcalá de Henares (MADRID)


1. WHAT IBUKEY 5% gel IS AND WHAT IT IS USED FOR

IBUKEY 5% gel is a gel for cutaneous use (on skin).

It is presented in tubes of 30 g and 60 g.

This medicine acts as an analgesic and local anti-inflammatory.
IBUKEY 5% gel is indicated to locally relieve mild and occasional pain and inflammation caused by: small contusions, blows, distensions, stiff neck or other contractures, lumbago and mild sprains caused as a consequence of a twisting.


2. BEFORE YOU USE IBUKEY 5% gel

Do not use IBUKEY 5% gel if:

- You are allergic to ibuprofen or any of the components of the medicine.

- You have sunburn in the affected area.

- You have suffered from allergic reactions (rhinitis, difficulty to breath or asthma, urticaria, pruritus or others) caused by acetylsalicylic acid or other non-steroidal anti-inflammatories.

Be specially careful with IBUKEY 5% gel as:

- It should not be used on mucosas, or on skin with wounds, injuries or eczemas.

- If you are asthmatic or allergic to any colouring used in feeding or medicines (such as: yellow-orange tartrazine, etc...)

- You should avoid eye contact.

- You should not expose the treated area to the sunlight, or use with dressings or in extensive areas.

- IBUKEY 5% gel should not be applied simultaneously on the same area in which other medicines have been applied.

Pregnancy

Consult your doctor or pharmacist before you use this medicine.

Breast-feeding

Consult your doctor or pharmacist before you use this medicine.

Use in children

Do not use this medicine in children under 12 years old.

Use of other medicines

Inform your doctor or pharmacist if you are using or has used recently any other medicine, especially analgesics, even those bought without a prescription.


3. HOW TO USE IBUKEY 5% gel

Follow these instructions, unless your doctor has given you other indications.

IBUKEY 5% gel is a medicine of exclusively external cutaneous use (on skin).

People over 12 years old: apply a thin layer of the product on the sore area from 3 to 4 times daily and make a slight massage to facilitate penetration.

Wash your hands after each application.

Do not use more than 7 days in a row.

If you consider that the action of IBUKEY 5% gel is too strong or weak, tell your doctor or pharmacist.

If you use more IBUKEY 5% gel than you should:

Due to its external use, intoxication cases are not likely. In case of accidental ingestion go immediately to a medical centre, indicating the medicine and ingested quantity, since the following may occur: nausea, vomiting, abdominal pain, drowsiness, vertigo, spasms and decreased blood pressure.

 

4. POSSIBLE SIDE EFFECTS

Like all medicines, IBUKEY 5% gel may have side effects.

- Few frequent (in less than 1 out of 100 patients but in more than 1 out of 1000): reddening, itch and skin burning sensation in the application area, which disappear when suspending the treatment.

- Rare (in less than 1 out of 1000 patients): dermatitis (skin inflammation) caused by the sunlight.

If you observe these or any other side effect not reported in this leaflet, consult your doctor or pharmacist.


5. PRESERVATION OF IBUKEY 5% gel

Keep IBUKEY 5% gel out of reach and sight of children.

Preservation conditions: No special preservation conditions are required.

Expiry: Do not use IBUKEY 5% gel after the expiry date indicated on the package.


This leaflet was approved in: February 2006

LOCAL REPRESENTATIVE:
Laboratorio INKEYSA, S.A.
C/ Joan XXIII 15-19
08950 Esplugues de Llobregat – Barcelona

© 2019 by Pharminicio, S.L. All rights reserved.

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C/ Aribau 308

08006 Barcelona

regulatory@pharminicio.com

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