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Package Insert: Information for the Patient

Claritromicina Sandoz 250 mg Film-Coated Tablets

Claritromicina Sandoz 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

5Storage of Claritromicina Sandoz

6.Contents of the package and additional information

Claritromicina is a medication that belongs to the group of macrolide antibiotics. Antibiotics prevent the growth of certain bacteria.

Claritromicina is used for the treatment of adults and adolescents (12 years of age and older) of infections caused by microorganisms sensitive to claritromicina:

• throat andsinusitisinfections,
• respiratory tract infections, such as bronchitis and pneumonia,
• skin and soft tissue infections,
• gastric ulcerscaused by the bacteriaHelicobacter pylori.

Do not take Claritromicina Sandoz

• if you areallergicto clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medicine listed in section 6,
• if you or a family member has a history of certain abnormal heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or electrocardiogram (ECG) abnormalities, known as “long QT syndrome”,
• if you have severe liver failure and kidney problems at the same time,
• if you have abnormally low levels ofpotassium or magnesiumin the blood (hypokalemia or hypomagnesemia),
• if you are taking:
• ticagrelor, ivabradina, or ranolazine(for angina or to reduce the risk of myocardial infarction or stroke),ergotamine, dihydroergotamine(medicines for migraine treatment),
• midazolam oral(for anxiety or to help sleep),
• cisaprideanddomperidone(gastrointestinal medication),
• pimozide(antipsychotic),
• terfenadine,astemizole(hay fever, antihistamines),
• lovastatin, simvastatin(cholesterol-lowering medications),
• anlomitapide-containing medication,
• colchicine(for gout treatment),
• other medications known to cause severe heart rhythm disorders.

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 havediabetes,
• if you develop severe or prolonged diarrhea (pseudomembranous colitis) while taking or after taking clarithromycin, consult your doctor immediately. Pseudomembranous colitis has been reported with almost all antibacterial medications, including clarithromycin,
• if you haveheart problems.

Other medications and Claritromicina Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take with ergot alkaloids, astemizole, terfenadine, cisaprida, domperidone, pimozide, ticagrelor, ranolazine, colchicine, some cholesterol-lowering medications, and medications known to cause severe heart rhythm disorders (see“Do not take Claritromicina Sandoz”).

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

Claritromicina may increase the effect of the following medications:

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

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

• atazanavir, saquinavir (HIV medications),
• itraconazole (fungal infection medication).

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

The following medications may have a weak effect on clarithromycin:

• rifampicin, rifabutin, rifampin (antibiotics),
• efavirenz, etravirine, nevirapine (HIV medications),
• phenytoin, carbamazepine, phenobarbital (antiepileptic),
• Hierba de San Juan (a herbal preparation for depression treatment).

This is also important if you take medications called:

• hydroxychloroquine or chloroquine(used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other severe 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 variety of diseases).

Be aware that:

• ritonavir(antiviral) andfluconazole(fungal infection medication) may increase the effect of clarithromycin,
• clarithromycin may have a weak effect onzidovudine(antiviral). To eliminate this effect, leave a 4-hour interval between taking these medications.
• the use of clarithromycin withdigoxin, quinidine,disopyramideorverapamil(heart medications), or othermacrolide antibioticsmay cause serious adverse effects,
• the use of clarithromycin withdisopyramidemay cause a decrease in blood sugar levels (hypoglycemia).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

Clarithromycin does not generally affect the ability to drive and operate machinery but may cause adverse effects, such as dizziness, confusion, and disorientation. If you feel affected, do not drive, operate machinery, or participate in activities that 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 medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication 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 clarithromycin 250 mg tablet twice a day.

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

Peptic ulcer caused by the bacteriaHelicobacter pylori:

2 clarithromycin 250 mg tablets twice a day or 1 clarithromycin 500 mg tablet twice a day in combination with other suitable antibiotics and medications used for the treatment of excessive acid production in the stomach.

Children (under 12 years)

It is not recommended for use in children under 12 years.

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

Renal insufficiency

Your doctor may need to reduce the dose.

How to take Claritromicina Sandoz

Oral administration.

