CLARITHROMYCIN AUROVITAS 500 mg FILM-COATED TABLETS

2. What you need to know before taking Claritromicina Aurovitas

Do not take Claritromicina Aurovitas:

• if you are allergicto claritromicina, other macrolide antibiotics, or any of the other components of this medication (listed in section 6),
• if you have a history of heart rhythm disorders(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 severe liver diseasewith concurrent kidney disease,
• 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 can cause serious heart rhythm disorders. Consult your doctor about alternative medications,
• if you are taking other medications that are known to cause serious heart rhythm disorders,
• if you are taking oral midazolam (a sedative),
• if you have abnormally low levels of potassium or magnesiumin your blood (hypokalemia or hypomagnesemia),
• if you or a family member has a history of heart rhythm disorders (ventricular arrhythmias, including torsades de pointes) or electrocardiogram abnormalities (ECG) called ‘QT interval prolongation syndrome’,
• if you are taking any of the following medications:
• • ergotamine, dihydroergotamine(medications for treating migraines),
  • lovastatin, simvastatin(medications for lowering cholesterol),
  • colchicine(medication for treating gout),
  • ticagrelor, ivabradine, or ranolazine(medication for preventing stroke or heart attack).
• if you are taking medications containing lomitapide.

Consult your doctor and do not take this medication if any of the above applies to you or has applied to you 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 develop severe 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 claritromicina,
• if you have used claritromicina before on several occasions for a long period,
• patients should be advised to discontinue treatment and contact their doctor if they have developed signs and symptoms of liver disease, such as anorexia, jaundice, dark urine, pruritus, or sensitive abdomen,
• if you are taking claritromicina and benzodiazepines, such as alprazolam, triazolam, and midazolam (see section “Taking Claritromicina Aurovitas with Other Medications”),
• if you are taking other medications that affect your hearing. Hearing function (for 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 claritromicina should be discontinued immediately and adequate treatment initiated,
• concomitant use of claritromicina with lovastatin or simvastatin is contraindicated (see section “Do not take Claritromicina Aurovitas”). Caution should be exercised when taking claritromicina with other statins,
• if you are also taking oral anticoagulants with claritromicina, there is a risk of severe bleeding.

If any of these apply to you, consult your doctor before taking the claritromicina 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 (antiallergics), pimozida (antipsychotic), cisaprida, domperidona (for stomach disorders), ergotamine, dihydroergotamine (antimigraine), lovastatin, simvastatin (cholesterol-lowering medications) (see section “Do not take Claritromicina Aurovitas”),
• alprazolam, triazolam, midazolam oral (hypnotics) (for anxiety and to induce sleep),
• atorvastatin, rosuvastatin (cholesterol-lowering medications),
• warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban, edoxaban, fenprocoumon (anticoagulants): concomitant use may increase the risk of bleeding. Blood coagulation should be checked more frequently if you are taking Claritromicina Aurovitas concomitantly,
• nateglinida, repaglinida, sulfonylureas, or insulin (antidiabetics),
• carbamazepine, phenytoin, valproate (medications for treating epilepsy),
• cilostazol (used to improve circulation in the legs),
• colchicine (for treating gout),
• cyclosporine, sirolimus, tacrolimus (immunosuppressants),
• digoxin, verapamil, quinidine, disopyramide (heart medications), concomitant use of claritromicina and these medications may cause heart rhythm disorders,
• methylprednisolone (a corticosteroid for treating inflammation),
• omeprazole (medication for stomach disorders),
• rifabutin (antibiotic),
• sildenafil, tadalafil, vardenafil (medications for treating erectile dysfunction),
• theophylline (anti-asthmatic),
• tolterodine (for treating overactive bladder),
• ibrutinib, vinblastine (medication for treating cancer),
• medications with a risk of affecting hearing, especially aminoglycosides (a group of antibiotics administered intravenously),
• calcium channel blockers (medications for treating high blood pressure),
• atypical antipsychotics (e.g., quetiapine).

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

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

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

Claritromicina Aurovitas may reduce the effect of the following medications:

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

The following medications may reduce the effect of Claritromicina Aurovitas:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, nevirapine, etravirine (medications for treating HIV infection),
• phenytoin, carbamazepine, phenobarbital (antiepileptics),
• St. John's Wort (a herbal medication for treating depression).

The following medications may enhance the effect of Claritromicina Aurovitas:

• ritonavir (antiviral),
• fluconazole (medication for treating 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 claritromicina may increase the risk of abnormal heart rhythms and other serious adverse reactions affecting the heart.

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

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).

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

Pregnancy, Breastfeeding, and Fertility

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.

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

Driving and Using Machines

Generally, claritromicina does not have any effect on the ability to drive or use machines. However, if you experience side effects such as dizziness, confusion, and disorientation, your ability to drive or use machines may be affected. Be cautious when driving or using 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”.

3. How to take Claritromicina Aurovitas

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

Claritromicina Aurovitas can be taken with or without food.

The recommended dosages 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 triple combination therapy.

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 limit the 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 suitable for these children.

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

If you think 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

An overdose may cause gastrointestinal disorders and possibly other discomforts.

If you forget to take Claritromicina Aurovitas

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

If you stop taking Claritromicina Aurovitas

It is essential to take your medication according to your doctor's instructions. Do not stop taking Claritromicina Aurovitas suddenly without discussing it with your doctor first. Otherwise, symptoms may recur.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Severe Adverse Effects:

If you experience any of the following, stop taking this medicine and inform your doctor immediately or go to the emergency services of the nearest hospital:

• Allergic reactions such as sudden difficulty breathing, difficulty speaking, and difficulty swallowing.
• Severe 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, with stomach pain or fever. This can 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:

• Lack of appetite.
• Yellowish coloration of the skin or whites of the eyes (jaundice).
• Pale stools, dark-colored urine.
• Itching.
• Abdominal pain.

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

Other Possible Adverse 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.

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

• Fungal infections (candidiasis) (e.g., in the mouth).
• Vaginal infections.
• Decrease in the number of certain types of blood cells, making it more likely to suffer from infections (leukopenia, neutropenia).
• Increase in the number of certain leukocytes (eosinophilia).
• Lack of appetite.
• Anxiety, dizziness, difficulty sleeping, chills, dizziness.
• Sensation of rotational movement.
• Hearing loss or ringing in the ears (tinnitus).
• Palpitations.
• Inflammation of the stomach, mouth, and tongue.
• Flatulence, constipation, and indigestion.
• Dry mouth.
• Cholestasis.
• Increased liver enzymes in blood.
• Itching, hives.
• Muscle pain, muscle cramps.
• General discomfort.
• Weakness.
• Chest pain.
• Chills.
• Fatigue.

Unknown Frequency(cannot be estimated from available data):

• Intestinal inflammation with severe diarrhea called pseudomembranous colitis.
• St. Anthony's fire (erysipelas), acne.
• Severe decrease in lymphocytes associated with sudden high fever, severe throat pain, and ulcers in the mouth (agranulocytosis).
• Unusual bruising or bleeding caused by low platelet levels.
• Severe allergic reactions that cause inflammation of the face or throat (angioedema).
• Psychosis, feeling of loss of identity.
• Confusion, change in sense of reality or panic.
• Depression, nightmares, disorientation, hallucinations, mania.
• Seizures.
• Disorders in the sense of smell, loss of sense of smell or taste.
• Deafness.
• Ventricular fibrillation (uncoordinated contraction of the heart muscle).
• Numbness or tingling in hands or feet.
• Difficulty in blood coagulation.
• Discoloration of teeth and tongue.
• In the case of an allergic eruption, there may be a slight itching of the skin, but in rare cases, it can also be part of a potentially fatal syndrome called Stevens-Johnson syndrome (a sudden and severe allergic reaction involving 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 peeling of the skin).
• Acne.
• Muscle pain or weakness, rhabdomyolysis (breakdown of muscle tissue).
• Kidney inflammation, kidney failure.
• Abnormal urine coloration.

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

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 that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Clarithromycin Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Clarithromycin Aurovitas

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

• Core of the tablet:microcrystalline cellulose, sodium croscarmellose, 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 Package Contents

Film-coated tablet.

Light yellow film-coated tablets, biconvex, oval, 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.

Clarithromycin Aurovitas 500 mg film-coated tablets are available in blister packs of 7, 10, 12, 14, and 21 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

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 under the following names:

Cyprus Clarithromycin Aurobindo 500 mg film-coated tablets

France CLARITHROMYCINE AUROBINDO 500 mg, film-coated tablet

Malta Clarithromycin 500 mg film-coated tablets

Netherlands Claritromycine Aurobindo 500 mg, film-coated tablets

Spain Claritromicina Aurovitas 500 mg film-coated tablets EFG

Date of the Last Revision of this Leaflet: March 2024

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