PANTOMICINA 100mg/ml ORAL SUSPENSION GRANULES

Introduction

Package Leaflet: Information for the Patient

Pantomicina 100mg/ml, Granule for Oral Suspension

Erythromycin Ethylsuccinate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).

Contents of the pack:

1. What Pantomicina 100mg/ml is and what it is used for
2. What you need to know before you take Pantomicina 100mg/ml
3. How to take Pantomicina 100mg/ml
4. Possible side effects
5. Storage of Pantomicina 100mg/ml
6. Contents of the pack and further information

1. What Pantomicina 100mg/ml is and what it is used for

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

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

• Throat infections such as tonsillitis, sore throat (pharyngitis) and diphtheria (serious bacterial infection that causes sore throat, fever, swelling of the lymph nodes, and weakness)
• Lung infection (pneumonia)
• Skin, muscle, tendon, and fat infections
• Inflammation of the digestive tract (enterocolitis) and frequent soft stools (diarrhea)
• Whooping cough
• Urethritis (inflammation of the tube that empties the bladder), cervicitis (inflammation of the cervix) or inflammation of the rectal mucosa (last part of the digestive tube)
• Conjunctivitis (irritation and redness of the area that covers the eye) in newborns caused by Chlamydia trachomatis
• Lymphogranuloma venereum (sexually transmitted infection caused by a microorganism called

Chlamydia trachomatis)

Pantomicina 100mg/ml is also used to prevent the following infections:

• Prevention of relapses of rheumatic fever (acute non-contagious fever characterized by inflammation and joint pain) in patients allergic to penicillin.
• Post-exposure prevention to Corynebacterium diphtheriae(microorganism that produces diphtheria)
• Post-exposure prevention to Bordetella pertussis(microorganism that produces whooping cough)

2. What you need to know before you take Pantomicina 100mg/ml

Do not take Pantomicina 500 mg

• If you are allergic (hypersensitive) to erythromycin ethylsuccinate or to any of the other components of this medicine, including those listed in section 6.
• If you are allergic to any macrolide antibiotic, such as azithromycin and clarithromycin used to treat bacterial respiratory, throat, or nasal infections.
• If you are taking terfenadine or astemizole (antihistamines used to treat allergies), cisapride (used for intestinal movement problems), pimozide (antipsychotic), and ergotamine or dihydroergotamine (used to treat migraines).
• If you have abnormally low levels of potassium or magnesium in the blood (hypomagnesemia or hypokalemia).
• If you or a family member have a history of heart rhythm disturbances (ventricular cardiac arrhythmia or torsades de pointes) or an alteration in the electrocardiogram (heart electrical record) called "prolonged QT interval syndrome”.
• If you are taking cholesterol-lowering medications, such as simvastatin or lovastatin.
• If you are currently taking a medication called lomitapide (used to reduce increased blood fats, such as cholesterol and triglycerides). Taking this medication at the same time as erythromycin can cause an increase in liver cell enzymes (transaminases), which indicates that the liver is under stress and can cause 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 anomalies (prolonged QT interval) or slow heart rate (bradycardia).
• If you suffer from abnormal muscle breakdown that can 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 that they can adjust the treatment to your case.
• 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 the transmission of this infection to the newborn. You should receive treatment with a suitable penicillin regimen. Consult your doctor before taking erythromycin.
• If you suffer from mild to severe colon inflammation (pseudomembranous colitis).
• If you are taking other medications that are known to cause serious heart rhythm disturbances.
• If you have heart problems.
• If you have previously experienced frequent soft stools after recent use of antibiotics.
• If you suffer from or are likely to suffer from vision loss.
• If you suffer from a disease called myasthenia gravis, which causes muscle weakness.
• If you are about to undergo analytical tests. This medication interferes with urine analysis results.

The repeated or prolonged use of erythromycin can produce resistance in bacteria or fungi. In this case, treatment should be discontinued and appropriate measures taken.

If you are taking Pantomicina to treat pneumonia, check with your doctor or pharmacist, as Pantomicina is not the reference treatment due to the 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 small child and they become irritable or vomit when eating, contact your doctor immediately.

Use of Pantomicina 500 mg with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medication, including those without a prescription.

It is especially important that you inform them if you are taking any of the medications and treatments listed below.

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

• Medications for anxiety (such as benzodiazepines or hexobarbital)
• Ergot alkaloids (medications for migraines)
• Carbamazepine (medication for epileptic seizures)
• Cyclosporin (medication for rheumatic diseases and to prevent transplant rejection)
• Medications for allergies (such as terfenadine, astemizole, and mizolastine)
• Medications for fungal infections (such as fluconazole, ketoconazole, and itraconazole)
• Medications to reduce blood lipid levels (such as lovastatin and simvastatin)
• Rifabutin (medication for tuberculosis)
• Anticoagulants, e.g., warfarin, acenocoumarol, and rivaroxaban (used to thin the blood)
• Digoxin (medication for heart problems)
• Omeprazole (medication for heartburn and indigestion)
• Treatment for reflux (such as cisapride)
• Pimozide (medication used to treat behavioral problems)
• Theophylline (medication for asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))
• Alfentanil (medication used to anesthetize the patient before surgery)
• Bromocriptine (medication for Parkinson's disease)
• Anti-inflammatory medications (such as methylprednisolone)
• Cilostazol (medication for leg pain caused by poor circulation)
• Vinblastine (medication for cancer treatment)
• Sildenafil (medication for erectile dysfunction)
• Treatment for heart rhythm disorders or malaria (such as quinidine)
• Colchicine (medication for joint problems, such as gout and arthritis)
• Zopiclone (medication for sleep disorders)
• Corticosteroids, administered orally, by injection, or inhaled (used to help inhibit the body's immune system. This is useful for treating a wide range of diseases).
• 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 erythromycin can increase the risk of abnormal heart rhythms and other serious side effects that affect the heart.

