Azitromicina teva 200 mg/5ml polvo para suspensiÓn oral efg

Package Leaflet: Information for the User

Azitromicina Teva 200 mg/5ml Powder for Oral Suspension EFG

Azitromycin (as dihydrate)

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAzitromicina Tevaand what it is used for

2. What you need to know before you start takingAzitromicina Teva

3. How to takeAzitromicina Teva

4. Possible side effects

5. Storage ofAzitromicina Teva

6. Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

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

• Chest infections, such as acute bronchitis and pneumonia.
• Paranasal sinus, throat, tonsil, 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 Teva:

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

Warnings and precautions:

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

• Have ever had a severe allergic reaction with facial and throat inflammation and possible respiratory problems.

• Have kidney problems, your doctor may adjust the dose.
• Have liver problems, your doctor may need to monitor your liver function or stop treatment.
• Know that you have or have been diagnosed with a prolonged QT interval (a heart condition): 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), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies), antipsychotics (e.g. pimozide), antidepressants (e.g. citalopram) or certain antibiotics (e.g. moxifloxacino, levofloxacino). Azithromycin should be used with caution.
• Are taking medications known as ergot alkaloids (e.g. ergotamine), used to treat migraine: azithromycin is not recommended (see "Other medications and Azitromicina Teva" below)
• Have been diagnosed with any neurological disease, brain or nervous system disease.

• Have mental, emotional, or behavioral problems.
• If you have myasthenia gravis, a disease characterized by muscle weakness and fatigue, as azithromycin may exacerbate symptoms or trigger the disease.

If you experience any symptoms of liver dysfunction, such as loss of appetite, yellowing of the skin or eyes, dark urine, itching or abdominal pain, stop taking Azitromicina Teva and inform your doctor immediately.

If you have an allergic reaction (e.g. difficulty breathing, dizziness, facial or throat swelling, skin rash, hives, blisters), stop taking Azitromicina Teva and contact a doctor immediately.

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 azithromycin treatment or if you notice any persistent or new symptoms, contact your doctor.

Azitromicina Teva is not indicated for children under 6 months of age.

Other medications and Azitromicina Teva

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

Notify your doctor if you are taking any of the following medications:

• Antacids, for example, aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.
• Ergotamine derivatives, such as ergotamine, (used to treat migraine): Do not administer at the same time as it may develop ergotism (a potentially severe adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).

• Oral anticoagulants, such as warfarin (used to prevent blood clots): may increase the risk of bleeding.
• Digoxin (used to treat heart failure) or colchicine (used to treat gout and familial Mediterranean fever): may increase digoxin/colchicine levels in the blood.
• Zidovudine, nelfinavir (used to treat HIV): zidovudine or azithromycin levels may increase.

• Rifabutin (used to treat HIV and bacterial infections, including tuberculosis): may decrease the number of white blood cells in the blood.
• Ciclosporin (an immunosuppressant used after organ transplantation): ciclosporin levels may increase. Your doctor will need to monitor your ciclosporin levels in the blood.
• Hydroxychloroquine (used to treat rheumatic diseases or malaria): may cause cardiac problems.

• Cisapride (used to treat stomach problems): may cause heart problems.
• Astemizol, terfenadine (antihistamines used to treat allergies): their effects may be increased.

• Alfentanil (a pain medication): the effect of alfentanil may increase.
• Fluconazole (for fungal infections): azithromycin levels may be reduced.
• Atorvastatin (a cholesterol-lowering medication). The concomitant use of azithromycin and atorvastatin has been associated with an increased risk of muscle tissue breakdown (rhabdomyolysis) leading to muscle pain and dark urine.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

There is not enough information about the use of azithromycin during pregnancy and breastfeeding. Therefore, azithromycin is not recommended if you are pregnant, plan to become pregnant, or are breastfeeding. However, your doctor may prescribe it in severe cases.

Consult your doctor before taking Azitromicina Teva if you are breastfeeding. Your doctor will decide if Azitromicina Teva can be used during breastfeeding.

Azithromycin has been excreted in breast milk. No severe adverse reactions to azithromycin have been observed in babies.

Driving and operating machinery

This medication may cause adverse effects such as dizziness or convulsions. This may affect your ability to drive or operate machinery.

Azitromicina Teva contains alcohol bencílico, sodium, sacarose, glucose, sulfur dioxide, sulfites, and wheat starch

This medication contains 0.65 micrograms of alcohol bencílico in each 5 ml of suspension.

Alcohol bencílico may cause allergic reactions.

Alcohol bencílico has been associated with a risk of severe adverse effects, including respiratory problems ("breathing difficulty") in children.

Do not use for more than one week in children under 3 years of age unless instructed by your doctor or pharmacist.

This medication contains 35.2 mg of sodium (main component of table salt/for cooking) in each 5 ml of reconstituted suspension. This is equivalent to 1.8% of the recommended daily maximum sodium intake for an adult.

