Package Insert: Information for the User

Clarithromycin Tarbis 500 mg Coated Tablets

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 only for you, and you should not give it to others who may 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.

1. What is Clarithromycin Tarbis and how is it used

2. What you need to know before starting to take Clarithromycin Tarbis

3. How to take Clarithromycin Tarbis

4. Possible adverse effects

5. Storage of Clarithromycin Tarbis

6. Contents of the package and additional information

Claritromicina is an antibiotic that belongs to the group of macrolides and acts by eliminating bacteria.

This medication is used for the treatment of infections caused by sensitive bacteria in adults and adolescents aged 12 to 18 years:

• Upper respiratory tract infections, such as pharyngitis (throat infection causing sore throat), tonsillitis (infection of the tonsils) and sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes).
• Lower respiratory tract infections, such as acute bronchitis (infection and inflammation of the bronchi), exacerbation of chronic bronchitis (prolonged or repeated inflammation of the lungs) and bacterial pneumonias (inflammation of the lungs caused by bacteria). (see warnings and precautions section).
• Skin and soft tissue infections, such as folliculitis (infection of one or more hair follicles), cellulitis (acute skin inflammation) and erysipelas (a type of skin infection). (see warnings and precautions section).
• Gastric and duodenal ulcers
• And for the prevention and treatment of infections caused by microbacteria.

Do not take Claritromicina Tarbis

• If you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other components of this medication (listed in section 6).
• If you have a creatinine clearance of less than 30 ml/min.
• If you have an irregular heart rhythm.
• If you have severe kidney and liver problems.
• If you are taking ergotamine or dihydroergotamine or using inhalers of ergotamine for migraines while taking clarithromycin. Consult your doctor for alternative medications..
• If you are taking medications called terfenadine, astemizol (allergy or hay fever medication), cisapride, or domperidone (used for stomach problems) or pimozide (used to treat certain psychiatric disorders) as taking these medications with clarithromycin may cause severe heart rhythm disturbances. Consult your doctor for alternative medications.
• If you are taking ticagrelor (to prevent blood clots in your veins and used in heart attacks and other heart problems), ivabradina or ranolazine (for angina pectoris).
• If you are taking other medications known to cause severe heart rhythm disturbances.
• If you are taking midazolam oral (for anxiety or to help fall asleep).
• If you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormal electrocardiogram (ECG, heart electrical recording) called "prolongation of QT syndrome).
• If you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), as the combination of these medications may increase the risk of adverse effects. Consult your doctor for alternative medications.
• If you are taking colchicine (for gout).
• If you are taking a medication with lomitapida.

Warnings and precautions

Consult your doctor or pharmacist before starting to take clarithromycin:

• If you have heart, kidney, or liver problems.
• If you have or are prone to fungal infections (e.g., thrush).
• If you are pregnant or breastfeeding.
• If you are taking medications known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, simvastatin.
• If you are diabetic and taking hypoglycemic medications (medications to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or insulin) and clarithromycin may lower blood sugar too much. Careful glucose control is recommended.
• If you are taking a medication called warfarin (blood thinner).
• If you have myasthenia gravis, a condition where your muscles weaken and tire easily.

If you develop severe or prolonged diarrhea during or after taking clarithromycin, consult your doctor immediately.

If you are affected by any of these situations, consult your doctor before taking clarithromycin.

Children and adolescents

Do not administer this medication to children under 12 years old.

Older patients

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

Claritromicina Tarbis with other medications

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

This medication should not be taken with ergot alkaloids, astemizol, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medications for high cholesterol, and medications known to cause severe heart rhythm disturbances (see Do not take Claritromicina Tarbis).

This is especially important if you are taking medications for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Thinning the blood (e.g., warfarin or other anticoagulants such as dabigatran, rivaroxaban, apixaban, edoxaban).
• Migraines (e.g., ergotamine or dihydroergotamine).
• Epilepsy or bipolar disorder (carbamazepine, valproate, phenobarbital, or phenytoin).
• High cholesterol (e.g., simvastatin or lovastatin).

Or if you are taking any medication called:

• Theophylline (used in patients with breathing difficulties, such as asthma).
• Triazolam, alprazolam, or midazolam (sedatives).
• Cilostazol (for poor circulation).
• Methylprednisolone (a corticosteroid).
• Ibrutinib or vinblastine (for cancer treatment).
• Ciclosporin (immunosuppressant).
• Rifabutin (for the treatment of certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat erectile dysfunction in adult men or for pulmonary hypertension).
• Zidovudine (for viruses).
• St. John's Wort (herbal product for depression).
• Phenobarbital (medication for epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for tuberculosis).
• Omeprazole (for stomach acid and ulcers).
• Ritonavir (antiviral medication used in HIV treatment) may increase clarithromycin levels. The concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medications used in HIV treatment) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazole (antifungal) taken with clarithromycin may increase both medication levels.
• Fluconazole, another antifungal, may increase clarithromycin levels.
• Tolterodine (for overactive bladder syndrome). In some patients, tolterodine levels may increase when taken with clarithromycin.
• Quetiapine (for schizophrenia or other psychiatric conditions).
• Beta-lactam antibiotics (certain penicillins and cephalosporins).
• Aminoglycosides (used as antibiotics for infections).
• Calcium channel blockers (medications for high blood pressure).
• Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medications with clarithromycin may increase the risk of abnormal heart rhythms and other severe adverse 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, lactation, and fertility

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

The safety of clarithromycin during pregnancy has not been established, so your doctor will weigh the benefits against the potential risk, especially during the first three months of pregnancy.

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, vertigo, confusion, and disorientation, you should exercise caution when driving or operating hazardous machinery during treatment with this medication.

Claritromicina Tarbis contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free."

Clarithromycin tarbis is administered orally.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children over 12 years:

Patients with respiratory tract, skin, and soft tissue infections:

The usual dose is 250 mg 2 times a day for 7 days, although in more severe infections, the dose may be increased to 500 mg 2 times a day. The usual duration of treatment is 5 to 14 days, excluding community-acquired pneumonia and sinusitis that require 6 to 14 days of therapy.

Eradiation of Helicobacter pylori in patients with duodenal ulcers (adults):

In patients with peptic ulcers associated withHelicobacter pylorithe recommended treatments are: Triple therapy: one tablet of Clarithromycin Tarbis 2 times a day, with 30 mg of lansoprazole 2 times a day and 1,000 mg of amoxicillin 2 times a day for 10 days.

Or one tablet of Clarithromycin Tarbis with 1,000 mg of amoxicillin and 20 mg of omeprazole, administered all 2 times a day, for 7 to 10 days.

Geriatric patients:

As adults.

Patients with infections caused by mycobacteria:

The recommended dose for the prevention and treatment of infections caused by mycobacteria is one tablet of Clarithromycin tarbis every 12 hours. The duration of treatment should be established by the doctor.

Patients with renal insufficiency:

In patients with renal insufficiency and a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced to half, i.e., 250 mg once a day, or 250 mg 2 times a day in more severe infections. In these patients, treatment should be interrupted after 14 days. Since the tablet cannot be dosed to half, the daily dose cannot be less than 500 mg/day, so Clarithromycin Tarbis should not be administered in this group of patients.

Follow these instructions unless your doctor has given you other indications.

Remember to take your medication. Take the tablets at the same time every day.

Your doctor will indicate the duration of your treatment.

Use in children and adolescents

The suitable presentations for children, from 6 months, and adolescents under 12 years are: Clarithromycin granulated for oral suspension.

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

If you take more Clarithromycin Tarbis than you should

If you have taken more clarithromycin than you should, you can expect the appearance of gastrointestinal disturbances and consult your doctor or pharmacist immediately, as they will try to quickly eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis are not effective.

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.

If you forgot to take Clarithromycin Tarbis

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

Take the tablet as soon as possible and continue taking it every day at the same time.

If you interrupt treatment with Clarithromycin Tarbis

Do not stop treatment prematurely, as although you may already be feeling better, your disease could worsen or recur. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects are classified as very common (can affect more than 1 in 10 patients), common (can affect up to 1 in 10 patients), uncommon (can affect up to 1 in 100 patients), and unknown frequency (cannot be estimated from available data).

