Package Leaflet: Information for the User

Tigeciclina Accord 50 mg Powder for Solution for Infusion EFG

tigeciclina

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

• 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 side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Tigeciclina Accord is an antibiotic belonging to the group of glycyclcyclines that acts by blocking the growth of the bacteria causing the infection.

Your doctor has prescribed Tigeciclina Accord 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 beneath the skin), excluding diabetic foot infections.

• Complicated intra-abdominal infections.

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

No use Tigeciclina Accord

• If you are allergic to tigecycline 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 tigecycline.

Warnings and precautions

Inform your doctor or nurse immediately before taking Tigeciclina Accord:

• If you have slow or poor wound healing.
• If you have diarrhea before taking Tigeciclina Accord. 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 adverse effects due to the use of antibiotics in the tetracycline group (e.g. sensitivity to sunlight, tooth discoloration in development, inflammation of the pancreas, and alteration of certain laboratory tests to measure if your blood clots properly).

in development

• If you have or have had liver disorders. Depending on your liver condition, your doctor may reduce the dose to avoid possible side effects.

• If you have bile duct obstruction (cholestasis).

• If you have a bleeding disorder or are being treated with anticoagulant medications, as this medication may interfere with blood clotting.

During treatment with Tigeciclina Accord:

• 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 may cause severe abdominal pain, nausea, and vomiting).
• In certain severe infections, your doctor may consider the need to use Tigeciclina Accord 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 Accord 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 Accord should not be used in children under 8 years old 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 development.

Other medications and Tigeciclina Accord

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

Tigeciclina Accord 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). If so, your doctor will closely monitor you.

Tigeciclina Accord 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 Tigeciclina Accord.

Tigeciclina Accord 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 Accord 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 taking this medication.

The safety of tigecycline in breastfeeding women is unknown. Consult your doctor before starting breastfeeding.

Driving and operating machinery

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

Tigeciclina Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml of solution, which is essentially sodium-free.

Tigeciclina Accord should be administered by a doctor or nurse.

The recommended dose 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 Accord than you should

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

If you forget to administer a dose of Tigeciclina Accord

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

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

Pseudomembranous colitis may appear with most antibiotics, including Tigeciclina Accord. 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 feeling of indigestion), anorexia (loss of appetite).
• Increased liver enzymes, hyperbilirubinemia (excess bilirubin in the 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 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 potentially leading 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 the blood (which may lead to an increased tendency for bleeding and the 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]).
• Hepatic failure.
• Skin rash, potentially leading to severe blistering and skin peeling (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 not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.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 below 30°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

Reconstituted solution: Chemical and physical stability up to use has been demonstrated for 6 hours at 20-25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions up to use before use are the responsibility of the user and will not be greater than the times indicated above for chemical and physical stability up to use.

Diluted solution: Chemical and physical stability up to use has been demonstrated for 24 hours at 20-25°C and 49 hours at 2-8°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times and conditions up to use before use are the responsibility of the user and will not be greater than the times indicated above for chemical and physical stability up to use.

Tigeciclina Accord solution should have a color between yellow and orange after dissolution, if not, it should be discarded immediately.

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

Composition of Tigeciclina Accord

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

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

Appearance of Tigeciclina Accord and contents of the package

Tigeciclina Accord is supplied in the form of a powder for solution for infusion in vials containing orange-colored powder before being diluted. Tigeciclina Accord is marketed in a package of one vial or ten vials.

Only some package sizes may be marketed.

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 an intravenous infusion bag of 100 ml or another suitable hospital infusion container.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll de Barcelona, s/n,

Edifici Est 6th floor,

08039 Barcelona, Spain

Manufacturers:

Accord Healthcare Polska Sp.z o.o.

ul. Lutomierska 50,

95-200 Pabianice

Poland

Or

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind.

Zona Franca, Barcelona, 08040,

Spain

Last review date of this leaflet{MM/AAAA}.

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

Instructions for use and handling (see also section3.of the leaflet “How to use Tigeciclina Accord”):

The powder must be reconstituted with 5.3 ml of injectable sodium chloride solution 9 mg/ml (0.9%), with injectable dextrose solution 50 mg/ml (5%), or with injectable Ringer Lactate solution to achieve a concentration of 10 mg/ml of tigeciclina. 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 an intravenous infusion bag of 100 ml or another suitable infusion container (e.g. glass bottle).

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

Nota: The vial contains an excess of 6% of the dose. Thus, 5 ml of reconstituted solution are equivalent to 50 mg 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.

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

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

When administration is performed through a Y-connector, the compatibility of tigeciclina, diluted in sodium chloride for injection 0.9%, 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.

Tigeciclina Accord must not be mixed with other medications for which there are no compatibility data.

Reconstituted solution: Chemical and physical stability has been demonstrated for up to 6 hours at 20-25°C. From a microbiological point of view, the product must be used immediately. If not used immediately, storage times and conditions until use are the responsibility of the user and will not exceed the times indicated above for chemical and physical stability until use.

Diluted solution: Chemical and physical stability has been demonstrated for up to 24 hours at 20-25°C and 49 hours at 2-8°C. From a microbiological point of view, the product must be used immediately. If not used immediately, storage times and conditions until use are the responsibility of the user and will not exceed the times indicated above for chemical and physical stability until use.

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