Roxithromycin Sandoz 300 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Roxithromycin Sandoz 150 mg film-coated tablets EFG

Roxithromycin Sandoz 300 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Roxithromycin Sandoz is and what it is used for
2. What you need to know before taking Roxithromycin Sandoz
3. How to take Roxithromycin Sandoz
4. Possible adverse effects
5. How to store Roxithromycin Sandoz

Pack contents and additional information

1. What Roxitromycin Sandoz is and what it is used for

Roxitromycin Sandoz contains 150 and 300 mg of roxithromycin as the active substance.

Roxithromycin belongs to a group of antibiotics known as macrolide antibiotics.

It is used to treat the following infections:

• upper and lower respiratory tract infections, such as otitis (inflammation of the ear), sinusitis (inflammation of the nasal mucosa), pharyngitis (inflammation of the pharynx, throat), tonsillitis (inflammation of the throat), bronchitis (inflammation of the bronchi), and pneumonia (infection in the lungs),

• skin and soft tissue infections (tissues that are not bones, such as muscles, fat, nerves, tendons, blood, and vessels),

• urinary tract infections.

2. What you need to know before taking Roxithromycin Sandoz

Do not take Roxithromycin Sandoz if:

• you are allergic to roxithromycin or to any of the other ingredients of this medicine (listed in section 6),
• you are allergic to any other antibiotic in the macrolide group,
• you are being treated with medicines called ergot alkaloids,
• you have severe liver disease,
• you are taking medicines with a narrow therapeutic window that are substrates of CYP3A4 (e.g. astemizole, cisapride, pimozide and terfenadine).

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with roxithromycin.

• Before starting treatment with roxithromycin, your doctor must check that you are not taking ergot alkaloids.
• Inform your doctor if you have any liver disease, as periodic tests may be needed and your dose may even need to be reduced. Roxithromycin is not recommended in cases of severe hepatic impairment.
• If you develop diarrhoea during treatment with this medicine or after treatment has ended, inform your doctor.
• If you have any heart disease or are taking medicines for cardiac disorders, inform your doctor.
• Caution is advised if you are taking other medicines that may prolong the QT interval (see section “Use of Roxithromycin Sandoz with other medicines”).
• If you have myasthenia gravis (a chronic muscle disease characterised by fatigue and weakness), your condition may worsen.
• If you develop a severe and widespread skin rash, with blistering or peeling of the skin, along with flu-like symptoms and fever (Stevens-Johnson syndrome), general malaise, fever, chills and muscle pain (toxic epidermal necrolysis), or a red, scaly rash with bumps under the skin and blisters (acute generalised exanthematous pustulosis), consult a doctor immediately, as these skin reactions can be life-threatening.
• If you have rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, you should not take this medicine.

Kidney disease: Dose adjustment is not necessary in cases of renal impairment.

Elderly population: Dose adjustment is not necessary.

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

Other medicines and Roxithromycin Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

The following medicines must not be taken with Roxithromycin Sandoz:

• Ergot alkaloids, used to treat migraines and uterine bleeding.
• Terfenadine or astemizole (for allergies), cisapride (for gastrointestinal disorders), and pimozide (for psychiatric disorders). Taking roxithromycin with these medicines may cause disturbances in heart rhythm.

It is important to inform your doctor if you are taking:

• medicines that can prolong the QT interval and other heart medicines used to treat heart rhythm disorders or cardiac arrhythmias (e.g. quinidine, procainamide, disopyramide, dofetilide, amiodarone), citalopram, some antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungal medicines (e.g. fluconazole, pentamidine), and some antiviral medicines (e.g. telaprevir),
• digoxin and other cardiac glycosides,
• midazolam, used to treat sleep disorders,
• anticoagulants (vitamin K antagonists) such as warfarin (medicines to thin the blood),
• theophylline,
• bromocriptine,
• cyclosporine,
• rifabutin,
• oral contraceptives containing oestrogens and progestogens,
• HMG-CoA reductase inhibitors (statins). There is a possibility of increased muscle-related adverse effects when these medicines are taken with roxithromycin.

Taking Roxithromycin Sandoz with food and drink

It is recommended to take the medicine before meals.

Pregnancy and breastfeeding

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

If you are pregnant or think you may be, your doctor may decide not to prescribe this medicine, although there may be cases where it is considered necessary.

Roxithromycin passes into breast milk in small amounts; therefore, treatment or breastfeeding should be discontinued, depending on what is considered necessary.

Driving and using machines

Do not drive or perform tasks that require special attention while being treated with roxithromycin, as dizziness, visual disturbances and blurred vision may occur, which could affect the patient's ability to drive or operate machinery.

Roxithromycin contains lactose and sodium

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

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

3. How to take Roxithromycin Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

If gastrointestinal discomfort occurs, your doctor will consider whether to administer the medicine as one 150 mg tablet twice daily.

Roxithromycin should be administered orally, preferably before meals. The tablets should be swallowed with a sufficient amount of water. The score line is intended solely for dividing the tablet if you find it difficult to swallow whole.

If you take more Roxithromycin Sandoz than you should

If you have taken more roxithromycin than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Roxithromycin Sandoz

Do not take a double dose to make up for forgotten doses.

If you stop taking Roxithromycin Sandoz

Take the medicine for the full duration of the treatment. Do not stop even if you feel better. The medicine may not have completely eliminated all germs, and there is a risk of becoming ill again.

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

4. Possible adverse effects

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

Adverse reactions are listed in decreasing order of severity within each frequency category according to the organ system classification:

Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known (cannot be estimated from available data)

Infections and infestations:
Frequency not known: Superinfection (with prolonged use). As with other broad-spectrum antibiotics, Clostridium difficile-associated colitis (pseudomembranous colitis) has been reported in patients treated with macrolides.

Blood and lymphatic system disorders:
Uncommon: Eosinophilia.
Frequency not known: Agranulocytosis, neutropenia, and thrombocytopenia.

Immune system disorders:
Frequency not known: Anaphylactic shock.

Psychiatric disorders:
Frequency not known: Hallucinations, confusional state (confusion).

Nervous system disorders:
Common: Dizziness, headache.
Frequency not known: Paraesthesia. As with other macrolides, taste disturbances (dysgeusia), ageusia, and/or smell disturbances (parosmia), anosmia have been observed.

Eye disorders:
Frequency not known: Visual disturbances. Problems with vision (blurred vision).

Ear and labyrinth disorders:
Frequency not known: Temporary deafness, hypoacusis (loss of hearing), vertigo, and tinnitus.

Respiratory, thoracic and mediastinal disorders:
Frequency not known: Bronchospasm.

Gastrointestinal disorders:
Common: Nausea, vomiting, dyspepsia (epigastric pain (relatively more common with 300 mg tablets)), diarrhoea.
Frequency not known: Haemorrhagic diarrhoea and pancreatitis.

Hepatobiliary disorders:
Frequency not known: Cholestatic hepatitis or acute hepatocellular hepatitis.

Skin and subcutaneous tissue disorders:
Common: Skin rash.
Uncommon: Erythema multiforme, urticaria.
Frequency not known: Angioedema, purpura, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Severe skin reactions:
Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered as not known (cannot be estimated from available data).

Investigations:
Frequency not known: Increases in hepatic enzymes (ASAT, ALAT) and/or alkaline phosphatase.

Cardiac disorders:
Frequency not known: QT interval prolongation, ventricular tachycardia, and a condition known as Torsades de Pointes.

Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Roxithromycin Sandoz

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging and blister after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Roxithromycin Sandoz

• The active substance is roxitromycin.

Roxithromycin Sandoz 150 mg:

Each film-coated tablet contains 150 mg of roxitromycin.

Roxithromycin Sandoz 300 mg:

Each film-coated tablet contains 300 mg of roxitromycin.

• The other components are:

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

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

Appearance of the product and contents of the pack

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

Roxithromycin Sandoz 150 mg:

White, round, biconvex, film-coated tablets, scored on one side and marked with "R150" on the other side.

The score line is intended only to facilitate tablet splitting if you have difficulty swallowing the tablet whole.

Each PVC/Al pack contains 12 or 20 tablets.

Roxithromycin Sandoz 300 mg:

White, round, biconvex, film-coated tablets, scored on one side and marked with "R300" on the other side.

The score line is intended only to facilitate tablet splitting if you have difficulty swallowing the tablet whole.

Each PVC/Al pack contains 7 or 10 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Novartis Pharmaceuticals S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

or

Salutas Pharma GMBH

Otto Von Guericke Alle, 1

39179 Barleben

Germany

Date of the most recent revision of this leaflet: September 2021.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.