Leaflet: information for the user

Tigeciclina Normon 50 mg powder for solution for infusion EFG

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

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

1. What isTigeciclina Normonand what is it used for

2. What you need to know before starting to useTigeciclina Normon

3. How to useTigeciclina Normon

4. Possible side effects

5. Storage ofTigeciclina Normon

6. Contents of the pack and additional information

This medicationis an antibiotic from the group of glycyclins that acts by blocking the growth of the bacteria that causes the infection.

Your doctor has prescribed tigeciclina because you or your child, at least 8 years old, suffers from at least one of the following severe types of infections:

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

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

Do not use Tigeciclina Normon

• If you are allergic to tigeciclina or any of the other components of this medication (listed in section 6). If you are allergic to antibiotics in the tetracycline group (e.g., minocycline, doxycycline, etc.), you may be allergic to tigeciclina.

Warnings and precautions

Inform your doctor or nurse immediately before starting to use tigeciclina:

• If you have slow or poor wound healing.
• If you have diarrhea before taking tigeciclina. If you experience diarrhea during treatment or after treatment, inform your doctor immediately. Do not take any medication for diarrhea without consulting your doctor first.
• If you have or have had any side effects due to the use of antibiotics in the tetracycline group (e.g., sensitivity to sunlight, tooth discoloration in developing teeth, pancreatitis inflammation, and alteration of certain laboratory tests to measure if your blood clots properly).
• If you have or have had liver disorders. Depending on your liver condition, your doctor may reduce the dose to avoid potential side effects.
• If you have bile duct obstruction (cholestasis).
• If you have a bleeding disorder or are taking anticoagulant medications, as this medication may interfere with blood clotting.

During treatment with tigeciclina:

• Inform your doctor immediately if you develop symptoms of an allergic reaction.
• Inform your doctor immediately if you develop severe abdominal pain, nausea, and vomiting. These may be symptoms of acute pancreatitis (inflammation of the pancreas that can cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use tigeciclina in combination with other antibiotics.
• Your doctor will closely monitor you for the appearance of any other bacterial infections. If you contract another bacterial infection, your doctor may prescribe a different antibiotic specific to the type of infection you have.
• Although antibiotics like tigeciclina attack certain types of bacteria, other bacteria and fungi may continue to grow. This process is called overgrowth. Your doctor will closely monitor you to detect any possible infection and treat you if necessary.

Children

Tigeciclina should 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 induce permanent dental defects, such as discoloration of developing teeth.

Other medications and tigeciclina

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

Tigeciclina may prolong certain tests that measure if your blood clots properly. It is essential to inform your doctor if you are taking certain medications to avoid excessive blood clotting (called anticoagulants). In this case, your doctor will closely monitor you.

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

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

Pregnancy and breastfeeding

Tigeciclina may cause harm to the fetus. If you are pregnant or breastfeeding, believe you may be pregnant, or plan to become pregnant, consult your doctor before using tigeciclina.

The passage of tigeciclina into breast milk is unknown. Consult your doctor before starting breastfeeding.

Driving and operating machines

Tigeciclina may cause side effects such as dizziness. This may reduce your ability to drive or operate machines.

Tigeciclina should be administered by a doctor or nurse.

The recommended dose of tigeciclina in adults is an initial 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>

The recommended dose for adolescents aged 12 to <18>

The normal duration of treatment is 5 to 14 days. It will be your doctor who decides the appropriate duration of treatment for you.

If you receive more tigeciclina thanIf you think you may have received more doses of tigeciclina than you should, inform your doctor or nurse immediately.

If you forget to administer a dose of tigeciclina

If you are concerned that you have not received a dose, inform your doctor or nurse immediately.

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Pseudomembranous colitis may appear with most antibiotics, including tigecycline. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which may be a symptom of severe intestinal inflammation, which may appear during or after treatment.

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

• Nausea, vomiting, diarrhea.

