CLARITHROMYCIN SANDOZ 500 mg FILM-COATED TABLETS

2. What you need to know before taking Claritromicina Sandoz

Do not take Claritromicina Sandoz

• if you are allergicto clarithromycin, other macrolide antibiotics, or any of the other components of this medicine listed in section 6,
• if you or a family member have a history of certain abnormal heart rhythms (ventricular arrhythmia, including torsades de pointes) or electrocardiogram (ECG) alterations, known as "long QT syndrome",
• if you have severe liver failureand kidney problemsat the same time,
• if you have abnormally low levels of potassium or magnesiumin your blood (hypokalemia or hypomagnesemia),
• if you are taking:
• ticagrelor, ivabradine, or ranolazine(for angina or to reduce the risk of heart attack or stroke),
• ergotamine, dihydroergotamine(medicines for migraine treatment),
• oral midazolam(for anxiety or to help you sleep),
• cisapride and domperidone(gastric medicines),
• pimozide(antipsychotic),
• terfenadine, astemizole(hay fever, antihistamines),
• lovastatin, simvastatin(cholesterol-lowering medicines),
• a medicine containing lomitapide,
• colchicine(for gout treatment),
• other medicines known to cause serious heart rhythm disturbances.

Warnings and precautions

Consult your doctor or pharmacist before starting to take clarithromycin:

• if you are pregnant, think you may be pregnant, or plan to become pregnant,
• if you have reduced liver or kidney function,
• if you have diabetes,
• if you develop severe or prolonged diarrhea(pseudomembranous colitis) during or after taking clarithromycin, consult your doctor immediately. Inflammation of the colon (pseudomembranous colitis) has been reported with almost all antibacterial medicines, including clarithromycin,
• if you have heart problems.

Other medicines and Claritromicina Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, some cholesterol-lowering medicines, and medicines known to cause serious heart rhythm disturbances (see "Do not take Claritromicina Sandoz").

Some medicines may affect the efficacy of clarithromycin or vice versa. These medicines are:

Claritromicina may increase the effect of the following medicines:

• ibrutinib (chronic lymphocytic leukemia),
• alprazolam, triazolam, intravenous or oral midazolam (for anxiety or to help you sleep),
• digoxin, quinidine, disopyramide, amlodipine, diltiazem (heart medicines),
• theophylline (anti-asthmatic),
• warfarin or other anticoagulants, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (to thin the blood),
• other statins (not contraindicated with lovastatin and simvastatin) such as atorvastatin, rosuvastatin (cholesterol-lowering medicines),
• cyclosporin, sirolimus, tacrolimus (immunosuppressants),
• carbamazepine, phenytoin, or valproate (epilepsy medicines),
• cilostazol (used to improve leg circulation),
• insulin and other diabetes medicines (such as nateglinide, pioglitazone, rosiglitazone, or repaglinide),
• methylprednisolone (a corticosteroid for inflammation treatment),
• omeprazole (gastric medicine),
• sildenafil, tadalafil, vardenafil (medicines for erectile dysfunction treatment),
• tolterodine (medicine for overactive bladder treatment),
• vinblastine (cancer treatment medicine),
• medicines with a risk of producing hearing problems, especially aminoglycosides, such as gentamicin or neomycin (a group of antibiotics),

The effect of clarithromycin and the effect of the following medicines may be increased when taken together:

• atazanavir, saquinavir (HIV treatment medicines),
• itraconazole (fungal infection treatment medicine).

If your doctor recommends taking any of the above-mentioned medicines at the same time as clarithromycin, your doctor should monitor you more closely.

The following medicines may have a weak effect on clarithromycin:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, etravirine, nevirapine (HIV treatment medicines),
• phenytoin, carbamazepine, phenobarbitone (antiepileptic),
• St. John's Wort (a herbal preparation for depression treatment).

This is also important if you take medicines called:

• hydroxychloroquine or chloroquine(used to treat diseases such as rheumatoid arthritis or to treat or prevent malaria). Taking these medicines at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse reactions affecting the heart,
• corticosteroids, administered orally, by injection, or inhaled (used to suppress the immune system; this is useful in the treatment of a wide range of diseases).

