CLARITHROMYCIN ALTER 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Claritromicina Alter 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Claritromicina Alter and what is it used for

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

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

Adults:

1. Infections of the upper respiratory tract, such as pharyngitis, tonsillitis, and sinusitis.
2. Infections of the lower respiratory tract, such as acute bronchitis, exacerbation of chronic bronchitis, and bacterial pneumonia.
3. Infections of the skin and soft tissues, such as folliculitis, cellulitis, and erysipelas.
4. Infections caused by mycobacteria (a type of bacteria).
5. Eradiation of the bacterium Helicobacter pyloriin patients with gastric or duodenal ulcers.

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

1. Infections of the upper respiratory tract, such as pharyngitis.
2. Infections of the lower respiratory tract, such as bronchitis and bacterial pneumonia.
3. Acute otitis media.
4. Infections of the skin and soft tissues, such as impetigo, folliculitis, cellulitis, and abscesses.

2. What you need to know before you take Claritromicina Alter

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 ingredients of this medicine (listed in section 6).
• If you are taking any of the following medicines: cisapride, pimozide, and terfenadine, as they may cause heart rhythm disturbances when administered with clarithromycin.
• if you take medicines called ticagrelor, ivabradine, or ranolazine (for angina pectoris or to reduce the risk of myocardial infarction or stroke)
• If you are taking a medicine called lomitapide
• If you have abnormally low levels of potassium or magnesium in the blood (hypokalemia or hypomagnesemia)

Be careful with Claritromicina Alter:

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

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

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Claritromicina may interact with the following medicines, so your doctor will take precautions when administering them together with clarithromycin, and may even adjust the dose of the same:

• theophylline
• carbamazepine
• warfarin or other anticoagulants, such as dabigatran, rivaroxaban, apixaban, and edoxaban (to thin the blood)
• ergot alkaloids
• triazolam, midazolam
• lovastatin, simvastatin
• disopyramide
• phenytoin
• cyclosporin
• cisapride, pimozide, and terfenadine (see section "Do not take Claritromicina Alter")

This is also important if you take medicines called:

• hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as clarithromycin may increase the possibility of abnormal heart rhythms and other serious adverse reactions that affect 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 medicine. The safety of clarithromycin during pregnancy has not been established, so your doctor will carefully weigh the benefits against the potential risk, especially during the first three months of pregnancy. Therefore, if you are pregnant or think you may be pregnant, you should inform your doctor before taking this medicine.

Claritromicina passes into breast milk, so breastfeeding should be interrupted during treatment with clarithromycin.

Driving and using machines

Since clarithromycin can cause dizziness, you should be careful when driving or using hazardous machinery during treatment with Claritromicina Alter.

Important information about some of the ingredients of Claritromicina Alter

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

One tablet does not contain more than 189 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

3. How to take Claritromicina Alter

Follow the instructions for administration of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Claritromicina Alter is presented in film-coated 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 stop treatment before, as your disease may worsen or reappear, even if you feel better.

The recommended dose of clarithromycin is:

Adults and adolescents (from 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 the administration of doses less than 250 mg or for patients who have swallowing problems.

Patients with gastric or duodenal ulcers associated withHelicobacter pylori:

The recommended dose of clarithromycin for the eradication of the bacterium Helicobacter pyloriis 500 mg twice or three times a day, in combination 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 by half.

If you think the action of Claritromicina Alter is too strong or too weak, tell 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

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

If you forget to take Claritromicina Alter

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

In rare cases, low blood sugar levels have been described, sometimes associated with the use of diabetes medications.

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

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

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 exanthem). The frequency of this adverse effect is considered unknown (cannot be estimated from the available data).

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Claritromicina Alter

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

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, sodium croscarmellose, anhydrous colloidal silica, stearic acid, magnesium stearate, hypromellose (E 464), titanium dioxide (E 171), and glycerol triacetate.

Appearance of the product and contents of the pack

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

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

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Last revision of this leaflet: April 2021

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