Azithromicin Zim

Leaflet attached to the packaging: information for the user

Azithromycin ZIM, 500 mg, film-coated tablets

Azithromycin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azithromycin ZIM and what is it used for
• 2. Important information before taking Azithromycin ZIM
• 3. How to take Azithromycin ZIM
• 4. Possible side effects
• 5. How to store Azithromycin ZIM
• 6. Contents of the packaging and other information

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

Azithromycin ZIM belongs to a group of antibiotics called macrolides. It is an antibiotic used to treat infections located in different parts of the body caused by bacteria.
Azithromycin ZIM penetrates into infected tissues, where it is released slowly over time, fighting bacteria for several days after the last dose has been taken.

What infections does Azithromycin ZIM treat?

Azithromycin ZIM is indicated for the treatment of certain infections caused by susceptible microorganisms, such as: tonsillitis and/or pharyngitis, sinusitis, bronchitis, pneumonia, acute otitis media, skin and soft tissue infections (e.g., abscesses), as well as sexually transmitted diseases caused by Chlamydia trachomatisand Neisseria gonorrhoeae.

2. Important information before taking Azithromycin ZIM

When not to take Azithromycin ZIM

If the patient is allergic to azithromycin or other macrolide or ketolide antibiotics (including erythromycin) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Azithromycin ZIM, the patient should discuss it with their doctor or pharmacist if:

• the patient has ever had any complications while taking another medicine;
• the patient has liver function disorders: it may be necessary to monitor liver function or discontinue treatment;
• the patient has kidney function disorders.

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The patient should immediately consult a doctor:

• If the patient experiences any symptoms of liver disease, such as yellowing of the skin, loss of energy, dark urine, or any signs of bleeding or behavioral disorders, as liver function tests or additional diagnostic tests may be necessary.
• In case of heart palpitations or irregular heartbeat, dizziness, or fainting, or muscle weakness while taking Azithromycin ZIM.
• In case of diarrhea or loose stools during or after treatment, the patient should contact their doctor immediately. The patient should not take any medicine to treat diarrhea without first consulting their doctor. If the diarrhea does not resolve, the patient should inform their doctor.
• If the patient experiences any symptoms of an allergic reaction, such as a rash or hives, blisters, difficulty breathing, dizziness, swelling of the face or throat. The patient should stop taking this medicine and consult a doctor immediately. Serious allergic reactions to Azithromycin ZIM are rare.
• If a newborn experiences vomiting and irritability during feeding.

This antibiotic works on some bacteria, but not all, nor on fungal infections (fungal).

Azithromycin ZIM and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, they should definitely tell their doctor or pharmacist before starting treatment with Azithromycin ZIM:

• Antacids (used for heartburn or indigestion)
• Warfarin (or other blood-thinning medicine)
• Terfenadine (used to treat hay fever or skin allergies)
• Cyclosporin (used to suppress the immune system to prevent organ or bone marrow transplant rejection)
• Digoxin (used to treat heart failure)
• Colchicine (used to treat gout or familial Mediterranean fever)
• Ergotamine (used to treat migraines)
• Atorvastatin (used to lower cholesterol levels)
• Anti-arrhythmic medicines (used to treat heart conditions)
• Antipsychotic medicines (used to treat hallucinations or thought disorders)
• Antidepressant medicines (used to treat depression)
• Fluoroquinolones (antibiotics used to treat serious bacterial infections).

Azithromycin ZIM with food and drink

Azithromycin ZIM 500 mg should be taken with water or another drink, with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
There is insufficient experience with the use of azithromycin in pregnant women. As a precaution, treatment of pregnant women with Azithromycin ZIM should only be used in exceptional circumstances. The doctor must decide whether such an exceptional circumstance exists.
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Breastfeeding
If the patient is breastfeeding, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether Azithromycin ZIM can be used during breastfeeding.
The active substance of Azithromycin ZIM (azithromycin) passes into human milk. So far, no serious side effects have been observed in breastfed infants. In breastfed infants, hypersensitivity, gastrointestinal flora disorders, and fungal colonization may occur.

Driving and using machines

There is no data on the effect of Azithromycin ZIM on the ability to drive and use machines.

