Deflamon

Package leaflet: Information for the user

DEFLAMON 500 mg/100 ml infusion solution

Metronidazole
Please read 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 they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What DEFLAMON is and what it is used for

DEFLAMON contains the active substance metronidazole, which belongs to a group of medicines called antibiotics, used against infections caused by microorganisms.
This medicine is indicated for the treatment of severe infections (septicaemia, bacteraemia) in adults and children caused by the following bacteria: Bacteroides fragilis, Fusobacteria, Eubacteria, Clostridia, and anaerobic Gram-positive cocci.
DEFLAMON is particularly indicated for:

• the treatment of infections causing accumulation of infected material (brain and pelvic abscesses), severe lung infections (necrotizing pneumonia), bone and joint infections (osteomyelitis), uterine infections (puerperal fever), peritoneal infections (peritonitis), and infections causing wound complications following surgical procedures;
• the prevention of infections caused by bacteria (Bacteroides and anaerobic Gram-positive cocci) that may occur following surgical procedures.

2. What you should know before using DEFLAMON

Do not use DEFLAMON

• if you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from any blood or bone marrow disorder (haematological disorders);
• if you have any active neurological disease (active central nervous system disorders);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or nurse before you are given DEFLAMON.
DEFLAMON will always be administered under strict medical supervision.
DEFLAMON will be administered with great caution and at reduced doses if:

• you have severe kidney problems (severe impairment of renal function);
• you have severe liver problems (severe hepatic disease);
• you suffer from severe active or chronic diseases of the peripheral and central nervous system. Metronidazole should be used only if the expected benefits clearly outweigh the potential risks.

If you are to be given DEFLAMON for longer than 10 days:

• your doctor will assess the risk of developing peripheral nervous system problems (peripheral neuropathy);
• regular monitoring of your clinical condition will be performed.

Cases of liver toxicity (hepatotoxicity severe/acute liver failure), including cases resulting in death, have been reported with metronidazole-containing medicines in patients affected by Cockayne syndrome.
If you have Cockayne syndrome, your doctor will frequently monitor your liver function both during and after treatment with metronidazole.
Immediately inform your doctor and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greish-green stools, or itching;
• seizures, or numbness or altered sensation in a limb (paraesthesia);
• severe blistering skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis).

During treatment, your urine may become reddish-brown in colour due to the presence of soluble drug pigments.
Prolonged therapy with metronidazole may be associated with bone marrow suppression, resulting in impaired production of blood cells (haematopoiesis). Therefore, blood cell counts should be closely monitored during prolonged treatment.

Children and newborns
This medicine may be administered with caution in children.

Other medicines and DEFLAMON
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:

