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Package leaflet: Information for the user

Azithromycin 2care4 250 mg film-coated tablets

10-2022

P433596-3

azithromycin

Read this leaflet carefully before you start taking this medicine as it contains important information.
– Save the leaflet. You may need to read it again.
– Ask the doctor or pharmacist if there is more you want to know.
– The doctor has prescribed this medicine for you personally. Therefore, do not give the medicine to others. It can be harmful to others,
even if they have the same symptoms as you.
– Contact the doctor or pharmacist if you experience side effects, including side effects that are not mentioned in this leaflet. See section 4.

See the latest package insert at www.indlaegsseddel.dk.

Overview of the package leaflet

1. Effect and use 2. What you
need to know before you start taking
Azithromycin 2care4 3. How to take
Azithromycin 2care4 4. Side effects 5. Storage
6. Pack sizes and additional information

1. Effect and application

Azithromycin 2care4 contains an antibiotic of the macrolide type. You can take Azithromycin 2care4 against inflammation (infections) with bacteria, e.g. in: • tonsils, sinuses
and pharynx • the respiratory tract, e.g. bronchitis and pneumonia • skin and muscles • the genitals or in • otitis media.

Contact your doctor if you feel worse or if you do not get better.

2. What you need to know before you start taking Azithromycin 2care4
The doctor may have prescribed a different use or dosage than indicated in this information. Always follow your doctor's instructions and the information on the
dosage label.

Do not take Azithromycin 2care4:

– if you are allergic to azithromycin, other medicines of the same type (macrolide or ketolide antibiotics) or one of the other ingredients in
Azithromycin 2care4 (listed in section 6).

Warnings and precautions Contact

the doctor or pharmacist before taking Azithromycin 2care4: • if you have a bad
liver or kidney. • if you have problems with your heart (e.g. very slow heart rate or
irregular heart rate), especially if you are female or elderly. • if you are taking medication for migraines (eg ergotamine). • if you take medicines
that reduce the immune system (ciclosporin).

If you experience allergic reactions in the form of difficulty breathing, rash, shortness of breath, facial swelling and shock, contact a doctor or emergency room immediately.

Contact your doctor immediately if you get prolonged or bloody diarrhea when you receive or (up to 2 months) after you receive Azithromycin 2care4. It may be a sign of
severe intestinal inflammation (pseudomembranous colitis or clostridium difficile associated diarrhoea).

Always state at blood test and urine tests that you are being treated with Azithromycin 2care4. This may have an impact on the test results.

Abdominal strictures have been seen in neonates given azithromycin. Parents should therefore contact the doctor if the child vomits or shows irritability when eating.

Using other medicines with Azithromycin 2care4 Always tell

your doctor or pharmacist if you are taking other medicines, have recently taken other medicines or plan to take other medicines.

Other medicines can affect the effect of Azithromycin 2care4, or Azithromycin 2care4 can affect the effect of other medicines. If you want more information about this,
ask your doctor or pharmacist.

Talk to your doctor if you are taking the following

medicines: • Migraine medicine (ergotamine). •
Cholesterol-lowering medicines (eg lovastatin and atorvastatin). • Medicines
that reduce the immune system (ciclosporin). • Antibiotics against
tuberculosis (rifabutin). • Antacid medication against too much stomach
acid. • Blood-thinning medicines (warfarin, phenprocoumon, coumarin-like
medicines). • Heart medication (digoxin). • Medication against gout and Mediterranean fever
(colchicine).
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• Medication against HIV (nelfinavir, zidovudine).
• Medicines that can cause serious heart rhythm disturbances with a fast, irregular pulse (eg terfenadine and so-called class IA and III antiarrhythmics).
The doctor should then ensure that your clinical condition is closely monitored during treatment.

Using Azithromycin 2care4 with food and drink You can take
Azithromycin 2care4 with food and drink. You can also take Azithromycin 2care4 without food.

Pregnancy and breast-

feeding If you are pregnant or breast-feeding, suspect that you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this
medicine.

Pregnancy
You may only take Azithromycin 2care4 if strictly necessary and only as directed by your doctor.

Breast
-feeding If you are breast-feeding, you may only take Azithromycin 2care4 in consultation with your doctor.

Traffic and occupational

safety Azithromycin 2care4 does not affect occupational safety or the ability to drive safely in traffic.

Azithromycin 2care4 contains lactose and sodium Contact

the doctor before taking this medicine if the doctor has told you that you have an intolerance to certain sugars.

