PROSPECTO: INFORMATION FOR THE USER

Azitromicina Combix 500 mg film-coated tablets EFG

Azitromycin (as dihydrate)

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

• Keep this prospect as you may need to read it again.
• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others 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 medicines called macrolide antibiotics. It is used to treat infections caused by microorganisms such as bacteria. These infections include:

• Chest infections, such as bronchitis and pneumonia
• Upper respiratory tract infections, including sinuses, throat, tonsils, or ears
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin and subcutaneous tissue infections (cellulitis), and erysipelas, a skin infection with red inflammation
• Infections caused by a bacterium called Chlamydia trachomatis. These can cause inflammation in the urethra, which is the tube that carries urine from the bladder, or the cervix, where the uterus joins the vagina.

Do not take Azitromicina Combix

• if you are allergic (hypersensitive) to azithromycin or any of the other components of this medication (listed in section 6); or to other macrolide antibiotics, for example, erythromycin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Combix.

Be especially careful with Azitromicina Combix

Before starting treatment with this medication, inform your doctor if:

• you have ever had a severe allergic reaction characterized by symptoms such as swelling of the face or throat, possibly with difficulty breathing.
• you have severe kidney problems, your doctor may change your dose.
• you have liver problems: your doctor may need to monitor your liver function or decide to stop the medication
• you know that you have been diagnosed with prolonged QT interval (cardiac problem): azithromycin is not recommended for use
• you know that you have an irregular or slow pulse, or reduced cardiac function: azithromycin is not recommended for use
• you know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended for use
• you are taking medications known as antiarrhythmics (used to treat abnormal heart rhythm), cisaprida (used to treat stomach problems) or terfenadine (an antihistamine used to treat allergies): azithromycin is not recommended for use
• you are taking medications called ergot alkaloids (such as ergotamine) used to treat migraine: azithromycin is not recommended for use (see 'Use of other medications')
• you have been diagnosed with a neurological disease, which is a disease of the brain or nervous system
• you have mental, emotional, or behavioral problems

If you experience severe or persistent diarrhea during or after treatment, particularly if you notice blood or mucus, you should inform your doctor immediately.

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

Use of Azitromicina with other medications

Consult 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 the antacid
• Ergot derivatives, for example, ergotamine (used to treat migraine): azithromycin should not be taken simultaneously as it may cause ergotism (a potentially severe adverse reaction with numbness or tingling in the extremities, muscle cramps, headaches, seizures, chest or abdominal 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 (used in the treatment of HIV): may increase zidovudine levels
• Rifabutin (used in the treatment of HIV and bacterial infections including tuberculosis): both rifabutin and azithromycin levels in the blood may be affected, with a possible decrease in white blood cell count
• Theophylline (used to treat asthma and other respiratory diseases): the effect of theophylline may be increased
• Quinidine (used to control heart rhythm): quinidine levels may increase
• Ciclosporin (an immunosuppressant used after a transplant): your doctor should monitor your ciclosporin levels in the blood
• Pimozide (used to treat schizophrenia or other mental problems): pimozide levels may increase
• Cisaprida (used to treat stomach problems): may cause cardiac problems
• Astemizol, terfenadine (antihistamines used to treat allergic reactions): effects may be increased
• Triazolam and midazolam (sedatives): effects may be increased
• Alfentanil (an analgesic): the effect of alfentanil may be increased.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Pregnancy and breastfeeding

The available information on the safety of azithromycin during pregnancy is insufficient. Therefore, azithromycin is not recommended if you are pregnant or trying to become pregnant. However, your doctor may decide to prescribe it under grave circumstances.

You should not breastfeed while taking azithromycin, as it may cause adverse reactions in the infant, including diarrhea and infections. You may resume breastfeeding two days after stopping treatment with azithromycin.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Azithromycin may cause dizziness and seizures. If this is your case, do not drive or operate machinery.

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

Follow exactly the administration instructions for azitromicina as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets should be swallowed preferably with water, they can be taken with or without food.

