Caritex: detailed information

Package leaflet: Information for the patient

CARITEX

1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What CARITEX is and what it is used for
What you need to know before being given CARITEX
How CARITEX is administered
Possible side effects
How to store CARITEX
Package contents and other information

1. What CARITEX is and what it is used for

CARITEX contains the active substance ceftriaxone, which is an antibiotic administered to adults and children (including newborns). It works by killing the bacteria that cause infections.
It belongs to a group of medicines called cephalosporins. CARITEX is given by injection into a muscle using a solution containing lidocaine, which reduces the pain associated with the injection.

CARITEX is used to treat infections of:

the brain (meningitis)
the lungs
the middle ear
the abdomen and abdominal wall (peritonitis)
the urinary tract and kidneys
the bones and joints
the skin or soft tissues
the blood
the heart

It may also be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis)
to treat patients with a low white blood cell count (neutropenia) who have fever due to a bacterial infection
to treat chest infections in adults with chronic bronchitis
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age
to prevent infections during surgery.
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2. What you should know before being given CARITEX

Do not be given CARITEX if:

you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6)
you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make it difficult to breathe or swallow, sudden swelling of the hands, feet and ankles, or a severe rash that develops rapidly
you are allergic to lidocaine and CARITEX is to be administered by intramuscular injection
you have a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block)
you have a condition characterized by reduced blood volume (hypovolemia).

CARITEX must not be given to children in the following cases:

the child is premature
the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive, via intravenous infusion, a product containing calcium.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before being given CARITEX if:

you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”)
you have recently received or are about to receive products containing calcium
you have recently had diarrhoea after taking an antibiotic, or have had intestinal problems, particularly colitis (inflammation of the intestine)
you have liver or kidney problems (see section 4)
you have gallstones or kidney stones
you have other diseases, such as haemolytic anaemia (a reduction in red blood cells which may cause pale yellow skin and lead to weakness or shortness of breath)
you are on a low-sodium diet
you suffer from loss of muscle function and weakness (myasthenia gravis)
you have seizures (epilepsy)
you have any heart problems, especially if they affect your heart rate
you have respiratory problems
you suffer from porphyria (a rare inherited disease affecting the skin and nervous system).

If you need to have blood or urine tests
If you are given CARITEX for a prolonged period, you may need to have regular blood tests. CARITEX may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are due to have tests:

inform the person taking your sample that you have been given CARITEX.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems, as they may give inaccurate glucose readings during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative analytical methods should be used if necessary.
Children
Talk to your doctor, pharmacist or nurse before giving CARITEX to a child if:

the child has recently received or is about to receive, by intravenous infusion, a product containing calcium.

Other medicines and CARITEX
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines, as they may interact with ceftriaxone:

an antibiotic called an aminoglycoside
an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).
Various medicines may interact with lidocaine, resulting in altered effects. These include:
medicines used to treat infections (clarithromycin, erythromycin, rifampicin)
medicines used to treat stomach ulcers (e.g. cimetidine)
medicines used to treat epilepsy (barbiturates, phenytoin, carbamazepine, primidone)
medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Your doctor will weigh the benefits of treatment with CARITEX against any possible risks to the baby.

Driving and using machines
CARITEX may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Contact your doctor if you experience these symptoms.

CARITEX contains sodium
This medicine contains 82.9 mg of sodium (a main component of table salt) per 1 g vial. This is equivalent to 4% of the maximum daily dietary intake recommended for an adult.

3. How CARITEX is administered

CARITEX is generally administered by a doctor or nurse via an injection directly into a muscle. CARITEX will be prepared by a doctor, pharmacist, or nurse and will not be mixed or co-administered with injections containing calcium.
Usual dose
Your doctor will determine the correct dose of CARITEX for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the degree of function of your kidneys and liver. The number of days or weeks during which you will receive CARITEX will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):
3/20

1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given either as a single daily dose or as two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

50–80 mg of CARITEX once daily per kg of the child's body weight, depending on the severity and type of infection. If you have a severe infection, your doctor will prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be given either as a single daily dose or as two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

