Patient leaflet - Zaraxin 500 mg film-coated tablets
1. What Zaraxin 500 mg film-coated tablets is and what it is used for
Zaraxin 500 mg film-coated tablets belongs to a class of medicines called macrolide antiobiotics. Antibiotics are used to treat infections caused by microorganisms like bacteria.
Zaraxin 500 mg film-coated tablets is used to treat a number of infections caused by bacteria that are sensitive to azithromycin, including:
- chest, throat or nasal infections (tonsillitis, pharyngitis, sinusitis, bronchitis and pneumonia
- skin and soft tissue infections (such as abscesses and other infections or boil), with exception of infected burn wounds
- ear infections (e.g. acute Otitis media)
- uncomplicated urethritis and cervicitis caused by an organism called Chlamydia trachomatis
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Zaraxin 500 mg film-coated tablets can be used to prevent MAC-infections in patients with HIV disease.
2. What you need to know before you take Zaraxin 500 mg film-coated tablets
Do not take Zaraxin 500 mg film-coated tablets
- if you are allergic to azithromycin (the active ingredient in your medicine), or any other macrolide antibiotic (such as erythromycin or clarithromycin) or ketolide antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor , pharmacist or nurse before taking taking Zaraxin 500 mg film-coated tablets.
Special caution is needed if you have or have had any of the following conditions:
- if you have liver disease you should tell your doctor before taking Zaraxin 500 mg film-coated tablets. When using Zaraxin 500 mg film-coated tablets, cases of very severe liver inflammation have been observed which can lead to lifethreatening impairment of liverfunction. You should contact your doctor if you have signs of severe liver disease or abnormal liver function (such as rapidly progressive fatigue (asthenia) associated with jaundice, dark urine, bleeding or certain brain disease [Hepatic encephalopathy]): your doctor may need to monitor your liver function or stop the treatment.
- allergic reactions (itchin, rash) can occur due to the use of Zaraxin 500 mg film-coated tablets. However, if a severe allergic reaction occurs, you will notice rapid swelling of the face and throat (angio-oedema) causing a tight feeling or sudden severe illness (shock). Also high fever, rash, blisters on the skin, peeling of the skin, joint pain and/or inflammation of the eye (syndrome of Stevens-Johnson, toxic epidermal necrolysis, DRESS-syndrome or acute generalised pustular exanthema) may be signs of serious allergic reactions. If any of these reactions occur contact your doctor immediately.
- if you develop diarrhoea. Most of the antibiotics (medicines against bacterial infections) can cause diarrhea due to a shift in the balance of the intestinal bacteria. This can lead to overgrowth of bacteria that are insensitive to the agent used and that produce certain (toxic) waste products (toxines). The severity of the diarrhea can vary. If you develop severe bloody diarrhea,after you take Zaraxin 500 mg film-coated tablets, please contact your doctor.
- muscle weakness (Myastenia gravis)
- Like other macrolides it is known that Zaraxin 500 mg film-coated tablets can have influence the heart. If any of the following signs apply to you, especially if you are female or elderly, tell your doctor before using azithromycin.
- You have a condition called QT prolongation (the heart cells take longer than usual to get ready for the next heartbeat).
- You have a low levels of potassium or magnesium in your blood.You are taking another medicine that prolongs the QT interval (a medicine for an irregular heartbeat).
- You have a very slow heartbeat, a heart rhythm disorder or your heart function is greatly reduced.
Children and adolescents
If tablets cannot be swallowed, especially in young children, other forms should be used, like suspension. The tablets should not be taken by children under the 45 kg.
For children weighing less than 45 kg other medicine forms (e.g. suspensions) should be used. If you are giving this medicine to a newborn baby (less than 6 weeks old) and they vomit or become irritated while feeding, tell your doctor immediately.
Other medicines and Zaraxin 500 mg film-coated tablets
Tell your doctor or, pharmacist if you are taking, have recently taken or might take any other medicines
- digoxin (used for treatment of cardiac impairment) Co-administration with Zaraxin 500 mg film-coated tablets may lead to elevated digoxin levels due to delayed degradation in the gut. The amount of digoxin in the blood should be closely monitored and the digoxin dose adjusted if necessary.
- colchicine (used for gout and familial Mediterranean fever). The amount of colchicine in the blood should be closely monitored and the colchicine dose adjusted if necessary.
- medicines known as ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for migraines) should not be taken together with azithromycin.
- cumarine anticoagulants (warfarin or other medicines to thin your blood).Although the bloodthinning effect of the cumarine anticoagulants does not seem to be affected by aztihromycin, your blood clotting may need to be checked more frequently and the dose adjusted if necessary.
