125 mg and 250 mg hard capsules
vancomycin hydrochloride
What Vancomycin Xellia is and what it is used for
Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by killing certain bacteria that cause your infection.
Vancomycin 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 Vancomycin Xellia may also be approved to treat 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.
What you need to know before you take Vancomycin Xellia
Do not take Vancomycin Xellia
- if you are allergic 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 using Vancomycin Xellia if:
- You have ever had a severe skin rash or scaly skin, blisters, and/or sores in your 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.
- You have an inflammatory disease of the gastrointestinal tract (you may be at risk of side effects, especially if you also have kidney disease). Vancomycin 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 Vancomycin Xellia
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
Limited experience of use during pregnancy. 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 Vancomycin Xellia.
Vancomycin is excreted in breast milk. Therefore, consult a doctor before starting treatment with Vancomycin Xellia capsules while breastfeeding.
Driving ability and use of machinery
In rare cases, vancomycin can cause dizziness and lightheadedness. Do not drive or use machines if you are affected.
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. The 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 take Vancomycin Xellia
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.
If you use too much Vancomycin Xellia
If you have ingested too much medicine or if, for example, a child has ingested the drug by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Vancomycin Xellia
Do not take a double dose to make up for the missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
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.
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 people):
- Drop in blood pressure
- 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 people):
- Temporary or permanent hearing loss
Rare side effects (may affect up to 1 in 1,000 people):
- 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
- Vascular 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 people):
- 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 causes abdominal pain and diarrhea, which may contain blood
Has been reported (occurring in an unknown number of people):
- Vomiting, diarrhea
- Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine
- Eruptions 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 Vancomycin Xellia
Keep this medicine out of the sight and reach of children.
The capsules were used before the expiry date on the packaging.
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.
125 mg: 1 capsule contains 125 mg vancomycin hydrochloride equivalent to 125,000 IU vancomycin.
250 mg: 1 capsule contains 250 mg vancomycin hydrochloride equivalent to 250,000 IU vancomycin.
Other ingredients:
Macrogol 6000. The capsule consists of gelatin and the dyes black and yellow iron oxide (E172) and titanium dioxide E171. Capsules 250 mg also contain the dye indigo carmine (E132).
Ink:
Capsule 125 mg: Shellac, propylene glycol, ammonia, potassium hydroxide, black iron oxide (E172). Capsule 250 mg: Shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).
Appearance and package sizes of the medicine
The 125 mg capsule is light grey/grey and marked Vanco/125 mg.
The 250 mg capsule is green/turquoise and labeled Vanco/250 mg.
Xellia Pharmaceuticals ApS
Dalslandsgade 11
2300 Copenhagen S
Denmark