Document: Lidokain Isdin cream ENG PL change

• Lidokain Isdin cream PL
• Lidokain Isdin cream ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lidokain Isdin40 mg/g cream

Lidocaine

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Lidokain Isdin is and what it is used for

2. Before you use Lidokain Isdin

3. How to use Lidokain Isdin

4. Possible side effects

6. Further information

Lidokain Isdin 40 mg/g cream contains lidocaine and is a medicine for local numbing (local anaesthesia) of the skin.

Lidokain Isdin is used to numb the skin in connection with needle insertion (e.g. prior to blood sampling).

Do not use Lidokain Isdin

• if you are allergic (hypersensitive) to lidocaine, or any of the other ingredients of Lidokain Isdin.
  
  

• if you are allergic (hypersensitive) to local anaesthetics, soya or peanuts.
  
  

• on infants born too early (born before the 37^th full week of pregnancy).

Take special care with Lidokain Isdin

• in surgical interventions in the ear canal or inner ear as there is a risk of damage to the inner ear.
  
  

• if you suffer from severe underlying disease e.g. heart disease or severely reduced liver function.
  
  

• if you take medicines for heart rhythm disorders (see Using other medicines).
  
  

• near the eyes, as lidocaine may cause eye irritation. In addition, with the loss of protective reflexes, corneal irritation or grazing may occur. If Lidokain Isdin comes into contact with the eyes, rinse them immediately with lukewarm water and protect them until sensation returns.
  
  

• if you are about to receive a vaccination with live vaccine (e.g. tuberculosis vaccine). Vaccines should not be administered in areas where Lidokain Isdin has been applied as the effect of the vaccine may be affected.

Please inform your doctor if any of the above applies to you.

Lidokain Isdin should only be used on undamaged skin (not on mucous membranes, wounds or eczema).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is especially important for your doctor to know if you are already being treated with any of the medicines mentioned below, as the risk of side effects may be increased:

• lidocaine in high doses for other reasons

• other local anaesthetics

• medicines for arrhythmia (heart rhythm disorders) e.g. tocainide, mexiletine and amiodarone.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Temporary use of Lidokain Isdin during pregnancy is unlikely to cause harmful effects to the foetus.

Lidokain Isdin passes into breast milk but is unlikely to affect the breast fed child.

Driving and using machines

Lidokain Isdin has no known effect on the ability to drive or operate machinery.

Important information about some of the ingredients of Lidokain Isdin

Lidokain Isdin contains propylene glycol which may cause skin irritations.

Lidokain Isdin contains hydrogenated soy lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

Always use Lidokain Isdin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Children from 6 to 12 years:

The single application dose is 2-3g. Recommended application time, i.e. the time the cream should be on the skin, is 60 minutes, but no longer than two hours.

Adolescents over 12 years and Adults:

The single application dose is 2-3g. The maximum daily dose is 5 grams. The recommended application time is 60 minutes, but no longer than two hours.

Children from 2 to 6 years:

As there is insufficient experience, Lidokain Isdin is not recommended in this age group.

Children from 0 to 2 years:

As there is no experience, Lidokain Isdin should not be used in this age group.

1 g of cream corresponds to a strand of approximately 2.5 cm.

	1) A thick, even layer of cream should be applied to the skin area being treated.
	2) Leave the cream on the skin according to above application times. Use of a covering (e.g. plaster) is recommended to avoid the cream accidentally coming off before the application time is up.