Emla Cream 5x5g Tubes with 12 Dressings Emla Cream 5x5g Tubes with 12 Dressings

Talk to your doctor, pharmacist or nurse before using EMLA Cream:

• if you or your child have a rare inherited illness that affects the blood called 'glucose-6-phosphate dehydrogenase deficiency.
• if you or your child have a problem with blood pigment levels called 'methaemoglobinaemia'.
• Do not use EMLA Cream on areas with skin rash, cuts, grazes or other open wounds, with the exception of a leg ulcer. If any of these problems are present, check with your doctor, pharmacist or nurse before using the cream.
• if you or your child have an itchy skin condition called 'atopic dermatitis', a shorter application time may be sufficient. Application times of longer than 30 minutes may result in an increased incidence of local skin reaction (see also section 4 'Possible side effects').
• if you take particular products for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). In that case the doctor will monitor your heart function.

Due to the potentially enhanced absorption on the newly shaven skin, it is important to follow the recommended dosage, skin area and application time.

In particular, tell your doctor or pharmacist if you or your child have recently used or been given any of the following medicines:

• Medicines used to treat infections, called 'sulphonamides' and nitrofurantoin.
• Medicines used to treat epilepsy, called phenytoin and phenobarbital.
• Other local anaesthetics.
• Medicines to treat an uneven heartbeat, such as amiodarone.
• Cimetidine or beta-blockers, which may cause an increase in the blood levels of lidocaine.

This interaction is of no clinical relevance in short-term treatment with EMLA Cream in recommended.

Children and adolescents

In infants/newborn infants younger than 3 months a transient, clinically not relevant increase in blood pigment levels 'methaemoglobinaemia' is commonly observed up to 12 hours after EMLA Cream is put on.

The effectiveness of EMLA Cream when drawing blood from the heel of newborn infants or providing adequate analgesia for circumcision could not be confirmed in clinical studies.

EMLA Cream should not be applied to the genital skin (e.g. penis) and genital mucosa (e.g. in the vagina) of children (below 12 years of age) owing to insufficient data on the absorption of active substances.

EMLA Cream should not be used in children younger than 12 months of age who are being treated at the same time with other medicines that affect blood pigment levels 'methaemoglobinaemia' (e.g. sulphonamides, see also Section 2 Other medicines and EMLA Cream).

EMLA Cream should not be used in preterm newborn infants.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Occasional use of EMLA Cream during pregnancy is unlikely to have any adverse effects on the foetus.

The active substances in EMLA Cream (lidocaine and prilocaine) are passed into breast milk. However, the amount is so small that there is generally no risk to the child.

Animal studies have shown no impairment of male or female fertility.

Driving and using machines

EMLA Cream has no or negligible influence on the ability to drive and use machines when used at the recommended doses.

EMLA Cream contains macrogolglycerol hydroxystearate. Macrogolglycerol hydroxystearate may cause skin reactions.

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

Contact your doctor or pharmacist if any of the following side effects bother you or do not seem to go away. Tell your doctor about anything else that makes you feel unwell while you are using EMLA Cream.

If you experience any of the following effects while you are using EMLA Cream, stop using it and check with your doctor or pharmacist as soon as possible:

• Allergic reactions, which in rare cases may develop into anaphylactic shock (skin rash, swelling, fever, respiratory difficulties and fainting) during treatment of skin, genital mucosa or leg ulcers.
• Methaemoglobinaemia (blood disorder), which in rare cases may develop during treatment of the skin, and may cause signs and symptoms of hypoxaemia (abnormally low level of oxygen in the blood). Methaemoglobinaemia is more frequently observed, often in connection with overdose, in newborn infants and infants aged 0 to 12 months.

A mild reaction (paleness or redness of the skin, slight puffiness, initial burning or itching) may occur on the area on which EMLA is used. These are normal reactions to the cream and the anaesthetics and will disappear in a short while without any measures being needed.

If you experience any troublesome or unusual effects while you are using EMLA, stop using it and check with your doctor or pharmacist as soon as possible.

Common (may affect up to 1 in 10 people)

• Transient local skin reactions (paleness, redness, swelling) in the treated area during treatment of skin, genital mucosa or leg ulcers.
• An initially mild sensation of burning, itching or warmth at the treated area during treatment of genital mucosa or leg ulcers.

For Uncommon and rare side effects, please read the enclosed leaflet or click here.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

When you apply the cream, it is very important to exactly follow the instructions below:

1. Squeeze the cream into a mound where it is needed on your skin (for example where the needle is going to be put in). Half a 5 g tube corresponds to about 2 g EMLA Cream. One gram of EMLA Cream pressed out of a tube of 30g is approximately 3.5 cm. Do not rub the cream in.
2. Peel the paper layer from the 'centre cut-out' of the non-adhesive side of the dressing (leaving a frame of paper).
3. Remove the cover of the adhesive side of the dressing.
4. Remove the paper backing. Smooth down the edges of the dressing carefully. Then leave it in place for at least 60 minutes if the skin has not been damaged. The cream should not be left in place for more than 60 minutes in children under 3 months or for more than 30 minutes in children with an itchy skin condition called 'atopic dermatitis'. If the cream is used on the genitals or on ulcers, shorter applications times may be used as described below.
5. Your doctor or nurse will take the dressing off and remove the cream just before they do the medical procedure (for example just before the needle is put in).

For more information on directions for specific treatments click here.

Do not use EMLA Cream on the following areas:

• Cuts, grazes or wounds, excluding leg ulcers.
• Where there is a skin rash or eczema.
• In or near the eyes.
• Inside the nose, ear or mouth.
• In the back passage (anus).
• On the genitals of children.

Persons frequently applying or removing cream should ensure that contact is avoided in order to prevent the development of hypersensitivity.

The protective membrane of the tube is perforated by applying the cap.

The active substances are lidocaine and prilocaine. Each gram of cream contains 25 mg of lidocaine and 25 mg of prilocaine.

The other ingredients are macrogolglycerol hydroxystearate, Carbomer 974P, sodium hydroxide and purified water.