20–50 mg of CARITEX once daily per kg of the newborn's body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose than the usual one. Your doctor will decide how much CARITEX you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more CARITEX than you should
If you are accidentally given more CARITEX than prescribed, contact your doctor or the nearest hospital immediately.
If you miss a dose of CARITEX
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with CARITEX
Do not stop taking CARITEX unless your doctor tells you to. If you have any doubts about using 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.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you experience a severe allergic reaction, seek medical advice immediately.
Signs may include:

sudden swelling of the face, throat, lips or mouth. This may make breathing or swallowing difficult
sudden swelling of the hands, feet and ankles

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, seek medical advice immediately.
Signs may include:

severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain and rash, which generally resolves spontaneously. These symptoms occur shortly after starting treatment with CARITEX to treat spirochete infections such as Lyme disease.

Other possible side effects:
Common (may affect up to 1 in 10 people)

abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes)
loose stools or diarrhoea
changes in blood test results for liver function
rash

Uncommon (may affect up to 1 in 100 people)

fungal infections (e.g. oral thrush)
decreased number of white blood cells (granulocytopenia)
reduced number of red blood cells (anaemia)
blood clotting problems. Signs include easy bruising, joint pain and swelling
headache
dizziness
nausea or vomiting
itching
pain or burning sensation along the vein where CARITEX was administered. Pain at the injection site
fever
abnormal kidney function test results (increased blood creatinine)

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

inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain and fever
difficulty breathing (bronchospasm)
rash with raised red patches (urticaria), which may cover a large area of the body, associated with itching and swelling
blood or sugar in the urine
oedema (fluid retention)
chills

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

secondary infections that may not respond to the prescribed antibiotic
a form of anaemia characterised by destruction of red blood cells (haemolytic anaemia)
severe decrease in the number of white blood cells (agranulocytosis)
seizures
vertigo
inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back
inflammation of the mouth lining (stomatitis)
inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue
problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and pale, clay-coloured stools
a neurological condition that may develop in newborns with severe jaundice (kernicterus)
kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced
false positive Coombs test (a blood test to detect blood problems)
false positive test for galactosaemia (an abnormal accumulation of the sugar galactose)
CARITEX may interfere with certain types of blood glucose tests; please check with your doctor

Following accidental intravascular injection of lidocaine during intramuscular administration of CARITEX i.m., additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

changes in heart rhythm and heart rate
low blood pressure
slowed heart rate (below 60 beats per minute)
interruption of normal blood circulation due to cardiac arrest and reduced blood flow
tingling around the mouth, tongue numbness, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, nervousness, tremor, involuntary rhythmic muscle contractions (seizures), deep unconsciousness (coma)
blurred vision, double vision or temporary loss of vision
feeling unwell (nausea or vomiting)
breathing difficulties
reduced respiratory rate or possible interruption of breathing
unusual drowsiness or tiredness during the day or fainting

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

5. How to store CARITEX

Keep this medicine out of the sight and reach of children.
Expiry: see expiry date stated on the packaging.
6/20
Warning: do not use this medicine after the expiry date stated on the packaging.
The expiry date stated refers to the product in its original, undamaged packaging, correctly stored.
Do not store above 30°C. Keep the bottle in the original container.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What CARITEX contains
CARITEX 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains:
The active substance is: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g; one solvent vial contains:
aqueous solution of lidocaine 1%.
Description of the appearance of CARITEX and package contents
CARITEX 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use: 1 vial of powder + 1 solvent vial of 3.5 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l., Via Marghera, 29 - 20149 Milano, Italy
Manufacturer
ESSETI FARMACEUTICI SRL - Via Campobello, 15 - 00040 Pomezia (Rome)
Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:
Needles and syringes must never be reused.
Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
Keep the container out of reach of children.
Used sharps containers must not be disposed of in household waste.
Dispose of the full container according to local requirements or as instructed by your doctor.
Disposal of expired/unwanted medicines
Medicines should be kept out of the environment as much as possible. Medicines must not be disposed of via wastewater or household waste. Use dedicated collection systems, if available.
7/20

Patient Information Leaflet

CARITEX

1 g / 10 ml powder and solvent for injectable solution for intravenous use
Ceftriaxone
Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What CARITEX is and what it is used for
What you need to know before being administered CARITEX
How CARITEX is administered
Possible side effects
How to store CARITEX
Contents of the pack and other information

1. What CARITEX is and what it is used for

the brain (meningitis)
the lungs
the middle ear
the abdomen and abdominal wall (peritonitis)
the urinary tract and kidneys
the bones and joints
the skin or soft tissues
the blood
the heart.

