10 mg / ml and 20 mg / ml injection solution 
mepivacaine

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.

In this leaflet you will find information about: 
1. What Carbocaine is and what it is used for 
2. What you need to know before you are given Carbocaine 
3. How Carbocaine is given 
4. Possible side effects 
5. How to store Carbocaine 
6. Contents of the packaging and other information 

1. What Carbocaine is and what it is used for

Carbocaine contains the active substance mepivacaine hydrochloride, which is a local anesthetic. It temporarily blocks the nerve signals in the area where it is injected.

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

Mepivacaine hydrochloride contained in Carbocaine 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

Carbocaine should not be given:

  • if you are allergic to mepivacaine hydrochloride 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 )
  • as back anesthesia (epidural anesthesia) if you are in severe shock (ie have extremely low blood pressure, eg in severe heart problems or large blood or fluid losses).

Warnings and cautions

Talk to your doctor or nurse before giving Carbocaine:

  • if you are older or have a reduced general condition
  • if you have heart disease
  • 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 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 medicine being given in the eye or as a spinal anesthetic (epidural anesthesia).

Children

Carbocaine 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

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

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

  • other local anesthetics
  • drugs for arrhythmias in the heart

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 is not recommended for so-called cervical anesthesia during childbirth or for spinal anesthesia (epidural anesthesia) for cesarean section.

Breast-feeding:

Carbocaine passes into breast milk, but it is unlikely to have any effects on the breast-fed baby.

Driving and using machines

Depending on the dose you receive and how it is given, Carbocaine 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 contains sodium chloride

Carbocaine 10 mg / ml contains 0.137 mmol (3.15 mg) sodium per milliliter. This should be considered by patients on a low-salt diet.

Carbocaine 20 mg / ml contains 0.120 mmol (2.75 mg) sodium per milliliter. This should be considered by patients on a low-salt diet.

3. How Carbocaine is given

You will receive the medicine from a doctor or nurse, in the form of an injection. Dose one of Carbocaine is determined by your 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 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 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 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.

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 decreasing 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. Postal address

5. How to store Carbocaine

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

Do not store above 25 ° C. Do not freeze.

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

Solution without preservatives must be consumed immediately after the packaging has been broken.

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 substance is mepivacaine hydrochloride. One ml contains 10 mg and 20 mg mepivacaine hydrochloride, respectively.
  • The other ingredients are sodium chloride (see section 2 “Carbocaine contains sodium chloride” for further information), sodium hydroxide and/or hydrochloric acid (for pH adjustment), and water for injections.

What the medicine looks like and contents of the pack

Carbocaine is a solution for injection provided in glass vials.

One vial contains 20 ml of solution.

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

Leave a Reply