1 g of powder for infusion solution
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
– Save this information, you may need to read it again.
– If you have any further questions, ask your doctor or nurse.
– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
– If you get any side effects, talk to your doctor or nurse. This also applies to side effects that are not mentioned in this information. See section 4.
In this leaflet:
1. What Erythromycin Panpharma is and what it is used for
2. What you need to know before you use Erythromycin Panpharma
3. How to use Erythromycin Panpharma
4. Possible side effects
5. How to store Erythromycin Panpharma 6. Contents of the pack
and other information
What Erythromycin Panpharma is and what it is used for
Erythromycin Panpharma is an antibiotic that contains erythromycin (as erythromycin lactobionate). It is a type of antibiotic called macrolide that works by preventing bacteria from growing and multiplying.
Erythromycin Panpharma is used for treating serious infections caused by bacteria in children and adults when treatment to be swallowed is not possible or insufficient. It is also used in patients whose infection is of severity requiring high levels of erythromycin or when the patient is allergic or hypersensitive to beta-lactam antibiotics or when treatment of these antibiotics for other reasons is not appropriate.
Once the acute phase of infection is controlled, your doctor will replace intravenous erythromycin with erythromycin to be swallowed.
Erythromycin Panpharma is used to treat infections such as:
- Respiratory tract infections: pneumonia, pertussis
- ear infections
- eye infection (conjunctivitis)
- infection in the skin and soft tissues (eg muscles, blood vessels, tendons, adipose tissue)
- infection is in the gastrointestinal tract
- urogenital infection ( infection of the genitals and urinary tract)
- lymphogranuloma vender um (a sexually transmitted disease)
- diphtheria (an upper respiratory tract disease).
Erythromycin contained in Erythromycin Panpharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Erythromycin Panpharma
Do not use Erythromycin Panpharma
- if you are allergic (hypersensitive) to erythromycin
- if you are allergic (hypersensitive) to other macrolide antibiotics
- if you are taking any of the following medicines:
- astemizole, terfenadine (used to treat allergic reactions )
- disopyramide ( antiarrhythmics for the treatment of ventricular tachycardia )
- cisapride (used to treat gastroesophageal reflux )
- pimozide (used to treat mental illness )
- ergotamine and dihydroergotamine (for migraines )
- lovastatin, simvastatin, and atorvastatin (medicines that lower blood cholesterol )
- antiarrhythmics class I and III (used for the treatment of ventricular arrhythmia s, for preventing paroxysmal recurrent atrial fibrillation, to treat Wolff-Parkinson-White syndrome, for treating ventricular tachycardia s, atrial fibrillation, and atrial flutter )
- neuroleptics (used to treat psychosis (including delusions, hallucinations, and confusion )tri- and tetracyclic antidepressants (used to treat depression )
- fluoroquinolone s (an antibiotic used to treat certain infectious s )
- arsenic trioxide (used to treat cancer )
- methadone (used to control opioid dependence, eg heroin abuse)
- budipine (a medicine used to treat Parkinson’s disease )
- antifungal drugs and malaria drugs
- if you have impaired liver function This is because erythromycin is mainly excreted by the liver (see section 3, “How to use Erythromycin Panpharma”)
- if you have any heart disease
- if you have electrolyte disturbances (for example, lack of potassium or magnesium ).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Erythromycin Panpharma:
- if you have heart disease, heart rhythm disorders such as QT extensions: or ventricular arrhythmia occur. Talk to your doctor, pharmacist, or nurse before using Erythromycin Panpharma
- Serious allergic reactions may occur, do not use Erythromycin Panpharma if you are allergic or hypersensitive to erythromycin or other medicines in the macrolide antibiotic group. Talk to your doctor, pharmacist, or nurse before using Erythromycin Panpharma
- if you have myasthenia gravis because erythromycin may worsen the symptoms which in turn can lead to severe breathing problems.
- if you are older, as the risk of developing kidney disease is greater. Your doctor will adjust the dose to suit your kidney function (see section 3, “How to use Erythromycin Panpharma”).