This medication contains sacarose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3.75 g of sacarose per 5 milliliters.

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

This medication contains sulfites. May cause severe allergic reactions and bronchospasm.

This medication contains sulfur dioxide. May cause severe allergic reactions and bronchospasm.

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.

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

Preparation of the suspension

By yourself:You can prepare the suspension yourself using the dosing syringe included.

First, give the bottle a few gentle shakes to loosen the powder well.

For 15 ml (600 mg) bottles: Add 9.5 ml of water.

For 22.5 ml (900 mg) bottles: Add 12.0 ml of water.

For 30 ml (1,200 mg) bottles: Add 16.5 ml of water.

For 37.5 ml (1,500 mg) bottles: Add 20.0 ml of water.

Shake vigorously until a homogeneous suspension is achieved.

Dose

Azithromycin suspension should be administered as a single dose once a day, with or without food.

Shake the bottle vigorously before using the suspension.

The recommended dose is as follows:

Use in children and adolescents over45 kgin weight, adults, and the elderly

The total dose of azithromycin is 37.5 ml (1,500 mg) administered as a single dose over 3 consecutive days (12.5 ml (500 mg) once a day). Alternatively, the same total dose can be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day and continue with6.25ml (250 mg) once a day).

For urethral or cervical inflammation caused byChlamydia trachomatis, the dose is 25 ml (1,000 mg) as a single dose.

Only the treatment of sinusitis is indicated for adults and adolescents over 16 years of age.

Use in children and adolescents under45 kgin weight

Azithromycin suspension treatment should be measured carefully, with the help of the dosing syringe included, and should be administered according to the following table:

For the treatment ofpharyngitis/tonsillitisin children 2 years of age or older: the recommended dose of azithromycin is 10 mg/kg or 20 mg/kg for 3 days, with a maximum daily dose of 500 mg not to be exceeded.

Sinusitis

Available data in children under 16 years of age are limited for the treatment of sinusitis.

Patients with liver or kidney problems:

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

Instructions for the use of the dosing syringe

Filling the syringe with the medication

1. Shake the bottle before use and remove the child-resistant safety cap
2. Place the bottle on a flat and secure surface and hold it firmly with one hand and with the other insert the syringe tip into the adapter.
3. Pull the syringe plunger slowly until the graduation line indicated on the plunger is level with the top edge of the cylinder.
4. If large bubbles are seen, press the syringe plunger slowly. With this operation, the medication will pass back into the bottle. Repeat step 3.
5. Remove the syringe from the bottle.

Use of the medication using the syringe

1. Ensure the child is in a vertical position before administering the medication.
2. Insert the syringe tip carefully into the child's mouth. Point the syringe towards the inner cheek.
3. Press the syringe plunger slowly:Do not expel the medication quickly. The medication will be administered inside the child's mouth.
4. Allow the child to swallow the medication.
5. Replace the cap on the bottle. Wash the syringe according to the instructions that follow.

6.When administering for three days, daily doses less than 5 ml will leave

some suspension in the bottle. The remaining suspension should be discarded.

Cleaning and storage of the syringe

Remove the plunger from the syringe and wash the two parts with warm running water or by immersion in a sterilizing solution used for baby bottles, etc.

Dry the two parts. Replace the plunger in the syringe. Store it in a clean and safe place along with the medication. After administering the last dose of medication to the child, wrap the syringe in paper and discard.

WARNING: ADMINISTER THE MEDICATION SLOWLY TO THE CHILD AND ENSURE THEY ARE SEATED OR IN A VERTICAL POSITION. THIS WILL PREVENT THE RISK OF ASPHYXIATION.

If you take more Azitromicina Teva than you should

If you or someone takes more azithromycin than recommended, 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 your doctor or pharmacist immediately or call the Toxicology Information Service, phone:91 562 04 20. Bring this leaflet, the remaining medication, and the packaging to the hospital or your doctor so they know what medication you have taken.

If you forget to take Azitromicina Teva

If you have forgotten to take a dose, take it as soon as possible, unless it is almost time to take the next one. Do not take a double dose to make up for the missed ones.

If you interrupt treatment with Azitromicina Teva

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

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 any of the following side effects occur, stop using Azitromicina Teva and tell your doctor immediately or go to the nearest hospital emergency department:

Rare: may affect up to 1 in 100 people

• Angioedema: an allergic reaction with swelling of the lips, face, or neck, causing severe breathing difficulty; skin rash or hives.

Rare: may affect up to 1 in 10,000 people

• A skin rash characterized by the rapid appearance of red skin patches with small white or yellow pustules (small blisters filled with a white or yellow liquid)

Very rare: (may affect up to 1 in 10,000 people)

• Drug reaction with eosinophilia and systemic symptoms (DRESS): an allergic reaction with skin rash, fever, lymph node inflammation, and possible organ damage.

