Prospect: Information for the User

Azitromicina Kern Pharma 200 mg/5 ml powder for oral suspension EFG

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used to treat bacterial infections caused by microorganisms such as bacteria. These infections include:

• Worsening of chronic bronchitis and pneumonia (mild to moderate severity).
• Upper respiratory tract infections, throat, tonsils, or ear infections.
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin infection, and cellulitis, or erysipelas, a skin infection with redness and swelling.
• Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the urethra or cervix.

Do not take Azitromicina Kern Pharma

• If you are allergic to azithromycin or any of the other components of this medication (listed in section 6) or another macrolide or ketolide antibiotic, such as erythromycin or telithromycin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Kern Pharma if you:

• Have ever had a severe allergic reaction with facial and throat inflammation and possible respiratory problems.
• Have liver problems, your doctor may need to monitor your liver function or discontinue treatment.
• Are taking medications known as ergot alkaloids (such as ergotamine), used to treat migraines: azithromycin is not recommended (see "Use of Azitromicina Kern Pharma with other medications").
• Have severe kidney problems, your doctor may modify the dose.
• Know that you have or have been diagnosed with prolonged QT interval (a heart disease): azithromycin is not recommended.
• Know that you have a slow or irregular pulse or reduced cardiac function: azithromycin is not recommended.
• Know that you have low levels of potassium or magnesium 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 any neurological disease, 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 exacerbate the 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 completing treatment with azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Children and adolescents

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

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

Other medications and Azitromicina Kern Pharma

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

• Antacids, for example, aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergot derivatives, for example, ergotamine (used to treat migraines): Do not administer at the same time as it may develop ergotism (a potentially serious adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Coumarin derivatives, for example, 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 to treat gout and familial Mediterranean fever)
• Zidovudine, nelfinavir (used in HIV treatment): zidovudine or azithromycin levels may increase.
• Rifabutin (used in HIV and bacterial infections, including tuberculosis): may occur a decrease in the number of white blood cells in the blood.
• Ciclosporin (an immunosuppressant used after organ transplant): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• Cisapride (used to treat stomach problems): may cause heart problems.
• Astemizol, terfenadine (antihistamines used to treat allergic reactions), their effects may be increased.
• Alfentanil (sedative): 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).

Use of Azitromicina 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

Do not breastfeed while taking this medication as it may cause side effects such as diarrhea and infection in the baby. You can continue breastfeeding two days after completing treatment with Azitromicina Kern Pharma.

Driving and operating machines

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

Azitromicina Kern Pharma contains saccharose, sodium, wheat starch, and glucose

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

This medication contains sodium. Patients on low-sodium diets 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 wheat allergy (other than 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 certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication is administered orally. To facilitate administration, each bottle is accompanied by a dosing syringe.

This medication is not indicated for children under 1 year of age, see the "Children and Adolescents" section.

Dosage

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 of weight, adults, and elderly people

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 continue with 6.25 ml (250 mg) once a day).

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

The 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 with a weight over 45 kg.

Use in children and adolescents under 45 kg of weight

The treatment with azithromycin suspension should be measured carefully, with the help of the dosing syringe that comes with it, according to the child's weight, as follows:

For the treatment of pharyngitis/tonsillitis 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 over 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:

Inform your doctor if you have liver or kidney problems as you may need to modify the usual dose.

Preparation of the suspension:

• Invert the bottle and shake it gently until all the powder is freely moving.
• Open the bottle and add the following amount of water according to the size of the bottle, using the dosing syringe that comes with it:

Bottle of 15 ml: add 10 ml of water

Bottle of 30 ml: add 15 ml of water

Place the plastic stopper with a hole and press it until it is inserted into the mouth of the bottle.

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

Administration of the prepared suspension:

• Shake the suspension before each dose.
• Open the safety metal cap. Insert the syringe into the plastic stopper with a hole.
• Maintaining the syringe inserted, invert the bottle so that it remains in a vertical position.
• Fill the syringe to the dose indicated by your doctor.
• Return the bottle to its original position, extract the syringe, and proceed with the administration.
• Wash the syringe after each administration.

