Planicid

Package leaflet: Information for the user

Planicid 200 mg powder for injectable/infusion solution or oral solution, 400 mg powder for injectable/infusion solution or oral solution

teicoplanin
Generic medicine
Please read this leaflet carefully before you are given this medicine because it contains
important information for you.

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

What this leaflet contains

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

1. What Planicid is and what it is used for

Planicid is an antibiotic that contains the active substance "teicoplanin". It works by killing the bacteria responsible for infections in your body.
Planicid is used in adults and children (including newborns) to treat bacterial infections of:

• skin and underlying tissues – sometimes called "soft tissues"
• bones and joints
• lungs
• urinary tract
• heart – sometimes called "endocarditis"
• abdominal wall – peritonitis
• blood, when caused by one of the above-mentioned conditions.

Planicid may be used to treat certain intestinal infections caused by the bacterium "Clostridioides difficile". In this case, the solution is taken orally.

2. What you need to know before being given Planicid

Planicid must not be administered:

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

Warnings and precautions
Talk to your doctor, pharmacist or nurse before being given Planicid:

• if you are allergic to an antibiotic called “vancomycin”
• if you have previously experienced redness of the upper part of the body (red man syndrome)
• if you have a low platelet count (thrombocytopenia)
• if you have kidney problems
• if you are taking other medicines that could cause hearing and/or kidney problems. You may need regular tests to monitor whether your kidneys and/or liver are functioning properly (see “Other medicines and Planicid”).

If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist or nurse before being given Planicid.
Severe skin reactions have been reported in association with teicoplanin treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you develop a severe rash or other skin symptoms described in section 4, stop taking Planicid and contact your doctor immediately or seek medical assistance.

Tests
During treatment, you may need to undergo tests to monitor your blood, liver, kidneys and/or hearing. This is more likely:

• if the treatment will last a long time
• if you are to receive high loading doses (12 mg/kg twice daily)
• if you have kidney problems
• if you are taking or may take other medicines that can affect the nervous system, kidneys or hearing.

In patients receiving long-term treatment with Planicid, bacteria not affected by the antibiotic may grow more than usual – your doctor will carry out checks to monitor this possibility.

Other medicines and Planicid
Tell your doctor, pharmacist or nurse if you are using, have recently used, or might use any other medicines. This is because Planicid may affect how other medicines work. In addition, some medicines may affect the way Planicid works.
In particular, inform your doctor, pharmacist or nurse if you are taking the following medicines:

• aminoglycosides, which must not be mixed with Planicid in the same injection. These may also cause hearing and/or kidney problems.
• amphotericin B – a medicine used to treat fungal infections that may cause hearing and/or kidney problems
• cyclosporine – a medicine that affects the immune system and may cause hearing and/or kidney problems
• cisplatin – a medicine used to treat malignant tumours that may cause hearing and/or kidney problems
• diuretic tablets (such as furosemide) which may cause hearing and/or kidney problems.
  If any of the above applies to you (or if you are unsure), talk to your doctor, pharmacist or nurse before being given Planicid.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether or not you should be given this medicine during pregnancy. There may be a potential risk of inner ear and kidney problems for the unborn baby.
If you are breastfeeding, inform your doctor before being given this medicine. Your doctor will decide whether you can continue breastfeeding while receiving Planicid.
Animal reproduction studies have not shown evidence of fertility problems.

Driving and using machines
While being treated with Planicid, you may experience headache or dizziness. If this occurs, do not drive or operate tools or machinery.

Planicid contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is essentially “sodium-free”.

3. How Planicid is administered

The recommended dose is
Adults and adolescents (aged 12 years and older) with normal kidney function
Skin and soft tissue, lung, and urinary tract infections

• Initial dose (for the first 3 doses): 6 mg per kg of body weight, administered every 12 hours by intravenous or intramuscular injection.
• Maintenance dose: 6 mg per kg of body weight, administered once daily by intravenous or intramuscular injection.

Bone and joint infections, and heart infections

• Initial dose (for the first 3–5 doses): 12 mg per kg of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 12 mg per kg of body weight, administered once daily by intravenous or intramuscular injection.

