Azax 500 mg. 6 tablets

What is Azax and what is it used for?

Azax contains the drug azithromycin, which belongs to a new class of macrolide antibiotics called azalides.

Azax is an antibiotic with a broad antibacterial spectrum that works effectively against most bacterial strains. It suppresses protein synthesis in the bacterial cell wall and thus the bacteria's ability to grow and multiply.

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

Upper respiratory tract infections: bacterial pharyngitis (acute inflammation of the lining of the pharynx), tonsillitis (inflammation of the tonsils), sinusitis (inflammation of the sinuses), and inflammation of the middle ear

Lower respiratory tract infections: inflammation of the bronchi and lungs

Skin and soft tissue infections: erythema chronica migrans (first stage of Lyme disease - infection after a bite from an infected tick), erysipelas (red wind - an acute infectious disease of the skin that is caused by a streptococcal infection), impetigo (an acute infectious disease of the skin, proceeding with blisters, which later become crusted) and secondary pyoderma (a bacterial infection of the skin, most often caused by staphylococci or streptococci, with suppuration as the main symptom), 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.

2. What you need to know before you take Azax

Do not take Azax?

if you are allergic (hypersensitive) to azithromycin, erythromycin or other macrolide antibiotics, or to any of the other ingredients of Azax. An allergic reaction can be recognized by the presence of: rash, itching, reddening of the skin or difficulty breathing.

if you are using medicinal products containing ergotamine derivatives, due to the theoretical possibility of the occurrence of ergotism (dizziness, nervous disorder, impaired blood circulation, which leads to bruising of the extremities).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azax:

if you have impaired liver function

if you have severe kidney failure, as special care is needed.

Children and adolescents

For children with a body weight of less than 45 kg, suspension treatment is recommended.

Elderly patients

No dosage adjustment is necessary in elderly patients with normal renal and hepatic function receiving azithromycin at recommended dosages.

Other medicines and Azax

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

An interaction has been established with the simultaneous use of macrolide antibiotics (especially azithromycin) and the following medicinal products:

Antacid medicinal products (for increased acidity of the stomach). An interval of at least 2 hours is recommended between administration of azithromycin and any antacid

Warfarin or oral coumarin anticoagulants (to prevent blood clotting) - increased bleeding tendency has been observed

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

Digoxin (for arrhythmias and heart failure)

Rifabutin (antibiotic)

Nelfinavir (antiviral medicinal product - in patients with HIV)

Terfenadine (for allergy treatment)

Do not take ergoalkaloids (ergotamine or dihydroergotamine) and azithromycin at the same time, due to the theoretical possibility of ergotism.

Macrolide antibiotics are known to interact with astemizole, triazolam, midazolam, or alfentanil. Although there is no data on the interaction between azithromycin and these medicinal products, careful monitoring of the patient is recommended when co-administered.

There are no significant interactions with simultaneous use of azithromycin and methylprednisolone, carbamazepine, didanosine, zidovudine.

There are no reports of an interaction between azithromycin and theophylline, cimetidine.

Azax with food, drink and alcohol

Azax should be taken at least 1 hour before or 2 hours after a meal.

Azax film-coated tablets should be swallowed whole.

Pregnancy, lactation and fertility

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Azax should not be used during pregnancy unless clearly necessary.

Breastfeeding

During breastfeeding, Azax should be used only when the benefit to the mother is judged to be greater than the potential risk to the fetus.

More about AZAX

Breastfeeding

During breastfeeding, Azax should be used only when the benefit to the mother is judged to be greater than the potential risk to the fetus.

Driving and using machines

There is no evidence that Azax affects the ability to drive and use machines.

Azax contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicinal product.

3. How to take Azax?

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Azax is administered orally once daily.

Azax should be taken at least 1 hour before or 2 hours after a meal.

Azax film-coated tablets should be swallowed whole.

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

Indications

Recommended dose

Duration of treatment

Upper and lower respiratory tract and skin and soft tissue infections (except erythema migrans and aspe vulgaris) 1 tablet Azax (500 mg azithromycin) (single daily dose) for 3 days

Erythema migrans 2 tablets Azax (1 g azithromycin) at a time on the first day, followed by 1 tablet Azax (500 mg azithromycin) from the second to the fifth day as a single daily dose

Acne vulgaris 1 tablet Azax (500 mg azithromycin as a single daily dose) for 3 days Then 500 mg once a week to a total dose of 6 g (for 9 weeks) The second week's dose should be taken 7 days after the first tablet . The following 8 weeks should be taken one tablet per week (at equal 7-day intervals.

Sexually Transmitted Diseases 2 Azax tablets (1 g azithromycin) once daily dose

Children and adolescents

For children with a body weight of less than 45 kg, suspension treatment is recommended.

No dose adjustment is required in the elderly.

No change in the dosage of azithromycin is required for mild renal insufficiency. In patients with severe renal failure and impaired liver function, azithromycin should be administered with particular caution.

If you take more Azax than you should

If you have taken more than the required dose of Azax, immediately visit the nearest medical facility, taking the medicine or its packaging with you, or contact your doctor.

Typical symptoms of macrolide antibiotic overdose may include reversible hearing loss, severe nausea, vomiting, and diarrhea.

Do not exceed the recommended dose and duration of treatment.

If you forget to take Azax

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

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

If you have stopped taking Azax

Do not stop treatment before you have completed the full course of treatment, even if you feel better. You may not have fully recovered and some of the symptoms may recur.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

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

Adverse drug reactions are most often mild and short-lived and pass after stopping the drug.

In this leaflet, when side effects are described as 'common', this means that they are reported in more than 1 in 100 patients but less than 1 in 10 patients.

When side effects are 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 are described as 'rare', this means that they are reported in more than 1 in 10,000 patients, but less often than 1 in 1,000 patients.

When side effects are described as 'very rare', this means that they have been reported in less than 1 in 10,000 patients, including individual cases of unknown frequency.

Disorders of the blood and lymphatic system

Rare: Thrombocytopenia (decrease in the number of platelets in the blood, which can increase the tendency to bleed and bruise), mild and transient neutropenia (decrease the number of white blood cells), but a causal relationship with azithromycin has not been confirmed.

Mental disorders

Rare: Aggressiveness, restlessness, anxiety and nervousness Nervous system disorders

Uncommon: Dizziness/vertigo, somnolence, headache, convulsions (found after use of other macrolides), altered taste, syncope (temporary loss of consciousness followed by spontaneous recovery)

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

Disorders of the ear and labyrinth

Rare: Macrolides have been found to cause hearing impairment. Hearing disorders, deafness,

Heart disorders

Rare: Palpitations and arrhythmia, including ventricular tachycardia (palpitations), also seen after use with other macrolides

Vascular disorders

Rare: Hypotension (blood pressure lower than normal)

Gastrointestinal disorders

Common: Nausea, vomiting, diarrhea, stomach discomfort (pain, cramps)

Uncommon: Loose stools, flatulence, indigestion, anorexia,

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

Hepato-biliary disorders:

Rare: Hepatitis and cholestatic jaundice, including elevation of liver enzymes, rarely liver necrosis and fatal liver failure

Disorders of the skin and subcutaneous tissue

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

Disorders of the musculoskeletal system and connective tissue

Uncommon: Arthralgia (joint pain)

Kidney and urinary tract disorders

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

Disorders of the reproductive system and the breast

Uncommon: Vaginitis (inflammation of the vagina)

General disorders and administration site conditions

Rare: Anaphylactic reactions including edema (rarely fatal), candidiasis (fungal infections), fatigue, malaise

5. How to store Azax?

Keep out of the reach of children.

To be stored in the original packaging.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What does Azax contain?

The active substance is: azithromycin. Each film-coated tablet contains azithromycin dihydrate equivalent to 500 mg of azithromycin.

The other ingredients are:

Tablet core: pregelatinized starch, hydroxypropylcellulose, sodium lauryl sulfate, croscarmellose sodium, calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, anhydrous lactose, magnesium stearate

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

What does Azax look like and what does it contain?

Package sizes:

3 film-coated tablets (one blister)

5 film-coated tablets (one blister)

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