Myzat 200 mg/5 ml Oral Suspension

MYZAT contain a medicine called azithromycin dihydrate. This belongs to one of the antibiotic medicines group called as macrolide.

For children under 45 kg: MYZAT is used to treat inflammation of the tonsils, inflammation of the ear and sore throat caused by different type of bacterial organisms.

For adults and children over 45 kg: Bronchial tubes membrane lining inflammation, uncomplicated skin and soft tissue infections and one of the paranasal sinuses inflammations.

Do not take MYZAT:

• If you are allergic to azithromycin, erythromycin or any of MYZAT’s ingredients.
• If you are allergic to any group of macrolide derivative medicines.
• If you are already taking medicines called ergot derivatives this may leads to ergotism (physiological state produced by a poison due to concurrent administration of MYZAT with ergot derivatives).
• If you have any liver problems.

Warnings and Precautions

Take special care with MYZAT:

Tell your doctor,

• If you develop any skin or allergic reactions.
• If you develop severe diarrhoea.
• If you have any problems with your kidney. You doctor will tell about cautions for how to take MYZAT.
• If you have any liver problem (like jaundice - yellowing of the skin and the eyes).
• If your baby is below 12 months of age.
• If you face cardiac dysrhythmia (an abnormal rate of muscle contractions in the heart) and torsade de pointes.
• If you suffer from an autoimmune neuromuscular disease called myasthenia gravis, your symptoms may become worse when taking MYZAT.

Taking other medicines with MYZAT:

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines). MYZAT may have an effect on other medicines or other medicines may have an effect on MYZAT.

• Warfarin or any similar medicine used to prevent blood clots: use together can increase the risk of bleeding.
• Nelfinavir (an antiretroviral medicine that prevents human immunodeficiency virus (HIV) cells from multiplying in your body) levels may increase. Your doctor will check your blood levels and monitor you.
• Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs, muscle cramps and gangrene of hands and feet due to poor blood circulation) may occur. Use together is therefore not recommended.
• Digoxin (used for heart failure): digoxin levels may increase. Your doctor will check your blood levels.
• Atorvastatin (used to treat high blood cholesterol) taken with MYZAT can result in the breakdown of muscle.
• Antacids (used for indigestion) can interact with MYZAT. MYZAT tablets should be taken at least 1 hour before or 2 hours after an antacid.
• Caution is advised if you are taking MYZAT with ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow).
• Rifabutin (used to treat tuberculosis) and MYZAT: when taken together this can result in decreased white blood cell count.

Taking MYZAT with food and drink:

MYZAT suspension should be taken with food.

Pregnancy, breastfeeding and fertility

Do not take MYZAT if you are pregnant or breastfeeding your baby MYZAT passes into breastmilk. If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking MYZAT.

Driving and using machinery:

After taking MYZAT you may get dizziness (a feeling that you are about to fall). Do not drive or operate any machinery for your safety.

MYZAT contains sucrose: MYZAT contains sucrose, which is a type of sugar. So before taking MYZAT, please consult your doctor for advice if you have intolerance to some sugars.

Do not share medicines prescribed for you with any other person. Always take MYZAT exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

MYZAT powder should be reconstituted with required quantity of water as given below:

Amount of water to be added

Total deliverable volume (azithromycin content)

Azithromycin concentration after reconstitution

9 mL

15 mL (600 mg)

200 mg/5 mL

15 mL

30 mL (1 200 mg)

200 mg/5 mL

MYZAT should be administered as a single daily dose (i.e., 200 mg/5 mL). Shake well before each use.

Use in children: 1 year and older. The total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg for 3 days according to the following guidance:

• < 15 kg : 10 mg/kg once daily on days 1 - 3.
• 15 - 25 kg : 200 mg (5 mL) once daily on days 1 - 3.
• 26 - 35 kg : 300 mg (7,5 mL) once daily on days 1 - 3.
• 36 - 45 kg : 400 mg (10 mL) once daily on days 1 - 3.
• > 45 kg : Dose as per adults.

Always take MYZAT exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of MYZAT is too strong or too weak, tell your doctor or pharmacist. Your doctor will tell you how long your treatment with MYZAT will last. Do not stop treatment early because this may reoccurrence of your condition. If you have the impression that the effect of MYZAT is too strong or too weak, tell your doctor or pharmacist.

MYZAT can have side effects: Not all side effects reported for MYZAT are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this MYZAT, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking MYZAT and tell your doctor immediately or go to the casualty department at your nearest hospital:

• difficulty in breathing, swelling of eyelids, face, mouth, throat 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 MYZAT as this may be a sign of serious bowel inflammation.
• severe skin rash causing redness and flaking.
• rapid or irregular heartbeat.
• low blood pressure.

