Tigecycline Normon 50 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tigecycline Normon 50 mg powder for solution for infusion EFG

Read the entire leaflet carefully before this medicine is administered to you or your child, as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Tigecycline Normon is and what it is used for

This medicine is an antibiotic belonging to the glycylcycline group, which works by inhibiting the growth of the bacteria causing the infection.

Your doctor has prescribed tigecycline because you or your child is at least 8 years old and has one of the following types of serious infections:

• Complicated skin and soft tissue infections (the tissue beneath the skin), excluding diabetic foot infections.
• Complicated intra-abdominal infections.

Tigecycline is only used when the doctor considers that alternative antibiotics are not suitable.

2. What you need to know before using Tigecycline Normon

Do not use Tigecycline Normon

• If you are allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6). If you are allergic to antibiotics belonging to the tetracycline group (e.g., minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions

Inform your doctor or nurse immediately before starting tigecycline:

• If you have poor or delayed wound healing.
• If you have diarrhoea before taking tigecycline. If you develop diarrhoea during or after treatment, inform your doctor immediately. Do not take any medication for diarrhoea without first consulting your doctor.
• If you have experienced any side effects from using antibiotics belonging to the tetracycline group (e.g., skin sensitivity to sunlight, staining of developing teeth, inflammation of the pancreas, or changes in certain laboratory tests measuring blood clotting).
• If you have or have previously had liver problems. Depending on your liver condition, your doctor may reduce the dose to avoid possible side effects.
• If you have biliary duct obstruction (cholestasis).
• If you have a bleeding disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with tigecycline:

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop severe abdominal pain, nausea, or vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas that may cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider using tigecycline in combination with other antibiotics.
• Your doctor will closely monitor you for the development of any additional bacterial infections. If you develop another bacterial infection, your doctor may prescribe a different antibiotic appropriate for the specific type of infection.
• Although antibiotics such as tigecycline target certain types of bacteria, other bacteria and fungi may continue to grow. This process is known as overgrowth. Your doctor will closely monitor you for any possible infections and treat you if necessary.

Children

Tigecycline must not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and because it may cause permanent dental defects, such as staining of developing teeth.

Other medicines and tigecycline

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Tigecycline may prolong certain tests measuring blood clotting. It is important that you inform your doctor if you are taking certain medicines to prevent excessive blood clotting (called anticoagulants). If so, your doctor will monitor you closely.

Tigecycline may interfere with oral contraceptives (birth control pills). Ask your doctor about the need to use an additional contraceptive method while receiving tigecycline treatment.

Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or cyclosporine). It is important that you inform your doctor if you are taking these medicines so that you can be closely monitored.

Pregnancy and breastfeeding

Tigecycline may cause harm to the foetus. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using tigecycline.

It is unknown whether tigecycline passes into breast milk. Consult your doctor before starting breastfeeding.

Driving and using machines

Tigecycline may cause side effects such as dizziness. This could reduce your ability to drive or operate machinery.

3. How to use Tigecycline Normon

Tigecycline must be administered by a doctor or nurse.

The recommended dose of tigecycline in adults is a loading dose of 100 mg, followed by 50 mg every 12 hours. These doses are administered intravenously (directly into the bloodstream) over a period of 30 to 60 minutes.

The recommended dose in children aged 8 to <12 years is 1.2 mg/kg administered intravenously every 12 hours, up to a maximum dose of 50 mg every 12 hours.

The recommended dose for adolescents aged 12 to <18 years is 50 mg administered every 12 hours.

The usual duration of treatment is 5 to 14 days. Your doctor will decide the appropriate duration of treatment for you.

If you receive more tigecycline than you should
If you think you may have received more tigecycline than you should have, inform your doctor or nurse immediately.

If a dose of tigecycline was missed
If you are concerned that a dose has not been given, inform your doctor or nurse immediately.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Pseudomembranous colitis may occur with most antibiotics, including tigecycline. Pseudomembranous colitis involves severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which may be a sign of serious intestinal inflammation, and can occur during or after treatment.

Very common adverse effects (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhoea.

