5 mg / ml + 5 micrograms / mL, 10 mg / ml + 5 micrograms / mL, 20 mg / ml + 5 micrograms / ml injection solution 
mepivacaine hydrochloride and adrenaline

Read all of this leaflet carefully before you are given this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information on: 
1. What Carbocaine adrenaline is and what it is used for 
2. What you need to know before you are given Carbocaine adrenaline 
3. How Carbocaine adrenaline is given 
4. Possible side effects 
5. How to store Carbocaine adrenaline 
6. Contents of the packaging and other information 

What Carbocaine Adrenaline is and what it is used for

Carbocaine adrenaline contains two different active substances. One is mepivacaine hydrochloride, which is a local anesthetic that temporarily blocks the nerve signals in the area where it is injected. The other is adrenaline, which gives mepivacaine hydrochloride a longer-lasting effect. Adrenaline also reduces the risk of side effects.

Carbocaine adrenaline is used to temporarily reduce or remove the sensation in a part of the body.

Mepivacaine hydrochloride and adrenaline contained in Carbocaine adrenaline may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you are given Carbocaine adrenaline

Carbocaine adrenaline should not be given:

  • if you are allergic to mepivacaine hydrochloride, adrenaline, or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to other local anesthetics belonging to the same group (eg bupivacaine, lidocaine )
  • if you are allergic to the preservatives methyl or propyl parahydroxybenzoate (parabens) or para amino benzoic acid (PABA) or are allergic to other local anesthetics belonging to a group called ester – local anesthetics
  • if you are allergic to the preservative sodium metabisulfite.

Warnings and cautions

Talk to your doctor or nurse before giving Carbocaine adrenaline:

  • if you are older or have a reduced general condition
  • if you have a type of arrhythmia in your heart called AV block II or III
  • if you are being treated with antiarrhythmic drugs
  • if you have severe liver disease
  • if you have severe renal impairment
  • if you have very high blood pressure or untreated high blood pressure
  • if you have too much hormone production in the thyroid gland ( hyperthyroidism)
  • if you have heart disease
  • if you have severe diabetes
  • if you have problems with blood circulation in the brain
  • if you have acute porphyria (a hereditary disease that affects the nervous system)

The doctor will be observant of any side effects that may occur in connection with the administration of the drug in the eye.

The doctor will also be careful when giving the medicine in peripheral parts of the body such as fingers (or parts of the body that otherwise have a low blood supply) and when giving large amounts.

Children

Carbocaine adrenaline should not be given to newborns and infants under 6 weeks of age, as their liver has a harder time breaking down the drug.

For the treatment of small children over 6 weeks of age, no data are available and the doctor must therefore be especially careful.

Other drugs and Carbocaine adrenaline

Tell your doctor, pharmacist, or another healthcare professional if you are taking, have recently taken, or might take any other medicines.

Carbocaine adrenaline can affect or be affected by other drugs, such as:

  • other local anesthetics
  • drugs for arrhythmias in the heart

Adrenaline can affect or be affected by other drugs, such as:

  • medicines for high blood pressure, angina, heart failure, arrhythmias, and glaucoma, for the prevention of migraines and after myocardial infarction (non-selective beta-blockers, eg propranolol)
  • inhaled anesthetics
  • antidepressants ( tricyclic antidepressants )
  • medicines used to expel the placenta and reduce bleeding after childbirth (medicines of the ergotamine type )
  • medicines used to treat psychosis, such as sleeping pills and nausea (phenothiazines and butyrophenones).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy: 

There are no known risks of using this medicine during pregnancy.

Carbocaine adrenaline is not recommended for so-called cervical anesthesia during childbirth.

Breast-feeding:

Carbocaine adrenaline passes into breast milk, but it is unlikely to have any effects on the breast-fed baby. It is not known whether adrenaline passes into breast milk, but it is unlikely that breastfed babies can be affected.

Driving and using machines

Depending on the dose you receive and how it is given, Carbocaine adrenaline can have a transient effect on your mobility, coordination, and attention.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Carbocaine adrenaline contains sodium metabisulfite, methyl parahydroxybenzoate, and sodium chloride

Carbocaine adrenaline contains sodium metabisulfite (E223) which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea. Tell your healthcare provider if you are allergic to sodium metabisulfite.

Carbocaine adrenaline contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed) and, exceptionally, convulsions in the trachea.

Carbocaine adrenaline 5 mg / ml + 5 micrograms / ml contains 0.142 mmol (3.23 mg) sodium per milliliter. This should be considered by patients on a low-salt diet.

Carbocaine adrenaline 10 mg / ml + 5 micrograms / ml contains 0.133 mmol (3.10 mg) sodium per milliliter. This should be considered by patients on a low-salt diet.

Carbocaine adrenaline 20 mg / ml + 5 micrograms / ml contains 0.116 mmol (2.67 mg) sodium per milliliter. This should be considered by patients on a low-salt diet.

How Carbocaine Adrenaline is given

You will receive the medicine from a doctor or nurse, in the form of an injection. Dose one of Carbocaine adrenaline is determined by the doctor and depends on the type of anesthesia you need, the area to be anesthetized, and the duration of the anesthesia. The doctor adjusts the dose to your age, weight, and general health and uses the lowest possible dose that provides adequate anesthesia.

Use for children

Carbocaine adrenaline should not be given to newborns and infants under 6 weeks of age. For children between 6 weeks of age and 12 years of age, the doctor calculates the appropriate dose based on the patient’s weight.

If you take more Carbocaine adrenaline than you should

If you think you have been given too much medicine, tell your doctor or nurse immediately.

In case of overdose, poisoning reactions can occur, usually within 15‑60 minutes. If Carbocaine adrenaline is accidentally injected into a blood vessel, intoxication reactions may occur immediately (within seconds or minutes). The reactions mainly affect the central nervous system and the cardiovascular system. The first symptoms are usually a feeling of intoxication, numbness around the mouth and in the tongue, visual disturbances, tinnitus, and sensitivity to sound. Then you may have more severe symptoms, such as difficulty speaking clearly, muscle twitching or shaking, and finally cramps and unconsciousness. In addition, you may have difficulty breathing. In severe cases, you can get a drop in blood pressure, slow heart rate, irregular heartbeat, and even cardiac arrest and respiratory arrest. Such reactions must be treated immediately. Therefore, your doctor always makes sure that there is resuscitation equipment nearby when using Carbocaine adrenaline.

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

4. Possible side effects

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

If you experience the following symptoms, stop treatment, and contact a doctor immediately :

  • signs of intoxication reactions in the central nervous system, such as cramps, tingling or numbness around the mouth, numbness in the tongue, increased sensitivity to sound, visual disturbances, loss of consciousness, tremors, intoxication, tinnitus, difficulty speaking clearly, CNS depression (drowsiness, impaired breathing declining heart rate, unconsciousness, coma ) (uncommon side effects, may affect up to 1 in 100 people)
  • cardiac arrest ( rare side effect )
  • a severe allergic reaction that may be life-threatening, with symptoms such as difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure(anaphylactic shock ) ( rare side effect )

Other side effects that may occur:

Very common (may affect more than 1 user in 10) :

  • low blood pressure
  • nausea.

Common (may affect up to 1 in 10 people) :

  • high blood pressure
  • dizziness
  • tingling sensation in the skin
  • slow heart rate
  • vomiting.

Rare (may affect up to 1 in 1,000 people):

  • irregular heartbeat
  • allergic reactions
  • breathing difficulties
  • pathological changes or damage to the nerves
  • Inflammation of the arachnoid membrane (the middle meninges)
  • double vision

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Carbocaine adrenaline

Keep this medicine out of the sight and reach of children.

Do not store above 15 ° C. Do not freeze. Sensitive to light. Store in the outer carton.

The vial may be used for a maximum of three days after opening.

Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP. date. The expiration date is the last day of the specified month.

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. Contents of the packaging and other information

Content declaration

  • The active substances are mepivacaine hydrochloride and adrenaline. One ml contains 5 mg, 10 mg, and 20 mg of mepivacaine hydrochloride and 5 micrograms of adrenaline respectively.
  • The other ingredients are sodium chloride, sodium metabisulfite (E223), methyl parahydroxybenzoate (E218) ( preservative ), sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injections. See section 2 “Carbocaine adrenaline contains sodium metabisulphite, methyl parahydroxybenzoate, and sodium chloride” for further information.

What the medicine looks like and the contents of the pack

Carbocaine adrenaline is a solution for injection provided in glass vials.

One vial contains 20 ml.

One pack contains 5 vials.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Aspen Pharma Trading Limited

3016 Lake Drive, Citywest Business Campus

Dublin 24, Ireland

Tel .: 0046 856642572

Manufacturer

AstraZeneca AB

151 85 Södertälje

Muhammad Nadeem

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