CLARITHROMYCIN ALTAN 500 mg LYOPHILIZED POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Claritromicina Altan 500 mgLyophilized powder for solution for infusion EFG

Read all of this leaflet carefully before you start using this medicine.

• 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 Altan 500 mg and what is it used for
2. What you need to know before you use Claritromicina Altan 500 mg
3. How to use Claritromicina Altan 500 mg
4. Possible side effects
5. Storage of Claritromicina Altan 500 mg
6. Contents of the pack and other information

1. What is Claritromicina Altan 500 mg and what is it used for

Claritromicina is an antibiotic belonging to a group of substances called macrolides. Antibiotics interrupt the growth of bacteria (germs) that cause infections.

Claritromicina is indicated when parenteral therapy is required for the treatment of infections caused by susceptible organisms in adults and adolescents (from 12 years of age) in the following conditions:

• Pharyngitis (infection of the pharynx that causes sore throat) or streptococcal tonsillitis (infection of the tonsils): only in cases where first-line treatment with beta-lactams is not possible or when Streptococcus pyogeneshas shown sensitivity to clarithromycin.
• Acute bacterial sinusitis (infection of the paranasal sinuses that are around the forehead, cheeks, and eyes) (adequately diagnosed)
• Community-acquired pneumonia (inflammation of the lungs caused by various germs and originating outside a hospital).
• Acute exacerbation of chronic bronchitis (worsening of prolonged or recurrent lung inflammation).
• Mild to moderate skin and soft tissue infections when beta-lactam antibiotics are not appropriate.

2. What you need to know before you use Claritromicina Altan 500 mg

Do not useClaritromicina Altan 500 mg

• if you are allergic (hypersensitive) to clarithromycin or other macrolide antibiotics such as erythromycin or azithromycin or to 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 heartbeat.
• if you have severe kidney and liver problems.
• if you are taking ergotamine or dihydroergotamine or use ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for advice or alternative medications.
• if you are taking medications called terfenadine, astemizole (medication for hay fever or allergies), cisapride or domperidone (used for stomach problems) or pimozide (medication used to treat certain psychiatric disorders) as taking these medications with clarithromycin can cause serious 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), ivabradine or ranolazine (for angina pectoris).
• if you are taking other medications known to cause serious heart rhythm disturbances.
• if you are undergoing treatment with oral midazolam (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 have a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or electrocardiogram (ECG, electrical recording of the heart) abnormalities called “QT prolongation syndrome”.
• if you are taking medications called lovastatin or simvastatin (to lower cholesterol levels), as the combination of these medications can increase the risk of side effects. Consult your doctor for alternative medications.
• if you are taking colchicine (for gout)
• if you are taking a medication with lomitapide.

Warnings and precautions

Consult your doctor or pharmacist before starting to receive Claritromicina Altan 500 mg

• if you have heart, kidney, or liver problems.
• if you have or are prone to fungal infections (such as 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 agents (medications to lower blood sugar levels such as nateglinide, pioglitazone, rosiglitazone, and repaglinide, sulfonylureas, or insulin) and clarithromycin may lower blood sugar levels too much. Careful monitoring of blood sugar is recommended.
• if you are taking a medication called warfarin or any other anticoagulant, for example: dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood).
• 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 any of these situations apply to you, consult your doctor before receiving clarithromycin.

Use of Claritromicina Altan 500 mg with other medications

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

• Claritromicina Altan 500 mg should not be used with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, ivabradine, pimozide, ticagrelor, ranolazine, colchicine, some medications for high cholesterol, and medications known to cause serious heart rhythm disturbances (see Do not use Claritromicina Altan 500 mg).

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 like dabigatran, rivaroxaban, apixaban, or edoxaban).
• Migraine (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).
• Cyclosporine (immunosuppressant).
• Rifabutin (for treatment of some infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (for treating impotence in adult men or for pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).
• Zidovudine (for treating viruses).
• St. John's Wort (a herbal product for treating depression).
• Phenobarbital (a medication for treating epilepsy).
• Nevirapine and efavirenz may decrease clarithromycin levels.
• Rifampicin or rifapentine (for treating tuberculosis).
• Omeprazole (for treating stomach acid and stomach or intestinal ulcers).
• Ritonavir (an antiviral medication used in the treatment of HIV infection) may increase clarithromycin levels. The concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medications used in the treatment of HIV infection) with clarithromycin may increase both atazanavir (or saquinavir) and clarithromycin levels.
• Itraconazole (an antifungal) taken with clarithromycin may increase the levels of both medications.
• Fluconazole, another antifungal medication, may increase clarithromycin levels.
• Tolterodine (for treating symptoms of overactive bladder). 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 to treat infections).
• Calcium channel blockers (medications to treat high blood pressure).
• 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 clarithromycin may increase the risk of abnormal heart rhythms and other serious 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 range of diseases)

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this 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.

