Azithromycin Tecnigen 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azitromicina TecniGen 500 mg film-coated tablets EFGAzithromycin (dihydrate)

Read all of this leaflet carefully before you start taking this medicine

• Keep this leaflet as 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. Do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

Leaflet contents:

1. What Azitromicina TecniGen is and what it is used for
2. Before you take Azitromicina TecniGen
3. How to take Azitromicina TecniGen
4. Possible side effects
5. How to store Azitromicina TecniGen
6. Further information

1. What Azithromycin TecniGen is and what it is 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
• Sinus, throat, tonsil, or ear infections
• Mild to moderate skin and soft tissue infections, e.g. infections of the hair follicles (folliculitis), bacterial skin infections and infections of the underlying subcutaneous layers (cellulitis), skin infections with red inflammatory rash (erysipelas)
• Infections caused by a bacterium called Chlamydia trachomatis. These may cause inflammation in the urinary tract from the bladder (urethra) or where the uterus joins the vagina (cervix)

2. Before taking Azithromycin TecniGen

Do not take Azithromycin TecniGen

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

Take special care with Azithromycin TecniGen

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 adjust your dose
• you have liver problems; your doctor may need to monitor your liver function or decide to stop the treatment
• you know you have ever been diagnosed with QT interval prolongation (a heart problem); the use of azithromycin is not recommended
• you know you have irregular or slow heartbeat, or reduced heart function; the use of azithromycin is not recommended
• you know you have low levels of potassium or magnesium in your blood; the use of azithromycin is not recommended
• you are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythm), cisapride (used to treat stomach problems), or terfenadine (an antihistamine used to treat allergies); the use of azithromycin is not recommended
• you take medicines called ergot alkaloids (such as ergotamine) used to treat migraine; the use of azithromycin is not recommended (see 'Use with 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 must inform your doctor immediately.

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

Use with other medicines

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

• Antacids, e.g. aluminium hydroxide: take azithromycin at least 1 hour before or 2 hours after taking the antacid
• Ergot derivatives, e.g. ergotamine (used to treat migraine): azithromycin should not be taken simultaneously, as ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headache, seizures, chest or abdominal pain) may occur
• 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): blood levels of both rifabutin and azithromycin may be affected, with a possible decrease in white blood cell count
• 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
• Cyclosporine (an immunosuppressant used after transplantation): your doctor should monitor your blood levels of cyclosporine
• Pimozide (used to treat schizophrenia or other mental problems): pimozide levels may increase
• Cisapride (used to treat stomach problems): heart problems may occur
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): effects may increase
• Triazolam and midazolam (sedatives): their effects may be increased
• Alfentanil (a painkiller): the effect of alfentanil may be increased

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

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 serious circumstances.

You must 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 azithromycin treatment.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Azithromycin may cause dizziness and seizures. If this affects you, do not drive or operate machinery.

Important information about some of the ingredients of Azithromycin TecniGen

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Azithromycin TecniGen

Follow exactly the instructions for the administration of azithromycin provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

The tablets should preferably be swallowed with water and may be taken with or without food. The usual dose is:

Adults (including elderly patients) and children weighing more than 45 kg:

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

• For 3 days: 500 mg per day.
• For 5 days: 500 mg on the first day, followed by 250 mg on days 2 to 5.
• Inflammation of the urethra or cervix caused by Chlamydia: 1,000 mg taken as a single dose on one day only.

Children and adolescents weighing less than 45 kg:

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

Patients with renal or hepatic impairment:

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

If you take more Azithromycin TecniGen than you should

If you (or someone else) ingest many tablets at once, or if you suspect a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the packaging 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 TecniGen

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 missed doses.

If you stop taking Azithromycin TecniGen

Do not stop taking the medicine without first consulting your doctor, even if you already feel better. It is important that you continue taking azithromycin for the period of time indicated by your doctor; otherwise, the infection may recur.

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

4. Possible adverse effects

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

If you notice any of the following adverse effects, stop taking the tablets and contact 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 hives)
• Blisters or bleeding on 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 diarrhoea with blood or mucus.

These are rare but very serious adverse effects. They may require urgent medical attention or hospitalization.

The following adverse effects have been reported:

Common (affects between 1 and 10 in every 100 people):

• Feeling dizzy, vomiting, diarrhoea
• Abdominal pain and cramps

Uncommon (affects between 1 and 10 in every 1,000 people):

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

Rare (affects between 1 and 10 in every 10,000 people):

• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers, unusual bleeding or unexpected bruising, low blood count causing unusual tiredness or weakness
• Aggression, restlessness, anxiety, nervousness
• Feeling of unreality
• Confusion, especially in elderly patients
• Tingling or numbness
• Fainting, lethargy, difficulty sleeping, weakness, hyperactivity
• Hearing disturbances including hearing loss, deafness and ringing in the ears, which usually resolve after treatment ends
• Changes in heart rhythm, abnormal heart rate or pulse, awareness of heartbeat (palpitations), low blood pressure (which may be associated with weakness, dizziness and fainting)
• Constipation, discoloration of the tongue and teeth, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Changes in liver enzymes or hepatitis (liver inflammation), yellowing of the skin or whites of the eyes due to liver or blood problems, liver injury, liver failure (rarely fatal)
• Kidney problems
• Fungal infections of the mouth and vagina (candidiasis)
• Redness and blistering of the skin during sun exposure
  • Skin rash characterized by the sudden appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid).

The frequency of the following adverse effects is unknown:

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Azithromycin TecniGen

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions. Do not transfer the tablets to another container. Do not use azithromycin after the expiry date stated on the packaging after the abbreviation "Exp.". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Azithromycin TecniGen

The active substance is azithromycin.

Each tablet contains 500 mg of azithromycin (as azithromycin dihydrate).

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

Appearance of the medicinal product and content of the container

Azithromycin TecniGen 500 mg is presented as white, film-coated, oblong, biconvex 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:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Spain

Manufacturer: BLUEPHARMA – Indústria Farmacêutica, S.A. S. Martinho do Bispo. 3045-016 Coimbra Portugal

This leaflet was last reviewed in March 2020