Prospect: information for the user

Tigecycline TecniGen 50 mg powder for solution for infusion EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, 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 prospect. See section 4.

Tigeciclina 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 because you or your child, at least 8 years old, suffers from one of the following severe types of infections:

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

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

No use Tigeciclina TecniGen

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

Consult your doctor or nurse before starting to use Tigeciclina.

• If you have poor or slow wound healing.
• If you have diarrhea before taking tigecycline. 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 development, pancreatitis inflammation, and alteration of certain laboratory tests to measure if your blood clots properly).
• If you have or have had previous 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:

• 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 tigecycline 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 tigecycline 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

Tigecycline 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 TecniGen

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

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

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

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

Pregnancy and breastfeeding

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

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

Driving and operating machinery

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

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 than you should

If you believe you may have received more doses of tigeciclina than you should have, 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 can appear with most antibiotics, including tigecycline. Pseudomembranous colitis consists of severe, persistent, or bloody diarrhea associated with abdominal pain or fever, which can be a symptom of severe intestinal inflammation, which can appear during or after treatment.

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

• Nausea, vomiting, diarrhea.

Common side effects are (can 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 urea nitrogen in the 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 can 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 (can 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 the blood (which can lead to an increase in bleeding tendency and appearance of petechiae/hematomas).

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

• Low levels of fibrinogen 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 can range from mild to severe, including a sudden and generalized allergic reaction that can lead to life-threatening shock [e.g., difficulty breathing, decreased blood pressure, rapid pulse]).
• Liver failure.
• Skin rash, which can lead to the formation of blisters and severe skin peeling (Stevens-Johnson syndrome).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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:https://www.notificaram.es.By 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.

Store below 30°C

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 a yellow to orange coloration 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 of the containers and medications that you no longer need. In this way, you will help to protect the environment.

Tigecycline TecniGen Composition

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

The other components are: trehalose, hydrochloric acid (to adjust the pH) and sodium hydroxide (to adjust the pH).

Appearance of the product and contents of the package

This medicine is supplied in the form of a powder for solution for infusion in vials containing orange-colored powder before being diluted. These vials are marketed in packages of 10 vials. The powder must be mixed in the vial with a small amount of solution. The vial must be gently agitated until the medicine 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.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Sofarimex – Indústria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride,

2735-213 Cacém

Portugal

Local representative

Pharmavic Ibérica, S.L.

C. Compositor Lehmberg Ruiz, 6. Office 7

29007 Málaga. Spain.

Last review date of this leaflet:November 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

The following information is intended solely for healthcare professionals:

Instructions for use and handling (see also section 3 of the prospectus “How to use Tigecycline TecniGen”):

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 tigecycline. The vial must be gently agitated 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 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.

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 principles, the route must be cleaned before and after the perfusion of tigecycline with a 0.9% sodium chloride solution for injection or with a 5% dextrose solution for injection. 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 solution for injection, 5% dextrose solution for injection, and Ringer Lactate solution for injection.

When administration is performed through a Y route, the compatibility of tigecycline, diluted in 0.9% sodium chloride solution for injection, has been verified with the following drugs or diluents: dobutamine, dopamine HCl, gentamicin, Ringer Lactate, metoclopramide, norepinephrine, piperacillin / tazobactam (EDTA formulation), potassium chloride, propofol, and tobramycin.

Tigecycline must not be mixed with other medications for which there is no compatibility data.

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

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