It may also be given:

to treat specific sexually transmitted infections (gonorrhoea and syphilis)
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to a bacterial infection
to treat chest infections in adults with chronic bronchitis
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age
to prevent infections during surgery.

8/20

2. What you need to know before being given CARITEX

Do not be given CARITEX if:

you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6)
you have previously had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of the hands, feet and ankles, or a severe rash that develops rapidly
you are allergic to lidocaine and CARITEX is to be administered by intramuscular injection.

CARITEX must not be given to children in the following cases:

the child is premature.
the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive intravenously a product containing calcium.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before being given CARITEX if:

you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions; see also section 4 “Possible side effects”)
you have recently received or are about to receive products containing calcium
you have recently had diarrhoea after taking an antibiotic, or have intestinal problems, particularly colitis (inflammation of the intestine)
you have liver or kidney problems (see section 4)
you have gallstones or kidney stones
you have other diseases, such as haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, weakness or shortness of breath)
you are on a low-sodium diet.

inform the person taking your sample that you have been given CARITEX.

If you are diabetic or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems that may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.
Children
Talk to your doctor, pharmacist or nurse before giving CARITEX to a child if:

the child has recently received or is about to receive intravenously a product containing calcium.

an antibiotic called an aminoglycoside
an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before taking this medicine. Your doctor will weigh the benefits of treatment with CARITEX against any possible risks to the unborn or breastfed baby.

Driving and using machines
CARITEX may cause dizziness. If you feel dizzy, do not drive or operate tools or machinery. Contact your doctor if you experience these symptoms.
CARITEX contains sodium
This medicine contains 82.9 mg of sodium (a main component of table salt) per 1 g vial. This corresponds to 4% of the maximum daily recommended dietary intake of sodium for an adult.

3. How CARITEX is administered

CARITEX is generally administered by a doctor or nurse through an intravenous infusion (IV infusion) or via an injection directly into a vein. CARITEX will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered simultaneously with calcium-containing injections.
Usual dose
Your doctor will determine the correct dose of CARITEX for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the degree of function of your kidneys and liver. The number of days or weeks during which you will receive CARITEX will depend on the type of infection you have.
Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor may administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

Neonates, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

50–80 mg of CARITEX once daily per kg of the child’s body weight, depending on the severity and type of infection. If you have a severe infection, your doctor may prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If your daily dose exceeds 2 g, it may be administered as a single daily dose or divided into two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the adult usual dose.

Neonates (0–14 days of age)

20–50 mg of CARITEX once daily per kg of the neonate’s body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the neonate’s body weight.

10/20
Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide the amount of CARITEX you need and will closely monitor you, depending on the severity of your liver or kidney disease.
If you are given more CARITEX than you should
If you are accidentally given more CARITEX than prescribed, contact your doctor or go to the nearest hospital immediately.
If you miss a dose of CARITEX
If you miss an injection, it should be given as soon as possible. However, if it is almost time for your next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.
If you stop treatment with CARITEX
Do not stop taking CARITEX unless your doctor tells you to. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or disorders of the
nervous system, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (not known, frequency cannot be determined from available data)
If you have a severe allergic reaction, seek medical attention immediately.
Signs may include:

sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult
sudden swelling of the hands, feet, and ankles.

Severe skin reactions (not known, frequency cannot be determined from available data)
If you develop a severe skin reaction, seek medical attention immediately.
Signs may include:

Severe rash developing rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, elevated liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain, and rash, which generally resolves spontaneously. These symptoms occur shortly after starting treatment with CARITEX for spirochete infections such as Lyme disease.

11/20
Other possible side effects:
Common (may affect up to 1 in 10 people)

Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhoea.
Changes in blood test results indicating liver function.
Rash.

