500 mg tablets
erythromycin
1. What Abboticin Novum is and what it is used for
Abboticin Novum interferes with the bacteria’s production of proteins and thus prevents the bacteria from multiplying.
Abboticin Novum is mainly used for various bacterial infections of the respiratory tract such as pneumonia, pertussis, and diphtheria. Abboticin Novum is also used to treat genital infections caused by a Chlamydia bacterium.
Abboticin Novum is also used to treat ear infections, sore throats, pneumonia, and various skin infections in people who cannot tolerate penicillin or where penicillin is inappropriate for other reasons.
Erythromycin contained in Abboticin Novum may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Abboticin Novum
Do not take Abboticin Novum
- if you are allergic to erythromycin or any of the other ingredients of this medicine (listed in section 6).
- if you have abnormally low levels of potassium or magnesium in your blood (hypomagnesemia or hypokalaemia )
- if you or someone in your family has a history of cardiac arrhythmias (ventricular arrhythmia or torsades de pointes ) or an abnormality in the electrocardiogram (electrical recording of the heart) called “long QT syndrome”
- if you are taking any of the following medicines:
- astemizole or terfenadine (medicines for allergies )
- cisapride (medicine for gastrointestinal disorders)
- dihydroergotamine (medicine for low blood pressure )
- disopyramide (medicine for heart problems)
- ergotamine (anti-migraine medication )
- pimozide (medicine for mental illness)
- drugs called statins, e.g. simvastatin, atorvastatin, and lovastatin (medicines to treat high blood fats).
- domperidone (medicines for nausea and vomiting)
Warnings and cautions
Talk to your doctor or pharmacist before taking Abboticin Novum:
- if you have impaired liver function.
- if you have heart problems
- if you are taking other medicines that are known to cause severe heart rhythm disorders
- If you suffer from Myasthenia gravis, then symptoms may worsen.
If your child takes Abboticin Novum and starts vomiting or becomes irritable during feeding, contact a doctor immediately.
Bacteria can cause diarrhea during and after treatment with Abboticin Novum. Contact your doctor if you get prolonged or severe diarrhea.
Contact a doctor if you get a new infection while you are being treated with Abboticin Novum. Your doctor will decide if you need to change treatment.
If you notice any visual impairment after taking this medicine, consult a doctor.
If you are going to take a urine sample, tell your doctor that you are using erythromycin, as it may affect some tests.
Other medicines and Abboticin Novum
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
It is especially important to consult a doctor if you are taking any of the medicines mentioned in the section “Do not take Abboticin Novum”.
Ask your doctor for advice if you are taking the following medicines:
- fluconazole, ketoconazole, and itraconazole (used to treat fungal infections)
- protease inhibitors (used in HIV – infection )
- oral contraceptives ( birth control pills )
- clarithromycin, rifampicin (for bacterial infections)
- digoxin, quinidine (used for heart problems)
- cilostazol (used for window disease )
- anticoagulants, e.g. warfarin, acenocoumarol, and rivaroxaban (used for blood thinning)
- fexofenadine (used to treat allergies )
- valproate, carbamazepine, phenobarbital, or phenytoin (for epilepsy )
- theophylline (used for asthma and other respiratory problems)
- ciclosporin, tacrolimus (used after organ transplantation)
- bromocriptine (used to treat Parkinson’s disease )
- zopiclone, triazolam, alprazolam, clozapine, midazolam, hexobarbitone (used for anxiety, worry, and sleep disorders)
- alfentanil (for pain during surgery)
- cimetidine, omeprazole (used to treat acid reflux and stomach ulcers )
- colchicine (used for joint pain)
- methylprednisolone (used to suppress the body’s immune system eg in case of allergies and inflammation )
- St. John’s wort (a natural remedy)
- verapamil (used to treat heart disease such as high blood pressure )
- vinblastine (used to treat certain types of cancer)
- sildenafil (used for erection problems)
Important! Do not change the dosage of one of these drugs on your own without first talking to your doctor.