- ciclosporin ( a medicine used for following organ transplants) The amount of ciclosporin in the blood should be closely monitored and the ciclosporin dose adjusted if necessary.
- mineral antacids. Co-administration of mineral antacids and azithromycin resulted in decreased serum peak concentrations without altering the bioavailability of azithromycin. You should therefore only take mineral antacids and Zaraxin 500 mg film-coated tablets at a time interval of 2 to 3 hours.
- hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.
Pregnancy, breast-feeding and fertility
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
If you are pregnant you should only use Zaraxin 500 mg film-coated tablets after consulting your doctor.
Breast-feeding
Zaraxin 500 mg film-coated tablets has been reported to be excreted in human milk. No serious side effects of azithromycin were observed in infants. Consult your doctor before take Zaraxin 500 mg film-coated tablets if you are breast-feeding.
There is still insufficient experience with pregnant women in treatment with azithromycin.
Driving and using machines
Due to the occurrence of side effects (see section 4) the ability to react could be impaired which may eventually have an effect in driving or operating machinery.
Zaraxin 500 mg film-coated tablets may cause drowsiness and sleepiness.
Zaraxin 500 mg film-coated tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Zaraxin 500 mg film-coated tablets contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Zaraxin 500 mg film-coated tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablets should be swallowed whole with a liquid. The engraved score line is only there to help you break the tablet if you have difficulty swallowing it whole.
This medicine should be taken in a single daily dose. You can take the tablets with or without food.
Always continue with the course even if you feel better. If your infection gets worse or you do not start to feel better within a few days or a new infection develops, go back and see your doctor.
Doctors sometimes prescribe different doses to the recommended dose. The label on the pack will tell you which dose you should take. If you are still not sure, ask your doctor or pharmacist.
The recommended dose is:
Children over 45 kg body weight and adults, including elderly patients:
- infections of the upper and the lower respiratory tract
- acute otitis media
- skin and soft tissue infections
The total dosage of azithromycin is 1500 mg which should be given in a therapy over three days or over five days.
3-days-therapy
In the course of 3 days, 500 mg azithromycin should be given once daily (500 mg once daily).
5-days-therapy
Alternatively, the dosage may be staggered over five days (500 mg as a single dose on the first day, and then 250 mg equivalent to ½ Zaraxin 500 mg film-coated tablets once daily on days 2, 3, 4 and 5).
The efficacy of azithromycin is sufficient using the 5-days-therapy in the treatment of pneumonia. In most cases, the application of the 3-days-therapy appears to be adequate.
Treatment of uncomplicated urethritis and cervicitis
For some diseases caused by Chlamydia trachomatis the dose is 1000 mg (2 tablets) taken all together on one day only in a single occasion.
For the prevention of Mycobacterium avium complex (MAC) infection in HIV-patients the recommended dose is: 1200 mg taken once per weekly.
Eldery:
Elderly receive the usual adult doses.
Use in children and adolescents with a body weight below 45 kg:
Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin may be used, for children over the age of 1 year, such as suspensions which are dosed based on the body weight. Dosing instructions are provided in the respective package leaflet.
Patients with kidney or liver problems problems:
You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.
If you take more Zaraxin 500 mg film-coated tablets than you should
If you take too much Zaraxin 500 mg film-coated tablets you may feel unwell. Tell your doctor or contact your nearest hospital casualty department immediately.
Symptons of overdose may include severe nausea, vomiting and diarrhoea and reversible loss of hearing.
If you forget to take Zaraxin 500 mg film-coated tablets
If you forgot to take a dose of your medicine, take it´s as soon as possible. Do not take a double dose to make up for a forgotten dose or take more than one dose in a single day. Please contact your doctor.
Always keep going with the therapy as prescribed and informed by your doctor or pharmacist.
If you stop taking Zaraxin 500 mg film-coated tablets
If you stop taking Zaraxin 500 mg film-coated tablets too soon, the infection may return. Take the tablets for the full time of treatment, even when you begin to feel better.
If you have any further questions on 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 everybody gets them.
