AZITHROMYCIN STADA 500 mg FILM-COATED TABLETS

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

Do not take Azithromycin STADA:

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

Warnings and precautions

Consult your doctor or pharmacist before starting Azithromycin STADA if you:

• Have ever had a severe allergic reaction with facial and throat swelling and potential respiratory problems.
• Have liver problems; your doctor may need to monitor your liver function or interrupt treatment.
• Are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Using Azithromycin STADA with other medicines").
• Have severe kidney problems; your doctor may need to adjust the dose.
• Know you have or have been diagnosed with a prolonged QT interval (a heart condition): azithromycin is not recommended.
• Know you have a slow or irregular pulse or reduced heart function: azithromycin is not recommended.
• Know you have low potassium or magnesium levels in your blood: azithromycin is not recommended.
• Are taking medicines known as anti-arrhythmics (used to treat abnormal heart rhythm), cisapride (used to treat stomach problems), or terfenadine (an antihistamine used to treat allergies): azithromycin is not recommended.
• Have been diagnosed with a neurological disorder, a brain or nervous system disease.
• Have mental, emotional, or behavioral problems.
• If you have a disease called myasthenia gravis, with muscle weakness and fatigue, as azithromycin may contribute to worsening the symptoms of this disease or triggering it.

If you experience severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

If symptoms persist after completing treatment with azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

Tablets are not recommended for children and adolescents weighing less than 45 kg (see section 3).

Using Azithromycin STADA with other medicines

Inform your doctor if you are taking, have recently taken, or might take any other medicines:

• Antacids, such as aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergotamine derivatives, such as ergotamine (used to treat migraines): should not be administered at the same time, as ergotism (a potentially serious side effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may develop.
• Coumarin derivatives, such as warfarin (used to prevent blood clotting): may increase the risk of bleeding.
• Digoxin (used to treat heart failure): may increase digoxin levels in the blood.
• Colchicine (used for gout and familial Mediterranean fever)
• Zidovudine, nelfinavir (used to treat HIV): zidovudine or azithromycin levels may increase.
• Rifabutin (used to treat HIV and bacterial infections, including tuberculosis): may result in a decrease in the number of white blood cells in the blood.
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin blood levels.
• Cisapride (used to treat stomach problems): heart problems may occur.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (a pain reliever): the effect of alfentanil may be increased.
• Fluconazole (for fungal infections): azithromycin levels may be reduced.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence) and trimethoprim/sulfamethoxazole (a combination antibiotic).

Using Azithromycin STADA with food and drinks

Tablets can be taken with or without food and drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough information on the safety of azithromycin during pregnancy. Therefore, azithromycin is not recommended if you are pregnant or wish to become pregnant. However, your doctor may prescribe it in severe circumstances.

Breastfeeding is not recommended while being treated with this medicine, as it may cause side effects such as diarrhea and infection in the baby. You can continue breastfeeding two days after completing treatment with Azithromycin STADA.

Driving and using machines

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

Azithromycin STADA contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Azithromycin STADA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Take the tablets preferably with a glass of water; they can be taken with or without food. Other formulations are available for different dosing regimens.

The usual dose is:

Adults (including elderly patients) and children weighing over 45 kg:

The usual dose is 1,500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

Inflammation of the urethra or cervix caused by Chlamydia

1,000 mg taken as a single dose, in one day.

Children and adolescents weighing less than 45 kg:

Tablets are not recommended for these patients. Other pharmaceutical forms containing azithromycin (e.g., suspensions) may be used.

Patient with liver or kidney problems

Tell your doctor if you have liver or kidney problems, as the normal dose may need to be adjusted.

The score line is only to facilitate breaking the tablet if you have difficulty swallowing it whole.

If you take more Azithromycin STADA than you should

If you (or someone else) have taken too many tablets at once or if you think a child has swallowed some, contact your doctor or pharmacist immediately. Overdose may cause reversible hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring this leaflet, any remaining tablets, and the packaging to the hospital or your doctor so they know what tablets you have taken.