• Disulfiram (a medicine used to treat chronic alcohol dependence) within the previous two weeks: DEFLAMON may cause psychotic reactions (e.g. confusion, behavioural changes, hallucinations).
• Warfarin, acenocoumarol, dicoumarol, phenprocoumon (oral anticoagulants): DEFLAMON may increase bleeding time; therefore, your doctor may ask you to have frequent prothrombin time (INR) tests and may adjust your anticoagulant dose accordingly.
• Lithium: DEFLAMON may increase serum lithium levels (lithaemia); therefore, lithium therapy should be discontinued during DEFLAMON treatment. If concomitant use of lithium and DEFLAMON is necessary, regular monitoring of blood levels of lithium, creatinine, and electrolytes (sodium, potassium, chloride) is essential.
• Phenytoin, phenobarbital (antiepileptic medicines): by increasing liver activity, they may accelerate the elimination of DEFLAMON, thereby reducing its blood concentration.
• Cyclosporine (an immunosuppressant medicine): DEFLAMON may reduce the liver’s ability to eliminate cyclosporine, leading to its accumulation in the blood and risk of toxicity.
• Cimetidine (a medicine used for ulcers, reflux esophagitis, or gastritis): may slow down the elimination of DEFLAMON from the blood, increasing its concentration.
• Tacrolimus (a medicine used to prevent organ transplant rejection): concomitant use with DEFLAMON may increase the risk of cardiac disorders (QT interval prolongation and arrhythmias). DEFLAMON may also reduce the liver’s elimination of tacrolimus, leading to its accumulation in the blood and risk of toxicity.
• Medicines causing cardiac disorders (QT interval prolongation): concomitant use with DEFLAMON may increase the risk of such disorders.
• Cholestyramine (a medicine used to lower blood cholesterol): may reduce the effectiveness of DEFLAMON.
• Carbamazepine (a medicine used for epilepsy and trigeminal neuralgia): DEFLAMON may slow down the elimination of carbamazepine, leading to its accumulation in the blood and risk of central nervous system toxicity.
• Amprenavir (a medicine used to treat HIV): DEFLAMON must not be administered together with oral amprenavir solution due to the potential risk of toxicity from an excipient in amprenavir (propylene glycol).
• Mycophenolate mofetil (a medicine used to prevent acute organ transplant rejection): if DEFLAMON is administered concomitantly with norfloxacin (an antibiotic) and mycophenolate mofetil, exposure to the latter may be reduced. No interactions have been observed if DEFLAMON or norfloxacin are administered together with mycophenolate mofetil but separately from each other.
• Herbal preparations containing silibinin (e.g. milk thistle): may reduce the blood concentration of DEFLAMON, thereby reducing its efficacy.
• Ergotamine and dihydroergotamine (medicines used to treat migraine): DEFLAMON may increase blood levels of these medicines, increasing the risk of toxicity.
• Busulfan (a medicine used in conditioning treatment prior to haematopoietic stem cell transplantation): DEFLAMON may increase busulfan blood levels, increasing the risk of toxicity.
• 5-fluorouracil (an anticancer medicine): DEFLAMON may increase blood levels of this medicine, increasing the risk of toxicity.

DEFLAMON and alcohol
Do not drink alcohol while being treated with DEFLAMON, as you may experience symptoms such as nausea, vomiting, and abdominal cramps.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or nurse before this medicine is administered.
DEFLAMON must not be administered if you are pregnant or breastfeeding.

Driving and using machines
Due to its neurological effects, metronidazole may impair your ability to drive or operate machinery.

DEFLAMON contains sodium
This medicine contains 311 mg of sodium (the main component of table salt) per vial. This corresponds to 15.5% of the maximum daily dietary intake recommended for an adult.

3. How to use DEFLAMON

This medicine will be administered to you only under the strict supervision of qualified healthcare personnel (physician or nurse). If you have any doubts, consult your physician or nurse.
This medicine must be administered only by slow intravenous infusion (5 ml/min). This route of administration is particularly useful in emergency situations and is indicated in surgical patients when:

• anaerobic infection is present or suspected in the preoperative phase, e.g. septicemia, peritonitis, subphrenic or pelvic abscess;
• signs of septic state caused by anaerobic organisms appear during surgery;
• there is a risk of contamination by anaerobes originating from the gastrointestinal tract, female genital tract, or oropharynx during surgery.

If necessary, the medicine may be diluted with the following solutions: physiological saline, isotonic dextrose solution, 5% dextrose solution, or potassium chloride (20 mmol/L and 40 mmol/L).
Avoid adding other medicines, apart from metronidazole, to the infusion solution.
Use in adults and children over 12 years of age
The recommended dose is 100 ml for intravenous infusion (at a rate of 5 ml/min) every 8 hours. In most patients, 7 days of therapy are sufficient, but in some cases (inaccessible areas for drainage, new contamination, etc.) a longer treatment duration may be required.
The recommended dose for prevention of infections is 100 ml by intravenous infusion immediately before, during, or after surgery, followed by the same dose every 8 hours.
Use in children under 12 years of age and in neonates
The recommended dose is:

• children aged between 8 weeks and 12 years: 20–30 mg/kg/day as a single dose or divided into doses of 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg depending on the severity of the infection. Treatment duration is usually 7 days.
• children under 8 weeks of age: 15 mg/kg/day as a single dose or divided into doses of 7.5 mg/kg every 12 hours. In premature neonates: the physician must administer the medicine with caution and monitor blood levels of the drug.

The recommended dose for prevention of infections is:

• children under 12 years: 20–30 mg/kg as a single dose given 1–2 hours before surgery;
• premature neonates: 10 mg/kg body weight as a single dose before surgery.