Take the medication with a glass of water.

This medication 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 case of streptococcal infections, the minimum treatment duration is 10 days.
• The treatment of peptic ulcer caused byHelicobacter pylorishould continue for 7 days.

If you take more Claritromicina Sandoz than you should

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

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

If you forget to take Claritromicina Sandoz

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

If you interrupt the treatment with Claritromicina Sandoz

It is essential to take your medication according to your doctor's instructions. Do not stop the treatment with clarithromycin abruptly without consulting your doctor first.

Otherwise, the symptoms may reappear.

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

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

Severe side effects:

If you experience any of the following symptoms of asevere allergic reaction, stop taking the medicine andcontact your doctor immediately or go to the nearest emergency serviceof your hospital:

• sudden difficulty breathing, speaking, and swallowing, swelling of the lips, face, and neck,
• extreme dizziness or collapse,
• severe skin eruptions or itching, especially if blisters appear and you have pain in your eyes, mouth, and genital organs.

• Severe diarrheafor a prolonged period during or after treatment, or with blood, abdominal pain, or fever. This may be a sign of severe intestinal inflammation. Your doctor should discontinue treatment. Do not take medications to reduce intestinal movements,
• Liver problems with possible signs of:
• loss of appetite,
• yellowing of the skin or the white part of the eyes (jaundice),
• unusually dark urine, pale stools,
• pruritus,
• abdominal pain.
• Irregular heartbeat,
• pancreatitis, which causesintense abdominal and back pain,
• red, scaly, itchy rash with blisters and lumps under the skin (pustular psoriasis).

Other possible side effects:

Frequent 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, dizziness, or vomiting, diarrhea, indigestion,
• abnormal liver function test results,
• pruritus,
• excessive sweating,
• vasodilation.

Rare(may affect up to 1 in 100 people)

• yeast infections (candidiasis), for example, in the mouth,
• vaginal infections,
• low white blood cell count (leukopenia, neutropenia),
• increased number of certain white blood cells (eosinophilia),
• allergic reactions,
• loss of appetite, anorexia,
• anxiety, dizziness, somnolence, tremors,
• dizziness,
• alteration of hearing, tinnitus,
• prolongation of the QT interval on the ECG,
• feeling of heartbeat,
• inflammation of the stomach, mouth, and tongue,
• gas, constipation, belching, bloating of the stomach and intestines
• dry mouth,
• bile duct obstruction,
• unpleasant feeling,
• general feeling of discomfort,
• weakness,
• chest pain,
• chills,
• fatigue,
• syncope,
• dermatitis herpetiformis (see "Severe side effects" above).

Unknown frequency(cannot be estimated from available data)

• intestinal inflammation, from mild to severe (see "Severe side effects" above),
• certain skin and subcutaneous tissue infections (erysipelas),
• severe decrease in certain white blood cells (agranulocytosis),
• low platelet count in the blood: signs may be bruising and bleeding

unusual,

• severe allergic reaction (anaphylactic reaction, see "Severe 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 sense of smell, loss of sense of smell and taste,
• tingling or numbness,
• hearing loss,
• cardiac arrhythmias, including fatal cases (ventricular arrhythmia, torsades de pointes, see "Severe side effects" above),
• prolongation of blood coagulation time,
• acute pancreatitis (see "Severe side effects" above),
• discoloration of teeth and tongue,
• severe liver failure, including fatal cases (see "Severe side effects" above),
• yellowing of the skin or the white part of the eyes (jaundice),
• severe skin diseases with discomfort, redness, peeling, and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, see "Severe side effects" above),
• acne,
• muscle pain or weakness,
• kidney inflammation, renal insufficiency,
• abnormal urine color,
• vision problems (blurred vision),
• vision alteration.

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 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 side effects, you can contribute to providing more information on the safety of this medicine.

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

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

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 components are:

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

Covering: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 contents of the package

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

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

It is presented in a PVC/PVDC/Aluminum blister.

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 responsible manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Lek Pharmaceuticals d.d.

Verovskova ulica57

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 with the following names

Last review date of this leaflet:May 2024

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/