The recommended dose is:

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

The usual dose is 1,500 mg divided over 3 or 5 days in the following way:

• For 3 days, 500 mg per day.
• For 5 days, 500 mg on the first day and then 250 mg on days 2 to 5.
• Urethral or cervical inflammation caused by Chlamydia

Patients with renal or hepatic impairments:

You must inform your doctor immediately if you have kidney or liver problems as this may require modification of the usual dose.

Use in children and adolescents

Children and adolescents under 45 kg of weight:

The tablets are not indicated for these patients. Other pharmaceutical forms of azitromicina medications (e.g. suspensions) may be used.

If you take more Azitromicina Combix than you should

If you (or another person) ingest many tablets at once, or if you believe a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount used. It is recommended to bring the packaging and leaflet to the healthcare professional. A overdose may cause reversible hearing loss, intense nausea (sensation of dizziness), vomiting, and diarrhea.

If you forget to take Azitromicina Combix

If you forget to take a tablet, take it as soon as possible, unless it is almost time for the next dose.

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

If you interrupt the treatment with Azitromicina Combix

Do not stop taking the medication without consulting your doctor first, even if you feel better. It is essential to continue taking azitromicina for the indicated period of time as prescribed by your doctor, as this may prevent the infection from recurring.

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

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

If you notice any of these side effects, stop taking the tablets and inform your doctor immediately or visit the nearest emergency service:

• An allergic reaction (swelling of the lips, face, or neck that can lead to severe breathing difficulties; skin rash or urticaria)
• Blisters/bleeding in the 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 or mucus.

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

The following side effects have been reported:

Frequent (can affect up to 1 in 10 patients):

• Dizziness, vomiting, diarrhea
• Abdominal pain and cramps

Infrequent (can affect up to 1 in 100 patients):

• Dizziness, drowsiness, headache
• Seizures, alteration of taste or smell
• Diarrhea, flatulence, digestive problems, loss of appetite
• Allergic reactions such as rashes or itching
• Joint pain
• Vaginal inflammation.

Rare (can affect up to 1 in 1,000 patients):

• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers, unusual bleeding or bruising, low blood count causing unusual fatigue or weakness
• Aggression, restlessness, anxiety, nervousness
• Feeling of unreality
• Confusion, especially in elderly patients
• Tingling or numbness
• Fainting, lethargy, sleep problems, weakness, hyperactivity
• Changes in hearing, including hearing loss, deafness, and tinnitus, which usually resolve after treatment
• Abnormal heart rhythm, heart rate, or frequency, awareness of heartbeat (palpitations), low blood pressure (which may be associated with weakness, dizziness, and fainting)
• Constipation, tongue and tooth discoloration, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Changes in liver enzymes or hepatitis (liver inflammation), yellowing of the skin or white of the eyes caused by liver or blood problems, liver damage, liver failure (rarely fatal)
• Kidney problems
• Fungal infections in the mouth and vagina (candidiasis)
• Redness and blisters on the skin during sun exposure.
• A skin rash characterized by the rapid appearance of red skin patches with small white/yellow-filled blisters.

The frequency of the following side effects is unknown:

• Eye disorders
• Chest pain and inflammation
• Indigestion, stomach inflammation with abdominal pain
• Skin rash
• Pain.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://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.

This medication does not require special storage conditions. Do not change the tablets to another container.

Do not use this medication after the expiration date that appears on the container 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. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Azitromicina Combix

- The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

- The other components are: maize pregelatinized starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E-171), lactose monohydrate, glyceryl triacetate.

Appearance of the product and contents of the package

Azitromicina Combix 500 mg is presented in the form of film-coated tablets, white in color, oblong, biconvex, marked on one face.

Each package contains blisters with 3 or 150 tablets.

It is possible that not all sizes will be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Combix, S.L.U. Laboratories

C/ Badajoz 2, Edificio 2

28223- Pozuelo de Alarcon (Madrid)

Spain

Responsible for manufacturing:

Bluepharma - Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

This prospectus was approved in March 2018.

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