Note that:

• ritonavir(antiviral) and fluconazole(fungal infection treatment medicine) may increase the effect of clarithromycin,
• clarithromycin may have a weak effect on zidovudine(antiviral). To avoid this effect, you should leave a 4-hour interval between taking these medicines.
• the use of clarithromycin with digoxin, quinidine, disopyramide, or verapamil(heart medicines) at the same time, or other macrolide antibioticsmay cause serious side effects,
• the use of clarithromycin with disopyramidemay cause a decrease in blood sugar levels (hypoglycemia).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

Claritromicina does not generally affect the ability to drive and use machines, but it may cause side effects such as dizziness, confusion, and disorientation. If you feel affected, do not drive, operate machinery, or engage in activities where you may put yourself or others at risk. Visual disturbances and blurred vision may affect the patient's ability to drive or operate machinery.

Claritromicina Sandoz contains sodium

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

3. How to take Claritromicina Sandoz

Follow the administration instructions of this medicine exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dose

Adults and adolescents (12 years of age and older)

The recommended dose is 1 tablet of clarithromycin 250 mg twice a day.

The dose may be increased to 2 tablets of clarithromycin 250 mg twice a day or 1 tablet of clarithromycin 500 mg twice a day.

Gastric ulcer caused by the bacteria Helicobacter pylori:

2 tablets of clarithromycin 250 mg twice a day or 1 tablet of clarithromycin 500 mg twice a day in combination with other suitable antibiotics and medicines used to treat excessive gastric acid production.

Children (under 12 years)

The use of this medicine is not recommended in children under 12 years of age.

For these patients, other pharmaceutical forms are available, e.g., suspension.

Renal insufficiency

Your doctor may need to reduce the dose.

How to take Claritromicina Sandoz

For oral use.

Take the medicine with a glass of water.

This medicine can be taken with or without food.

Treatment duration

• The treatment duration is generally 6 to 14 days. The treatment should be continued for at least 2 days after the symptoms have disappeared.
• In the case of streptococcal infections, the minimum treatment duration is 10 days.
• Treatment of gastric ulcer caused by Helicobacter pylorishould continue for 7 days.

If you take more Claritromicina Sandoz than you should

If you have taken many tablets of clarithromycin at the same time, contact your doctor or go to the emergency department as soon as possible. The symptoms of overdose include gastrointestinal symptoms.

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

If you forget to take Claritromicina Sandoz

If you forget to take clarithromycin, continue the treatment with the normal recommended dose indicated by your doctor. Do not take a double dose to make up for the forgotten doses.

If you stop taking Claritromicina Sandoz

It is essential to take your medicine according to your doctor's instructions. Do not stop taking clarithromycin suddenly without consulting your doctor first.

Otherwise, the symptoms may reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If you experience any of the following symptoms of a severe allergic reaction, stop taking the medicine and contact your doctor immediately or go to the emergency departmentof your nearest hospital:

• sudden difficulty breathing, speaking, or swallowing, swelling of the lips, face, and neck,
• extreme dizziness or collapse,
• severe skin rash or itching, especially if blisters appear and there is pain in the eyes, mouth, and genitals.

• severe diarrheafor a prolonged period during or after treatment, or with blood, with stomach pain or fever. This can be a symptom of a severe intestinal inflammation. Your doctor should stop the treatment. Do not take medicines to reduce bowel movements,
• liver problems with possible signs of:
• loss of appetite,
• yellowing of the skin or the whites of the eyes (jaundice),
• unusually dark urine, pale stools,
• itching of the skin,
• abdominal pain.
• rapid or irregular heartbeat,
• inflammation of the pancreas, which causes severe abdominal and back pain,
• red and scaly rash with blisters and bumps under the skin (pustular exanthematous eruption).

Other possible side effects:

Common side effects(may affect up to 1 in 10 people)

• insomnia,
• headache,
• changes in taste and smell (e.g., metallic or bitter taste),
• abdominal pain, feeling sick or vomiting, diarrhea, indigestion,
• abnormal liver function test results,
• rash,
• excessive sweating,
• vasodilation.