Azithromycin 2care4 film-coated tablets contain less than 1 mmol (23 mg) sodium per tablet, i.e. they are essentially sodium free.

3. How to take Azithromycin 2care4 Always take

Azithromycin 2care4 exactly as directed by your doctor or pharmacist. If you are in doubt, ask your doctor or pharmacist.

The tablets must be split, but not chewed or crushed.

The recommended dose

is: Adults: 500 mg once
daily for 3 days, or 500 mg on the first day, then 250 mg once daily for 4 days.

For chlamydia infection or infection with the bacterium Haemophilus ducreyi (genital ulcers):
1,000 mg as a single dose.

For inflammation of the genitals (gonorrhea):

1,000 mg or 2,000 mg as a single dose. The tablets may need to taken together with ceftriaxone - follow the doctor's instructions.

Elderly:
It is not necessary to reduce the dose.

Impaired renal function: It may be necessary to reduce the dose in patients with severely impaired renal function. You must follow the doctor's instructions.

Impaired liver function: It may be necessary to reduce the dose in patients with severely impaired liver function. You must follow the doctor's instructions.

It is important to take the entire course of Azithromycin 2care4, as otherwise the disease may flare up.

If you have taken too much Azithromycin 2care4

Contact the doctor, emergency room or pharmacist if you have taken more Azithromycin 2care4 than is stated in this information or more than prescribed by the doctor
(and you feel unwell).

If you have taken too much Azithromycin 2care4, you may experience temporary hearing loss, severe nausea, vomiting,
abdominal pain and diarrhoea.

If you forget to take Azithromycin 2care4 If you miss

a dose, take it as soon as you remember. If you need to take the next dose soon, skip the missed dose. Do not take a double dose to make up for the missed dose.

If you stop taking Azithromycin 2care4 You may only take

a break or stop treatment in agreement with your doctor. Ask the doctor or pharmacist if there is anything you are unsure about.

4. Side effects

This medicine, like all other medicines, can cause side effects, but not everyone gets side effects.

Serious side effects

Uncommon side effects (affects between 1 and 10 in 1,000 patients) • Inflammation of the liver,
jaundice. Contact a doctor or emergency department. • Blister-shaped rash and inflammation of the
skin, especially on the hands and feet and in and around the mouth, accompanied by fever. Contact a doctor or emergency room. • Pneumonia. Contact the doctor.

Rare side effects (affects between 1 and 10 in 10,000 patients) • Skin rash with small blisters
accompanied by fever. Contact the doctor. • Fever, rash, inflammation of some organs and
swollen lymph nodes, as well as changes in the blood (e.g. high number of white blood cells). Contact the doctor.
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Side effects, the frequency of which is not known •
Sudden rash, difficulty breathing and fainting (within minutes to hours), due to hypersensitivity (anaphylactic reaction). Can be life-threatening. Ring
112.
• Severe diarrhea due to inflammation of the colon. Contact the doctor. •
Bleeding from the skin and mucous membranes and bruising due to changes in the blood (too few platelets). Contact a doctor or emergency room.
• Severe anemia with jaundice. Contact a doctor or emergency room. • Abnormal fatigue and paralysis of muscles, especially of the eyelids, difficulty
breathing. Immediately contact the doctor or emergency room. In case of breathing difficulties, call 112. • Serious heart rhythm disturbances with fast, irregular pulse.
Immediately contact the doctor or emergency room. Call if necessary 112. • Violent abdominal pain and fever due to inflammation of the pancreas. Contact a doctor or
emergency room. • Jaundice, lethargy, possibly unconsciousness due to liver failure. Contact a doctor or emergency room. • Violent, rapidly developing jaundice with nausea,
vomiting and very pronounced lethargy. Contact a doctor or emergency department. • Jaundice with itchy skin. Contact the doctor. • Strong peeling and rejection of skin.
Contact a doctor or emergency department. • Nausea, vomiting, general lethargy and decreased urine production due to acute kidney failure. Contact a doctor or emergency
room. • Slowly decreasing kidney function with attacks of pain over the lower back, cloudy or bloody urine due to kidney damage. Contact a doctor or emergency department.

Not serious side effects Very

common side effects (affects more than 1 in 10 patients) • Diarrhoea, stomach pain, nausea,
flatulence.

