CARITEX 1 G/3.5 ML Powder and solvent for injectable solution

Зміст інструкції

1. CARITEX
   1. What is CARITEX and what it is used for
   2. What you need to know before you are given CARITEX
   3. How CARITEX is administered
   4. Possible side effects
   5. How to store CARITEX
   6. Package contents and other information
2. CARITEX
   1. What is CARITEX and what is it used for
   2. What you need to know before you are given CARITEX
   3. How CARITEX is administered
   4. Possible side effects
   5. How to store CARITEX
   6. Contents of the pack and other information
3. CARITEX
   1. What is CARITEX and what is it used for
   2. What you need to know before you are given CARITEX
   3. How CARITEX is administered
   4. Possible side effects
   5. How to store CARITEX
   6. Contents of the pack and other information

CARITEX

1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What CARITEX is and what it is used for
• 2. What you need to know before you are given CARITEX
• 3. How CARITEX is given
• 4. Possible side effects
• 5. How to store CARITEX
• 6. Contents of the pack and other information

1. What is CARITEX 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 administered by injection into
a muscle in a solution containing lidocaine, which reduces the pain associated with the injection.
CARITEX is used to treat infections:

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

It can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis)
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life 1/20
• to prevent infections during a surgical procedure.

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

You must not be given CARITEX if:

• you are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6)
• you have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, penicillins, monobactams and carbapenems). Possible signs include a sudden swelling of the throat or face, which can make it difficult to breathe or swallow, a sudden swelling of hands, feet and ankles, and a severe skin rash that develops rapidly
• you are allergic to lidocaine and CARITEX is to be given to you by injection into a muscle
• you suffer from an abnormality in the propagation of the heart impulse that causes a reduction in blood pressure and a slowing of the heart rate (complete atrioventricular block)
• you suffer from a state of 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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or must receive through a vein a product containing calcium.

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

• you experience or have experienced in the past any combination of the following symptoms: skin 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 and an increase in a type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe 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 problems with diarrhea after taking an antibiotic. You have had problems with the intestine, in particular colitis (inflammation of the intestine)
• you have problems with the liver or kidneys (see section 4)
• you have gallstones or kidney stones
• you have other diseases, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath)
• you are following a low-sodium diet
• you suffer from loss of muscle function and weakness (myasthenia gravis)
• you suffer from seizures (epilepsy)
• you suffer from any heart problem, especially if this affects the heart rate
• you have breathing problems
• you suffer from porphyria (a rare hereditary disease that affects the skin and nervous system).

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

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

If you are diabetic or need monitoring of blood glucose levels, you should not use some
2/20
blood glucose monitoring systems that may detect blood glucose incorrectly during
treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, the
pharmacist or the nurse. If necessary, alternative analytical methods must be used.

Children
Talk to your doctor, pharmacist or nurse before giving CARITEX to the child if:

• the child has recently received or is about to receive through a vein 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, tell your doctor or pharmacist if you are taking any of the following medicines, as
they can interact with ceftriaxone:

• a type of antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections). Several drugs can interact with lidocaine, resulting in altered effects. These drugs include:
• medicines used to treat infections (clarithromycin, erythromycin, rifampicin)
• medicines used in the treatment of stomach ulcers (e.g. cimetidine)
• medicines used to treat epilepsy (barbiturates, phenytoin, carbamazepine, primidone);
• medicines used to treat irregular heartbeat (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor for advice before taking this medicine.
The doctor will assess the benefits of treatment with CARITEX for you and the possible risks to the
child.

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

CARITEX contains sodium
This medicine contains 82.9 mg of sodium (the main component of table salt) per vial of 1

• g. This is equivalent to 4% of the recommended daily intake of salt 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, nor will it be administered simultaneously with injections containing calcium.

Usual dose
The doctor will determine the right dose of CARITEX for you. The dose will depend on the severity and type of infection, any concomitant treatment with other antibiotics, your weight and age, the degree of functioning 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 and children aged 12 years or older with a body weight of 50 kilograms (kg) or more:
3/20

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

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

• 50-80 mg CARITEX once a day for each kg of the child's body weight depending on the severity and type of infection. If you have a severe infection, the doctor will prescribe a higher dose starting from 100 mg per each kg of body weight up to a maximum of 4 g per day. If your daily dose is more than 2 g, you may take it as a single dose once a day or as two separate doses
• children with a body weight of 50 kg or more should be administered the usual adult dose.

Newborns (0- 14 days of life)

• 20-50 mg CARITEX once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per each kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of CARITEX you need and will monitor you closely, depending on the severity of the liver and kidney disease.

If you take more CARITEX than you should
If you are accidentally administered more CARITEX than the prescribed dose, contact your doctor or the nearest hospital immediately.

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

If you stop taking CARITEX
Do not stop taking CARITEX unless your doctor tells you to. If you have any doubts about the use of this medicine, ask 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 impairment or nervous system pathologies, may rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

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

• sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow
• sudden swelling of the hands, feet and ankles. 4/20

Serious skin reactions (frequency not known, cannot be estimated from available data)
If you develop a serious skin reaction, seek medical attention 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 by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome). Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with CARITEX to treat infections from spirochetes such as Lyme disease.)

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

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood test results for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Decrease in the 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 values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with hives (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated from available data)
5/20

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that spreads to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (Kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may decrease.
• A false positive result to the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• CARITEX may interfere with some types of tests to measure blood glucose; check with your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of
CARITEX i.m. other side effects may occur, which may include:

Frequency not known (cannot be estimated from available data)

• Changes in heart rate and rhythm.
• Low blood pressure.
• Slowing of the heart rate (below 60 beats/minute).
• Interruption of normal blood circulation due to cardiac arrest and decreased blood flow.
• Tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, nervousness, rhythmic involuntary muscle contractions (convulsions), deep state of unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (Nausea or vomiting).
• Difficulty breathing.
• Decreased breathing rate or possible cessation of breathing.
• An unusual feeling of sleepiness or fatigue during the day or fainting.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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
indicated on the packaging.
6/20
Caution: do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored.
Do not store at a temperature above 30°C. Keep the bottle in its original container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer 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 powder vial contains:
The active ingredient is: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1g; 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 Authorisation Holder and manufacturer
Marketing Authorisation 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 in a special container for sharp objects (disposable puncture-proof container).
Keep the container out of reach of children.
Used sharp object containers must not be placed in household waste.
Dispose of the full container in accordance with local requirements or according to the doctor's instructions.

Disposal of expired/unused medicines

The release of medicines into the environment must be minimized. Medicines should not be discarded

into wastewater and household waste. Use appropriate collection systems, if available.
7/20

CARITEX

1 g / 10 ml powder and solvent for injectable solution for intravenous use
Ceftriaxone
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is CARITEX and what is it 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 used to treat infections:

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

It can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis)
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 life
• to prevent infections during a surgical procedure.

8/20

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

Do not be given CARITEX if:

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

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 life) and has certain blood problems or jaundice (yellowing of the skin or the white of the eye) 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 have or have had in the past any combination of the following symptoms: skin 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 and an increase in a type of white blood cells (eosinophilia) and enlargement of the lymph nodes (signs of severe 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 problems with diarrhoea after taking an antibiotic. You have had problems with your intestines, in particular colitis (inflammation of the intestines)
• you have problems with your liver or kidneys (see section 4)
• you have gallstones or kidney stones
• you have other illnesses, for example hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath)
• you are following a low-sodium diet.

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

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

If you are diabetic or need monitoring of blood glucose levels, you should not use some blood glucose monitoring systems that may detect blood glucose incorrectly during treatment
with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, pharmacist or
nurse. If necessary, alternative analytical methods must be used.

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 a product containing calcium through a vein.

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, tell your doctor or pharmacist if you are taking any of the following medicines:
9/20

• a type of antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections). Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. The doctor will assess the benefits of treatment with CARITEX for you and the possible risks to the baby.

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

CARITEX contains sodium
This medicine contains 82.9 mg of sodium (the main component of table salt) per vial of 1

• g. This is equivalent to 4% of the recommended daily intake of salt with the diet of an adult.

3. How CARITEX is administered

CARITEX is generally administered by a doctor or nurse via an intravenous drip (intravenous
infusion) or via an injection directly into a vein. CARITEX will be prepared by a
doctor, pharmacist or nurse and will not be mixed, nor will it be administered simultaneously with
injections containing calcium.

Usual dose
The doctor will determine the right dose of CARITEX for you. The dose will depend on the severity and type of
infection, any concomitant treatment with other antibiotics, your weight and age, 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, the elderly and children aged 12 years or older with a body weight of 50
kilograms (kg) or more:

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

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

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

Newborns (0- 14 days of life)

• 20-50 mg CARITEX once a day for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per each kg of the newborn's body weight.

10/20

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
CARITEX you will need and will monitor you carefully, depending on the severity of the liver and
kidney disease.

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

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

If you stop taking CARITEX
Do not stop taking CARITEX unless your doctor tells you to do so. If you have any doubts about the use
of this medicine, ask 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 kidney failure or nervous system pathologies, may rarely cause a decrease in consciousness, abnormal movements, agitation and convulsions.

Serious allergic reactions (frequency not known, cannot be estimated 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 can make it difficult to breathe or swallow
• sudden swelling of the hands, feet and ankles.

Serious skin reactions (frequency not known, cannot be estimated from available data)
If you develop a serious skin reaction, seek medical attention 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 by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), enlarged lymph nodes and involvement of other organs in the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally resolves spontaneously. These symptoms occur shortly after starting treatment with CARITEX for infections caused by spirochetes 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 decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea.
• Changes in blood tests for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decrease in the number of white blood cells (granulocytopenia).
• Decrease in the 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 values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Rash with hives (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated from available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain that extends to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive result on the Coombs test (a test to detect blood problems).
• A false positive result for galactosemia (an abnormal accumulation of galactose sugar).
• CARITEX may interfere with some types of tests to measure blood glucose; check with your 12/20

doctor.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through 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 indicated on the packaging.
Caution: do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored. Do not
store at a temperature above 30°C. Keep the vial in its original container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack 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 ingredient is: ceftriaxone disodium 3.5 H2O 1.193 g equivalent to ceftriaxone 1g; 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 solvent vial of 10 ml.

Marketing Authorisation Holder and manufacturer
Marketing Authorisation 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 respected regarding the use and disposal
of syringes and other sharp medical devices:
Needles and syringes must never be reused.
Insert all used needles and syringes into a special sharp object container (disposable puncture-proof container).
Keep the container out of reach of children.
Used sharp object containers must not be placed in household waste.
Dispose of the full container in accordance with local requirements or according to the doctor's instructions.

Disposal of expired/unused medicines

The release of medicines into the environment must be minimized. Medicines should not be discarded
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into the wastewater and household waste. Use appropriate collection systems, if available.
14/20

CARITEX

2 g powder for infusion solution
Ceftriaxone
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What CARITEX is and what it is used for
• 2. What you need to know before you are given CARITEX
• 3. How CARITEX is given
• 4. Possible side effects
• 5. How to store CARITEX
• 6. Contents of the pack and other information

1. What is CARITEX and what is it 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 used to treat infections:

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

It can be administered:

• to treat specific sexually transmitted infections (gonorrhea and syphilis)
• to treat patients with a low number of white blood cells in the blood (neutropenia) who have a 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 those aged 15/20

newborns from 15 days of life

• to prevent infections during surgery.

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

You must not be given CARITEX if:

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

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 life) and has some blood problems or jaundice (yellowing of the skin or the white of the eye) or needs to receive a product containing calcium through a vein. Warnings and precautionsTalk to your doctor, pharmacist or nurse before you are given CARITEX if:
• you have or have had in the past any combination of the following symptoms: skin 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 and increased type of white blood cells (eosinophilia) and swollen lymph nodes (signs of severe 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 problems with diarrhea after taking an antibiotic. You have had problems with the intestines, in particular colitis (inflammation of the intestine)
• you have problems with the liver or kidneys (see section 4)
• you have gallstones or kidney stones
• you have other illnesses, such as hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath)
• you are on a low-sodium diet.

If you are to undergo a blood or urine test
If you are given CARITEX for a prolonged period, you may need to undergo regular
blood tests. CARITEX can affect the results of urine tests related to sugar 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 are diabetic or need monitoring of blood glucose levels, you should not use some blood glucose monitoring systems that can detect blood glucose incorrectly during treatment with ceftriaxone. If you use such systems, check the instructions for use and inform your doctor, pharmacist or nurse. If necessary, alternative analytical methods must be used.

Children
Talk to your doctor, pharmacist or nurse before giving CARITEX to the child if:

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

Other medicines and CARITEX
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take
any other medicines.
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In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• a type of antibiotic called an aminoglycoside
• an antibiotic called chloramphenicol (used to treat infections, especially eye infections). Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine. The doctor will assess the benefits of treatment with CARITEX for you and the possible risks to the baby.

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

CARITEX contains sodium
This medicine contains 165.9 mg of sodium (the main component of table salt) per vial of 2

• g. This is equivalent to 8.3% of the recommended daily intake of salt for an adult.

3. How CARITEX is administered

CARITEX is generally administered by a doctor or nurse via an intravenous drip (intravenous
infusion) or via an injection directly into a vein. CARITEX will be prepared by a
doctor, pharmacist or nurse and will not be mixed, nor will it be administered simultaneously with
injections containing calcium.

