AZITROMICINA 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Azitromicina Krka 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Azitromicina Krka and what it is used for
   2. What you need to know before using Azitromicina Krka
   3. How to take Azitromicina Krka
   4. Possible side effects
   5. How to store Azitromicina Krka
   6. Package contents and other information
2. Azitromicina Krka 40 mg/ml powder for oral suspension
   1. What is Azitromicina Krka and what it is used for
   2. What you need to know before using Azitromicina Krka
   3. How to use Azitromicina Krka
   4. Possible side effects
   5. How to store Azitromicina Krka
   6. Contents of the pack and other information

Azitromicina Krka 250 mg film-coated tablets, 500 mg film-coated tablets

Azitromicina

Generic medicine

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. (See section 4).

Contents of this leaflet:

• 1. What Azitromicina Krka is and what it is used for
• 2. What you need to know before you use Azitromicina Krka
• 3. How to use Azitromicina Krka
• 4. Possible side effects
• 5. How to store Azitromicina Krka
• 6. Contents of the pack and other information

1. What is Azitromicina Krka and what it is used for

Azithromycin, the active substance of Azitromicina Krka, belongs to the group of macrolide antibiotics.
It is used for the treatment of some infections including:

• acute bacterial infections of the sinuses,
• acute bacterial infections of the ears,
• tonsillitis, pharyngitis,
• acute bacterial exacerbation of chronic bronchitis,
• mild to moderately severe pneumonia,
• mild to moderately severe skin and soft tissue infections e.g. folliculitis, cellulitis, erysipelas,
• infection of the tube that carries urine from the bladder (urethra) or the cervix caused by bacteria called Chlamydia trachomatis.

2. What you need to know before using Azitromicina Krka

Do not take Azitromicina Krka:

• if you are allergic to azithromycin or other macrolides (such as erythromycin or clarithromycin) or to ketolide antibiotics or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Azitromicina Krka:

• if you suffer from certain heart conditions (e.g. serious heart problems, “prolongation of the QT interval”) or if you are taking medicines that cause changes in the electrical function of the heart such as cisapride (used to increase intestinal movement);
• if you have a slow or irregular heartbeat;
• if you have altered electrolyte levels in the blood, especially low levels of magnesium and potassium;
• if you are taking other medicines that cause abnormal changes in the ECG (see section “Other medicines and Azitromicina 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 a new infection (which may be a sign of excessive growth of resistant organisms);
• if you have nervous (neurological) or mental health (psychiatric) problems.

Rarely, severe hypersensitivity reactions with swelling of the face, mouth and
throat (sometimes fatal) have been reported. If these symptoms occur stop taking Azitromicina
Krka and contact your doctor immediately.
Antibiotics can cause diarrhea, which may be a sign of severe inflammation
of the intestine. If you have watery or bloody diarrhea, call your doctor. Do not use medicines to stop
diarrhea unless your doctor has told you to do so.

Children and adolescents
The film-coated tablets of Azitromicina Krka are notsuitable for newborns and children (under
2 years of age) and for children and adolescents (up to 17 years of age) with a body weight

less than 45 kg.
Information regarding the administration of Azitromicina Krka in children and adolescents
over 45 kg can be found in section 3 “How to take Azitromicina Krka”.

Other medicines and Azitromicina KrkaTell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
It is particularly important that you inform your doctor or pharmacist if you are taking:

• medicines known as ergot derivatives, e.g. ergotamine or dihydroergotamine (medicines used for migraine or to reduce blood flow), as these medicines must not be taken at the same time as Azitromicina Krka
• cyclosporine (a medicine used for skin conditions, rheumatoid arthritis or following an organ transplant),
• atorvastatin (for the treatment of high cholesterol levels in the blood),
• cisapride (used to treat stomach problems),
• theophylline (for breathing problems),
• warfarin or other medicines to make the blood more fluid,
• digoxin (for heart problems),
• colchicine (used for gout and familial Mediterranean fever),
• zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections),
• rifabutin (for HIV infections or the treatment of tuberculosis),
• terfenadine (a medicine for the treatment of allergies),
• fluconazole (for the treatment of fungal infections),
• medicines known as antacids (medicines that neutralize stomach acids). Your Azitromicina Krka tablets must be taken at least 1 hour before or 2 hours after you have taken antacids,
• astemizole (a medicine for the treatment of allergies), alfentanil (painkiller).

