AZITHROMYCIN ALMUS 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

AZITHROMYCIN ALMUS 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.

• 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.

1. What Azithromycin Almus 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
• Infections of the paranasal sinuses, throat, tonsils, or ears
• Mild or moderate skin and soft tissue infections, e.g., hair follicle infections (folliculitis), bacterial skin and subcutaneous tissue infections (cellulitis), skin infections with red inflammation (erysipelas)
• 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 Almus

Do not take Azithromycin Almus

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

Be cautious with Azithromycin Almus

• Consult your doctor or pharmacist before starting to take Azithromycin Almus if you: have ever had a severe allergic reaction characterized by symptoms such as swelling of the face or throat, possibly with difficulty breathing
• have severe kidney problems, your doctor may need to change the dose.
• have liver problems: your doctor may need to monitor your liver function or decide to interrupt the medication
• know that you have been diagnosed with a prolonged QT interval (heart problem): azithromycin is not recommended
• know that you have an irregular or slow pulse, or reduced cardiac function: azithromycin is not recommended
• know that you have low potassium or magnesium levels in your blood: azithromycin is not recommended
• 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
• take medicines called ergot alkaloids (such as ergotamine) used to treat migraines: azithromycin is not recommended (see 'Using Azithromycin 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 behavioral problems
• If you have been diagnosed with a disease called myasthenia gravis, with muscle weakness and fatigue, as azithromycin may contribute to worsening the symptoms of this disease or triggering it.

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 completing 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).

Using Azithromycin Almus with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other 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 simultaneously 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 stop 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): may increase colchicine levels in the blood
• Zidovudine (used in HIV treatment): may increase zidovudine levels
• Rifabutin (used in HIV and bacterial infection treatment, including tuberculosis): both rifabutin and azithromycin levels in the blood may be affected, with a possible decrease in the number of white blood cells
• Quinidine (used to control heart rhythm): quinidine levels may increase
• Cyclosporin (an immune system suppressor 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

• Alfentanil (a pain reliever): 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough 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.

You should 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.

Driving and using machines

Azithromycin is not expected to affect your ability to drive or use machines.

Azithromycin Almus contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Azithromycin Almus

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

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

The usual 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.

Children and adolescents under 45 kg in weight:

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

Patient with kidney or liver problems:

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

If you take more Azithromycin Almus than you should

If you (or someone else) swallow many tablets at once, or if you think a child has swallowed some of the tablets, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 Almus

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 Almus

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, otherwise, the infection may 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, this medicine 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 hives)
• 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:

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

• Diarrhea

Common (affects 1 to 10 users 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 1 to 10 users in 1,000)

• Fungal infections, for example, in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the stomach lining and intestines
• Shortness of breath, chest pain, wheezing, and cough (respiratory disorders), stuffy nose
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Lack of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, taste disturbances, tingling or numbness
• Vision disorders
• Hearing problems
• Dizziness (vertigo)
• Abnormal heart rhythm or frequency and heartbeat detection (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleeds
• Inflammation of the stomach, constipation, gas, indigestion, difficulty swallowing
• Feeling bloated, 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
• Inflammation of bones and joints, muscle pain, back pain, neck pain
• Difficulty and pain when urinating, kidney pain
• Inflammation of the vagina, irregular menstrual bleeding, testicular disorders
• Chest pain, swelling, discomfort, weakness, fatigue
• Facial inflammation, fever, pain.
• Changes in liver enzymes and blood test values

Rare (affects 1 to 10 users in 10,000)

• Agitation
• Feeling that things are unreal.
• Confusion, especially in elderly patients.
• Discoloration of the teeth
• Abnormal liver function, jaundice (yellowing of the skin)
• Photosensitivity: Redness and blistering of the skin when exposed to sunlight
• Skin rash characterized by the rapid appearance of red skin areas dotted with small blisters (small blisters filled with white/yellow liquid)

Not known (frequency cannot be estimated from the available data)

• Intestinal infection (pseudomembranous colitis)
• Blood disorders characterized by uncommon bleeding or unexplained bruising, decreased red blood cell count causing weakness or fatigue
• Anaphylactic reaction
• Feeling unwell, anxiety, confusion, seeing or hearing things that are not happening
• Fainting, seizures, 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)
• Abnormal hearing including deafness and/or ringing in the ears.
• Change in heart rate, changes in heart rhythm detected on an electrocardiogram (prolonged QT interval and torsades de pointes)
• Decrease in blood pressure (which may be associated with weakness, fainting, and fainting)
• Discoloration of the tongue, pancreatitis that produces nausea, vomiting, abdominal pain, back pain
• Liver failure (rarely fatal)
• Skin rash with blisters and blisters
• Joint pain (arthralgia)
• Kidney problems

The following side effects have been reported in patients treated with azithromycin for the prevention of Mycobacterium AviumComplex (MAC) infections:

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)

• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Feeling of tingling or numbness (paresthesia)
• Taste changes (dysgeusia)
• Visual disturbances
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Decreased sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears
• Abnormal heart rhythm or frequency and heartbeat detection (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding on the lips, eyes, nose, mouth, and genitals, which can be caused by Stevens-Johnson syndrome.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any 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 Almus

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions. Do not change the tablets to another container. Do not use azithromycin after the expiry date stated on the package after the abbreviation "Cad.". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the package and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the package and any unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Azitromicina Almus Composition

The active ingredient 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), lactose monohydrate, glycerol triacetate.

Product Appearance and Packaging Content

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.

Not all sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder:

Almus Farmacéutica S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Manufacturer:

BLUEPHARMA – Indústria Farmacêutica, S.A.

• Martinho do Bispo. 3045-016 Coimbra

Portugal

Date of the Last Revision of this Prospectus: July 2021

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