25 mg/g + 25 mg/g cream
Lidocaine and prilocaine
What Tapin is and what it is used for
Tapin contains two active substances, lidocaine, and prilocaine. They belong to the drug group local anesthetics (local anesthetics).
Tapin works by numbing the skin for a short time. The cream is applied to the skin before certain medical procedures. The pain in the skin decreases but you can still feel pressure and touch.
Adults, youth, and children
Tapin cream can be used to numb the skin before
- needle stick (eg an injection or a blood test)
- minor operations in the skin.
The lidocaine and prilocaine contained in Tapin may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tapin
Do not use Tapin
- if you are allergic to lidocaine or prilocaine or similar types of local anesthetics, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Tapin:
- if you or your child have a rare hereditary blood disorder called “glucose-6-phosphate dehydrogenase deficiency”.
- if you or your child have problems with the pigment content in the blood, so-called “methemoglobinemia”.
- do not use Tapin on skin areas with rashes, cuts, abrasions, or other open wounds, except leg ulcers. If you have any of these problems, talk to your doctor or pharmacist before using the cream.
- if you or your child has itchy skin called atopic eczema, it may be enough if the cream is on the skin for a shorter time. If the cream is left on the skin for longer than 30 minutes, it can lead to more local skin reactions (see also section 4 “Possible side effects”).
- if you use certain medicines to treat heart rhythm disorders ( class III antiarrhythmics, such as amiodarone ). In that case, the doctor will monitor your heart function.
Because the cream may be absorbed more easily in freshly shaved skin, it is important to follow the recommended dosage, skin surface, and application time.
Avoid getting Tapin in the eyes as it may irritate. If you accidentally get Tapin in your eyes, immediately rinse with plenty of warm water or saline (sodium chloride). Be careful not to get anything in your eye before the sensation has returned.
Tape should not be used on a damaged eardrum.
If you use Tapin before you are vaccinated with a live vaccine (eg tuberculosis vaccine), you should go to the doctor or nurse at the scheduled return visits to check the results of the vaccination.
Children and young people
In infants/newborn children under 3 months of age, a temporary increase in the blood pigment methemoglobin is common for up to 12 hours after Tapin cream is applied. However, this temporary increase has no significant impact on the child.
Clinical studies have not been able to confirm that Tapin has an effect when sampling the heel of newborn babies or that it provides sufficient pain relief during circumcision.
Tape should not be applied to the genitals (e.g. on the penis) and the genital mucosa (e.g. in the vagina) in children (under 12 years of age). There is insufficient data on how the active ingredients are taken up in the body.
Tape should not be used in children under 12 months who are simultaneously treated with other drugs that affect the amount of the blood pigment methemoglobin (eg sulfonamides, see also section 2, “Other drugs and Tapin”).
“Other medicines and Tapin”).
Tape should not be used on premature babies.
Other medicines and Tapin
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines. This also applies to non-prescription drugs and herbal remedies. Namely, Tapin can affect how certain other medicines work, and certain medicines can affect how Tapin works. You must tell your doctor or pharmacist if you or your child have recently taken or been treated with any of the following medicines:
- medicines for the treatment of infections, sulfonamides, and nitrofurantoin.
- medicines for the treatment of epilepsy, phenytoin, and phenobarbital.
- other local anesthetics.
- medicines for irregular heartbeats, such as amiodarone.
- cimetidine or beta-blockers, as these, can increase the level of lidocaine in the blood. This effect has no practical significance in recommended doses for short-term treatment with Tapin.
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.
Single-use of Tapin during pregnancy is unlikely to hurt the fetus.
The active substances in Tapin (lidocaine and prilocaine) are excreted in breast milk, but in such small amounts that it generally poses no risk to the baby.
Animal studies have not shown any impairment of male or female fertility.
Driving ability and use of machinery
Tapin has no or negligible effect on the ability to drive and use machines when used in recommended doses.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Tapin contains macrogol glycerol hydroxy stearate
Tapin contains macrogol glycerol hydroxy stearate which can cause skin reactions.
How to use Tapin
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. Consult a doctor, pharmacist, or nurse if you are unsure.
How to use Tapin
- Where the cream should be used, how much to use, and how long it should be left on depends on what it is to be used for. Half a 5-gram tube corresponds to approximately 2 g of Tapin.
- Tape should be used on the genitals only by a doctor or nurse.
- If Tapin is to be used on leg ulcers, a doctor or nurse must supervise its use.
Do not use Tapin in the following areas:
- cuts, abrasions, or wounds, except leg wounds.
- on skin with rashes or eczema.
- in or near the eyes.
- inside the nose, ears, or mouth.
- in the anal opening.
- on the genitalia of children.
People who frequently apply or remove cream should avoid contact with the cream to prevent the development of hypersensitivity.
Make a hole in the protective membrane of the tube by pressing the lid against the membrane.
Use on the skin before minor procedures (e.g. needle stick or simpler skin operations):
- Put the cream on the skin in a thick layer. Follow the instructions on the package leaflet or from healthcare professionals. In some cases, the healthcare professional applies a cream .
- Then cover the cream with a bandage (plastic film). This is removed just before the procedure. If you are going to apply the cream yourself, check that you have been given a dressing by the doctor, pharmacist or nurse.
