Zimanel: detailed information

Package leaflet: Information for the user

ZIMANEL 1 g/4 ml powder and solvent for injectable solution for intramuscular use

Cefotaxime sodium and lidocaine hydrochloride
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What ZIMANEL is and what it is used for
What you need to know before using ZIMANEL
How to use ZIMANEL
Possible side effects
How to store ZIMANEL
Contents of the pack and other information

1. What ZIMANEL is and what it is used for

The powder contained in the ZIMANEL vial contains the active substance sodium cefotaxime, belonging to a group of medicines called antibiotics (beta-lactam antibiotics or third-generation cephalosporins) which are used to treat bacterial infections.
The solvent vial of ZIMANEL contains the active substance lidocaine hydrochloride, which belongs to a group of medicines called local anaesthetics that relieve pain at the injection site. ZIMANEL is indicated for the treatment of severe bacterial infections caused by certain bacteria (Gram-negative "difficult" organisms) or by a mixture of different types of bacteria (mixed flora) including Gram-negative bacteria resistant to common antibiotics. In these cases, it is also indicated for debilitated patients or those with impaired immune defences (immunocompromised patients).
This medicine is also indicated for the prevention of infections caused by surgical procedures.

2. What you need to know before using ZIMANEL

Do not use ZIMANEL

if you are allergic to sodium cefotaxime, to other similar medicines (cephalosporins), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously had allergies to other antibiotics belonging to the same group as ZIMANEL called penicillins, as cross-allergic reactions may occur (see section “Warnings and Precautions”).

ZIMANEL 1 g/4 ml powder and solvent for injectable solution for intramuscular use contains a local anaesthetic called lidocaine; therefore, it must not be administered in case of:

allergy to lidocaine or to other similar anaesthetics;
severe heart problems (heart block in the absence of a pacemaker and severe heart failure);
intravenous administration (endovenous administration);
infants under 30 months of age.

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Warnings and precautions
Talk to your doctor or nurse before ZIMANEL is administered to you.
As with other similar medicines (antibiotics), the use of this medicine may promote the occurrence of other infections caused by bacteria to which ZIMANEL is not effective, or superinfections may arise. If this occurs, you should consult your doctor, who will recommend appropriate therapy.
During treatment with ZIMANEL, the following may occur:

allergic reactions. Before starting therapy with this medicine, your doctor will perform specific tests to confirm that you are not allergic to cefotaxime, cephalosporins, penicillins, or other medicines. Use this medicine with caution and inform your doctor if you have previously experienced allergic reactions, especially to penicillins (beta-lactam antibiotics). If you notice signs of an allergic reaction, stop treatment with this medicine immediately and contact your doctor or go to the nearest hospital: a doctor will determine the appropriate treatment based on your condition;
appearance of blisters on the skin (severe blistering rashes such as Stevens-Johnson syndrome or toxic epidermal necrolysis). If you notice skin or mucosal reactions with blistering or bullae, stop treatment and contact your doctor immediately;
intestinal problems caused by a bacterium called Clostridium difficile. You may experience mild or severe diarrhoea in case of inflammation of the intestine (pseudomembranous colitis). If you develop severe or persistent diarrhoea during treatment with ZIMANEL, your doctor may perform specific tests (endoscopy or histological examination) to confirm whether it is caused by this bacterium. If you experience mild colitis, stop treatment to resolve symptoms. If you experience moderate or severe colitis, contact your doctor, who will recommend appropriate therapy. Do not take medicines that affect the intestine (peristalsis inhibitors) while taking ZIMANEL, as they may promote the occurrence of Clostridium difficile-associated disease. If you have suffered from intestinal diseases in the past, especially colitis, inform your doctor;
blood disorders (leucopenia, neutropenia, bone marrow failure, pancytopenia, agranulocytosis, thrombocytopenia, haemolytic anaemia), especially if you are using the medicine for prolonged periods. Therefore, if you have been prescribed treatment for 7–10 days or longer, you should undergo blood tests. Discontinue treatment with ZIMANEL if blood abnormalities occur, as some problems resolve after stopping treatment;
a condition causing brain disturbances (encephalopathy), which may include seizures, confusion, altered consciousness, and movement disorders. This type of antibiotic (beta-lactam antibiotic) increases this risk, particularly when administered at high doses or if you have kidney problems (impaired renal function). If you notice any of these symptoms, stop treatment and contact your doctor immediately.

