Chloramphenicol Fisiopharma

Package leaflet: Information for the user

CHLORAMPHENICOL FISIOPHARMA 1 g/10 ml powder and solvent for injectable solution for

intravenous use
Sodium chloramphenicol succinate
Please read carefully this leaflet before using this medicine because it contains important information for you.

• 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 CHLORAMPHENICOL FISIOPHARMA is and what it is used for
2. What you need to know before using CHLORAMPHENICOL FISIOPHARMA
3. How to use CHLORAMPHENICOL FISIOPHARMA
4. Possible side effects
5. How to store CHLORAMPHENICOL FISIOPHARMA
6. Contents of the pack and other information

1. What CLORAMFENICOLO FISIOPHARMA is and what it is used for

CLORAMFENICOLO FISIOPHARMA contains the active substance sodium chloramphenicol succinate, which belongs to a group of medicines called systemic antibacterial agents that work by inhibiting bacterial growth.
This medicine is administered by intravenous injection (intravenous use) when it cannot be taken by mouth (oral route) due to vomiting, diarrhoea, or a severe infection affecting the whole body (severe septic conditions), or when other less toxic medicines have proven ineffective or are contraindicated.
CLORAMFENICOLO FISIOPHARMA is indicated for the treatment of the following infections caused by various types of bacteria:

• typhoid fever and salmonellosis ( Salmonella typhi );
• bacterial meningitis ( Haemophilus influenzae, Neisseria meningitidis ), an acute infectious disease characterized by inflammation of the meninges;
• rickettsial infections ( Rickettsia );
• brucellosis ( Brucella );
• psittacosis ( Chlamydophila psittaci ), an infectious disease transmitted from birds to humans;
• lymphogranuloma venereum ( Lymphogranuloma-psittacosis ), a sexually transmitted disease;
• urinary tract infections caused by Gram-negative bacteria;
• infections caused by anaerobic bacteria ( Gram-positive cocci, Clostridium ).

2. What you should know before using CLORAMFENICOLO FISIOPHARMA

Do not use CLORAMFENICOLO FISIOPHARMA

• if you are allergic to sodium chloramphenicol succinate or to any of the other ingredients of this medicine (listed in section 6);
• if you have bone marrow disorders (bone marrow depression);
• if you are breastfeeding (See section “Pregnancy and breastfeeding”);
• if you are due to be vaccinated (active immunization phase).

This medicine must not be administered for the prevention of bacterial infections
or for the treatment of mild infections.
Chloramphenicol may interfere with immune mechanisms and must not be administered
during active immunization (see section 4.5).

Warnings and precautions
Talk to your doctor or nurse before you are given CLORAMFENICOLO
FISIOPHARMA.
Your doctor will determine the duration of treatment based on the type of infection you have,
and generally treatment should not exceed 2 weeks.
During administration of this medicine, your doctor must carefully monitor the results of your blood tests (haematological parameters), as a reduction in the number of red blood cells (aplastic anaemia) may occur even weeks or months after treatment has been discontinued.
These checks are particularly important in cases of treatment with high doses or for prolonged or repeated periods.
Treatment must be stopped immediately if these tests show that you have a reduced number of white blood cells (leucocytes below 4,000 per mm³, granulocytes reduced by 40%), unless you suffer from a specific type of infection (typhoid fever).
CLORAMFENICOLO FISIOPHARMA must be administered with great caution:

• if you have blood disorders (impaired blood clotting);
• if you have liver or kidney problems (hepatic or renal insufficiency) (See section “Use in patients with liver or kidney problems”).

During treatment with CLORAMFENICOLO FISIOPHARMA, blood coagulation problems (decreased prothrombin time) and complications of the ongoing infection (superinfections caused by bacteria resistant to chloramphenicol or by fungi) may occur.

Other medicines and CLORAMFENICOLO FISIOPHARMA
Inform your doctor or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor if you are taking the following medicines:

• dicoumarol and warfarin, medicines that make the blood less likely to clot;
• phenobarbital, phenytoin and fosphenytoin, used to treat seizures and epilepsy;
• clopidogrel, used to prevent blood clots;
• voriconazole, used to treat fungal infections;
• cyclophosphamide and methotrexate, used to treat certain types of cancer and immune system disorders;
• ciclosporin and tacrolimus, used after organ transplantation;
• rifampicin, penicillins, cephalosporins, used to treat bacterial infections;
• paracetamol, used to relieve pain and fever;
• cyanocobalamin (vitamin B12), used in cases of vitamin B12 deficiency or nerve disorders;
• entacapone, used to treat Parkinson’s disease;
• hypoglycaemic sulfonamides (tolbutamide, chlorpropamide, glimepiride, etc.), used to treat diabetes;
• iron, used to treat anaemia (reduced red blood cells).

CLORAMFENICOLO FISIOPHARMA must not be administered if you are simultaneously due to receive a vaccination (such as tetanus or typhoid vaccine).
This medicine may interfere with the results of certain urine tests used to monitor sugar (glucose) levels in the body (copper reduction method); therefore, alternative methods (glucose oxidase reactions) must be used.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or nurse for advice before this medicine is administered.
If you are pregnant, this medicine must not be administered except in cases of absolute necessity and under direct medical supervision.
CLORAMFENICOLO FISIOPHARMA must not be administered during breastfeeding, as it may cause serious harm to your baby (See section “Do not use CLORAMFENICOLO FISIOPHARMA”).

