Prospect: information for the user

Tigecycline Hikma 50 mg powder for solution for infusion EFG

Read this prospect carefully before starting to use this medication, 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.

Do not use TigeciclinaHikma

• 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

Consult your doctor or nurse before starting to use Tigeciclina Hikma.

• If you have poor or slow 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 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 Hikma:

• 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 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 Hikma

Inform your doctor if you are using, have used recently, or may need to use 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). If so, 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, think 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 machinery

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

This medication contains sodium.

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

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 Hikma than you should

If you think 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 Hikma

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

Like all medicines, this medicine may cause 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 (may affect more than 1 in 10 people):

• Nausea, vomiting, diarrhea.

Common side effects (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 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 that may lead to failure of multiple organs and death).
• Local reaction at the injection site (pain, redness, inflammation).
• Low blood protein levels.

Uncommon side effects (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 the blood (which may lead to an increase in bleeding tendency and appearance of petechiae/hematomas).

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

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

Unknown frequency (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 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 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.

Do not use this medication after the expiration date that appears on the vial and the packaging after “CAD”. The expiration date is the last day of the month indicated.

Store below 25°C.

Storage after preparation

Chemical and physical stability has been demonstrated for a period of 48 hours at 2-8°C once the product has been reconstituted with 0.9% sodium chloride or 5% Dextrosa.

From a microbiological point of view, the product should be used immediately.If not used immediately, the user is responsible for the storage times and conditions prior to use and they should not normally be greater than 24 hours between 2and8 °C, unless the dilution was performed in controlled and validated aseptic conditions.

The solution of this medication should have a yellow to orange color after dissolution, if not, it should be discarded immediately.

Medicines should not be thrown away through 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 Hikma Composition

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

The other components are: arginine, 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 powder or compact powder for solution for infusion in vials containing orange to reddish-brown powder before being diluted. These vials are marketed in hospitals in packs of 10 vials or 1 vial. Some pack sizes may only be marketed.

The powder must be mixed in the vial with a small amount of solution. The vial must be shaken gently until the medicine dissolves. Subsequently, the solution must be removed immediately from the vial and must be added to a 100 ml intravenous infusion bag or other suitable hospital infusion container.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, Nº 8, 8A e 8B

Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer responsible

Hikma Italia S.p.A.

Viale Certosa 10, 27100 – Pavia (PV)

Italy

Or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36

San Agustín de Guadalix, 28750, Madrid,

Spain

Or

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola,
PLA 3000,

Malta

Or

Galenicum Health, S.L.U

Sant Gabriel 50,
Esplugues de Llobregat 08950 Barcelona
Spain

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

Last review date of this leaflet:August 2024

Detailed and updated information about 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 only for healthcare professionals:

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

The powder must be reconstituted with 5.3 ml of 0.9% sodium chloride injection or with 5% dextrose injection 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 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 or Y-vein. If the same intravenous vein is used for sequential perfusion of other active ingredients, the vein must be cleaned before and after tigecycline perfusion with 0.9% sodium chloride injection or 5% dextrose injection. The injection must be made with a solution compatible with tigecycline and any other medication through this common vein.

Intravenous solutions compatible include: 0.9% sodium chloride injection and 5% dextrose injection. It has been verified that the product is not compatible with Ringer Lactate solution.

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

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

Once reconstituted and diluted in the infusion bag or other suitable 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.