Common side effects (affects between 1 and 10 in 100 patients) • Loss of appetite, vomiting,
heartburn. • Dizziness, headache, taste disturbances. • Tingling, tingling sensations or numbness
in the skin. • Visual disturbances. • Rash, itching. • Pain in the joints. • Exhaustion. • Changes in
the number of some white blood cells and the level of bicarbonate in the blood.

Uncommon side effects (occurs in between 1 and 10 out of 1,000 patients) • Inflammation of the vagina,
fungal infection in the mouth, for example (thrush), bacterial infection. • Sore throat, gastrointestinal infection.
• Difficulty breathing, stuffy nose. • General lethargy, tendency to inflammation (infections) especially sore
throat and fever due to changes in the blood (too few white blood cells). Can become serious.

If you develop a fever, contact your doctor immediately.

• Rash (hives) and swelling. Can be serious. Talk to the doctor. If there is swelling of the face, lips and tongue, it can be life-threatening. Call 112. • Hypersensitivity. • Nervousness.
• Drowsiness, insomnia. • Impaired hearing/deafness, ringing in the ears (tinnitus), dizziness due to ear disorders. • Heart palpitations. • The redness. • Weather training difficulties,
nosebleeds. • Constipation, inflammation of the stomach, bloating, dry mouth, belching, sores in the mouth, increased saliva production. • Increased sensitivity of the skin to light,
hives. • Inflammation in bones and joints, muscle pain, back pain, neck pain. • Pain and burning when urinating, pain above the lower back (kidney pain). • Irregular and heavy
menstruation, disorders of the testicles. • Chest pain, water in the body or face (swelling), weakness, malaise, fever, pain. • Complications after surgery. • Eczema or skin irritation/
rash, dry skin, increased sweating.

Rare side effects (occurs between 1 and 10 in 10,000 patients) • Restless restlessness. •
Influence on the function of the liver, possibly with jaundice. Can be serious. If you develop
jaundice, contact a doctor.

Side effects, the frequency of which is not known •

Aggressiveness, anxiety, confusion, hallucinations (hearing or seeing things that are not there). •
Fainting. In case of normal pulse and breathing and rapid awakening, talk to a doctor. In all other cases call 112. • Cramps,
hyperactivity, reduced sense of smell, lack of taste perception, distorted sense of smell. • Irregular and/or rapid heart rate. May be or
become serious. If you get a very fast and irregular pulse or feel unwell or pass out, you should
contact a doctor or emergency room. Call if necessary
112. • Dizziness, possibly fainting due to low blood
pressure. • Discoloration of the tongue. • Fever, rash on
the face and on the arms and legs. • Reduced sensation to
touch.

Azithromycin 2care4 can also cause side effects that you normally do not notice. It concerns changes in certain laboratory samples, e.g. blood tests.
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Reporting side effects If you
experience side effects, you should talk to your doctor, pharmacist or nurse. This also applies to possible side effects that are not included in this leaflet. You or your
relatives can also report side effects directly to the Danish Medicines Agency via the Danish Medicines Agency Axel Heides Gade 1 DK-2300 Copenhagen S Website:
www.meldenbivirkning.dk

By reporting side effects, you can help provide more information about the safety of this medicine.

5. Storage Keep

the medicine out of the reach of children.

Do not store above 30 °C.

Do not take Azithromycin 2care4 after the expiry date which is stated on the carton after EXP. The expiration date is the last day of that month.

Ask the pharmacy staff how to dispose of drug residues. For the sake of the environment, you must not throw medicinal residues down the drain, toilet or rubbish bin.

6. Package sizes and additional information

Azithromycin 2care4 contains: –
Active substance: azithromycin.
1 film-coated tablet contains 250 mg of azithromycin as azithromycin dihydrate.
– Other ingredients: pregelatinized starch; anhydrous calcium hydrogen phosphate; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate.
Film coating: hypromellose; lactose, titanium dioxide (E 171); triacetin.

What Azithromycin 2care4 film-

coated tablets 250 mg looks like and contents of the pack are white, oblong, film-coated tablets marked ZTM 250 on one side and PFIZER on the other.

Azithromycin 2care4 is available in packs of 6 film-coated tablets.

Marketing authorization
holder: 2care4

Stenhuggervej 12
6710 Esbjerg V

Manufacturer:
2care4
Stenhuggervej 12-14
6710 Esbjerg V

Azithromycin 2care4 is similar to Zithromax.

This leaflet was last modified October 2022.