Package Insert: Information for the User

Claritromycin Aurovitas 500 mg Film-Coated Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it 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.

Claritromicina belongs to a group of medicines called macrolide antibiotics. Antibiotics interrupt the growth of bacteria that cause infections.

Claritromicina Aurovitas is used in the treatment of the following infections:

• chest infections, such as bronchitis and pneumonia,
• throat and sinus infections,
• skin and soft tissue infections,
• duodenal ulcers caused by the bacteriaHelicobacter pylori.

Do not take Claritromicina Aurovitas:

• if you areallergicto clarithromycin, other macrolide antibiotics, or any of the other components of this medication (listed in section 6),
• if you have a history ofheart arrhythmias(ventricular arrhythmia, including torsades de pointes) or changes in heart activity such as the measurement on the electrocardiogram called “prolongation of the QT interval”,
• if you have a severe liver disordercombined with kidney disorder,
• if you are taking medications called terfenadine or astemizol (for allergic rhinitis or allergy), or cisapride or domperidone or pimozide tablets, as combining these medications may cause serious heart rhythm disturbances. Consult your doctor about alternative medications,
• if you are taking other medications that are known to cause serious heart rhythm disturbances,
• if you are taking oral midazolam (a sedative),
• if you have abnormally low levels ofpotassium or magnesiumin the blood (hypokalemia or hypomagnesemia),
• if you or a family member has a history of heart rhythm disturbances (ventricular arrhythmias, including torsades de pointes) or abnormal electrocardiogram (ECG, heart electrical recording) called “QT interval prolongation syndrome”,
• if you are taking any of the following medications:
• • ergotamine, dihydroergotamine(migraine medications),
  • lovastatin, simvastatin(cholesterol-lowering medications),
  • colchicine(gout medication),
  • ticagrelor, ivabradine, or ranolazine(medications to prevent stroke or heart attack).
• if you are taking medications containing lomitapida.

Consult your doctor and do not take this medication if any of the above applies to you or if you have experienced it in the past.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Claritromicina Aurovitas:

• if you are allergic to lincomycin or clindamycin antibiotics,
• if you have reduced liver or kidney function,
• if you have, or have had, heart problems,
• if you are pregnant (see section “Pregnancy, breastfeeding, and fertility”),
• if you developsevere or prolonged diarrhea(pseudomembranous colitis) during or after taking Claritromicina Aurovitas, consult your doctor immediately. Inflammation of the colon (pseudomembranous colitis) has been reported with almost all antibacterial medications, including clarithromycin,
• if you have used clarithromycin before for a long period of time,
• patients should be advised to interrupt treatment and contact their doctor if they have developed signs and symptoms of liver disease, such as anorexia, jaundice, dark urine, pruritus, or abdominal tenderness,
• if you are taking benzodiazepines, such as alprazolam, triazolam, and midazolam (oral), concomitantly with clarithromycin (see section “Taking Claritromicina Aurovitas with other medications”),
• if you are taking other medications that affect your hearing. Hearing function (hearing loss) should be checked during and after treatment,
• in the case of acute severe hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, treatment with clarithromycin should be discontinued immediately and appropriate treatment initiated,
• concomitant use with lovastatin or simvastatin is contraindicated (see section “Do not take Claritromicina Aurovitas”). Caution should be exercised when taking clarithromycin with other statins,
• if you are also taking oral anticoagulants with clarithromycin, there is a risk of severe bleeding.

If any of this applies to you, consult your doctor before taking clarithromycin tablets.

Other medications and Claritromicina Aurovitas

Certain medications may affect the effectiveness of Claritromicina Aurovitas or vice versa.

Claritromicina Aurovitas may increase the effect of the following medications:

