Label: information for the user

Tygacil 50mg powder for solution for infusion

tigecycline

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label.See section4.

1.What Tygacil is and for what it is used

2.What you need to know before starting to use Tygacil

3.How to use Tygacil

4.Possible adverse effects

5.Storage of Tygacil

6.Contents of the package and additional information

Tygacil is an antibiotic belonging to the glycylcycline group that acts by blocking the growth of the bacteria causing the infection.

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

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

• Complicated intra-abdominal infections.

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

Do not use Tygacil

• If you are allergic to tigecycline or any of the other components of this medication (listed in section6). If you are allergic to antibiotics in the tetracycline group (e.g. minocycline, doxycycline, etc.), you may be allergic to tigecycline.

Warnings and precautions

Inform your doctor or nurse immediately before taking Tygacil:

• If you have slow or poor wound healing.
• If you have diarrhea before taking Tygacil. 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, pancreatitis, and alteration of certain laboratory tests to measure blood clotting).
• If you have or have had liver problems. 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 Tygacil:

• 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 Tygacil in combination with other antibiotics.
• Your doctor will closely monitor you for the development 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 Tygacil 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

Tygacil should not be used in children under 8years due to the lack of safety and efficacy data in this age group and because it may induce permanent dental defects, such as tooth discoloration in developing teeth.

Use of Tygacil with other medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Tygacil may prolong certain tests that measure blood clotting. It is essential to inform your doctor if you are taking certain medications to avoid excessive blood clotting (called anticoagulants). If so, your doctor will closely monitor you.

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

Tygacil 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

Tygacil may cause harm to the fetus. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using Tygacil.

The safety of Tygacil during breastfeeding is unknown. Consult your doctor before starting breastfeeding.

Driving and operating machinery

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

Tygacil contains sodium

This medication contains less than 1mmol of sodium (23mg) per 5ml of solution; it is essentially “sodium-free”.

Tygacil must be administered by a doctor or nurse.

The recommended dose of Tygacil 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 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 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 Tygacil than you should

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

If you forget to administer a dose of Tygacil

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

Like all medicines, this product may cause side effects, although not everyone will experience them.

Pseudomembranous colitis may appear with most antibiotics, including Tygacil. 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):

• Abcesses (accumulation of pus), infections.
• Laboratory test alterations indicating a decrease in the ability to coagulate 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 poor wound healing.
• Headache.
• Increased amylase, which is an enzyme present in salivary glands and the pancreas, increased blood urea nitrogen (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.

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

• Acute pancreatitis (inflammation of the pancreas causing 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 coagulation).

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]).
• Hepatic failure.
• Skin rash, which may lead to the formation of blisters and severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below25°C. Do not use this medication after the expiration date that appears on the vial. 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.

Tygacil solution should have a coloration between yellow and orange after dissolution, if not, it must be discarded immediately.

Medications should not be thrown down the drains or in the trash.Ask your pharmacist how to dispose ofthe containers and the medications that you no longerneed.By doing so, you will help protect the environment.

Tygacil Composition

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

The other components are lactose monohydrate, hydrochloric acid and sodium hydroxide.

Tygacil Appearance and Packaging

Tygacil is supplied as a powder for solution for infusion in vials containing orange-colored powder before being diluted. Tygacil is marketed in packs of ten vials. The powder must be mixed in the vial with a small amount of solution. The vial must be gently agitated until the medication is dissolved. The solution must then be immediately removed from the vial and added to a 100ml intravenous infusion bag or other suitable hospital infusion container.

Marketing Authorization HolderManufacturer

For more information about this medication, please contact the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel:+34 91 490 99 00

Last Review Date of this Leaflet

For detailed information about this medication, please visit the European Medicines Agency website:http://www.ema.europa.eu.

The following information is intended only for healthcare professionals:

Instructions for Use and Handling (see also section3.of the leaflet“How to use Tygacil”):

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

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

Nota: The vial contains an excess of 6%. Thus, 5 ml of reconstituted solution are equivalent to 50mg of active ingredient. The reconstituted solution must be yellow to orange in color; if 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 a dedicated line or through a Y-line. If the same intravenous line is used for sequential infusion of other active ingredients, the line must be cleaned before and after tigecycline infusion with 9mg/ml sodium chloride injection (0.9%) or 50mg/ml dextrose injection (5%) for injection. The injection must be made with a solution compatible with tigecycline and any other medication through this common line.

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

When administration is performed through a Y-line, 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.

Tygacil 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 infusion container (e.g. glass bottle), tigecycline must be used immediately.

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