Azithromycin ZIM contains lactose and sodium

This medicine contains 40.85 mg of lactose per tablet. This should be taken into account in patients with diabetes.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Azithromycin ZIM

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

In adults and children with a body weight over 45 kg, the recommended dose for most indications is 500 mg once daily (1 tablet of 500 mg), and the duration of treatment is 3 days.
In the treatment of sexually transmitted diseases caused by Chlamydia trachomatisor Haemophilus ducreyi, the recommended dose is 1 g given as a single dose (2 tablets of 500 mg), and for Neisseria gonorrhoeae, the recommended dose is 1 g or 2 g in combination with 250 mg or 500 mg of ceftriaxone.

Use in children and adolescents

Azithromycin ZIM tablets should only be given to children with a body weight over 45 kg.

Patients with kidney or liver function disorders

The patient should inform their doctor if they have kidney or liver function disorders. The doctor may need to change the usual dose.

Method of administration

Oral administration.
Azithromycin ZIM tablets should be taken with water or another drink, with or without food.

Most convenient time to take the medicine

The medicine should be taken at the same time every day, with or without food.
Azithromycin ZIM should be taken only once a day.

Average treatment duration

In order for the treatment with Azithromycin ZIM to be effective, it should be carried out for at least 3 days, although the effect of Azithromycin ZIM lasts longer.

Taking a higher dose of Azithromycin ZIM than recommended

If someone (e.g., a child) accidentally takes too many Azithromycin ZIM tablets at once, they should immediately contact their doctor.
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Missing a dose of Azithromycin ZIM

In case of a missed dose, the patient should take it as soon as possible and then continue taking the medicine as prescribed.
The patient should not take a double dose to make up for the missed tablet.

Stopping treatment with Azithromycin ZIM

The patient should never stop treatment with Azithromycin ZIM on their own. They should first discuss it with their doctor. If azithromycin is stopped too early, the infection may return. The tablets should be taken for the entire treatment period, even if the patient feels better.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following symptoms of a severe allergic reaction occur, the patient should stop taking the medicine and immediately consult a doctor or go to the emergency department of the nearest hospital:

Very common:may occur more often than in 1 in 10 patients

• diarrhea.

Common:may occur less often than in 1 in 10 patients

• headache;
• vomiting, abdominal pain, nausea;
• changes in white blood cell count and blood bicarbonate levels.

Uncommon:may occur less often than in 1 in 100 patients

• angioedema: swelling of the lips, face, or throat leading to severe breathing difficulties;
• skin rash or urticaria.

Rare:may occur less often than in 1 in 1,000 patients

• severe skin reactions characterized by rapid onset of areas of redness on the skin covered with small blisters (blisters filled with white or yellow fluid).

Very rare:may occur less often than in 1 in 10,000 patients

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): an allergic reaction with rash, fever, swollen lymph nodes, and possible organ damage.

Frequency not known:frequency cannot be estimated from the available data

• Anaphylactic reaction: a serious allergic reaction causing breathing difficulties or dizziness.
• Severe liver function disorders or liver failure (rarely life-threatening): symptoms may include rapidly developing fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, or bleeding or behavioral disorders.
• Blisters and/or bleeding from the lips, eyes, nose, mouth, and genital organs, which may be caused by Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme, which are serious diseases. 4
• Changes in heart rate, changes in heart rhythm detected in an electrocardiogram (QT interval prolongation, ventricular tachycardia, and torsades de pointes).
• Prolonged diarrhea with blood and mucus (pseudomembranous colitis).

This is a very serious side effect. The patient may need urgent medical attention or hospitalization.

