Prospect: information for the user

Azitromicina TecniGen 500 mg film-coated tablets EFGAzitromicina (as dihydrate)

Read this prospect carefully before starting to take this medicine

• 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 for you. Do not pass it to others even if they have the same symptoms, as it may harm them.

• If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

Contents of the prospect:

1. What Azitromicina TecniGen is and for what it is used

2. Before taking Azitromicina TecniGen

3. How to take Azitromicina TecniGen

4. Possible adverse effects

5. Storage of Azitromicina TecniGen

6. Additional information

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 sinus, throat, tonsil, and ear infections

• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin and subcutaneous tissue infections, 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 where the uterus joins the vagina (cervix).

Do not take Azitromicina TecniGen

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

Be especially careful with Azitromicina TecniGen

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 brain or nervous system disease

•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, inform your doctor immediately.

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

Use of other medications

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

•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 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, 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 to treat gout and familial Mediterranean fever)

•Zidovudine (used in HIV treatment): may increase zidovudine levels

•Rifabutin (used in HIV treatment 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 lung diseases): theophylline effect may be increased

•Quinidine (used to control heart rhythm): quinidine levels may increase

•Cyclosporine (an immunosuppressant used after transplantation): your doctor will need to monitor your cyclosporine levels in the blood

•Pimozide (used to treat schizophrenia or other mental health 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): alfentanil effect may be increased.

Inform your doctor or pharmacist if you are using or have recently used other medications, including 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 for use if you are pregnant or trying to become pregnant. However, your doctor may decide to prescribe it under severe 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 azithromycin treatment.

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.

Important information about some of the components of Azitromicina TecniGen

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions for azitromicina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The tablets should be swallowed preferably with water, they can be taken with or without food. The usual 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 byChlamydia: 1,000 mg taken as a single dose, on a single day.

Children and adolescents under 45 kg of weight:

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

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.

If you take more Azitromicina TecniGen than you should

If you (or another person) ingest many tablets together, or if you believe a child has ingested any of the tablets, contact your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 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 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 compensate for the missed doses.

If you interrupt the treatment with Azitromicina TecniGen

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 by your doctor, if it is not possible to repeat the infection.

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

Like all medications, azithromycin may 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:

• A 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 pulse

• Prolonged diarrhea with blood or mucus.

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

The following side effects have been reported:

Frequent (affects between 1 and 10 in 100):

• Sensation of dizziness, vomiting, diarrhea

• Abdominal pain and cramps

Infrequent (affects between 1 and 10 in 1,000):

• Dizziness, somnolence, 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 (affects between 1 and 10 in 10,000):

• 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

• Sensation of unreality

• Confusion, especially in elderly patients

• Tingling or numbness

• Fainting, lethargy, sleep problems, weakness, hyperactivity

• Auditory alterations 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 (inflammation of the liver), yellowing of the skin or eyes caused by liver or blood problems, liver damage, liver failure (rarely fatal)

• Renal 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 areas dotted with small pustules (small blisters filled with a 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.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

This medication does not require special conditions for conservation. Do not change the tablets to another container. Do not use azithromycin after the expiration date that appears on the container after the abbreviation “Cad.”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Azitromicina TecniGen

The active ingredient is azithromycin.

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

The other components are: pregelatinized cornstarch, 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 TecniGen 500 mg is presented in the form of film-coated, white, oblong, biconvex tablets, 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:

Tecnimede España Industria Farmacéutica, S.A.

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

28108 Alcobendas, Spain

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

This leaflet has been reviewed in March 2020