AZITHROMYCIN COMBIX 500 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Azithromycin Combix 500 mg film-coated tablets EFG

Azithromycin (as dihydrate)

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Azithromycin Combix and what is it used for
2. What you need to know before you take Azithromycin Combix
3. How to take Azithromycin Combix
4. Possible side effects
5. Storage of Azithromycin Combix
6. Contents of the pack and other information

1. What is Azithromycin Combix and what is it used for

Azithromycin 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
• Infections of the paranasal sinuses, throat, tonsils, or ears
• Mild or moderate skin and soft tissue infections, e.g., folliculitis (infection of the hair follicles), bacterial skin and subcutaneous infections (cellulitis), or erysipelas (skin infection with redness)
• Infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammation in the urinary tract that starts from the bladder (urethra) or where the uterus connects to the vagina (cervix).

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

Do not take Azithromycin Combix

• if you are allergic (hypersensitive) to azithromycin or any of the other ingredients of this medicine (listed in section 6); or to other macrolide antibiotics, e.g., erythromycin.

Warnings and precautions

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

Be careful with Azithromycin Combix

Before starting treatment with this medicine, tell 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 need to change the 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 a prolonged QT interval (heart problem): azithromycin is not recommended
• you know that you have an irregular or slow pulse, or reduced cardiac function: azithromycin is not recommended
• you know that you have low potassium or magnesium levels in your blood: azithromycin is not recommended
• you 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
• you take medications called ergot alkaloids (such as ergotamine) used to treat migraines: azithromycin is not recommended (see 'Using other medicines')
• you have ever 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, especially if you notice blood or mucus, you should inform your doctor immediately.

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

Using Azithromycin with other medicines

Consult your doctor if you are taking any of the following medicines:

• Antacids, e.g., aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking the antacid
• Ergot derivatives, e.g., ergotamine (used to treat migraines): azithromycin should not be taken at the same time as it may cause ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headaches, seizures, chest or abdominal pain)
• Coumarin derivatives, e.g., 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 (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 the number of white blood cells
• Theophylline (used to treat asthma and other lung diseases): the effect of theophylline may increase
• Quinidine (used to control heart rhythm): quinidine levels may increase
• Cyclosporin (an immunosuppressant used after a transplant): your doctor should monitor your cyclosporin levels in the blood
• Pimozide (used to treat schizophrenia or other mental problems): pimozide levels may increase
• Cisapride (used to treat stomach problems): may cause heart problems
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): effects may increase
• Triazolam and midazolam (sedatives): effects may increase
• Alfentanil (a pain reliever): the effect of alfentanil may increase.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

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

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Azithromycin may cause dizziness and convulsions. If this is the case, do not drive or use machinery.

Azithromycin Combix contains lactose.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 Combix

Follow the instructions for taking azithromycin exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

The recommended dose is:

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

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

• 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.
• Inflammation of the urethra or cervix caused by Chlamydia: 1,000 mg taken as a single dose, for one day only.

Patient with renal or hepatic impairment:

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

Use in children and adolescents

Children and adolescents under 45 kg in weight:

The tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing medicines (e.g., suspensions) may be used.

If you take more Azithromycin Combix than you should

If you (or someone else) swallow many tablets at once, or if you think a child has swallowed any of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and leaflet to the healthcare professional. An overdose may cause reversible hearing loss, severe nausea (feeling of dizziness), vomiting, and diarrhea.

If you forget to take Azithromycin 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 make up for forgotten doses.

If you stop taking Azithromycin Combix

Do not stop taking the medicine without consulting your doctor first, even if you are feeling better. It is important that you continue taking azithromycin for the period of time indicated by your doctor, or it may be possible for the infection to 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, azithromycin can cause side effects, although not everybody gets them.

If you notice any of the following side effects, stop taking the tablets and inform your doctor immediately or go to the nearest emergency department:

• An allergic reaction (swelling of the lips, face, or neck leading to severe breathing difficulties; skin rash or urticaria)
• blisters/bleeding on the lips, eyes, nose, mouth, and genitals, which can 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 need urgent medical attention or hospitalization.

The following side effects have been reported:

Common (may affect up to 1 in 10 people):

• Feeling of dizziness, vomiting, diarrhea
• Abdominal pain and cramps

Uncommon (may affect up to 1 in 100 people):

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

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

• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers, unusual bleeding or bruising, low blood count that causes unusual tiredness or weakness
• Aggression, restlessness, anxiety, nervousness
• Feeling of unreality
• Confusion, especially in elderly patients
• Numbness or tingling
• Fainting, lethargy, sleep problems, weakness, hyperactivity
• Changes in hearing, including hearing loss, deafness, and ringing in the ears, which usually disappear after treatment
• Changes in heart rhythm, abnormal heart rhythm or frequency, palpitations, low blood pressure (which may be associated with weakness, dizziness, and fainting)
• Constipation, discoloration of the tongue and teeth, pancreatitis that causes nausea, vomiting, abdominal pain, back pain
• Changes in liver enzymes or hepatitis (inflammation of the liver), yellowing of the skin or the whites of the eyes caused by liver or blood problems, liver damage, liver failure (rarely with a fatal outcome)
• Kidney problems
• Fungal infections in the mouth and vagina (candidiasis)
• Redness and blisters on the skin during sun exposure.
• Skin rash characterized by the rapid appearance of areas of red skin dotted with small blisters (small bumps filled with white/yellow liquid).

The frequency of the following side effects is unknown:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through 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 Combix

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

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

Do not use this medicine after the expiry date which is stated on the package after “EXP.”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Further information

Composition of Azithromycin Combix

• The active substance is azithromycin. Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).
• The other ingredients are: pregelatinized corn starch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate, hypromellose, titanium dioxide (E-171), lactose monohydrate, glycerol triacetate.

Appearance of the product and contents of the pack

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

Each pack contains blisters with 3 or 150 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223- Pozuelo de Alarcon (Madrid)

Spain

Manufacturer:

Bluepharma - Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

This leaflet was approved in March 2018.

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