250 mg, 500 mg film-coated tablets
azithromycin
1. What Azithromycin Krka is and what it is used for
Azithromycin, the active substance in Azithromycin Krka, belongs to a group of antibiotics called macrolides. The drug is used to treat various infections including:
- acute bacterial infection you in the sinuses
- acute bacterial ear infections
- infection is in the throat or throat
- acute bacterial exacerbation of chronic tracheal catarrh
- mild to moderate pneumonia
- mild to moderate infections of the skin and soft tissues, such as hair follicle inflammation ( folliculitis ), bacterial infections of the skin or underlying skin tissue ( cellulite ), rose fever
- infection of the urinary tract or infection of the cervix ( cervical ) caused by the bacterium Chlamydia trachomatis
Azithromycin contained in Azithromycin Krka 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.
2. What you need to know before you use Azithromycin Krka
Do not use Azithromycin Krka
- if you are allergic to azithromycin, other macrolide antibiotics (eg erythromycin or clarithromycin), ketolide antibiotics 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 Krka.
- if you have certain heart problems (eg severe heart problems, “long QTsyndrome”) or if you are taking medicines that cause altered electrical function of the heart such as cisapride (used to stimulate bowel movement);
- if you have a slow or irregular heartbeat;
- if you have altered electrolyte levels in your blood, especially if your blood levels of potassium or magnesium are too low;
- if you are taking other medicines that result in abnormal ECG changes (see section “Other medicines and Azithromycin Krka”);
- if you have severe kidney problems;
- if you have severe liver problems: your doctor may need to monitor your liver function or stop treatment;
- if you develop signs of a new infection (which may be a sign of overgrowth of resistant organisms )
- you have neurological or mental (mental) problems.
Severe hypersensitivity reactions with swelling of the face, mouth and tongue (sometimes fatal) have been reported in rare cases. If such symptoms occur, stop taking Azithromycin Krka and contact a doctor immediately.
Antibiotics can cause diarrhea, which can be a sign of severe intestinal inflammation. If you experience diarrhea that is watery or bloody, call a doctor immediately. Do not use any stopping medicine for diarrhea unless your doctor has recommended it.
Children and young people
Azithromycin Krka film-coated tablets are not suitable for infants or young children (under 2 years) or children and adolescents (up to 17 years) weighing less than 45 kg.
For information on administering Azithromycin Krka to children and adolescents over 45 kg, see section 3 “How to take Azithromycin Krka”.
Other medicines and Azithromycin Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important that you tell your doctor or pharmacist if you are taking:
- Drugs called ergotamine derivatives such as ergotamine or dihydroergotamine (used to treat migraines or reduce blood flow), as these medicines should not be taken with Azithromycin Krka,
- Ciclosporin (a medicine used to treat skin problems, rheumatism or after organ transplantation),
- Atorvastatin (for high blood cholesterol levels),
- Cisapride (for stomach problems),
- Theophylline (for respiratory problems)
- Warfarin or other blood thinners
- Digoxin (for heart problems)
- Colchicine (used to treat gout and familial Mediterranean fever)
- Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (used to treat HIV – infection s)
- Rifabutin (used to treat HIV – infection s or tuberculosis )
- Terfenadine (used to treat allergies )
- Fluconazole (for fungal infections)
- Medicines called antacids (medicines that neutralize stomach acid). Your Azithromycin Krka tablets should be taken at least one hour before or two hours after taking antacids.
- Astemizole (used to treat allergies ), alfentanil (painkiller)
Azithromycin Krka with food, drink, and alcohol
The tablets should be taken with water.
This medicine can be taken with or without food as it does not affect the absorption of azithromycin.
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.
You should not use this medicine during pregnancy or breast-feeding unless your doctor tells you to.
Driving and using machines
This medicine may cause dizziness. You should avoid driving or using machines if you feel dizzy.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Krka contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose , ie essentially ‘sodium-free’.
3. How to use Azithromycin Krka
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
| Treatment for; | Dosage |
| acute bacterial infection you in the sinuses,acute bacterial ear infections,infection is in the throat or throat,acute bacterial exacerbation of chronic tracheal catarrh ,mild to moderate pneumonia ,mild to moderate infection in the skin and soft tissues | 500 mg once daily for 3 days with a total dose of 1,500 mg.or500 mg as a single dose on the first day and 250 mg once daily on days 2–5, with a total dose of 1,500 mg |
| infection of the cervix or urethra caused by Chlamydia trachomatis | 1,000 mg as a single dose |
Children and adolescents weighing less than 45 kg:
The tablets are not recommended. Children and adolescents weighing less than 45 kg should use other forms of azithromycin-containing medicines.
Patients with kidney or liver problems:
Tell your doctor if you have kidney or liver problems as your doctor may need to change your normal dose .
Dosage for the elderly:
Elderly people can take the same dose as adults.
How to take this medicine:
Swallow the tablets without chewing them, with water. This medicine can be taken with or without food as it does not affect the absorption of azithromycin.
If you forget to use Azithromycin Krka
Do not take a double dose to make up for a forgotten dose. If you miss a dose, take the missed dose as soon as you remember. If it is time for your next dose , skip the missed dose and take the next one when it is time for your next dose .
If you stop using Azithromycin Krka
Do not stop taking the tablets until the whole course is complete, even if you feel better. It is important for you to continue taking the tablets as directed by your doctor.
