Package Insert: Information for the User

Claritromycin Alter 500 mg Film-Coated Tablets

Read this package insert carefully before starting to take this 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 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Claritromicina is a medication that belongs to the group of macrolide antibiotics.

Claritromicina Alter is used for the treatment of infections caused by sensitive microorganisms in adults and adolescents (from 12 years of age to less than 18 years):

Adults:

1. Upper respiratory tract infections, such as pharyngitis, tonsillitis, and sinusitis.
2. Lower respiratory tract infections, such as acute bronchitis, exacerbation of chronic bronchitis, and bacterial pneumonias.
3. Skin and soft tissue infections, such as folliculitis, cellulitis, and erysipelas.
4. Infections caused by mycobacteria (a type of bacteria).
5. Eradiation of the Helicobacter pylori bacteria in patients with gastric or duodenal ulcers.

Adolescents (from 12 years of age to less than 18 years):

1. Upper respiratory tract infections, such as pharyngitis.
2. Lower respiratory tract infections, such as bronchitis and bacterial pneumonias.
3. Acute otitis media.
4. Skin and soft tissue infections, such as impetigo, folliculitis, cellulitis, and abscesses.

Do not take Claritromicina Alter:

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other components of this medication (listed in section 6).
• If you are taking any of the following medications: cisapride, pimozide, and terfenadine, as they may cause cardiac rhythm disturbances when administered with clarithromycin.
• Medications called ticagrelor, ivabradina, or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke)
• Medications with lomitapida
• If you have abnormally low levels of potassium or magnesium in your blood (hypopotasemia or hypomagnesemia)

Be especially careful with Claritromicina Alter:

• Since clarithromycin is eliminated by the liver and kidneys, caution should be exercised in patients with liver function disorders, moderate or severe renal insufficiency, and in the elderly.

• If you experience intense or persistent diarrhea, consult your doctor immediately.

Other medications

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those purchased without a prescription.

Clarithromycin may interact with the following medications, so your doctor will take precautions when administering them together with clarithromycin, and may even adjust the dosage of these medications:

• Theophylline
• Carbamazepine
• Warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, and edoxaban (to thin the blood)
• Ergotamine alkaloids
• Triazolam, midazolam
• Lovastatin, simvastatin
• Disopyramide
• Phenytoin
• Ciclosporin
• Cisapride, pimozide, and terfenadine (see section “Do not take Claritromicina Alter”)

This is also important if you are taking medications called:

• Hydroxychloroquine or chloroquine (used to treat conditions 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)

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.The safety of clarithromycin during pregnancy has not been established, so your doctor will carefully weigh the benefits against the potential risks, especially during the first three months of pregnancy. Therefore, if you are pregnant or think you may be pregnant, you must inform your doctor before taking this medication.

Clarithromycin passes into breast milk, so it is recommended to stop breastfeeding during treatment with clarithromycin.

Driving and operating machinery

Since clarithromycin may cause dizziness, you should exercise extreme caution when driving or using hazardous machinery during treatment with Claritromicina Alter.

Important information about some of the components of Claritromicina Alter

The starch present in this medication contains very low levels of gluten and is very unlikely to cause problems if you have celiac disease.

A tablet contains no more than 189 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Claritromicina Alter is presented in tablets for oral administration. Take the tablets at the same time every day.

Your doctor will indicate the duration of your treatment with Claritromicina Alter. Do not discontinue treatment beforehand, as, although you may feel better, your disease could worsen or reappear.

The recommended dose of clarithromycin is:

Adults and adolescents (12 years of age to less than 18 years): the recommended dose is 250 mg twice a day. In more severe infections, the dose may be increased to 500 mg twice a day. The usual duration of treatment is 6 to 14 days.

Children under 12 years: the recommended dose is 7.5 mg/kg twice a day, up to a maximum of 500 mg twice a day. The usual duration of treatment is 5 to 10 days depending on the type and severity of the infection.

This pharmaceutical form is not suitable for administration of doses less than 250 mg or for patients who have swallowing problems.

Patients with gastric or duodenal ulcer associated withHelicobacter pylori:

The recommended dose of clarithromycin for eradication of the bacteriumHelicobacter pyloriis 500 mg twice or three times a day, in association with omeprazole and another antibiotic, for 7 to 14 days.

Patients with renal insufficiency:

In patients with renal insufficiency, the dose of clarithromycin should be reduced to half.

If you estimate that the action of Claritromicina Alter is too strong or too weak, inform your doctor or pharmacist.

If you take more Claritromicina Alter than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet of the medication to the healthcare professional.

The most frequent symptoms that accompany an overdose are gastrointestinal disturbances.

If you forgot to take Claritromicina Alter

Do not take a double dose to compensate for the missed doses.

Take the tablet as soon as you remember and continue respecting the 12-hour interval between doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The adverse effects that may appear withgreater frequencyare related to the digestive system, such as nausea, stomach discomfort or indigestion, diarrhea, vomiting, and abdominal pain. Other adverse reactions include headaches, altered taste, and transient increases in liver enzymes.

Withless frequency, liver alterations (which are generally reversible) have been observed, allergic reactions that can range from mild skin itching and rashes to severe allergies, transient central nervous system adverse effects (blurred vision, anxiety, insomnia, nightmares, confusion, hallucinations, and behavioral disorders), hearing loss (usually reversible with treatment interruption), normal alteration of smell accompanied by altered taste, gum inflammation, superficial tongue inflammation, fungal infections in the mouth, and tongue discoloration, as well as tooth discoloration (this discoloration usually disappears with a professional dental cleaning).

Inrare cases, low blood sugar levels have been described, in some cases associated with the use of diabetes medications.

Exceptionally, cases of decreased white blood cells or platelets, as well as elevated creatinine levels in the blood, have been observed.

Rarely, alterations in the electrocardiogram or heart rhythm have been described.

Seek medical attention 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 adverse effect is considered unknown (cannot be estimated from available data).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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

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. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofClaritromicina Alter

The active ingredient is clarithromycin. Each tablet contains 500 mg of clarithromycin.

The excipients are: Polysorbate 80, povidone, wheat starch, microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171) and triacetin.

Appearance of the product and contents of the packaging

Claritromicina Alter 500 mg is presented in the form of coated tablets in packs containing 14 or 21 tablets.

Other presentations: Claritromicina Alter 250 mg is available in packs with blisters containing 14 tablets

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Last review of this leaflet: April 2021

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