It is generally not recommended to combine erythromycin with:
- alfuzosin (used to treat benign prostatic hyperplasia )
- buspirone (used to treat anxiety disorder)
- ciclosporin and tacrolimus (used in organ transplantation to avoid rejection )
- colchicine (used to treat gout )
- ebastine ( antihistamine )
- tolterodine (used to treat urinary incontinence )
- triazolam (used as a sedative in the treatment of severe insomnia ).
You will be given this medicine continuously or slowly to avoid pain.
Newborn babies and children
Contact a doctor immediately if your child vomits (cascade vomiting without bile) and/or if he/she has difficulty eating during treatment with this medicine. Your doctor will decide on your child’s dose (see section 3, “How to use Erythromycin Panpharma”).
Other medicines and Erythromycin Panpharma
If you are going to take a urine sample, tell your doctor that you are using erythromycin as it may affect some tests.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In general, it is not recommended to combine erythromycin with:
- warfarin and coumarin derivatives (used to reduce blood supply )
- zopiclone (induces sleep )
- theophylline (facilitates breathing )
- sildenafil (used to treat erection problems and high pulmonary artery pressure )
- certain chemotherapy you and vinblastine (used to treat cancer )
- digoxin (for heart problems )
- carbamazepine (used to treat epilepsy and neuropathic pain )
- alfentanil ( anesthesia )
- bromocriptine (used to treat Parkinson’s disease and hyperprolactinemia )
- cilostazol (used to treat window disease )
- methylprednisolone ( corticosteroid used for its anti-inflammatory effect )
- midazolam (used to induce anesthesia or for moderate insomnia )
- omeprazole (used to reduce gastric acid secretion )
- valproate ( antiepileptic drugs and mood stabilizers)
- cimetidine (inhibits gastric acid production )
- rifampicin ( antibiotic )
- phenytoin ( drugs against epilepsy )
- phenobarbital ( drugs against epilepsy )
- benzodiazepines ( anxiolytics, anticonvulsants, muscle relaxants, sedatives )
- fexofenadine (used to treat allergic reactions )
- St. John’s wort ( Hypercurium perforatum ) (a medicinal plant used to treat moderate depression ).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Erythromycin has been reported to pass through the placenta and reach the unborn baby.
Erythromycin is excreted in human milk.
Your doctor will decide if the medicine is suitable for you only after you have ensured that the benefits outweigh the potential risks.
Driving and using machines
Side effects of Erythromycin Panpharma may affect the ability to drive and use machines.
Experience shows that erythromycin has a negligible effect on the ability to concentrate and react.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Erythromycin Panpharma
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. This medicine is always given by a doctor or healthcare professional. It is given intravenously (into a vein) for 60 minutes.
Adults and children over 12 years or weighing over 40 kg
The usual dose is 1 to 2 g per day corresponding to 25 mg/kg/day in divided doses(generally 3-4 single doses). This can be increased to 4 g per day in case of very serious infections.
It is important that you complete the entire course of antibiotics and that the infusion treatment is not stopped prematurely, even if you feel better.
Children over 1 month to 12 years or weighing 40 kg or less
The usual dose is 15‑20 mg/kg body weight divided into 3‑4 single doses. Your doctor will calculate the exact dose your child will receive, taking into account the child’s weight.
Full-term infants (birth to 1 month)
The usual dose is 10-15 mg/kg body weight divided into 3 single doses. Your doctor will calculate the exact dose your child will receive, taking into account the child’s weight.
Use in patients with severe kidney problems
Your doctor will calculate the exact dose based on your kidney function.
Use in elderly patients
Your doctor will carefully determine the dose, taking into account your kidney and liver function, as elderly patients may be at increased risk of developing kidney disease.
If you use more Erythromycin Panpharma then you should
If you think your child has been given too much, contact your doctor. Symptoms of overdose include ototoxicity (hearing damage), hearing loss, severe nausea, vomiting, and diarrhea.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Erythromycin Panpharma
If you think you have missed a dose of this medicine, tell your doctor or another healthcare professional immediately.
If you stop using Erythromycin Panpharma
Use this medicine for as long as your doctor prescribes it.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get an allergic reaction, this can lead to rashes and swelling in certain parts of the body including the face and throat, accompanied by difficulty breathing. If this happens to you, stop taking this medicine and seek medical advice immediately.