Other side effects

Uncommon:may occur less often than in 1 in 100 patients

• Fungal infections, e.g., oral thrush, vaginal thrush, pneumonia, bacterial infection.
• Sore throat, gastritis, gastrointestinal disorders.
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), stuffy nose.
• Blood disorders characterized by fever or chills, sore throat, mouth ulcers, or swollen lymph nodes.
• Allergic reactions.
• Lack of appetite.
• Nervousness, sleep disturbances.
• Dizziness, drowsiness, taste disorders, tingling, or numbness.
• Vision disorders.
• Hearing problems.
• Dizziness (feeling of spinning).
• Abnormal heartbeat or palpitations.
• Flushes.
• Breathing difficulties.
• Nosebleeds.
• Gastritis, constipation, gas, indigestion, swallowing difficulties.
• Feeling of bloating, dry mouth.
• Belching, mouth ulcers, increased salivation, loose stools.
• Liver problems (such as hepatitis).
• Rash, itching, urticaria.
• Skin inflammation, dry skin, increased sweating.
• Arthritis, muscle pain, back pain, neck pain.
• Difficulty or painful urination, back pain (kidney pain).
• Vaginitis, irregular menstrual bleeding, testicular disorders.
• Chest pain, swelling, malaise, weakness, fatigue.
• Facial swelling, hand, foot, and/or ankle swelling, fever, pain.
• Changes in laboratory test results for liver enzymes and blood parameters.

Rare:may occur less often than in 1 in 1,000 patients

• Feeling of excitement.
• Feeling of unreality towards oneself and one's feelings.
• Tooth discoloration.
• Abnormal liver function, jaundice (yellow skin pigmentation).
• Sensitivity to light (redness and blistering of the skin due to sunlight).

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Frequency not known:frequency cannot be estimated from the available data

• Blood disorders characterized by unusual bleeding or unexplained bruising, low red blood cell count causing unusual fatigue or weakness.
• Feeling of anger, restlessness, disorientation, seeing or hearing things that do not really exist.
• Fainting, seizures, weakness of sensation, overexcitement, changes in or loss of smell, loss of taste, myasthenia (muscle weakness and fatigue, see section 2 "Warnings and precautions").
• Hearing disorders, including deafness and/or tinnitus.
• Low blood pressure (which may be associated with weakness, dizziness, and fainting).
• Discoloration of the tongue, pancreatitis causing nausea, vomiting, abdominal pain, back pain.
• Rash with spots and blisters.
• Arthralgia.
• Kidney problems.

The following side effects have been reported in patients taking azithromycin to prevent Mycobacterium AviumComplex (MAC) infections:
Very common:may occur more often than in 1 in 10 patients

• Diarrhea.
• Abdominal pain.
• Nausea.
• Gas (bloating).
• Feeling of discomfort in the abdominal cavity.
• Loose stools.

Common:may occur less often than in 1 in 10 patients

• Lack of appetite (anorexia).
• Dizziness.
• Headache.
• Feeling of tingling or numbness (paresthesia).
• Changes in taste.
• Vision disorders.
• Deafness.
• Skin rash.
• Itching.
• Arthralgia.
• Feeling of fatigue.

Uncommon:may occur less often than in 1 in 100 patients

• Sensory disturbances (hypoesthesia).
• Hearing disorders, tinnitus.
• Abnormal heartbeat or palpitations.
• Liver problems, such as hepatitis.
• Blisters and/or bleeding from the lips, eyes, nose, mouth, and genital organs, which may be caused by Stevens-Johnson syndrome.

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• Skin allergic reactions, such as sensitivity to sunlight; red, peeling, and swollen skin,
• Weakness (asthenia).
• General malaise.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Azithromycin ZIM

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Azithromycin ZIM contains

• The active substance of the medicine is azithromycin. Each film-coated tablet contains 524.1 mg of azithromycin dihydrate, which corresponds to 500 mg of azithromycin (Azithromycinum)
• Other ingredients are:

Core:

Cornstarch
Lactose monohydrate
Sodium carmellose (E466)
Povidone (K30) (E1201)
Colloidal anhydrous silica
Sodium croscarmellose
Talc (E553b)
Magnesium stearate
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Coating:

Opadry II 85F18422 White:
Partially hydrolyzed polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol 3350 (E1521)
Talc (E553b).

What Azithromycin ZIM looks like and what the pack contains

Azithromycin tablets are white or almost white, capsule-shaped, biconvex, film-coated tablets with a length of approximately 16.70 mm, a width of 8.00 mm, and a thickness of 6.10 mm, with a dividing line on one side and a smooth surface on the other, packaged in blisters.
The dividing line on the tablet is not intended for breaking the tablet.
The tablets are packaged in the following pack sizes:
A cardboard box with an aluminum/PVC blister pack containing 3 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
SIA ZIM Laboratories Limited
Vangažu iela 23
LV-1024 Riga,
Latvia
phone: +48 885 500 706
Importer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000, Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:

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