DEFLAMON 250 mg Coated Tablet

Зміст інструкції

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
7. DEFLAMON 250 mg film-coated tablets
   1. What is DEFLAMON and what is it 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

DEFLAMON 500 mg/100 ml solution for infusion
Metronidazole

Read this leaflet carefully before you use 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 DEFLAMON is and what it is used for
• 2. What you need to know before you use 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 ingredient 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 (septicemia, bacteremia) in adults and children
caused by the following bacteria: Bacteroides fragilis, Fusobacteria, Eubacteria, Clostridiaand Gram-positive anaerobic Cocci.
DEFLAMON is particularly indicated for:

• the treatment of infections causing accumulation of infected material (brain and pelvic abscesses), severe lung infections (necrotizing pneumonia), affecting bones and joints (osteomyelitis), the uterus (puerperal fever), the peritoneum (peritonitis) and infections causing sores following surgical operations;
• the prevention of infections caused by bacteria (Bacteroidesand Gram-positive anaerobic Cocci) that may occur following surgical operations.

2. What you need to know before using DEFLAMON

Do not use DEFLAMON

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

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

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

If DEFLAMON is given to you for a period longer than 10 days:

• the doctor will assess the risk of peripheral nervous system problems (peripheral neuropathy);
• regular checks of your clinical condition will be carried out.

Cases of liver toxicity (severe hepatotoxicity/acute hepatic failure), including cases leading to death, have been reported with medicines containing metronidazole, in patients suffering from
Cockayne syndrome.
If you suffer from Cockayne syndrome, your doctor will also 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 greenish-grey stools, or itching
• convulsions and numbness or altered sensation of a limb (paresthesia)
• severe blistering skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis or acute generalized exanthematous pustulosis).

During treatment, urine may turn reddish-brown due to the presence of
soluble pigments of the drug.
Prolonged therapy with metronidazole may be associated with bone marrow depression with
consequent impairment of blood cell production (hematopoiesis). Therefore, during prolonged therapy, blood cell counts should be carefully monitored.

Children and infants
This medicine can be administered with caution in children.

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

• Disulfiram (medicine for the treatment of chronic alcohol dependence) when taken within the previous two weeks: DEFLAMON can cause psychotic reactions (e.g. confusion, behavioral changes and hallucinations).
• Warfarin, acenocoumarol, dicoumarol, phenprocoumon (oral anticoagulant drugs): DEFLAMON can increase bleeding time, so your doctor may ask you to have frequent prothrombin time (INR) tests and possibly adjust the dose of the anticoagulant drug.
• Lithium: DEFLAMON can increase lithium levels in the blood (lithiemia), so lithium therapy should be discontinued if DEFLAMON is taken; if it is necessary to take lithium and DEFLAMON at the same time, it is important to regularly monitor lithium, creatinine and electrolyte (sodium, potassium and chlorine) levels in the blood.
• Phenytoin, phenobarbital (antiepileptic drugs): by increasing liver activity, they can accelerate the elimination of DEFLAMON, decreasing its concentration in the blood.
• Cyclosporine (immunosuppressant drug): DEFLAMON can reduce the liver’s elimination activity of

cyclosporine, which can accumulate in the blood with a risk of toxicity.

• Cimetidine (drug used in ulcers, reflux esophagitis or gastritis): can slow down the elimination of DEFLAMON from the blood, increasing its concentration.
• Tacrolimus (drug used in the prevention of organ transplant rejection): concomitant use with DEFLAMON can increase the risk of cardiac disorders (QT prolongation and arrhythmias). DEFLAMON can also reduce the liver’s elimination of tacrolimus, which can accumulate in the blood with a risk of toxicity.
• Medicines that cause cardiac disorders (QT prolongation): concomitant use with DEFLAMON can increase the risk of these disorders.
• Cholestyramine (drug used to reduce blood cholesterol): the effectiveness of DEFLAMON may be reduced.
• Carbamazepine (drug used in the therapy of epilepsy and trigeminal neuralgia): DEFLAMON can slow down the elimination of carbamazepine, which can accumulate in the blood with a risk of toxicity to the central nervous system.
• Amprenavir (drug used for the treatment of HIV): DEFLAMON should not be administered together with amprenavir oral solution due to the potential risk of toxicity of an excipient of amprenavir (propylene glycol).
• Mycophenolate mofetil (drug used to prevent acute rejection after organ transplantation): if DEFLAMON is administered concurrently with norfloxacin (antibiotic) and mycophenolate mofetil, exposure to the latter drug 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 based on silymarin (e.g. milk thistle): can reduce the concentration of DEFLAMON in the blood and therefore reduce its effectiveness.
• Ergotamine and dihydroergotamine (drugs for the treatment of migraine): DEFLAMON can cause an increase in the concentrations of these drugs in the blood with a risk of toxicity.
• Busulfan (drug indicated for preparative treatment for hematopoietic stem cell transplantation): DEFLAMON can cause an increase in the concentrations of busulfan in the blood with a risk of toxicity.
• 5-fluorouracil (anticancer drug): DEFLAMON can cause an increase in the concentrations of this drug in the blood with a risk of toxicity.

