Clarithromycin Aurovitas 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Clarithromycin Aurovitas 500 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 only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clarithromycin Aurovitas is and what it is used for
2. What you need to know before taking Clarithromycin Aurovitas
3. How to take Clarithromycin Aurovitas
4. Possible side effects
5. How to store Clarithromycin Aurovitas
6. Contents of the pack and other information

1. What Claritromycin Aurovitas is and what it is used for

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

Clarithromycin Aurovitas is used to treat the following infections:

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

2. What you need to know before taking Clarithromycin Aurovitas

Do not take Clarithromycin Aurovitas:

• if you are allergic to clarithromycin, other macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6),
• if you have a history of cardiac arrhythmias (ventricular arrhythmia, including torsade de pointes) or changes in heart activity seen on electrocardiogram known as “prolongation of the QT interval”,
• if you have severe hepatic impairment together with renal impairment,
• if you are taking medicines called terfenadine or astemizole (for allergic rhinitis or allergies), or cisapride or domperidone or pimozide tablets, as combining these medicines may cause serious disturbances in heart rhythm. Consult your doctor about alternative treatments,
• if you are taking other medicines known to potentially cause serious disturbances in heart rhythm,
• if you are taking oral midazolam (a sedative),
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia),
• if you or a family member has a history of heart rhythm disturbances (ventricular cardiac arrhythmias, including torsades de pointes) or electrocardiogram (ECG, electrical recording of the heart) abnormalities called ‘QT interval prolongation syndrome’,
• if you are taking any of the following medicines:
  • ergotamine, dihydroergotamine (medicines for migraine),
  • lovastatin, simvastatin (medicines to lower cholesterol),
  • colchicine (a medicine for treating gout),
  • ticagrelor, ivabradine or ranolazine (medicines to prevent strokes or heart attacks).
• if you are taking medicines containing lomitapide.

Consult your doctor and do not take this medicine if any of the above apply to you or have applied to you in the past.

Warnings and precautions

Consult your doctor or pharmacist before taking Clarithromycin 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 diarrhoea (pseudomembranous colitis) during or after taking Clarithromycin Aurovitas, consult your doctor immediately. Inflammation of the colon (pseudomembranous colitis) has been reported with nearly all antibacterial medicines, including clarithromycin,
• if you have previously used clarithromycin multiple times over a long period,
• patients should be advised to stop treatment and contact their doctor if they develop signs and symptoms of liver disease, such as loss of appetite, jaundice, dark urine, itching, or tender abdomen,
• if you are taking clarithromycin concomitantly with benzodiazepines such as alprazolam, triazolam, and midazolam (see section “Taking Clarithromycin Aurovitas with other medicines”),
• if you are taking other medicines that affect your hearing function. Hearing function (for hearing loss) should be monitored during and after treatment,
• in case of severe acute hypersensitivity reactions, such as anaphylaxis, Stevens-Johnson syndrome, or toxic epidermal necrolysis, treatment with clarithromycin must be stopped immediately and appropriate therapy started urgently,
• concomitant use of clarithromycin with lovastatin or simvastatin is contraindicated (see section “Do not take Clarithromycin Aurovitas”). Caution is required when taking clarithromycin with other statins,
• if you are also taking oral anticoagulants together with clarithromycin, there is a risk of severe bleeding.

If any of these apply to you, consult your doctor before taking clarithromycin tablets.

Other medicines and Clarithromycin Aurovitas

Certain medicines may affect the effectiveness of Clarithromycin Aurovitas or vice versa.

Clarithromycin Aurovitas may increase the effect of the following medicines:

• astemizole, terfenadine (antihistamines), pimozide (antipsychotic), cisapride, domperidone (for stomach disorders), ergotamine, dihydroergotamine (anti-migraine medicines), lovastatin, simvastatin (cholesterol-lowering medicines) (see section “Do not take Clarithromycin Aurovitas”),
• alprazolam, triazolam, oral (oromucosal) midazolam (hypnotics) (for anxiety and sleep induction),
• atorvastatin, rosuvastatin (cholesterol-lowering medicines),
• warfarin or any other oral anticoagulant, e.g., 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 Clarithromycin Aurovitas concomitantly,
• nateglinide, repaglinide, sulfonylureas or insulin (antidiabetics),
• carbamazepine, phenytoin, valproate (medicines for epilepsy),
• cilostazol (used to improve circulation in the legs),
• colchicine (for treating gout),
• cyclosporine, sirolimus, tacrolimus (immunosuppressants),
• digoxin, verapamil, quinidine, disopyramide (heart medicines), concomitant use of clarithromycin and these medicines may cause cardiac arrhythmias,
• methylprednisolone (a corticosteroid used to treat inflammation),
• omeprazole (a medicine for stomach disorders),
• rifabutin (antibiotic),
• sildenafil, tadalafil, vardenafil (medicines for treating erectile dysfunction),
• theophylline (anti-asthma medicine),
• tolterodine (for treating overactive bladder syndrome),
• ibrutinib, vinblastine (medicines for treating cancer),
• medicines with risk of affecting hearing, especially aminoglycosides (a group of antibiotics administered intravenously),
• calcium channel blockers (medicines for treating high blood pressure),
• atypical antipsychotics (e.g., quetiapine).

The effect of both Clarithromycin Aurovitas and the following medicines may be increased when taken together:

• atazanavir, saquinavir (medicines for treating HIV infection),
• itraconazole (a medicine for treating fungal infections).

If your doctor has specifically advised you to take Clarithromycin Aurovitas and you are also taking any of the medicines listed above, your doctor may need to monitor you closely.

Clarithromycin Aurovitas may reduce the effect of the following medicines:

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

The following medicines may reduce the effect of Clarithromycin Aurovitas:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, nevirapine, etravirine (medicines for treating HIV infection),
• phenytoin, carbamazepine, phenobarbital (antiepileptics),
• St. John’s wort (a herbal medicine for treating depression).

The following medicines may enhance the effect of Clarithromycin Aurovitas:

• ritonavir (antiviral),
• fluconazole (a medicine for treating fungal infections).

Hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse effects affecting the heart.

Using clarithromycin together with digoxin, quinidine, disopyramide or verapamil (heart medicines), or any other macrolide antibiotic, may cause cardiac arrhythmias.

Corticosteroids administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in treating a wide range of conditions).

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

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 medicine.

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

Driving and using machines

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

Clarithromycin Aurovitas contains sodium

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

3. How to take Clarithromycin Aurovitas

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

Clarithromycin Aurovitas may be taken with or without food.

The recommended normal doses are given below:

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

The normal dose is 250 mg twice daily. In severe infections, your doctor may increase the dose to 500 mg twice daily. The usual duration of treatment is 7 to 14 days and should continue for at least two days after symptoms have disappeared.

Use in H. pylori infections:

In adult patients with stomach and duodenal ulcers due to H. pylori infection, the normal dose administered is 500 mg twice daily as part of a triple therapy regimen.

Use in patients with kidney problems:

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

Use in children and adolescents under 12 years of age:

The use of Clarithromycin Aurovitas tablets in children under 12 years of age (weighing less than 30 kg) is not recommended. Your doctor will prescribe another medicine appropriate for these children.

For children with a body weight above 30 kg, the same dose as for adults should be used.

If you think that the effect of this medicine is too strong or too weak, contact your doctor or pharmacist.

If you take more Clarithromycin Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

An overdose may cause gastrointestinal disturbances and possibly other discomforts.

If you forget to take Clarithromycin Aurovitas

If you forget to take a dose of Clarithromycin Aurovitas, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you stop taking Clarithromycin Aurovitas

It is important that you take your medicine according to your doctor's instructions. Do not stop taking Clarithromycin Aurovitas suddenly without first talking to your doctor. Otherwise, symptoms may recur.

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.

Serious adverse effects:

If you experience any of the following, stop taking this medicine immediately and contact your doctor right away or go to the nearest hospital emergency department:

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

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

• Severe or prolonged diarrhea, possibly with blood, stomach pain, or fever. This may be a sign of serious intestinal inflammation. Your doctor may discontinue treatment. Do not take medications that reduce intestinal motility.

• Liver function problems with the following possible symptoms:

• Loss of appetite.

• Yellowing of the skin or whites of the eyes (jaundice).

• Pale stools, dark-colored urine.

• Pruritus (itching).

• Abdominal pain.

• Palpitations or irregular heartbeat.

• Severe pain in the abdomen and back, caused by inflammation of the pancreas.

Other possible adverse effects:

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

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

Uncommon (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 infections more likely (leukopenia, neutropenia).
• Increase in certain white blood cells (eosinophilia).
• Loss of appetite.
• Anxiety, dizziness, difficulty sleeping, chills, dizziness.
• Sensation of spinning (vertigo).
• Hearing loss or ringing in the ears (tinnitus).
• Palpitations.
• Inflammation of the stomach, mouth, and tongue.
• Flatulence, constipation, indigestion.
• Dry mouth.
• Cholestasis.
• Increased liver enzymes in blood.
• Itching, hives.
• Muscle pain, muscle cramps.
• Malaise.
• Weakness.
• Chest pain.
• Chills.
• Fatigue.

Frequency not known (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 sore throat, and mouth ulcers (agranulocytosis).
• Unusual bruising or bleeding due to low platelet count.
• Severe allergic reactions causing swelling of the face or throat (angioedema).
• Psychosis, feeling of loss of identity.
• Confusion, altered sense of reality, or panic.
• Depression, nightmares, disorientation, hallucinations, mania.
• Seizures.
• Disorders of the sense of smell, loss of smell or taste.
• Deafness.
• Ventricular fibrillation (uncoordinated contraction of the heart muscle).
• Tingling or numbness in the hands or feet.
• Difficulty in blood clotting.
• Discoloration of teeth and tongue.
• In case of an allergic rash, there may be mild itching of the skin, but in rare cases it may be part of a potentially life-threatening 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, skin blisters, and skin peeling).
• Acne.
• Muscle pain or weakness, rhabdomyolysis (breakdown of muscle tissue).
• Kidney inflammation, kidney failure.
• 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 (exanthematous pustulosis). The frequency of this adverse effect is considered not known (cannot be estimated from available data).

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Clarithromycin Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Claritromycin Aurovitas

• The active substance is clarithromycin. Each tablet contains 500 mg of clarithromycin.

• The other components (excipients) are:

• Tablet core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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 medicine and contents of the pack

Film-coated tablet.

Light yellow, biconvex, oval film-coated tablets, marked with "D" on one side and "63" on the other side. The size is 18.5 mm x 8.1 mm.

Claritromycin Aurovitas 500 mg film-coated tablets are available in blisters 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Cyprus Clarithromycin Aurobindo 500 mg επικαλυμμένο με λεπτό υμένιο δισκία

France CLARITHROMYCINE AUROBINDO 500 mg, comprimé pelliculé

Malta Clarithromycin 500 mg film-coated tablets

Netherlands Claritromycine Aurobindo 500 mg, filmomhulde tabletten

Spain Claritromicina Aurovitas 500 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: March 2024

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