Patient Information Leaflet

Eritromicina Normon 500 mg Coated Tablets

erythromycin ethylsuccinate

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Eritromicina Normon

3.How to take Eritromicina Normon

4.Possible side effects

5Storage of Eritromicina Normon

6.Contents of the pack and additional information

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

Erythromycin is used to treat:

• Throat infections such as tonsillitis, sore throat (pharyngitis), and diphtheria (a severe bacterial infection that causes sore throat, fever, swollen lymph nodes, and weakness)
• Pneumonia (lung infection)
• Skin, muscle, tendon, and fat infections
• Inflammation of the digestive tract (enterocolitis) and frequent soft stools (diarrhea)
• Tonsillitis (sore throat)
• 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 eye area) caused byChlamydia trachomatis
• Lymphogranuloma venereum (a sexually transmitted infection caused by a microorganism calledChlamydia trachomatis)

Erythromycin is also used to prevent the following infections:

• Prevention of recurrent rheumatic fever (a non-contagious acute fever characterized by joint inflammation and pain) in patients allergic to penicillin.
• Prevention of exposure toCorynebacterium diphtheriae(the microorganism that causes diphtheria)
• Prevention of exposure toBordetella pertussis(the microorganism that causes whooping cough)

Do not take Eritromycin

• If you are allergic to erythromycin or any of the other components of this medication (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 motility problems), pimozide (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 electrocardiogram (ECG) abnormality called "prolonged QT interval syndrome."
• If you are taking medications to lower cholesterol, such as simvastatin or lovastatin.
• If you are currently taking a medication called lomitapida (used to reduce blood lipid 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 erythromycin.

• If you have heart problems or heart rate issues, 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 diagnosed with a sexually transmitted disease called syphilis. In this case, erythromycin may not be effective in preventing transmission to the newborn. You should receive appropriate penicillin treatment. 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 antibiotic use.
• If you are experiencing or are likely to experience 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 urine analysis results.

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 erythromycin to treat pneumonia, verify this with your doctor or pharmacist, as erythromycin 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 vomiting when eating, contact your doctor immediately.

Other Medications and Eritromycin Normon

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.

Erythromycin may increase the effect of:

- Anxiolytics (such as benzodiazepines or hexobarbital)

- Ergot alkaloids (medications used to treat migraines)

- Carbamazepine (medication used to treat epilepsy)

- Ciclosporin (medication used to treat rheumatic diseases and prevent transplant rejection)

- Antihistamines (such as terfenadine, astemizol, and mizolastina)

- Antifungal medications (such as fluconazole, ketoconazole, and itraconazole)

- Cholesterol-lowering medications (such as lovastatin and simvastatin)

- Rifabutina (medication used to treat tuberculosis)

- Anticoagulants (such as warfarin, acenocoumarol, and rivaroxaban used to thin the blood)

- Digoxin (medication used to treat heart problems)

- Omeprazole (medication used to treat heartburn and indigestion)

- Medications used to reduce reflux (such as cisapride)

- Pimozide (medication used to treat behavioral problems)

- Theophylline (medication used to treat asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))

- Alfentanilo (medication used to anesthetize patients before surgery)

- Bromocriptine (medication used to treat Parkinson's disease)

- Anti-inflammatory medications (such as methylprednisolone)

- Cilostazol (medication used to treat lower limb pain caused by poor circulation)

- Vinblastine (medication used to treat cancer)

- Sildenafil (medication used to treat erectile dysfunction)

- Medications used to treat heart rhythm disorders or malaria (such as quinidine)

- Colchicine (medication used to treat joint problems, such as gout and arthritis)

- Zopiclone (medication used to treat 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 pathologies).

The following medications may reduce the effect of erythromycin:

- Rifampicin (used to treat some infections),

- Phenobarbital, carbamazepine, and phenytoin (used to treat epilepsy)

- St. John's Wort (herbal medication used to treat depression)

Erythromycin may decrease the effect of:

- Contraceptives (medications used for birth control)

- HIV treatment called protease inhibitors

- Medications used to treat infections (such as clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, and colistin)

The use of erythromycin with calcium channel blockers, such as verapamil, may cause low blood pressure, decreased heart rate, or acidosis.

The use of erythromycin with cimetidine (medication used to treat ulcers) may cause an increase in erythromycin blood levels.

The use of erythromycin 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 severe side effects affecting the heart.

Use of Eritromycin Normon with Food and Beverages

Erythromycin can be taken before or after meals.

Pregnancy, Breastfeeding, and Fertility

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

Erythromycin 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 erythromycin at the beginning of pregnancy.

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

Driving and Operating Machines

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

Warning about Excipients

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

This medication may cause allergic reactions because it contains Red C (Ponceau 4 R) (E-124). It may cause asthma, especially in patients allergic to aspirin.

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 tablet can 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 can be increased up to 8 tablets per day, depending on the severity of the infection.

Children over 8 years old

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

Children aged 2 to 8 years

Your doctor will prescribe the most suitable form of erythromycin according to age, weight, and dose.

For children, it is usually recommended to use erythromycin suspensions.

Senior patients

The recommended dose is 2 or 4 tablets per day, divided into 3 or 4 doses, which is the usual dose. This dose can 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 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 must be used regularly at the prescribed doses and for the duration 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 Eritromicina Normon than you should

The usual symptoms are nausea, vomiting, and diarrhea.

Discontinue treatment and initiate supportive treatment.

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 Eritromicina Normon

If you forget a 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 Eritromicina Normon

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, it is possible that the infection has not 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 may cause side effects, although not everyone will experience them.

Consult a doctor 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 may be serious, if you experience any of the following, stop taking the medicine and seek medical attention immediately:

• Itching in the skin 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 may 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 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 may 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):

• Loss of appetite
• Feeling of discomfort (nausea)
• Vomiting
• Abdominal 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):

• Urticaria

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

• Accelerated heart rate
• Liver inflammation
• Abnormal liver function test results

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

• Dizziness/fainting
• Convulsions/attacks
• Abnormal mental state (confusional state)
• Temporary alteration of consciousness (psychomotor crisis)
• Colonic infection
• Skin rash (erythema multiforme)
• Skin reaction

Frequency unknown (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, inability of the liver to function properly (may detect yellowing of the skin, dark urine, clear stools, or itching on the skin)
• Small blood vessels allowing fluid to leak 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 prospectus. 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.

No requires special conditions for conservation.

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 thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Eritromicina Normon

The active principle is erythromycin (in the form of ethylsuccinate). Each coated tablet contains 500 mg of erythromycin ethylsuccinate.

The other components (excipients) are:

• Core: magnesium stearate, cornstarch, povidone, and sodium carboxymethylcellulose from potato (type A).
• Coating: hypromellose, glycerol (E-422), macrogol 6000, red cochineal A (Ponceau 4R) (E-124), and titanium dioxide (E-171).

Appearance of the product and content of the packaging

Eritromicina Normon 500 mg is presented in coated tablets of pink color, oblong, and scored.

Each package contains 30 or 40 coated tablets and clinical packages with 500 coated tablets.

Only some package sizes may be commercially marketed.

Holder of marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid

Spain

Date of the last review of this prospectus:April2023

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