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g., thrush).
Decreased number of white blood cells (granulocytopenia).
Reduced number of red blood cells (anaemia).
Blood clotting problems. Signs include easy bruising, joint pain, and swelling.
Headache.
Dizziness.
Nausea or vomiting.
Itching.
Pain or burning sensation along the vein where CARITEX was administered. Pain at the injection site.
Fever.
Abnormal kidney function tests (increased blood creatinine).

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

Inflammation of the large intestine (colon). Signs include diarrhoea, often with blood and mucus, stomach pain, and fever.
Breathing difficulties (bronchospasm).
Rash with raised itchy welts (urticaria), which may cover large areas of the body, associated with itching and swelling.
Blood or sugar in the urine.
Oedema (fluid accumulation).
Chills.

Not known (frequency cannot be determined from available data)

Secondary infections that may not respond to the prescribed antibiotic.
A form of anaemia characterized by destruction of red blood cells (haemolytic anaemia).
Severe decrease in the number of white blood cells (agranulocytosis).
Seizures.
Vertigo.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain extending to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and clay-coloured stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test (a blood test to detect blood-related problems).
False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
CARITEX may interfere with certain types of tests to measure glucose in the blood; please check with your 12/20

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

5. How to store CARITEX

Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
Warning: do not use this medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original intact packaging, correctly stored. Do not store at temperatures above 30°C.
Keep the bottle in the original container.
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 CARITEX contains
CARITEX 1 g / 10 ml powder and solvent for injectable solution for intravenous use
One vial of powder contains:
The active substance is: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1 g; one solvent vial contains:
water for injection.

Description of the appearance of CARITEX and contents of the pack
CARITEX 1 g / 10 ml powder and solvent for injectable solution for intravenous use: 1 vial of powder + 1 10 ml solvent vial.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l., Via Marghera, 29, 20149 Milano, Italy
Manufacturer
ESSETI FARMACEUTICI SRL - Via Campobello, 15 - 00040 Pomezia (Roma)

Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of syringes and other sharp medical devices:

Needles and syringes must never be reused.
Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
Keep the container out of reach of children.
Used sharps containers must not be disposed of in household waste.
Dispose of the full container in accordance with local requirements or as instructed by your physician.

Disposal of expired/unwanted medicines
Medicines released into the environment should be minimized. Medicines must not be disposed of via wastewater or in household waste. Use dedicated collection systems, if available.
13/20
14/20

Patient information leaflet

CARITEX

2 g powder for solution for infusion
Ceftriaxone
Equivalent medicine
Please read this leaflet carefully before you are given this medicine as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What CARITEX is and what it is used for
What you need to know before you are given CARITEX
How CARITEX is administered
Possible side effects
How to store CARITEX
Contents of the pack and other information

1. What CARITEX is and what it is used for

the brain (meningitis)
the lungs
the middle ear
the abdomen and abdominal wall (peritonitis)
the urinary tract and kidneys
the bones and joints
the skin or soft tissues
the blood
the heart

It may also be administered:

to treat specific sexually transmitted infections (gonorrhoea and syphilis)
to treat patients with a low number of white blood cells in the blood (neutropenia) who have fever due to bacterial infection
to treat chest infections in adults with chronic bronchitis
to treat Lyme disease (caused by tick bites) in adults and children, including newborns from 15 days of age
to prevent infections during surgical procedures

2. What you need to know before you are given CARITEX

Do not be given CARITEX if:

you are allergic to ceftriaxone or to any of the other ingredients of this medicine (listed in section 6).
you have had a sudden or severe allergic reaction to penicillin or to similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include sudden swelling of the throat or face, which may make breathing or swallowing difficult, sudden swelling of hands, feet and ankles, and a severe rash that develops rapidly.
you are allergic to lidocaine and CARITEX is to be administered by intramuscular injection.