Once the syringe is prepared, administer immediately.

WARNING: ADMINISTER THE MEDICINE SLOWLY TO THE CHILD AND ENSURE IT IS INCORPORATED. THIS WAY YOU WILL AVOID THE RISK OF ASPHYXIATION.

If you take more Azitromicina Kern Pharma than you should

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

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

If you forget to take Azitromicina Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Azitromicina Kern Pharma

Do not stop taking your medicine without consulting your doctor, even if you feel better. It is very important that you continue taking Azitromicina Kern Pharma for the time your doctor has indicated, as the infection may recur if you stop treatment.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Azitromicina Kern Pharma and seek immediate medical attention or visit the nearest hospital emergency room:

• Allergic reaction (swelling of the lips, face, or neck, causing severe difficulty breathing; skin rash or hives).
• Blisters/blood in the lips, eyes, nose, mouth, and genitals, which may 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 side effects. You may need urgent medical attention or hospitalization.

The following 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)

• Alteration of the number of some 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 infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestine
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders), nasal congestion
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness
• Dizziness, drowsiness, taste alterations, tingling or numbness
• Visual disturbances
• Auditory problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and heart palpitations
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Inflammation of the stomach, constipation, difficulty swallowing, feeling bloated, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Jaundice (inflammation of the liver)
• Skin rash, itching, urticaria (hives)
• 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, inflammation of the face, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Feeling that things are unreal
• Confusion, especially in elderly patients
• Teeth discoloration
• Abnormal liver function, jaundice (yellowing of the skin)
• Allergic reactions including angioneurotic edema
• Redness and blistering of the skin upon exposure to sunlight
• Skin rash characterized by the rapid appearance of red skin areas dotted with small white/yellow pustules.

Unknown (frequency cannot be estimated from available data)

• Blood disorders characterized by rare bleeding or unexplained bruises, rare anemia causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Loss of consciousness, 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)
• Alteration in hearing including deafness and/or ringing in the ears.
• Changes in heart rate, changes in heart rhythm detected by electrocardiogram (prolongation of the QT interval and Torsade de Pointes).
• Decreased blood pressure (which may be associated with weakness, dizziness, and loss of consciousness)
• Discoloration of the tongue, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Acute liver failure (rarely fatal)
• Skin rash with blisters and spots
• Renal problems
• Severe inflammation of the intestine (pseudomembranous colitis)
• Severe allergic reaction that can cause anaphylaxis

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

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)

• Loss of appetite (anorexia)
• Dizziness (dizziness)
• Headache
• Sensation of tingling or numbness (paresthesia)
• Changes in taste (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Reduced sensitivity (hypoaesthesia)
• Loss of hearing or ringing in the ears
• Abnormal heart rhythm or frequency and heart palpitations
• Liver problems such as hepatitis
• Blisters/blood in the lips or eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome
• Allergic reactions of the skin such as sensitivity to sunlight, red, flaky, and inflamed skin
• Weakness (asthenia)
• General feeling of discomfort

Reporting of side effects

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

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

Sealed bottles: Do not store at a temperature above 25ºC. Store in the original packaging.

Reconstituted solution: Note in the box and on the bottle label the day and month of the suspension reconstitution. Do not take the medication after 10 days from its reconstitution; discard any remaining product after this time. Do not store at a temperature above 25 ºC.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 components (excipients) are: sucrose, hydroxypropylcellulose (E463), anhydrous trisodium phosphate, xanthan gum (E415), cherry flavor (contains wheat-derived maltodextrin), vanilla flavor (contains wheat-derived maltodextrin), and banana flavor (contains wheat-derived maltodextrin) (see section 2).

Appearance of the product and contents of the package

White, powdery, and fruity-smelling dry powder for oral suspension.

It is packaged in a topaz-colored glass vial, closed with an aluminum capsule. The perforated stopper and the accompanying syringe are made of plastic.

It is presented in packages of 15 ml or 30 ml vials and in packages of 20 vials of 15 or 30 ml (clinical package).

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.

It may only be marketed in some package sizes.

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: May 2018.

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