Each vial is for single use only; any unused portion must not be retained.
If you use more DEFLAMON than you should
This medicine will be administered by specialized personnel, so it is unlikely that you will receive an excessive dose. However, if an overdose is administered, consult your physician who will advise appropriate therapy for your symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience neurological problems (neuropathy, epileptic seizures), treatment must be discontinued.
Frequency not known (the frequency of adverse reactions cannot be determined from the available data)

• gastrointestinal disorders (of the digestive system),
• anorexia (loss of appetite),
• nausea,
• coated tongue,
• dry mouth,
• metallic taste,
• glossitis (inflammation of the tongue),
• stomatitis (inflammation of the mucous membranes of the mouth),
• headache,
• skin rashes,
• dizziness,
• ataxia (lack of coordination of movement),
• depression,
• insomnia,
• nasal congestion (stuffy nose),
• urticaria,
• pruritus,
• angioedema (swelling of the skin of the face and mucous membranes which may cause difficulty in swallowing and breathing),
• anaphylaxis (severe, rapidly occurring allergic reaction),
• dysuria (difficulty in passing urine),
• cystitis (inflammation of the urinary bladder),
• fever,
• polyuria (passing an abnormally large volume of urine),
• pyuria (presence of pus in the urine),
• decreased libido (reduced sexual desire),
• psychiatric disorders, including confusion, hallucinations,
• encephalopathy (manifesting as confusion, fever, headache, hallucinations, paralysis, mild sensitivity, visual and movement disturbances, stiff neck),
• subacute cerebellar syndrome (manifesting as ataxia, dysarthria, gait disturbance, nystagmus and tremor),
• eye disorders such as diplopia, myopia, optic neuropathy/optic neuritis,
• cardiac disorders such as tachycardia, palpitations,
• ear disorders such as impaired hearing, hearing loss (including sensorineural), tinnitus,
• liver and pancreas disorders (elevated liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice and pancreatitis),
• acute liver failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”),
• muscle pain,
• joint pain,
• Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (two severe, potentially life-threatening skin diseases), Acute Generalized Exanthematous Pustulosis (AGEP),
• Candida infections.

After prolonged or intensive therapy, isolated cases of transient leukopenia,
agranulocytosis, neutropenia, thrombocytopenia, pancytopenia (low levels of white blood cells, granulocytes, and platelets in the blood), or peripheral neuropathy (damage to peripheral nerve endings) have been reported.
During treatment, urine may turn reddish-brown due to soluble drug pigments.

Side effects in children
The frequency, type, and severity of side effects in children are the same as in adults.

Reporting of side effects
If you get any side effects, including ones 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 DEFLAMON

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 the word “Exp.”.
The expiry date refers to the last day of that month and applies to the product in its original, undamaged packaging
and properly stored.
Store the medicine protected from light.
Each vial is for single use only; any remaining contents must not be reused.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What DEFLAMON contains

• The active substance is metronidazole. Each 100 ml vial contains 500 mg of metronidazole.
• The other components are: sodium chloride, citric acid, sodium phosphate, water for injections.

Description of the appearance of DEFLAMON and pack contents
DEFLAMON is supplied in packs containing either 1 vial or 25 vials of 100 ml.
Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILAN, ITALY.
Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - Grosotto (SO).

Patient information leaflet: information for the patient

DEFLAMON 250 mg film-coated tablets

Metronidazole
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What DEFLAMON is and what it is used for
2. What you need to know before taking DEFLAMON
3. How to take DEFLAMON
4. Possible side effects
5. How to store DEFLAMON
6. Package contents and other information

1. What DEFAMON is and what it is used for

DEFAMON belongs to the pharmaceutical category of antiprotozoals (medicines used against protozoal
infections), and gynaecological anti-infectives and antiseptics (medicines that prevent or slow down the
growth of microorganisms).
This medicine is used in adults and adolescents from the age of 12 years for:
Symptomatic urethritis and vaginitis due to Trichomonas vaginalis (inflammation of the urethra or vagina
caused by the protozoan Trichomonas vaginalis).