CARITEX must not be given to children in the following cases:

the child is premature
the child is a newborn (up to 28 days of age) and has certain blood disorders or jaundice (yellowing of the skin or whites of the eyes), or needs to receive a product containing calcium through a vein.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given CARITEX if:

you are experiencing or have previously experienced any combination of the following symptoms: rash, skin redness, blistering on lips, eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes detectable in blood tests, increase in a type of white blood cells (eosinophilia), and swollen lymph nodes (signs of serious skin reactions, see also section 4 “Possible side effects”)
you have recently received or are about to receive products containing calcium
you have recently had diarrhoea after taking an antibiotic. You have had intestinal problems, particularly colitis (inflammation of the intestine)
you have liver or kidney problems (see section 4)
you have gallstones or kidney stones
you have other diseases, for example haemolytic anaemia (a reduction in red blood cells which may cause pale yellow skin, weakness or breathlessness)
you are on a low-sodium diet.

If you are undergoing blood or urine tests
If you are given CARITEX for a prolonged period, you may need to have regular blood tests. CARITEX may affect the results of urine sugar tests and a blood test known as the Coombs test. If you are about to undergo tests:

inform the person taking your sample that you have been given CARITEX. If you have diabetes or require monitoring of blood glucose levels, do not use certain blood glucose monitoring systems which may inaccurately measure blood glucose during treatment with ceftriaxone. If such systems are used, check the instructions for use and inform your doctor, pharmacist or nurse. Alternative analytical methods should be used if necessary.

Children
Talk to your doctor, pharmacist or nurse before CARITEX is given to a child if:

the child has recently received or is about to receive a product containing calcium through a vein.

an antibiotic called an aminoglycoside
an antibiotic called chloramphenicol (used to treat infections, particularly eye infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. Your doctor will weigh the benefits of treatment with CARITEX for you against the possible risks to the baby.

Driving and using machines
CARITEX may cause dizziness. If you feel dizzy, do not drive or use tools or machinery. Contact your doctor if you experience these symptoms.

CARITEX contains sodium
This medicine contains 165.9 mg of sodium (a key component of table salt) per 2 g vial. This is equivalent to 8.3% of the maximum daily recommended dietary intake of sodium for an adult.

3. How CARITEX is administered

CARITEX is generally administered by a doctor or nurse through an intravenous infusion (intravenous drip) or via an injection directly into a vein. CARITEX will be prepared by a doctor, pharmacist, or nurse and will not be mixed or administered at the same time as injections containing calcium.

Usual dose
Your doctor will determine the correct dose of CARITEX for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your body weight and age, and the extent of kidney and liver function. The number of days or weeks during which you will receive CARITEX will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years or older with a body weight equal to or greater than 50 kilograms (kg):

1 to 2 g once daily, depending on the severity and type of infection. If you have a severe infection, your doctor will administer a higher dose (up to 4 g per day). If your daily dose exceeds 2 g, it may be given as a single daily dose or divided into two separate doses.

Newborns, infants, and children from 15 days to 12 years of age with a body weight below 50 kg:

50–80 mg of CARITEX once daily per kg of the child's body weight, depending on the severity and type of infection. If the child has a severe infection, the doctor will prescribe a higher dose, starting from 100 mg per kg of body weight, up to a maximum of 4 g per day. If the daily dose exceeds 2 g, it may be administered as a single daily dose or divided into two separate doses.
Children with a body weight equal to or greater than 50 kg should receive the usual adult dose.

Newborns (0–14 days of life):

20–50 mg of CARITEX once daily per kg of the newborn's body weight, depending on the severity and type of infection.
The maximum daily dose must not exceed 50 mg per kg of the newborn's body weight.

Patients with liver or kidney problems
You may be given a different dose from the usual one. Your doctor will decide how much CARITEX you need and will closely monitor you, depending on the severity of your liver or kidney disease.

If you are given more CARITEX than you should
If you are accidentally given more CARITEX than prescribed, contact your doctor or go to the nearest hospital immediately.

If you miss a dose of CARITEX
If you miss an injection, you should receive it as soon as possible. However, if it is almost time for the next scheduled injection, skip the missed dose. Do not take a double dose (two injections together) to make up for a missed dose.

If you stop treatment with CARITEX
Do not stop taking CARITEX unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With this medicine, you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation, and seizures.

