Flagyl 500 mg vaginal tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Flagyl 500 mg vaginal tablets

metronidazole

Read the entire leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet.

Leaflet contents

1. What Flagyl 500 mg vaginal tablets are and what they are used for
2. What you need to know before using Flagyl 500 mg vaginal tablets
3. How to use Flagyl 500 mg vaginal tablets
4. Possible adverse effects
5. How to store Flagyl 500 mg vaginal tablets
6. Contents of the pack and other information

1. What Flagyl 500 mg vaginal tablets are and what they are used for

Flagyl 500 mg vaginal tablets is an antimicrobial medicine belonging to the imidazole group.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

It is used to treat infections caused by parasites and bacteria that are susceptible to this medicine. Infections treatable with Flagyl 500 mg vaginal tablets include those caused by Trichomonas, such as urethritis (inflammation of the urethra) and vaginitis (inflammation of the vagina).

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

Do not use Flagyl 500 mg vaginal tablets

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

Warnings and precautions

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

• If you have severe liver (hepatic) disorders.
  • 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 conditions such as paresthesia (tingling in feet or hands), ataxia (lack of coordination), dizziness, and seizures.
  • If you have severe acute or chronic diseases of the central or peripheral nervous system, due to the possible risk of worsening.
  • If you have severe kidney disorders. In this case, your doctor may reduce your dose when you are not undergoing dialysis or when blood levels of this drug are not monitored.
  • It may darken the color of your urine.
  • If you experience dizziness.
  • The simultaneous use of metronidazole vaginal tablets with condoms or diaphragms may increase the risk of latex rupture.

Cases of severe hepatic toxicity/acute liver failure, some with fatal outcomes, have been reported in patients with Cockayne syndrome treated with metronidazole-containing medicines.

If you have Cockayne syndrome, your doctor must frequently monitor your liver function during and after treatment with metronidazole.

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

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

Serious bullous skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP), have been reported with metronidazole (see “Possible side effects”). If symptoms or signs of AGEP, SJS, or TEN occur, treatment with Flagyl must be stopped immediately.

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

Using Flagyl 500 mg vaginal tablets with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

The combined use of metronidazole and oral anticoagulants (medicines that help prevent blood clots, such as warfarin) may increase the risk of bleeding. If metronidazole is administered at the same time as these medicines, close medical monitoring is required.

There is a risk of increased blood levels of lithium (a medicine for depression) and cyclosporine (a medicine that suppresses the immune system) when these are administered together with metronidazole. Therefore, if they are used together, it must be under strict medical supervision.

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 in cancer treatment).

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

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

Alcoholic beverages and medicines containing alcohol should not be consumed during treatment with metronidazole and for at least one day afterwards, due to the possible occurrence of the so-called disulfiram-like (Antabuse) reaction, characterized by skin flushing, vomiting, and tachycardia.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Since metronidazole crosses the placental barrier and there are insufficient data to establish its safety during pregnancy, your doctor will carefully assess whether the use of Flagyl during pregnancy is appropriate.

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

Driving and using machines

While using Flagyl, you may feel dizzy or experience vertigo (spinning sensation), confusion, hallucinations (seeing or hearing things that are not real), seizures (fits), or vision problems (such as blurred or double vision). If this happens, do not drive or operate machinery.

Flagyl 500 mg vaginal tablets contain wheat starch

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

Patients with allergy to wheat starch (other than celiac disease) must not take this medicine.

3. How to use Flagyl 500 mg vaginal tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor again.

Remember to use your medicine.

Your doctor will determine your daily dose and the duration of your treatment. Do not stop your treatment early. The dose is individual to you and may be adjusted by your doctor depending on your response to treatment.

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

This medicine must be administered vaginally, by inserting one tablet at night into the back of the vagina, for 10–20 days. This therapy should always be accompanied by oral administration of metronidazole (Flagyl 250 mg tablets).

Regardless of whether your partner shows symptoms of Trichomonas vaginalis infection or not, even if laboratory tests are negative, treatment with oral metronidazole is necessary.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: (91) 562 04 20, stating the medicine and the amount ingested.

Accidental overdose may cause vomiting, incoordination of movements, and mild disorientation.

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

If you forget to use Flagyl 500 mg vaginal tablets

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

4. Possible adverse effects

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

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

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

Severe allergic reactions such as anaphylactic shock.

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

• Nervous system disorders: loss of sensation in the limbs, headache, seizures, dizziness, vertigo (sensation of spinning). Neurological disorders, for example: confusion, lack of coordination, speech disorders, gait disturbances, involuntary eye movements, and tremors, which may resolve upon discontinuation of treatment.

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

Frequency not known (cannot be estimated from available data): Posterior reversible encephalopathy syndrome (PRES), a brain disorder presenting with symptoms such as headache, confusion, visual disturbances, and seizures.

• Eye disorders: transient visual disturbances such as double vision (diplopia), myopia, blurred vision, decreased visual acuity, changes in colour vision. Injury or inflammation of the optic nerve that may cause sudden vision loss in the affected eye (optic neuropathy / neuritis).

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

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

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

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

Cases of liver failure requiring liver transplantation have been reported 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 (skin irritation and itching), and pustular eruptions (pus-filled spots), red and scaly rash with lumps under the skin and blisters (acute generalized exanthematous pustulosis). Drug-induced fixed eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis.

• General disorders and administration site conditions: fever.

Reporting of adverse effects

If you experience any type of adverse effect, please consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Flagyl 500 mg vaginal tablets

• The active substance is metronidazole.

Each tablet contains 500 mg of metronidazole.

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

Appearance of the product and contents of the package

Each package contains 10 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja - Torona Building

Avenida de Europa, 24 - Building A - 1 B

28108 Alcobendas - Madrid – Spain

Manufacturer:

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

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/