Tigecycline Cipla

Package Leaflet: Information for the User

Tigecycline Cipla 50 mg powder for solution for infusion

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

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

Contents of this leaflet

1. What Tigecycline Cipla is and what it is used for
2. What you need to know before receiving Tigecycline Cipla
3. How Tigecycline Cipla is administered
4. Possible side effects
5. How to store Tigecycline Cipla
6. Contents of the pack and other information

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

Tigecycline Cipla is an antibiotic belonging to the glycylcycline group that works by inhibiting the growth of bacteria causing infections.
Your doctor has prescribed Tigecycline Cipla because you or your child who is at least 8 years old has one of the following serious types of infection:

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

Tigecycline Cipla is used only when your doctor considers that other antibiotics are not suitable.

2. What you need to know before receiving Tigeciclina Cipla

Do not use Tigeciclina Cipla

• If you are allergic to tigecycline or to any of the other ingredients of this medicine (listed in section 6). 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 receiving Tigeciclina Cipla:

• If you have poor or delayed wound healing.

• If you already have diarrhoea before starting treatment with Tigeciclina Cipla. If you develop diarrhoea during or after treatment, 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, tooth discolouration in developing teeth, pancreatitis, or changes in certain laboratory test values used to assess 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 potential adverse effects.

• If you have biliary obstruction (cholestasis).

• If you have a blood clotting disorder or are taking anticoagulant medicines, as this
  medicinal product may interfere with blood clotting.
  During treatment with Tigeciclina Cipla:

• 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. inflamed pancreas, which can cause severe abdominal pain, nausea, and vomiting).

• For certain serious infections, your doctor may decide to use Tigeciclina Cipla in combination with other antibiotics.

• Your doctor will closely monitor you for the development of any additional bacterial infections. In such cases, your doctor may prescribe a different antibiotic specific to the type of infection present.

• Although antibiotics such as Tigeciclina Cipla 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 treatment.

Children
Tigeciclina Cipla must not be used in children under 8 years of age, due to lack of data on safety and efficacy in this age group and because it may cause permanent tooth defects such as discolouration of developing teeth.

Other medicines and Tigeciclina Cipla
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Tigeciclina Cipla 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 such cases, your doctor will monitor you closely.
Tigecycline may interfere with oral contraceptives (birth control pills). Talk to your doctor about the need for an additional contraceptive method during treatment with Tigeciclina Cipla.
Tigecycline may increase the effect of medicines used to suppress the immune system (such as tacrolimus or ciclosporine). It is important that you inform your doctor if you are taking these medicines so that you can be closely monitored.

Pregnancy and breastfeeding
Tigecycline may cause fetal harm. If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking Tigeciclina Cipla.
It is not known whether tigecycline is excreted in human milk. Consult your doctor before breastfeeding.

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

Tigeciclina Cipla contains sodium
Tigeciclina Cipla contains less than 1 mmol (23 mg) of sodium per 5 mL of solution, i.e. essentially ‘sodium-free’.

3. How Tigecycline Cipla is administered

Tigecycline Cipla will be administered to you by a doctor or nurse.
The recommended dose in adults is initially 100 mg, followed by 50 mg every 12 hours.
This dose is given by intravenous infusion (into a vein) over a period of 30 to 60 minutes.
The recommended dose for children aged 8 to 12 years is 1.2 mg/kg administered every 12 hours by intravenous infusion, 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.
A treatment course usually lasts from 5 to 14 days. Your doctor will decide the duration of treatment.
If you receive more Tigecycline Cipla than you should
If you are concerned that you may have received too much Tigecycline Cipla, speak immediately to your doctor or nurse.
If you forget a dose of Tigecycline Cipla
If you are concerned that you may have missed a dose, speak immediately to your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Pseudomembranous colitis may occur with most antibiotics, including Tigecycline Cipla. It consists of severe, persistent diarrhoea or diarrhoea with blood, associated with abdominal pain or fever, which may be signs of a serious inflammation of the intestine that can occur during or after treatment.

Very common: may affect more than 1 in 10 people

• Nausea, vomiting, 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).
• Injection site reactions (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 levels of platelets 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 levels of fibrinogen in the blood (a protein involved in blood clotting).

Not known: frequency cannot be estimated from the available data

• Anaphylactic/anaphylactoid reaction (which may range from mild to severe, including sudden and generalized allergic reaction that may lead to life-threatening shock [e.g. difficulty in 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).

Reporting of side effects

If you experience 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Reporting side effects may help provide more information on the safety of this medicine.

5. How to store Tigecycline Cipla

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.
Storage after preparation
After reconstitution and dilution, Tigecycline powder for solution for infusion should be used immediately; however, if necessary, it can be stored for up to 6 hours at 2°C to 8°C (if reconstituted and diluted with 0.9% sodium chloride or 5% dextrose) and up to 24 hours at 2°C to 8°C.
The solution of Tigecycline Cipla after dissolution should be yellow to orange in colour; 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Tigecycline Cipla contains

• The active substance is tigecycline. Each vial contains 50 mg of tigecycline.
• The excipients are trehalose dihydrate, hydrochloric acid 1.25N (for pH adjustment), and sodium hydroxide 5N (for pH adjustment).

Description of the appearance of Tigecycline Cipla and package contents
Tigecycline Cipla is supplied as a powder for solution for infusion in a vial and, before dilution, appears as an orange powder or tablet. These vials are distributed to hospitals in packs of ten vials. The powder must be mixed in the vial with a small amount of solution. The vial should be gently shaken until the drug is completely dissolved. Then, the solution should be immediately withdrawn from the vial and added to a 100 mL intravenous infusion bag or another suitable container for hospital infusion.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Cipla Europe NV
De Keyserlei 58-60, Box-19,
2018 Antwerp
Belgium
Manufacturer:
Sofarimex – Indústria Química e Farmacêutica, S.A.
Av. das Indústrias, Alto do Colaride,
2735-213 Cacém
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal    Tigecycline Cipla
Spain      Tigecycline Cipla 50 mg powder for solution for infusion
Italy       Tigecycline Cipla
Germany    Tigecyclin Cipla 50 mg Powder for the preparation of an infusion solution

The following information is intended exclusively for healthcare professionals:

Instructions for use and handling (see also section 3. "How is Tigecycline Cipla administered" in this package leaflet)
The powder must be reconstituted with 5.3 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, or lactated Ringer's solution for injection to achieve a concentration of 10 mg/mL of tigecycline. The vial should be gently shaken until the product 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 another suitable infusion container (e.g., a glass bottle).
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 bottle).
Note: The vial contains a 6% overage. Therefore, 5 mL of the reconstituted solution is equivalent 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 intravenously 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 injection or dextrose 50 mg/mL (5%) solution for injection. Infusion through this common line must be performed using an infusion solution compatible with both tigecycline and the other drug, if any.
Compatible intravenous solutions include: sodium chloride 9 mg/mL (0.9%) solution for injection, dextrose 50 mg/mL (5%) solution for injection, and lactated Ringer's solution for injection.
When administered via a Y-site connector, compatibility of tigecycline diluted in 0.9% sodium chloride solution for injection has been demonstrated with the following drugs or diluents: amikacin, dobutamine, dopamine hydrochloride, gentamicin, haloperidol, lactated Ringer's, lidocaine hydrochloride, metoclopramide, morphine, noradrenaline, piperacillin/tazobactam (EDTA-containing formulation), potassium chloride, propofol, ranitidine hydrochloride, theophylline, and tobramycin.
Tigecycline Cipla must not be mixed with medicinal products for which compatibility data are not available.
Once reconstituted and diluted in an infusion bag or another suitable container (e.g., glass bottle), tigecycline must be used immediately.
For single use only; any unused solution must be discarded.