• astemizol, terfenadine (antihistamines), pimozide (antipsychotic), cisapride, domperidone (for stomach disorders), ergotamine, dihydroergotamine (migraine medications), lovastatin, simvastatin (cholesterol-lowering medications) (see section “Do not take Claritromicina Aurovitas”),
• alprazolam, triazolam, midazolam oral (oromucosal) (hypnotics) (for anxiety and to induce sleep),
• atorvastatin, rosuvastatin (cholesterol-lowering medications),
• warfarin or any other anticoagulant, for example, dabigatran, rivaroxaban, apixaban, edoxaban, phenprocoumon (anticoagulants): concomitant use may increase the risk of bleeding. Blood coagulation should be checked more frequently if you are taking Claritromicina Aurovitas concomitantly,
• nateglinide, repaglinide, sulfonylureas, or insulin (antidiabetic medications),
• carbamazepine, phenytoin, valproate (epilepsy medications),
• cilostazol (used to improve circulation in the legs),
• colchicine (for gout),
• ciclosporin, sirolimus, tacrolimus (immunosuppressants),
• digoxin, verapamil, quinidine, disopyramide (heart medications), concomitant use of clarithromycin and these medications may cause heart arrhythmias,
• prednisolone (a corticosteroid for inflammation),
• omeprazole (stomach disorder medication),
• rifabutin (antibiotic),
• sildenafil, tadalafil, vardenafil (erectile dysfunction medications),
• theophylline (antiasmatic medication),
• tolterodine (for overactive bladder syndrome),
• ibrutinib, vinblastine (cancer medications),
• medications with a risk of affecting hearing, especially aminoglycosides (a group of antibiotics administered intravenously),
• calcium channel blockers (medications for high blood pressure),
• atypical antipsychotics (e.g., quetiapine).

The effect of Claritromicina Aurovitas and the following medications may be increased when taken concomitantly:

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

If your doctor has specifically recommended taking Claritromicina Aurovitas and you are taking any of the medications mentioned above at the same time, your doctor may need to monitor you closely.

Claritromicina Aurovitas may weaken the effect of the following medications:

• zidovudine (used to treat HIV). To avoid this interaction, you should leave a 4-hour interval between taking these medications.

The following medications may weaken the effect of Claritromicina Aurovitas:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, nevirapine, etravirine (HIV medications),
• phenytoin, carbamazepine, phenobarbital (antiepileptic medications),
• St. John's Wort (a plant-based medication for depression).

The following medications may potentiate the effect of Claritromicina Aurovitas:

• ritonavir (antiviral),
• fluconazole (medication for fungal infections).

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.

The use of clarithromycin at the same time as digoxin, quinidine, disopyramide, or verapamil (heart medications), or any other macrolide antibiotic, may cause heart arrhythmias.

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).

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, do not take Claritromicina Aurovitas without consulting your doctor.

Driving and operating machines

Generally, clarithromycin has no effect on the ability to drive or operate machines. However, if you experience side effects such as dizziness, confusion, and disorientation, your ability to drive or operate machines may be affected. Exercise caution when driving or operating machinery until you know how this medication affects you.

Claritromicina Aurovitas 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.

Claritromicina Aurovitas can be taken with or without food.

The recommendations for normal doses are presented below:

Use in adults including elderly patients and adolescents (children 12 years of age and older):

The normal dose is 250 mg twice a day. In severe infections, your doctor may increase the dose to 500 mg twice a day. The normal treatment duration is 7 to 14 days and should last until at least two days after the disappearance of symptoms.

Use in H. pylori infections:

In adult patients with stomach and duodenal ulcers caused by H.pylori infection, the normal dose administered is 500 mg twice a day as part of the triple therapeutic combination.

Use in patients with kidney problems:

If you have severe kidney problems, your doctor may reduce your dose to half, i.e., once a day, and restrict treatment to a maximum of 14 days.

Use in children and adolescents under 12 years of age:

The use of Claritromicina Aurovitas tablets in children under 12 years of age (weight less than 30 kg) is not recommended. Your doctor will prescribe another medication that is suitable for these children.

For children with a body weight over 30 kg, the same dose as for adults is used.

If you believe the effect of this medication is too strong or too weak, contact your doctor or pharmacist.

If you take more Claritromicina Aurovitas than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20 indicating the medication and the amount ingested.

An overdose may cause gastrointestinal disturbances and possibly other discomforts.

If you forgot to take Claritromicina Aurovitas:

If you forgot to take a dose of Claritromicina Aurovitas, take it as soon as you remember. If it is almost time to take the next dose, do not take the missed dose and continue taking the rest as usual. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Claritromicina Aurovitas:

It is essential that you take your medication according to your doctor's instructions. Do not suddenly stop Claritromicina Aurovitas without first talking to your doctor. Otherwise, symptoms may recur.

If you have any other doubts 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.

Severe side effects:

If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reactions such as sudden difficulty breathing, difficulty speaking, and difficulty swallowing.
• Intense dizziness or fainting.
• Severe skin rash or itching, especially if it shows blisters and there is pain in the eyes, mouth, or genital organs.

