250 mg film-coated tablets 
azithromycin

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

Azithromycin is an antibiotic closely related to erythromycin and belongs to a class called macrolide antibiotics. It works by disrupting the bacteria’s production of proteins and thus prevents the bacteria from multiplying.

Azithromycin Stada is used to treat bacterial infections such as:

  • infection in the upper respiratory tract
    • sinusitis ( sinusitis )
    • inflammation of the throat ( pharyngitis )
    • inflammation of the tonsils ( tonsillitis , sore throat)
  • infection in the lower respiratory tract
    • acute bacterial respiratory infection ( acute exacerbation of chronic bronchitiscaused by a certain type of bacteria)
    • mild to moderate lung infection that did not occur during hospitalization (community- acquired pneumonia )
  • acute otitis media ( otitis media )
  • skin and soft tissue infections
  • chlamydia infection (uncomplicated inflammation of the urinary tract (urethritis) or cervicitis caused by the bacterium Chlamydia trachomatis ).

Your doctor has prescribed Azithromycin Stada for the short-term treatment of your bacterial infection. Note that there is no experience regarding the safety and efficacy of long-term treatment with azithromycin. If your infection comes back quickly or regularly, your doctor may need to prescribe you another antibiotic .

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

2. What you need to know before you use Azithromycin STADA

Do not use Azithromycin STADA

  • if you are allergic to azithromycin, other macrolide antibiotics (eg erythromycin, clarithromycin, roxithromycin), soy or peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before taking Azithromycin Stada.

Tell your doctor if you have or have had a medical problem or disease, especially if you have had any of the following:

  • Allergic reactions ( hypersensitivity reactions ): Severe allergic reactions, including angioedema and anaphylaxis , have been reported rarely. Symptoms may include reddening of the skin, hives, swelling of the lips, tongue, and throat ( angioedema ), and difficulty breathing or dizziness ( anaphylaxis ). These conditions are life-threatening and require emergency medical care. If you experience any of these symptoms, contact your doctor immediately. These reactions may recur and may therefore require medical attention for an extended period of time.
  • Superinfection: As with all antibiotics, treatment with azithromycin can give rise to a new infection caused by bacteria or fungi that are or have become resistant (resistant) to azithromycin. You should pay attention to signs of inflammation or infection and tell your doctor if they occur.
  • Clostridium difficile -associated diarrhea (CDAD): This condition has been reported with the use of almost all antibacterial agents, including azithromycin, and can vary in severity from mild diarrhea to severe inflammation of the colon (colitis ) causing e.g. abdominal pain, loss of appetite, cramps, fever.
  • bacterial infection of the colon (pseudomembranous colitis ): This condition has been reported in patients taking macrolide antibiotics. It is characterized by diarrhea, fever and abdominal pain. If you experience these symptoms, contact a doctor immediately. You should not take any medication that reduces bowel activity if you get these symptoms.
  • disorders of heart rhythm and conduction, such as irregular heartbeat ( arrhythmia or congenital or acquired ECG disorder), low heart rhythm ( bradycardia ) or severe heart disease.
  • changes in the amount of certain substances in the blood (disturbed electrolyte balance), especially low levels of potassium or magnesium .
  • infection caused by the bacterium Streptococcus Pyogenes:  Inflammation of the throat or tonsils and rheumatic fever caused by this bacterium should be treated with penicillin .
  • infection is caused by the bacterium Treponema pallidum  (eg syphilis ).
  • severe renal impairment.
  • Liver problems: your doctor may need to check your liver function or stop treatment.
  • neurological or psychiatric illness.
  • Exacerbation and onset of myasthenia gravis (muscle disease in which muscles gradually become weaker) have been reported.
  • infected burns.
  • severe infection you that require a high level of antibiotics in the blood to be achieved quickly.

Other medicines and Azithromycin STADA

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

In particular, Azithromycin Stada may interact with the following drugs:

  • ergot or ergotamine
  • warfarin or similar medicines to prevent blood clots
  • ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow )
  • antacids (used to treat heartburn and acid reflux)
  • digoxin (used to treat heart failure)
  • colchicine (used to treat gout and familial Mediterranean fever)
  • terfenadine (used to treat hay fever or skin allergy).

Azithromycin STADA with food, drink and alcohol

You can take Azithromycin Stada with food.