If you forget to take Azithromycin STADA

If you forget to take a tablet, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Azithromycin STADA

Do not stop taking your medicine without talking to your doctor first, even if you feel better. It is very important that you take Azithromycin STADA for the duration indicated by your doctor; otherwise, the infection may recur.

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 experience any of the following, stop taking Azithromycin STADA and contact your doctor immediately or go to the casualty department of your nearest hospital:

• Allergic reaction (swelling of the lips, face, or throat, which may cause severe difficulty in breathing; rash or hives on the skin).
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome or toxic epidermal necrolysis, both of which are serious conditions.
• Irregular heartbeat
• Prolonged diarrhea with blood and mucus.

These are very serious but rare side effects. You may need urgent medical attention or hospitalization.

The following other 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)

• Changes in the number of certain types of white blood cells and bicarbonate in the blood
• Headache
• Vomiting, stomach pain, nausea

Uncommon (may affect up to 1 in 100 people)

• Fungal infections, such as thrush (in the mouth or vagina), pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestines
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), stuffy nose
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness
• Difficulty sleeping
• Dizziness, drowsiness, changes in taste, tingling or numbness
• Vision problems
• Hearing problems
• Dizziness (vertigo)
• Abnormal heart rhythm or rate and detection of heartbeat (palpitations)
• Hot flushes
• Breathing difficulties
• Nosebleeds
• Inflammation of the stomach, constipation, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (inflammation of the liver)
• Rash, itching, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, tiredness, facial inflammation, fever, pain.
• Changes in liver enzymes and blood test values

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

• Agitation
• Feeling that things are not real.
• Confusion, especially in elderly patients.
• Discoloration of the teeth
• Abnormal liver function, jaundice (yellowing of the skin)
• Allergic reactions including angioedema
• Redness and blistering of the skin when exposed to sunlight
• Severe skin reactions
• Rash characterized by the rapid appearance of red skin areas dotted with small blisters (small bumps filled with white/yellow fluid).

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

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in blood cell count causing weakness or tiredness
• Aggression, anxiety, confusion, seeing or hearing things that are not there
• Fainting, seizures, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, alteration or loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and precautions" above)
• Changes in hearing, including deafness and/or ringing in the ears
• Changes in heart rate or rhythm and detection of heartbeat (palpitations), changes in the heart rhythm detected on an electrocardiogram (prolongation of the QT interval and Torsade de Pointes)
• Decrease in blood pressure (which may be associated with weakness, dizziness, and fainting)
• Discoloration of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely fatal)
• Rash with blisters and bumps
• Kidney problems
• Severe intestinal inflammation (pseudomembranous colitis)
• Severe allergic reaction that can cause shock (anaphylactic reaction)

The following side effects have been reported in patients taking azithromycin for the prevention of Mycobacterium Avium Complex (MAC) infections:

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

• Diarrhea
• Abdominal pain
• Nausea
• Gas (flatulence)
• Abdominal discomfort
• Soft stools

Common (may affect up to 1 in 10 people)

• Lack of appetite (anorexia)
• Feeling of dizziness (dizziness)
• Headache
• Feeling of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual disturbances
• Deafness
• Rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Tiredness

Uncommon (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoesthesia) - Loss of hearing or ringing in the ears
• Abnormal heart rhythm or rate and detection of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome.
• Skin allergic reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• Feeling of general discomfort

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin STADA

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

No special storage conditions are required. Store in the original packaging.

Do not use Azithromycin STADA after the expiry date which is stated on the carton, after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Azitromicina STADA Composition

• Each tablet contains 500 mg of the active ingredient azithromycin (as dihydrate).
• The other components are: calcium hydrogen phosphate, pregelatinized corn starch, sodium croscarmellose, sodium lauryl sulfate (E 487), magnesium stearate, hypromellose, polydextrose, titanium dioxide (E-171), macrogol 4000.

Product Appearance and Package Contents

Coated tablets, white, elongated, with biconvex faces, with a notch on one face and the inscription "500" on the other.

They are presented in PVC blisters sealed with a heat-sealable aluminum foil in packs of 3 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Neuraxpharm Pharmaceuticals S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the Last Revision of this Leaflet:May 2018

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es