Abboticin Novum with food and drink
The tablets should be taken immediately before a meal.
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.
Pregnancy
Women planning to become pregnant or pregnant should not use Abboticin Novum. Treatment with Abboticin Novum should be given only if absolutely necessary and only after a doctor’s prescription.
Breast-feeding
Abboticin Novum should be used with caution in breast-feeding mothers as erythromycin is excreted in human milk and may cause side effects in the baby.
Driving and using machines
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.
No effects were observed.
3. How to take Abboticin Novum
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you. The size of the dose depends on the type and severity of the infection.
The recommended dose for adults and children over 35 kg is 2 tablets twice daily or 1 tablet 4 times daily. Distribute the dose evenly over the day, e.g. at 8 in the morning and at 8 in the evening when dosing twice daily. This means that the amount of the active ingredient is kept at a sufficiently high level in the body throughout the treatment period.
Even after a couple of days of treatment with Abboticin Novum, you can feel better. However, it is very important that the entire course is completed according to the doctor’s prescription. If this does not happen, the bacteria are given the opportunity to recover and infection can flare up again.
If you forget to take Abboticin Novum
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on 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 a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
These symptoms may be signs of angioedema or allergic reaction ( anaphylaxis ). Angioedema occurs in an unknown number of people (no known frequency) while allergic reactions can occur in up to 1 in 100 people (rare).
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).
Contact a doctor if you get prolonged or severe diarrhea.
Common (may affect up to 1 in 10 people)
- stomach upset (in the form of nausea, stomach cramps, and diarrhea). rash.
Uncommon (may affect up to 1 in 100 people)
- hives.
Rare (may affect up to 1 in 1000 people)
- arrhythmias ( arrhythmia )
- temporary hearing loss, especially in patients with high doses or who have impaired renal function).
- elevated liver values (seen with laboratory tests)
- bile stasis (a condition caused by a blockage in the liver)
- liver inflammation ( hepatitis ).
No known frequency (cannot be calculated from the available data):
- feeling sick
- abdominal pain
- inflamed pancreas ( pancreatitis )
- vomiting
- tinnitus ( tinnitus )
- deafness
- chest pain
- Abnormal heart rhythm (including palpitations, fast heartbeats, life-threatening irregular heartbeats called torsades de pointes or abnormal ECG heart tracking) or cardiac arrest
- extended QTc interval (visible on ECG )
- fever
- loss of appetite
- confusion
- cramps
- dizziness
- impaired vision
- hallucinations (seeing or hearing things that are not there)
- inflammation of the kidneys (a condition called interstitial nephritis)
- low blood pressure
- itching
- skin and mucosal changes (sometimes severe)
- severe widespread skin damage (skin peeling)
- increase in the number of white blood cells in the blood ( eosinophilia )
- certain forms of hepatitis (cholestatic and hepatocellular hepatitis )
- jaundice (causes yellowing of the skin and whites of the eyes)
- hepatic impairment, liver enlargement, and liver failure.
Fungal overgrowth in the oral cavity and abdomen may occur.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Abboticin Novum
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 carton. The expiration date is the last day of the specified month.
No special storage instructions.
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
Content declaration
- The active substance is erythromycin. 1 tablet contains erythromycin ethyl succinate equivalent to erythromycin 500 mg.
- The other ingredients are hypromellose, calcium hydrogen phosphate dihydrate, magnesium stearate, maize starch, macrogol 400 and 8000, sodium starch glycolate, povidone, sorbic acid, quinoline yellow (E104), and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Printed packaging, 1 x 30 and 1 x 40 tablets.
Plastic jar, 100 tablets.
Marketing Authorization Holder and Manufacturer
| Marketing Authorization Holder / Information provided by: | Manufacturer: |
| Amdipharm LimitedTemple Chambers3, Burlington RoadDublin 4IrelandTel. +44 1268 82 3049 |