DEFLAMON with alcohol
Do not drink alcohol if you have been given 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 a pregnancy, or are breastfeeding, ask your doctor or nurse for advice before this medicine is given to you.
If you are pregnant or breastfeeding, DEFLAMON should not be given to you.

Driving and using machines
Due to its neurological effects, metronidazole may impair the 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
is equivalent to 15.5% of the recommended maximum daily intake of salt with the diet for an adult.

3. How to use DEFLAMON

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

• in the pre-operative phase, an infection by anaerobes is present or suspected, e.g., septicemia, peritonitis, subphrenic or pelvic abscess;
• during the operation, signs of a septic state caused by anaerobic germs appear;
• during the operation, there is a possibility of contamination by anaerobes from the gastro-intestinal tract, the female genital tract, or the oropharynx.

If necessary, the medicine can be diluted with the following solutions: physiological solution, isotonic dextrose solution, 5% dextrose solution, or potassium chloride (20 mmol/L and 40 mmol/L).
Avoid adding other medicines, besides metronidazole, to the solution to be infused.

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 (regions inaccessible to
drainage, new contamination, etc.) the treatment needs to be continued for a longer period.
The recommended dose for the prevention of infections is 100 ml for intravenous infusion
immediately before, during or after the operation, followed by the same dose every 8 hours.

Use in children under 12 years of age and in newborns
The recommended dose is:

• children between 8 weeks and 12 years of age: 20 - 30 mg/kg per day in a single dose or divided into 7.5 mg/kg every 8 hours. The daily dose may be increased to 40 mg/kg, depending on the severity of the infection. The duration of treatment is usually 7 days.
• children under 8 weeks of age: 15 mg/kg per day in a single dose or divided into 7.5 mg/kg every 12 hours. In premature infants: the doctor must administer the medicine with caution and monitor the amount of medicine in the blood.

The recommended dose for the prevention of infections is:

• children under 12 years: 20-30 mg/kg in a single dose given 1-2 hours before surgery;
• premature infants: 10 mg/kg of body weight in a single dose before surgery.

Each vial is for single use only; any remaining contents must not be used again.

If you use more DEFLAMON than you should
This medicine will be administered by specialized personnel, so it is unlikely that you will be
administered an excessive dose. However, if you are administered an excessive dose, contact
your doctor, who will indicate appropriate therapy for your symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience neurological problems (neuropathies, seizures), you should stop treatment.

Frequency not known(the frequency of side effects cannot be established based on 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 oral mucosa),
• headache,
• skin rashes,
• dizziness,
• ataxia (lack of coordination of movements),
• depression,
• insomnia,
• nasal congestion (stuffy nose),
• urticaria,
• itching,
• angioedema (swelling of the skin of the face and mucous membranes that can cause difficulty swallowing and breathing),
• anaphylaxis (severe allergic reaction with rapid onset),
• dysuria (difficulty emitting urine),
• cystitis (inflammation of the urinary bladder),
• fever,
• polyuria (emission of an amount of urine higher than normal),
• pyuria (presence of pus in the urine),
• decreased libido (decreased sexual desire),
• psychotic disorders, including confusion, hallucinations,
• encephalopathy (which manifests with confusion, fever, headache, hallucinations, paralysis, slight sensitivity, visual and movement disorders, stiff neck),
• subacute cerebellar syndrome (which manifests with ataxia, dysarthria, gait disturbance, nystagmus and tremor),
• eye disorders, such as diplopia, myopia, optic neuropathy/neuritis,
• cardiac pathologies such as tachycardia, palpitations,
• ear disorders, such as impaired hearing, hearing loss (including sensorineural), tinnitus,
• liver and pancreas disorders (increased liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice and pancreatitis),
• acute hepatic failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”),
• muscle pain,
• joint pain,
• Stevens-Johnsons syndrome and Toxic Epidermal Necrolysis (two serious skin diseases potentially fatal), acute generalized exanthematous pustulosis (AGEP),
• Candida infections.

