AZAKS table. 500 mg. 3 tablets

AZAKS WHAT IS AND WHAT IT IS USED

AZAKS contains the active ingredient azithromycin, which belongs to a new class of macrolide antibiotics, called azalidi. AZAKS antibiotic with a broad antibacterial spectrum, which is effective against most strains. It inhibits protein synthesis in bacteria and thus their ability to grow and multiply.

AZAKS is indicated for the treatment of patients with infections caused by microorganisms susceptible to azithromycin: Gram-positive and Gram-negative cocci and aerobic bacteria, anaerobic microorganisms, intracellular and clinically atypical microorganisms:

Infections of the upper respiratory tract bacterial pharyngitis (acute inflammation of the eaters), tonsillitis (tonsillitis), sinusitis (inflammation of the paranasal sinuses (sinuses) and otitis media

Infections of the lower respiratory tract inflammation of the bronchi and lungs

Infections of skin and soft tissue infections: erythema chronicum migrans (first Lyme disease - infection by the bite of an infected tick), erysipelas (erysipelas - an acute infectious disease of the skin that is caused by streptococcal infection), impetigo (an acute infectious disease skin occurring with bubbles, which later covered with a crust) and secondary pyoderma (bacterial skin infection most commonly caused by staphylococci or streptococci, the main symptom suppuration), acne vulgaris

Sexually transmitted diseases: uncomplicated urethritis (inflammation of the urethra caused by microorganisms, manifested by itching, burning, pain during urination), cervicitis (inflammation of the mucous membrane of the cervix) caused by Chlamidia trachomatis, Ureaplasma urealyticum, and Neisseria gonorrhoeae.

BEFORE YOU TAKE AZAKS

Do not take AZAKS

 If you are allergic (hypersensitive) to azithromycin, erythromycin or any other macrolide antibiotics, or any of the other ingredients of AZAKS. An allergic reaction may be recognized by the presence of: rash, itching, redness of skin and difficulty breathing.

 If you are taking medicines containing ergot derivatives because of the theoretical possibility of ergotism (dizziness, nervous disorder, impaired circulation, causing bruising of the limbs).

Take special care with AZAKS

 Before treatment AZAKS tell your doctor if you have:

liver dysfunction

severe renal insufficiency as necessary caution.

Use in children and adolescents

For children weighing less than 45kg recommended treatment suspension.

Use in elderly patients

No alteration of dosage in elderly patients with normal renal and hepatic function receiving the recommended doses of azithromycin.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is an interaction with concomitant administration of macrolide antibiotics (azithromycin in particular) and the following drugs:

Antacids (for gastric acidity). It is recommended that an interval of at least 2 hours between administration of azithromycin and some antacid

Warfarin, or oral anticoagulants (to prevent blood clotting) - An increased tendency to haemorrhage

Cyclosporine (in transplant patients to suppress the immune system and prevent rejection of organ transplants)

Digoxin (for arrhythmias and heart failure)

Rifabutin (antibiotics)

Nelfinavir (an antiviral medicine - in patients with HIV)

Terfenadine (for allergies)

Do not take both ergot alkaloids (ergotamine and dihydroergotamine) and azithromycin because of the theoretical possibility of ergotism.

It is known that macrolide antibiotics interact with astemizole, triazolam, midazolam. Although there is no evidence of an interaction between azithromycin and these drugs when co-administration is recommended careful control over the patient.

No significant interactions with concomitant azithromycin and methylprednisolone, carbamazepine, didanosine, zidovudine.

There are no reported interactions between azithromycin and theophylline, cimetidine.

Taking AZAKS with food and drink

AZAKS should be taken at least 1 hour before or 2 hours after meals. AZAKS tablets should be swallowed whole.

Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine.

Before taking AZAKS is important to tell your doctor if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed.

AZAX should not be used during pregnancy unless clearly necessary.

During lactation AZAKS should be used only when the benefit to the mother is judged to be greater than the potential risk to the fetus.

Driving and operating machinery

No data AZAKS your ability to drive or operate machinery.

Important information about some of the ingredients of AZAKS

AZAKS contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

 HOW TO TAKE AZAKS

Always AZAKS exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.

AZAX be administered once daily by mouth.

AZAX should be taken at least 1 hour before or 2 hours after meals. AZAX tablets should be swallowed whole.

Adults and adolescents over 16 years of age (over 45 kg)

Witness

Recommended dose / duration of treatment

Upper and lower respiratory tract and skin and soft tissue (excluding erythema migrans and acne vulgaris)

1 tablet AZAX (500 mg azithromycin) (single dose) for 3 days

Erythema migrans

2 tablets AZAX (azithromycin 1 g) once the first day, followed by 1 tablet AZAX (500 mg Azithromycin) from the second to the fifth day once daily dosing

Acne vulgaris

1 tablet AZAX (500 mg azithromycin as a single dose) for 3 days

Then 500 mg once a week to a total dose of 6 g (for 9 weeks)

The dose for the second week should be taken seven days after the first dose. The next eight weeks should be taken as one tablet once a week (at regular 7-day intervals).

Diseases STDs

2 tablets Azax (azithromycin 1 g) once daily dose

For children weighing less than 45kg recommended treatment with azithromycin suspension.

No changes in dose for the elderly.

In mild renal impairment do not require dosage adjustment of azithromycin.

In patients with severe renal impairment or hepatic dysfunction azithromycin should be used with caution.

If you take more than the dose AZAKS

If you take more than the dose AZAKS immediately go to the nearest hospital and taking medicine or packaging with you or call your doctor.

Typical symptoms of overdose with macrolide antibiotics can include reversible hearing loss, severe nausea, vomiting and diarrhea.

Do not exceed the recommended dose and duration of treatment.

If you forget to take AZAKS

If you forget to take a tablet, take it as soon as you remember. Take your next dose after 24 hours. Further follow your prescribed treatment.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking AZAKS

Do not stop treatment before they have completed the full course of treatment even if you feel better. You may not have healed completely and some of the symptoms to recur.

If you have any further questions on the use of this product, ask

Your doctor or pharmacist.

 POSSIBLE SIDE EFFECTS

Like all medicines, AZAKS can cause side effects, although not everybody gets them.

Adverse events were mostly mild and transient and resolved after discontinuation of the drug.

In this leaflet, when a side effect is described as "common", this means that they have been reported in more than 1 in every 100 patients but less than 1 in 10 patients.

When side effects were described as "uncommon", this means that they have been reported in more than 1 in 1,000 patients but less than 1 in 100 patients.

When side effects were described as "rare", this means that they have been reported in more than 1 in 10,000 patients, but less than 1 in 1000 patients.

When side effects were described as "very rare", this means that they have been reported in less than 1 in 10,000 patients, including some cases not known.

Blood and lymphatic system

Rare: Thrombocytopenia (decreased number of platelets in the blood, which may increase susceptibility to bleeding and bruising), mild and transient neutropenia (decrease in white blood cells), but not confirmed a causal relationship with azithromycin

Psychiatric Disorders

Rare: Aggression, agitation, anxiety and nervousness

Nervous System

Uncommon: Dizziness / vertigo, drowsiness, headache, convulsions (established after the use of other macrolides), taste perversion, syncope (temporary loss of consciousness followed by spontaneous recovery)

Rare: Paraesthesia (numbness or tingling) and asthenia (weakness, weakness), insomnia and hyperactivity

Ear and labyrinth disorders

Rare: It was found that macrolides cause hearing damage. Some patients reported hearing impairment, deafness, tinnitus azithromycin in high doses and for prolonged periods of time. Most of these disorders are transient.

Cardiac disorders

Rare: Palpitations and arrhythmias including ventricular tachycardia (rapid heart beat) observed after use of other macrolides

Vascular Disorders

Rare: Hypotension (blood pressure lower than normal)

Gastrointestinal Disorders

Common: Nausea, vomiting, diarrhea, abdominal discomfort (pain, cramping)

Uncommon: Loose stools, flatulence, indigestion, anorexia,

Rare: Constipation, discoloration of tongue, pancreatitis (inflammation of the pancreas, leading to pain, nausea, vomiting, diarrhea), pseudomembranous colitis (severe diarrhea and severe abdominal cramps)

Hepatobiliary disorders:

Rare: Hepatitis and cholestatic jaundice, including increased liver enzymes, rarely hepatic necrosis and hepatic failure with fatal

Skin and subcutaneous tissue disorders

Uncommon: Allergic reactions including pruritus (itching) and rash

Rare: Allergic reactions, including angioedema (swelling of the face, extremities, lips, tongue and / or throat), urticaria (hives), photosensitivity (skin reaction when exposed to light), serious skin reactions such as erythema multiforme, Syndrome Stevens-Johnson syndrome and toxic epidermal necrolysis (blistering of the skin, mouth, eyes and genitals, skin peeling)

Disorders of the musculoskeletal system and connective tissue

Uncommon: arthralgia (joint pain)

Renal and urinary disorders

Rare: Interstitial nephritis (kidney inflammation) and acute renal failure

Reproductive system and breast disorders

Uncommon: vaginitis (inflammation of the vagina)

General disorders and administration site conditions

Rare: Anaphylactic reactions, including swelling (occasionally fatal), candidiasis (yeast infections), fatigue, malaise

If any of the side effects gets serious, or you notice other effects not listed in

this leaflet, please tell your doctor or pharmacist.

 HOW TO STORE AZAKS

Keep out of reach of children.

Store in original container.

AZAKS Do not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.

 ADDITIONAL INFORMATION

What AZAKS

 The active substance is azithromycin. Each tablet contains azithromycin dihydrate equivalent to 500 mg azithromycin.

The other ingredients are:

Core: pregelatinized starch, hydroxypropyl cellulose, sodium lauryl sulfate, sodium croscarmellose, calcium hydrogen phosphate dihydrate, silica colloidal anhydrous, lactose anhydrous, magnesium stearate

Film coating: hypromellose, microcrystalline cellulose, titanium dioxide (E171), macrogol stearate

AZAKS looks like and contents of pack

One blister contains 3 pieces tablets.

Pack sizes: 3 pcs tablets.

Oval, white, film-coated tablets, scored on one side