Tigecycline Piramal

Patient Information Leaflet: Information for the User

Tigecycline Piramal 50 mg powder for solution for infusion

tigecycline
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Tigecycline Piramal is and what it is used for
2. What you need to know before using Tigecycline Piramal
3. How to use Tigecycline Piramal
4. Possible side effects
5. How to store Tigecycline Piramal
6. Package contents and other information

1. What Tigecycline Piramal is and what it is used for

Tigecycline Piramal is an antibiotic belonging to the glycylcycline group that works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tigecycline Piramal because you or your child (aged at least 8 years) have one of the following serious infections:

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

Tigecycline Piramal is used only when your doctor considers other antibiotics to be inappropriate.

2. What you need to know before using Tigeciclina Piramal Do not use Tigeciclina Piramal

• If you are allergic to tigecycline, the active substance in Tigeciclina Piramal.
• If you are allergic to the class of antibiotics known as tetracyclines (e.g. minocycline, doxycycline, etc.), you may also be allergic to tigecycline.

Warnings and precautions
Talk to your doctor or nurse before using Tigeciclina Piramal:

• if you have poor or delayed wound healing.
• if you are suffering from diarrhoea before starting treatment with Tigeciclina Piramal. If you develop diarrhoea during or after treatment with Tigeciclina Piramal, inform your doctor immediately. Do not take medicines for diarrhoea without first consulting your doctor.
• if you have or have previously had any adverse reactions to antibiotics belonging to the tetracycline class (e.g. skin photosensitivity due to sunlight, tooth discoloration in developing teeth, inflammation of the pancreas, and changes in certain laboratory values assessing your blood's clotting ability).
• if you have or have previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid adverse effects.
• if you have biliary duct obstruction (cholestasis).
• if you have a blood coagulation disorder or are taking anticoagulant medicines, as this medicine may interfere with blood clotting.

During treatment with Tigeciclina Piramal:

• 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 could be symptoms of acute pancreatitis (i.e. inflammation of the pancreas, which may cause severe abdominal pain, nausea, and vomiting).
• For certain serious infections, your doctor may decide to use Tigeciclina Piramal in combination with other antibiotics.
• Your doctor will closely monitor you for the development of any additional infections. In such cases, you may be prescribed a different antibiotic specific to the type of infection present.
• Although antibiotics such as Tigeciclina Piramal fight certain bacteria, other bacteria and fungi may continue to grow; this phenomenon is known as overgrowth. Your doctor will closely monitor you for any possible infections and, if necessary, initiate appropriate therapy.

Children
Tigeciclina Piramal must 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 cause permanent
tooth defects such as discoloration of developing teeth.

Other medicines and Tigeciclina Piramal
Always tell your doctor if you are taking or have recently taken any other medicines.
Tigeciclina Piramal may alter certain tests measuring how well your blood clots. It is
important that you inform your doctor if you are taking medicines to prevent excessive
blood clotting (called anticoagulants). In this case, your doctor will monitor you closely.
Tigeciclina Piramal may interfere with the oral contraceptive pill (birth control pill).
Discuss with your doctor the need for an additional contraceptive method during
treatment with Tigeciclina Piramal.
Tigeciclina Piramal may increase the effect of medicines used to suppress the immune system
(such as tacrolimus or ciclosporina). It is important that you inform your doctor if you are taking these
medicines so that you can be closely monitored.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant,
ask your doctor for advice before taking Tigeciclina Piramal.
Tigeciclina Piramal may cause fetal harm.
It is not known whether Tigeciclina Piramal is excreted in human breast milk. Ask your doctor for advice before
breastfeeding.

Driving and using machines
Tigeciclina Piramal may cause adverse effects such as dizziness. This may affect your ability
to drive vehicles or operate machinery.

3. How to use Tigecycline Piramal

Tigecycline Piramal will be administered to you by a doctor or nurse.
The recommended dose in adults is initially 100 mg, followed by a dose of 50 mg every 12 hours. This dose is given intravenously (into a vein) over a period of 30 to 60 minutes.
The recommended dose in children aged between 8 and 12 years is 1.2 mg/kg administered every 12 hours intravenously, up to a maximum dose of 50 mg every 12 hours.
The recommended dose in adolescents aged between 12 and 18 years is 50 mg administered every 12 hours.
A treatment course usually lasts from 5 to 14 days. Your doctor will decide the duration of treatment.
If you use more Tigecycline Piramal than you should
If you are concerned that you may have been given too much Tigecycline Piramal, speak immediately with your doctor or nurse.
If you forget a dose of Tigecycline Piramal
If you are concerned that you may have missed a dose, speak immediately with your doctor or nurse.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Pseudomembranous colitis may occur with most antibiotics, including Tigecycline Piramal. It is characterised by severe, persistent diarrhoea or diarrhoea with blood, associated with abdominal pain or fever, which may be signs of a serious inflammation of the intestine. This may occur during or after treatment.

