ZARAXIN 500 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Zaraxin® 500 mg film-coated tablets

Azithromycin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What Zaraxin 500 mg film-coated tablets is and what it is used for

• 2. What you need to know before you take information

• 3. How to take Zaraxin 500 mg film-coated tablets

• 4. Possible side effects

• 5. How to store Zaraxin 500 mg film-coated tablets

• 6. Contents of the pack and other information

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 antibiotics. Antibiotics are used to treat infections caused by micro-organisms 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)

• – ear infections (e.g. acute Otitis media)

• – uncomplicated urethritis and cervicitis caused by an organism called Chlamydia trachomatis and Neisseria gonorrhoea.

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 Zaraxin 500 mg film-coated tablets.

Special caution is needed if you have or have had any of the following conditions:

• – kidney condition (glomerular filtration rate <10 ml/min)

• – heart conditions: In other macrolides, an increase in cardiac repolarization and QT-interval has been observed, leading to arrhythmias and Torsades de pointes. For azithromycin, a similar effect cannot be completely ruled out (s. section 4)

• – severe liver disease or abnormal liver function (such as rapidly progressive fatigue 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

• – neurological condition or psychiatric condition

• – muscles fatigue (Myastenia gravis)

• – and if you are taking any ergot derivatives such as ergotamine (used to treat migraine): co-administration with azithromycin or macrolide antibiotics has been shown to accelerate the development of ergot poisoning (ergotism) symptoms. These medicines should not be taken together with azithromycin

Secondary infections caused by another pathogen

Attention should be paid to possible symptoms of secondary infections caused by non-sensitive agents, such as fungi.

Zaraxin 500 mg film-coated tablets is not indicated for the treatment of severe infections where high concentrations of the antibiotic have to be reached rapidly.

Zaraxin 500 mg film-coated tablets is not the recommended first choice treatment for paranasal sinuses inflammation, acute otitis media, pharyngitis, inflammation of the palatine tonsils, and for prevention of acute rheumatic fever.

Zaraxin 500 mg film-coated tablets should not be used:

• – with other agents that prolong the QT interval, such as certain antiarrhythmics, cisapride and terfenadine, as well as certain antipsychotic agents, antidepressants and antimicrobial agents (fluoroquinolones),

• – in patients with electrolyte imbalances, especially if there is no reduction in potassium and magnesium in the blood,

• – in patients with certain heart disease (clinically relevant bradycardia, cardiac arrhythmias or severe heart failure),

• – in women and elderly patients with existing pro-arrhythmias,

• – in infections with erythromycin-resistant gram-positive bacterial strains (cross-resistance) and most strains of methicillin-resistant staphylococci.

There is no experience of safety and efficacy of azithromycin

in the long-term of the above indications. If there is a rapid recurrence of the infection, treatment with another antibiotic should be considered.

Zaraxin 500 mg film-coated tablets is not intended for the treatment of infected burns.

Children and adolescents

• – Cases of narrowing in the area of the gastric outlet (Infantile hypertrophic pyloric stenosis, IHPS ) have been reported following the use of azithromycin in neonates (treatment in the first 42 days after birth). Contact your doctor if vomiting or irritation occurs with your child during feeding.

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). Coadministration with Zaraxin 500 mg film-coated tablets may lead to elevated digoxin levels due to delayed degradation in the gut.

• – colchicine (used for gout and familial Mediterranean fe­ver)

• – dihydroergotamine or non-hydrogenated ergot alkaloids, which can lead to circulatory disorders, especially on the fingers and toes, due to a vasoconstrictor effect and therefore should not be used simultaneously with Zaraxin 500 mg film-coated tablets as a precaution

• – zidovudine (for HIV). Zaraxin 500 mg film-coated tablets may reduce the blood levels of zidovudine and should therefore be taken at least 1–2 hours before or after zidovudine

• – rifabutin (for HIV or tuberculosis). In persons receiving azithromycin and rifabutin, hemorrhagic disorders were observed (see section 4).

• – medicines known as ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for migraines or reducing blood flow) should not be taken together with azithromycin

• – warfarin or other medicines to thin your blood

• – ciclosporin (a medicine used for skin conditions, rheumatoid arthritis, or following organ transplants)

A possible cross-resistance between azithromycin and macrolide antibiotics (such as erythromycin) as well as lincomycin and clindamycin should be considered. A simultaneous administration of several medicines from this group of substances is therefore not recommended.

