AZITHROMYCIN KERN PHARMA 200 mg/5 ml ORAL SUSPENSION POWDER

2. What you need to know before you take Azithromycin Kern Pharma

Do not take Azithromycin Kern Pharma

• If you are allergic to azithromycin or any of the other ingredients of this medication (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 to take Azithromycin Kern Pharma 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 medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Using Azithromycin Kern Pharma with other medications").
• 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 medications known as antiarrhythmics (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 symptoms of this disease or trigger 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 finishing treatment with azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

This medication is not indicated in children under 1 year of age.

For the treatment of sinusitis, the available data in children under 16 years of age are limited (see section 3).

Other medications and Azithromycin Kern Pharma

Inform your doctor if you are taking, have recently taken, or may need to take any other medication:

• 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 in the treatment of HIV): zidovudine or azithromycin levels may increase.
• Rifabutin (used in the treatment of HIV and bacterial infections, including tuberculosis): a decrease in the number of white blood cells in the blood may occur.
• Cyclosporin (an immunosuppressant used after organ transplantation): cyclosporin levels may increase. Your doctor will need to monitor your cyclosporin levels in the blood.
• Cisapride (used to treat stomach problems): heart problems may appear.
• Astemizole, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (a pain reliever): the effect of alfentanil may increase.
• 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 Kern Pharma with food and drinks

The oral suspension 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 regarding the safety of azithromycin during pregnancy. Consequently, the use of azithromycin is not recommended if you are pregnant or wish to become pregnant. However, your doctor may prescribe it in serious circumstances.

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

Driving and using machines

There is no evidence that azithromycin affects the ability to drive or use machines.

Azithromycin Kern Pharma contains sucrose, sodium, wheat starch, and glucose

This medication contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine. Patients with diabetes mellitus should note that this medication contains 3.624 g of sucrose per 5 ml of reconstituted suspension.

This medication contains sodium. Patients on a low-sodium diet should note that this medication contains 18.7 mg (0.79 mmol) of sodium per 5 ml of reconstituted suspension (derived from anhydrous trisodium phosphate).

This medication contains wheat starch. It is suitable for patients with celiac disease. Patients with a wheat allergy (distinct from celiac disease) should not take this medication.

This medication contains glucose (in maltodextrin from wheat). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Azithromycin Kern Pharma

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medication is administered orally. To facilitate administration, each bottle comes with a dosing syringe.

This medication is not indicated in children under 1 year of age, see "Children and adolescents" section.

Dose

The azithromycin suspension should be administered in a single dose once a day, with or without food.

Shake the bottle vigorously before using the suspension.

Other presentations are available for different dosing regimens.

The usual dose is as follows:

Use in children and adolescents over 45 kg in weight, adults, and the elderly

The total dose of azithromycin is 37.5 ml (1,500 mg) administered over 3 days (12.5 ml (500 mg) once a day). Alternatively, the dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and continued with 6.25 ml (250 mg) once a day).

For the treatment of urethritis or cervicitis caused by Chlamydia, the dose is 25 ml (1,000 mg) in a single dose.

Treatment of sinusitis is only indicated for adults and adolescents over 16 years of age.

Other presentations are available that are more suitable for patients weighing over 45 kg.

Use in children and adolescents under 45 kg in weight

Treatment with azithromycin suspension should be carefully measured, using the dosing syringe provided, based on the child's weight, according to the following table:

For the treatment of tonsillitis/pharyngitis in children 2 years of age or older: the recommended dose of azithromycin is a single dose of 10 mg/kg or 20 mg/kg for 3 days, not exceeding a maximum daily dose of 500 mg.

Sinusitis

For the treatment of sinusitis, the available data in children under 16 years of age are limited.

Patients with liver or kidney problems:

You should inform your doctor if you have liver or kidney problems, as they may need to adjust the normal dose.

Preparation of the suspension:

• Invert the bottle and shake it gently until all the powder moves freely.
• Open the bottle and add the following amount of water, using the dosing syringe provided, depending on the bottle size:

Bottle of 15 ml: add 10 ml of water

Bottle of 30 ml: add 15 ml of water

Place the plastic perforated cap and press it until it is fully inserted into the bottle mouth.

• Close the bottle with the metal cap.
• Shake vigorously until a homogeneous suspension is obtained. The suspension level will be at the mark on the label. The suspension has a milky appearance.
• Do not forget to shake the suspension before each intake.

Administration of the preparation:

• Shake the suspension before each intake.
• Open the metal safety cap. Insert the syringe into the plastic perforated cap.
• While keeping the syringe inserted, invert the bottle so that it remains in a vertical position.
• Fill the syringe up to the mark corresponding to the dose prescribed by your doctor.
• Invert the bottle again, remove the syringe, and proceed with administration.
• Wash the syringe after each administration.

Once the syringe is prepared, administer immediately.

WARNING: ADMINISTER THE MEDICATION SLOWLY TO THE CHILD AND ENSURE IT IS SWALLOWED. THIS WILL AVOID THE RISK OF ASPHYXIA.

If you take more Azithromycin Kern Pharma than you should

If you (or someone else) take more azithromycin than you should, inform your doctor or pharmacist immediately. A overdose is likely to cause temporary hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562 04 20.

If you forget to take Azithromycin Kern Pharma

Do not take a double dose to make up for forgotten doses.

If you stop taking Azithromycin Kern Pharma

Do not stop taking your medication without consulting your doctor first, even if you feel better. It is very important that you continue taking Azithromycin Kern Pharma for the time indicated by your doctor, otherwise the infection may recur.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following, stop taking Azitromicina Kern Pharma and consult your doctor immediately or go to the emergency room of the nearest hospital:

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

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

Other adverse effects have been reported, which are described below:

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

• Diarrhea

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Fungal infection, for example in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach and intestine lining
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders), congested nose
• Blood disorders characterized by fever or chills, sore throat, ulcers in the mouth or throat
• Allergic reactions
• Lack of appetite
• Nervousness
• Dizziness, drowsiness, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Vertigo (feeling of spinning)
• Abnormality in heart rhythm or frequency and detection of heartbeat (palpitations)
• Hot flashes
• Difficulty breathing
• Nosebleeds
• Stomach inflammation, constipation, difficulty swallowing, feeling of being bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Hepatitis (inflammation of the liver)
• Skin 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, fatigue, 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 unreal
• Confusion, especially in elderly patients
• Discoloration of teeth
• Abnormal liver function, jaundice (yellowish skin pigmentation)
• Allergic reactions including angioedema
• Redness and blistering of the skin when exposed to sunlight
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled blisters (small blisters filled with white/yellow liquid)

Unknown frequency (frequency cannot be estimated from available data)

• Blood disorders characterized by uncommon bleeding or unexplained bruising, decrease in blood cell count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• 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
• Change in heart rate, changes in heart rhythm detected on electrocardiogram (prolongation of 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)
• Skin rash with spots and blisters
• Kidney problems
• Severe intestinal inflammation (pseudomembranous colitis)
• Severe allergic reaction that can cause shock (anaphylactic reaction)

The following adverse effects have been reported in patients being treated with 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 impairment
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azitromicina Kern Pharma

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

Closed bottles: Do not store above 25°C. Store in the original packaging.

Reconstituted solution: Write the day and month of reconstitution of the suspension in the box provided on the box and the label of the bottle. Do not take the medicine after 10 days from reconstitution; after this time, discard the remaining product. Do not store above 25°C.

Do not use Azitromicina Kern Pharma after the expiration date stated on the packaging, after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Additional information

Composition of Azitromicina Kern Pharma

• The active ingredient is azithromycin (as dihydrate). Each 5 ml of reconstituted suspension contains 200 mg of azithromycin. Each ml of reconstituted suspension contains 40 mg of azithromycin.
• The other ingredients (excipients) are: sucrose, hydroxypropylcellulose (E463), anhydrous trisodium phosphate, xanthan gum (E415), cherry flavor (contains maltodextrin from wheat), vanilla flavor (contains maltodextrin from wheat) and banana flavor (contains maltodextrin from wheat) (see section 2).

Appearance and packaging of the product

Dry powder for oral suspension, ivory in color and fruity in smell.

It is packaged in a topaz glass bottle, closed with an aluminum cap. The pierced cap and the dosing syringe that accompany the bottle are made of plastic.

It is available in packaging of 1 bottle of 15 ml or 30 ml and in packaging of 20 bottles of 15 or 30 ml (clinical packaging).

A dosing syringe with three types of scales is included: in kg (from 0 to 40 kg) based on body weight; in ml (from 0 to 10 ml) based on the volume of suspension; and in mg (from 0 to 400 mg) based on the amount of active ingredient.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet: May 2018.

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