Teicoplanin Seacross 400 mg powder for solution for injection/infusion or oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Teicoplanin Seacross is and what it is used for
2. What you need to know before you are given Teicoplanin Seacross
3. How to use Teicoplanin Seacross
4. Possible side effects
5. How to store Teicoplanin Seacross
6. Contents of the pack and other information

• you are allergic to teicoplanin or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before you are given Teicoplanin Seacross if:

• you are allergic to an antibiotic called ‘vancomycin’
• you have had a flushing of your upper part of your body (red man syndrome)
• you have a decrease in platelet count (thrombocytopenia)
• you have kidney problems
• you are taking other medicines which may cause hearing problems and/or kidney problems. You may have regular tests to check if your kidneys and/or liver are working properly (see ‘Other medicines and Teicoplanin Seacross’).

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Teicoplanin Seacross.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of teicoplanin. If you develop a serious rash or other skin symptoms as described in section 4, stop taking Teicoplanin Seacross and contact your doctor or seek medical attention immediately.

During treatment you may have tests to check your blood, your kidneys, your liver and/or your hearing. This is more likely if:

• your treatment will last for a long time
• you need to be treated with high loading doses (12mg/kg twice a day)
• you have a kidney problem
• you are taking or may take other medicines that may affect your nervous system, kidneys or hearing.

In people who are given teicoplanin for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this.

Tell your doctor, pharmacist or nurse if you are using, have recently used or might use any other medicines. This is because teicoplanin can affect the way some other medicines work. Also, some medicines can affect the way teicoplanin works. In particular, tell your doctor, pharmacist or nurse if you are taking the following medicines:

• Aminoglycosides as they must not be mixed together with teicoplanin in the same injection. They may also cause hearing problems and/or kidney problems.
• amphotericin B - a medicine that treats fungal infections which may cause hearing problems and/or kidney problems
• ciclosporin - a medicine that affects the immune system which may cause hearing problems and/or kidney problems
• cisplatin - a medicine that treats malignant tumors which may cause hearing problems and/or kidney problems
• water tablets (such as furosemide) - also called ‘diuretics’ which may cause hearing problems and/or kidney problems.

If any of the above apply to you, (or you are not sure), talk to your doctor, pharmacist or nurse before being given Teicoplanin Seacross.

If you are pregnant, think that you might be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before being given this medicine. They will decide whether or not you are given this medicine while you are pregnant. There may be a potential risk of inner ear and kidney problems.

Tell your doctor if you are breast-feeding, before being given this medicine. He/she will decide whether or not you can keep breast-feeding, while you are given Teicoplanin Seacross. Studies in animal reproduction have not shown evidence of fertility problems.

You may have headaches or feel dizzy while being treated with Teicoplanin Seacross. If this happens, do not drive or use any tools or machines.

This medicine contains less than 1 mmol sodium (23 mg) per vial and is essentially ‘sodium-free’.

Adults and children (12 years and over) with no kidney problems

Skin and soft tissue, lung and urinary tract infections

• Starting dose (for the first three doses): 6 mg for every kilogram of body weight, given every 12 hours, by injection into a vein or muscle
• Maintenance dose: 6 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle

Bone and joint infections, and heart infections

• Starting dose (for the first three to five doses): 12 mg for every kilogram of body weight, given every 12 hours, by injection into a vein
• Maintenance dose: 12 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle

Infection caused by ‘Clostridium difficile’ bacteria

The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days.

Adults and elderly patients with kidney problems

If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment:

• For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day.
• For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day.

Peritonitis for patients on peritoneal dialysis

The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by:

• Week one: 20 mg/L in each dialysis bag
• Week two: 20 mg/L in every other dialysis bag
• Week three: 20 mg/L in the overnight dialysis bag.

Babies (from birth to the age of 2 months)

• Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein.
• Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein.

Children (from 2 months to 12 years)

• Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every 12 hours, by injection into a vein.
• Maintenance dose: 6 to 10 mg for every kilogram of body weight, given once a day, by injection into a vein.

The medicine will normally be given to you by a doctor or nurse.

• It will be given by injection into a vein (intravenous use) or muscle (intramuscular use).
• It can also be given as an infusion through a drip into a vein.

Only the infusion should be given in babies from birth to the age of 2 months.

To treat certain infections, the solution may be taken by mouth (oral use).

It is unlikely that your doctor or nurse will give you too much medicine. However, if you think you have been given too much Teicoplanin Seacross or if you are agitated, talk to your doctor or nurse straight away.

Your doctor or nurse will have instructions about when to give you Teicoplanin Seacross. It is unlikely that they will not give you the medicine as prescribed. However, if you are worried, talk to your doctor or nurse.

Do not stop having this medicine without first talking to your doctor, pharmacist or nurse.

Stop your treatment and tell your doctor or nurse straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• sudden life-threatening allergic reaction - the signs may include: difficulty in breathing or wheezing, swelling, rash, itching, fever, chills

Rare (may affect up to 1 in 1000 people)

• flushing of the upper body

Not known (frequency cannot be estimated from the available data)

• blistering of the skin, mouth, eyes or genitals - these may be signs of something called ‘toxic epidermal necrolysis’ or ‘Stevens-Johnson syndrome’
• red scaly widespread rash with bumps under the skin (including your skin folds, chest, abdomen, (including stomach), back and arms) and blisters accompanied by fever - these may be symptoms of something called ‘Acute generalized exanthematous pustulosis (AGEP)’
• ‘drug reaction with eosinophilia and systemic symptoms (DRESS)’. DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

Tell your doctor or nurse straight away, if you notice any of the side effects above.

Uncommon (may affect up to 1 in 100 people)

• swelling and clotting in a vein
• difficulty in breathing or wheezing (bronchospasm)
• getting more infections than usual - these could be signs of a decrease in your blood cell count

Not known (frequency cannot be estimated from the available data)

• lack of white blood cells - the signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• kidney problems or changes in the way your kidneys work - shown in tests. Frequency or severity of kidney problems may be increased if you receive higher doses
• epileptic fits

Tell your doctor or nurse straight away, if you notice any of the side effects above.

Talk to your doctor, pharmacist or nurse if you get any of these:

Common (may affect up to 1 in 10 people)

• Rash, erythema, pruritus
• Pain
• Fever

Uncommon (may affect up to 1 in 100 people)

• decrease in platelet count.
• raised blood levels of liver enzymes
• raised in blood levels of creatinine (to monitor your kidney)
• hearing loss, ringing in the ears or a feeling that you, or things around you are moving
• feeling or being sick (vomiting), diarrhoea
• feeling dizzy or headache

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

• infection (abscess).

Not known (frequency cannot be estimated from the available data)

• problems where the injection was given - such as reddening of the skin, pain or swelling
• low levels of all types of blood cells.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

United Kingdom

You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is teicoplanin. Each vial contains either 200 mg or 400 mg teicoplanin.
• The other ingredients are sodium chloride and sodium hydroxide.

Teicoplanin Seacross is a powder for solution for injection/infusion or oral solution.

The powder is almost white to pale yellow loose lyophilised mass and powder. The powder is packaged:

• in a Type I, colourless glass vial of useful volume of 10 mL for 200 mg sealed with butyl rubber stopper and aluminum flip-off seal.
• in a Type I, colourless glass vial of useful volume of 20 mL for 400 mg sealed with butyl rubber stopper and aluminum flip-off seal.

Pack size:

• 1 powder vial

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