Ceftriaxone Teva Italia

Patient Information Leaflet

CEFTRIAXONE TEVA ITALIA 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use

CEFTRIAXONE TEVA ITALIA 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
Ceftriaxone (as ceftriaxone sodium)
Lidocaine (as lidocaine hydrochloride)
Generic medicine
Please read this leaflet carefully before using 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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ceftriaxone Teva Italia is and what it is used for

Ceftriaxone Teva Italia contains the active substance ceftriaxone, which is an antibiotic used in adults and children (including newborns). It works by killing the bacteria that cause infections. It belongs to a group of medicines called cephalosporins.
Ceftriaxone Teva Italia 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 bones and joints.
• of the skin or soft tissues.
• of the blood.
• of the heart.

It may also be used:

• 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.

2. What you should know before using Ceftriaxone Teva Italia

Do not use Ceftriaxone Teva Italia 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 hands, feet and ankles, chest pain, and a severe rash that develops rapidly.
• you are allergic to lidocaine and Ceftriaxone Teva Italia is to be administered by intramuscular injection.
• you suffer from a heart conduction disorder causing low blood pressure and slowed heart rate (complete atrioventricular block).
• you suffer from reduced blood volume (hypovolemia).

Ceftriaxone Teva Italia must not be used in 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 must receive a product containing calcium intravenously.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ceftriaxone Teva Italia 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 liver enzyme levels 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 that 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 suffer from seizures (epilepsy).
• you have any heart condition, especially if it affects 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 undergo blood or urine tests
If you are using Ceftriaxone Teva Italia for a prolonged period, you may need to have regular blood tests.
Ceftriaxone Teva Italia 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 collecting your sample that you have been administered Ceftriaxone Teva Italia.

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 analytical methods should be used if necessary.

Children
Talk to your doctor, pharmacist, or nurse before using Ceftriaxone Teva Italia in a child if:

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

Other medicines and Ceftriaxone Teva Italia
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).
• medicines used to treat stomach ulcers (e.g. cimetidine).
• strong painkillers such as codeine and meperidine (narcotic or opioid drugs).
• medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

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 using this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone Teva Italia for you and the possible risks for your baby.

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

Ceftriaxone Teva Italia 500 mg/2 ml powder and solvent for injectable solution for intramuscular use
contains sodium
This medicine contains 41.5 mg of sodium (main component of table salt) per vial.
This corresponds to 2% of the maximum daily intake recommended in an adult's diet.

Ceftriaxone Teva Italia 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
contains sodium
This medicine contains 83 mg of sodium (main component of table salt) per vial.
This corresponds to 4% of the maximum daily intake recommended in an adult's diet.

3. How to use Ceftriaxone Teva Italia

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose
Your doctor will determine the correct dose of Ceftriaxone Teva Italia 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 function of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone Teva Italia will depend on the type of infection you have.

Adults, elderly, and adolescents aged 12 years and older 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, your doctor may 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 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 Ceftriaxone Teva Italia 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 given either as a single daily dose or divided into two separate doses.

• Children with a body weight of 50 kg or more should receive the standard adult dose.

Neonates (0–14 days of life)

• 20–50 mg of Ceftriaxone Teva Italia 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.

Patients with liver or kidney problems
You may be given a different dose than the standard one. Your doctor will decide the amount of Ceftriaxone Teva Italia you need and will monitor you closely, depending on the severity of your liver or kidney disease.

Method of administration
Ceftriaxone Teva Italia is generally administered by a doctor or nurse via an injection directly into a muscle. Ceftriaxone Teva Italia will be prepared by a doctor or nurse and must not be mixed with, nor administered simultaneously with, calcium-containing injections.

If you use more Ceftriaxone Teva Italia than you should
If you accidentally receive an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.

If you forget to use Ceftriaxone Teva Italia
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 use a double dose (two injections together) to make up for the forgotten dose.

If you stop using Ceftriaxone Teva Italia
Do not stop using Ceftriaxone Teva Italia 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 everybody gets them.

Treatment with ceftriaxone, especially in elderly patients with severe renal impairment or disorders of the nervous system, may rarely cause reduced level of consciousness, abnormal movements, agitation, and seizures.

With this medicine, you may experience the following side effects:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)
If you have 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.
• Chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

Severe skin reactions (not known, frequency cannot be estimated from the available data)
If you develop a severe skin reaction, inform a doctor 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, 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, which usually resolves spontaneously. These symptoms occur shortly after starting treatment with Ceftriaxone Teva Italia 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 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).
• Problems with blood clotting. Signs include easy bruising, joint pain and swelling.
• Headache.
• Dizziness.
• Nausea or vomiting.
• Itching.
• 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 wheals (urticaria), which may affect 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 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.
• Gallbladder and/or liver problems, 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 reduced urine output.
• False positive Coombs test (a blood test to detect blood-related problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Teva Italia may interfere with certain types of tests to measure blood glucose; please check with your doctor.

Following accidental injection of lidocaine into a blood vessel during intramuscular administration of Ceftriaxone Teva Italia, additional side effects may occur, which may include:
Not known (frequency cannot be estimated from the available data)

• Changes in heart rhythm and rate.
• Low blood pressure.
• Slowed heart rate (less than 60 beats per minute).
• Interruption of normal blood circulation due to cardiac arrest and reduced blood flow.
• Loss of balance, tingling around the mouth, numbness of the tongue, difficulty tolerating everyday sounds (hyperacusis), ringing in the ears (tinnitus), dizziness or lightheadedness, confusion, nervousness, involuntary rhythmic muscle contractions, seizures or epileptic fits, deep unconsciousness (coma).
• Blurred vision, double vision or temporary loss of vision.
• Feeling unwell (nausea or vomiting).
• Breathing difficulties.
• Reduced respiratory rate or possible cessation 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 Ceftriaxone Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month. The expiry date applies to the product in its original, undamaged packaging, stored correctly.
From a microbiological standpoint, the product must be used immediately after reconstitution. If not used immediately, the conditions and duration of storage prior to use are the responsibility of the user. Chemical and physical stability of the medicine after reconstitution has been demonstrated for 24 hours between +2°C and +8°C and for 6 hours when stored at temperatures below 25°C.
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 Ceftriaxone Teva Italia contains
Ceftriaxone Teva Italia 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 596.5 mg equivalent to 500 mg of ceftriaxone;
One solvent ampoule contains: aqueous solution of 1% lidocaine.
Ceftriaxone Teva Italia 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use
One vial of powder contains: ceftriaxone sodium 1.193 g equivalent to 1 g of ceftriaxone;
One solvent ampoule contains: aqueous solution of 1% lidocaine.

Description of the appearance of Ceftriaxone Teva Italia and contents of the pack
Ceftriaxone Teva Italia 500 mg / 2 ml powder and solvent for injectable solution for intramuscular use is supplied in a carton containing one 500 mg powder vial and one 2 ml solvent ampoule.
Ceftriaxone Teva Italia 1 g / 3.5 ml powder and solvent for injectable solution for intramuscular use is supplied in a carton containing one 1 g powder vial and one 3.5 ml solvent ampoule.

Marketing Authorization Holder
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milan

Manufacturer
Laboratorio Farmaceutico CT S.r.l.
Via Dante Alighieri, 71
18038 Sanremo (IM)