Ceftriaxone Almus

Patient Information Leaflet

Ceftriaxone Almus 1 g/3.5 ml powder and solvent for injectable solution for intramuscular use
Generic 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 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 Almus is and what it is used for
2. What you need to know before being given Ceftriaxone Almus
3. How Ceftriaxone Almus is administered
4. Possible side effects
5. How to store Ceftriaxone Almus
6. Contents of the pack and other information

1. What Ceftriaxone Almus is and what it is used for

Ceftriaxone Almus 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.
Ceftriaxone Almus is administered by intramuscular injection in a solution containing lidocaine, which reduces the pain associated with the injection.
Ceftriaxone Almus 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 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 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 being given Ceftriaxone Almus

Do not be given Ceftriaxone Almus 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 Almus 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 Almus 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 disorders or jaundice (yellowing of the skin or whites of the eyes), or is to receive a calcium-containing product intravenously.

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

• you have recently received or are about to receive calcium-containing products.
• 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, 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 conditions, 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).
• 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”).

If you are to have a blood or urine test
If you are given Ceftriaxone Almus for a prolonged period, you may need regular blood tests. Ceftriaxone Almus 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 Ceftriaxone Almus.

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 Ceftriaxone Almus to a child if:

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

Other medicines and Ceftriaxone Almus
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 drugs may interact with lidocaine, resulting in altered effects. These drugs include:

• medicines used to treat infections (clarithromycin, erythromycin).
• medicines used to treat stomach ulcers (e.g. cimetidine).
• strong painkillers such as codeine and pethidine (narcotic or opioid medicines).
• medicines used to treat irregular heart rate (e.g. mexiletine, tocainide).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Your doctor will assess the benefits of treatment with Ceftriaxone Almus against any possible risks to the unborn or breastfed child.

Driving and using machines
Ceftriaxone Almus 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 Almus contains sodium
Ceftriaxone Almus contains 82.8 mg of sodium (a main component of table salt) per 1 g vial.
This corresponds to 4.14% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Ceftriaxone Almus is administered

Ceftriaxone Almus is generally administered by a doctor or nurse via an injection given directly into a muscle.
Ceftriaxone Almus 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 Ceftriaxone Almus for you. The dose will depend on the severity and type of infection, whether you are receiving concomitant treatment with other antibiotics, your body weight and age, and the functioning of your kidneys and liver. The number of days or weeks during which you will receive Ceftriaxone Almus will depend on the type of infection you have.

Adults, elderly patients, and children aged 12 years and 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 either 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 Ceftriaxone Almus 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 may 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 either 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 Ceftriaxone Almus 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 the amount of Ceftriaxone Almus you will need and will monitor you closely, depending on the severity of your liver or kidney disease.

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

If you miss a dose of Ceftriaxone Almus
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 administer a double dose (two injections together) to make up for the missed dose.

If you stop treatment with Ceftriaxone Almus
Do not stop taking Ceftriaxone Almus unless instructed by your doctor. If you have any doubts about using this medicine, consult your doctor, pharmacist, 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:

Severe allergic reactions (not known, frequency cannot be estimated from the 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 estimated from the available data)
If you develop a severe skin reaction, inform your doctor 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 (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 Almus for spirochete infections such as Lyme disease.

Conditions to watch for
Allergic reactions:
Chest pain in the context of allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome).

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).
• 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 CEFTRIAXONE ALMUS 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.
• Difficulty breathing (bronchospasm).
• Rash with raised red patches (urticaria), which may cover large areas of the body, associated with itching and swelling.
• Blood or sugar in the urine.
• Oedema (fluid retention).
• Chills.

Treatment with ceftriaxone, especially in elderly patients with severe renal insufficiency or neurological disorders, may rarely cause reduced consciousness, abnormal movements, agitation and seizures.

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.
• 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.
• Gallbladder and/or liver problems, which may cause pain, nausea, vomiting, yellowing of the skin (jaundice), 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 your urine output may decrease.
• False positive Coombs test (a test to detect blood problems).
• False positive test for galactosaemia (an abnormal accumulation of the sugar galactose).
• Ceftriaxone Almus may interfere with certain types of blood glucose tests; please check with your doctor.

Following accidental intravascular injection of lidocaine during intramuscular administration of Ceftriaxone Almus i.m., the following additional side effects may occur:

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

• Changes in heart rhythm and rate.
• Low blood pressure.
• Slowing of the heart rate (below 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 effect, 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. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ceftriaxone Almus

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 indicated applies to the product stored correctly in its original packaging.
It is recommended to use the solutions immediately after reconstitution, although once dissolved the medicine is stable for 6 hours at temperatures below 25°C and for 24 hours in a refrigerator (2°C - 8°C).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ceftriaxone Almus contains
The active substances are ceftriaxone and lidocaine.
Each vial of powder contains 1 g of ceftriaxone (as ceftriaxone sodium).
Each solvent vial contains an aqueous solution of 1% lidocaine.
Description of the appearance of Ceftriaxone Almus and contents of the pack
1 vial of powder + 1 solvent vial of 3.5 ml.
Marketing Authorization Holder
ALMUS S.r.l. - Via Cesarea 11/10 - 16121 Genoa
E-mail: [email protected]
Manufacturer
LABORATORIO FARMACEUTICO CT S.r.l. - Via Dante Alighieri 71 - 18038 Sanremo (IM)