Contact a doctor immediately if you get a serious skin reaction: red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ). This side effect occurs in an unknown number of users (has been reported).
The most common side effects are loss of appetite, nausea, vomiting, abdominal pain, nausea, gas in the stomach, stomach upset, cramps, soft stools, or diarrhea.
The following side effects have been reported:
Uncommon (may affect up to 1 in 100 people):
- thrush ( Candida – infection ) in the mouth with white coats
- vaginal inflammation
- genital itching in women
- allergic reactions
- widespread rash ( hives )
- itching of the skin
- redness of the skin with increased blood flow ( hyperplasia )
- abnormal liver and bile function values
- pain or irritation at the injection site
- swelling and redness along a vein that is extremely sore to the touch
Rare (may affect up to 1 in 1,000 people)
- swelling of certain body parts including face and throat (allergic edema/angioedema, anaphylaxis )
- symptoms of loss of appetite
- abdominal pain radiating to the back with nausea, vomiting, diarrhea, and loss of appetite (pancreatitis)
- itching with jaundice, pale stools, and dark urine (cholestasis and jaundice)
- swelling leads
- inflammation of the colon with severe diarrhea
Very rare (may affect up to 1 in 10,000 people):
- occurrence or exacerbation of a rare disease associated with muscle weakness ( myasthenia gravis )
- ear infections ( tinnitus ) and for the most part transient hearing loss
- abnormal liver function
- abnormal kidney function
- severe skin reactions ( Stevens-Johnson syndrome and erythema multiforme)
- scaly skin ( toxic epidermal necrolysis )
No known frequency (cannot be calculated from the available data):
- chest pain, malaise
- irregular heartbeat, the heart beats hard or fast
- chest discomfort, difficulty breathing, abnormally fast or shallow breathing, pain in the upper spine
- dyspnoea (including asthmatic conditions)
- visual disturbances including double vision and blurred vision
- mental disorders (such as mood swings and impaired judgment)
- confusion, hallucinations
- dizziness, fatigue, vertigo
- epileptic seizures, convulsions
- low blood pressure ( hypotension )
- blood diseases that affect blood cells and are usually detected in blood tests
Additional side effects in newborns and children
Vomiting (cascade vomiting without bile) or difficulty eating and weight loss (infantile hypertrophic pyloric stenosis).
5. How to store Erythromycin Panpharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
The expiration date is the last day of the specified month.
A diluted solution should be used immediately.
The prepared solution should not be frozen.
For reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours in a refrigerator (2-8 ° C).
For dilute solution: Chemical and physical in-use stability has been demonstrated for 24 hours in a refrigerator (2-8 ° C).
From a microbiological point of view, that product should be used immediately.
If the solution is not used immediately, the user is responsible for the times and conditions of storage after preparation, which should not normally be longer than 24 hours in the refrigerator unless dilution has taken place under controlled and validated aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
The active substance is erythromycin (as erythromycin lactobionate).
Each vial contains 1 g of erythromycin.
There are no other ingredients in this medicine.
What the medicine looks like and the contents of the pack
Before preparation is Erythromycin Panpharma a white to slightly yellow hygroscopic powder for infusion solution in a vial of glass. After reconstitution, the solution is clear and colorless.
Erythromycin Panpharma is available in packs of 1, 10, or 25 glass vials. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
ZI. of Claire
ZA. du Pré-Chênot
This medicinal product is authorized in the EEA Member States under the following names:
|Denmark||ERYTHROMYCIN PANPHARMA 1 g, powder for solution for infusion|
|Finland||Erythromycin Panpharma 1 g, infusion solution, liqueur varten|
|Germany||ERYTHROMYCIN PANPHARMA 1 g powder for the preparation of an infusion solution|
|Norway||Erythromycin Panpharma 1 g, powder for solution for infusion|
|Spain||ERYTHROMYCIN PANPHARMA 1 g, powder for solution for perfusion|
|UK||ERYTHROMYCIN 1g, powder for solution for infusion|