FLAGYL 500 mg VAGINAL TABLETS

2. What you need to know before taking Flagyl 500 mg vaginal tablets

Do not use Flagyl 500 mg vaginal tablets

• If you are allergic (hypersensitive) to metronidazole, imidazoles, or any other component 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 request that you undergo regular blood tests, especially to monitor your white blood cell count. You will also be closely monitored for the risk of nervous system disorders such as paresthesia (tingling in feet or hands), ataxia (lack of coordination), vertigo, and convulsions.
• If you have acute or chronic severe central or peripheral nervous system disorders, due to the possible risk of worsening.
• If you have severe kidney disorders. In this case, your doctor may reduce the dose when you are not undergoing dialysis or when your blood levels of this medicine are not controlled.
• It may darken the color of your urine.
• If you experience vertigo.
• The simultaneous use of metronidazole ovules with condoms or diaphragms may increase the risk of latex rupture.

There have been reports of severe liver toxicity/liver failure, some of which were fatal, in patients with Cockayne syndrome taking metronidazole.

If you have Cockayne syndrome, your doctor should closely monitor your liver function while you are being treated with metronidazole and afterwards.

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

• stomach pain, loss of appetite, nausea, vomiting, fever, general malaise, fatigue, jaundice, dark urine, clay-colored stools, or itching.

There have been reports of severe cutaneous bullous reactions with metronidazole, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP) (see "Possible side effects"). If symptoms or signs of AGEP, SJS, or TEN appear, treatment with Flagyl should be discontinued immediately.

If you are going to have a blood test, inform your doctor or nurse that you are taking Flagyl. Flagyl may alter the results of some blood tests.

Using Flagyl 500 mg vaginal tablets with other medicines

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

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

The concomitant administration of metronidazole and oral anticoagulant medicines (medicines that help prevent blood clot formation, such as warfarin) may increase the risk of bleeding. If metronidazole is administered with these medicines, you should be closely monitored by your doctor.

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

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

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

Inform your doctor if you are taking any medicine that may cause changes in heart rhythm (prolongation of the QT interval that can be seen on an ECG), such as certain antiarrhythmics (medicines for heart rhythm disorders), certain antibiotics, and medicines primarily used to control psychosis (including delusions, hallucinations, paranoia, or disordered thinking).

Using Flagyl 500 mg vaginal tablets with food, drinks, and alcohol

Drinks and medicines containing 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Since metronidazole crosses the placental barrier and there is not enough data to establish its safety during pregnancy, your doctor will carefully assess the convenience of using Flagyl during pregnancy.

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

Driving and using machines

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

Flagyl 500 mg vaginal tablets contain wheat starch

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

Patients with a wheat starch allergy (different from celiac disease) should not take this medicine.

3. How to use Flagyl 500 mg vaginal tablets

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor again.

Remember to use your medicine.

Your doctor will indicate your daily dose and the duration of your treatment. Do not stop treatment before completing it. The dose is individualized for you and may be modified by your doctor based on your response to treatment.

If you think the effect of Flagyl is too strong or too weak, inform your doctor or pharmacist.

This medicine should be administered vaginally, placing one tablet at the back of the vagina at night, for 10-20 days. This therapy should always be associated with the administration of metronidazole orally (Flagyl 250 mg tablets).

Whether your partner has symptoms of Trichomonas vaginalisinfection or not, even if laboratory tests are negative, it is necessary for them to be treated with metronidazole orally.

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 Toxicology Information Service. Phone: (91) 562 04 20, indicating the medicine and the amount ingested.

An accidental overdose could cause vomiting, lack of coordination, and mild disorientation.

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

If you forget to use Flagyl 500 mg vaginal tablets

Do not use a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 platelet count).

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

Severe allergic reactions, such as anaphylactic shock.

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

• Nervous system disorders: loss of sensitivity in the limbs, headache, convulsions, dizziness, vertigo (sensation of spinning). Neurological disorders, such as confusion, lack of coordination, speech disorders, gait disturbances, involuntary eye movements, and tremors, which may disappear with treatment interruption.

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

Frequency not known (cannot be estimated from available data): posterior reversible encephalopathy syndrome (PRES), a brain disorder characterized by symptoms such as headache, confusion, vision problems, and convulsions.

• Eye disorders: transient vision disorders, such as double vision (diplopia), myopia, blurred vision, decreased visual acuity, changes in color vision. Damage or inflammation of the optic nerve, which can cause sudden vision loss in the affected eye (optic neuropathy/neuritis).

• Ear and labyrinth disorders: frequency not known: altered hearing/loss of hearing (including sensorineural), tinnitus (ringing in the ears).

• Cardiac disorders: frequency not known: changes in heart rhythm (prolongation of the QT interval that can be seen on an ECG), particularly when Flagyl is administered with other medicines that can cause changes in heart rhythm.

• Gastrointestinal disorders: upper stomach pain, nausea, vomiting, diarrhea, oral mucosa inflammation, taste disorders, loss of appetite, and reversible pancreatitis (inflammation of the pancreas), tongue discoloration/furry tongue (e.g., due to fungal overgrowth).

• Gastrointestinal disorders: increased liver enzymes (AST, ALT, alkaline phosphatase), liver inflammation with difficulty in bile flow, hepatocellular damage, sometimes with yellowing of the eyes and skin.

There have been reports of liver failure requiring liver transplantation in patients treated with metronidazole in combination 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 (irritation and itching of the skin), and pustular eruptions (pustules). Fixed drug eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• General disorders and administration site conditions: fever.

Reporting side effects

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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Flagyl 500 mg vaginal tablets

Keep out of sight and reach of children.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Flagyl 500 mg vaginal tablets

• The active ingredient is metronidazole.

Each tablet contains 500 mg of metronidazole.

• The other ingredients are: wheat starch (gluten content: 1.6 mg, equivalent to 800 ppm), magnesium stearate, calcium phosphate.

Appearance of the product and package contents

Each package contains 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Edificio Torona

Avenida de Europa, 24 - Edificio A - 1 B

28108 Alcobendas - Madrid – España

Manufacturer:

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Date of the last revision of this leaflet: June 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/