Following prolonged or intensive therapies, sporadic cases of transient leukopenia,
agranulocytosis, neutropenia, thrombocytopenia, pancytopenia (low number 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 assume a reddish-brown color due to soluble pigments of the
medicine.

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 experience any side effect, including those not listed in this leaflet, please inform your
doctor or pharmacist. 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 DEFLAMON

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 the words “Exp.”.
The expiry date refers to the last day of that month and the product in intact and correctly stored packaging.
Store the medicine protected from light.
Each vial is for single use only; any remaining contents must not be used.
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 DEFLAMON contains

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

Description of the appearance of DEFLAMON and contents of the pack
DEFLAMON is presented in a pack containing either 1 bottle or 25 bottles of 100 ml.

Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILAN.

Manufacturer
Bieffe Medital S.p.A. - Via Nuova Provinciale - Grosotto (SO).

DEFLAMON 250 mg film-coated tablets

Metronidazole

Read this leaflet carefully before taking 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 or pharmacist.
• 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 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 you use DEFLAMON
• 3. How to take DEFLAMON
• 4. Possible side effects
• 5. How to store DEFLAMON
• 6. Contents of the pack and other information

1. What is DEFLAMON and what is it used for

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

2. What you need to know before using DEFLAMON

Do not use DEFLAMON

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

Warnings and precautions
Consult 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 hepatic failure) have been reported with medicines containing metronidazole, including cases leading to death, in patients with
Cockayne syndrome.
If you suffer from 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 greenish-gray 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 therapy with metronidazole.
If you experience signs or symptoms of these diseases, stop taking the medicine and contact
your doctor immediately.

Pay particular attention:

• if you suffer from severe liver and kidney dysfunction.

Use this medicine always under strict medical supervision.
If DEFLAMON will be administered to you for a period longer than 10 days:

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

During treatment, urine may turn reddish-brown due to soluble pigments from 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 the doctor.

Other medicines and DEFLAMON
Tell your doctor or nurse if you are taking, have recently taken, or might take any
other medicines, including those available without a prescription.
In particular, inform your doctor if you are taking:

• Disulfiram (medicine for the treatment of chronic alcohol dependence) when taken in the previous two weeks: Deflamon may cause psychotic reactions (e.g. confusion, behavioral changes, and hallucinations).
• Warfarin, acenocoumarol, dicoumarol, phenprocoumon (oral anticoagulant drugs): Deflamon may increase bleeding time, so your doctor may ask you to have frequent prothrombin time (INR) tests and possibly adjust the dose of the anticoagulant drug.
• Lithium: Deflamon may increase lithium levels in the blood (lithiemia), so lithium therapy should be discontinued if Deflamon is taken; if it is necessary to take lithium and Deflamon simultaneously, it is important to regularly monitor lithium, creatinine, and electrolyte (sodium, potassium, and chloride) levels in the blood.
• Phenytoin, phenobarbital (antiepileptic drugs): by increasing liver activity, they can accelerate the elimination of Deflamon, decreasing its concentration in the blood.
• Cyclosporine (immunosuppressant drug): Deflamon may reduce the liver’s ability to eliminate cyclosporine, which may accumulate in the blood with the risk of toxicity.
• Cimetidine (medicine used for ulcers, reflux esophagitis, or gastritis): may slow down the elimination of Deflamon from the blood, increasing its concentration.
• Tacrolimus (medicine used to prevent organ transplant rejection): concomitant use with Deflamon may increase the risk of heart problems (QT prolongation and arrhythmias). Deflamon may also reduce the liver’s elimination of tacrolimus, which may

accumulate in the blood with the risk of toxicity.