Usual dose
The 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 weight and age, 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 12 years of age and over with a body weight of 50
kilograms (kg) or more:

• 1 to 2 g once daily depending on the severity and type of infection. If you have a severe infection, the doctor will administer a higher dose (up to 4 g per day). If your daily dose is more than 2 g, you can take it as a single dose once daily or as two separate doses. Newborns, infants and children from 15 days to 12 years of age with a body weight of less than 50 kg:
• 50-80 mg CARITEX once daily for each kg of the child's body weight depending on the severity and type of infection. If you have 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 your daily dose is more than 2 g, you can take it as a single dose once daily or as two separate doses.
• children with a body weight of 50 kg or more should be given the usual adult dose.

Newborns (0- 14 days of life)

• 20-50 mg CARITEX once daily for each kg of the newborn's body weight depending on the severity and type of infection.
• The maximum daily dose should not exceed 50 mg per kg of the newborn's body weight.

People with liver and kidney problems
You may be given a different dose than usual. The doctor will decide the amount of
CARITEX you need and will monitor you carefully, depending on the severity of the liver and
kidney disease.
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If you take more CARITEX than you should
If you are accidentally given more CARITEX than the prescribed dose, contact
your doctor or the nearest hospital immediately.

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

If you stop taking CARITEX
Do not stop taking CARITEX unless your doctor tells you to. If you have any doubts about the use
of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
With this medicine you may experience the following side effects:
Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or nervous system pathologies, may rarely cause a reduction in consciousness, abnormal movements, agitation and convulsions

Serious allergic reactions (frequency not known, cannot be estimated based on available data)
If you have a serious allergic reaction, seek medical attention immediately.
Signs may include:

• sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow
• sudden swelling of the hands, feet and ankles.

Serious skin reactions (frequency not known, cannot be estimated based on available data)
If you develop a serious skin reaction, seek medical attention 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 by the acronyms SJS and TEN).
• Any combination of the following symptoms: widespread rash, high body temperature, increased liver enzymes, abnormalities in blood tests (eosinophilia), enlarged lymph nodes and involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms, also known by the acronym DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction, which can cause fever, chills, headache, muscle pain and rash, which generally tends to resolve spontaneously. These symptoms occur shortly after starting treatment with CARITEX to treat infections from spirochetes such as Lyme disease.)

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

• White blood cell abnormalities (such as decreased leukocytes and increased eosinophils) and platelets (decreased thrombocytes).
• Soft stools or diarrhea. 18/20
• Changes in blood tests for liver function.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• Decreased number of white blood cells (granulocytopenia).
• Decreased number of red blood cells (anemia).
• Blood clotting problems. Signs include easy bruising, pain and swelling of the joints.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• Pain or burning sensation along the vein where CARITEX was administered. Pain where the injection was given.
• Fever.
• Abnormal values in kidney function tests (increased creatinine in the blood).

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

• Inflammation of the large intestine (colon). Signs include diarrhea, often with blood and mucus, stomach pain and fever.
• Difficulty breathing (bronchospasm).
• Skin rash with wheals (urticaria) that can cover a large area of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Edema (fluid retention).
• Chills.

Frequency not known (cannot be estimated based on available data)

• Secondary infections that may not respond to the prescribed antibiotic.
• A form of anemia characterized by the destruction of red blood cells (hemolytic anemia).
• Severe decrease in the number of white blood cells (agranulocytosis).
• Convulsions.
• Vertigo.
• Inflammation of the pancreas (pancreatitis). Signs include severe stomach pain, radiating to the back.
• Inflammation of the oral mucosa (stomatitis).
• Inflammation of the tongue (glossitis). Signs include swelling, redness and irritation of the tongue.
• Problems with the gallbladder and/or liver, which can cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay-colored stools.
• A neurological condition that can develop in newborns with severe jaundice (Kernicterus).
• Kidney problems caused by calcium-ceftriaxone deposits. Pain may occur when urinating, or the amount of urine produced may be reduced.
• A false positive Coombs test (a test to detect blood problems).
• A false positive for galactosemia (an abnormal accumulation of galactose sugar).
• CARITEX may interfere with some types of tests to measure blood glucose; check with your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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

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Keep this medicine out of the sight and reach of children.
Expiry date: see the expiry date indicated on the packaging.
Caution: do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, correctly stored. Do not
store at a temperature above 30°C. Keep the vial in its original container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CARITEX contains
CARITEX 2 g powder for solution for infusion:
One vial of powder contains:
The active ingredient 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 Authorisation Holder and manufacturer
Marketing Authorisation 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 in a suitable sharp object container (disposable puncture-proof container).
Keep the container out of the reach of children.
Used sharp object containers must not be placed in household waste.
Dispose of the full container in accordance with local requirements or as instructed by your doctor.

Disposal of expired/unused medicines

The release of medicines into the environment must be minimized. Medicines should not be discarded

into wastewater and household waste. Use appropriate collection systems, if available.
20/20