Azitromicina Krka with food and drink
The tablets should be taken with water.
You can take the medicine with or without food as this does not affect the absorption
of azithromycin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
This medicine must not be used during pregnancy or breastfeedingunless you
have discussed it with your doctor.

Driving and using machines
This medicine may make you feel dizzy. If you feel dizzy, do not drive or use tools or
machinery.

Azitromicina Krka contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to take Azitromicina Krka

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor or pharmacist.

For adults and children and adolescents with a body weight of 45 kg or more:

Children and adolescents with a body weight of less than 45 kg
Tablets are not recommended. Children and adolescents with a body weight of less than 45 kg
should use other pharmaceutical forms containing azithromycin.

Patients with kidney or liver problems
You should inform your doctor if you have liver or kidney problems as your doctor may need
to adjust the usual dose.

Dosage for the elderly
The same dosage as for adults applies to the elderly.

Administration
Swallow the tablets whole with a little water.
You can take the medicine with or without food as this does not affect the absorption
of azithromycin.

If you take more Azitromicina Krka than you should
It is important to stick to the dose prescribed by your doctor. If you or someone else swallows more
tablets at the same time, or if you think a child has swallowed any tablets,
contact your doctor, pharmacist or hospital emergency room immediately. Always bring
the remaining tablets and the packaging with you, as this will make it easier to identify the
tablets. Symptoms of overdose may include severe nausea, vomiting and diarrhea, and reversible hearing loss.

If you forget to take Azitromicina Krka
Do not take a double dose to make up for a missed dose. If you have forgotten a dose,
take it as soon as you remember. However, if it is almost time to take the next dose, skip the missed dose
and continue with the remaining medicine as usual.

If you stop taking Azitromicina Krka
Do not stop treatment prematurely. Even if you start to feel better, it is important that
you continue to take your tablets for the entire time that your doctor has told you.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
These are usually mild to moderate and stop when treatment is discontinued.

If you suffer from any of the following side effects, stop taking the tablets and immediately
consult a doctor or go to the nearest hospital emergency room. You may have developed a
rare, serious allergic reaction to the tablets:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat
• Difficulty swallowing or breathing
• Severe skin reactions including Stevens-Johnson Syndrome (a severe rash) and other severe rashes that may include blistering or peeling (toxic epidermal necrolysis)
• Severe and persistent diarrhea, especially if it contains blood or mucus (this may be pseudomembranous colitis, an inflammation of the intestine).

Other side effects reported are:

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

• diarrhea

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

• headache
• feeling unwell (vomiting), abdominal pain, feeling unwell (nausea)
• changes in the number of white blood cells
• changes in some blood tests (reduced bicarbonate in the blood)

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

• thrush (candidiasis) - a fungal infection of the mouth and vagina
• pneumonia, bacterial throat infection, inflammation of the gastrointestinal tract, breathing difficulties, inflammation of the mucous membrane inside the nose
• changes in white blood cells (leukopenia, neutropenia, eosinophilia)
• swelling of the eyelids, face or lips (angioedema), allergic reactions
• loss of appetite (anorexia)
• nervousness, difficulty sleeping (insomnia)
• feeling dizzy, feeling sleepy (somnolence), changes in the sense of taste (dysgeusia), sensation of tingling or numbness (paresthesia)
• impaired vision
• ear disorders, feeling of spinning (vertigo)
• feeling your heartbeat (palpitations)
• hot flashes
• sudden shortness of breath, nosebleeds
• constipation, gas, impaired digestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, release of gas from the stomach (eructation), mouth ulceration, increased salivation
• rash, itching, hives, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
• difficulty urinating (dysuria), kidney pain
• irregular uterine bleeding (metrorrhagia), testicular disorders
• edema, weakness, general feeling of unwellness, facial edema, chest pain, fever, pain, peripheral edema
• abnormal values in laboratory tests (e.g. blood or liver tests)