Use this medicine with caution and inform your doctor if you have severe kidney problems (severe renal failure). In such cases, your doctor may decide to halve the maintenance dose depending on your condition. Undergo kidney function monitoring if you are taking ZIMANEL together with medicines for severe infections (aminoglycoside antibiotics), probenecid (a medicine to reduce blood uric acid levels), nephrotoxic medicines (drugs harmful to the kidneys), if you are elderly, or if you have kidney problems.
ZIMANEL may not be effective (antibiotic resistance), especially against certain families of bacteria (Enterobacteriaceae and Pseudomonas), in people with weakened immune defences (immunocompromised) or following concomitant use of similar medicines (beta-lactam antibiotics).
ZIMANEL and laboratory tests
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Inform your doctor that you are using this medicine before undergoing certain laboratory tests, as ZIMANEL may interfere with some laboratory tests, such as: Coombs test, blood compatibility test, urine sugar tests (Benedict, Fehling, "Clinitest" methods).
Other medicines and ZIMANEL
Inform your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.
ZIMANEL must not be mixed in the same syringe with other medicines, particularly antibiotics used to treat bacterial infections.
This medicine should be administered with caution if you are taking any of the following medicines:

aminoglycoside antibiotics, medicines used to treat bacterial infections, or diuretics, medicines that help eliminate fluids such as furosemide. Consult your doctor, as kidney function monitoring may be required in such cases.
probenecid, a medicine used to reduce uric acid levels in the blood, as it may slow down the urinary elimination of ZIMANEL.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Do not use ZIMANEL during pregnancy unless your doctor considers it necessary.
If you are breastfeeding, consult your doctor, who will assess whether breastfeeding or treatment with this medicine should be discontinued. Infants breastfed by mothers taking ZIMANEL may develop diarrhoea.
Driving and using machines
This medicine may cause dizziness or encephalopathy (a brain disorder) that may include seizures, confusion, altered consciousness, and movement disorders. This may impair your ability to drive or operate machinery. If these effects occur, avoid driving vehicles or operating machinery.
ZIMANEL contains sodium
ZIMANEL contains 50.5 mg (2.2 mmol) of sodium (the main component of table salt) per vial. This corresponds to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How to use ZIMANEL

This medicine will be administered to you by medical personnel who will always follow exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor or nurse.
Your doctor will determine the required dose and duration of treatment depending on the type and severity of the infection, your condition and body weight.
It is recommended to continue treatment for at least 3 days after your fever has subsided.
It is advisable to always use freshly prepared solutions, although the medicine, once dissolved with the contents of the solvent vial, may be stored in the refrigerator for up to 24 hours. Do not mix ZIMANEL with sodium bicarbonate solutions or with medicines used to treat bacterial infections (aminoglycoside antibiotics) or with other drugs.
The recommended dose for adults for intramuscular injection is 2 g per day, divided into two doses of 1 g every 12 hours.
This dose may be increased to 3–4 g per day.
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Use in children under 12 years of age
ZIMANEL 1 g/4 ml powder and solvent for injectable solution for intramuscular use must not be administered in children under 12 years of age because it contains lidocaine.
The recommended dose is 50–100 mg per kg of body weight per day, divided into 2–4 daily injections. In life-threatening situations or very severe cases, the dose has been increased up to 200 mg per kg of body weight per day. In premature newborns, the recommended dose must not exceed 50 mg per kg of body weight per day, as kidney function is not yet fully developed.
Use in patients with severe kidney problems
In cases of severe renal impairment, lower doses are recommended. If you are undergoing haemodialysis or peritoneal dialysis, the recommended dose ranges from 1 to 2 g per day depending on the severity of your infection. On the day of haemodialysis, ZIMANEL will be administered to you after the dialysis session. This precaution is not necessary in the case of peritoneal dialysis.
If you use more ZIMANEL than you should
Symptoms of overdose may correspond to the undesirable effects (see section 4) and brain damage (encephalopathies) may occur. In such cases, administration of this medicine must be stopped and your doctor will recommend appropriate therapy.
If you think you have been given too much of this medicine, contact your doctor immediately or go to the nearest hospital.
If you forget to use ZIMANEL
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

