Package Leaflet: Information for the User

Roxitromicina Sandoz 150 mg Film-Coated Tablets

Roxitromicina Sandoz 300 mg Film-Coated Tablets

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.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Roxitromicina Sandoz contains 150 and 300 mg of roxitromicina as the active ingredient.

Roxitromicina belongs to a group of antibiotics called macrolide antibiotics.

It is used for the treatment of the following infections:

• Upper and lower respiratory tract infections, such as otitis (ear inflammation), sinusitis (nasal mucosa inflammation), pharyngitis (throat inflammation), tonsillitis (throat inflammation), bronchitis (bronchiole inflammation), and pneumonia (lung infection),
• skin and soft tissue infections (tissues that are not bones, such as muscles, fat, nerves, tendons, blood, and vessels),

• urinary tract infections.

Do not take Roxitromicina Sandoz if:

• You are allergic to roxitromicina, or to any of the other components of this medication (listed in section 6),
• You are allergic to any other antibiotic in the macrolide group,
• You are being treated with certain medications called ergot alkaloids,
• You have severe liver disease,
• You are taking medications with a narrow therapeutic window and that are substrates of CYP3A4 (for example astemizol, cisaprida, pimocida, and terfenadina).

Warnings and precautions

Consult your doctor or pharmacist before starting to take roxitromicina.

• Before starting treatment with roxitromicina, your doctor must check that you are not being treated with ergot alkaloids.
• Inform your doctor if you have any liver disease, as it may be necessary to perform periodic tests and even reduce your dose. In cases of severe liver insufficiency, the use of roxitromicina is not recommended.
• If during treatment with this medication or after it has been completed you experience diarrhea, inform your doctor.
• If you have any heart disease or are receiving medications for cardiac alterations, inform your doctor.
• Be cautious if you are being treated with other medications that may prolong the QT interval (see section “Use of Roxitromicina Sandoz with other medications”).
• If you have myasthenia gravis (a chronic muscle disease characterized by fatigue and weakness), your condition may worsen.
• If you experience a severe and generalized skin rash, with blistering or peeling of the skin, as well as signs of flu and fever (Stevens-Johnson syndrome), general discomfort, fever, chills, and muscle pain (toxic epidermal necrolysis), or a red and scaly rash with bumps under the skin and blisters (acute generalized pustular psoriasis), consult a doctor as soon as possible, as these skin effects can be fatal.
• If you are a patient with rare hereditary intolerances to galactose, Lapp lactase deficiency, or glucose-galactose malabsorption, do not take this medication.

Kidney disease: No dosage adjustment is necessary in cases of renal insufficiency.

Geriatric population: No dosage adjustment is necessary.

Pediatric population: Your doctor may decide to reduce the dose. Roxitromicina should not be used in children under 4 years of age.

Other medications and Roxitromicina Sandoz

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Roxitromicina may interact with other medications. Inform your doctor or pharmacist if you are taking any of the following medications:

Thesemedications should not be taken with Roxitromicina Sandoz:

• Ergot alkaloids for the treatment of migraines and uterine hemorrhages.
• Terfenadina or astemizol (for allergies), cisaprida (for gastrointestinal disorders) and pimozida (for psychiatric disorders). Treatment with roxitromicina and these medications may cause cardiac rhythm alterations.

It is importantto inform your doctor if you are taking:

• Medications that can prolong the QT interval and other medications for the heart for the treatment of cardiac arrhythmias or heart rhythm disorders (e.g. quinidina, procainamida, disopiramida, dofetilida, amiodarona), citalopram, some antidepressants, metadona, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacino), some antifungal medications (e.g. fluconazol, pentamidina), and some antiviral medications (e.g. telaprevir),
• Digoxina and other cardiac glycosides,
• Midazolam, for the treatment of sleep disorders,
• Anticoagulants (vitamin K antagonists), such as warfarina (medications to thin the blood),
• Theophylline,
• Bromocriptina,
• Ciclosporina,
• Rifabutina,
• Oral contraceptives with estradiol and progestogens,
• HMG-CoA reductase inhibitors (statins). There is a possibility of increased muscle side effects when these medications are taken with roxitromicina.

Taking Roxitromicina Sandoz with food and drinks

It is recommended to take the medication before meals.

Pregnancy and lactation

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

If you are pregnant or think you may be pregnant, your doctor may decide not to prescribe this medication, although there may be cases where they decide to prescribe it anyway.

Roxitromicina passes into breast milk in small amounts; therefore, treatment or breastfeeding should be suspended, as necessary.

