Macroflud 200mg/5ml 15ml suspension

Form

fkhvnili suspenziistvis

Dosage mg

200მგ/5

Pack

1

MACROFLUID 200mg/5ml powder for oral suspension preparation before taking the medicine, read the instructions carefully as it contains important information for you Keep the 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. Do not give it to others. It may harm them, even if their symptoms are the same as yours. In case of any side effects, or if you notice any side effects not described here, please contact your doctor. See section 4. Contents: 1) What MACROFLUID is and what it is used for 2) What you need to know before taking MACROFLUID 3) How to take MACROFLUID 4) Possible side effects 5) How to store MACROFLUID 6) What MACROFLUID contains and further information What MACROFLUID is and what it is used for Azithromycin belongs to the group of antibiotics called macrolides. Antibiotics are used to treat bacterial infections and are not used to treat viral diseases such as flu. It is important to follow the dose prescribed by your doctor, the interval between doses, and the duration of treatment. Do not store or reuse this medicine. After completing the treatment, return any remaining antibiotic to the pharmacist for proper disposal. Do not discard in the sewage system or with household waste. It is used to treat bacterial infections caused by microorganisms. These infections include: Exacerbations of chronic bronchitis and pneumonia (mild to moderate). Infections of the paranasal sinuses, throat, tonsils, or ear. Mild to moderate skin and soft tissue infections, such as infections of the hair follicles (folliculitis), bacterial infections of the skin and its deeper layers (cellulitis), superficial bacterial skin infection with swelling (erysipelas). Infections caused by the bacterium Chlamydia trachomatis, which can cause inflammation of the urethra and cervix. What you need to know before taking MACROFLUID Do not take MACROFLUID: If you are allergic to azithromycin, or any of the other ingredients of this medicine (listed in section 6) or to other macrolide or ketolide antibiotics, such as erythromycin or telithromycin. Warnings and precautions before taking MACROFLUID Tell your doctor or pharmacist if: you have had a serious allergic reaction with swelling of the face and throat and respiratory problems; you have liver problems. Your doctor may need to monitor your liver function or stop treatment. you are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Taking MACROFLUID with other medicines"); you have kidney problems. Your doctor may need to adjust the dose. if you have a prolonged QT interval (heart disease): azithromycin is not recommended; you have a slow or irregular pulse or reduced heart function: azithromycin is not recommended. you have low levels of potassium or magnesium in your blood: azithromycin is not recommended. you are taking antiarrhythmic drugs (used to treat heart rhythm disorders), cisapride (a stomach medicine) or terfenadine (an antihistamine for allergies): azithromycin is not recommended. you have a neurological disease (disease of the brain or nervous system). you have mental, emotional, or behavioral problems. you have myasthenia gravis, characterized by muscle weakness and fatigue, as azithromycin may worsen or cause a recurrence of the symptoms of this disease. If you develop severe and persistent diarrhea during or after treatment, especially with bloody and/or mucous stools, consult your doctor immediately. Tell your doctor if your symptoms persist after completing treatment with azithromycin or if you notice any new, persistent symptoms. Children and adolescents This medicine is not used in children under 6 months of age. There is insufficient information for the treatment of sinusitis in children under 16 years of age. (See section 3). Taking MACROFLUID with other medicines Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines. Antacids, for example, aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking the antacid. Ergotamine derivatives, such as ergotamine (used to treat migraines): may cause ergotism (numbness or tingling in the extremities, cramps, headache, abdominal or chest pain). Coumarin derivatives, such as warfarin (blood thinner): may increase the risk of bleeding. Digoxin (used to treat heart failure): may increase digoxin levels in the blood. Zidovudine, nelfinavir (used to treat HIV): may increase zidovudine or azithromycin levels. Rifabutin (used to treat HIV and bacterial infections, including tuberculosis): may cause a decrease in white blood cells. Cyclosporine (immunosuppressant used after organ transplantation): may increase cyclosporine levels. Your doctor will need to monitor cyclosporine levels in your blood. Cisapride (used to treat stomach disorders): may cause heart problems. Astemizole, terfenadine (antihistamines used to treat allergic reactions): may increase their effect. Alfentanil (sedative): the effect of alfentanil may be increased. Fluconazole (used to treat fungal infections): azithromycin levels may be reduced. No interactions have been observed between azithromycin and the following agents: Cetirizine (antihistamine); Didanosine, efavirenz, indinavir (for HIV infection); Atorvastatin (for cholesterol and heart disease); Carbamazepine (for epilepsy), Cimetidine (antacid); Methylprednisolone (immunosuppressant); Midazolam, triazolam (sedative); Sildenafil (for impotence); Theophylline (for asthma); and Trimethoprim/sulfamethoxazole (combination antibiotic treatment). Taking MACROFLUID with food and drink The oral suspension can be taken with or without food and drink. Pregnancy, breastfeeding and fertility If you are pregnant or suspect you may be pregnant, or are planning to become pregnant, ask your doctor for advice before taking this medicine. There is insufficient information on the use of azithromycin during pregnancy; therefore, azithromycin is not recommended if you are pregnant or planning to become pregnant. However, your doctor may prescribe it if necessary. Breastfeeding is not recommended during treatment with MACROFLUID, as it may cause side effects such as diarrhea and fetal infection. You can resume breastfeeding two days after completing treatment with MACROFLUID. Driving or operating machinery There is no evidence that MACROFLUID affects the ability to drive or operate machinery. MACROFLUID contains sucrose and glucose This medicine contains sucrose and glucose. If you have been told by your doctor that you have an intolerance to sugar, consult your doctor before taking this medicine. Patients with diabetes mellitus should note that 5ml of this medicine contains 3.879g of sucrose. How to take MACROFLUID Always take this medicine exactly as your doctor or pharmacist has told you. If you are in doubt, ask your doctor or pharmacist. This medicine is for oral use. A dosing syringe is provided with each bottle to facilitate administration. This medicine is not used in children under 6 months of age. See Children and adolescents. Dosage Azithromycin suspension is taken once daily as a single oral dose with or without food. Shake the bottle before taking the suspension. Dosage: Children and adolescents weighing over 45 kg, adults and the elderly The total dose of azithromycin is 37.5 ml (1,500 mg) over 3 days (12.5 ml [500 mg] once daily). Alternatively, the dose can be taken over 5 days (12.5 ml) as a single dose of 500 mg on the first day, followed by 6.25 ml (250 mg) once daily. For urethritis or cervicitis caused by Chlamydia, the dose is 25 ml (1,000 mg) as a single dose. Sinusitis treatment is indicated only in adults and adolescents over 16 years of age. For patients weighing over 45 kg, other more appropriate packaging is available. For children and adolescents weighing less than 45 kg, follow the dosage regimen when treating with azithromycin suspension, using the dosing syringe also provided in the box, according to the child's weight, as per the following table: Weight 3-day treatment 5-day treatment 10-15 kg 0.25 ml/kg (10 mg/kg) once daily, for 1-3 days 0.25 ml/kg (10 mg/kg) as a single dose on the first day, then 0.125 ml (5 mg/kg) once daily, for days 2-5 16-25 kg 5 ml (200 mg) once daily, for 1-3 days 5 ml (200 mg) as a single dose on the first day, then 2.5 ml (100 mg) once daily, for days 2-5 26-35 kg 7.5 ml (300 mg) once daily, for 1-3 days 7.5 ml (300 mg) as a single dose on the first day, then 3.75 ml (150 mg) once daily, for days 2-5 35-45 kg 10 ml (400 mg) once daily, for 1-3 days 10 ml (400 mg) as a single dose on the first day, then 5 ml (200 mg) once daily, for days 2-5 > 45 kg: Same dose as for adults For children over 2 years of age for the treatment of tonsillitis/pharyngitis: The recommended dose of azithromycin is a single dose of 10 mg/kg or 20 mg/kg over 3 days, with a maximum daily dose not exceeding 500 mg. Sinusitis For the treatment of sinusitis, data is limited in children under 16 years of age. Patients with liver or kidney problems: Tell your doctor if you have liver or kidney problems, as the normal dose may need to be adjusted. Preparing the suspension Preparation of the suspension 1) Shake the bottle 2) Add 10 ml of water (for a 15 ml bottle) using the provided dosing syringe. 3) Close with the perforated plastic cap 4) Shake until a homogeneous suspension is obtained. 5) The level of the suspension should reach the fill line. Each 5 ml of reconstituted suspension contains 200 mg of azithromycin. The diluted oral suspension can be stored at room temperature for 10 days. The powder for suspension may exceed the mark on the bottle due to the specific density of the preparation. Administering the dose 1) Remove the cap and insert the dosing syringe into the bottle. 2) Invert the bottle and draw up the dose prescribed by your doctor. 3) Take directly from the dosing syringe 4) Replace the cap on the bottle 5) Wash the dosing syringe after each use. The dosing syringe is also graduated so that the dose can be administered according to the child's weight. Use the syringe immediately after preparation. Warning: Administer slowly to children and ensure that the child swallows. This will reduce the risk of spitting out. Overdose: If you accidentally take more azithromycin than prescribed, contact your doctor or pharmacist immediately. Symptoms of overdose may include: temporary hearing loss, severe nausea, vomiting, and diarrhea. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately. Or call the Spanish Poison Control Center at: +34 91 562 04 20. Missed dose: Do not take a double dose to compensate for a missed dose. Stopping MACROFLUID Do not stop treatment with MACROFLUID without consulting your doctor, even if you feel better. It is important to complete the course prescribed by your doctor. Otherwise, the infection may return. If you have any further questions regarding this product, ask your doctor or pharmacist. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. If any of the following side effects occur, stop taking it immediately and consult your doctor. Allergic reaction (swelling of the lips, face or throat causing difficulty breathing, rash). Stevens-Johnson syndrome, erythema multiforme or toxic epidermal necrolysis, which are serious conditions. Irregular heartbeat Bloody and mucous prolonged diarrhea These side effects are serious but rare. You may need urgent medical attention or hospitalization. The following side effects also occur: Very common (affects more than 1 in 10 patients): Diarrhea Common (affects 1 in 10 patients): Changes in certain types of white blood cells and blood bicarbonate Headache Vomiting, stomach pain, nausea Uncommon (affects 1 in 100 patients): Fungal infection, such as in the mouth (oral candidiasis), vaginal infection, pneumonia, bacterial infection Sore throat, gastrointestinal inflammation Shortness of breath, chest pain, wheezing and cough (breathing difficulties), nasal congestion Blood disorders characterized by fever or swelling, sore throat, mouth ulcers. Allergic reactions Loss of appetite Neurosis Dizziness, drowsiness, decreased taste sensation, tingling or numbness Visual disturbances Hearing problems Vertigo Rapid heart rate or noticeable palpitations. Hot flashes Difficulty breathing Nosebleeds Stomach inflammation, constipation, difficulty swallowing, swelling, dry mouth Itching, mouth ulcers, increased salivation, frequent loose stools Hepatitis (inflammation of the liver) Rash, itching, hives Skin inflammation, dry skin, excessive sweating Joint inflammation, muscle pain, back pain, neck pain Difficulty urinating Vaginal inflammation, irregular menstrual bleeding, testicular disorders Chest pain, swelling, malaise, weakness, fatigue, facial swelling, fever, pain Changes in liver enzymes and blood laboratory values. Rare (affects 1 in 1,000 patients): Anxiety Depersonalization Confusion, especially in elderly patients Change in tooth color Liver dysfunction, jaundice Allergic reactions, including angioneurotic edema Redness and blisters on the skin when exposed to sunlight Unknown (frequency cannot be established from the available data): Blood disorders characterized by unusual bleeding or bruising, reduction in blood cell counts, leading to weakness or fatigue. Aggression, anxiety, confusion, hallucinations Feeling of fainting, seizures, reduced sensitivity, hyperactivity, decreased or lost sense of smell, decreased or lost sense of taste, myasthenia gravis (muscle weakness and fatigue; see "Warnings and precautions") Hearing impairment, including deafness and/or ringing in the ears Changes in heart rhythm, heart rhythm changes detected on an electrocardiogram (prolonged QT interval and ventricular fibrillation/flutter (torsade de pointes)) Low blood pressure (associated with weakness, feeling of fainting) Change in tongue color, inflammation of the pancreas, causing nausea, vomiting, abdominal pain, back pain. Liver failure (rarely fatal) Rash with spots and blisters Kidney problems Severe intestinal inflammation (pseudomembranous colitis) Serious allergic reaction that can cause shock (anaphylactic reaction) The following side effects are observed in patients treated with azithromycin to prevent MAC (Mycobacterium avium complex) infections: Very common (affects more than 1 in 10 patients): Diarrhea Abdominal pain Nausea Gas accumulation (flatulence) Abdominal bloating and discomfort Frequent loose stools Common (affects 1 in 10 patients): Loss of appetite (anorexia) Dizziness Headache Tingling or numbness (paresthesia) Taste disturbance (dysgeusia) Visual disturbances Deafness Rash Itching Joint pain (arthralgia) Fatigue Uncommon (affects 1 in 100 patients): Decreased sensitivity (hypoesthesia) Hearing loss or ringing in the ears Abnormal heart rhythm or palpitations Liver problems, such as hepatitis Stevens-Johnson syndrome Skin allergic reactions, such as sensitivity to sunlight and red, greasy, and inflamed skin Weakness (asthenia) General weakness Reporting of side effects If you notice any side effects, including any possible side effects not listed in the instructions for use, tell your doctor or pharmacist. By reporting side effects, you can help provide more information about the safety of this medicine. How to store MACROFLUID Sealed bottle: This medicine does not require special storage conditions. Store in the original packaging. Diluted solution: 10 days. Note the day and month of preparation of the solution. Do not take the medicine after 10 days from dilution. Keep out of reach of children Do not use MACROFLUID after the expiry date indicated on the packaging. The expiry date applies to the last day of that month. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist about disposal. These measures will help protect the environment. What MACROFLUID contains and further information What MACROFLUID 200mg/5ml powder for oral suspension contains. The active substance is azithromycin (as dihydrate). Each 5 ml of diluted solution contains 200 mg of azithromycin (as dihydrate). Each ml of diluted solution contains 40 mg of azithromycin (as dihydrate). Other ingredients are: sucrose, sodium phosphate anhydrous, hydroxypropyl cellulose, xanthan gum, banana flavor (contains glucose and corn starch), strawberry flavor (contains glucose and corn starch). Appearance and contents of the pack: This medicine is a white to off-white powder for oral suspension with a strawberry-banana flavor. It is packaged in a Type III glass bottle, sealed with a polyethylene cap. Each cardboard box contains a 15 ml bottle. A polypropylene/polyethylene dosing syringe with a polyethylene cap is included in the packaging. Dispensing regime: Pharmaceutical product group - II, dispensed with prescription form №3