Package leaflet: Information for the patient

Flagyl 250 mg tablets

Metronidazole
Please read this entire 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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Flagyl is and what it is used for
What you need to know before taking Flagyl
How to take Flagyl
Possible side effects
How to store Flagyl
Contents of the pack and other information

1. What Flagyl is and what it is used for

Flagyl belongs to the pharmaceutical category of antiprotozoals (medicines used against protozoal infections), anti-infectives, and gynaecological antiseptics (medicines that prevent or slow the growth of microorganisms).
This medicine is used for:
Symptomatic urethritis and vaginitis due to Trichomonas vaginalis in adults and children (inflammation of the urethra or vagina caused by the protozoan Trichomonas vaginalis);
Eradication of Helicobacter pylori in adults and children (a bacterium that causes inflammation of the stomach mucosa), as part of an appropriate therapeutic regimen.

2. What you should know before taking Flagyl

Do not take Flagyl

if you are allergic to metronidazole or other nitroimidazole derivatives, or to any of the other ingredients of this medicine (listed in section 6);
if you have blood disorders or diseases of the central nervous system (CNS) in the active phase;
if you are pregnant or suspect you may be pregnant, and during breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Flagyl.
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 cases resulting in death, have been reported in patients treated with metronidazole-containing medicines, particularly 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.
Inform your doctor immediately and stop taking metronidazole if you experience:

stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale and grey-green stools, or itching.

Exercise particular caution:

if you have severe impairment of liver or kidney function;
if treatment needs to be prolonged for more than 10 days, as clinical and laboratory monitoring (complete blood count with differential white blood cell count) is recommended.

Use this medicine under strict medical supervision.
During treatment, 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 should be carefully evaluated by your doctor.

Other medicines and Flagyl
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not consume alcohol during treatment with Flagyl, as its combination with metronidazole may cause a disulfiram-like reaction, including nausea, vomiting, and abdominal cramps.
Flagyl may affect or be affected by other medicines.

Disulfiram (a medicine used to treat chronic alcohol dependence): if taken within the previous two weeks, Flagyl may cause psychiatric reactions (e.g. confusion, behavioral changes, hallucinations).
Warfarin, acenocoumarol, dicoumarol, phenprocoumon (oral anticoagulants):
Flagyl may increase bleeding time; therefore, your doctor may ask you to have frequent prothrombin time (INR) tests and possibly adjust the dose of your anticoagulant.
Lithium: Flagyl may increase serum lithium levels (lithemia); therefore, lithium therapy should be discontinued during Flagyl treatment. If concomitant use of lithium and Flagyl is necessary, regular monitoring of serum lithium, creatinine, and electrolytes (sodium, potassium, chloride) is essential.
Phenytoin, phenobarbital (antiepileptic medicines): by increasing liver activity, they may accelerate the elimination of Flagyl, reducing its blood concentration.
Cyclosporine (an immunosuppressant medicine): Flagyl may reduce the liver clearance of 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 Flagyl from the blood, increasing its concentration.
Tacrolimus (a medicine used to prevent transplant rejection): concomitant use with Flagyl may increase the risk of cardiac disorders (QT interval prolongation and arrhythmias). Flagyl may also reduce the liver clearance of tacrolimus, leading to its accumulation in the blood and risk of toxicity.
Medicines causing cardiac disorders (QT interval prolongation): concomitant use with Flagyl may increase the risk of such disorders.
Cholestyramine (a medicine used to lower blood cholesterol): may reduce the effectiveness of Flagyl.
Carbamazepine (a medicine used to treat epilepsy and trigeminal neuralgia): Flagyl 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): Flagyl should not be administered together with amprenavir oral 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 Flagyl is administered concomitantly with norfloxacin (an antibiotic) and mycophenolate mofetil, exposure to the latter may be reduced. No interactions have been observed when Flagyl 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 Flagyl, thereby reducing its efficacy.
Ergotamine and dihydroergotamine (medicines used to treat migraine): Flagyl may increase blood concentrations of these medicines, increasing the risk of toxicity.
Busulfan (a medicine used in conditioning treatment prior to hematopoietic stem cell transplantation): Flagyl may increase blood concentrations of busulfan, increasing the risk of toxicity.
5-fluorouracil (an antineoplastic medicine): Flagyl may increase blood concentrations of this medicine, increasing the risk of toxicity.

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 Flagyl if you are pregnant or suspect pregnancy, or during breastfeeding (see section “Do not take Flagyl”).

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

Flagyl tablets contain lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Flagyl

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended doses are:
For symptomatic Trichomonas vaginalis urethritis and vaginitis
Adults and adolescents: 8 tablets as a single dose (2,000 mg daily, in both women and men).
Children under 10 years of age: 40 mg/kg orally as a single dose, or 15–30 mg/kg daily divided into 2–3 doses for 7 days. Do not exceed a single dose of 2,000 mg.
For eradication of Helicobacter pylori:
Adults: 4–6 tablets daily, divided into 2–3 doses, for periods ranging from 7 to 14 days.
Children: as part of a combination therapy, 20 mg/kg daily, without exceeding 500 mg twice daily, for 7–14 days.
Metronidazole has proven effective and well tolerated when used as part of an appropriate therapeutic regimen (usually combined with proton pump inhibitors and other antibiotics), at dosages between 1,000 and 1,500 mg (4–6 tablets).
If you forget to take Flagyl
Do not take a double dose to make up for the forgotten dose.
If you take more Flagyl than you should
In case of accidental ingestion/overdose of Flagyl, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flagyl can cause side effects in adults and children, although not
everyone experiences them.

Gastrointestinal disorders (of the digestive system),
Anorexia (loss of appetite),
Nausea,
Vomiting,
Furred tongue,
Dry mouth,
Metallic taste,
Glossitis (inflammation of the tongue),
Stomatitis (inflammation of the mucous membranes of the mouth),
Headache,
Skin rashes (of the skin).

Less frequently:

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

Exceptionally, 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 occurring allergic reaction),
Dysuria (difficulty in passing urine),
Cystitis (inflammation of the urinary bladder),
Fever,
Polyuria (excretion of an amount of urine greater than normal),
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,
Disorders of the liver and pancreas (elevation of liver enzymes, cholestatic hepatitis, hepatocellular damage, jaundice and pancreatitis),
Muscle pain,
Joint pain.

Very rarely:

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

Frequency not known:
Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").
Following prolonged or intensive therapy, isolated 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 turn reddish-brown due to soluble drug pigments.
If neurological symptoms occur, stop treatment immediately.

Reporting of side effects
If you experience any side effect, 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 Flagyl

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.
Store in the original packaging to protect the medicine from light.
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

The active substance is metronidazole. One tablet contains 250 mg of metronidazole.
The other components are: maize starch, polyvinylpyrrolidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, lactose.

Description of the appearance of Flagyl and pack contents
Pack containing 20 tablets
Marketing Authorization Holder and Manufacturer
TEOFARMA S.r.l., via F.lli Cervi, 8 – 27010 Valle Salimbene (PV)
Manufacturer
TEOFARMA S.r.l., Viale Certosa, 8/A – 27100 Pavia

Flagyl