Driving and operating machinery

Do not drive or perform tasks that require special attention while taking roxitromicina, as you may experience dizziness, visual disturbances, and blurred vision, which may affect your ability to drive and operate machinery.

Roxitromicina contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 300 mg per day, divided into 150 mg doses every 12 hours, or one 300 mg tablet once a day.

If gastrointestinal discomfort appears, your doctor will assess the possibility of administering the medication by taking one 150 mg tablet twice a day.

Roxitromicina should be taken orally, preferably before meals. Tablets should be swallowed with a sufficient amount of water.The groove is only for breaking the tablet, if it is difficult to swallow it whole.

If you take more Roxitromicina Sandoz than you should

If you have taken more roxitromicina than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Roxitromicina Sandoz

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Roxitromicina Sandoz

Take the medication until you finish the treatment. Do not interrupt it even if you feel better. The medication may not have finished eliminating all the germs and there is a risk of feeling unwell again.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Adverse reactions are listed in decreasing order of severity within each frequency interval according to the Organ System Classification:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Unknown frequency (cannot be estimated from available data)

Infections and infestations:

Unknown frequency: superinfection (in prolonged use). Like other broad-spectrum antibiotics, the appearance of Clostridium difficile-induced colitis (pseudomembranous colitis) has been described in patients treated with macrolides.

Blood and lymphatic system disorders:

Uncommon: eosinophilia.

Unknown frequency: agranulocytosis, neutropenia, and thrombocytopenia.

Immune system disorders:

Unknown frequency: anaphylactic shock.

Mental and behavioural disorders:

Unknown frequency: hallucinations, confusional state (confusion).

Nervous system disorders:

Common: sensations of dizziness, headaches.

Unknown frequency: paresthesias. As with other macrolides, alterations in taste (dysgeusia), ageusia, and/or alterations in smell (parosmia), anosmia have been observed.

Eye disorders:

Unknown frequency: visual disturbance. Visual problems (blurred vision).

Ear and labyrinth disorders:

Unknown frequency: temporary hearing loss, hearing loss (reduced auditory capacity), vertigo, and tinnitus.

Respiratory, thoracic, and mediastinal disorders:

Unknown frequency: bronchospasm.

Gastrointestinal disorders:

Common: nausea, vomiting, dyspepsia (epigastric pain (more frequent with the use of 300 mg tablets)), diarrhea.

Unknown frequency: hemorrhagic diarrhea and pancreatitis.

Hepatobiliary disorders:

Unknown frequency: cholestatic hepatitis or acute hepatocellular hepatitis.

Skin and subcutaneous tissue disorders:

Common: skin rash.

Uncommon: erythema multiforme, urticaria.

Unknown frequency: angioedema, purpura, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Severe skin reactions:

Seek medical attention as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

Investigations:

Unknown frequency: increases in liver enzymes ASAT, ALAT, and/or alkaline phosphatase.

Cardiac disorders:

Unknown frequency: QT interval prolongation, ventricular tachycardia, and a disease called Torsades de Pointes.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

No requires special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the packaging and blister after “CAD/EXP”. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Roxitromicina Sandoz

• The active ingredient is roxitromycin.

Roxitromicina Sandoz 150 mg:

Each film-coated tablet contains 150 mg of roxitromycin.

Roxitromicina Sandoz 300 mg:

Each film-coated tablet contains 300 mg of roxitromycin.

• The other components are:

Tablet core: microcrystalline cellulose (E 460), povidone K30, croscarmellose sodium, colloidal silicon dioxide, poloxamer 188, magnesium stearate (E 572).

Tablet coating: white coating mixture based on HPMC (lactose monohydrate, titanium dioxide (E 171), hypromellose, macrogol).

Appearance of the product and contents of the package

The film-coated tablets are packaged in PVC/Al blisters.

Roxitromicina Sandoz 150 mg:

They are white, round, biconvex, scored tablets on one side and marked with "R150" on the other side.

The score is only for breaking the tablet if it is difficult to swallow whole.

Each PVC/Al package contains 12 and 20 tablets.

Roxitromicina Sandoz 300 mg:

They are white, round, biconvex, scored tablets on one side and marked with "R300" on the other side.

The score is only for breaking the tablet if it is difficult to swallow whole.

Each PVC/Al package contains 7 and 10 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

S.C. Sandoz, S.R.L

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GMBH

Otto Von Guericke Alle, 1

39179 Barleben

Germany

Last review date of this leaflet: September 2021.

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.