Pantomicina 100 mg/ml granules for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pantomicina 100 mg/ml granules for oral suspension

ethylsuccinate erythromycin

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it 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 Pantomicina 100 mg/ml is and what it is used for
2. What you need to know before taking Pantomicina 100 mg/ml
3. How to take Pantomicina 100 mg/ml
4. Possible side effects
5. How to store Pantomicina 100 mg/ml
6. Contents of the pack and other information

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

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

Pantomicina 100 mg/ml granules for oral suspension are indicated for the treatment of:

• Throat infections such as tonsillitis, sore throat (pharyngitis), and diphtheria (a serious bacterial infection causing sore throat, fever, swollen lymph nodes, and weakness)
• Lung infection (pneumonia)
• Skin, muscle, tendon, and fat infections
• Inflammation of the digestive tract (enterocolitis) and frequent loose stools (diarrhea)
• Whooping cough (pertussis)
• Urethritis (inflammation of the tube draining the bladder), cervicitis (inflammation of the neck of the uterus), or inflammation of the rectal mucosa (last part of the digestive tract)
• Conjunctivitis (irritation and redness of the membrane covering the eye) in newborns caused by Chlamydia trachomatis
• Lymphogranuloma venereum (a sexually transmitted infection caused by a microorganism called Chlamydia trachomatis)

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

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

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

Do not take Pantomicina 100 mg/ml

• If you are allergic (hypersensitive) to erythromycin ethylsuccinate or to any of the other ingredients of this medicine, listed in section 6.
• If you are allergic to any macrolide antibiotic, such as azithromycin or clarithromycin, used to treat respiratory, throat, or nasal bacterial infections.
• If you are taking terfenadine or astemizole (antihistamines used to treat allergies), cisapride (used for intestinal motility problems), pimozide (an antipsychotic), or 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 abnormality in the electrocardiogram (ECG) known as "QT prolongation syndrome".
• If you are taking cholesterol-lowering medicines, such as simvastatin or lovastatin.
• If you are currently taking a medicine called lomitapide (used to reduce elevated blood fats such as cholesterol and triglycerides). Taking this medicine together with erythromycin may increase liver enzymes (transaminases), indicating liver stress and potentially causing liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pantomicina 100 mg/ml.

• If you have heart problems or heart rhythm issues, such as ECG abnormalities (prolonged QT interval) or slow heart rate (bradycardia).
• If you experience abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis). Fever, nausea, vomiting, and unusual muscle pain may indicate muscle damage.
• If you have liver problems, inform your doctor so they can adjust your treatment accordingly.
• If you are pregnant and have been diagnosed with a sexually transmitted infection called syphilis. In this case, erythromycin may not be effective in preventing transmission of the infection to the newborn. You should 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 medicines known to cause serious heart rhythm disturbances.
• If you have heart problems.
• If you have previously experienced frequent loose stools after recent antibiotic use.
• If you have or are likely to develop vision loss.
• If you have a condition called myasthenia gravis, which causes muscle weakness.
• If you are about to undergo laboratory tests. This medicine may interfere with urine test results.

Repeated or prolonged use of erythromycin may lead to bacterial or fungal resistance. In such cases, 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 first-choice treatment due to frequent resistance of the main causative pathogen. In such cases, it should only be used in combination with other antibiotics.

Children and adolescents

If you are treating a young child who is irritable or vomits when eating, contact your doctor immediately.

Taking Pantomicina 100 mg/ml with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

It is especially important that you inform them if you are taking any of the following medicines or treatments.

Administration of Pantomicina 100 mg/ml granules for oral suspension may increase the effect of:

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

The following medicines may reduce the effect of Pantomicina 100 mg/ml granules for oral suspension:

• Rifampicin (for treatment of certain infections)
• Phenytoin, carbamazepine, phenobarbital (treatment of seizures)
• St. John’s wort (herbal remedy for depression)

Administration of Pantomicina 100 mg/ml granules for oral suspension may reduce the effect of:

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

Using Pantomicina 100 mg/ml granules for oral suspension together with calcium channel blockers, such as verapamil, may cause low blood pressure, slow heart rate, or blood acidification.

Using Pantomicina 100 mg/ml granules for oral suspension together with cimetidine (a medicine used to treat ulcers) may increase the blood levels of Pantomicina.

Taking Pantomicina 100 mg/ml with food and drinks

Pantomicina 100 mg/ml granules for oral suspension can be taken before or after meals.

Pregnancy, breastfeeding, and fertility

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.

The active ingredient in Pantomicina 100 mg/ml granules for oral suspension may cross the placenta in pregnant women and be excreted in breast milk. Data from studies on the risk of congenital malformations are inconsistent, but some studies have reported heart abnormalities after using Pantomicina 100 mg/ml early in pregnancy.

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

Driving and using machines

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

3. How to take Pantomicina 100 mg/ml

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

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

For oral use only.

The recommended dose is:

Adults and children over 8 years of age: 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.

Paediatric population

Children from 2 to 8 years of age: The usual dose is 2.5 ml twice daily.

Children under 2 years of age: The usual dose is 1.25 ml four times daily or 2.50 ml twice daily.

Elderly patients

The same dose as for adults.

Patients with liver or kidney problems

Inform your doctor if you have renal or hepatic impairment, as your dose may need to be adjusted.

Duration of treatment

The duration of treatment depends on the individual patient and the type and severity of the infection. To be effective, this antibiotic must be taken regularly at the prescribed dose and for the length of time indicated by your doctor. Do not stop taking this medicine even if you feel better; early discontinuation of treatment may cause the infection to reappear.

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

The usual symptoms are nausea, vomiting, and diarrhoea.

Treatment should be discontinued and supportive treatment initiated.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Pantomicina 100 mg/ml

If you miss a dose, take it as soon as possible. Then continue as directed. 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 full course of treatment prescribed by your doctor, even if you start to feel better after a few days. If you stop taking this medicine before the prescribed time, the infection may not be completely cured and symptoms may return or even worsen.

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

If you have any further questions about the use of 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.

Contact a doctor as soon as possible if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from the available data).

Some adverse effects may be serious. If you experience any of the following, stop taking the medicine and seek medical advice immediately:

• Itching and red rash on the skin
• Severe allergic reaction with swelling of the tongue, throat, face, or lips (angioedema)
• Feeling dizzy or faint, narrowing of the airways, which may cause wheezing or breathing difficulties (severe allergic reaction)
• Hearing loss, ringing in the ears (tinnitus), or sensation of imbalance (ototoxicity) in elderly patients with kidney or liver disease
• Irregular heartbeat (fast or slow)
• Serious 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 breakdown of muscle tissue that may lead to kidney problems (rhabdomyolysis)
• Muscle weakness and fatigue (myasthenia gravis)
• Inflammation of the kidney or inability of the kidney to function properly (tubulointerstitial nephritis)
• If blood tests show a low white blood cell count (eosinophilia)
• If you have been diagnosed with pancreatitis
• Abnormal heart rhythms (such as palpitations, faster heartbeat, irregular heartbeat potentially leading to life-threatening arrhythmia called torsades de pointes, or abnormal ECG findings) or cardiac arrest

Other adverse effects include:

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

• Loss of appetite
• Feeling unwell (nausea)
• Vomiting
• Stomach pain
• Diarrhea (frequent loose 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):

• Rapid heartbeat
• Inflammation of the liver
• Abnormal results in liver function tests

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

• Dizziness/fainting
• Seizures/episodes
• Confusional state (abnormal mood or mental state)
• Temporary disturbance of consciousness (psychomotor seizures)
• Infection of the large intestine (colon)
• Skin rash (Erythema multiforme)
• Skin reaction

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

• Seeing or hearing things that are not real (hallucinations)
• Inability to see properly
• Hypotension
• Intestinal inflammation
• Changes in liver enzyme levels, inability of the liver to function properly (you may notice yellowing of the skin, dark urine, pale stools, or itching of the skin)
• Small blood vessels leaking fluid into tissues, causing swelling
• Itching
• Chest pain
• Fever
• Malaise

Additional adverse 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 adverse effects

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

5. Storage of Pantomicina 100 mg/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 EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantomicina 500 mg

The active substance is erythromycin (as ethylsuccinate).

Each tablet contains 500 mg of erythromycin (as ethylsuccinate).

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

Appearance of the product and contents of the pack

Yellowish oval-shaped tablet. Pack containing 30 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

Amdipharm Limited

Unit 17, Northwood House

Northwood Crescent

Northwood, Dublin 9

D09 V504, Ireland

Manufacturer Responsible for Batch Release

Aesica Queenborough Limited

Whiteway Road (Queenborough, Kent)

ME11 5EL – United Kingdom

Local representative

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7th floor

28046 Madrid (Spain)

Tel. +34 900 834 889

[email protected]

Date of the most recent review of this leaflet: February 2023

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