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

• feeling irritated
• abnormal liver function, yellowing of the skin or eyes
• allergic skin reactions such as being sensitive to sunlight
• rash characterized by the rapid appearance of areas of red skin with small pustules (small blisters filled with white/yellow liquid)

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

• drug reaction with eosinophilia (increased amount of a certain type of white blood cells) and systemic symptoms such as fever and enlarged lymph nodes (DRESS syndrome)

Not known (the frequency cannot be estimated from the available data)

• infection of the intestine (colon) (pseudomembranous colitis)
• reduced number of red blood cells due to increased breakdown of cells (hemolytic anemia); reduction in the number of platelets
• severe allergic reaction (anaphylactic reaction)
• feeling angry, aggressive, feeling of fear and worry (anxiety), acute confused state (delirium), hallucination
• fainting (syncope)
• seizures (convulsions)
• reduced sense of touch (hypoesthesia)
• feeling hyperactive
• alteration in the sense of smell (anosmia, parosmia)
• loss of the sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• life-threatening irregular heartbeat (torsades de pointes), irregular heart tracing on ECG (prolongation of the QT interval)
• impaired hearing including deafness or ringing in the ears
• low blood pressure
• inflammation of the pancreas (pancreatitis)
• the tongue changes color
• liver disorders (liver failure which rarely causes death, hepatic necrosis), inflammation of the liver (hepatitis)
• severe allergic skin reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome)
• joint pain (arthralgia)
• inflammation of the kidneys (interstitial nephritis) and kidney failure

Adverse reactions possibly or probably related toMycobacterium avium complex
(MAC) prophylaxis and treatment (MAC):
Very common (may affect more than 1 in 10 people)

• diarrhea
• abdominal pain
• feeling unwell (nausea)
• gas
• abdominal cramps
• loss of stool

Common (may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• feeling dizzy
• headache
• sensation of tingling or numbness (paresthesia)
• change in your sense of taste (dysgeusia)
• visual impairment
• deafness
• rash, itching
• joint pain (arthralgia)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• reduced sense of touch (hypoesthesia)
• impaired hearing, ringing in the ears
• perception of heartbeat (palpitations)
• inflammation of the liver (hepatitis)
• severe allergic skin reactions
• skin more sensitive to sunlight than normal
• weakness
• general feeling of unwellness

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Azitromicina 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 packaging after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azitromicina Krka contains

• The active ingredient is azithromycin. Azitromicina Krka 250 mg film-coated tablets

Each film-coated tablet contains 250 mg of azithromycin (as azithromycin
dihydrate).
Azitromicina Krka 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of azithromycin (as azithromycin
dihydrate).

• The other ingredients (excipients) are microcrystalline cellulose (E460), pregelatinized potato starch, sodium lauryl sulfate, hypromellose (E464), sodium croscarmellose (E468), anhydrous colloidal silica (E551) and magnesium stearate (E470b) in the tablet core and hypromellose 5 cP (E464), titanium dioxide (E171) and macrogol 400 in the coating of the 250 mg tablets and macrogol copolymer grafted with poly(vinyl alcohol), titanium dioxide (E171), talc, glyceryl monocaprylocaprate, polyvinyl alcohol in the coating of the 500 mg tablets. See section 2 “Azitromicina Krka contains sodium”.

Description of the appearance of Azitromicina Krka and package contents
250 mg: white to almost white, capsule-shaped, film-coated tablets (length 13.8-
14.2 mm, width: 6.3-6.7 mm), with “S19” imprinted on one side and smooth on the other side.
500 mg: white to almost white, capsule-shaped, film-coated tablets (length 16.7-
17.3 mm, width: 8.2-8.8 mm), with “S5” imprinted on one side and a score line on the other side. The
tablet can be divided into two equal doses.
250 mg:
are available in boxes of 4 and 6 film-coated tablets in blisters.
500 mg:
are available in boxes of 2, 3 and 30 film-coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany
KRKA-FARMA d.o.o., DPC Jastrebarsko, Cvetković bb, 10450 Jastrebarsko, Croatia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