• Drugs that cause heart problems (QT prolongation): concomitant use with Deflamon may increase the risk of these problems.
• Cholestyramine (medicine used to reduce blood cholesterol): the effectiveness of Deflamon may be reduced.
• Carbamazepine (medicine used in the treatment of epilepsy and trigeminal neuralgia): Deflamon may slow down the elimination of carbamazepine, which may accumulate in the blood with the risk of toxicity to the central nervous system.
• Amprenavir (medicine used to treat HIV): Deflamon should not be administered together with amprenavir oral solution due to the potential toxicity of an excipient of amprenavir (propylene glycol).
• Mycophenolate mofetil (medicine used to prevent acute rejection after organ transplantation): if Deflamon is administered simultaneously with norfloxacin (antibiotic) and mycophenolate mofetil, exposure to the latter drug 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 based on silymarin (e.g. milk thistle): may reduce the concentration of Deflamon in the blood and therefore reduce its effectiveness.
• Ergotamine and dihydroergotamine (medicines for the treatment of migraine): Deflamon may cause an increase in the concentrations of these drugs in the blood with the risk of toxicity.
• Busulfan (medicine indicated for preparative treatment before hematopoietic stem cell transplantation): Deflamon may cause an increase in the concentrations of busulfan in the blood with the risk of toxicity.
• 5-fluorouracil (anticancer drug): Deflamon may cause an increase in the concentrations of this drug in the blood with the risk of toxicity.

DEFLAMON with alcohol
Do not drink alcohol if you have been administered DEFLAMON because 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 with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take DEFLAMON if you are confirmed or suspected to be pregnant and during breastfeeding
(see section “Do not use DEFLAMON”).

Driving and operating machinery
Due to its effects on the nervous system, metronidazole may impair the ability to drive or operate
machinery.

DEFLAMON contains sucrose
This medicine contains sucrose. If you have been diagnosed with intolerance to certain sugars,
contact your doctor before taking this medicine.

3. How to use DEFLAMON

Take this medicine following 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 in adults and adolescents starting from 12 years of age is 8 tablets divided appropriately into 4 administrations in a single day (2 g per day, in both women and men).

If you forget to take DEFLAMON
Do not take a double dose to make up for a missed dose.

If you take more DEFLAMON than you should
In case of accidental ingestion/intake of an excessive dose of DEFLAMON, immediately inform your doctor or go to the nearest hospital.

4. Possible side effects

Like all medicines, DEFLAMON can cause side effects, although not everybody gets them.

• 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 oral mucosa),
• headache,
• skin rashes.

Less frequently:

• drowsiness,
• dizziness,
• ataxia (lack of coordination of movements),
• depression,
• insomnia,
• nasal congestion (stuffy nose).

Exceptionally, the following may occur:

• urticaria,
• itching,
• angioedema (swelling of the skin of the face and mucous membranes that can cause difficulty in swallowing and breathing),
• anaphylaxis (severe allergic reaction with rapid onset),
• dysuria (difficulty in urination),
• cystitis (inflammation of the urinary bladder),
• fever,
• polyuria (emission of an amount of urine higher than normal),
• pyuria (presence of pus in the urine),
• decreased libido (decreased sexual desire),
• psychotic disorders, including confusion, hallucinations,
• encephalopathy (which manifests with confusion, fever, headache, hallucinations, paralysis, slight sensitivity, visual and movement disorders, stiff neck),
• subacute cerebellar syndrome (which manifests with ataxia, dysarthria, gait disturbance, nystagmus and tremor),
• eye disorders, such as diplopia, myopia, optic neuropathy/neuritis,
• cardiac pathologies such as tachycardia, palpitations,
• ear disorders, such as hearing impairment, hearing loss (including sensorineural), tinnitus,
• liver and pancreas disorders (increased liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice and pancreatitis),
• acute hepatic failure in patients with Cockayne syndrome (see section 2 “Warnings and precautions”),
• muscle pain,
• joint pain.

Very rarely:

• Stevens-Johnson syndrome and Toxic Epidermal Necrolysis (two serious skin diseases that can be potentially fatal), acute generalized exanthematous pustulosis (AGEP).

Following prolonged or intensive therapies, sporadic cases of transient leukopenia,
agranulocytosis, neutropenia, thrombocytopenia, pancytopenia (low number of white blood cells, granulocytes,
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 pigments of the
drug.
If you notice the onset of neurological symptoms, stop treatment immediately.
Side effects in adolescents
The frequency, type and severity of side effects in adolescents are the same as in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 DEFLAMON

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

• The active ingredient is metronidazole. 1 tablet contains 250 mg of metronidazole.
• The other components of the medicine are: basic calcium phosphate, sucrose, talc, magnesium stearate, starch, cellulose acetophthalate, diethyl phthalate.

Description of the appearance of DEFLAMON and contents of the pack
DEFLAMON is presented in the form of film-coated tablets. Each pack contains a bottle with
20 tablets.

Marketing Authorisation Holder
SPA - Società Prodotti Antibiotici S.p.A. - Via Biella, 8 - 20143 MILANO.

Manufacturer
Francia Farmaceutici S.r.l. – Via dei Pestagalli, 7 – Milano.