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

• Anaphylactic reaction: a severe allergic reaction causing breathing difficulty or dizziness
• Severe liver damage or liver failure (rarely life-threatening): symptoms may include fatigue associated with yellowing of the skin or white of the eyes (jaundice), dark urine, tendency to bleed
• Blisters/bleeding of 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.
• Changes in heart rate, changes in electrocardiogram rhythm or frequency (prolongation of the QT interval, ventricular tachycardia, and torsades de pointes)

• Prolonged diarrhea with blood and mucus (pseudomembranous colitis)

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

Other side effects

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

• Diarrhea

Common (may affect up to 1 in 10 people)

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

Rare (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, difficulty sleeping
• Dizziness, somnolence, alteration of taste, tingling or numbness
• Eye disorders
• Ear disorders
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Sensation of swelling, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Heptatitis (inflammation of the liver)
• Rash, itching, urticaria (rash with itching)
• Inflammation of the skin, dry skin, increased sweating
• Inflammation of the bones and joints, muscle pain, back pain, neck pain
• Pain and difficulty urinating, kidney pain (back pain)
• Inflammation of the vagina, irregular menstrual bleeding, testicular disorders
• Chest pain, generalized swelling, discomfort, weakness, fatigue
• Inflammation of the face, hands, legs, and feet, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Feeling of unreality.
• Teeth discoloration
• Abnormal liver function, jaundice (yellowish pigmentation of the skin)
• Sensitivity to light (redness and blistering of the skin upon exposure to sunlight)

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

• Blood disorders characterized by rare bleeding or unexplained petechiae, decrease in red blood cell count causing weakness or fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not happening
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration or loss of smell, loss of taste, myasthenia gravis (muscle weakness and fatigue, see 2 "Warnings and precautions")
• Alteration of hearing including deafness and/or tinnitus
• Decrease in blood pressure (which may be associated with weakness, loss of consciousness, and fainting)
• Discoloration of the tongue, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Rash with blisters and pustules
• Joint pain
• Renal problems

The following side effects have been reported in the treatment of prophylaxis against 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
• Headache
• Sensation of tingling or numbness (paresthesia)
• Changes in sense of taste (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthritis)
• Fatigue

Rare (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoaesthesia)
• Loss of hearing or tinnitus
• Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth, and genitals, which may be caused by Stevens-Johnson syndrome.
• Allergic skin reactions such as sensitivity to sunlight, red, scaly, and inflamed skin
• Weakness (asthenia)
• Sensation of general discomfort

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines for Human Use Pharmacovigilance System Website: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.

Do not use azithromycin after the expiration date that appears on the carton and the bottle after CAD.

Powder for suspension: Store below 25°C

After reconstitution: store below 25°C and use within 5 days (azithromycin suspension 15 ml and 22.5 ml) or within 10 days (azithromycin suspension 30 ml and 37.5 ml).

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Azitromicina Teva

• The active ingredient is azithromycin.

Each ml contains 40 mg of azithromycin (as dihydrate) after reconstitution with water (the equivalent of 200 mg of azithromycin per each 5 ml of suspension).

• The other components are: anhydrous colloidal silica, sucrose, xanthan gum (E415), anhydrous trisodium phosphate, hydroxypropylcellulose, cherry flavor (contains wheat-derived maltodextrin, gum arabic, benzyl alcohol, and sulfur dioxide E220), vanilla flavor (contains sulfites, wheat-derived and corn-derived maltodextrin, and gum arabic), banana flavor (contains sulfites, wheat-derived maltodextrin) (see section 2).

Appearance of the product and contents of the package

• The powder for the preparation of the suspension is a white to off-white powder. Once reconstituted with water, it gives a white to off-white suspension.
• The oral suspension powder is packaged in bottles with 600, 900, 1,200, or 1,500 mg of azithromycin, which after reconstitution with water provide 600 mg/15 ml, 900 mg/22.5 ml, 1,200 mg/30 ml, and 1,500 mg/37.5 ml of azithromycin suspension, respectively.

Package sizes:

Azitromicina 600 mg/15 ml: 12.555 g of powder for the preparation of 15 ml of suspension.

Azitromicina 900 mg/22.5 ml: 18.8325 g of powder for the preparation of 22.5 ml of suspension.

Azitromicina 1,200 mg/30 ml: 25.110 g of powder for the preparation of 30 ml of suspension.

Azitromicina 1,500 mg/37.5 ml: 31.3875 g of powder for the preparation of 37.5 ml of suspension.

A dosing syringe is included with the bottles.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer responsible:

Teva Operations Poland Sp. Z.o.o.

ul. Mogilska 80

31-546 Cracovia

Poland

or

Merckle GmbH

Ludwig Merckle Straße 3

89143 Blaubbeuren

Germany

or

PLIVA CROATIA LIMITED (PLIVA

KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

10000 Zagreb, Croatia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: May 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es