Leaflet: information for the user

AZITROMICINA ALMUS 500 mg film-coated tablets EFG

Azithromycin (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 the same symptoms as you, as it may harm them.

Azitromicina belongs to a group of medications 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
• Paranasal sinus, throat, tonsil, or ear infections
• Mild to moderate skin and soft tissue infections, for example, folliculitis, bacterial skin infections, and subcutaneous tissue infections (cellulitis), and erysipelas, a skin infection with red inflammation
• Infections caused by a bacteria called Chlamydia trachomatis.This 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 Almus

• if you are allergic to azithromycin, or to any of the other ingredients of this medicine (listed in section 6) or to another macrolide or ketolide antibiotic, for example erythromycin or telithromycin.

Take special care with Azitromicina Almus

• Consult your doctor or pharmacist before starting to take Azitromicina Almus if you:have ever had a severe allergic reaction characterised by symptoms such as swelling of the face or throat, possibly with difficulty breathing
• have severe kidney problems, your doctor may change your dose.
• have liver problems: your doctor may need to monitor your liver function or decide to stop treatment
• know that you have been diagnosed with a prolonged QT interval (a heart problem): azithromycin is not recommended for use
• know that you have an irregular or slow pulse, or reduced heart function: azithromycin is not recommended for use
• know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended for use
• 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): azithromycin is not recommended for use
• are taking medicines called ergot alkaloids (such as ergotamine) used to treat migraine: azithromycin is not recommended for use (see 'Taking Azitromicina Almus with other medicines')
• have ever been diagnosed with a neurological disease, which is a disease of the brain or nervous system
• have mental, emotional or behavioural problems
• If you have myasthenia gravis, a condition that causes muscle weakness and fatigue, azithromycin may worsen your symptoms or trigger the condition.

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

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

Children and adolescents

The tablets are not recommended for children and adolescents weighing less than 45 kg (see section 3).

Taking Azitromicina Almus with other medicines

Inform your doctor if you are taking, have taken recently or might have to take any other medicine:

• 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 at the same time as ergotamine as it may cause ergotism (a potentially serious adverse reaction with numbness or tingling in the limbs, muscle cramps, headaches, convulsions, 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): may increase colchicine levels in the blood
• Zidovudine (used in HIV treatment): may increase zidovudine levels
• Rifabutin (used in HIV and bacterial infections including tuberculosis treatment): both rifabutin and azithromycin levels in the blood may be affected, with a possible decrease in white blood cell count
• Quinidine (used to control heart rhythm): quinidine levels may increase
• Ciclosporin (an immunosuppressant used after a transplant): your doctor will need to monitor your ciclosporin levels in the blood
• Pimozide (used to treat schizophrenia and other mental health problems): pimozide levels may increase
• Cisapride (used to treat stomach problems): may cause heart problems
• Astemizole, terfenadine (antihistamines used to treat allergic reactions): may increase the effects

• Alfentanil (an analgesic): the effect of alfentanil may be increased.
• Fluconazole (for fungal infections): azithromycin levels may be reduced.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

Azithromycin is unlikely to affect your ability to drive or use machines.

Azitromicina Almus contains lactose

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially 'sodium-free'.

Follow exactly the administration instructions for azithromycin 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 by Chlamydia : 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 azithromycin-containing medications (e.g. suspensions) may be used.

Patients with renal or hepatic impairment:

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

If you take more Azithromycin Almus than you should

If you (or someone else) have ingested 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 Toxicology 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 (feeling of dizziness), vomiting, and diarrhea.

If you forget to take Azithromycin Almus

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Azithromycin Almus

Do not stop taking the medication without consulting your doctor first, even if you feel better. It is essential to continue taking azithromycin 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, this medicine 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:

• 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 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 require urgent medical attention or hospitalization.

The following side effects have been reported:

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

•Diarrhea

Common (affects between 1 and 10 in 100):

• Alteration of the number of some types of white blood cells and bicarbonate in the blood
• Vomiting, stomach pain, nausea, headache

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

• Fungal infection, for example in the mouth (aphthae), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestine
• Lack of breathing, 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, drowsiness, taste alterations, tingling or numbness
• Eye disorders
• Ear problems
• Dizziness (sensation of spinning)
• Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)
• Hot flashes
• Difficulty breathing
• Nasal bleeding
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Sensation of swelling, dry mouth
• Belching, mouth ulcers, increased salivation, soft stools
• Liver problems, (such as liver inflammation, hepatitis)
• Itchy skin rash, hives (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Bone and joint inflammation, muscle pain, back pain, neck pain
• Difficulty and pain while urinating, kidney pain
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue
• Face inflammation, fever, pain.
• Changes in liver enzymes and blood values

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

• Agitation
• Sensation that things are unreal.
• Confusion, especially in elderly patients.
• Teeth discoloration
• Abnormal liver function, jaundice (yellowish discoloration of the skin)
• Photosensitivity: Redness and blistering of the skin upon exposure to sunlight
• Itchy skin rash characterized by rapid appearance of red skin areas with small white/yellow pustules

Unknown (frequency cannot be estimated from available data)

•Intestinal infection (pseudomembranous colitis)

•Blood disorders characterized by rare bleeding or unexplained petechiae, decrease in red blood cell count causing weakness or fatigue

•Anaphylactic reaction

•Bad mood, anxiety, confusion, seeing or hearing things that are not happening

•Fainting, convulsions, decreased sensitivity, hyperactivity, alteration or loss of sense of smell, loss of sense of taste, myasthenia gravis (muscle weakness and fatigue, see "Warnings and precautions" above)

•Changes in hearing including deafness and/or ringing in the ears.

•Changes in heart rate, changes in heart rhythm detected by electrocardiogram (prolongation of the QT interval and torsades de pointes)

•Decreased blood pressure (which may be associated with weakness, fainting, and dizziness)

•Discoloration of the tongue, pancreatitis that causes nausea, vomiting, abdominal pain, back pain

•Acute liver failure (rarely fatal)

•Itchy skin rash with spots and blisters

•Joint pain (arthralgia)

•Kidney problems

The following side effects have been reported in patients treated with azithromycin for the prevention of infections by 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 (dizziness)

•Headache

•Sensation of tingling or numbness (paresthesia)

•Changes in taste (dysgeusia)

•Visual impairment

•Deafness

•Skin rash

•Itching (pruritus)

•Joint pain (arthralgia)

•Fatigue

Uncommon (may affect up to 1 in 100 people)

•Decreased sensitivity (hypoaesthesia)

•Loss of hearing or ringing in the ears

•Abnormal heart rhythm or frequency and detection of heartbeats (palpitations)

•Liver problems such as hepatitis

•Blisters/bleeding in the lips, eyes, nose, mouth, and genitals, which can be caused by Stevens-Johnson syndrome.

•Allergic skin reactions such as sensitivity to sunlight, red, flaky, and inflamed skin

•Weakness (asthenia)

•General feeling of discomfort

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Vigilance 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 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 azitromicina after the expiration date that appears on the container after the abbreviation “Cad.”. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the containers and the

medicines that you do not need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and the medicines that you do not need. In this way, you will help to protect the environment.

Composition of Azitromicina Almus

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 packaging

AZITROMICINA ALMUS 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 manufacturer

Holder:

Almus Farmacéutica S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

S. Martinho do Bispo. 3045-016 Coimbra

Portugal

Last review date of this leaflet: July 2021

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