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

• Abscesses (pus accumulation), infections.
• Abnormalities in certain laboratory tests indicating reduced blood clotting ability.
• Dizziness.
• Vein irritation at the injection site, including pain, inflammation, swelling, and blood clot formation.
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in blood).
• Pruritus (itching), skin rash.
• Poor or delayed wound healing.
• Headache.
• Increased amylase (an enzyme present in the salivary glands and pancreas), increased blood urea nitrogen (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (a serious infection affecting the entire body and bloodstream)/septic shock (a life-threatening medical condition resulting from sepsis that may lead to multiple organ failure and death).
• Local reaction at the injection site (pain, redness, swelling).
• Low levels of protein in blood.

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

• Acute pancreatitis (inflammation of the pancreas causing severe abdominal pain, nausea, and vomiting).
• Jaundice (yellowing of the skin), liver inflammation.
• Low platelet count in blood (which may lead to increased tendency for bleeding and bruising).

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

• Low levels of fibrinogen in blood (a protein involved in blood clotting).

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (ranging from mild to severe, including sudden and widespread allergic reactions that may lead to life-threatening shock [e.g. difficulty breathing, decreased blood pressure, rapid pulse]).
• Liver failure.
• Skin rash, potentially progressing to blistering and severe skin peeling (Stevens-Johnson Syndrome).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tigecycline Normon

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the vial after EXP. The expiry date refers to the last day of the month indicated.

Storage after preparation

Once the powder has been reconstituted and diluted and is ready for use, it should be administered immediately.

The solution of this medicine should be orange in colour after dissolution; if not, it must be discarded immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Tigecycline Normon

The active substance is tigecycline. Each vial contains 50 mg of tigecycline.

The other components are arginine, hydrochloric acid 1N, and nitrogen.

Appearance of the product and contents of the container

This medicine is supplied as a powder for solution for infusion in vials containing orange-coloured powder prior to dilution. This medicine is marketed in packs of ten vials. The powder must be mixed in the vial with a small amount of solution. The vial should be gently shaken until the medicine is dissolved. The solution must then be withdrawn immediately from the vial and added to a 100 ml intravenous infusion bag or another suitable hospital infusion container.

Marketing Authorization Holder responsible for manufacturing

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos, Madrid
Spain

Date of latest revision of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/84604/P_84604.html

The following information is intended for healthcare professionals only.

Instructions for use and handling (see also section 3. of the leaflet “How to use Tigecycline Normon”):

The powder must be reconstituted with 5.3 ml of sodium chloride 9 mg/ml (0.9%) injection solution, dextrose 50 mg/ml (5%) injection solution, or Ringer Lactate injection solution to obtain a tigecycline concentration of 10 mg/ml. The vial should be gently shaken until the active substance is dissolved. Immediately after reconstitution, 5 ml of the reconstituted solution should be withdrawn from the vial and added to a 100 ml intravenous infusion bag or another suitable infusion container (e.g., glass bottle).

To obtain a 100 mg dose, two vials should be reconstituted into one 100 ml intravenous infusion bag or another suitable infusion container (e.g., glass bottle).

Note: the vial contains a 6% overfill. Thus, 5 ml of reconstituted solution corresponds to 50 mg of active substance. The reconstituted solution should be orange in colour; if not, the solution must be discarded. Parenteral products should be inspected visually for particulate matter and discoloration (e.g., green or black particles) prior to administration.

Tigecycline must be administered intravenously through a dedicated line or via a Y-site. If the same intravenous line is used for sequential infusion of other active substances, the line must be flushed before and after tigecycline infusion with 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) dextrose injection solution. The injection must be administered using a solution compatible with tigecycline and any other medication through this common line.

Compatible intravenous solutions include: sodium chloride 9 mg/ml (0.9%) injection solution, dextrose 50 mg/ml (5%) injection solution, and Ringer Lactate injection solution.

When administration is performed via a Y-site, the compatibility of tigecycline diluted in 0.9% sodium chloride for injection has been established with the following drugs or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, lactated Ringer, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.

Tigecycline Normon must not be mixed with other medicines for which compatibility data are not available.

Once reconstituted and diluted in an infusion bag or other suitable infusion container (e.g., glass bottle), tigecycline must be used immediately.

This medicine is intended for single-dose administration only; any unused solution must be discarded.