The most common and more common adverse reactions related to clarithromycin treatment, both in adults and children, are abdominal pain, diarrhea, nausea, vomiting, and taste alteration. These adverse reactions are usually mild in intensity and coincide with the known safety profile of macrolide antibiotics (see below).

There were no significant differences in the incidence of these gastrointestinal adverse reactions during clinical trials between patients with or without pre-existing mycobacterial infections.

Summary of side effects:

Side effects are described in order of decreasing severity within the same body system:

Very common (can affect more than 1 in 10 patients, with the intravenous formulation):phlebitis (inflammation of the vein) at the injection site.

Common (can affect up to 1 in 10 patients):

• Gastrointestinal system: diarrhea, vomiting, dyspepsia (digestive disorder that makes digestion difficult), nausea, abdominal pain.
• Nervous system: taste alteration, headache, taste alteration.
• Skin: mild skin eruptions, excessive sweating.
• Psychiatric disorders: insomnia.
• Vascular disorders: vasodilation.
• Liver disorders: abnormal liver function tests.
• Administration site disorders: pain and inflammation at the injection site (only with the intravenous formulation).

Uncommon (can affect up to 1 in 100 patients):

• Infections: cellulitis (only with the intravenous formulation), candidiasis (infection by a type of fungus), gastroenteritis (only with prolonged-release tablets), infection (only with oral suspension granules), vaginal infection.
• Blood disorders: decreased white blood cells, decreased neutrophils (a type of white blood cell, only with immediate-release tablets), increased platelets and, to a lesser extent, red and white blood cells in the blood (only with oral suspension granules), increased eosinophils (a type of white blood cell, only with immediate-release tablets).
• Immune system disorders: anaphylactoid reaction (generalized allergic reaction, only with intravenous formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Feeding disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety and nervousness (the latter only with oral suspension granules).
• Nervous system: loss of consciousness and difficulty moving (both effects, only with intravenous formulation), dizziness, somnolence, tremors.
• Auditory and balance disorders: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and alteration of heart rhythm (fibrillation of the auricle) (both effects, only with intravenous formulation), prolongation of the QT interval (electrocardiogram indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat, only with intravenous formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or morning cough, only with intravenous formulation), nasal hemorrhages (only with prolonged-release tablets), pulmonary embolism (blockage of the pulmonary artery that causes chest pain on one side, cough, and difficulty breathing, only with intravenous formulation).
• Gastrointestinal disorders: esophagitis (inflammation of the esophagus, only with intravenous formulation), gastroesophageal reflux disease (damage to the esophagus that causes burning sensation, chronic cough, lack of air, and difficulty swallowing, only with prolonged-release tablets), gastritis (inflammation of the stomach lining), anal and rectal pain (only with prolonged-release tablets), oral mucosa inflammation, tongue inflammation, abdominal distension (only with immediate-release tablets), constipation, dry mouth, belching, flatulence.
• Liver disorders: decreased or suppressed bile flow to the intestine and liver inflammation (hepatitis) (both effects, only with immediate-release tablets), increased alanine aminotransferase (liver enzyme), increased aspartate aminotransferase (another liver enzyme), and increased gamma-glutamyltransferase (another liver enzyme, only with immediate-release tablets).
• Skin: dermatitis herpetiformis (vesicular eruptions, only with intravenous formulation), pruritus, urticaria (edematous, red, and itchy skin lesions), maculopapular eruption (skin lesion with a papule or wart on a patch, only with oral suspension granules).
• Musculoskeletal disorders: muscle spasms (only with oral suspension granules), musculoskeletal rigidity (only with intravenous formulation), muscle pain (only with prolonged-release tablets).
• Renal disorders: increased serum creatinine and urea (both effects, indicating impaired renal function, only with intravenous formulation).
• General disorders: malaise (only with immediate-release tablets), chest pain, chills, and fatigue (the latter three, only with immediate-release tablets).
• Laboratory tests: abnormal albumin-globulin ratio (only with intravenous formulation), increased serum alkaline phosphatase, and increased lactate dehydrogenase in blood (both effects, only with immediate-release tablets).

Unknown frequency (frequency cannot be determined from available data):

• Infections: pseudomembranous colitis (diarrhea that can be severe), erysipelas (skin redness of variable extent that can cause pain, itching, and fever).
• Blood disorders: decreased neutrophils (a type of white blood cell), decreased platelets.
• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (subcutaneous swelling).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, and somnambulism (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decreased or lost sense of taste, altered sense of smell, lost or decreased sense of smell, paresthesia, numbness, or tingling in hands, feet, arms, or legs.
• Auditory disorders: hearing loss.
• Cardiac disorders:torsades de pointes(a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats per minute with at least 3 consecutive irregular beats).
• Vascular disorders: hemorrhage.
• Gastrointestinal disorders: acute pancreatitis (inflammation of the pancreas), tongue discoloration, tooth discoloration.
• Liver disorders: liver function failure, icteric hepatitis (yellow discoloration of skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized eruption with blisters and skin peeling, primarily affecting genital, oral, and trunk areas), generalized acute exanthematous pustulosis (generalized scaly eruption with red color, with subcutaneous nodules and blisters, accompanied by fever, primarily located in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genital areas, causing generalized skin peeling (more than 30% of body surface area) and systemic symptoms such as fever, glandular inflammation, and abnormal blood test results (such as eosinophilia and elevated liver enzymes)). In the event of these reactions, discontinue clarithromycin treatment immediately and consult a doctor to initiate appropriate treatment.
• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that can cause renal damage), myopathy (muscle disease of multiple causes).
• Renal disorders: renal function failure, interstitial nephritis (inflammation of renal tubules).
• Laboratory tests: increased international normalized ratio (calculation for detecting blood coagulation), prolonged prothrombin time (indicating coagulation deficiency), and abnormal urine color.

Specific side effects:

Flebitis at the injection site, pain at the injection site, pain at the venipuncture site, and inflammation at the injection site are specific to the intravenous formulation of clarithromycin.

After marketing, reports have been received of central nervous system effects (e.g., somnolence and confusion) with the simultaneous use of clarithromycin and triazolam. It is suggested to monitor the patient.

In some of the reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see section 2.Do not take Claritromycin TarbisandWarnings and Precautions).

Rarely, there have been reports of clarithromycin prolonged-release tablets appearing in the stool, many of these cases have occurred in patients with anatomical or functional gastrointestinal disorders (including ileostomy or colostomy) or with shortened gastrointestinal transit time. In several reports, the residues of tablets have appeared in the context of diarrhea. It is recommended that patients who present tablet residues in the stool and do not experience any improvement change to another clarithromycin formulation (e.g., suspension) or to another antibiotic.

Side effects in children and adolescents:

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Immunocompromised patients:

In patients with AIDS and in other patients with damaged immune systems, treated with high doses of clarithromycin for long periods of time for mycobacterial infections, it is often difficult to distinguish side effects possibly associated with clarithromycin administration from those caused by the disease or other diseases that the patient may have with AIDS.

In adult patients treated with daily total doses of 1,000 mg and 2,000 mg of clarithromycin, the most common adverse reactions that appeared were: nausea, vomiting, taste alteration, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, auditory disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle damage). With lesser frequency, difficulty breathing, insomnia, and dry mouth appeared. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but generally were 3 to 4 times more frequent in those who received a daily total dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, around 2% to 3% who received 1,000 mg or 2,000 mg of clarithromycin daily presented severely abnormal elevated transaminases, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups had elevated blood urea nitrogen levels (which may indicate impaired renal function). In patients who received 4,000 mg daily, slightly higher incidences of abnormal values in all parameters, except white blood cell count, were observed.

Consult a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with subcutaneous nodules and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

No special storage conditions are required.

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 unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Claritromicina Tarbis

• The active ingredient is clarithromycin. Each coated tablet contains 500 mg of clarithromycin.
• The other components are:
• Core: pregelatinized cornstarch, sodium croscarmellose, povidone 25, microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate.
• Coating: hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E-171), talc, propylene glycol (E-1520).

Appearance of the product and contents of the packaging

Claritromicina Tarbis is presented in the form of coated tablets, white in color, capsule-shaped, in packaging with 14 or 21 coated tablets in a PVC/aluminum blister or a clinical packaging of 500 coated tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna, 66-68-70, Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: February 2024

The 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/