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

CLORAMFENICOLO FISIOPHARMA contains sodium
This medicine contains 71.16 mg (3.09 mmol) of sodium per vial. This should be taken into account in patients with impaired renal function or those on a low-sodium diet.

3. How to use CLORAMFENICOLO FISIOPHARMA

This medicine will be administered to you in hospital by a doctor or specialized healthcare personnel. If you have any doubts, consult your doctor or nurse.
CLORAMFENICOLO FISIOPHARMA will be administered immediately after opening the vial and proper reconstitution (with water for injections, physiological saline solution, or 5% glucose solution). The reconstituted solution must be injected immediately.
This medicine must be administered by intravenous infusion.
CLORAMFENICOLO FISIOPHARMA must not be mixed with the following medicines:

• chlorotetracycline;
• sodium novobiocinate.

The following incompatibilities with chloramphenicol have also been reported:

• chlorpromazine;
• erythromycin;
• fluconazole;
• glycopyrrolate;
• hydrocortisone sodium succinate;
• hydroxyzine;
• methicillin;
• metoclopramide;
• oxytetracycline;
• phenytoin;
• polymyxin B;
• procaine;
• prochlorperazine edisylate;
• prochlorperazine mesylate;
• promazine;
• promethazine;
• sulfadiazine;
• tetracyclines;
• tripelennamine;
• vancomycin.

Adults and adolescents
The recommended dose for treating most infections is 50–100 mg/kg per day, divided into 4 doses (every 6 hours).
Newborns up to 2 weeks
The recommended dose for treating most infections is 25 mg/kg per day, divided into 4 doses (every 6 hours).
Specifically, for newborns younger than 1 week or weighing less than 2 kg, the recommended dose is 25 mg/kg per day as a single dose. For newborns older than 1 week and weighing more than 2 kg, the recommended dose is 25 mg/kg per day divided into 2 doses (every 12 hours).
Newborns over 2 weeks and children (up to 12 years)
The recommended dose for treating most infections is 50 mg/kg per day, divided into 4 doses (every 6 hours).
Use in patients with kidney problems (renal impairment) and undergoing dialysis
If you have severe kidney problems (renal impairment), your doctor must perform frequent blood tests to adjust, if necessary, the dose of medicine to be administered.
The amount of medicine removed by hemodialysis is not significant enough to require dosage adjustment in all cases. Dosage adjustment is not required in patients undergoing continuous ambulatory peritoneal dialysis (CAPD) or continuous arteriovenous hemofiltration (CAVH).
Use in patients with liver problems
If you have severe liver problems (impaired liver function), your doctor must perform frequent blood tests to adjust, if necessary, the dose of medicine to be administered.
Specifically, if you have:

• liver failure, the initial dose is 1 g followed by 500 mg every 6 hours;
• hepatic cirrhosis, the recommended dose is 500 mg every 6 hours;
• jaundice, the dose must not exceed 25 mg/kg per day.

If you use more CLORAMFENICOLO FISIOPHARMA than you should
This medicine will be administered by specialized personnel; therefore, it is unlikely that you will receive an excessive dose.
In case of overdose, blood disorders (hematological complications) may occur.
If you think you have been given too much of this medicine, contact your doctor or nurse immediately.
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 will experience them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data)

• blood disorders (agranulocytosis, anaemia, leucopenia, thrombocytopenia, reticulocytopenia), including severe cases (aplastic anaemia), particularly in patients with kidney and/or liver problems (renal and/or hepatic insufficiency);
• nausea, vomiting, unpleasant taste sensation (dysgeusia), diarrhoea, inflammation of the mouth (stomatitis), inflammation of the tongue (glossitis), inflammation of the intestine (enterocolitis), irritation of the area near the anus (perineal);
• allergic reactions (hypersensitivity), accompanied by fever, skin rashes, and which may be very severe (anaphylaxis);
• inflammation of the optic nerve or other nerves (optic neuritis, peripheral neuritis), hearing disorders (ototoxicity), headache and confusion;
• Jarisch-Herxheimer reaction, characterized by chills, headache (cephalalgia), fever, and skin and mucosal lesions;
• mild depression and delirium;
• difficulty in breathing (bronchospasm);
• liver disorders (hepatotoxicity).

Additional side effects in newborns
In children, administration of excessive doses of this medicine may result in the "Grey Baby Syndrome", a serious condition whose symptoms include:

• abdominal swelling, abdominal pain, flatulence, diarrhoea, constipation (abdominal distension);
• vomiting;
• skin colour turning grey (ashen);
• reduced body temperature (hypothermia);
• bluish discoloration of the skin (progressive cyanosis);
• severe circulatory problems (circulatory collapse) which may lead to death within a few hours or days.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CLORAMFENICOLO FISIOPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine in its original packaging at room temperature.
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. Package contents and other information

What CLORAMFENICOLO FISIOPHARMA contains

• The active substance is sodium chloramphenicol succinate. Each vial contains 1.378 g of sodium chloramphenicol succinate powder (equivalent to 1 g of chloramphenicol).
• The other component is water for injections.

Description of the appearance of CLORAMFENICOLO FISIOPHARMA and contents of the package
Each package contains:

• one vial containing chloramphenicol (1 g);
• one ampoule containing an injectable solvent (water for injections, sufficient to make up 10 ml).

Marketing Authorization Holder and Manufacturer
FISIOPHARMA SRL
Industrial Area – 84020 Palomonte (SA), Italy