Stop taking the tablets as soon as possible, contact your doctor if you develop the following symptoms:

• Severe or prolonged diarrhea, which may present with blood, stomach pain, or fever. This may be a sign of severe intestinal inflammation. Your doctor may suspend treatment. Do not take medications that reduce intestinal motility.
• Liver function with the following possible symptoms:

• Loss of appetite.
• Yellowing of the skin or white of the eyes (jaundice).
• Pale stools, dark-colored urine.
• Itching.
• Abdominal pain.

• Palpitations or irregular heartbeat.
• Intense pain in the abdomen and back, caused by pancreatitis inflammation.

Other possible side effects:

Frequent(may affect up to 1 in 10 people):

• Difficulty sleeping.
• Headache.
• Changes in taste.
• Abdominal pain, nausea, vomiting, diarrhea, indigestion.
• Abnormal liver function test results.
• Skin rash.
• Excessive sweating.

Rare(may affect up to 1 in 100 people):

• Infections caused by fungi (candidiasis) (e.g., in the mouth).
• Vaginal infections.
• Decreased number of certain types of blood cells, making it more likely to get infections (leucopenia, neutropenia).
• Increased number of certain white blood cells (eosinophilia).
• Loss of appetite.
• Anxiety, dizziness, difficulty sleeping, chills, nausea.
• Sensation of rotational movement.
• Loss of hearing or tinnitus.
• Palpitations.
• Stomach, mouth, and tongue inflammation.
• Flatulence, constipation, and indigestion.
• Dry mouth.
• Cholestasis.
• Increased liver enzymes in the blood.
• Itching, urticaria.
• Muscle pain, muscle cramps
• General discomfort.
• Weakness.
• Chest pain.
• Chills.
• Fatigue.

Unknown frequency(cannot be estimated from available data):

• Severe intestinal inflammation with severe diarrhea called pseudomembranous colitis.
• St. Anthony's fire (erysipela), acne.
• Severe decrease in lymphocytes associated with sudden high fever, intense throat pain, and mouth ulcers (agranulocytosis).
• Unusual bruising or bleeding caused by low platelet count.
• Severe allergic reactions that cause facial or throat inflammation (angioedema).
• Psychosis, feeling of loss of identity.
• Confusion, change in sense of reality or panic.
• Depression, nightmares, disorientation, hallucinations, mania.
• Seizures.
• Disorders of the sense of smell, loss of sense of smell or taste.
• Deafness.
• Ventricular fibrillation (uncoordinated contraction of the heart muscle).
• Tickling or numbness in the hands or feet.
• Blood clotting difficulty.
• Coloration of the teeth and tongue.
• In case of an allergic rash, there may be a slight itching sensation on the skin, but in rare cases it may be part of a potentially fatal syndrome called Stevens-Johnson syndrome (a sudden and severe allergic reaction that involves other blisters in the mouth, lips, and skin) or toxic epidermal necrolysis (a sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling).
• Acne.
• Muscle pain or weakness, rhabdomyolysis (muscle tissue rupture).
• Kidney inflammation, renal insufficiency.
• Abnormal urine color.

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 (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Reporting 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 Vigilance 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 packaging and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Claritromicina Aurovitas

• The active ingredient is clarithromycin. Each tablet contains 500 mg of clarithromycin.
• The other components (excipients) are:

• Tablet core:microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, magnesium stearate, povidone (K-30).
• Coating:hypromellose, propylene glycol, titanium dioxide (E-171), hydroxypropyl cellulose, vanillin, sorbic acid, yellow iron oxide (E-172).

Appearance of the product and contents of the package

Coated tablet.

Yellowish-colored, biconvex, oval-shaped tablets, marked with “D” on one face and “63” on the other face of the tablet. The size is 18.5 mm x 8.1 mm.

Claritromicina Aurovitas 500 mg coated tablets are available in blisters of 7, 10, 12, 14, and 21 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

CyprusClarithromycin Aurobindo 500 mgfilm-coated tablets

FranceCLARITHROMYCINEAUROBINDO 500 mg,film-coated tablet

MaltaClarithromycin500 mg film-coated tablets

NetherlandsClaritromycine Aurobindo 500 mg, film-coated tablets

SpainClaritromicina Aurovitas 500 mg coated tablets

Last review date of this leaflet: March 2024

More detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)