Intizol Vaginal 1,000 mg ovules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Intizol vaginal 1,000 mg ovules

metronidazole

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet as 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Intizol vaginal is and what it is used for
2. What you need to know before using Intizol vaginal
3. How to use Intizol vaginal
4. Possible side effects
5. How to store Intizol vaginal
6. Contents of the pack and other information

1. What Intizol vaginal is and what it is used for

Intizol vaginal is a medicine that belongs to the group of 5-nitroimidazole antibiotics.

It is used to treat bacterial vaginosis (an imbalance in the vaginal bacteria that may be accompanied by vaginal discharge with a bad odor) in adult women.

2. What you need to know before using Intizol vaginal

Do not use Intizol vaginal

• If you are allergic to metronidazole, other imidazoles, soy, peanuts, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Intizol vaginal if:

• You have severe liver disorders, blood formation disorders, diseases of the brain or spinal cord, or disorders of the nervous system. In such cases, your doctor will carefully assess whether treatment with this medicine is appropriate.

• You have Cockayne syndrome. Your doctor will regularly monitor your liver function during and after treatment with metronidazole. Cases of severe liver toxicity/acute liver failure, including fatal outcomes, have been reported in patients with Cockayne syndrome who received medications containing metronidazole.

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

• Stomach pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, pale stools, or itching.

• You use latex condoms or diaphragms, as simultaneous use with this medicine may reduce the effectiveness of latex contraceptives.

• You are scheduled for a blood test. This medicine may alter the results of certain blood tests.

Inform your doctor immediately and stop taking metronidazole if:

• You experience difficulty breathing, dizziness, and vomiting, which may occur in very rare cases of severe allergy (anaphylactic shock). Seek urgent medical attention and discontinue treatment with this medicine immediately.

• You develop severe and prolonged diarrhea during treatment or in the first few weeks after stopping treatment. This may be a symptom of a serious intestinal disease (pseudomembranous colitis) requiring immediate medical attention.

This medicine may darken the color of your urine.

Children and adolescents

This medicine must not be used in girls and adolescents under 18 years of age.

Other medicines and Intizol vaginal

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

When using this medicine, approximately 20% of the active ingredient (metronidazole) passes into the bloodstream. For this reason, the following interactions are those observed with oral administration of medicines containing metronidazole.

Other medicines that affect the effect of Intizol vaginal

Administration of metronidazole together with disulfiram (used in the treatment of alcoholism) may cause confusion or certain mental disorders (psychosis).

Metronidazole may be less effective when taken with phenobarbital (a barbiturate used for sleep disorders, seizures, and anesthesia) or phenytoin (used to treat seizures and certain types of arrhythmias).

In isolated cases, cimetidine (used to treat digestive disorders such as acidity and ulcers) may increase the effect and toxicity of metronidazole.

Effect of Intizol vaginal on other medicines

Metronidazole may enhance the effect of certain medicines that prevent blood clotting (anticoagulants such as warfarin or acenocoumarol), so it may be necessary to adjust the anticoagulant dose.

Simultaneous administration of metronidazole and cyclosporine (used in organ transplants and immune system disorders) may increase blood levels of cyclosporine, increasing its effect and toxicity. Therefore, blood levels of cyclosporine and kidney function should be closely monitored.

Metronidazole reduces the elimination of 5-fluorouracil (a chemotherapeutic drug for tumor treatment), which may increase its toxicity when administered simultaneously.

Metronidazole may significantly increase the toxicity of busulfan (a drug used in chemotherapy) when administered together. Concomitant administration is not recommended due to the risk of severe toxicity and death.

Simultaneous administration of metronidazole and lithium (used as a mood stabilizer in bipolar disorder and treatment-resistant major depression) may increase blood levels of lithium, posing a risk of lithium intoxication. Therefore, blood levels of lithium and kidney function should be closely monitored.

Simultaneous administration of metronidazole and tacrolimus (a medicine to prevent organ transplant rejection) leads to increased blood levels of tacrolimus. Therefore, kidney function and tacrolimus blood levels should be monitored frequently.

Concurrent use of metronidazole and amiodarone (a medicine used to treat heart arrhythmias) may affect heart activity. Therefore, regular monitoring of heart activity by electrocardiogram (ECG) is recommended. Consult your doctor immediately if you notice symptoms of heart arrhythmia, such as dizziness, palpitations, or brief fainting spells.

The absorption of mycophenolic acid (a medicine that suppresses the immune system) may be reduced when administered together with medicines that alter gastrointestinal flora, such as antibiotics. Therefore, the effect of mycophenolic acid may be reduced when administered together with metronidazole. Close monitoring of the patient, including laboratory tests, is recommended.

Simultaneous administration of metronidazole with phenytoin (used to treat seizures and certain types of arrhythmias) or carbamazepine (used to treat seizures) may increase blood levels of phenytoin or carbamazepine, increasing the toxicity of these medicines.

Concomitant administration of metronidazole and mebendazole should be avoided, as serious skin adverse reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) have been reported in patients receiving both medicines.

Taking Intizol vaginal with food, drinks, and alcohol

Alcohol consumption should be avoided, as signs of intolerance may occur, such as skin flushing in the head and neck area, increased heart rate (tachycardia), nausea, vomiting, headache, and dizziness.

Pregnancy and breastfeeding

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 sufficient data are not available to establish its safety during pregnancy, your doctor will carefully evaluate whether the use of this medicine during pregnancy is justified.

Metronidazole passes into breast milk; therefore, administration should be avoided during breastfeeding.

Driving and using machines

This medicine may cause adverse reactions that reduce your ability to drive or operate machinery. Do not drive or operate machinery if you experience any of the following symptoms: confusion, dizziness, vertigo (spinning sensation), hallucinations, seizures/spasms, or vision disorders (such as blurred vision or double vision).

Intizol vaginal contains soya lecithin

This medicine contains soya lecithin and therefore should not be used if you are allergic to soya or peanuts.

3. How to use Intizol vaginal

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

The recommended dose is one ovule per day for two consecutive days. Administration is recommended at night, before going to bed.

Intizol vaginal is intended to be inserted deeply into the vagina (see illustration).

The ovule is inserted more easily into the vagina while lying on your back, with knees bent.

If you use more Intizol vaginal than you should

In case of metronidazole intoxication, you may experience nausea, vomiting, increased or exaggerated reflexes (hyperreflexia), muscle coordination disorder (ataxia), increased heart rate (tachycardia), difficulty breathing, and disorientation. There is no known specific antidote for this medicine.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Intizol vaginal

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

If you miss a dose, consult your doctor, as it may be necessary to extend the treatment by one additional day.

If you stop using Intizol vaginal treatment prematurely

If you stop treatment with this medicine too early, consult your doctor, as the treatment may not be effective.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

When using this medicine, approximately 20% of the active substance (metronidazole) passes into the bloodstream. For this reason, the following adverse reactions are listed, which occur with oral administration of medicines containing metronidazole.

Frequent adverse effects (may affect up to 1 in 10 people)

• Decreased appetite
• Metallic taste in the mouth, burping, white tongue, inflammation of the tongue, mouth or lips, nausea, vomiting, diarrhoea
• Abnormal urine colour

Uncommon adverse effects (may affect up to 1 in 100 people)

• Genital fungal infection (Candida)
• Decreased count of certain blood cells (leucopenia and granulocytopenia)
• Psychosis, hallucinations, excitability, depression
• Headache, dizziness, sleep disturbances (drowsiness and insomnia), coordination disorders (ataxia), seizures, and a nervous disorder with loss of strength and altered sensation such as numbness or tingling, and occasionally pain (peripheral neuropathy)
• Visual disturbances, including inflammation of the optic nerve (optic neuropathy), double vision, myopia, blurred vision, decreased visual acuity, and changes in colour vision
• Itching, skin redness, urticaria
• Muscle weakness
• Difficulty or pain when urinating, bladder inflammation (cystitis), urinary incontinence
• Fever
• Increased blood transaminases or bilirubin

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Decreased count of blood cells (agranulocytosis) and platelets (thrombocytopenia)
• Severe allergic reaction (anaphylactic shock). For further information, see Warnings and precautions in section 2.
• Severe and persistent diarrhoea (pseudomembranous colitis; for further information, see Warnings and precautions in section 2), inflammation of the pancreas (pancreatitis)
• Joint pain

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

• Decreased count of certain blood cells (neutropenia)
• Inflammation in the mouth, tongue, face or throat (angioedema)
• Sensation of spinning (vertigo), ringing or buzzing in the ears (tinnitus), decreased hearing and deafness
• Nervous system disorder with altered mental state (encephalopathy)
• Nervous system disorder affecting speech, coordination and gait, rapid involuntary eye movements, seizures (cerebellar syndrome)
• Aseptic meningitis (a type of inflammation of the brain and spinal cord)
• Inflammation of the liver (hepatitis), yellowing of the skin and eyes (jaundice), liver function failure (for further information, see Warnings and precautions in section 2)
• Severe skin adverse reactions which may be associated with fever, fatigue, malaise and pain (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, erythema multiforme). Redness and swelling of the skin, rashes, blisters, pustules and skin peeling may occur.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Intizol vaginal

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 blister and the cardboard box after "EXP". The expiry date refers to the last day of the month indicated.

Store below 25 °C.

Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Intizol vaginal

• The active substance is metronidazole. Each ovule contains 1,000 mg of metronidazole.
• The other components are solid semisynthetic glycerides with additives and soybean lecithin.

Appearance of the product and contents of the pack

Pale yellow, torpedo-shaped ovules, packed in blisters and placed in a cardboard box.

The pack contains 2 vaginal ovules.

Marketing Authorization Holder

SEID, S.A.

Carretera de Sabadell a Granollers, km 15

08185 Lliçà de Vall, Barcelona, Spain

Manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel
Sudbrackstrasse 56
33611 Bielefeld, Germany

Date of the most recent review of this leaflet: December 2024

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