Package Insert: Information for the Patient

Pantomicina 100mg/ml, Granulated for Oral Suspension

Eritromycin Etsylsuccinate

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert (see section 4).

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Pantomicina 100mg/ml contains erythromycin ethylsuccinate, an antibiotic that belongs to a group called macrolides.

Pantomicina 100mg/ml granulated for oral suspension is indicated for the treatment of:

• Throat infections such as tonsillitis, sore throat (pharyngitis) and diphtheria (a severe bacterial infection that produces sore throat, fever, lymph node inflammation and weakness)
• Pulmonary infection (pneumonia)
• Skin, muscle, tendon and fat infections
• Intestinal tract inflammation (enterocolitis) and frequent soft stools (diarrhea)
• Whooping cough
• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix) or inflammation of the rectal mucosa (the last part of the digestive tract)
• Newborn conjunctivitis (irritation and redness of the area covering the eye) caused byChlamydia trachomatis
• Lymphogranuloma venereum (a sexually transmitted infection caused by a microorganism called

Chlamydia trachomatis)

Pantomicina 100mg/ml is also used for the prevention of the following infections:

• Prevention of recurrences of rheumatic fever(an acute non-contagious fever that is characterized by joint inflammation and pain)in patients allergic to penicillin.
• Post-exposure prevention toCorynebacterium diphtheriae(a microorganism that produces diphtheria)
• Post-exposure prevention toBordetella pertussis(a microorganism that produces whooping cough)

Do not take Pantomicina 500 mg

• If you are allergic (hypersensitive) to erythromycin ethylsuccinate or to any of the other components of this medication, including those listed in section 6.
• If you are allergic to any macrolide antibiotic, such as azithromycin and clarithromycin used to treat respiratory, throat, or nasal infections.
• If you are taking terfenadine or astemizol (antihistamines used to treat allergies), cisapride (used to treat intestinal problems), pimozide (antipsychotic), and ergotamine or dihydroergotamine (used to treat migraines).
• If you have abnormally low levels of potassium or magnesium in your blood (hypomagnesemia or hypokalemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia or torsades de pointes) or an electrocardiogram (ECG) alteration called "prolongation of the QT interval”.
• If you are taking cholesterol-lowering medications, such as simvastatin or lovastatin.
• If you are taking a medication called lomitapida (used to reduce blood fat levels, such as cholesterol and triglycerides). Taking this medication with erythromycin may cause an increase in liver enzymes (transaminases), indicating liver stress and potential liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pantomicina 500 mg.

• If you have heart problems or heart rate problems, such as ECG abnormalities (prolonged QT interval) or bradycardia.
• If you have abnormal muscle degradation that may cause kidney problems (rhabdomyolysis). Fever, nausea, vomiting, and abnormal muscle pain are indicative of muscle damage.
• If you have liver problems, inform your doctor so they can adjust your treatment accordingly.
• If you are pregnant and have been confirmed to have a sexually transmitted disease called syphilis. In this case, erythromycin may not be effective in preventing transmission of this infection to the newborn. You will need to receive treatment with an appropriate penicillin regimen. Consult your doctor before taking erythromycin.
• If you have mild to severe inflammation of the colon (pseudomembranous colitis).
• If you are taking other medications known to cause severe heart rhythm disorders.
• If you have heart problems.
• If you have previously experienced frequent soft stools after recent use of antibiotics.
• If you suffer or are likely to suffer vision loss.
• If you have a condition called myasthenia gravis, which causes muscle weakness.
• If you are about to undergo analytical tests. This medication interferes with the results of urine tests.

The repeated or prolonged use of erythromycin may cause resistance in bacteria or fungi. In this case, treatment should be interrupted and appropriate measures taken.

If you are taking Pantomicina to treat pneumonia, verify it with your doctor or pharmacist, as Pantomicina is not the reference treatment due to frequent resistance of the main pathogen. In this case, it will only be used in combination with other antibiotics.

Children and adolescents

If you are treating a young child and they are irritable or vomit when eating, contact your doctor immediately.

Use of Pantomicina 500 mg with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including over-the-counter medications.

It is especially important to inform them if you are taking any of the following medications and treatments.

The administration of Pantomicina 500 mg coated tablets may increase the effect of:

• Medications for anxiety (such as benzodiazepines or hexobarbital)
• Ergot alkaloids (medications for migraines)
• Carbamazepine (medication for epilepsy)
• Ciclosporin (medication for rheumatic diseases and to prevent transplant rejection)
• Medications for allergies (such as terfenadine, astemizol, and mizolastina)
• Medications for fungal infections (such as fluconazole, ketoconazole, and itraconazole)
• Medications to reduce blood lipid levels (such as lovastatin and simvastatin)
• Rifabutina (medication for tuberculosis)
• Anticoagulants, e.g., warfarin, acenocoumarol, and rivaroxaban (used to thin the blood)
• Digoxin (medication for heart problems)
• Omeprazol (medication for heartburn and indigestion)
• Treatment for reflux (such as cisapride)
• Pimozida (medication used for behavioral problems)
• Theophylline (medication for asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))
• Alfentanilo (medication used to anesthetize the patient before surgery)
• Bromocriptina (medication for Parkinson's disease)
• Anti-inflammatory medications (such as methylprednisolone)
• Cilostazol (medication for pain in the lower extremities caused by poor circulation)
• Vinblastina (medication for cancer)
• Sildenafilo (medication for erectile dysfunction)
• Treatment for heart rate disorders or malaria (such as quinidine)
• Colchicina (medication for joint problems, such as gout and arthritis)
• Zopiclona (medication for sleep disorders)
• Corticosteroids, administered orally, by injection, or inhaled (used to help inhibit the action of the body's immune system. This is useful for treating a wide range of pathologies).
• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications with erythromycin may increase the risk of abnormal heart rhythms and other severe side effects affecting the heart.