These are all very serious side effects. If you have them, you may have a serious reaction to MYZAT. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Acute generalised exanthematous pustulosis (AGEP) (skin reaction),
• Stevens - Johnson syndrome (A rare, serious disorder of the skin and mucous membranes,
• a range of conditions affecting blood cells (Leukopenia, Neutropenia, Eosinophilia, Thrombocytopenia, Haemolytic anaemia), which are characterised by fatigue, shortness of breath, muscle weakness and irregular heartbeat.
• Palpitations (A sensation that the heart is racing, pounding, fluttering or skipping a beat, often bothersome, but hardly ever a sign of heart disease).
• Hepatic function abnormal, Jaundice cholestatic (which are characterised by yellowing of the skin and eyes, abdominal pain and swelling, pale stools and dark urine).

Frequent side effects:

• headache
• Diarrhoea, vomiting, abdominal pain, nausea
• Lymphocyte count decreased, Eosinophil count increased, Blood bicarbonate decreased, Basophils increased, Monocytes increased, Neutrophils increased (which are detectable through laboratory tests).

Less frequent side effects:

• yeast infections of the mouth and vagina (thrush)
• Hypersensitivity and anaphylactic reaction (a severe, potentially life - threatening allergic reaction)
• Anorexia (An eating disorder causing people to obsess about weight and what they eat)
• Nervousness, Insomnia, Agitation
• Aggression, Anxiety
• Delirium (serious disturbance in mental abilities that results in confused thinking and reduced awareness of surroundings), Hallucination
• Dizziness, Somnolence (Strong desire for sleep and feeling of drowsiness)
• Dysgeusia (an altered or impaired sense of taste)
• Paraesthesia (tingling or prickling, “pins - and - needles” sensation)
• Syncope (fainting or a sudden temporary loss of consciousness)
• Convulsion (a sudden, violent, irregular movement of the body)
• Hypoesthesia (a decreased sense of touch or sensation)
• Psychomotor hyperactivity (which include excessive unnecessary pacing, tapping your toes or rapid talking).
• Anosmia (partial or complete loss of the sense of smell)
• Visual impairment, blurred vision
• Ear disorder, Vertigo (a sudden internal or external spinning sensation, often triggered by moving your head too quickly)
• Hearing impairment including deafness and/or tinnitus (ringing sensation in ear)
• Rash, itchiness, Urticaria, Dermatitis, Dry skin
• Hyperhidrosis (abnormally excessive sweating involving the extremities, underarms and face, usually unrelated to body temperature or exercise)
• Sensitivity to light reaction
• Hot flush
• Hypotension
• Dyspnoea (Difficult or laboured breathing)
• Nose bleeds
• Constipation, Flatulence, Dyspepsia (stomach discomfort), Gastritis dysphagia (chronic stomach reflux), Abdominal distension, Dry mouth, Eructation (excess wind in stomach), Mouth ulceration
• Salivary hypersecretion
• Pancreatitis (inflammation of the pancreas)
• Tongue discolouration
• Liver failure (which has rarely resulted in death)
• Osteoarthritis, Myalgia (pain in a muscle or group of muscles), Back pain, Neck pain
• Arthralgia (physical discomfort where two or more bones meet to form a joint, ranging from mild to disabling)
• Dysuria (Discomfort, pain or burning when urinating)
• Renal failure acute, Nephritis interstitial (characterised by increase in urination, blood in your urine or dark urine, nausea or vomiting or swelling in any area of your body).
• abnormal bleeding from the womb
• Testicular disorder
• Oedema (swelling), Asthenia (abnormal physical weakness or lack of energy), Malaise (a general feeling of discomfort, illness, or unease whose exact cause is difficult to identify), tiredness, Face swelling, Chest pain, fever, Pain

Side effects detectable through laboratory tests

• Aspartate aminotransferase increased, Alanine aminotransferase increased, blood bilirubin increased, blood urea increased,
• Blood creatinine increased, blood potassium abnormal, blood alkaline phosphatase increased
• Chloride increased, glucose increased, platelets increased, Haematocrit decreased, Bicarbonate increased, abnormal sodium.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get 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 via https://www.sahpra.org.za/documents/86422f1b6.04_ARF1_Jul16_v4.pdf. By reporting side effects, you can help provide more information on the safety of this medicine.

For dry powder: Store at or below 25 °C

For reconstitution suspension: The reconstitution suspension should be stored at or below 25 °C and any unused suspension should be discarded after 10 days. No refrigeration required.

Keep the bottle in the carton until required for use. Keep HDPE bottles tightly close. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).