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

• Nausea (feeling unwell), vomiting (being sick), diarrhoea.

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

• Abscess (collection of pus), infections;
• Laboratory tests showing reduced blood clotting ability;
• Dizziness;
• Vein irritation due to injection, including pain, inflammation, swelling and clotting;
• Abdominal pain, dyspepsia (stomach pain and indigestion), anorexia (loss of appetite);
• Increased liver enzymes, hyperbilirubinaemia (excess bile pigments in the blood);
• Itching, skin rash;
• Incomplete or slow wound healing;
• Headache;
• Increased amylase, an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN);
• Pneumonia;
• Low blood sugar levels;
• Sepsis (serious infection in the body and blood)/septic shock (a serious medical condition that may lead to multiple organ failure and death as a result of sepsis);
• Reactions at the injection site (pain, redness, inflammation);
• Low levels of protein in the blood;

Uncommon (may affect up to 1 in 100 people):

• Acute pancreatitis (inflammation of the pancreas which may present with severe abdominal pain, nausea and vomiting);
• Jaundice (yellowing of the skin), liver inflammation;
• Low platelet levels in the blood (which may lead to increased tendency to bleed and bruising/haematoma).

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

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

Not known (frequency cannot be estimated from the available data):

• Anaphylactic/anaphylactoid reaction (ranging from mild to severe, including sudden and widespread allergic reaction that may lead to life-threatening shock [e.g. difficulty breathing, rapid drop in blood pressure, rapid pulse]);
• Liver failure;
• Skin reaction, which may present with severe blistering and peeling of the skin (Stevens-Johnson Syndrome);
• Low fibrinogen levels in the blood (a protein involved in blood clotting).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Tigecycline Piramal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Storage after reconstitution/dilution
Once the powder has been dissolved into a solution and diluted for use, it should be
administered immediately.
The solution of Tigecycline Piramal should be yellow to orange in colour after reconstitution; if not, the solution must be discarded.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What Tigecycline Piramal contains
The active substance is tigecycline.
Each vial contains 50 mg of tigecycline.
After reconstitution, the solution contains 10 mg/1 ml of tigecycline.
The other components are arginine and hydrochloric acid (1 N) (for pH adjustment).

Description of the appearance of Tigecycline Piramal and pack contents
Tigecycline Piramal is supplied as a powder for infusion solution in a colourless glass vial (type 1) with a grey chlorobutyl rubber stopper, aluminium seal, and tear-off ring pull.
It appears as an orange powder or tablet before reconstitution and dilution.
Number of dosage units: 10 vials in a pack with tray.

Marketing Authorisation Holder
Piramal Critical Care Italia S.P.A.
Via XXIV Maggio 62/A,
San Giovanni Lupatoto (VR)
37057 Italy

Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo,
6 - 28760 Tres Cantos - Madrid (SPAIN)

This leaflet was last approved on
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The following information is intended for healthcare professionals only:

Instructions for use and handling (see also section 3. "How to use Tigecycline Piramal" in this package leaflet)

The powder must be reconstituted with 5.3 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion, or with dextrose 50 mg/mL (5%) solution for infusion, or with Ringer's lactate solution for infusion, to obtain a concentration of 10 mg/mL of tigecycline. The vial should be gently shaken until the active substance is completely dissolved. Then, 5 mL of the reconstituted solution should be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or to another suitable infusion container (e.g. a glass vial).

For a 100 mg dose, reconstitute using two vials into a 100 mL intravenous infusion bag or another suitable infusion container (e.g. a glass vial).

Note: The vial contains a 6% overage. Therefore, 5 mL of the reconstituted solution corresponds to 50 mg of active substance. The reconstituted solution should be yellow to orange in color; if not, the solution must be discarded. Parenteral products should be inspected visually for particulate matter and discoloration (e.g. green or black) prior to administration.

Tigecycline must be administered by intravenous infusion through a dedicated line or via a Y-site connector. If the same intravenous line is used for sequential infusions of different active substances, the line must be flushed before and after administration of tigecycline with either sodium chloride 9 mg/mL (0.9%) solution for infusion or dextrose 50 mg/mL (5%) solution for infusion. Infusion through this common line must be performed using an infusion solution compatible with tigecycline and with any other concomitant drug.

Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) solution for infusion, dextrose 50 mg/mL (5%) solution for infusion, and Ringer's lactate solution for infusion.

When administered via a Y-site connector, compatibility of diluted tigecycline in 0.9% sodium chloride solution for infusion has been demonstrated with the following drugs or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, Ringer's lactate, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA-containing formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.

Tigecycline Piramal must not be mixed with medicinal products for which compatibility data are not available.

Once reconstituted and diluted in an infusion bag or other suitable infusion container (e.g. a glass vial), tigecycline must be used immediately.

For single use only; any unused solution must be discarded.

The following active substances must not be administered simultaneously through the same Y-site connector as tigecycline: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole, and intravenous solutions that may cause an increase in pH above 7.