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

• Abscesses (accumulation of pus), infections.
• Alterations in certain laboratory tests indicating a decrease in the ability to clot blood.
• Dizziness.
• Irritation of the vein in which the medication is injected, including pain, inflammation, swelling, and clot formation.
• Abdominal pain, dyspepsia (stomach pain and sensation of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in blood).
• Pruritus (itching), skin rash.
• Slow or delayed wound healing.
• Headache.
• Increased amylase, which is an enzyme present in salivary glands and the pancreas, increased urea nitrogen in blood (BUN).
• Pneumonia.
• Low blood sugar levels.
• Sepsis (severe infection affecting the entire body and blood)/septic shock (serious medical condition resulting from sepsis and may lead to failure of multiple organs and death).
• Local reaction at the injection site (pain, redness, inflammation).
• Low blood protein levels.

Rare side effects are (may affect up to 1 in 100 people):

• Acute pancreatitis (inflammation of the pancreas that produces severe abdominal pain, nausea, and vomiting).
• Icterus (yellowing of the skin), liver inflammation.
• Low platelet counts in blood (which may lead to an increase in bleeding tendency and appearance of petechiae/hematomas).

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

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

Side effects of unknown frequency are (frequency cannot be estimated from available data):

• Anaphylactic/anaphylactoid reactions (which may range from mild to severe, including a sudden and generalized allergic reaction that may lead to life-threatening shock [e.g., difficulty breathing, decreased blood pressure, rapid pulse]).
• Liver failure.
• Skin rash, which may lead to severe blistering and peeling of the skin (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears in the vial after CAD. The expiration date is the last day of the month indicated.

Storage after preparation

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

The solution of this medication should have an orange color after dissolution, if not, it must be discarded immediately.

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and of the medications that you no longer need. In this way, you will help to protect the environment.

Tigecycline Normon Composition

The active ingredient 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 package

This medication is supplied in the form of a powder for solution for infusion in vials containing orange-colored powder before being diluted. This medication is marketed in packages of ten vials. The powder must be mixed in the vial with a small amount of solution. The vial must be shaken gently until the medication dissolves. Subsequently, the solution must be removed immediately from the vial and added to a 100 ml intravenous infusion bag or other suitable hospital infusion container.

Responsible marketing authorization holder and manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Last review date of this leaflet:February 2025

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/

The following information is intended only for healthcare professionals.

Instructions for use and handling (see also section3.of the prospectus“How to use Tigecycline Normon”):

The powder must be reconstituted with 5.3 ml of 0.9% sodium chloride injection solution (9 mg/ml), with 5% dextrose injection solution (50 mg/ml), or with Ringer Lactate injection solution to achieve a concentration of 10 mg/ml of tigecycline. The vial must be shaken gently until the active ingredient dissolves. Subsequently, 5 ml of the reconstituted solution must be removed immediately from the vial and added to a 100 ml intravenous infusion bag or other suitable infusion container (e.g., glass bottle).

To obtain a dose of 100 mg, two vials must be reconstituted in a 100 ml intravenous infusion bag or other suitable infusion container (e.g., glass bottle).

Nota: The vial contains an excess of 6% of the dose. Thus, 5 ml of the reconstituted solution are equivalent to 50 mg of the active ingredient. The reconstituted solution must be orange in color; if it is not, the solution must be discarded. Parenteral products must be visually inspected to verify the presence of particles in suspension or changes in the color of the particles (e.g., green or black) before administration.

Tigecycline must be administered intravenously through an exclusive route or through a Y-route. If the same intravenous route is used for the sequential perfusion of other active ingredients, the route must be cleaned before and after the perfusion of tigecycline with a 0.9% sodium chloride injection solution (9 mg/ml) or with a 5% dextrose injection solution (50 mg/ml). The injection must be made with a solution compatible with tigecycline and any other medication through this common route.

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

When administration is performed through a Y-route, the compatibility of tigecycline, diluted in 0.9% sodium chloride for injection, has been verified with the following drugs or diluents: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Ringer lactate, 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 medications for which compatibility data are not available.

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

This medication should only be used for the administration of a single dose; any unused solution must be discarded.