Maxilene 40 mg / g Lidocaine Cream
What Maxilene Is And What It Is Used For
This medicine is called: Maxilene.
Maxilene is a type of medicine called a local anesthetic (local anesthetic) and is used to numb an area of the body.
Maxilene temporarily numbs the skin surface and relieves pain when a needle is inserted into a vein for medical purposes (venipuncture or venous cannulation), for example for blood tests. This use is intended for adults and children older than one month.
It can also be used on adults to numb the skin before initiating painful local treatments on large undamaged skin areas.
Lidocaine contained in Maxilene may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Maxilene
Do Not Use Maxilene
Talk to your doctor or pharmacist and do not use Maxilene if:
- You are allergic (hypersensitive) to lidocaine or any of the other ingredients of this medicine.
- You are allergic to similar local anesthetics.
- You are allergic to soy or peanuts (contains hydrogenated soybean lecithin).
Warnings And Cautions
Talk to your doctor or pharmacist before using Maxilene if:
- You are acutely ill, debilitated or elderly (you are then more sensitive to lidocaine ).
- If you have previously been sensitive to ingredients in medicines, especially other local anesthetics.
- You have a serious liver disease.
Other Medicines And Maxilene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:
- Maxilene, lidocaine or other local anesthetic.
- Medicines used to prevent or treat irregular heartbeat, such as tocainide, mexiletine or amiodarone.
- The beta-blocker propranolol for the treatment of high blood pressure.
- Cimetidine for the treatment of heartburn or stomach ulcers .
- If you will soon be vaccinated with a live vaccine (eg tuberculosis vaccine). Vaccines should not be given in areas where Maxilene has been applied as the effect of the vaccine may be affected.
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 taking this medicine.
Driving And Using Machines
Maxilene has no known effect on the ability to drive or use machines.
Maxilene Contains Excipients
Propylene glycol: May cause skin irritation.
Maxilene contains exuded soybean lecithin: If you are allergic to peanuts or soy, do not use this medicine.
How To Use Maxilene
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How to use Maxilene:
Maxilene uses
- The method of using Maxilene varies depending on why you are using the product. Make sure you select and follow the correct dosing section.
- Your doctor or nurse will tell you where to apply the Maxilene cream. If a cream is to be used over large areas, a doctor or nurse will apply it to you.
Precautions when using Maxilene:
- For external use only.
- Do not use on open wounds, blisters, rashes or eczema or on cuts, abrasions or injuries.
- Do not use in the ear, in the nose or in the mouth, on the outside or in the anal opening or on the mucous membranes of the genitals.
- Avoid getting Maxilene in your eyes as it can cause severe irritation. If you accidentally get a Maxilene cream in your eye, immediately rinse your eye thoroughly with lukewarm water or saline solution (sodium chloride) and protect your eye until you regain the feeling.
- When Maxilene is applied to the skin, the application site may temporarily fade and then temporarily blush.
- Application to larger areas or for longer than recommended can cause serious side effects due to the uptake of lidocaine into the body.
- Maxilene blocks all sensation in the treated area. Avoid scratching or rubbing the area and do not expose it to extreme heat or cold until the anesthetic effect has disappeared.
Maxilene uses
- The recommended dose of pain relief when a needle is inserted into a vein are:
- 1 g of cream corresponds approximately to a string of 5 cm of cream from a 5-gram stump or 3.5 cm from a 30-gram stump.
- Adults, as well as the elderly, and children over 1 year:
- 1 g to 2.5 g of cream to cover a skin surface of 2.5 x 2.5 cm where the needle will be inserted. Do not leave the cream on the skin for longer than 5 hours.
- Infants older than 3 months but younger than 1 year:
- A maximum of 1 g of cream may be applied. Do not leave the Maxilene cream on the skin for longer than 4 hours
- Infants older than 1 month but younger than 3 months:
- A maximum of 1 g of cream may be applied. Do not leave the cream on the skin for longer than 1 hour.
