Label: information for the userFlagyl 500 mg vaginal tablets

metronidazole

Read this label carefully before starting to use this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label.

Flagyl 500 mg vaginal tablets, is an anti-infective medication belonging to the group of imidazoles.

It is used in the treatment of infections caused by parasites and bacteria against which this medication is active. The infections susceptible to treatment with Flagyl 500 mg vaginal tablets are conditions caused byTrichomonas, such as urethritis (urethral inflammation) and vaginitis (vaginal inflammation).

Do not use Flagyl 500 mg vaginal tablets

-If you are allergic (hypersensitive) to metronidazole, imidazoles, or any of the other components of Flagyl.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Flagyl 500 mg vaginal tablets:

-If you have severe liver disorders (hepatic).

• If your treatment is prolonged. Your doctor may ask you to have regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for the risk of neurological problems such as paresthesia (tingling in the feet or hands), ataxia (loss of coordination), dizziness, and seizures.
• If you have acute or chronic severe disorders of the central or peripheral nervous system, due to the possible risk of worsening.
• Si you have severe kidney disorders. In this case, your doctor may reduce your dose when you are not undergoing dialysis or when your blood levels of this drug are not controlled.
• Your urine may darken.
• If you experience dizziness.
• The simultaneous use of metronidazole suppositories with condoms or diaphragms may increase the risk of latex rupture.

Severe liver toxicity/acute liver failure, some of which have been fatal, have been reported in patients with Cockayne syndrome who have taken metronidazole-containing medications.

If you have Cockayne syndrome, your doctor should closely monitor your liver function while you are taking metronidazole and after.

Inform your doctor immediately and stop taking metronidazole if you experience:

• stomach pain, anorexia, nausea, vomiting, fever, general malaise, fatigue, icterus, or dark urine, or clay-colored stools, or itching.

Severe skin reactions, such as Stevens-Johnson syndrome (SSJ), toxic epidermal necrolysis (TEN), or acute generalized pustular psoriasis (AGPP), have been reported with metronidazole. If you experience symptoms or signs of AGPP, SSJ, or TEN, discontinue Flagyl immediately.

Inform your doctor or nurse before having a blood test that you are taking Flagyl. Flagyl may affect the results of some blood tests.

Use of Flagyl 500 mg vaginal tablets with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

The concomitant administration of metronidazole and disulfiram (a medication used to help treat alcoholism) is not recommended, as there have been cases of mental disorders.

The concomitant administration of metronidazole and oral anticoagulants (medications that help prevent blood clotting, such as warfarin) may increase the risk of bleeding. If metronidazole is administered at the same time as these medications, you should be closely monitored by your doctor.

There is a risk of elevated blood levels of lithium (a medication for depression) and cyclosporine (a medication that reduces the body's defenses) when these medications are taken concomitantly with metronidazole. Therefore, if they are taken concomitantly, it should be under strict medical supervision.

Phenytoin and phenobarbital (antiepileptic medications) increase the elimination of metronidazole, thereby reducing its blood levels.

Metronidazole increases the toxicity of fluorouracil and busulfan (medications used to treat cancer).

Inform your doctor if you are taking any medication that may cause alterations in heart rhythm (prolongation of the QT interval, which can be seen on an ECG) as occurs with certain antiarrhythmics, certain antibiotics, and medications primarily used to control psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

Use of Flagyl 500 mg vaginal tablets with food, drinks, and alcohol

Drinks and medications that contain alcohol should not be consumed during treatment with metronidazole until at least one day after treatment, due to the possibility of the so-called Antabus effect, a reaction characterized by skin redness, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

As metronidazole crosses the placental barrier and there is insufficient data to establish its safety during pregnancy, your doctor will carefully evaluate the convenience of using Flagyl during pregnancy.

Metronidazole is excreted in breast milk, so it should be avoided during breastfeeding.

Driving and operating machinery

During the use of Flagyl, you may feel dizzy or experience vertigo (sensation of rotation), confusion, hallucinations (seeing or hearing things that do not exist), seizures (having attacks), or vision problems (such as blurred vision or double vision). If this occurs, do not drive vehicles or operate machinery.

Flagyl 500 mg vaginal tablets contain wheat starch

This medication contains wheat starch, 1.6 mg of gluten per tablet, equivalent to 800 ppm, which should be taken into account by patients with celiac disease.