2. What you should know before using DEFLAMON

Do not use DEFLAMON

• if you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6);
• if you have any blood or bone marrow disorder (haematological disorders);
• if you suffer from neurological problems (active central nervous system diseases);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking DEFLAMON.
If you experience signs or symptoms of an allergic reaction, stop treatment immediately and consult your doctor.
Cases of liver toxicity (severe hepatotoxicity/acute liver failure), including fatal cases, have been reported with metronidazole-containing medicines in patients with Cockayne syndrome.
If you have Cockayne syndrome, your doctor will frequently monitor your liver function both during and after treatment with metronidazole.
Contact your doctor immediately and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and greasy stools, or itching.

Rare cases of severe blistering skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis, have occurred during treatment with metronidazole.
If you develop signs or symptoms of these conditions, stop taking the medicine and contact your doctor immediately.
Exercise particular caution:

• if you have severe impairment of liver or kidney function.

Use this medicine only under strict medical supervision.
If DEFLAMON is to be administered for longer than 10 days:

• your doctor will assess the risk of developing peripheral nervous system problems (peripheral neuropathy);
• regular monitoring of your clinical condition will be performed.

During treatment, your urine may turn reddish-brown due to soluble pigments of the medicine.
The medicine has shown carcinogenic properties in animals under specific experimental conditions; therefore, the duration and repetition of treatments must be carefully evaluated by your doctor.
Other medicines and DEFLAMON
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
In particular, inform your doctor if you are taking:

• Disulfiram (a medicine used to treat chronic alcohol dependence) within the previous two weeks: DEFLAMON may cause psychiatric reactions (e.g. confusion, behavioural changes, hallucinations).

• Warfarin, acenocoumarol, dicoumarol, phenprocoumon (oral anticoagulants): DEFLAMON may increase bleeding time; therefore, your doctor may ask you to have frequent prothrombin time (INR) tests and may adjust your anticoagulant dose accordingly.

• Lithium: DEFLAMON may increase serum lithium levels; therefore, lithium therapy should be discontinued during treatment with DEFLAMON. If concomitant use of lithium and DEFLAMON is necessary, regular monitoring of blood levels of lithium, creatinine, and electrolytes (sodium, potassium, chloride) is essential.

• Phenytoin, phenobarbital (antiepileptic medicines): these may increase liver activity and accelerate the elimination of DEFLAMON, thereby reducing its blood concentration.

• Cyclosporine (an immunosuppressant medicine): DEFLAMON may reduce the liver’s ability to eliminate cyclosporine, leading to its accumulation in the blood and risk of toxicity.

• Cimetidine (a medicine used for ulcers, reflux esophagitis, or gastritis): may slow down the elimination of DEFLAMON from the blood, increasing its concentration.

• Tacrolimus (a medicine used to prevent organ transplant rejection): concomitant use with DEFLAMON may increase the risk of cardiac disorders (QT interval prolongation and arrhythmias). DEFLAMON may also reduce the liver’s elimination of tacrolimus, leading to its accumulation in the blood and risk of toxicity.

• Medicines that cause cardiac disorders (QT interval prolongation): concomitant use with DEFLAMON may increase the risk of such disorders.

• Cholestyramine (a medicine used to lower blood cholesterol): may reduce the effectiveness of DEFLAMON.

• Carbamazepine (a medicine used to treat epilepsy and trigeminal neuralgia): DEFLAMON may slow down the elimination of carbamazepine, leading to its accumulation in the blood and risk of central nervous system toxicity.

• Amprenavir (a medicine used to treat HIV): DEFLAMON must not be administered together with oral amprenavir solution due to the potential risk of toxicity from an excipient in amprenavir (propylene glycol).

• Mycophenolate mofetil (a medicine used to prevent acute organ transplant rejection): if DEFLAMON is administered together with norfloxacin (an antibiotic) and mycophenolate mofetil, exposure to the latter may be reduced. No interactions have been observed when DEFLAMON or norfloxacin are administered together with mycophenolate mofetil but separately from each other.

• Herbal preparations containing silibinin (e.g. milk thistle): may reduce the blood concentration of DEFLAMON and thus reduce its efficacy.

• Ergotamine and dihydroergotamine (medicines used to treat migraine): DEFLAMON may increase blood levels of these medicines, increasing the risk of toxicity.

• Busulfan (a medicine indicated for conditioning prior to haematopoietic stem cell transplantation): DEFLAMON may increase busulfan blood levels, increasing the risk of toxicity.