Severe allergic reactions (frequency not known; the frequency cannot be estimated from the available data)
If you experience a severe allergic reaction, seek immediate medical attention.
Signs may include:

sudden swelling of the face, throat, lips, or mouth. This may make breathing or swallowing difficult
sudden swelling of the hands, feet, and ankles.

Severe skin reactions (frequency not known; the frequency cannot be estimated from the available data)
If you develop a severe skin reaction, seek immediate medical attention.
Signs may include:

Severe rash that develops rapidly, with blistering or peeling of the skin and possible blistering in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis, also known as SJS and TEN).
Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome).
Jarisch-Herxheimer reaction, which may cause fever, chills, headache, muscle pain, and rash, usually resolving spontaneously. These symptoms may occur shortly after starting CARITEX treatment for spirochete infections such as Lyme disease.

Other possible side effects:
Common (may affect up to 1 in 10 people)

Abnormalities in white blood cells (such as reduced leukocytes and increased eosinophils) and platelets (reduced thrombocytes).
Soft stools or diarrhea. 18/20
Changes in blood test results indicating liver function abnormalities.
Rash.

Uncommon (may affect up to 1 in 100 people)

Fungal infections (e.g., oral thrush).
Decreased number of white blood cells (granulocytopenia).
Reduced number of red blood cells (anemia).
Blood clotting problems. Signs include easy bruising, joint pain, and swelling.
Headache.
Dizziness.
Nausea or vomiting.
Itching.
Pain or burning sensation along the vein where CARITEX was administered. Pain at the injection site.
Fever.
Abnormal kidney function test results (increased blood creatinine).

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

Inflammation of the large intestine (colitis). Signs include diarrhea, often with blood and mucus, stomach pain, and fever.
Difficulty breathing (bronchospasm).
Rash with raised itchy areas (urticaria), possibly affecting large areas of the body, associated with itching and swelling.
Blood or sugar in the urine.
Edema (fluid retention).
Chills.

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

Secondary infections that may not respond to the prescribed antibiotic.
A form of anemia characterized by destruction of red blood cells (hemolytic anemia).
Severe reduction in white blood cell count (agranulocytosis).
Seizures.
Dizziness.
Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain spreading to the back.
Inflammation of the mouth lining (stomatitis).
Inflammation of the tongue (glossitis). Signs include swelling, redness, and irritation of the tongue.
Problems with the gallbladder and/or liver, which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine, and pale stools.
A neurological condition that may develop in newborns with severe jaundice (kernicterus).
Kidney problems caused by calcium-ceftriaxone deposits. You may experience pain when urinating, or a reduced amount of urine produced.
False positive Coombs test result (a blood test used to detect blood-related problems).
False positive test result for galactosemia (an abnormal accumulation of the sugar galactose).
CARITEX may interfere with certain types of blood glucose tests; please consult your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, 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 helps provide more information on the safety of this medicine.

5. How to store CARITEX

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Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date stated on the packaging.
Warning: do not use this medicine after the expiry date stated on the packaging.
The stated expiry date refers to the product in its original, undamaged packaging, correctly stored. Do not
store above 30°C. Keep the bottle in the original container.
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 CARITEX contains
CARITEX 2 g powder for solution for infusion:
One vial of powder contains:
The active substance is: ceftriaxone disodium 3.5 H2O 2.386 g equivalent to ceftriaxone 2 g.
Description of the appearance of CARITEX and contents of the pack
CARITEX 2 g powder for solution for infusion: 1 vial of powder.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l
Via Marghera, 29
20149 Milan, Italy
Manufacturer
ESSETI FARMACEUTICI SRL - Via Campobello, 15 - 00040 Pomezia (Rome)
Disposal of syringes/sharp objects
The following list of points must be strictly observed regarding the use and disposal of
syringes and other sharp medical devices:

Needles and syringes must never be reused.
Place all used needles and syringes into a dedicated sharps container (single-use, puncture-resistant container).
Keep the container out of reach of children.
Used sharps containers must not be disposed of in household waste.
Dispose of the full container in accordance with local requirements or as instructed by your doctor.
Disposal of expired/unwanted medicines
Medicines should not be released into the environment. Medicines must not be disposed of via wastewater or in household waste. Use designated collection systems, if available.
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