pain at the injection site with intramuscular administration (intramuscular injection).
Uncommon (may affect up to 1 in 100 people)
decrease in the number of white blood cells (leucopenia), increase in the number of eosinophils (eosinophilia), decrease in the number of platelets (thrombocytopenia);
skin redness (rash), itching, hives, increased liver blood test values (ALAT, ASAT, LDH, gamma-GT, alkaline phosphatase, bilirubin);
Jarisch-Herxheimer reaction (manifesting as fever, joint problems, rash, itching, decreased white blood cells, liver function test abnormalities, breathing difficulties);
seizures (see Section “Warnings and Precautions”);
diarrhoea (see Section “Warnings and Precautions”);
reduced kidney function and increased creatinine, a substance indicating kidney function, especially when this medicine has been prescribed together with other medicines for bacterial infections (aminoglycoside antibiotics);
fever;
inflammatory reactions at the injection site, including inflammation of a vein with or without blood clots (thrombophlebitis/phlebitis). 4/6

Not known (frequency cannot be estimated from available data)

superinfections caused by microorganisms (superinfections, see Section “Warnings and Precautions”);
reduction in certain types of white blood cells (neutropenia, agranulocytosis), reduced bone marrow activity (bone marrow failure), decrease in all blood cells (pancytopenia) (see Section “Warnings and Precautions”), reduction in red blood cells (haemolytic anaemia);
allergic reactions, even severe ones (anaphylactic reactions, anaphylactic shock), swelling due to fluid accumulation around the mouth and eyes (angioedema), bronchial constriction causing breathing difficulties (bronchospasm);
headache (cephalalgia), dizziness;
encephalopathy (which may include seizures, confusion, altered consciousness, and movement disorders). This type of antibiotic increases this risk, particularly when administered at high doses or if you have kidney problems (renal impairment). See Section “Warnings and Precautions”);
changes in heart rhythm (arrhythmias) following rapid bolus infusion via a catheter inserted directly into a vein (central venous catheter);
nausea, vomiting, abdominal pain (abdominal pain), severe inflammation of the intestine (pseudomembranous colitis) (see Section “Warnings and Precautions”);
skin lesions, even severe ones, such as: erythema multiforme (widespread redness), Stevens-Johnson syndrome and toxic epidermal necrolysis (blisters, vesicles and bleeding at lips, eyes, mouth, nose and genitals), generalized exanthematous pustulosis (widespread red and infected lesions) (see Section “Warnings and Precautions”);
liver problems (hepatitis), sometimes with yellowing of the skin and eyes (jaundice);
kidney inflammation (interstitial nephritis), severe kidney dysfunction (acute renal failure) (see Section “Warnings and Precautions”);
reactions affecting multiple organs (systemic reactions) to lidocaine (a local anaesthetic) present in the solvent for intramuscular administration only;
loss of appetite (anorexia), inflammation of the tongue (glossitis), heartburn (gastric pyrosis);
vaginal inflammation caused by a fungus (Candida vaginitis), agitation, confusion, reduced muscle strength (asthenia), night sweats.
hardening and fragility at the injection site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 ZIMANEL
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Store below 25°C and protect from light.
It is recommended to use freshly prepared solutions whenever possible; however, after dissolving the powder in the vial with the solvent ampoule (reconstituted product), the medicine may be stored in the refrigerator (+2°C to +8°C) for up to 24 hours, protected from light.
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. Contents of the pack and other information
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What ZIMANEL contains
Vial of powder

The active substance is cefotaxime sodium. One vial of powder contains 1.048 g of cefotaxime sodium (equivalent to 1 g of cefotaxime).
Solvent ampoule
The active substance is lidocaine hydrochloride. One solvent ampoule contains 40 mg of lidocaine hydrochloride.
The other ingredient is water for injections.

Description of the appearance of ZIMANEL and contents of the pack

Vial of powder.
4 ml solvent ampoule.

Marketing Authorization Holder
PROGE FARM S.r.l. – Largo Donegani, 4/A – 28100 Novara – Italy
Manufacturers
Manufactured by:
Laboratorio Farmaceutico C.T. S.r.l. – Via Dante Alighieri 69/71 – San Remo (IM) – Italy
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