Uncommon side effects(may affect up to 1 in 100 people)

• fungal infections (candidiasis), for example, in the mouth,
• vaginal infections,
• low levels of white blood cells (leucopenia, neutropenia),
• increased levels of some white blood cells (eosinophilia),
• allergic reactions,
• anorexia, loss of appetite,
• anxiety, dizziness, somnolence, tremors,
• vertigo sensation,
• hearing disturbances, ringing in the ears (tinnitus),
• changes in heart activity measured on the ECG, called "prolonged QT",
• feeling the heartbeat,
• stomach, mouth, and tongue inflammation,
• gas, constipation, belching, bloating
• dry mouth,
• bile flow failure,
• discomfort,
• general feeling of discomfort,
• weakness,
• chest pain,
• chills,
• fatigue,
• fainting,
• bullous dermatitis (see "Serious side effects" above).

Frequency not known(cannot be estimated from the available data)

• inflammation of the intestine, from mild to severe (see "Serious side effects" above),
• certain skin and underlying tissue infections (erysipelas),
• severe reduction of certain white blood cells (agranulocytosis),
• reduced platelet count in the blood: the signs may be unusual bruising and bleeding

unusual,

• severe allergic reaction (anaphylactic reaction, see "Serious side effects" above),
• psychosis, a feeling of loss of identity,
• feeling of not being yourself, confusion,
• depression, abnormal sleep, disorientation, hallucinations, mania,
• seizures,
• changes in smell and taste, loss of smell and taste,
• tingling or numbness,
• deafness,
• heart rhythm disorders, including fatal cases (ventricular arrhythmia, torsades de pointes, see "Serious side effects" above),
• prolongation of blood coagulation time,
• acute pancreatitis (see "Serious side effects" above),
• discoloration of teeth and tongue,
• severe liver failure, including fatal cases (see "Serious side effects" above),
• yellowing of the skin or the whites of the eyes (jaundice),
• severe skin diseases with discomfort, redness, peeling, and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, see "Serious side effects" above),
• acne,
• muscle pain or weakness,
• kidney inflammation, kidney failure,
• abnormal urine color,
• vision problems (blurred vision),
• vision disturbances.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 Claritromicina Sandoz

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

Do not use this medicine after the expiry date which is stated on the blister and carton, after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Claritromicina Sandoz

• The active ingredient is clarithromycin.

Claritromicina Sandoz 250 mg film-coated tablets

Each tablet contains 250 mg of clarithromycin.

Claritromicina Sandoz 500 mg film-coated tablets

Each tablet contains 500 mg of clarithromycin.

• The other ingredients are:

Core:sodium croscarmellose (E 468), microcrystalline cellulose (E 460), povidone, magnesium stearate (E 572), colloidal anhydrous silica (E 551), talc (E 553b).

Coating:hypromellose (E 464), propylene glycol (E 1520), titanium dioxide (E 171), hydroxypropylcellulose (E 463), sorbitan monoleate (E 494), quinoline yellow (E104), vanilla.

Appearance of the Product and Package Contents

Claritromicina Sandoz 250 mg film-coated tablets are film-coated tablets, dark yellow in color, capsule-shaped (15.6 x 7.9 mm).

Claritromicina Sandoz 500 mg film-coated tablets are film-coated tablets, light yellow in color, oval-shaped (18.8 x 8.8 mm).

They are presented in PVC/PVDC/Aluminum blisters.

Package sizes:

Claritromicina Sandoz 250 mg film-coated tablets:

7, 10, 12, 14, or 21 film-coated tablets.

Claritromicina Sandoz 500 mg film-coated tablets:

7, 10, 14, or 21 film-coated tablets.

Only some package sizes may 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

Lek Pharmaceuticals d.d.

Verovskova ulica 57

1526 Ljubljana

Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini 2D, 9220

Lendava,

Slovenia

or

Lek S.A.

Ul. Domaniewska 50 C

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1

39179 Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names

Date of the last revision of this leaflet:May 2024

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