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

Driving and using machines

Since clarithromycin can cause dizziness, vertigo, confusion, and disorientation, during treatment with clarithromycin, you should exercise caution when driving or using hazardous machinery.

Claritromicina Altan 500 mg lyophilized powder for solution for infusion contains sodium

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

3. How to use Claritromicina Altan 500 mg

Claritromicina is administered intravenously.

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

The recommended daily dose of intravenous clarithromycin for adults 18 years of age and older is 1 g, divided into two equal doses and infused over a period of 60 minutes after appropriate dilution.

Treatment can be administered for 2-5 days, and should be switched to oral clarithromycin treatment when indicated by your doctor.

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 daily, or 250 mg twice daily in more severe infections. In these patients, treatment should be discontinued after 14 days.

Intravenous clarithromycin should not be administered as a bolus injection or intramuscularly.

Use in children and adolescents:

Children (under 12 years) should not use this medication. Your doctor will prescribe another suitable medication for your child.

For adolescents from 12 to 18 years of age, the same dose as for adults is used.

If you use moreClaritromicina Altan 500 mg than you should

If you use more Claritromicina Altan than you should, you can expect the appearance of digestive disorders, and consult your doctor or pharmacist immediately, as they will try to eliminate the clarithromycin that your body has not yet absorbed. Hemodialysis or peritoneal dialysis is not effective.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to useClaritromicina Altan 500 mg

If you think you may have forgotten a dose, consult your doctor or nurse. You should not be given a double dose to make up for forgotten doses.

If you stop treatment withClaritromicina Altan500 mg

If you have any further questions on the use of this product, 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.

Adverse effects are classified as very frequent (may affect more than 1 in 10 patients), frequent (may affect up to 1 in 10 patients), infrequent (may affect up to 1 in 100 patients), and unknown frequency (cannot be estimated from available data).

The frequent and very frequent adverse reactions related to treatment with clarithromycin, in both adults and children, are abdominal pain, diarrhea, nausea, vomiting, and alteration of taste. These adverse reactions are usually mild 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 the population of patients with or without pre-existing mycobacterial infections.

Summary of Adverse Effects

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

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

? With all medicines containing clarithromycin, the following have been frequently observed (may affect up to 1 in 10 patients):

• Digestive system: diarrhea, vomiting, gastric disorder that makes digestion difficult (dyspepsia), nausea, abdominal pain.
• Nervous system: alteration of taste, headache, alteration of taste.
• Skin: mild skin rash, excessive sweat production.
• Psychiatric disorders: insomnia.
• Vascular disorders: dilation of blood vessels in the body (vasodilation).
• Liver disorders: abnormal liver function tests.
• Disorders at the administration site: pain and inflammation at the injection site (only with the intravenous injection formulation).

? Infrequently observed (may affect up to 1 in 100 patients) are the following:

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (infection by a type of fungus), vaginal infection.
• Blood disorders: decrease in white blood cells.
• Immune system: anaphylactoid reaction (generalized allergic reaction, only with the intravenous injection formulation), hypersensitivity (exaggerated allergic reaction to external agents).
• Eating disorders: anorexia, decreased appetite.
• Psychiatric disorders: anxiety.
• Nervous system: loss of consciousness and difficulty moving (both effects, only with the intravenous injection formulation), dizziness, drowsiness, tremors.
• Ear and balance: vertigo, hearing problems, tinnitus.
• Heart disorders: cardiac arrest and alteration of heart rhythm (atrial fibrillation) (both effects, only with the intravenous injection formulation), prolongation of the QT interval (indicator of the electrocardiogram that ventricular arrhythmias may occur), extrasystoles (advancement of a heartbeat with respect to the normal heart rate, only with the intravenous injection formulation), palpitations (alterations in heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest oppression, and nocturnal or early morning cough, only with the intravenous injection formulation), pulmonary embolism (blockage of the pulmonary artery that causes chest pain on one side, cough, and difficulty breathing, only with the intravenous injection formulation).
• Gastrointestinal disorders: esophagitis (only with the intravenous injection formulation), gastroesophageal reflux disease (damage to the esophagus that causes a burning sensation, chronic cough, inflammation of the stomach mucosa (gastritis), inflammation of the oral mucosa, inflammation of the tongue, constipation, dry mouth, belching, flatulence.
• Liver disorders: increase in alanine aminotransferase (liver enzyme), aspartate aminotransferase (another liver enzyme).
• Skin: bullous dermatitis (bullous rash, only with the intravenous injection formulation), itching, urticaria (edematous, red, and very itchy skin lesions).
• Muscle disorders: musculoskeletal stiffness (only with the intravenous injection formulation).
• Kidney disorders: increase in serum creatinine and serum urea (both effects, which indicate poorer kidney function, only with the intravenous injection formulation).
• Laboratory analysis: abnormal albumin-globulin ratio (only with the intravenous injection formulation).

With an unknown frequency (whose frequency cannot be determined with the available data), the following have been observed:

• Infections: pseudomembranous colitis (diarrhea that can become severe), erysipelas (redness of the skin of variable extension that can cause pain, itching, and fever).
• Blood disorders: decrease in neutrophils (a type of white blood cell), decrease in platelets.
• Immune system: anaphylactic reaction (generalized allergic reaction), angioedema (swelling under the skin).
• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, daydreaming (attenuated perceptions of external stimuli).
• Nervous system: convulsions, decrease or loss of taste, alteration of the sense of smell, loss or decrease of the sense of smell, sensation of tingling, numbness, or paresthesia in hands, feet, arms, or legs.
• Ear: deafness.
• Heart disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (acceleration of heartbeats with more than 100 beats/minute with at least 3 consecutive irregular beats).
• Vascular disorders: hemorrhage.
• Digestive disorders: acute pancreatitis (acute inflammation of the pancreas), discoloration of the tongue, discoloration of the teeth.
• Liver disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).
• Skin: Stevens-Johnson syndrome (generalized rash with blisters and skin peeling, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (generalized scaly red rash with bumps under the skin and blisters, accompanied by fever, mainly located in skin folds, trunk, and upper limbs) and toxic epidermal necrolysis (generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing generalized skin peeling (more than 30% of the body surface) with flu-like symptoms, fever, gland inflammation, and abnormal blood test results (such as increased leukocytes (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)], acne. In the event of such reactions, treatment with clarithromycin should be immediately discontinued and a doctor consulted for appropriate treatment.
• Muscle disorders: rhabdomyolysis (muscle breakdown that can cause kidney damage), myopathy (muscle disease of multiple causes).
• Kidney disorder: kidney failure, interstitial nephritis (inflammation of the renal tubules).
• Laboratory analysis: increase in the international normalized ratio (calculation to detect blood coagulation), prolongation of prothrombin time (indicates a deficit in blood coagulation) and abnormal urine color.

Specific Adverse Effects

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

In some reports of rhabdomyolysis, clarithromycin was administered concomitantly with statins, fibrates, colchicine, or allopurinol (see Do not take Clarithromycin Altan 500 mg lyophilized for solution for infusionand Warnings and precautions).

Adverse Effects in Children and Adolescents:

Clinical trials have been conducted with clarithromycin pediatric suspension in children from 6 months to 12 years of age. Therefore, children under 12 years of age should take the pediatric suspension of clarithromycin. There is not enough data to recommend a dosing regimen for the intravenous formulation of clarithromycin in patients under 12 years of age.

It is expected that the frequency, type, and severity of adverse reactions in children will be the same as in adults.

Immunocompromised Patients

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

In adult patients treated with daily doses of 1,000 mg and 2,000 mg of clarithromycin, the most frequent adverse reactions that appeared were: nausea, vomiting, alteration of taste, abdominal pain, diarrhea, skin rash, flatulence, headache, constipation, auditory disturbances, and elevations in transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently, respiratory difficulty, insomnia, and dry mouth appeared. The incidences were similar in patients treated with 1,000 mg and 2,000 mg, but in general, they were 3 to 4 times more frequent in those who received a daily dose of 4,000 mg of clarithromycin.

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

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). 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. 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.

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5. Conservation of Clarithromycin

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

• Reconstituted solution (500 mg in 10 ml of water for injectable preparations): can be stored for 24 hours at room temperature and 48 hours in the refrigerator (2°C - 8°C).
• The final reconstituted solution (reconstituted infusion solution added to 250 ml of diluent, respectively, for each diluent mentioned) can be stored for 24 hours at room temperature (25°C) or for 48 hours in the refrigerator (2°C - 8°C).

Do not use Clarithromycin after the expiration date that appears on the packaging or on the vial label. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. In this way, you will help protect the environment.

6. Additional Information

Composition of Clarithromycin Altan 500 mg

• The active ingredient is clarithromycin 500 mg.
• The other components are lactobionic acid, sodium hydroxide, and water for injection.

Appearance of the Product and Packaging Content

Sediment or powder for solution for infusion, white to almost white in color, in a glass vial.

Package sizes: 1 vial, 6 vials, and 100 vials.

It may be that not all package sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª Planta, Edificio Prisma. Oficina F.

28230 Las Rozas (Madrid)

Manufacturer

Altan Pharmaceuticals, S.A.

Avda. de la Constitución 198-199, Polígono Industrial Monte Boyal,

45950 Casarrubios del Monte (Toledo) Spain

This prospectus was revised in July 2025

"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/"

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INFORMATION FOR HEALTHCARE PROFESSIONALS:

Adults:

The recommended dose in adults and adolescents (from 12 to 18 years) is 1 g per day, divided into two equal doses, each infused after subsequent dilution with an appropriate intravenous diluent, over a period of 60 minutes. There is currently no data to justify the use of intravenous clarithromycin in children. Clarithromycin should not be administered by bolus injection or intramuscularly.

Elderly Patients:

Same dose as adults.

Dosage in Patients with Mycobacterial Infections:

Although there is currently no data related to the use of intravenous clarithromycin in immunocompromised patients, there is data on the use of oral clarithromycin in patients infected with HIV. In disseminated or localized infections (M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended treatment in adults is 1,000 mg/day divided into two doses.

Intravenous treatment may be administered for 2-5 days in severely ill patients and should be switched to oral clarithromycin treatment as soon as possible when indicated by the doctor.

Renal Insufficiency:

In patients with renal insufficiency, who have a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced to half of the recommended dose.

Hepatic Insufficiency:

Clarithromycin should not be administered to patients with severe combined hepatic and renal insufficiency. (see section 4.3)

Pediatric Population:

There is not enough data to recommend a dosing regimen for the intravenous formulation of clarithromycin in patients under 12 years of age.

In adolescents (12 to 18 years of age), the dose is the same as in adults.

Instructions for Reconstitution and Dilution of the Medicine before Administration

1. Prepare the initial clarithromycin solution (reconstituted solution) by adding 10 ml of sterile water for injectable preparations to the 500 mg vial. Gently rotate until completely dissolved without any visible residue of undissolved macroparticles (it may take up to 5 minutes). Only sterile water for injectable preparations should be used, as other diluents may cause precipitation during reconstitution. Do not use diluents that contain preservatives or inorganic salts.

Observation: When the product is reconstituted as mentioned above, each ml of reconstituted solution contains 50 mg of clarithromycin.

The resulting solution contains an effective antimicrobial preservative. If stored at room temperature (25°C), the reconstituted product should be used within 24 hours, and if stored at 2-8°C, within 48 hours.

1. Before administration, the reconstituted solution (500 mg in 10 ml of water for injectable preparations) will be added to 250 ml of the following diluents:

1. Sodium chloride 0.9%
2. Dextrose 5%
3. Dextrose in sodium chloride 0.3%
4. Dextrose 5% in sodium chloride 0.45%
5. Dextrose 5% in lactated Ringer's solution
6. Lactated Ringer's solution.

The final diluted solution (the reconstituted solution to which 250 ml of the mentioned diluents have been added) should be used within 24 hours if stored at room temperature (25°C) or within 48 hours if stored in the refrigerator at 5°C.

No other medicines or chemical agents should be added to the final mixture unless their effect on the physical and chemical stability of the solution has been determined.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user/administrator and should not normally exceed 24 hours at 2-8°C, unless the dilution has been performed under aseptic and validated conditions.

PHARMACEUTICAL INCOMPATIBILITIES

None have been described.

Overdose

In case of overdose, treatment should be discontinued and appropriate supportive measures should be initiated.

Adverse reactions accompanying overdose should be treated by rapidly eliminating the unabsorbed drug and providing supportive measures.

It is not expected that clarithromycin levels will be significantly affected by hemodialysis or peritoneal dialysis.