Rhodogil 750.000 u.i./125 mg comprimidos recubiertos con pelicula

Leaflet: information for the user

Rhodogil 750,000 IU/125 mg film-coated tablets

Erythromycin and Metronidazole

Read the entire leaflet carefully before starting to take the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• 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 leaflet, inform your doctor or pharmacist.

1. What isRhodogil tabletsand what it is used for

2. Before takingRhodogil tablets

3. How to takeRhodogil tablets

4. Possible side effects

5. Storage ofRhodogil tablets

6. Additional information

This medication is a synergistic association of two antibacterials: metronidazole and spiramycin, which is effective against a large number of germs, especially those related to oral cavity infections (for example, dental infections).

It is indicated for:

• Treatment and prevention of acute, chronic, or recurrent oral infections such as dental abscesses and periodontitis.
• Oropharyngeal infections caused by anaerobic germs.
• Otitis and sinusitis.
• Prevention of local post-operative infectious complications in odontostomatological surgery.

Do not take Rhodogil tablets

• If you are allergic (hypersensitive) to metronidazole or spiramycin or imidazoles or any of the other components of Rhodogil.
• If you have liver problems.

In case of doubt, consult your doctor or pharmacist.

Be especially careful with Rhodogil tablets

- If you experience neurological disorders such as difficulty moving and lack of coordination of movement (ataxia), alteration of touch sensation or perception of pain, heat, pinpricks, burning, itching in some extremities, incoordination or convulsions, as well as alteration of balance sense (dizziness), you must discontinue the administration of the medication.

- If you suffer from severe nerve or brain diseases, you must inform your doctor due to the possibility of worsening of these conditions.

- If you suffer from or have suffered from any blood disease or alteration, your doctor will instruct you to perform periodic blood tests to make a white blood cell count (leukocytes), both during treatment and after it, since a reduction in the number of leukocytes in the blood (leucopenia) may appear.

- If you have liver insufficiency, your doctor will prescribe that you undergo tests and other liver tests, as the possibility of worsening of your disease may occur. Also, since this medication is eliminated from the body through the liver, the dose should be adjusted according to the degree of functional disability of the same.

- If you take alcoholic beverages, as they may appear a series of unpleasant reactions, known as Antabus effect, and which are among others: nausea, vomiting, sweating, and skin redness. Alcoholic beverages and medications containing alcohol should be avoided during treatment and at least one day after it.

- Cases of severe liver toxicity/acute liver insufficiency, some of them with a fatal outcome, have been described in patients with Cockayne syndrome with medications containing metronidazole.

If you have Cockayne syndrome, your doctor must closely monitor your liver function while receiving treatment with metronidazole and subsequently.

- Cases of severe skin reactions, such as Stevens-Johnson syndrome [(SSJ), generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals)], toxic epidermal necrolysis [(NET) similar to the previous reaction but causing generalized skin peeling (more than 30% of body surface area)], or generalized acute pustular psoriasis [(PEGA), generalized scaly rash with red color, with bumps under the skin and blisters, accompanied by fever. It is mainly located in skin folds, trunk, and upper limbs)], have been reported with metronidazole.

If symptoms or signs of this type of severe skin reaction (SSJ, NET, or PEGA) appear, treatment must be discontinued immediately.

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

• Dyspepsia, anorexia, nausea, vomiting, fever, general malaise, fatigue, jaundice, dark urine, clay-colored stools, or itching.
• Mental health problems such as irrational thoughts, hallucinations, feeling of 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 someone around you notices any of these symptoms, stop taking this medication and seek medical attention immediately.

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

Consult your doctor if you have suffered or suffer from any of the above situations.

If your treatment is prolonged, it is not recommended to use Rhodogil for longer periods than indicated by your doctor.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria): Taking these medications at the same time as Rhodogil may increase the likelihood of experiencing side effects that affect the heart and may put your life at risk.

The interactions of Rhodogil when taken with other medications may be due to spiramycin and metronidazole, which are the active principles of this medication.

Due to spiramycin:

You should be cautious when taking it with levodopa combined with carbidopa, as it may reduce the effect of levodopa.

Due to metronidazole:

• If you take disulfiram, do not take metronidazole at the same time, nor in the two weeks following the end of treatment with disulfiram, as it may cause the appearance of delirium attacks and states of confusion.

• Avoid taking beverages and medications containing alcohol, as they may cause a series of unpleasant reactions, known as Antabus effect, and which are among others: heat, redness, vomiting, rapid heartbeats.

-You should be cautious if you takemetronidazole with:

• Oral anticoagulants, as it may increase the risk of bleeding, Lithium, Cyclosporine, Phenobarbital, because it may increase the effects of these medications.
• Anti-acids (algedrato) and Prednisone, as they may reduce 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.

• Metronidazole may increase the toxicity of 5-fluorouracil, and when performing laboratory tests, metronidazole may give a false positive result in a test called the Nelson test.
• Inform your doctor if you are taking any medication that may cause alterations in the ECG (certain antiarrhythmics (medications for heart rhythm disorders), certain antibiotics, psychotropic medications).

Taking Rhodogil tablets with food and beverages

It is recommended not to take Rhodogil with food, as it may reduce its absorption.

It is recommended not to take beverages and medications containing alcohol.

Pregnancy and lactation

If you are pregnant or think you may be, do not take Rhodogil without consulting your doctor first.

Consult your doctor or pharmacist before using any medication.

If you are breastfeeding a baby, do not take Rhodogil, as metronidazole and spiramycin, the active principles of this medication, pass into breast milk.

Driving and operating machinery

Do not drive or operate machinery if you experience confusion, fatigue, alteration of balance sense (dizziness), hallucinations, convulsions, or eye disorders, after taking Rhodogil.

Rhodogil contains sorbitol and sodium

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

This medication contains 8 mg of sorbitol per tablet.

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

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 beforehand, as it may worsen your condition or lead to the development of bacterial resistance.

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

Your doctor will prescribe the minimum effective dose.

The recommended dose is:

Usual dose for adults over 15 years old

4 to 6 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 old

- 10 to 15 years: 3 tablets per day (corresponding to a dose of 2.25 million IU of spiramycin and 375 mg of metronidazole).

- The pharmaceutical form of this medication is not suitable for administration to children aged 5 to 10 years. Its use is at the discretion of the doctor. The usual recommended dose for this age group is 2 tablets per day (corresponding to a dose of 1.5 million IU of spiramycin and 250 mg of metronidazole).

If you have any kidney function impairment, your doctor will not need to adjust your dose, as the amount of medication eliminated by the kidneys is very small.

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

If you take more Rhodogil tablets than you should

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

The usual symptoms of overdose are vomiting, ataxia (incoordination of movements), mild disorientation, dry mouth, tendency to lipothymia (dizziness with impression of loss of consciousness), hot flashes, skin rash, headache, mild depression, altered sense of taste, and nausea. A gastric lavage and symptomatic treatment are recommended.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Rhodogil tablets

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

If you interrupt treatment with Rhodogil tablets

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

Like all medicines, Rhodogil can cause side effects, although not everyone will experience them.

Very common side effects (may affect more than 1 in 10 people)

• Paresthesia (tingling in hands or feet, alteration of the sense of touch or perception of pain and heat and prickling)

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

• Nausea
• Vomiting
• Diarrhea
• Alteration of taste
• Rash

Rare side effects (may affect up to 1 in 1000 people)

• Alteration of gait
• Ataxia (discoordinated muscle movement)
• Nasal bleeding
• Sweating
• Chest tightness
• Sensation 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 appear after antibiotic treatment)
• Anaphylactic shock (severe allergic reaction that may put your life at risk)
• Transient visual disturbances such as double vision
• Myopia (difficulty seeing distant objects)
• Blurred vision
• Headaches
• Increased liver enzymes (AST, ALT, alkaline phosphatase)
• With the use of metronidazole, a rare severe adverse reaction has been reported, it is a brain disease (encephalopathy). Symptoms vary, but you may experience fever, neck stiffness, headache, or see or hear things that do not exist. You may also have problems using your arms and legs or speaking, or feel confused. Immediately consult your doctor if you notice any of these adverse reactions.

Side effects of unknown frequency (frequency cannot be determined from available data)

• Abdominal pain
• Metalllic taste
• Anorexia (loss of appetite)
• Lingual discoloration
• Inflammation of the tongue with a sensation of dry mouth
• Stomatitis (inflammation of the mucous membrane of the mouth)
• Reversible pancreatitis (reversible inflammation of the pancreas)
• Indigestion
• Peripheral sensory neuropathy
• Seizures
• Subacute cerebellar syndrome (sudden appearance of uncoordinated muscle movement, speech disorder, involuntary and uncontrolled eye movement, gait alteration, and tremor, which disappear with treatment suspension)
• Optic neuritis (inflammation of the optic nerve)
• Headache
• Psychotic disorders (including confusion and hallucinations)
• Depression
• Difficulty falling asleep
• Optic neuropathy (nerve damage that may cause sudden vision loss in the affected eye)
• Decreased visual acuity
• Color vision impairment
• Agranulocytosis (decrease in a type of white blood cell, granulocytes)
• Neutropenia (decrease in a type of blood cell called neutrophils)
• Thrombocytopenia (decrease in the number of platelets in the blood)
• Cholestatic hepatitis (inflammation of the liver with bile flow difficulty)
• Mixed liver damage
• Hepatocellular damage (sometimes with jaundice)
• Liver failure
• Angioedema (inflammation of feet, hands, throat, lips, and respiratory tract)
• Stevens-Johnson syndrome (generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals)
• Toxic epidermal necrolysis (generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin peeling (more than 30% of body surface area)
• Generalized acute exanthematous pustulosis (generalized scaly rash with red color, with bumps under the skin and blisters, accompanied by fever. It is mainly located in skin folds, trunk, and upper limbs)
• Itching
• Urticaria
• Henoch-Schönlein purpura (a type of blood vessel inflammation)
• Fever
• Fatigue
• Vasculitis (inflammation of blood vessels)
• Dizziness
• Aseptic meningitis (a certain type of inflammation of the meninges, the membranes that surround the brain and spinal cord)
• ECG changes in heart activity (prolongation of the QT interval) have been seen when metronidazole was administered with medications that have the potential to prolong the QT interval.

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

Reporting of adverse effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep Rhodogil out of the reach and sight of children.

Do not use Rhodogil after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Rhodogil Tablets

Theactive ingredients are spiramycin and metronidazole. Each tablet contains 750,000 U.I. of the active ingredient spiramycin and 125 mg of the active ingredient metronidazole.

The other components are: cornstarch, povidone, croscarmellose sodium, anhydrous colloidal silica, sorbitol, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 6000, titanium dioxide (E-171).

Appearance of the Product and Contents of the Package

Rhodogil tablets are film-coated, round, white tablets for oral administration. They are presented in packages of 30 tablets.

Holder of the Marketing Authorization

Laboratorios Farmacéuticos Rovi, S.A.

C/Julián Camarillo, 35

28037 Madrid

Spain

Responsible for Manufacturing

ROVI Pharma Industrial Services, S.A.

Vía Complutense, 140

28805 Alcalá de Henares (Madrid)

Spain

Last Review Date of this Leaflet: July 2022

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