The following side effects have also been reported:
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Very Common:
- diarrhoea
- abdominal pain
- loose wind (flatulence)
- nausea
- abdominal discomfort
- loose stools
Common
- headache
- feeling dizzy
- drowsiness
- being sick (vomiting),
- lack of appetite (anorexia)
- change in the quantity of the white blood cells (decreased lymphocyte and eosinophils count, increased basophils, monocytes and neutrophils and decreased concentration of bicarbonate in the blood)
- taste disturbance (dysgeusia)
- perception of tingles, itching or tingling without cause (paraesthesia)
- visual impairment
- deafness
- regurgitation and heartburn (dyspepsia)
- skin rash
- itching (pruritus)
- joint pain (arthralgia)
- fatigue
Uncommon:
- thrush (candidiasis) - a fungal infection (oral or vaginal)
- fungal infection
- bacterial infection
- inflammation of the throat (pharyngitis)
- breathlessness, chest pain, wheeze and cough (respiratory disorder)
- inflammation of the mucous membrane inside the nose (rhinitis)
- stomach flu (gastroenteritis)
- inflammation inside your vagina (vaginitis)
- pneumonia
- changes in the number of white blood cells with increased susceptibility to infections (leucopenia, neutropenia and eosinophilia)
- difficulty breathing and/or skin rash due to allergic reaction (angioedema)
- hypersensitivity
- nervousness
- ear disorder
- spinning sensation (vertigo)
- palpitations
- hot flushes
- shortness of breath (dyspnoea)
- nosebleed (epistaxis)
- inflammation of the lining of the stomach (gastritis)
- constipation
- difficulty swallowing (dysphagia)
- swollen abdomen
- dry mouth
- belching
- mouth ulcer
- increased salivary flow
- itching
- inflammation of the skin (dermatitis)
- dry skin
- increased sweating (hyperhidrosis)
- pain, swelling and reduced motion in your joints (osteoarthritis)
- muscle pain (myalgia)
- back pain
- neck pain
- painful or difficult urination (dysuria)
- pain in the upper back (renal pain)
- testicular disorder
- urticaria
- chest pain
- fever
- pain
- swelling of extremities (peripheral oedema)
- swelling (oedema)
- general feeling of being unwell (malaise)
- weakness (asthenia)
- change in liver enzyme levels and blood levels
- post procedural complications
- irregular vaginal bleeding (metrorrhagia)
- face edema
- allergic skin reactions such as being sensitive to sunlight (photosensitivity reaction)
- blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS))
- respiratory disorder
- insomnia
- reduced sense of touch (hypoaesthesia)
- hearing impairment
- tinnitus
- hepatic function abnormal
- hepatitis
- sudden fluid build-up in the skin or mucous membranes (throat or tongue)
Rare:
- yellowing of the skin and whites of the eyes, dark urine, pale stool
- irritability
- jaundice cholestatic
- Acute Generalized Exanthematous Pustulosis (AGEP)
- Drug Rash with eosinophilia and systemic Symptoms (DRESS)
Not known:
- gut (colon) infection (pseudomembranous colitis)
- blood disorder with symptoms like bruising and bleeding easily (thrombocytopenia)
- anaemia
- allergic reaction
- feeling angry, aggressive
- anxiety
- delirium
- hallucinations
- fainting (syncope)
- fits (convulsions)
- feeling hyperactive
- change in your sense of smell (anosmia, parosmia)
- change in your sense of taste (ageusia)
- exacerbation or aggravation of muscle weakness (myasthenia gravis)
- abnormal heart function
- low blood pressure (hypotension)
- inflammation of the pancreas with severe pain in the upper abdomen radiating to the back, nausea and vomiting (pancreatitis)
- your tongue changes colour
- your tooth changes colour
- abnormal liver function
- liver failure
- severe allergic skin reactions with fever, blisters on the skin and peeling of the skin (toxic epidermal necrolysis)
- kidney failure, inflammation within the kidneys with dark urine, fever and pain in the flanks (interstitial nephritis) - toxic epidermal necrolysis
- erythema multiforme
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 via www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zaraxin 500 mg film-coated tablets
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Zaraxin 500 mg film-coated tablets contains
The active substance is azithromycin.
Each film-coated tablet of Zaraxin 500 mg film-coated tablets contains 500 mg of the active substance azithromycin
The other ingredients are: pregelatinised starch, crospovidone, calcium hydrogen phosphate, anhydrous sodium laurilsulfate and magnesium stearate. The coating contains hypromellose, titanium dioxide (E171), lactose monohydrate and triacetin.
What Zaraxin 500 mg film-coated tablets looks like and contents of the pack
White, oblong, biconvex, film coated tablets, scored on one side.
Zaraxin 500 mg film-coated tablets 500 mg film-coated tablets is available in packs of 3 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Maddox Pharma Swiss B.V.
Sylviusweg 74
2333 BE Leiden
The Netherlands
Manufacturer
Bluepharma Indústria Farmacêutica S.A.
S. Martinho do Bispo
3045-016 COIMBRA
Portugal
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.