The following medications may reduce the effect of Pantomicina 500 mg coated tablets:

• Rifampicin (for the treatment of some infections),
• Phenobarbital, carbamazepine, and phenytoin (treatment for epilepsy)
• St. John's Wort (medicinal herb for treating depression)

The administration of Pantomicina 500 mg coated tablets may decrease the effect of:

• Contraceptives (medications used for birth control)
• Anti-HIV medications called protease inhibitors
• Medications for infections (such as clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, and colistin)

The use of Pantomicina 500 mg coated tablets with calcium channel blockers, such as verapamil, may cause low blood pressure, decreased heart rate, or acidification of the blood.

The use of Pantomicina 500 mg coated tablets with cimetidine (medication used for treating ulcers) may cause an increase in Pantomicina blood levels.

Use of Pantomicina 500 mg with food and beverages

Pantomicina 500 mg coated tablets can be taken before or after meals.

Pregnancy, lactation, and fertility

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

The active ingredient in Pantomicina 500 mg coated tablets may cross the placenta in pregnant women and be excreted in breast milk. The information from studies on the risk of congenital anomalies is not consistent, but some studies have reported heart abnormalities after the use of Pantomicina 500 mg coated tablets at the beginning of pregnancy.

Erythromycin should be used in women during pregnancy or lactation only if absolutely necessary.

Driving and operating machinery

Pantomicina has a mild effect on the ability to drive or operate machinery. If you experience symptoms such as dizziness or somnolence, do not drive or operate machinery.

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

It is essential to follow the instructions related to the dose, administration schedule, and treatment duration prescribed by your doctor.

For oral use only.

The recommended dose is:

Adults and children over 8 years:10 ml or 20 ml per day divided into 3 or 4 doses is the usual dose. This dose may be increased up to 40 ml per day, depending on the severity of the infection.

Pediatric population

Children from 2 to 8 years:The usual dose is 2.5 ml twice a day.

Children under 2 years:The usual dose is 1.25 ml four times a day or 2.50 ml twice a day.

Geriatric patients

The same dose as for adults.

Patients with liver or kidney problems

Inform your doctor if you have kidney or liver problems, as your doctor may need to adjust the dose.

Treatment duration

The treatment duration depends on the individual and the type and severity of the infection. To be effective, this antibiotic should be used regularly at the prescribed doses and for the time indicated by your doctor. Do not stop taking this medication, even if you feel better, as early discontinuation of treatment may cause the infection to recur.

If you take more Pantomicina 100mg/ml than you should

The usual symptoms are nausea, vomiting, and diarrhea.

Treatment should be discontinued and supportive treatment initiated.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Pantomicina 100mg/ml

In case of a missed dose, take another as soon as possible. Then continue as directed. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pantomicina 100 mg/ml

It is essential to complete the treatment cycle indicated by your doctor, even if you start feeling better after a few days. If you stop taking this medication before the indicated time by your doctor, it is possible that the infection may not have been fully cured and symptoms may recur or worsen.

Do not stop taking this medication without informing your doctor first.

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

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

Seek medical attention as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Some side effects can be serious. If you experience any of the following, stop taking the medicine and seek medical attention immediately:

• Itching and red, inflamed rash
• Severe allergic reaction with inflammation of the tongue, throat, face, or lips (angioedema)
• Dizziness or fainting, narrowing of the airways, which can cause wheezing or difficulty breathing (severe allergic reaction)
• Loss of hearing, ringing in the ears, or feeling of imbalance (ototoxicity) in elderly patients with kidney or liver disease
• Irregular heartbeat (fast or slow)
• Severe skin reactions, such as the appearance of blisters on the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Abnormal muscle degradation that can cause kidney problems (rhabdomyolysis)
• Muscle weakness and fatigue (myasthenia gravis)
• Inflammation of the kidneys or inability of the kidneys to function properly (tubulointerstitial nephritis)
• If blood tests show a low white blood cell count (eosinophilia)
• If you have been told that you have pancreatitis
• Abnormal heart rhythms (such as palpitations, rapid heartbeat, potentially fatal irregular heartbeat called torsades de pointes, or abnormal ECG tracing) or cardiac arrest

Other side effects include:

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

Common (may affect up to 1 in 10 people):

Uncommon (may affect up to 1 in 100 people):

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

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

Frequency unknown(cannot be estimated from available data):

Additional side effects in children and adolescents:

Reporting of side effects

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

This medication does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pantomicina 500 mg

The active ingredient is erythromycin (in the form of ethylsuccinate).

Each tablet contains 500 mg of erythromycin (in the form of ethylsuccinate).

The other components are cornstarch, calcium dihydrogen phosphate, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, carboxymethylcellulose sodium, povidone, yellow quinoline sorbic acid (CI=47005, E-104), polyethylene glycol 8000 (macrogol 8000), sorbic acid.

Appearance of the product and content of the container

Ovate yellow tablet. Container of 30 tablets.

Holder of the Marketing Authorization and responsible for manufacturing

Holder

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4,

Ireland

Local representative of the holder of the marketing authorization

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Responsible for manufacturing

Aesica Queenborough Limited

Whiteway Road (queenborough, Kent)

ME11 5EL – United Kingdom

Last review date of this leaflet: February 2023

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