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Sanodin pomada bucal

Disodium carbenoxolone

Topical anti inflammatory and cytoprotector.

Localised treatment of thrush and ulcerations of the oral mucosa.

Reduces inflammation and protects the mucosa from foods.

Comfortable application of the ointment on the necessary area of the mouth thanks to the cannula that is included.


    Tube with 15g ointment with a cannula to facilitate its application.

    N.C. 681536.6

Follow the following instructions exactly, unless your doctor has indicated others. Consult your doctor or pharmacist if you have doubts.

This medicine is only for oral use (only to be used within the mouth).

Apply a fine coat of ointment over the area to be treated, 4 times a day, preferably after eating and before going to sleep.

The container comes with a cannula to facilitate the application of the ointment in the area of the mouth where it is needed.

Instructions for the correct application of the medicine:

1.    Unscrew the white lid from the tube, and once open screw on the cannula (see figure 1).
2.    Take the cap off the cannula.
3.    Apply the ointment to the affected area of the mouth (see figure 2).
4.    Unscrew the cannula and screw on the white lid so that it is securely closed.
5.    Wash the the cannula and store it with the cap.

For hygiene reasons wash your hands before and after each application.

If symptoms persist or worsen after 7 days treatment, consult your doctor.

MEDICATION GUIDE
SANODIN 20mg/g pomade bucal
Disodium carbenoxolone

Read the whole of this medication guide in detail, because it contains information that will be important to you.
This medication can be obtained without a prescription for the treatment of minor afflictions without the intervention of a doctor. However, you must use Sanodin pomada bucal with care to obtain the best results.
-Keep this leaflet; you may need to read it again.
-If you have any doubts, consult your doctor or pharmacists.
This medicine has been prescribed to you and must not be given to others. It may harm them, even when their symptoms are the same as yours.

In this medication guide:
1. What are Sanodin pomade bucal and what are they used for?
2. Before using Sanodin pomada bucal
3. How to use Sanodin pomada bucal
4. Possible adverse effects
5. Storage of Sanodin pomada bucal

1. WHAT IS SANODIN 20 mg/g pomada bucal AND WHAT IS IT USED FOR?

Carbenoxolone, the principal component of this medicine is a derivative of the liquorice root which has an anti-inflammatory activity.

Sanodin is indicated for the symptomatic relief of small mouth aphthas and ulcers, smaller than 1 cm.

These small aphthas and ulcers are also known as sores, which habitually appear on the inside of lips, cheeks at the base of gums or beneath the tongue.

2. Before using Sanodin 20mg/g pomada bucal

Do not use Sanodin
-If you are allergic (hypersensitive) to carbenoxolone or any of the other components of this medicine.
-If you are using corticoids (medicines used as anti inflammatories) for application in the mouth.

Be especially careful with Sanodin
-This medicine must only be administered orally (in the mouth) and must not be ingested.

First consult your doctor:
-if you suffer from the kidneys, heart or liver, as it can lead to retention of water and sodium, and a loss of potassium.
-if an infection with a bacterial origin presents itself.

Use of other medicines
Inform your doctor or pharmacist if you are using, or have recently used other medicines, including those acquired without prescription.
This medicine must not be used in conjunction with corticosteroids (medicines used as anti-inflammatories) applied in the mouth.

Use of Sanodin with food and drink
This medicine must be applied after eating or drinking, so as to avoid it moving from the position applied to.

Pregnancy and during breast feeding
Consult your doctor or pharmacist before using any medicine.

You must not use this medicine if you are pregnant or breast feeding, due to the lack of data in these circumstances.

Use in children
This medicine is not recommended for children under 12 due to the lack of data available in this group.

Use in those over 65
Those over 65 may be more susceptible to the side effects of carbenoxolone.

Driving and using machines
No effects on the capacity to drive or use machines have been reported.

3. HOW TO USE SANODIN 20mg/g pomada bucal.

Follow the following instructions exactly, unless your doctor has indicated others. Consult your doctor or pharmacist if you have doubts.

This medicine is only for oral use (only to be used within the mouth).

Apply a fine coat of ointment over the area to be treated, 4 times a day, preferably after eating and before going to sleep.

The container comes with a cannula to facilitate the application of the ointment in the area of the mouth where it is needed.

Instructions for the correct application of the medicine:

1.    Unscrew the white lid from the tube, and once open screw on the cannula (see figure 1).
2.    Take the cap off the cannula.
3.    Apply the ointment to the affected area of the mouth (see figure 2).
4.    Unscrew the cannula and screw on the white lid so that it is securely closed.
5.    Wash the the cannula and store it with the cap.

 

For hygiene reasons wash your hands before and after each application.

If symptoms persist or worsen after 7 days treatment, consult your doctor.

If you use more Sanodin than you should.
Cases of overdose have not been reported. The use of high doses, and for a prolonged period, of this medicine, or in the case of its accidental ingestion, can lead to the retention of water and sodium, and the loss of potassium, which could produce high blood pressure or hypokalaemia.

In the case of overdose or accidental ingestion consult your doctor or pharmacist, or phone the Toxicology Information Service, telephone 915620420, indicating the medicine and the quantity ingested.

If you forgot to take Sanodin
If you forgot to use this medicine at the corresponding time, apply the oral ointment as soon as you notice and continue with your habitual treatment regime. Do not apply a double dose to compensate those forgotten.
If you have any other doubt about the use of this medicine, consult your doctor or chemist.

4. POSSIBLE SIDE EFFECTS

As with all medicines, SANODIN can produce side effects, although not all people suffer from them.

No side effects have been reported with its oral use. Its accidental ingestion in high quantities can produce a retention of water and sodium and a loss of potassium.

During the period of use of the principal component of this medicine, carbenoxolone, the following side effects have been reported, though their frequency cannot be established exactly: increased blood pressure (hypertension), decrease in the level of potassium in the blood (hypokalemia) and disorders in the tolerance to glucose.

If you consider any of the side effects you suffer to be serious or if you appreciate a side effect not mentioned in this medication guide, inform your doctor or pharmacist.

5. CONSERVATION OF SANODIN 20mg/g pomada bucal

Keep out of sight and reach of children.

Keep the tube tightly closed to avoid the product being altered.

Do not use Sanodin after the expiry date indicated on the container after CAD. The expiry date is the last day of the month indicated.

Medicines must not be disposed of in the drains or thrown away. Leave unwanted medicines and containers at the SIGRE point in a chemist. Ask your pharmacist how to dispose of any containers or unneeded medicines. This way you will help look after the environment.

6. ADDITIONAL INFORMATION

Composition of Sanodin
Each gram of oral ointment contains 20 milligrams of disodium carbenoxolone as the principal ingredient. The other components (excipients) are macrogol, paraffin and karaya gum (E-416).

Product appearance and container contents
Beige or light brown oral ointment. It is presented in an aluminium tube, with a white lid and a white cannula and cap. Each tube contains 15 grams of oral ointment.

Holder of the authorisation for the commercialisation and fabrication of the product.

LABORATORIOS ERN, S.A. Pedro IV, 499 - 08020 Barcelona, España
Tel: 93 314 80 11   Fax: 93 314 40 96

Responsable for fabrication.
Laboratorios ERN, S.A. Gorcs i LLadó, 188 – 08210 Barberá del Vallés, Barcelona. España.
Laboratorios ERN, S.A. Perú, 228 – 08020 Barcelona. España.

This product was revised in April 2009.

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

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