Pregnancy, breastfeeding and fertility

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.

Driving and using machines

Azithromycin is not expected to affect your ability to drive or use machines.

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 STADA contains sodium and soy lecithin

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

This medicine contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

How to use Azithromycin STADA

Always take Azithromycin Stada exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults and the elderly

You should take azithromycin 500 mg daily for three consecutive days (total dose1,500 mg). Alternatively, you can take the same dose (1,500 mg) over five days with 500 mg on day one and 250 mg on days two to five.

Chlamydia infection:

You should take 1000 mg of azithromycin as a single dose.

Patients with renal impairment

Tell your doctor if you have kidney problems as your doctor may need to change your dosage .

If your kidney function is mild to moderate ( GFR 10 – 80 ml / min), you can take the normal adult dose. If your kidney function is severely impaired ( GFR less than 10 ml / min), dose reduction may be necessary. Ask your doctor for advice.

Patients with hepatic impairment

Tell your doctor if you have liver problems as your doctor may need to change your dosage .

Patients with mild to moderate hepatic impairment may take normal adult doses. If you have severe liver disease, do not take azithromycin. If this condition occurs during treatment, stop taking azithromycin. Ask your doctor for advice.

Method of administration

Take your tablets as a daily dose with or without food. Swallow the tablets whole with a glass of water.

Treatment time

Do not stop taking Azithromycin Stada unless your doctor tells you to stop.

Use for children and adolescents

Children weighing over 45 kg can take the same dose of Azithromycin Stada as adults. For children weighing less than 45 kg, other medicines (eg oral suspension ) should be used.

If you forget to use Azithromycin STADA

If you miss a dose , take it as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

If you stop using Azithromycin STADA

Do not stop taking Azithromycin Stada without talking to your doctor first.

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.

The following side effects have been reported:

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

  • nausea
  • diarrhea
  • loose stools
  • upset stomach (pain and cramps)
  • bloating ( flatulence ).

Common (may affect up to 1 in 10 people):

  • loss of appetite ( anorexia )
  • dizziness
  • headache
  • numbness and tingling ( paresthesia )
  • altered sense of taste ( dysgeusia )
  • visual impairment
  • deafness
  • vomiting
  • stomach upset ( dyspepsia )
  • rash
  • itching ( pruritus )
  • joint pain ( arthralgia )
  • fatigue (exhaustion)
  • altered white blood cell count ( lymphocytes , eosinophils , basophils , monocytesand neutrophils ) and decreased bicarbonate in the blood.

Uncommon (may affect up to 1 in 100 people):

  • fungal infection of the fungus Candida ( candidiasis ) including fungal infection of the mouth
  • infection you caused by bacteria and fungi
  • inflammation of the vagina ( vaginitis )
  • inflammation of the lungs ( pneumonia )
  • sore throat ( pharyngitis )
  • inflammation of the lining of the stomach and intestines (symptoms may include nausea, vomiting, diarrhea and stomach cramps)
  • breathing difficulties ( respiratory disorder)
  • swelling and irritation of the nose ( rhinitis )
  • decreased white blood cell count ( leukopenia , neutropenia )
  • increased amount of certain white blood cells ( eosinophilia )
  • severe allergic reactions that cause swelling of the mouth, tongue and throat ( angioedema )
  • allergic reactions (hypersensitivity)
  • nervousness
  • decreased sensitivity to pain or touch ( hypesthesia )
  • drowsiness ( somnolence )
  • insomnia ( insomnia )
  • hearing loss and / or tinnitus
  • a feeling of dizziness or vertigo ( vertigo )
  • earache (earache)
  • palpitations ( palpitation )
  • inflammation of the stomach ( gastritis )
  • constipation
  • difficulty swallowing ( dysphagia )
  • bloated stomach associated with an unpleasant feeling of bloating and the presence of a rumbling sound in the stomach (distended abdomen)
  • dry mouth
  • cold sores
  • burp
  • excessive salivation (hypersalivation)
  • inflammation of the liver ( hepatitis )
  • Stevens-Johnson syndrome (a serious skin condition with rash, blisters, red spots and skin lesions)
  • increased sensitivity to sunlight ( photosensitivity )
  • hives ( urticaria )
  • eczema or inflammation of the skin ( dermatitis )
  • dry skin
  • increased sweating ( hyperhidrosis )
  • swelling of the face (facial edema)
  • swollen ankles, feet or fingers (peripheral edema )
  • pain
  • fever
  • chest pain
  • degenerative joint disease that causes pain and stiffness ( osteoarthritis )
  • muscle pain ( myalgia )
  • back pain
  • neck pain
  • accumulation of fluid in the body ( edema )
  • painful or difficult urination ( dysuria )
  • pain in the lower back (kidney pain)
  • general malaise
  • general weakness ( asthenia )
  • hot flashes
  • difficulty breathing or painful breathing ( dyspnoea )
  • nosebleeds
  • uterine bleeding between periods ( metrorrhagia )
  • testicular disorders (testicular disorder)
  • changes in blood parameters (tell your doctor if you take a blood sample)
  • complications after surgery.

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

  • severe skin side effects: rash characterized by rapid appearance of areas of red skin with scattered small pustules (small blisters filled with white / yellow fluid)
  • restlessness ( agitation )
  • abnormal liver function
  • blocked bile flow from the liver to the intestine, which causes yellowing of the skin and whites of the eyes (cholestatic jaundice).

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

  • skin rash with other symptoms such as fever, swollen lymph nodes and increased amount of eosinophils ( white blood cells ). Rash appears as small, itchy, red dots.

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

  • bacterial infection of the colon (pseudomembranous colitis ). If you get fever, diarrhea and stomach pain, you should contact a doctor immediately.
  • low platelet count ( thrombocytopenia )
  • anemia caused by abnormal red blood cell breakdown ( haemolytic anemia )
  • severe life-threatening allergic reactions ( anaphylaxis ), including swelling of the mouth and throat ( edema ) – in rare cases life-threatening, contact your doctor immediately if you get these symptoms.
  • aggressiveness
  • concern
  • severe confusion ( delirium )
  • to see, hear or perceive things that do not exist (hallucinations)
  • fainting ( syncope )
  • seizures (convulsions)
  • feeling of overactivity
  • altered sense of smell ( parosmia , anosmia )
  • taste disorders ( ageusi )
  • worsening and onset of myasthenia gravis (muscle disease in which the muscles gradually become weaker)
  • irregular heartbeat ( arrhythmia ) including fast heartbeat (ventricular tachycardia)
  • increased risk of abnormal ECG (caused by irregular heartbeat) and torsade de pointes (life-threatening rapid heartbeat), especially in patients who are sensitive to these conditions
  • abnormal ECG measurement (prolonged QT time )
  • low blood pressure ( hypotension )
  • inflammation of the pancreas ( pancreatitis )
  • discolored tongue
  • inflammation of the liver ( hepatitis )
  • cell death in the liver and liver failure which in rare cases can be life threatening
  • toxic epidermal necrolysis (a very serious skin disease in which the skin comes loose)
  • erythema multiforme (a skin condition with itchy pink spots)
  • inflammation of the kidneys (interstitial nephritis)
  • acute renal failure .

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 STADA

Keep this medicine out of the sight and reach of children.

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

No special storage instructions.

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

The active substance is azithromycin.

Each Azithromycin Stada 250 mg tablet contains azithromycin monohydrate equivalent to 250 mg azithromycin.

Other ingredients are :

Tablet core:

  • microcrystalline cellulose
  • pregelatinized corn starch
  • sodium starch glycollate
  • colloidal anhydrous silica
  • sodium lauryl sulfate
  • magnesium stearate

Film coating:

  • polyvinyl alcohol
  • titanium dioxide (E 171)
  • talc
  • sojalecitin
  • xanthan gum

What the medicine looks like and the contents of the pack

Azithromycin Stada 250 mg film-coated tablets are white to off-white oblong film-coated smooth tablets.

Azithromycin Stada is packaged in PVC / PVdC / Aluminum blisters.

Pack sizes:

4, 6, 12, 24, 50 and 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

Manufacturer

Sandoz SRL, Str. Livezeni no. 7a, 540472 Targu Mures, Romania

Lek Pharmaceuticals dd, Verovškova 57, Ljubljana, Slovenia

Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

Local representative

STADA Nordic ApS

Marielundvej 46 A

2730 Herlev

Denmark

Muhammad Nadeem

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