1 g and 3 g powder for solution for injection / infusion, benzylpenicillin sodium solution

Read all of this leaflet carefully before you start using 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 pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Benzylpenicillin Meda is and what it is used for 
2. What you need to know before you use Benzylpenicillin Meda 
3. How to use Benzylpenicillin Meda 
4. Possible side effects 
5. How to store Benzylpenicillin Meda 6. Contents of the pack 
and other information 

1. What Benzylpenicillin Meda is and what it is used for

Benzylpenicillin Meda is a medicine that works against bacterial infections (an antibiotic ).

Benzylpenicillin Meda is used to treating infections caused by benzylpenicillin-sensitive bacteria.

Benzylpenicillin sodium contained in Benzylpenicillin Meda may also be approved for the treatment of other conditions not mentioned in this information. If you have any further questions, ask your doctor or pharmacist.

2. What you need to know before you use Benzylpenicillin Meda

Do not use Benzylpenicillin Meda

  • if you are allergic to benzylpenicillin or any of the other ingredients of this medicine (listed in section 6).
  • if you have previously had a severe allergic reaction to penicillin or cephalosporins (another type of antibiotic ).

Warnings and cautions

If any of the following applies to you, talk to your doctor, nurse, or pharmacist before using Benzylpenicillin Meda:

  • if you have impaired kidney function
  • if you have heart failure
  • if you have diarrhea
  • if you are over 60 years old
  • whether this medicine should be given to a newborn.

Other medicines and Benzylpenicillin Meda

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important that your doctor knows if you are taking any of the following:

  • methotrexate ( cytostatics ). Concomitant use with benzylpenicillin may increase the efficacy and toxicity of methotrexate.
  • probenecid (a gout medicine that inhibits the secretion of Benzylpenicillin Meda).

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 or pharmacist for advice before taking this medicine.

There are no known risks with the use of Benzylpenicillin Meda during pregnancy.

Benzylpenicillin passes into breast milk but the risk of affecting the baby is unlikely.

Driving and using machines

Benzylpenicillin Meda has no or negligible effect on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.

Benzylpenicillin Meda contains sodium

Benzylpenicillin Meda 1 g contains 64 mg sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 3.2% of the maximum recommended daily intake of sodium for adults.

Benzylpenicillin Meda 3 g contains 193 mg of sodium (the main ingredient in table salt/table salt) per vial. This corresponds to 9.7% of the maximum recommended daily sodium intake for adults.

Talk to your doctor or pharmacist if you are being treated with 7 g or more daily for an extended period of time, especially if you have been prescribed a low-salt (sodium-poor) diet.

How to use Benzylpenicillin Meda

You will receive this medicine as an injection by a doctor or nurse.

The doctor will determine the appropriate dose for you, and how and when the injection should be given.

Benzylpenicillin Meda is a dry powder that is dissolved by the doctor or nurse in a suitable diluent. The solution is given either in a blood vessel or muscle as an injection or via a blood vessel as a drip infusion.

If you take more Benzylpenicillin Meda than you should

Because an injection is given by a doctor or nurse, it is unlikely that you will receive too much.

If you think you have been given too much, you must tell the person who gave the injection.

Symptoms of overdose may include nausea, vomiting, diarrhea, loss of consciousness, seizures.

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

4. Possible side effects

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

Tell your doctor immediately if you think the medicine makes you feel sick, or if you experience any of the following:

Allergy to benzylpenicillin which may cause the following symptoms:

  • Skin rash, itching.
  • Difficulty breathing or tightness over the chest.
  • Swelling of eyelids, face, or lips.
  • Swelling or redness of the tongue.
  • Fever.
  • Joint pain.
  • Swollen lymph nodes.

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

  • Rash
  • Inflammation of a blood vessel ( thrombophlebitis ).

Uncommon (may affect up to 1 in 100 people):

  • Increased white blood cell count
  • Hives ( urticaria )
  • Severe allergic reactions.

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

  • Anemia ( anemia )
  • Decreased white blood cell count
  • Diarrhea
  • Itching.

Very rare (may affect up to 1 in 10,000 people):

  • Severe skin reactions.

Has been reported (occurs in an unknown number of users):

  • Decreased platelet count, which may increase the risk of bleeding ( thrombocytopenia ).
  • Decreased white blood cell count, which may increase the risk of infection ( neutropenia ).
  • The jarisch-Herxheimer reaction may occur where Lyme disease is treated with Benzylpenicillin MEDA, and cause fever, chills, headache, muscle aches, and rash.

Kidney effects and fungal overgrowth in the oral cavity and abdomen can also occur.

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 Benzylpenicillin Meda

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

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

Medicines should not be disposed of via wastewater. 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 benzylpenicillin sodium
  • No other ingredients are included in this medicine.

Pack sizes

Vials 5 x 1 g, 10 x 1 g, 5 x 3 g and 10 x 3 g.

Marketing Authorization Holder and Manufacturer

Meda AB

Box 906

170 09 Solna

Phone 08-630 19 00

Muhammad Nadeem

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