Patients with an allergy to wheat starch (other than celiac disease) should not take this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Remember to use your medication.

Your doctor will indicate your daily dose and the duration of your treatment. Do not suspend your treatment before. The dose is individual for you and may be modified by your doctor according to your response to treatment.

If you estimate that the action of Flagyl is too strong or too weak, inform your doctor or pharmacist.

This medication must be administered vaginally, placing one tablet at night, at the bottom of the vagina, for 10-20 days. This therapy must always be associated with the administration of metronidazole by mouth (Flagyl 250 mg tablets).

Whether your partner presents or not symptoms of infection byTrichomonas vaginalis, even if laboratory tests are not positive, it is necessary that they be treated with metronidazole by mouth.

If you use more Flagyl 500 mg vaginal tablets than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone:(91) 562 04 20, indicating the medication and the amount ingested.

An accidental overdose could produce vomiting, movement coordination disorder, and slight disorientation.

No specific antidote is known for metronidazole overdose. In cases where a massive ingestion is suspected, treatment will be based on symptoms.

If you forgot to use Flagyl 500 mg vaginal tablets

Do not use a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects with unknown frequency, although not everyone will experience them.

• Blood and lymphatic system disorders: agranulocytosis and/or neutropenia (decrease in a type of white blood cell, granulocytes or neutrophils respectively), and thrombocytopenia (reduction in the number of platelets).

• Immune system disorders: inflammation of the feet, hands, throat, lips, and respiratory tract (angioedema).

Severe allergic reactions such as anaphylactic shock.

• Mental health disorders: psychotic disorders, including confusion and hallucinations. Depressive behavior.

• Nervous system disorders: loss of sensation in the extremities, headache, convulsions, dizziness, vertigo (sensation of rotation). Neurological disorders, for example: confusion, movement coordination disorder, speech disorders, gait alteration, involuntary eye movements, and tremors, which may disappear with treatment interruption.

Certain type of inflammation of the meninges, the membranes that surround the brain and spinal cord (aseptic meningitis).

• Eye disorders: transient vision disturbances such as double vision (diplopia), myopia, blurred vision, decreased visual acuity, changes in color vision. Optic nerve damage or inflammation that can cause a sudden reduction in vision in the affected eye (optic neuropathy/neuritis).

• Ear and labyrinth disorders:unknown frequency: altered hearing/loss of hearing (including neurosensorial), tinnitus (ear ringing).

• Cardiac disorders:unknown frequency: cardiac rhythm alterations (prolongation of the QT interval that can be seen on the ECG), particularly when Flagyl is administered with other medications that can cause cardiac rhythm alterations.

• Gastrointestinal disorders:upper abdominal pain, nausea, vomiting, diarrhea, oral mucosa inflammation, taste disturbances, loss of appetite, and reversible cases of pancreatitis, tongue discoloration/tongue hairy (e.g. due to fungal proliferation).

-Hepatobiliary disorders:increase in liver enzymes (AST, ALT, alkaline phosphatase), liver inflammation with bile flow difficulty, hepatocellular damage, sometimes with yellow discoloration in eyes and skin.

Cases of liver failure requiring liver transplant have been reported in patients treated with metronidazole along with other antibiotics.

Acute liver failure in patients with Cockayne Syndrome (see section 2 “Warnings and precautions”).

• Skin and subcutaneous tissue disorders: skin rash, itching, flushing, urticaria (skin irritation and itching) and pus-filled pimples (pustular eruptions), red and scaly rash with bumps under the skin and blisters (acute generalized pustular exanthema). Fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• General disorders and administration site conditions:fever.

Reporting of adverse reactions

If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Flagyl 500 mg vaginal tablets

-The active ingredient is metronidazole.

Each tablet contains 500 mg of metronidazole.

-The other components are: wheat starch (contains gluten: 1.6 mg equivalent to 800 ppm), magnesium stearate, calcium phosphate.

Appearance of the product and contents of the packaging

Each package contains 10 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Torona Building

Avenida de Europa, 24 - Building A - 1 B

28108 Alcobendas - Madrid – Spain

Responsible for manufacturing:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Last review date of this leaflet: March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/