In contrast, relevant studies have shown that known interactions do not occur in case of simultaneous use of macrolides and the substances listed below:

• – terfenadine (for hay fever or skin allergy). There are seldom reports of a possibility of an interaction that has not been completely ruled out while no specific evidence for such interaction has been found. Caution is recommended when azithromycin and terfenadine are co-administered.

• – theophylline (for breathing problems). As a precaution, a control for typical signs of elevated theophylline levels is recommended in case of simultaneous administration of azithromycin and theophylline derivatives.

• – warfarin. However, there have been reports of increased anticoagulation following co-administration of azithromycin and coumarin-type oral anticoagulants. Although a causal relationship has not been established, the control frequency of prothrombin time should be taken into account.

• – 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.

• – cimetidine had no effect on the rate and extent of azithromycin resorption. It can therefore be taken concomitantly with Zaraxin 500 mg film-coated tablets.

• – didanosine. Its effectiveness is not affected by Zaraxin 500 mg film-coated tablets.

• – nelfinavir. Co-administration led in this case to increased concentrations of azithromycin. No significant side effects were observed, no dose adjustment is necessary.

Zaraxin 500 mg film-coated tablets should not be taken with other medicines that prolong the QT interval.

The following medicines have not been shown to interact with azithromycin in clinical trials: atorvastatin (Post-marketing experience has reported though on certain muscle diseases [Rhabdomyolysis ] in patients receiving azithromycin in combination with various statins), carbamazepine, cetirizine, efavirenz, fluconazole, indinavir, methylprednisolone, midazolam, sildenafil, triazolam, trimethoprim / sulfamethoxazole. However, caution should be exercised when using these substances with Zaraxin 500 mg film-coated tablets.

Zaraxin 500 mg film-coated tablets with food, drink and alcohol

This medicine can be taken with or without food.

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.

There is still insufficient experience with pregnant women in treatment with azithromycin.

Zaraxin 500 mg film-coated tablets is not recommended if you are pregnant or planning to become pregnant. As a precaution, Zaraxin 500 mg film-coated tablets should only be used during pregnancy when the benefit outweighs the risk. Your doctor should decide if such exceptional situation does exist. Azithromycin passes into breast milk. Among the others, a risk to the suckling infant cannot be excluded, such as sensibilization of the breast-fed infant, as well as irritation of the gut flora and fungal colonization.

It is recommended during the treatment and two days after its completion to pump and discard the milk. After that, the breastfeeding can be resumed.

Driving and using machines

Based on the present experience azithromycin does not show an impact on the cognition in general such as concentration and reaction ability. 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 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.

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 Ya 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 a condition caused by Neisseria gonorrheae the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with 250 mg or 500 mg of ceftriaxone. If you are allergic to penicillin and/or cephalosporins, you should consult your doctor.

Eldery:

Elderly receive the usual adult doses may be used. This patients group may be more susceptible to severe cardiac arrhythmia and torsade de pointes.

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, 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:

You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

Patients with impaired kidney function

No dose adjustment is required in patients with mild to moderate renal impairment (GFR 10 to 80 ml / min).

Patients with impaired liver function

No dose adjustment is required in patients with mild to moderate hepatic impairment.

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.

Symptoms 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 continue taking your tablets as per normal. Do not take a double dose to make up for a forgotten dose.

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.

Tell your doctor immediately if you may be experiencing a rare severe allergic reaction to the tablets:

• – sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)

• – severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with Zaraxin 500 mg film-coated tablets as this may be a sign of serious bowel inflammation

• – severe skin rash causing redness and flaking

• – rapid or irregular heartbeat

• – low blood pressure

• – serious skin reactions:

o blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS))

o blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN))

o skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

o Rare: skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid).

Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical attention immediately

The following side effects have also been reported:

• - Very common (affects more than 1 user in 10)

• - Common (affects 1 to 10 users in 100)

• - Uncommon (affects 1 to 10 users in 1,000):

• - Rare (affects 1 to 10 users in 10,000):

• - Very rare (affects less than 1 user in 10,000)

• - Not known – frequency cannot be estimated from available data

Very Common:

• – Diarrhoea

Common

• – headache

• – being sick (vomiting), stomach pain or cramps, loss of appetite

• – change in the quantity of the white blood cells and the concentration of bicarbonate in the blood

Uncommon:

• – thrush (candidiasis) – a fungal infection

• – 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

• – angioedema

• – hypersensitivity

• – lack of appetite (anorexia)

• – nervousness

• – feeling drowsy (somnolence)

• – changes in your sense of taste

• – sensation of pins and needles or numbness (paraesthesia)

• – visual impairment

• – having difficulty sleeping (insomnia)

• – ear disorder

• – dizziness

• – spinning sensation (vertigo)

• – palpitations

• – hot flushes

• – shortness of breath

• – nosebleed

• – inflammation of the lining of the stomach (gastritis)

• – constipation

• – loose wind (flatulence)

• – difficulty swallowing

• – swollen abdomen

• – dry mouth

• – belching

• – mouth ulcer

• – increased salivary flow

• – skin rash

• – itching

• – inflammation of the skin (dermatitis)

• – dry skin

• – increased sweating

• – pain, swelling and reduced motion in your joints (osteoarthritis)

• – muscle pain

• – back pain

• – neck pain

• – increase in blood urea levels

• – painful or difficult urination

• – pain in the upper back (renal pain)

• – spotting

• – testicular disorder

• – urticaria

• – chest pain

• – face swelling

• – fever

• – pain

• – swelling of extremities (peripheral oedema)

• – swelling (oedema)

• – general feeling of being unwell (malaise)

• – fatigue

• – weakness (asthenia)

• – change in liver enzyme levels and blood levels

• – post procedural complications

Rare:

• – feeling agitated

• – abnormal hepatic function, yellowing of the skin and whites of the eyes, dark urine, pale stool

• – allergic skin reactions such as being sensitive to sunlight

Not known – frequency cannot be estimated from available data

• – gut (colon) infection (pseudomembranous colitis)

• – reduced number of red blood cells due to destruction (haemolytic anaemia); reduction in number of platelets (thrombocytopenia)

• – anaphylactic reaction

• – feeling angry, aggressive

• – anxiety

• – confusion

• – hallucination

• – fainting (syncope)

• – fits (convulsions)

• – reduced sense of touch (hypoesthesia)

• – 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)

• – impaired hearing including loss of hearing, ringing in your ears

• – rapid (ventricular tachycardia) or irregular heartbeat, sometimes being life-threatening, changes of the heart rhythm found by an electro-cardiogram (QT prolongation and torsade de pointes)

• – low blood pressure

• – inflammation of the pancreas (pancreatitis)

• – your tongue changes colour

• – liver failure

• – severe allergic skin reactions

• – joint pain (arthralgia)

• – kidney failure, inflammation within the kidneys

The following side effects have been reported in prophylactic treatment against Mycobacterium Avium complex (MAC):

Very common:

• – diarrhoea

• – abdominal pain

• – feeling sick (nausea)

• – loose wind (flatulence)

• – abdominal discomfort

• – loose stools

Common:

• – lack of appetite (anorexia)

• – feeling dizzy

• – headache

• – sensation of pins and needles or numbness (paraesthesia)

• – changes in your sense of taste

• – visual impairment

• – deafness

• – being sick (vomiting), stomach pain or cramps, loss of appetite, problems digesting your food

• – skin rashes and itching

• – joint pain (arthralgia)

• – fatigue

Uncommon:

• – reduced sense of touch (hypoaesthesia)

• – hearing loss or ringing in your ears

• – palpitations

• – liver problems such as hepatitis

• – severe form of skin flushing

• – allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin

• – general feeling of being unwell (malaise)

• – weakness (asthenia)

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 is available in packs of 3 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Maddox Pharma Swiss B.V.

Wilhelminapark 17

2342 AD Oegstgeest

The Netherlands

Manufacturer:

Bluepharma Industria Farmaceutica 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.

This leaflet was last revised in 08/2019

Leaflet Zaraxin 500 mg UK 148×425mm 15.01.2020.indd 2

15–01–20 20:32