Azitromicina Krka 40 mg/ml powder for oral suspension

Azitromicina

Generic medicine

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet:
• 1. What Azitromicina Krka is and what it is used for
• 2. What you need to know before you use Azitromicina Krka
• 3. How to use Azitromicina Krka
• 4. Possible side effects
• 5. How to store Azitromicina Krka
• 6. Contents of the pack and other information

1. What is Azitromicina Krka and what it is used for

Azitromicina, the active substance of Azitromicina Krka, belongs to the group of macrolide antibiotics.
It is used for the treatment of various infections such as:

• acute bacterial infections of the upper respiratory tract,
• acute bacterial ear infections,
• tonsillitis, pharyngitis,
• acute bacterial exacerbation of chronic bronchitis,
• mild to moderately severe pneumonia,
• mild to moderately severe skin and soft tissue infections such as folliculitis, cellulitis, erysipelas,
• infections of the urinary tract (urethra) or the cervix caused by the bacterium Chlamydia trachomatis.

2. What you need to know before using Azitromicina Krka

Do not use Azitromicina Krka

• if you are allergic to azithromycin, to other macrolides (such as erythromycin or clarithromycin), ketolide antibiotics or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Azitromicina Krka.

• if you have any heart problems (e.g. serious heart problems, "prolongation of the QT interval") or if you are taking medicines that cause an altered electrical activity of your heart, such as cisapride (used to increase intestinal movement);
• if you have a slow or irregular heartbeat;
• if you have altered electrolyte levels in your blood, especially if you have low levels of potassium and magnesium;
• if you are taking other medicines that cause changes in the ECG (see section "Other medicines and Azitromicina Krka");
• if you have serious kidney problems;
• if you have serious liver problems: your doctor may need to check your liver function or stop treatment;
• if you develop a new infection (which may be a sign of growth of resistant microorganisms);
• if you have neurological or psychiatric problems;
• if you are giving the medicine to a newborn (less than 6 weeks old) who vomits or becomes irritable after administration;
• rarely, serious hypersensitivity reactions with difficulty breathing, dizziness, swelling of the face or throat, skin rashes, hives and blisters (sometimes fatal) have been reported. If you experience these symptoms stop taking Azitromicina Krka and contactyour doctor immediately. Antibiotics can cause diarrhea, which may be a sign of severe intestinal inflammation. If you experience watery or bloody diarrhea, contact your doctor. Do not take medicine to stop the diarrhea unless your doctor has told you to.

Other medicines and Azitromicina Krka
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
It is important to tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines known as ergot derivatives such as ergotamine or dihydroergotamine (medicines used for migraine or to reduce blood flow), these medicines must not be taken at the same time as Azitromicina Krka,
• Cyclosporine (a medicine used for some skin conditions, for rheumatoid arthritis or following an organ transplant),
• Atorvastatin (for treating high cholesterol levels in the blood),
• Cisapride (used to treat stomach problems),
• Theophylline (for breathing problems),
• Warfarin or other medicines to thin the blood,
• Digoxin (for heart problems),
• Some medicines for irregular heartbeat (called anti-arrhythmics such as quinidine, amiodarone, sotalol). Concomitant use is not recommended.
• Zidovudine, efavirenz, indinavir, nelfinavir, didanosine (for HIV infections),
• Rifabutin (for HIV infections or for the treatment of tuberculosis),
• Terfenadine (a medicine used to treat allergies),
• Fluconazole (for the treatment of fungal infections),
• Medicines known as antacids (medicines that neutralize stomach acid). You should take Azitromicina Krka at least one hour before or two hours after taking antacids,
• Astemizole (a medicine for the treatment of allergies), alfentanil (painkiller).

Azitromicina Krka with food and drink
You can take your medicine with or without food because it has no effect on the absorption
of azithromycin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before using this
medicine.

Do not use this medicine during pregnancyand breastfeedingunless your
doctor has specifically recommended it.

Driving and using machines
This medicine can cause dizziness. If you feel dizzy, do not drive or use
machines.

