Important Warnings and Precautions for EMLA Cream 5%
Please read these warnings carefully. If you have any concerns, consult your doctor, pharmacist, or nurse.
Do not use EMLA Cream if:
- You are allergic (hypersensitive) to lidocaine, prilocaine, other similar local anaesthetics, or any other ingredients of EMLA Cream 5%.
Check with your doctor, pharmacist or nurse before using EMLA Cream if:
- You or your child are anaemic (a blood problem with too few red blood cells).
- You or your child have a rare inherited illness affecting the blood, called 'glucose-6-phosphate dehydrogenase deficiency'.
- You or your child have a problem with blood pigment levels, called 'methaemoglobinaemia'.
- You or your child have a skin condition called atopic dermatitis; a shorter application time (30 minutes) may be sufficient, as longer times could increase local skin reactions.
- Your child is a pre-term newborn infant.
- Your child is younger than 12 months and is being treated with other medicines affecting blood pigment levels ('methaemoglobinaemia').
- You take particular products for heart rhythm disorders (class III antiarrhythmics, such as amiodarone). Your doctor will monitor your heart function.
Avoid using 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. If EMLA Cream accidentally gets into your eye, rinse thoroughly with lukewarm water or salt (sodium chloride) solution and be careful to avoid getting anything in your eye until feeling returns.
- Inside the nose, ear, or mouth.
- In the back passage (anus).
- On the genitals of children.
- On an impaired eardrum.
- On an area of newly shaven skin larger than 600 cm² (e.g., 30 cm by 20 cm). The maximum total dose is 60g.
If you are pregnant, may become pregnant, or are breastfeeding, consult your doctor or pharmacist before use. The active substances pass into breast milk but in amounts generally too small to pose a risk to the child.
Potential Side Effects
Like all medicines, EMLA Cream can cause side effects, though not everyone experiences them. If you experience any severe allergic reactions (e.g., rash, shortness of breath, low blood pressure, swelling of face/lips/tongue), stop using the cream and seek immediate medical attention.
Common side effects (affect less than 1 in 10 people):
- Redness, slight swelling, or pale skin where the cream was used (usually temporary).
- Mild burning, itching, or warmth sensation (common on genital mucosa or leg ulcers).
Uncommon side effects (affect less than 1 in 100 people):
- Mild burning, itching, or warmth sensation on the skin.
- Tingling sensation in the treated area (genital mucosa).
- Irritation of treated skin during leg ulcer treatment.
Rare side effects (affect less than 1 in 1,000 people):
- Small red dots on the skin where cream was applied (more likely in children with atopic dermatitis).
- Eye irritation if cream accidentally enters the eyes.
If you use more EMLA Cream than recommended, or if you experience symptoms like feeling light-headed or dizzy, tingling around the mouth, numbness of the tongue, abnormal taste, blurred vision, or ringing in the ears, seek medical advice immediately.
Storage Information
- Keep out of the reach and sight of children.
- Do not store above 30°C and do not freeze.
- Do not use after the expiry date shown on the tube and package.
- Dispose of medicines responsibly; ask your pharmacist for advice.