Infections caused by the bacteria ‘Clostridioides difficile’
The recommended dose is 100–200 mg taken orally twice daily for 7–14 days.
Adults and elderly patients with kidney problems
If you have kidney problems, your dose usually needs to be reduced after the fourth day of treatment:

• For patients with mild to moderate kidney impairment: the maintenance dose will be administered every two days, or half the maintenance dose will be given daily.
• For patients with severe kidney impairment or on haemodialysis: the maintenance dose will be administered every three days, or one-third of the maintenance dose will be given daily.

Peritonitis in patients undergoing peritoneal dialysis
The initial dose is 6 mg per kg of body weight, given as a single intravenous injection, followed by:

• Week one: 20 mg/l in each dialysis bag
• Week two: 20 mg/l in alternate bags
• Week three: 20 mg/l in the nighttime bag.

Children (birth to 2 months of age)

• Initial dose (on the first day): 16 mg per kg of body weight, administered as an intravenous infusion.
• Maintenance dose: 8 mg per kg of body weight, administered once daily as an intravenous infusion.

Children (2 months to 12 years of age)

• Initial dose (for the first 3 doses): 10 mg per kg of body weight, administered every 12 hours by intravenous injection.
• Maintenance dose: 6–10 mg per kg of body weight, administered once daily by intravenous injection.

How Planicid is administered
This medicine will generally be administered to you by a doctor or nurse.

• It will be given by intravenous (IV) or intramuscular (IM) injection.
• It may also be administered as an infusion via a catheter. In children from birth up to 2 months of age, it must be administered only by infusion. For the treatment of certain infections, the solution may be taken orally.

If you receive more Planicid than you should
It is unlikely that the doctor or nurse will give you too much medicine. However, if you think you have been given too much Planicid, or if you feel unwell, inform your doctor or nurse immediately.
If you miss a dose of Planicid
The doctor or nurse will have specific instructions on when to administer Planicid. It is unlikely that you will not receive the medicine as prescribed. However, if you are concerned, inform your doctor or nurse.
If you stop treatment with Planicid
Do not stop taking this medicine without first talking to your doctor, pharmacist, or nurse.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop treatment and immediately contact your doctor or nurse 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 allergic reaction that could be life-threatening – signs may include: difficulty breathing or wheezing, swelling, rash, itching, fever, chills

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

• hot flushes in the upper part of the body

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

• skin, mouth, eye or genital lesions – these may be signs of a condition called "toxic epidermal necrolysis" or "Stevens-Johnson syndrome"
• widespread red, scaly rash with bumps under the skin (including skin folds, chest, abdomen (including stomach), back and arms) and blisters accompanied by fever – these may be symptoms of "acute generalised exanthematous pustulosis (AGEP)"
• drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face which then spreads, accompanied by high fever, increased liver enzyme levels in blood tests, increased levels of a type of white blood cell (eosinophilia), and swollen lymph nodes.

Immediately contact your doctor or nurse if you notice any of the side effects listed above.
Immediately contact your doctor or nurse 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)

• swelling and blood clot in a vein
• difficulty breathing or wheezing (bronchospasm)
• increased occurrence of infections – these may be signs of a reduced number of blood cells

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

• lack of white blood cells – signs may include: fever, severe chills, sore throat or mouth ulcers (agranulocytosis)
• low levels of all types of blood cells
• kidney problems or changes in kidney function – shown by blood tests. The frequency and severity of kidney problems may increase if you receive higher doses
• seizures
  Immediately contact your doctor or nurse if you notice any of the side effects listed above.

Other side effects
Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Common (may affect up to 1 in 10 people)

• rash, erythema, itching
• pain
• fever

Uncommon (may affect up to 1 in 100 people)

• decreased number of platelets
• increased liver enzyme levels in blood
• increased creatinine levels in blood (to monitor kidney function)
• hearing loss, ringing in the ears or sensation that you or things around you are moving
• feeling unwell or nausea, diarrhoea
• dizziness 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 at the injection site – such as redness of the skin, pain or swelling

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Planicid

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 and on the label of the
vial after Exp. The expiry date refers to the last day of that month.
Do not store above 25°C.
Information on storage and the duration of use of Planicid after reconstitution and ready for use are
described in the “Practical information for healthcare professionals on the preparation and handling of
Planicid”.