Azitromicina Krka contains sucrose and sodium
6.5 ml of suspension contains 5 g of sucrose. This should be taken into account in patients with
diabetes mellitus. If your doctor has told you that you have an intolerance to some sugars, inform your
doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per 12.5 ml of suspension
(which is the maximum dose), i.e. essentially “sodium-free”.

3. How to use Azitromicina Krka

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Adults and children weighing more than 45 kg:
Azitromicina is taken for a therapy of 3 or 5 days
3-day therapy: Take 12.5 ml (500 mg) once a day
5-day therapy:

• Take 12.5 ml (500 mg) on Day 1
• Take 6.25 ml (250 mg) on Days 2, 3, 4 and 5

For infections of the urethra and cervix caused by Chlamydia, the therapy is 1 day:
1-Day therapy: 25 ml (1000 mg).

Children and adolescents weighing less than 45 kg:
Azitromicina is taken for a therapy of 3 or 5 days. The daily amount is calculated based on the child's weight.

3-day therapy
WeightDay 1-3
10 kg 2.5 ml (100 mg)
12 kg 3 ml (120 mg)
14 kg 3.5 ml (140 mg)
16 kg 4 ml (160 mg)

• 17 – 25 kg 5 ml (200 mg)
• 26 – 35 kg 7.5 ml (300 mg)
• 36 – 45 kg 10 ml (400 mg) >45 kg 12.5 ml (500 mg)

5-day therapy
WeightDay 1Day 2-5
10 kg 2.5 ml (100 mg) 1.25 ml (50 mg)
12 kg 3 ml (120 mg) 1.5 ml (60 mg)
14 kg 3.5 ml (140 mg) 1.75 ml (70 mg)
16 kg 4 ml (160 mg) 2 ml (80 mg)

• 17 – 25 kg 5 ml (200 mg) 2.5 ml (100 mg)
• 26 – 35 kg 7.5 ml (300 mg) 3.75 ml (150 mg)
• 36 – 45 kg 10 ml (400 mg) 5.0 ml (200 mg) >45 kg 12.5 ml (500 mg) 6.25 ml (250 mg)

Patients with liver or kidney problems:
You must tell your doctor if you have kidney or liver problems because the doctor may change the normal dose administered.

Dose for the elderly:
The same dosage as for adults is used for the elderly.

Administration:
Shake well before use.
You can take your medicine with or without food because it has no effect on the absorption of azitromicina.
Azitromicina Krka is administered once a day. In children, the dose for the entire treatment should not exceed 1500 mg.

How to measure the dose

• 1) A 10 ml syringe marked with notches for every 0.25 ml is supplied in the package with the medicine together with an adapter that fits the bottle.
• 2) Shake the bottle before use and remove the child-proofcap.
• 3) Apply the adapter to the neck of the bottle.
• 4) Apply the end of the syringe to the adapter.
• 5) Turn the bottle upside down.
• 6) Pull the plunger of the syringe to aspirate the necessary dose.
• 7) If large bubbles are seen in the syringe, slowly push the plunger into the syringe. This will force the medicine into the bottle. Repeat this step for 6.
• 8) Turn the bottle upside down again, remove the syringe, leave the adapter applied to the bottle and close it. Consult your doctor or pharmacist for advice on how to dose the medicine.

Administration of the medicine via the syringe:

• 1) Make sure the child is supported in an upright position.
• 2) Carefully insert the tip of the syringe into the child's mouth. Point the tip of the syringe towards the inside of the cheek.
• 3) Slowly push the plunger of the syringe. The medicine should not come out of the syringe quickly, but drip into the child's mouth.
• 4) Give the child time to swallow the medicine. How to clean and store the syringe
• 1) Remove the plunger of the syringe and clean both parts by holding them under lukewarm running water.
• 2) Dry the two parts. Push the plunger into the syringe. Keep it in a safe and dry place together with the syringe. How to prepare this medicineShake the container with the powder well. Using a graduated pipette, graduated cylinder or graduated pipette (supplied in the package) add the amount of water written below (X mL) to the powder. At home, you can use freshly boiled and cooled water. While adding water, hold the bottle tilted so that most of the powder is not at the bottom of the bottle, otherwise it may remain stuck to the bottom. The correct amount of water depends on the size of the bottle and is indicated below: Due to losses during administration, a larger volume of reconstituted suspension is prepared. Azitromicina Krka 40 mg/ml
• For 15 ml of suspension (600 mg) add 9.0 ml of water
• For 22.5 ml of suspension (900 mg) add 12.5 ml of water
• For 30 ml of suspension (1200 mg) add 16 ml of water
• For 37.5 ml of suspension (1500 mg) add 19 ml of water After adding the indicated amount of water, close the bottle tightly, immediately turn it upside down, so that the powder mixes with the water, and shake it vigorously. This helps to obtain a homogeneous suspension. Check if the powder is completely dispersed!. If you use more Azitromicina Krka than you should

