Document: Elamal cream ENG PL change

• Elamal cream PL
• Elamal cream ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Elamal40 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 Elamal is and what it is used for

2. Before you use Elamal

3. How to use Elamal

4. Possible side effects

6. Further information

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

Elamal is used to numb the skin in connection with needle insertion (e.g. prior to blood sampling) in children aged 6 to 12 years, adolescents over 12 years and adults.

Do not use Elamal

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

• 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 Elamal

• 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 Elamal 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 Elamal has been applied as the effect of the vaccine may be affected.

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

Elamal 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 Elamal during pregnancy is unlikely to cause harmful effects to the foetus.

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

Driving and using machines

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

Important information about some of the ingredients of Elamal

Elamal contains propylene glycol which may cause skin irritations.

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

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

The recommended dose is:

Adolescents over 12 years and Adults:

The single application dose is 2-3g. The maximum daily dose is 20 grams. The recommended application time is 60 minutes, but no longer than two hours.

Use in children

Children from 6 to 12 years:

The single application dose is 2-3g. The maximum daily dose is 10 grams. Recommended application time, i.e. the time the cream should be on the skin, is 60 minutes, but no longer than two hours.

Children from 2 to 6 years:

Elamal is not recommended in this age group, as there is insufficient experience.

Children from 0 to 2 years:

Elamal should not be used in this age group, as there is no experience, .

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.
	3) Wipe off the cream afterwards. The skin area should be washed prior to surgery. Close the tube after use.

If you have the impression that the effect of Elamal is too strong or too weak, please talk to your doctor or pharmacist.

If you use more Elamalthan you should

Overdose is unlikely in normal use on undamaged skin.

If you have used more Elamal than you should, or if a child has taken the medicine by accident or got too much on the skin, please contact your doctor or the hospital to get a risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Elamal can cause side effects, although not everybody gets them.

Uncommon (1 to 10 users in 1,000):

Local skin reactions (pallor, redness, itching and stinging) in the treated area. The symptoms are usually temporary and mild.

Rare (1 to 10 users in 10,000):

Allergic contact eczema.

Very rare (less than 1 user in 10,000):

Allergic reactions (in severe cases, anaphylactic shock)

Stop using Elamal and contact your doctor immediately if you get any of the following symptoms (anaphylactic shock)

• Swelling of the face, tongue or throat

• Difficulty swallowing

• Urticaria and trouble breathing.

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.

5. HOW TO STORE ELAMAL

Keep out of the reach and sight of children.

Use before the expiry date which is stated on the carton and the tube after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

After opening the tube, the shelf life is 6 months.

Keep the tube tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Elamalcontains

• The active substance is lidocaine. 1 gram cream contains 40 mg lidocaine.

• The other ingredients are purified water, propylene glycol, hydrogenated soy lecithin, benzyl alcohol, polysorbate 80, carbomer 940, trolamine, cholesterol.

What Elamallooks like and contents of the pack

Elamal is a white to yellowish cream.

Pack sizes: 5 g, 10 g, 20 g, 30 g, 40 g and 50 g in aluminium tubes. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

[to be completed nationally]

For Sweden:

Scharper S.P.A.

Viale Ortles, 12

20139 Milano

Italy

Phone: +39 022629161

Manufacturer

Almirall Hermal GmbH

Scholtzstraße 3

21465 Reinbek

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Sweden: Elamal

Austria, Germany, Luxembourg: Dolocupin 40 mg/g

Italy: Elidoxil

This leaflet was last approved in 17 April 2014