6. Package contents and other information

What Planicid contains

• The active substance is teicoplanin. Each vial contains 200 mg of teicoplanin, equivalent to not less than 200,000 IU. After reconstitution, 3.0 ml of solution contains 200 mg of teicoplanin.

Each vial contains 400 mg of teicoplanin, equivalent to not less than 400,000 IU.
After reconstitution, 3.0 ml of solution contains 400 mg of teicoplanin.

• The other components are sodium chloride and sodium hydroxide (for pH adjustment).

Description of the appearance of Planicid and contents of the pack
Planicid is a powder for injectable solution/infusion or oral solution.
White or pale yellow lyophilized powder.
The lyophilized medicinal product is packaged in:
Type I colourless glass vial with a useful volume of 10 ml for 200 mg, closed with a grey
bromobutyl rubber stopper Hualan 283, sealed with an aluminium seal and a tear-off cap.
Type I colourless glass vial with a useful volume of 20 ml for 400 mg, closed with a grey
bromobutyl rubber stopper Hualan 283, sealed with an aluminium seal and a tear-off cap.
Pack size: 1 vial

Marketing Authorisation Holder
ELC Group s.r.o.
Pobrezni 394/12, Karlin
186 00, Prague 8
Czech Republic

Manufacturer
QPlab - Pharma Services Lda
Campus De Fcul, Campo Grande,
Lisbon, 1749-016,
Portugal

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Teicoplanin ELC 200 mg Powder for the preparation of an injection/infusion solution or oral solution
Teicoplanin ELC 200 mg Powder for the preparation of an injection/infusion solution or oral solution
Bulgaria Planicid 200 mg прах за инжекционен/инфузионен или перорален разтвор
Planicid 400 mg прах за инжекционен/инфузионен или перорален разтвор
Italy Planicid
[To be completed with national data]

The following information is intended exclusively for physicians or healthcare professionals:
Practical information for healthcare professionals on the preparation and handling of Planicid.
This medicine is for single use only.

Method of administration
The reconstituted solution may be injected directly or alternatively further diluted.
The injection may be administered as a bolus over 3-5 minutes or as a 30-minute infusion.
In children from birth up to 2 months of age, administration must be by infusion only.
The reconstituted solution may also be administered orally (oral use).

Preparation of the reconstituted solution
Reconstitute the powder by adding 3.0 ml of water for injections to the vial containing 200 mg or 400 mg of powder. Water for injections should be added slowly to the vial, which should then be rotated gently until the powder is completely dissolved, to avoid foaming. If foaming occurs, allow the solution to stand for approximately 15 minutes until the foam disappears.
Only clear solutions should be used.
The colour of the solution may vary from pale yellow to dark yellow.
The final solution is isotonic with plasma and has a pH of 7.2–7.8.

| Vial content nominal teicoplanin | 200 mg | 400 mg | |----------------------------------|--------|--------| | Powder vial volume | 10 ml | 20 ml | | Volume containing the nominal dose of teicoplanin (extracted with a 5 ml syringe and 23 G needle) | 3.0 ml | 3.0 ml |

Preparation of the diluted solution prior to infusion
Planicid may be administered in the following infusion solutions:

• Sodium chloride 9 mg/ml (0.9%) solution
• Ringer's solution
• Ringer lactate solution
• Dextrose 50 mg/ml (5%) injection
• Dextrose 100 mg/ml (100%) injection
• Sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) solution
• Sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) solution
• Peritoneal dialysis solution containing 13.6 mg/ml (1.36%) or 38.6 mg/ml (3.86%) glucose solution.

Stability period of the reconstituted solution:
Chemical and physical in-use stability of the reconstituted solution prepared as indicated has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.

Stability period of the diluted solution:
Chemical and physical in-use stability of the diluted solution prepared as indicated has been demonstrated for 24 hours at a temperature between 2 and 8°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and must not exceed the time limits indicated above for chemical and physical in-use stability.

Incompatibilities
Teicoplanin and aminoglycosides are incompatible when mixed directly and must not be mixed prior to injection.
If teicoplanin is administered in combination therapy with other antibiotics, the preparations must be administered separately.

Disposal
Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local applicable regulations.