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

• Rifampicin (for the treatment of some infections),
• Phenytoin, carbamazepine, phenobarbital (treatment of seizures)
• St. John's Wort (herbal remedy for depression)

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

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

The use of Pantomicina 500 mg film-coated tablets along with calcium channel blockers, such as verapamil, can cause a drop in blood pressure, a decrease in heart rate, or acidification of the blood.

The use of Pantomicina 500 mg film-coated tablets along with cimetidine (medication used to treat ulcers) can cause an increase in Pantomicina levels in the blood.

Use of Pantomicina 500 mg with food and drinks

Pantomicina 500 mg film-coated tablets can be administered before or after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The active ingredient of Pantomicina 500 mg film-coated tablets can cross the placenta in pregnant women and be excreted in breast milk. Information from studies on the risk of congenital anomalies is inconsistent, but some studies have reported cardiac anomalies after the use of Pantomicina 500 mg film-coated tablets at the beginning of pregnancy.

Erythromycin should be used in women during pregnancy or breastfeeding only if it is considered absolutely necessary

Driving and using machines

Pantomicina has a mild influence on the ability to drive or use machines. If you experience symptoms such as dizziness or drowsiness, do not drive or use machines.

3. How to take Pantomicina 100mg/ml

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

It is important that you follow the instructions regarding the dose, administration schedule, and duration of treatment prescribed by your doctor.

For oral use only.

The recommended dose is:

Adults and children over 8 years:10 ml or 20 ml/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.

Elderly patients

The same dose as for adults.

Patients with liver or kidney problems

Tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

Treatment duration

The duration of treatment depends on the person 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 interruption of this treatment may cause the infection to recur.

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

Common 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 Toxicology 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 forgetting a dose, take another as soon as possible. Then continue as indicated. Do not take a double dose to make up for forgotten doses.

If you stop taking Pantomicina 100 mg/ml

It is important that you complete the treatment cycle indicated by your doctor, even if you start to feel better after a few days. If you stop taking this medication before your doctor indicates, it is possible that the infection has not been fully cured and the symptoms may return 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.

4. Possible side effects

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

Contact a doctor as soon as possible if you experience a severe skin reaction: a red and scaly rash with bumps under the skin and blisters (pustular exanthematous eruption). 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 medication and seek medical attention immediately:

• Itching of the skin and reddened 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)
• Hearing loss, 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 blisters on the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Abnormal muscle breakdown that can cause kidney problems (rhabdomyolysis)
• Muscle weakness and fatigue (myasthenia gravis)
• Kidney inflammation or inability of the kidney to function properly (tubulointerstitial nephritis)
• If blood tests reveal a low white blood cell count (eosinophilia)
• If you have been told you have an inflamed pancreas
• Abnormal heart rhythms (such as palpitations, faster heart rate, irregular heartbeat potentially leading to torsades de pointes or abnormal ECG tracing) or cardiac arrest

Other side effects include:

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

• Lack of appetite
• Feeling of discomfort (nausea)
• Vomiting
• Stomach pain
• Diarrhea (frequent soft stools)

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

• Changes in liver enzyme levels

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

• Hives

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

• Accelerated heartbeats
• Liver inflammation
• Abnormal liver function test results

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

• Dizziness/fainting
• Seizures/attacks
• Confusional state (abnormal mood or mental state)
• Temporary alteration of consciousness (psychomotor crises)
• Intestinal infection (colon)
• Skin rash (erythema multiforme)
• Skin reaction

Frequency not known(cannot be estimated from available data):

• Seeing or hearing things that are not real (hallucinations)
• Difficulty seeing properly
• Hypotension
• Intestinal inflammation
• Changes in liver enzyme levels, inability of the liver to function properly (it is possible to detect yellowing of the skin, dark urine, light-colored stools, or itching of the skin)
• Small blood vessels leak fluid into tissues, causing inflammation
• Itching
• Chest pain
• Fever
• Discomfort

Additional side effects in children and adolescents:

• Symptoms of worsening vomiting, dehydration, and increased appetite (this could be a sign of infantile hypertrophic pyloric stenosis)

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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pantomicina 100mg/ml

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the carton after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

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 ingredients are corn starch, calcium hydrogen phosphate dihydrate, magnesium stearate, hypromellose, polyethylene glycol 400, titanium dioxide, sodium carboxymethyl cellulose, povidone, quinoline yellow lake (CI=47005, E-104), polyethylene glycol 8000 (macrogol 8000), sorbic acid.

Appearance of the Product and Package Contents

Ovoid-shaped yellow tablet. Package of 30 tablets.

Marketing Authorization Holder and Manufacturer

Holder

Amdipharm Limited

Unit 17

Northwood House

Northwood Crescent

Northwood

Dublin 9

D09 V504

Ireland

Local Representative of the Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Spain

Manufacturer

Aesica Queenborough Limited

Whiteway Road (Queenborough, Kent)

ME11 5EL – United Kingdom

Date of the Last Revision of this Leaflet: February 2023

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