- Do not use in infants less than one month of age.
- Apply Maxilene at least 30 minutes before starting the medical procedure.
- Use the amount indicated above and apply cream one on the skin in an evenly thick layer.
- Cover the cream with a bandage if your doctor or nurse tells you to do so to prevent the cream from being accidentally rubbed off the skin.
- Remove the dressing after about 30 minutes. Immediately wipe off the cream one with a gauze compress.
- The needle should be inserted into the vein shortly after the cream has been wiped off.
Recomended Dose
The recommended dose of an order before stunning painful local treatments on large areas of skin unharmed is listed below.
- Do not use in patients under 18 years of age
- 1 g of cream corresponds approximately to a string of 5 cm of cream from a 5-gram stump or 3.5 cm from a 30-gram stump.
- Adults and older than 18 years:
- Use 1.5 g to 2 g on a skin area of 10 cm 2 (square centimeters) to cover a total area of not more than 300 cm 2 (200 cm 2 corresponds to approximately one face and 300 cm 2 one arm). Do not exceed the recommended dose.
- Apply Maxilene approximately 30 to 60 minutes before starting the medical procedure.
- Apply the amounts listed above and apply cream one on the skin in an evenly thin layer.
- Make sure that the cream is not rubbed away from the skin by mistake.Wipe off the cream with a clean gauze compress after about 30 to 60 minutes.
- The procedure should be started shortly after the removal of the cream.
- Cream one must not be reapplied until at least 12 hours after removal.
Possible Maxilene Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the maxilene side effects listed below, remove the cream immediately, discontinue use and talk to your doctor or pharmacist.
Allergic reactions are rare – may affect up to 1 in 1,000 people. Symptoms may include
- Rash
- Swelling
- Very low blood pressure
- Anaphylactic shock
- Skin irritation
- Redness
- Itching
- Rash on the application site are common side effects that can occur in up to 1 in 10 users.
Eye irritation can occur if the cream is accidentally applied in or around the eye. It is not known how many people are affected as the frequency can not be calculated from the available data. See “Precautions when using Maxilene” in section 3 for instructions on what to do immediately after accidental eye contact.
How To Store Maxilene
- Keep this medicine out of the sight and reach of children.
- Do not freeze.
- Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiration date is the last day of the specified month.
- After the tube is opened, the shelf life is 6 months.
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.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is lidocaine. 1 g of cream contains 40 mg of lidocaine .
- The other ingredients are
- Benzyl alcohol
- Carbomer
- Cholesterol
- Hydrogenated soybean lecithin
- Polysorbate 80
- Propylene glycol
- Trolamine
- All- rac -α-tocopheryl acetate
- Purified water
What The Medicine Looks Like And Contents Of The Pack
Maxilene is a white to off-white yellowish cream that comes in either:
- An aluminum tube with epoxy phenol lacquer on the inside and a screw cap made of polypropylene, or – an aluminum tube with polyamidimide lacquer on the inside and a screw cap made of high-density polyethylene.
- Pack sizes:
- Carton with tube / tubes, 1 x 5 g or 5 x 5 g
- Carton with tube / tubes, 1 x 5 g or 5 x 5 g including 2 or 10 cover bandages.
- Carton with tube, 1 x 30 g
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Ferndale Laboratories Ltd, Lee View House, South Terrace, Cork, T12 T0CT, Ireland
Manufacturer
Medinfar SA Laboratory, Rua Henrique de Paiva Couceiro, Nº 29, Venda Nova 2700-451 Amadora – Portugal
or
Adamed Pharma SA,
Administrative address: Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland.
Place of manufacture: ul. Marszałka Józefa Piłsudskiego 5, 95-200 Pabianice, Poland
Information provided by:
FrostPharma AB
Berga Backe 2
182 53 Danderyd
This medicinal product is authorized under the European Economic Area under the names:
Ireland: Dolocopin
Italy: ASANSOL
Germany: Lidocaine Ferndale Pharmaceuticals