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 side effects , stop your treatment immediately and contact your doctor or go to the nearest emergency department. You may have had a rare severe allergic reaction to the tablets:
- swelling of hands, feet, ankles, face, lips, mouth, or neck
- difficulty swallowing or breathing
- severe skin reactions including Stevens-Johnson syndrome (a severe skin rash) and other severe skin rashes that may involve blistering or scaling (toxic epidermal necrosis )
- severe, prolonged diarrhea, especially if it contains blood or mucus (this may be pseudomembranous colitis , an inflammation of the colon)
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
- diarrhea
Common (may affect up to 1 in 10 people)
- headache
- vomiting, abdominal pain, nausea
- altered white blood cell count
- other changes in the blood (low bicarbonate content )
Uncommon (may affect up to 1 in 100 people)
- cod (candida infection) – a fungal infection of the mouth or abdomen
- pneumonia , bacterial infection of the throat, inflammation of the gastrointestinal tract, difficulty breathing, inflammation of the nasal mucosa
- changes in white blood cells ( leukopenia, neutropenia, eosinophilia )
- swelling of the eyelids, face, or lips ( angioedema ), allergic reactions
- poor appetite ( anorexia )
- nervousness, difficulty sleeping (insomnia)
- dizziness, drowsiness ( somnolence ), taste changes ( dysgeusia ), tingling or numbness ( paresthesia )
- visual impairment
- impaired hearing, dizziness ( vertigo )
- palpitation
- heat wave
- sudden wheezing, nosebleeds
- constipation, flatulence, indigestion ( dyspepsia ), inflammation of the lining of the stomach ( gastritis ), difficulty swallowing ( dysphagia ), distended abdomen, dry mouth, belching, cold sores, increased salivation
- rash, itchy hives, dermatitis, dry skin, abnormally increased sweating ( hyperhidrosis )
- degrading joint disease ( osteoarthritis ), muscle pain, back pain, neck pain
- difficulty urinating ( dysuria ), kidney pain
- irregular bleeding from the uterus ( metrorrhagia ), testicular problems
- edema (swelling due to fluid retention), weakness, general discomfort, facial edema, chest pain, fever, pain, peripheral edema (eg in hands and feet)
- abnormal laboratory test values (eg blood or liver values)
Rare (may affect up to 1 in 1000 people)
- feel annoyed
- abnormal liver function, yellowing of the skin or eyes
- allergic skin reactions such as increased sun sensitivity
- a skin 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)
- drug rash with eosinophilia (increased number of white blood cells ) and systemic symptoms such as fever and swollen lymph nodes (DRESS)
No known frequency (cannot be calculated from the available data)
- colon infection (pseudomembranous colitis )
- decreased number of red blood cells due to. increased cell degradation ( hemolytic anemia ), decreased platelet count ( platelets )
- severe allergic reaction (anaphylactic shock )
- feeling angry, aggression, feeling scared and anxious (anxiety), confusion ( delirium ), hallucination
- fainting ( syncope )
- seizures
- decreased sensation ( hypoesthesia )
- feeling of hyperactivity
- altered sense of smell ( anosmia, parosmia )
- loss of taste ( ageusia )
- muscle weakness ( myasthenia gravis )
- life-threatening irregular heart rate ( torsades de pointes ), abnormal ECG (long QT syndrome)
- impaired hearing including deafness and tinnitus
- low blood pressure
- inflammation of the pancreas ( pancreatitis )
- discoloration of the tongue
- liver problems (liver failure which in rare cases has led to death, liver necrosis), liver inflammation ( hepatitis )
- severe allergic skin reaction (toxic epidermal necrosis, erythema multiforme, Stevens-Johnson syndrome )
- joint pain ( arthralgia )
- renal inflammation (interstitial nephritis) and renal failure
The following side effects have been reported with prophylactic treatment against Mycobacterium Avium Complex (MAC):
Very common (affects more than 1 in 10 people)
- diarrhea
- abdominal pain
- feeling sick (nausea)
- gas in the stomach ( flatulence )
- feeling of discomfort in the abdomen
- loose stools
Common (affects up to 1 in 10 people)
- decreased appetite ( anorexia )
- feeling dizzy
- headache
- feeling of tingling or numbness ( paresthesia )
- changes in smell and taste ( dysgeusia )
- visual impairment
- deafness
- skin rash and itching
- joint pain ( arthralgia )
- fatigue
Uncommon in up to 1 in 100 people)
- impaired touch ( hypoesthesia )
- hearing loss or ringing in the ears
- palpitations ( palpitation )
- liver problems such as inflammation of the liver ( hepatitis )
- allergic skin reactions
- abnormal sensitivity to sunlight
- weakness ( asthenia )
- 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 Krka
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 carton 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.Azithromycin Krka 250 mg film-coated tablets:Each film-coated tablet contains 250 mg of azithromycin (as azithromycin dihydrate).Azithromycin Krka 500 mg film-coated tablets:Each film-coated tablet contains 500 mg of azithromycin (as azithromycin dihydrate).
- The other ingredients are microcrystalline cellulose (E460), pregelatinised potato starch, sodium lauryl sulphate, hypromellose (E464), croscarmellose sodium (E468), colloidal anhydrous silica (E551) and magnesium stearate (E470k2b) c E171) and macrogol 400 in the film coating.See section 2 “Azithromycin Krka contains sodium”.
What the medicine looks like and the contents of the pack
250 mg: The film-coated tablets are white to off-white, capsule-shaped (length: 13.8 mm-14.2 mm, width: 6.3 mm-6.7 mm), marked with “S19” on one side and without marking on other side.
500 mg: The film-coated tablets are white to off-white, capsule-shaped (length: 16.7 mm-17.3 mm, width: 8.2 mm-8.8 mm), marked with “S5” on one side and with a notch on other side. The tablet can be divided into two equal doses .
250 mg: Cartons of 4 and 6 film-coated tablets in blisters are available.
500 mg: Cartons of 2, 3 and 30 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Local representative :
KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm