Erythromycin Normon 500 mg film-coated tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Erythromycin Normon 500 mg Film-coated Tablets

erythromycin ethylsuccinate

Read the entire leaflet carefully before you start taking this medicine, as 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 others, 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 Erythromycin Normon is and what it is used for
2. What you need to know before taking Erythromycin Normon
3. How to take Erythromycin Normon
4. Possible side effects
5. How to store Erythromycin Normon
6. Contents of the pack and other information

1. What Eritromicina Normon is and what it is used for

Eritromicina Normon contains erythromycin ethylsuccinate, an antibiotic that belongs to a group of antibiotics called "macrolides", and works by preventing the growth and multiplication of bacteria.

Erythromycin is used 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 cervix), or inflammation of the rectal mucosa (the 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)

Erythromycin is also used for the prevention of the following infections:

• Prevention of recurrences of rheumatic fever (an acute, non-contagious fever 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 Eritrocimina Normon

Do not take Erythromycin

• If you are allergic to erythromycin or to any of the other components 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 enzyme levels (transaminases), indicating liver stress and potentially causing liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before starting erythromycin.

• If you have heart problems or irregular heartbeats, such as ECG abnormalities (prolonged QT interval) or slow heart rate (bradycardia).
• If you have 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 that your treatment can be adjusted accordingly.
• If you are pregnant and have been diagnosed with a sexually transmitted infection called syphilis. In this case, erythromycin may not effectively prevent 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 resistance in bacteria or fungi. In such cases, treatment should be discontinued and appropriate measures taken.

If you are taking erythromycin to treat pneumonia, check with your doctor or pharmacist, as erythromycin 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.

Other medicines and Eritromicina Normon

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

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

Erythromycin 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 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)
• Medicines 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 due to 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)
• Oral, injectable, or inhaled corticosteroids (used to suppress the body's immune response, helpful in treating a wide range of conditions)

The following medicines may reduce the effect of erythromycin:

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

Erythromycin may reduce the effect of:

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

Using erythromycin together with calcium channel blockers such as verapamil may cause low blood pressure, slow heart rate, or blood acidification.

Using erythromycin together with cimetidine (a medicine used to treat ulcers) may increase erythromycin levels in the blood.

Using erythromycin together with hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis or to treat or prevent malaria) may increase the risk of abnormal heart rhythms and other serious heart-related side effects.

Eritromicina Normon with food and drinks

Erythromycin 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, speak with your doctor or pharmacist before using this medicine.

Erythromycin can cross the placenta in pregnant women and is excreted in breast milk. Information from studies on the risk of congenital malformations is inconsistent, but some studies have reported heart abnormalities after erythromycin use in early pregnancy.

Erythromycin should be used in pregnant or breastfeeding women only if considered absolutely necessary.

Driving and using machines

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

Warning about excipients

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

This medicine may cause allergic reactions as it contains Cochineal Red A (Ponceau 4R) (E-124). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Erythromycin Normon

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 the dose, dosing schedule, and duration of treatment prescribed by your doctor.

For oral use only.

The tablet may be divided into equal doses.

The recommended dose is:

Adults and adolescents

The recommended dose is 2 or 4 tablets per day, divided into 3 or 4 doses, which is the usual dose. This dose may be increased up to 8 tablets per day, depending on the severity of the infection.

Children over 8 years of age

The recommended dose is 1 or 2 g/day divided into 3 or 4 doses. This dose may be increased up to 4 g per day, depending on the severity of the infection.

Children from 2 to 8 years of age

Your doctor will prescribe the most appropriate erythromycin pharmaceutical form according to age, weight, and required dose.

For children, erythromycin suspensions are normally recommended.

Elderly patients

The recommended dose is 2 or 4 tablets per day, divided into 3 or 4 doses, which is the usual dose. This dose may be increased up to 8 tablets per day, depending on the severity of the infection.

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 and the type and severity of the infection. To be effective, this antibiotic must be taken regularly at the prescribed doses 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 return.

If you take more Erythromycin Normon 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Erythromycin Normon

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 a missed dose.

If you stop treatment with Erythromycin Normon

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 side effects

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

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

• Itching and red, blotchy rash
• Severe allergic reaction with swelling of the tongue, throat, face, or lips (angioedema)
• Dizziness or fainting, narrowing of the airways, which may cause wheezing or difficulty breathing (severe allergic reaction)
• Hearing loss, ringing in the ears, or a sense of imbalance (ototoxicity) in elderly patients with kidney or liver disease
• Irregular heartbeat (fast or slow)
• Serious skin reactions, such as blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction known as Stevens-Johnson syndrome/toxic epidermal necrolysis)
• Abnormal muscle breakdown that may lead to kidney problems (rhabdomyolysis)
• Muscle weakness and fatigue (myasthenia gravis)
• Kidney inflammation or impaired kidney function (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, potentially life-threatening irregular heartbeat known as Torsades de pointes, or abnormal ECG findings) or cardiac arrest

Other side 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
• Liver inflammation
• Abnormal liver function test results

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

• Dizziness/fainting
• Seizures/convulsions
• 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 available data):

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

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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Erythromycin Normon

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eritromicina Normon

The active substance is erythromycin (as ethylsuccinate). Each coated tablet contains 500 mg of erythromycin ethylsuccinate.

The other components (excipients) are:

• Core: magnesium stearate, corn starch, povidone, and sodium carboxymethyl potato starch (type A).
• Coating: hypromellose, glycerol (E-422), macrogol 6000, carmine red A (Ponceau 4R) (E-124), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Eritromicina Normon 500 mg is presented as pink, oval, film-coated tablets with a score line.

Each pack contains 30 or 40 tablets, and hospital packs containing 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
Spain

Date of the most recent revision of this leaflet: April 2023

Detailed 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/.