METRONIDAZOLE/SPIRAMYCIN FARMALIDER 250 mg/1.5 MU FILM-COATED TABLETS

Introduction

Package Leaflet:Information for the User

Metronidazole/Spiramycin Farmalider 250 mg/1.5 MUI Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Metronidazole/Spiramycin Farmalider is and what it is used for
2. What you need to know before taking Metronidazole/Spiramycin Farmalider
3. How to take Metronidazole/Spiramycin Farmalider
4. Possible side effects

5 Storage of Metronidazole/Spiramycin Farmalider

1. Contents of the pack and further information

1. What Metronidazole/Spiramycin Farmalider is and what it is used for

This medication is a synergistic combination of two antibacterial agents: metronidazole and spiramycin, which is effective against a large number of germs, especially those related to oral cavity infections (e.g., dental infections).

This medication is indicated in:

• Treatment and prevention of acute, chronic, or recurrent stomatological infections, such as dental abscesses and periodontitis.
• Buco-pharyngeal infections caused by anaerobic microorganisms.
• Prevention of local infections that may occur after oral and/or dental surgery.

2. What you need to know before taking Metronidazole/Spiramycin Farmalider

Do not take Metronidazole/Spiramycin Farmalider

• If you are allergic (hypersensitive) to metronidazole or spiramycin or imidazoles or any of the other components of this medication (listed in section 6).
• If you have liver problems.

In case of doubt, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Metronidazole/Spiramycin Farmalider:

• If you have neurological disorders such as difficulty moving and lack of coordination (ataxia), altered sense of touch or perception of pain, heat, pricking, burning, tingling in some extremity, incoordination, or convulsions, as well as altered sense of balance (vertigo), you should discontinue the administration of the medication.

• If you have severe nerve or brain diseases, you should inform your doctor due to the possibility of worsening of these conditions.

• If you have or have had any blood disease or disorder, your doctor will indicate that you undergo periodic blood tests to perform a white blood cell count (leukocytes), both during and after treatment, as a reduction in the number of leukocytes in the blood (leukopenia) may occur.

• If you have liver failure, your doctor will prescribe that you undergo tests and other tests on the liver due to the possibility of worsening of your disease. Also, since this medication is eliminated from the body through the liver, the dose should be adjusted according to the degree of functional impairment of the liver.

• If you consume alcoholic beverages, as unpleasant reactions may occur, known as the Antabuse effect, which include: nausea, vomiting, sweating, and flushing of the skin. Alcoholic beverages and medications containing alcohol should be avoided during treatment and until at least one day after treatment.

• Severe hepatic toxicity/hepatic failure has been reported in patients with Cockayne syndrome taking metronidazole-containing medications, some of which have been fatal.

• If you have Cockayne syndrome, your doctor should closely monitor your liver function while you are receiving treatment with metronidazole and thereafter.

• Severe skin reactions have been reported with metronidazole, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). If you experience symptoms or signs of these severe skin reactions, treatment should be discontinued immediately.

• Caution should be exercised in patients with known risk factors for cardiac arrhythmias, such as QT interval prolongation: hypocalcemia, hypomagnesemia, congenital long QT syndrome, heart disease, and concomitant use of medications with a known effect of QT interval prolongation.

Elderly patients, neonates, and women may be more sensitive to the effect of QT interval prolongation.

Inform your doctor immediately and stop taking this medication if you experience:

• Stomach pain, anorexia, nausea, vomiting, fever, general malaise, fatigue, jaundice, dark urine, clay-colored stools, or itching.
• Mental health problems such as irrational thoughts, hallucinations, confusion, or depression, including thoughts of self-harm or suicide. These symptoms may occur even in people who have never had similar problems before. If you or others around you notice any of these symptoms, stop taking this medication and consult your doctor immediately.

• Metronidazole, one of the active ingredients of this medication, may cause a brownish-red discoloration of the urine due to pigments resulting from the transformation of the medication in the body.

• It is essential to inform your doctor if you have a deficiency of glucose-6-phosphate dehydrogenase (a rare hereditary disease that causes an enzymatic deficiency of red blood cells, which can cause anemia).

Consult your doctor if you have or have had any of the above situations.

If your treatment is prolonged, it is not recommended to use Metronidazole/Spiramycin Farmalider for periods longer than indicated by your doctor.

Other medications and Metronidazole/Spiramycin Farmalider

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

Interactions of Metronidazole/Spiramycin Farmalider when taken with other medications may be due to spiramycin or metronidazole, which are the two active ingredients of this medication.

Due to spiramycin:

• Caution should be exercised when taking it with levodopa and carbidopa, as it may decrease the effect of levodopa.

• Spiramycin, like other antibiotics, should be used with caution in patients being treated with medications known to prolong the QT interval (e.g., anti-arrhythmics of Class IA and III, some antidepressants, anti-infectives, or antipsychotics) (see Warnings and precautions).

Due to metronidazole:

• If you take disulfiram, you should not take metronidazole at the same time or in the two weeks following the end of disulfiram treatment, as it may cause delirium and confusion.

• You should avoid taking beverages and medications that contain alcohol, as unpleasant reactions may occur, known as the Antabuse effect, which include: heat, flushing, vomiting, and rapid heartbeat.

• Caution should be exercised when taking metronidazole with:

• Oral anticoagulants, as it may increase the risk of bleeding.
• Lithium, cyclosporine, or phenytoin, as it may increase the effects of these medications.
• Phenobarbital, antacids (algedrate), or prednisone, as they may decrease the effect of metronidazole.
• Cimetidine, as it may potentiate the effect and/or toxicity of metronidazole.
• Busulfan, as metronidazole may increase the toxicity and plasma levels of busulfan.
• Amiodarone (used to treat cardiac arrhythmias): when taking this medication, cardiac function should be monitored. You should consult your doctor if you notice any abnormality in cardiac function, dizziness, or fainting.
• Carbamazepine (medication for the treatment of epilepsy): this combination also requires caution, as this medication may increase the duration of action of carbamazepine.
• Oral contraceptives: your birth control pill may be less effective while you are taking this medication.
• Mycofenolate mofetil (used to prevent organ rejection after transplantation): its effect may be weakened by the use of Metronidazole/Spiramycin Farmalider, so careful monitoring of its effect is recommended.
• Tacrolimus (medication used to reduce unwanted immune reactions): blood levels of this medication and renal function should be monitored when starting and stopping treatment with Metronidazole/Spiramycin Farmalider.

• Metronidazole increases the toxicity of 5-fluorouracil, and when performing laboratory tests, metronidazole may give a false positive result in a test called the Nelson test.

Taking Metronidazole/Spiramycin Farmalider with food, beverages, and alcohol

It is recommended not to take Metronidazole/Spiramycin Farmalider with food, as its absorption may be decreased.

It is recommended not to take beverages and medications that contain alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

If you are breastfeeding, do not take Metronidazole/Spiramycin Farmalider, as metronidazole and spiramycin, the active ingredients of this medication, pass into breast milk.

Driving and using machines

Do not drive or operate machines if, after taking Metronidazole/Spiramycin Farmalider, you experience confusion, fatigue, altered sense of balance (vertigo), hallucinations, convulsions, or eye disorders.

Metronidazole/Spiramycin Farmalider contains sorbitol

This medication contains 16 mg of sorbitol per tablet. This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Metronidazole/Spiramycin Farmalider

Follow your doctor's instructions for taking this medication exactly. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Swallow the tablets without chewing with a sufficient amount of liquid (a glass of water).

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment before, as it may worsen your condition or lead to the development of bacterial resistance.

If you think the effect of Metronidazole/Spiramycin Farmalider is too strong or too weak, inform your doctor or pharmacist.

Your doctor will prescribe the lowest sufficient dose to produce the desired effect.

The recommended dose is:

Usual dose for adults and adolescents over 15 years

2 to 3 tablets per day, divided into 2 or 3 doses (corresponding to a dose of 3-4.5 million IU of spiramycin and 500-750 mg of metronidazole).

Usual dose for children under 15 years

• 10 to 15 years: 1.5 tablets per day (corresponding to a dose of 2.25 million IU of spiramycin and 375 mg of metronidazole).

• 5 to 10 years: 1 tablet per day (corresponding to 1.5 million IU of spiramycin and 250 mg of metronidazole).

If you have kidney function impairment, your doctor will assess whether it is necessary to reduce the dose, as most of the elimination of metronidazole occurs through the urine.

The usual duration of treatment is 6 to 10 consecutive days.

If you take more Metronidazole/Spiramycin Farmalider than you should

Consult your doctor or pharmacist immediately, or go to the emergency department of the nearest hospital. Bring this package leaflet with you.

The usual symptoms of overdose are vomiting, ataxia (incoordination), mild disorientation, dry mouth, tendency to lipotimia (feeling of loss of consciousness), flushing, skin rash, headache, mild depression, and altered sense of taste and nausea. Gastric lavage and symptomatic treatment are recommended.

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 medication and the amount ingested.

If you forget to take Metronidazole/Spiramycin Farmalider

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

If you interrupt treatment with Metronidazole/Spiramycin Farmalider

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Very common side effects (may affect up to 1 in 10 people)

Paresthesia (tingling in hands or feet, altered sense of touch or perception of pain and heat and pricking) that is transient.

Common side effects (may affect up to 1 in 100 people)

Nausea, vomiting, and diarrhea.

Altered taste

Skin rash

Rare side effects (may affect up to 1 in 1,000 people)

Gait disturbance, ataxia

Epistaxis

Sweating

Chest tightness, feeling of cold in the mouth or throat

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

Pseudomembranous colitis (severe inflammation of the intestine that may rarely occur after antibiotic treatment)

Severe allergic reaction that can be life-threatening (anaphylactic shock)

Encephalopathy or brain damage

Transient vision disorders such as diplopia, myopia, and blurred vision

Hemolytic anemia

Hot flashes

Increased liver enzymes (AST, ALT, alkaline phosphatase)

Side effects of unknown frequency

Metallic taste, indigestion, anorexia (loss of appetite), stomatitis, inflammation of the tongue (glossitis) with dry mouth sensation, inflammation of the oral mucosa (stomatitis), reversible pancreatitis, and discoloration of the tongue.

Inflammation of the feet, hands, throat, lips, and respiratory tract (angioedema)

Peripheral sensory neuropathy, headaches, convulsions, peripheral sensory neuropathy, subacute cerebellar syndrome (e.g., ataxia, dysarthria, nystagmus, and tremor), aseptic meningitis

Psychotic disorders, including confusion and hallucinations, depression, and difficulty sleeping. Depressive behavior.

Optic neuropathy/neuritis, decreased visual acuity, changes in color vision

Decreased white blood cell count, decreased neutrophil count, decreased platelet count in the blood

Cholestatic or mixed hepatitis and hepatocellular damage, sometimes with jaundice (yellowing of the eyes and skin)

In addition, cases of liver failure requiring liver transplantation have been reported in patients treated with metronidazole in combination with other antibiotics

Itching, hot flashes, urticaria (irritation and itching of the skin), and pustular eruptions

Isolated cases of vasculitis (inflammation of blood vessels), Stevens-Johnson syndrome (widespread erosions affecting the skin and mucous membranes and purple-colored lesions, preferably on the trunk), and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with shedding of the outer layer of the skin) have also been reported.

Fever

Vasculitis

Vertigo

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Metronidazole/Spiramycin Farmalider

Keep this medication out of the sight and reach of children.

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.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Metronidazole/Spiramycin Farmalider

The active ingredients are spiramycin and metronidazole. Each tablet contains 1.5 MIU of the active ingredient spiramycin and 250 mg of the active ingredient metronidazole.

The other components are: corn starch, sodium croscarmellose (E468), anhydrous colloidal silica (E551), sorbitol (E420), magnesium stearate (E470b), microcrystalline cellulose (E460), talc (E553b), low-substituted hydroxypropylcellulose (E463a), Opadry White: hypromellose (E464), macrogol 6000, titanium dioxide (E171).

Appearance of the Product and Packaging Content

Metronidazole/Spiramycin Farmalider is presented in the form of tablets for oral administration, in packages of 30 tablets.

Marketing Authorization Holder

Farmalider S.A.

C/ La Granja, 1

28108 Alcobendas, Madrid

Spain

Manufacturer

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Farmalider, S.A.

C/ Aragoneses, 2

28108 Alcobendas - Madrid

Spain

Date of the Last Revision of thisProspectus: March 2022

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/”