• 5-fluorouracil (an anticancer medicine): DEFLAMON may increase blood levels of this medicine, increasing the risk of toxicity.

DEFLAMON and alcohol
Do not drink alcohol while taking DEFLAMON, as you may experience symptoms such as nausea, vomiting, and abdominal cramps.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take DEFLAMON during confirmed or suspected pregnancy or during breastfeeding (see section “Do not use DEFLAMON”).
Driving and using machines
Due to its neurological effects, metronidazole may impair your ability to drive or operate machinery.
DEFLAMON contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use DEFLAMON

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults and adolescents aged 12 years and older is 8 tablets, appropriately divided into 4 administrations in a single day (2 g per day, both in women and men).
If you forget to take DEFLAMON
Do not take a double dose to make up for the missed dose.
If you take more DEFLAMON than you should
In case of accidental ingestion/overdose of DEFLAMON, inform your doctor immediately or go to the nearest hospital.

4. Possible adverse reactions

Like all medicines, DEFLAMON may cause adverse reactions, although not everyone experiences them.

• Gastrointestinal disorders (of the digestive system),
• Anorexia (loss of appetite),
• Nausea,
• Furred tongue,
• Dryness of the mouth,
• Metallic taste,
• Glossitis (inflammation of the tongue),
• Stomatitis (inflammation of the oral mucosa),
• Headache,
• Skin rashes.

Less frequently:

• Drowsiness,
• Dizziness,
• Ataxia (lack of coordination of movements),
• Depression,
• Insomnia,
• Nasal congestion (stuffy nose).

Rarely the following may occur:

• Urticaria,
• Pruritus (itching),
• Angioedema (swelling of the skin of the face and mucous membranes which may cause difficulty in swallowing and breathing),
• Anaphylaxis (severe, rapidly developing allergic reaction),
• Dysuria (difficulty in passing urine),
• Cystitis (inflammation of the urinary bladder),
• Fever,
• Polyuria (excretion of an above-normal amount of urine),
• Pyuria (presence of pus in the urine),
• Decreased libido (reduced sexual desire),
• Psychotic disorders, including confusion, hallucinations,
• Encephalopathy (manifesting as confusion, fever, headache, hallucinations, paralysis, mild sensitivity, visual and movement disturbances, stiff neck),
• Subacute cerebellar syndrome (manifesting as ataxia, dysarthria, gait disturbances, nystagmus, and tremor),
• Eye disorders such as diplopia, myopia, optic neuropathy/optic neuritis,
• Cardiac disorders such as tachycardia, palpitations,
• Ear disorders such as impaired hearing, hearing loss (including sensorineural), tinnitus,
• Liver and pancreas disorders (elevated liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice, and pancreatitis),
• Acute liver failure in patients affected by Cockayne syndrome (see section 2 “Warnings and precautions”),
• Muscle pain,
• Joint pain.

Very rarely:

• Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (two severe, potentially life-threatening skin diseases), Acute Generalized Exanthematous Pustulosis (AGEP).

After prolonged or intensive treatment, isolated cases of transient leukopenia, agranulocytosis, neutropenia, thrombocytopenia, pancytopenia (low levels of white blood cells, granulocytes, and platelets in the blood), or peripheral neuropathy (damage to peripheral nerve endings) have been reported.
During treatment, urine may turn reddish-brown due to soluble drug pigments.
If neurological symptoms appear, discontinue treatment immediately.

Adverse reactions in adolescents
The frequency, type, and severity of adverse reactions in adolescents are the same as in adults.

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

5. How to store DEFLAMON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 DEFLAMON contains

• The active substance is metronidazole. One tablet contains 250 mg of metronidazole.
• The other components of the medicine are: calcium phosphate dibasic, sucrose, talc, magnesium stearate, starch, cellulose acetate phthalate, diethyl phthalate.

Description of the appearance of DEFLAMON and pack contents
DEFLAMON is available as film-coated tablets. Each package contains a bottle with 20 tablets.
Marketing Authorization Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILAN, Italy.
Manufacturer
Francia Farmaceutici S.r.l. – Via dei Pestagalli, 7 – Milan, Italy.