If you/ your child take too much Azitromicina Krka you may feel unwell. Immediately inform your doctor or go to the nearest hospital. Bring the remaining medicine with you. Symptoms of overdose may include severe nausea, vomiting, diarrhea and reversible hearing loss.

If you forget to use Azitromicina Krka
Do not take a double dose to make up for the missed dose. If you forget to take a dose, take it as soon as you remember. However, if it is almost time to take the next dose, do not consider the dose you forgot and continue normally with the rest of the medicine.

If you stop the treatment with Azitromicina Krka
Do not stop the treatment before time.
Even if you start to feel better, it is important that you continue to take your medicine for the period that your doctor has told you.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Usually these effects are mild to moderate and disappear once treatment is stopped.

If you experience any of the following side effects, stop taking this
medicine and contact your doctor immediately or go to the nearest
hospital. You may develop a rare, serious allergic reaction to the
medicine:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat,
• Difficulty swallowing or breathing,
• Severe skin reactions such as Stevens-Johnson syndrome (a severe skin reaction) and other severe skin reactions that can involve blisters and peeling (toxic epidermal necrolysis),
• Severe and persistent diarrhea, especially with mucus or blood (may be pseudomembranous colitis, an inflammation of the intestine). Other side effects are:

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

• diarrhea

Common (may affect up to 1 in 10 people)

• headache
• feeling sick (vomiting), abdominal pain, feeling unwell (nausea)
• alteration of the number of white blood cells in the blood
• alteration of other blood parameters (decrease in blood bicarbonate)

Uncommon (may affect up to 1 in 100 people)

• thrush (candidiasis) - a fungal infection of the mouth and vagina
• pneumonia, a bacterial infection of the throat, inflammation of the gastrointestinal tract, breathing problems, inflammation of the mucous membranes of the nose
• changes in the number of white blood cells (leukopenia, neutropenia, eosinophilia)
• swelling of the eyelids, face or lips (angioedema), allergic reactions
• loss of appetite (anorexia)
• nervousness, difficulty falling asleep (insomnia)
• feeling dizzy, feeling tired (somnolence), change in sense of taste (dysgeusia), sensation of pins and needles, tingling or numbness (paresthesia)
• vision problems
• ear disorders, dizziness (vertigo)
• awareness of heartbeat (palpitations)
• hot flashes
• sudden wheezing, nosebleeds
• constipation, gas, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), abdominal distension, dry mouth, release of gas from the stomach (eructation), mouth ulcers, increased salivation
• skin rash, itching, hives, dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• degenerative joint disease (osteoarthritis), muscle pain, back pain, neck pain
• difficulty urinating (dysuria), kidney pain
• irregular menstrual bleeding (metrorrhagia), testicular disorders
• edema, weakness, general feeling of discomfort, facial edema, chest pain, fever, pain, peripheral edema
• abnormal laboratory test values (e.g. blood and liver tests)
• post-operative complications

Rare (may affect up to 1 in 1000 people)

• restlessness
• abnormal liver function, yellowing of the skin and eyes
• allergic skin reactions such as light sensitivity
• skin rash characterized by the rapid appearance of areas of red skin with small pustules (small blisters filled with white/yellow liquid). Very rare (may affect up to 1 in 10,000 people)
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Not known (frequency cannot be estimated from available data)

• infections of the intestine (colon) (pseudomembranous colitis)
• reduction in the number of red blood cells due to increased breakdown of cells (hemolytic anemia); reduction in the number of platelets
• severe allergic reactions (anaphylactic reactions)
• feeling angry, aggression, feeling fearful and worried (anxiety), acute confused state (delirium), hallucinations
• fainting (syncope)
• seizures (convulsions)
• reduced sense of touch (hypoesthesia)
• hyperactivity
• changes in sense of smell (anosmia, parosmia)
• loss of sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• life-threatening irregular heartbeat (torsades de pointes), irregular heart tracing on ECG (QT prolongation)
• hearing impairment including deafness or ringing in the ears
• low blood pressure
• inflammation of the pancreas (pancreatitis)
• change in tongue color
• liver disorders (liver failure which rarely led to death, hepatic necrosis), inflammation of the liver (hepatitis)
• severe allergic skin reactions (toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome)
• joint pain (arthralgia)
• kidney inflammation (interstitial nephritis) and kidney failure Adverse reactions possibly or probably related to prophylaxis andtreatment (MAC) of Mycobacterium avium complex (MAC)

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

• diarrhea
• abdominal pain
• feeling unwell (nausea)
• gas
• abdominal discomfort
• loose stools Common (may affect up to 1 in 10 people)
• loss of appetite (anorexia)
• feeling dizzy
• headache
• sensation of needles and tingling or numbness (paresthesia)
• changes in sense of taste (dysgeusia)
• impaired vision
• deafness
• rash, itching
• joint pain (arthralgia)
• fatigue Uncommon (may affect up to 1 in 100 people)
• reduced sense of touch (hypoesthesia)
• impaired hearing or ringing in the ears
• awareness of heartbeat (palpitations)
• inflammation of the liver (hepatitis)
• severe allergic skin reactions
• increased sensitivity of the skin to light than normal
• weakness
• general feeling of discomfort

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, speak to your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Azitromicina 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 pack after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
This medicine does not require any particular storage temperature.
Bottles with 15 ml and 22.5 ml of suspension:
After reconstitution the product must be used within 5 days. Do not store at
temperatures above 25°C.
Bottles with 30 ml and 37.5 ml of suspension:
After reconstitution the product must be used within 10 days. Do not store at
temperatures above 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Azitromicina Krka contains

• The active ingredient is azithromycin. 1 ml of oral suspension contains 40 mg of azithromycin (as azithromycin dihydrate).
• The other ingredients (excipients) are sucrose, hydroxypropylcellulose, trisodium phosphate anhydrous (E339), xanthan gum, colloidal anhydrous silica, banana flavour (sucrose, maltodextrin, acacia gum, flavouring), wild cherry flavour (sucrose, maltodextrin, acacia gum, flavouring) and vanilla flavour (maltodextrin, flavouring, natural flavouring substance). See section 2 "Azitromicina Krka contains sucrose and sodium".

Description of the appearance of Azitromicina Krka and contents of the pack
The oral suspension powder is from white to almost white. After reconstitution
with water it forms a homogeneous suspension from pale yellow to yellowish brown with a
characteristic banana and wild cherry aroma.
Azitromicina Krka 40 mg/ml is available in packs with:

• 12.6 g of powder for reconstitution of 15 ml of oral suspension (containing 600 mg of azithromycin), in a carton,
• 18.9 g of powder for reconstitution of 22.5 ml of oral suspension (containing 900 mg of azithromycin), in a carton,
• 25.2 g of powder for reconstitution of 30 ml of oral suspension (containing 1200 mg of azithromycin), in a carton,
• 31.5 g of powder for reconstitution of 37.5 ml of oral suspension (containing 1500 mg of azithromycin), in a carton.

The packs are distributed with a 10 ml PE/PP graduated oral syringe in
0.25 ml increments with an adapter.
The reconstituted suspension contains 5 ml of overdose in order to ensure the
administration of a complete dose.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy
KRKA Farmaceutici Milano S.r.l. – Italy

This medicinal product is authorised in the Member States of the European Economic
Area under the following denominations: