PANTOMICINA 1g POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Pantomicina 1g Powder for Solution for Infusion

Do not use Pantomicina 1g Powder for Solution for Infusion

• If you are allergic to erythromycin or any of the other components of this medicine (listed in section 6).
• If you are allergic to other macrolide antibiotics.
• If you are taking terfenadine or astemizole (antihistamines used to treat allergies), cisapride (used for intestinal movement problems), pimozide (an 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 cardiac arrhythmia or torsades de pointes) or an alteration in the electrocardiogram (heart electrical record) called "prolonged QT interval syndrome".
• If you are currently taking a medicine called Lomitapide (used to reduce increased blood fats, such as cholesterol and triglycerides). Taking this medicine at the same time as erythromycin can cause an increase in liver enzymes (transaminases), which indicates that the liver is under stress and can cause liver problems.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Pantomicina 1g Powder for Solution for Infusion:

Clostridium difficile(CDAD) related to the use of antibacterial drugs, including erythromycin, and can cause mild diarrhea to fatal colitis.
• In long-term or repeated treatment, there is a possibility of spread of non-sensitive bacteria or fungi. If this type of infection appears, treatment should be stopped and appropriate measures taken. Local infection areas may require drainage along with antibacterial therapy.

Children

If a baby or child is receiving antibiotics and is irritable or vomits when feeding, you should inform your doctor immediately. There is a risk that the child may develop a severe stomach disorder called pyloric stenosis.

Using Pantomicina 1g Powder for Solution for Infusion with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicine.

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

This is also important if you are taking medicines called:

• 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 variety of diseases).
• Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medicines at the same time as erythromycin can increase the chances of suffering from abnormal heart rhythms and other serious side effects that affect the heart.

The administration of Pantomicina 1g Powder for Solution for Infusion may increase the effect of:

• Medicines for treating anxiety (such as benzodiazepines or hexobarbital)
• Ergot alkaloids (medicines for treating migraines)
• Carbamazepine (medicine for treating epileptic seizures)
• Cyclosporin (medicine for treating rheumatic diseases and preventing transplant rejection)
• Medicines for treating allergies (such as terfenadine, astemizole, and mizolastine)
• Medicines for treating fungal infections (such as fluconazole, ketoconazole, and itraconazole)
• Medicines for reducing blood lipid levels (such as lovastatin and simvastatin)
• Rifabutin (medicine for treating tuberculosis)
• Anticoagulants, e.g., warfarin, acenocoumarol, and rivaroxaban (used to thin the blood)
• Digoxin (medicine for treating heart problems)
• Omeprazole (medicine for treating heartburn and indigestion)
• Treatment for reflux (such as cisapride)
• Pimozide (medicine used to treat behavioral problems)
• Theophylline (medicine for treating asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))
• Alfentanil (medicine used to anesthetize the patient before surgery)
• Bromocriptine (medicine for treating Parkinson's disease)
• Anti-inflammatory medicines (such as methylprednisolone)
• Cilostazol (medicine for treating leg pain caused by poor circulation)
• Vinblastine (medicine for treating cancer)
• Sildenafil (medicine for treating erectile dysfunction)
• Treatment for heart rhythm disorders or malaria (such as quinidine)
• Colchicine (medicine for treating joint problems, such as gout and arthritis)
• Zopiclone (medicine for treating sleep disorders)

The following medicines may reduce the effect of Pantomicina 1g Powder for Solution for Infusion:

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

The administration of Pantomicina 1g Powder for Solution for Infusion may decrease the effect of:

• Contraceptives (medicines 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 1g Powder for Solution for Infusion 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 1g Powder for Solution for Infusion along with cimetidine (a medicine used to treat ulcers) can cause an increase in Pantomicina levels in the blood.

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 using this medicine.

Pantomicina 1g Powder for Solution for Infusion should only be used during pregnancy and breastfeeding if your doctor thinks it is necessary and follows their recommendations. The safety of erythromycin during pregnancy has not been established. Erythromycin crosses the placental membrane and also appears in breast milk.

Information from studies on the risk of congenital anomalies is not consistent, but some studies have reported cardiac anomalies after the use of Pantomicina 1g Powder for Solution for Infusion at the beginning of pregnancy. It is essential to use effective contraceptive methods during treatment with this medicine (see section "Using Pantomicina 1g Powder for Solution for Infusion with other medicines").

Driving and Using Machines

Treatment with Pantomicina has a mild influence on the ability to drive or use machines.

3. How to use Pantomicina 1g Powder for Solution for Infusion

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again. This medicine will always be administered by a doctor or nurse.

The recommended dose is

For the treatment of severe infections in adults and children, the recommended intravenous dose is 15 to 20 mg/kg/day. In cases of very severe infections, higher doses may be used, up to 4 g/day.

For the treatment of "Legionnaires' disease", although the optimal doses have not been established, the recommended doses, according to known clinical data, are 1 to 4 g per day in divided doses.

For the treatment of acute inflammatory disease of the pelvis caused by N. gonorrhoeaein women who are hypersensitive to penicillin, administer 500 mg of erythromycin lactobionate every 6 hours for 3 days, followed by 250 mg of erythromycin orally every 6 hours for 7 days.

Elderly Patients

Elderly patients usually require lower doses than adult patients. It is more likely that adverse reactions will occur in these patients. Your doctor will provide you with special information about the necessary precautions, doses, and follow-up.

If you are given more Pantomicina 1g Powder for Solution for Infusion than you should

No type of poisoning has been described with the intravenous administration of erythromycin. If hypersensitivity manifestations occur, treatment should be discontinued and appropriate therapy initiated: administration of adrenaline, steroids, etc.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone: 91 562 04 20.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor or pharmacist as soon as possible if you experience the following side effects:

• Sudden rash, difficulty breathing, and fainting (anaphylactic reaction)
• Pancreatitis, liver inflammation.
• Worsening of a disease called myasthenia gravis.
• Narrowing of the stomach outlet area called pylorus in children**.
• Diarrhea caused by antibiotic use (pseudomembranous colitis).
• Severe skin disorders (conditions known as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).
• Yellowing of the skin and/or eyes, lack of energy, and loss of appetite (symptoms of liver problems such as hyperbilirubinemia, liver inflammation with cholestasis, jaundice, and liver failure) and alteration of liver function.
• Skin inflammation called angioedema.
• Kidney inflammation.
• Abnormal heart rhythms (such as palpitations, faster heart rate, irregular heartbeat potentially leading to death called torsades de pointes or abnormal ECG tracing);
• Contact a doctor immediately if you experience a severe skin reaction: a red and scaly rash with bumps under the skin and blisters (pustular exanthematous). The frequency of this side effect is considered unknown (cannot be estimated from the available data).

The following side effects have been observed with the administration of this medicine:

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

Stomach pain

Nausea

Vomiting

Diarrhea

Lack of appetite (anorexia).

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

Increased liver enzymes and bilirubin

Skin rash.

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

Allergic reactions in the form of hives that cause intense itching.

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

Reversible hearing loss*

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

Disorientation

Hallucinations

Seizures

Dizziness

Hearing noises in the ear (tinnitus)

State of confusion

Sensation of rotational movement (vertigo)

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

Low levels of white blood cells (eosinophilia)

Hallucinations

Visual impairment

Deafness

Drop in blood pressure (hypotension)

Itching

Chest pain

Pain at the injection site ***

Fever

Malaise.

• Erythromycin in intravenous infusion at the highest doses (4 g of erythromycin or higher per day) may rarely cause reversible hearing loss.

** Hypertrophic pyloric stenosis in children

*** Sometimes venous irritation and pain have been found; if the infusion is administered slowly, preferably by continuous or intermittent intravenous infusion in no less than 20 to 60 minutes, this effect can be minimized.

If you think any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantomicina 1g Powder for Solution for Infusion

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

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month shown.

Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Pointof the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Pantomicina 1g powder for solution for perfusion

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

Appearance of the Product and Container Content

Liofilized powder for solution for perfusion in 1 sterile vial

Marketing Authorization Holder and Manufacturer

Holder:

Amdipharm Limited

Unit 17

Northwood House

Northwood Crescent

Northwood

Dublin 9

D09 V504

Ireland

Local Representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Manufacturer

DELPHARM SAINT REMY

Rue de l'Isle

Saint Remy sur Avre,

28380, – France

Date of the Last Revision of this Leaflet: February 2023

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