- Usual dose for adults and adolescents over 12 years of age is 2 g (gram).
- For adults and adolescents over 12 years of age, the cream is applied at least 60 minutes before the procedure. However, do not apply the cream earlier than 5 hours before the procedure.
- In the case of children, the amount of Tapin and how long it should be used depends on the child’s age.
- The doctor, nurse or pharmacist will tell you how much cream to take and when to put it on, so follow the dosing instructions below.
Children
Use on the skin before minor procedures (e.g. needle stick or simpler skin operations).
Newborns and infants 0-2 months: up to 1 g of cream on a total area of skin no larger than 2×5 cm. At most 1 time per day for 1 hour.
Infants aged 3-11 months: up to 2 g of cream on a total skin area no larger than 4×5 cm for 1 hour. A maximum of 2 doses at least 12 hours apart can be given during a 24 hour period.
Children aged 1-5 years: up to 10 g of cream on a total skin area no larger than 10×10 cm for 1 hour, but no more than 5 hours. A maximum of 2 doses at least 12 hours apart can be given in a 24 hour period.
Children aged 6-11 years: up to 20 g of cream on a total skin area no larger than 20×10 cm for 1 hour, but no more than 5 hours. A maximum of 2 doses at least 12 hours apart can be given in a 24 hour period.
Tapin can be used on children and young people with atopic dermatitis ( atopic eczema ), but then the application time is a maximum of 30 minutes.
It is very important that you exactly follow the instructions below when applying the cream .
1. Squeeze out a dab of cream on the place to be numbed (e.g. where the needle is to be inserted). Half a 5-gram tube corresponds to approximately 2 g of Tapin. Do not rub in the cream.
2. Peel away the paper layer from the middle part of the non-adhesive side of the dressing (leaving a paper frame).
3. Remove the adhesive backing from the adhesive side of the dressing.
4. Carefully place the dressing over the click with cream.
Do not push cream under the dressing.
5. Remove the paper layer. Carefully iron the edges of the dressing against the skin. Then let it sit for at least 60 minutes.
6. The doctor or nurse removes the dressing and cream just before the procedure (for example just before the needle stick).
If you have used too much Tapin
If you have used more Tapin than the amount stated in the leaflet or more than your doctor, pharmacist or nurse has told you, talk to one of them straight away, even if you have no symptoms.
The symptoms when you have used too much Tapin are enumerated in the list below. If Tapin is used as recommended, these symptoms are unlikely to occur.
- you feel dizzy or faint.
- tingling in the skin around the mouth and numbness in the tongue.
- abnormal taste experience.
- blurred vision
- tinnitus.
- there is also a risk of acute methemoglobinemia (problems with the amount of pigment in the blood).
- the risk is greater if you have taken certain other medicines at the same time. If this were to happen, the skin would turn blue-gray due to lack of oxygen.
In severe cases of overdose, symptoms may include seizures, low blood pressure , slow breathing, respiratory arrest and altered heartbeats. These reactions can be life-threatening.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor, hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact a doctor or pharmacist if any of the following side effects become troublesome or persist. Tell the doctor if there is anything else that makes you feel unwell while you are using Tapin.
A mild reaction (pale or reddened skin, slight swelling, burning or itching sensation at the beginning) may occur on the skin where Tapin is used. These are normal reactions to the cream and anesthetic. They disappear after a short while without you having to do anything.
If you get any bothersome or unusual reactions while using Tapin, stop using the cream and talk to your doctor or pharmacist as soon as possible.
Common side effects (may affect up to 1 in 10 users):
- Transient local skin reactions (paleness, redness, swelling) on the treated area when treating skin, genital mucosa or leg ulcers.
- In the beginning, a slight burning sensation, itching or feeling of heat in the treated area when treating mucous membranes on the genitals or leg ulcers.
Uncommon side effects (may affect up to 1 in 100 users):
- In the beginning, a slight burning sensation, itching or feeling of warmth in the treated area when treating the skin.
- Numbness (pins and needles) in the treated area when treating genital mucosa .
- Irritated skin in the treated area when treating leg ulcers
Rare side effects (may affect up to 1 in 1,000 users):
- Allergic reactions, which in rare cases can turn into anaphylactic shock (rash, swelling, fever, difficulty breathing and fainting) when treating skin, genital mucosa on genitals or leg ulcers.
- Methemoglobinemia (blood disorder) in the treatment of skin.
- Small point-shaped bleeding in the treated area (especially in children with eczema if the cream is left on the skin for a long time) when treating the skin.
- Eye irritation if Tapin accidentally comes into contact with the eyes when treating the skin.
More severe side effects in children
Methemoglobinemia, a blood disorder, is more common in newborns and infants aged 0–12 months, often associated with overdose.
How to store Tapin
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after Utg.dat/EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substances are lidocaine and prilocaine
- Other ingredients are macrogolglycerol hydroxystearate, carbomer, sodium hydroxide, water.
Appearance and package sizes of the medicine
White cream .
5 grams + 3 cover dressings.
Orifarm Generics A/S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB
Box 56048, 102 17 Stockholm
info@orifarm.com