125 mg Capsules
Vancomycin
What Vancocin is and what it is used for
Vancocin contains vancomycin, which is an antibiotic that belongs to a group of antibiotics called ‘glycopeptides’. Vancomycin works by killing certain bacteria that cause your infection.
Vancocin is used in adults and adolescents from the age of 12 for the treatment of infection in the mucosa of the small and large intestine with damage to the mucosa (pseudomembranous colitis ), which is caused by the bacterium Clostridium difficile.
The vancomycin contained in Vancocin may also be approved to treat other conditions not listed in this product information. 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 you use Vancocin
Do not use Vancocin
- if you are hypersensitive to vancomycin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Vancocin if you:
- have reduced kidney function
- have problems with the ears, such as hearing loss
- have an inflammatory disease of the gastrointestinal tract (you may be at risk of side effects, especially if you also have kidney disease)
- have ever had a severe skin rash or scaly skin, blisters, and/or sores in the mouth after taking vancomycin?
Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using vancomycin and contact your doctor immediately if you notice any of the symptoms described in section 4.
Vancocin capsules are not suitable for children under 12 years of age or for adolescents who cannot swallow them. Other formulations of this medicine may be more suitable for children. Ask your doctor or pharmacist.
Children and young people
Vancocin capsules are not suitable for children under 12 years of age or for adolescents who cannot swallow them. Other formulations of this medicine may be more suitable for children. Ask your doctor or pharmacist.
Other medicines and Vancocin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
- Medicines that can damage the kidneys (eg aminoglycoside antibiotics, iodinated contrast agents, platinum-based chemotherapy (cancer medicines), methotrexate at high doses, and certain medicines for viral infections such as pentamidine, foscarnet, aciclovir, ganciclovir, famciclovir, valaciclovir, valganciclovir, ciclosporin or tacrolimus). If these drugs are given at the same time as vancomycin, the harmful effect on the kidneys may be enhanced. In such cases, a careful and regular check of kidney function is necessary.
- Medicines that can damage hearing (eg aminoglycosides, platinum-based chemotherapy, and some diuretics). If these drugs are given at the same time as vancomycin, the harmful effect on hearing may be enhanced. In such cases, a careful and regular check of the hearing function is necessary.
- Muscle relaxants (eg succinylcholine). If these drugs are given at the same time as vancomycin, the effect of the muscle relaxant may be enhanced or prolonged.
The effect of birth control pills may be reduced when Vancocin is used at the same time.
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.
The experience of treatment with vancomycin during pregnancy is limited. If you are pregnant, your doctor should only give you vancomycin if necessary and after carefully weighing the benefits and risks.
Vancomycin is excreted in breast milk. Therefore, consult your doctor or pharmacist before starting the treatment.
Driving ability and use of machinery
Vancocin has no known effects 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Vancocin
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Adults and adolescents (from 12 years and older)
The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to give a higher daily dose of up to 500 mg every 6 hours. The maximum daily dose must not exceed 2 g.
If you have had a mucosal infection before, you may need a different dose and a different treatment time.
Mode of administration
To be swallowed.
Swallow the capsules whole with water.
The usual duration of treatment is 10 days but may vary depending on the individual response to treatment for each patient.
If you used too much Vancocin
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Vancocin
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock ) are rare. Contact a doctor immediately if you suddenly experience wheezing, difficulty breathing, redness of the upper body, rash, or itching.
Stop using vancomycin and contact your doctor immediately if you notice any of the following symptoms:
- Red, non-raised, target-like, or round spots on the trunk, often with blisters in the center, scaly skin, and sores in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome and toxic epidermal necrolysis ).
- Widespread rash, fever, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
- Red, widespread, and scaly rash with subcutaneous nodules and blisters along with fever that occurs at the beginning of treatment ( Acute generalized exanthematous pustulosis )
Absorption of vancomycin from the gastrointestinal tract is negligible. Therefore, side effects after taking capsules are unlikely.
However, if you have an inflammatory disease of the gastrointestinal tract, especially if you also have kidney disease, side effects similar to those that occur when vancomycin is given by infusion may occur. Therefore, side effects and frequencies reported for vancomycin as an infusion are included.
Common side effects ( may affect up to 1 in 10 users):
- blood pressure drop
- shortness of breath, noisy breathing (a raspy sound that occurs due to obstructed airflow in the upper airways)
- rash and inflammation of the mucous membrane of the mouth, itching, itchy rash, hives
- kidney problems that can be seen mainly through blood tests
- redness on the upper body and face, inflammation of a vein.
Uncommon side effects ( may affect up to 1 in 100 users):
- temporary or permanent hearing loss.
Rare side effects ( may affect up to 1 in 1,000 users):
- decrease in white blood cells, red blood cells, and platelets (blood cells responsible for blood clotting)
- increase in certain white blood cells in the blood
- loss of balance, ringing in the ears, dizziness
- blood vessel inflammation
- nausea
- inflammation of the kidneys and kidney failure
- pain in chest and back muscles
- fever chills.
Very rare side effects ( may affect up to 1 in 10,000 users):
- sudden onset severe allergic skin reaction with peeling skin, blisters, or peeling. This may be associated with high fever and joint pain
- cardiac arrest
- inflammation of the intestine causing abdominal pain and diarrhea, which may contain blood.
Has been reported (occurring in an unknown number of users):
- vomiting, diarrhea
- confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine
- rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (swollen lymph nodes ), abnormal blood and liver function tests
- rash with blisters and fever.
How to store Vancocin
Keep this medicine out of the sight and reach of children.
Do not use before the expiry date which is stated on the blister and the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the 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 substance is vancomycin hydrochloride equivalent to 125 mg of vancomycin.
- Other ingredients are macrogol 6000, and gelatin; the capsule dyes: indigo carmine (E132), red and yellow iron oxide (E172), and titanium dioxide (E171); labeling on the capsule: Industrial methyl alcohol, shellac, red iron oxide (E 172), 2-ethoxyethanol, purified water, soy lecithin, Antifoam DC1510.
Appearance and package sizes of the medicine
The capsules are blue/brown, 18 x 6 mm, and marked 125.
30 capsules in printed packaging
Marketing Authorisation Holder
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark
Manufacturer:
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany