250 mg film-coated tablets 
azithromycin

1. What Azithromycin Mylan is and what it is used for

Azithromycin Mylan belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria. This medicine is usually prescribed to treat:

  • infection of the trachea and lungs such as bronchitis and pneumonia
  • infection is in the sinuses, pharynx, tonsils, or ears
  • mild or moderate inflammation in the skin and soft tissues, e.g. hair follicle inflammation ( folliculitis ), bacterial infections of the skin or underlying skin tissue ( cellulite ), rose fever (swollen glossy red skin)
  • chlamydia infections can cause inflammation of the urinary tract and cervix.

Azithromycin contained in Azithromycin Mylan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Azithromycin Mylan

Do not use Azithromycin Mylan:

  • if you are allergic to azithromycin, other antibiotics of macrolides (such as erythromycin or clarithromycin) or ketolides, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include skin rash or wheezing.

Warnings and cautions

If you are taking Azithromycin Mylan, talk to your doctor or pharmacist

  • have previously suffered from severe allergic reactions with swelling of the face and throat and perhaps also difficulty breathing, rash, swollen glands, or an increase in eosinophils (a kind of white blood cell )
  • have kidney problems. Your doctor may need to change dose one.
  • have liver problems: Your doctor may need to check your liver values ​​or stop treatment
  • has myasthenia gravis (local muscle weakness)
  • have neurological disease (disease of the brain or nervous system)
  • have mental, emotional, or behavioral problems
  • use medicines called ergot alkaloids (such as ergotamine ) used to treat migraines: azithromycin is not recommended (see ‘Other medicines and Azithromycin Mylan’ below)

As azithromycin may increase the risk of abnormal heart rhythm, talk to your doctor if you have any of the following problems before taking this medicine (especially if you are a woman or elderly):

  • a heart problem that appears on an electrocardiogram or an ECG machine and is called “long QT syndrome” (prolongation of the QT interval ). Treatment with azithromycin is not recommended.
  • heart problems, such as slow or irregular heartbeat or weak heart ( heart failure ). Treatment with azithromycin is not recommended.
  • low levels of potassium or magnesium in the blood. Treatment with azithromycin is not recommended.
  • if you are taking medicines belonging to the group of antiarrhythmics (such as quinidine, procainamide, dofetilide, amiodarone, sotalol) used to treat irregular heartbeat, cisapride (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies ), or antipsychotic drugs (such as pimozide), antidepressants (such as citalopram ), certain antibiotics (such as monofloxacin and levofloxacin) that may affect the heart rhythm: Treatment with azithromycin is not recommended (see ‘Other drugs and Azithromycin Mylan’ below).

If you develop severe diarrhea that lasts for a long time during or after your treatment with azithromycin, you should contact a doctor immediately. This is especially true if your stool contains blood or mucus.

Contact a doctor if your symptoms persist or if you notice new persistent symptoms after treatment.

Other medicines and Azithromycin Mylan

If you are taking any of the medicines listed below, tell your doctor before taking Azithromycin Mylan:

  • Warfarin or other similar medicines used to prevent blood clots; concomitant use may increase the risk of bleeding.
  • Ergotamine, dihydroergotamine (used to treat migraines ): ergotism (ie itching of the arms and legs, muscle cramps, and cold sores (gangrene) in the hands and feet caused by poor blood circulation) can occur. Concomitant use is therefore not recommended.
  • Ciclosporin (used to inhibit the immune system to prevent and treat rejection of a transplanted organ or bone marrow ): if concomitant use is required, your doctor will check your blood counts regularly and possibly adjust your dose.
  • Digoxin (used for heart failure ): Digoxin levels may increase. Your doctor will check your blood levels.
  • Colchicine (used for gout and familial Mediterranean fever).
  • Antacids (for indigestion ): Azithromycin should be taken at least 1 hour before or 2 hours after antacids.
  • Cisapride (for stomach problems ), terfenadine (used to treat hay fever ): concomitant use with azithromycin may cause heart problems.
  • Drugs for irregular heartbeat (so-called antiarrhythmics ) or to lower cholesterol(so-called statins ) such as atorvastatin.
  • Alfentanil (used in anesthesia ) or astemizole (used to treat hay fever ): concomitant use with azithromycin may increase the effect of these medicines.

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

Pregnancy and breastfeeding

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.

You should not use this medicine during pregnancy unless your doctor tells you to

have especially recommended it.

This medicine passes into breast milk. You should talk to your doctor before taking this medicine if you are breast-feeding

Driving and using machines

Azithromycin Mylan can cause side effects such as dizziness and cramps. Do not drive or use any tools or machines if you are affected.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Azithromycin Mylan contains soybean oil

If you are allergic to peanuts or soy, do not use this medicine (see also the section above (“Do not use Azithromycin Mylan”).

Azithromycin Mylan contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Azithromycin Mylan

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Azithromycin Mylan should be given as a single daily dose. Swallow the tablets together with 1 glass of water. You can take them with or without food.

The recommended dose is:

Adults (including elderly patients), children or adolescents weighing more than 45 kg:

The recommended dose is 1500 mg over 3 or 5 days as follows:

  • 3-day regimen: 500 mg once daily
  • 5-day regimen: 500 mg as a single dose on day 1 and then 250 mg once daily during day 2 to day 5.
  • Inflammation of the urinary tract and cervix caused by chlamydia infections: 1000 mg as a single dose, one day.

In case of infection in the sinuses, treatment is indicated for adults and adolescents from the age of 16.

Children and adolescents weighing 45 kg and less:

Tablets are not recommended for these patients. Other preparations with azithromycin (eg suspension ) may be used.

Patients with kidney or liver problems:

Tell your doctor that you have kidney or liver problems. Your doctor may need to change your dose.

Excessive medication can cause temporary deafness, severe nausea, vomiting, and diarrhea.

Take this information and pack of remaining tablets to a doctor or hospital to show what you have taken.

If you forget to take Azithromycin Mylan

If you forget to take a tablet, take it as soon as you remember unless it is time for the next dose. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Azithromycin Mylan

Do not stop taking the tablets without first talking to your doctor, even if you feel better. It is very important to continue taking Azithromycin Mylan according to your doctor’s instructions, otherwise the infection may return.

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

4. Possible side effects

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

If you get any of the following symptoms, stop your treatment and contact your doctor immediately or go to the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

  • A severe skin reaction that causes blisters/bleeding on lips, eyes. nose, mouth, and genitals (Steven-Johnson syndrome).
  • yellowing of the skin and whites of the eyes, fatigue, and loss of appetite, which can be caused by inflammation of the liver ( hepatitis ).

Rare (may affect up to 1 in 1,000 people)

  • yellowing of the skin and eyes (jaundice).
  • rash characterized by the rapid appearance of areas of red skin with scattered small pustules (small blisters filled with white/yellow fluid).

Very rare (may affect up to 1 in 10,000 people)

  • skin rash with other symptoms such as fever, swollen glands, and an increase in eosinophils (a kind of white blood cell ).

Has been reported (occurs in an unknown number of users)

  • allergic reaction (swelling of the lips, face, or neck with severe breathing difficulties, skin rash, or hives).
  • severely flaky skin or itchy rash with reddish rings around a lighter middle part ( toxic epidermal necrolysis, erythema multiforme).
  • abnormally fast heart rhythm called QT prolongation (delayed transmission of electrical signals that can be seen on an electrocardiogram ( ECG ), recording of the electrical activity of the heart). In some people, a potentially serious heart defect called Torsades de pointes can develop. This can result in a very fast heart rhythm that can cause a sudden loss of consciousness.
  • irregular heartbeat.
  • the feeling of weakness and shortness of breath with yellowing of the skin, which can be caused by red blood cells being destroyed and decreasing in number ( hemolytic anemia ).
  • prolonged diarrhea with blood and mucus.
  • stomach pain that extends to the back, with nausea and vomiting, which can be caused by inflammation of the pancreas ( pancreatitis ).
  • pain in the middle of the back and difficulty urinating, kidney inflammation, or impaired kidney function.
  • pain in the upper right side of the stomach with nausea and vomiting, bloated stomach, yellowing of the skin and whites of the eyes which may be due to impaired liver function (rarely life-threatening).
  • cramps.

These are very serious side effects. You may need urgent medical attention or be hospitalized.

The following side effects have been reported:

Very common (may affect more than 1 user in 10)

  • diarrhea.
  • nausea.
  • abdominal pain.
  • gas formation ( flatulence ).

Common (may affect up to 1 in 10 people)

  • headache.
  • dizziness, drowsiness ( somnolence ), taste changes, numbness, or tingling ( paresthesia ).
  • visual disturbances.
  • deafness.
  • vomiting.
  • indigestion.
  • rash.
  • itching.
  • joint pain ( arthralgia ).
  • fatigue.
  • changes in the number of white blood cells in blood samples.
  • the low value of bicarbonate in the blood.

Uncommon (may affect up to 1 in 100 people)

  • impaired feeling or feeling ( hypoesthesia ).
  • altered liver function.
  • increased sun sensitivity of the skin.
  • fungal infections of the mouth or abdomen (cod), vaginal infections, fungal infections, bacterial infections, inflammation of the throat, inflammation of the stomach and intestines, difficulty breathing, runny or stuffy nose.
  • allergic reactions of varying severity.
  • impaired appetite.
  • nervousness.
  • insomnia ( insomnia ).
  • ear disease, dizziness.
  • hearing damage including hearing loss.
  • tinnitus (ringing in the ears).
  • palpitation.
  • hot flashes.
  • often recurring infection you with fever, chills, sore throat, sores in the mouth, which can be caused by a decreased number of white blood cells in the blood.
  • severe infection of the lungs with fever, chills, shortness of breath, cough, and mucus formation ( pneumonia ).
  • general swelling.
  • nosebleeds.
  • constipation, inflammation of the gastric mucosa ( gastritis ), difficulty swallowing, bloating, dry mouth, belching, cold sores, increased amount of saliva.
  • hives, inflammation of the skin ( dermatitis ), dry skin, increased sweating.
  • pain in legs and joints, muscle aches, back pain, neck pain.
  • pain when urinating, kidney pain.
  • abnormal or unexpected vaginal bleeding,
  • problems with the testicles.
  • the general feeling of weakness, general malaise, swelling of the face, chest pain, fever, pain, swelling of the lower extremities.
  • abnormal laboratory test values ​​(eg blood or liver values).
  • complications after surgery.
  • shortness of breath.

Rare (may affect up to 1 in 1,000 people)

  • concern.
  • irritability.

No known frequency (cannot be calculated from the available data)

  • longer time for blood to clot and increased tendency to get bruises due to decreased platelet count ( thrombocytopenia ).
  • aggression, anxiety, severe confusion ( delirium ), seeing, feeling, and hearing things that do not exist (hallucinations).
  • fainting, feeling of hyperactivity, loss of sense of smell or altered sense of smell, loss of sense of taste.
  • muscle weakness or aggravated muscle weakness ( myasthenia gravis ).
  • low blood pressure.
  • discoloration of the tongue.
  • discoloration of teeth.

The following adverse reactions are reported in the prophylactic treatment of Mycobacterium avium – complex (MAC):

Very common (may affect more than 1 user in 10)

  • diarrhea.
  • abdominal pain.
  • nausea.
  • gas formation.
  • a feeling of discomfort in the abdomen.
  • loose stools.

Common (may affect up to 1 in 10 people)

  • decreased appetite.
  • drowsiness.
  • headache.
  • numbness or tingling ( paresthesia ).
  • taste disorder.
  • visual impairment.
  • deafness.
  • skin rash and/or itching.
  • joint pain.
  • fatigue.

Uncommon (may affect up to 1 in 100 people)

  • decreased sensitivity to touch or feeling ( hypoesthesia ).
  • hearing loss or ringing in the ears.
  • palpitation.
  • more sun-sensitive skin than normal.
  • general weakness.
  • general malaise.

Reporting of side effects

If you get any 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 directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Azithromycin Mylan

Keep out of sight and reach of children.

No special storage instructions.

Do not transfer the tablets to another package.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

Azithromycin Mylan 250 mg film-coated tablets: The active substance is azithromycin monohydrate equivalent to 250 mg azithromycin.

– The other ingredients are:

Tablet core: microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silica (E551), sodium lauryl sulfate, and magnesium stearate (E470b).

Tablet coating: polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E 171), talc (E553b), soy lecithin (see “Azithromycin Mylan contains soybean oil”), and xanthan gum (E 415).

What the medicine looks like and the contents of the pack

Azithromycin Mylan 250 mg film-coated tablets are white or off-white, oval, film-coated, and smooth on both sides.

Pack sizes:

250 mg tablet: Blister pack of 4, 6, 12, 24, 50 or 100 tablets.

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Mylan AB

Box 23033

104 35 Stockholm

Manufacturer:

McDermott Laboratories Limited to Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria

Sandoz SRL, Livezeni Street no 7A, 540472 Targu Mures, Romania

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1 TL, UK

Muhammad Nadeem

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