Clarithromycin Altan 500 mg lyophilisate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Claritromycin Altan 500 mg Lyophilisate for solution for infusion EFG

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet. 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. Do not give it to other people, 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.

Leaflet contents:

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

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

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

Clarithromycin is indicated whenever 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:

• Streptococcal pharyngitis (infection of the pharynx causing sore throat) or tonsillitis: only in those cases where first-line treatment with beta-lactam antibiotics is not possible or when sensitivity of Streptococcus pyogenes to clarithromycin has been demonstrated.
• Acute bacterial sinusitis (infection of the paranasal sinuses located around the forehead, cheeks, and eyes) (adequately diagnosed).
• Community-acquired pneumonia (inflammation of the lungs caused by various pathogens and contracted outside of the hospital).
• Acute exacerbation of chronic bronchitis (sudden worsening of long-standing 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 using Clarithromycin Altan 500 mg

Do not use Clarithromycin Altan 500 mg

• if you are allergic (hypersensitive) to clarithromycin or to other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• if your creatinine clearance is less than 30 ml/min.
• if you have an irregular heartbeat.
• if you have severe kidney or liver problems.
• if you are taking ergotamine or dihydroergotamine, or using ergotamine inhalers for migraine while taking clarithromycin. Consult your doctor for advice or alternative medications.
• if you are taking medicines called terfenadine, astemizole (medicines for hay fever or allergies), cisapride or domperidone (used for stomach problems), or pimozide (a medicine used to treat certain psychiatric conditions), as taking these with clarithromycin may cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines.
• 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).
• if you are taking other medicines known to cause serious disturbances in heart rhythm.
• if you are being treated with oral midazolam (for anxiety or to help you sleep).
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia).
• if you or a family member have a history of heart rhythm disorders (ventricular arrhythmia, including Torsade de Pointes) or abnormalities on the electrocardiogram (ECG, electrical recording of the heart) known as "QT prolongation syndrome".
• if you are taking medicines called lovastatin or simvastatin (to lower cholesterol levels), as combining these with clarithromycin may increase the risk of adverse effects. Consult your doctor for advice on alternative medicines.
• if you are taking colchicine (for gout).
• if you are taking a medicine containing lomitapide.

Warnings and precautions

Consult your doctor or pharmacist before starting Clarithromycin Altan 500 mg

• 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 medicines known as colchicine, triazolam, midazolam (for anxiety or insomnia), lovastatin, or simvastatin.
• if you are diabetic and taking hypoglycaemic agents (medicines to lower blood sugar such as nateglinide, pioglitazone, rosiglitazone, repaglinide, sulfonylureas, or insulin), as clarithromycin may excessively lower blood glucose. Careful monitoring of blood glucose is recommended.
• if you are taking a medicine called warfarin or any other anticoagulant, for example: dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood).
• if you have myasthenia gravis, a condition in which your muscles become weak and tire easily.
• if you develop severe or prolonged diarrhoea 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 Clarithromycin Altan 500 mg with other medicines

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

• Clarithromycin Altan 500 mg must not be used with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, ivabradine, pimozide, ticagrelor, ranolazine, colchicine, certain medicines for high cholesterol, or medicines known to cause serious disturbances in heart rhythm (see Do not use Clarithromycin Altan 500 mg).

This is especially important if you are taking medicines for:

• Heart problems (e.g., digoxin, verapamil, quinidine, or disopyramide).
• Blood thinning (e.g., warfarin or other anticoagulants such as 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 medicine 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 (an immunosuppressant).
• Rifabutin (for treating certain infections).
• Tacrolimus or sirolimus (for organ transplants and severe eczema).
• Sildenafil, tadalafil, or vardenafil (to treat impotence in adult men or for pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs)).
• Zidovudine (to treat viruses).
• St. John’s wort (a herbal product used to treat depression).
• Phenobarbital (a medicine to treat epilepsy).
• Nevirapine and efavirenz may reduce levels of clarithromycin.
• Rifampicin or rifapentine (to treat tuberculosis).
• Omeprazole (to treat stomach acidity and stomach or intestinal ulcers).
• Ritonavir (an antiviral medicine used in the treatment of HIV infection) may increase levels of clarithromycin. Concomitant use of atazanavir, etravirine, and saquinavir (also antiviral medicines used in the treatment of HIV infection) with clarithromycin may increase levels of both atazanavir (or saquinavir) and clarithromycin.
• Itraconazole (an antifungal) taken with clarithromycin may increase levels of both medicines.
• Fluconazole, another antifungal medicine, may increase levels of clarithromycin.
• Tolterodine (to treat symptoms of overactive bladder syndrome). In some patients, levels of tolterodine 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 (medicines to treat high blood pressure).
• 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 reactions affecting the heart.
• Corticosteroids, administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in treating a wide range of conditions).

Pregnancy, breastfeeding, and fertility

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

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

Clarithromycin passes into breast milk, so breastfeeding should be discontinued during treatment with clarithromycin.

Driving and use of machines

Since clarithromycin may cause dizziness, vertigo, confusion, and disorientation, you should exercise extreme caution when driving or operating dangerous machinery during treatment with clarithromycin.

Clarithromycin Altan 500 mg lyophilisate for solution for infusion contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; therefore, it is essentially "sodium-free".

3. How to use Claritromycin Altan 500 mg

Clarithromycin is administered intravenously.

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

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

Treatment may be given for 2–5 days and should be switched to oral clarithromycin treatment as directed by your doctor.

In patients with renal impairment and a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced by 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 must not be administered as a bolus injection or by intramuscular route.

Use in children and adolescents:

Children (under 12 years of age) must not use this medicine. Your doctor will prescribe another appropriate medicine for your child.

For adolescents aged 12 to 18 years, the same dose as in adults is used.

If you use more Claritromycin Altan 500 mg than you should

If you use more Claritromycin Altan than you should, gastrointestinal disturbances may occur. Contact your doctor or pharmacist immediately, as they will need to rapidly eliminate any clarithromycin not yet absorbed by your body. Hemodialysis and peritoneal dialysis are ineffective.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to use Claritromycin Altan 500 mg

If you think you may have missed a dose, consult your doctor or nurse. A double dose must not be administered to make up for the missed dose.

If you stop using Claritromycin Altan 500 mg

If you have any further questions about 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 everyone will experience them.

Adverse effects are classified as very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), and frequency not known (cannot be estimated from the available data).

Common and very common reactions associated with clarithromycin treatment in both adults and children include abdominal pain, diarrhoea, nausea, vomiting, and taste disturbance. These adverse reactions are usually mild in intensity and consistent 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 patient populations with or without pre-existing mycobacterial infections.

Summary of adverse effects

Adverse effects are listed in order of decreasing severity within each body system:

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

? The following have been observed commonly (may affect up to 1 in 10 patients) with all medicines containing clarithromycin:

• Gastrointestinal system: diarrhoea, vomiting, gastric discomfort impairing digestion (dyspepsia), nausea, abdominal pain.
• Nervous system: altered taste sensation, headache, taste disturbance.
• Skin: mild skin rashes, excessive sweating.
• Psychiatric disorders: insomnia.
• Vascular disorders: vasodilation (widening of blood vessels).
• Hepatic disorders: abnormal liver function tests.
• Administration site reactions: pain and inflammation at the injection site (only with the intravenous injection formulation).

? The following have been observed uncommonly (may affect up to 1 in 100 patients):

• Infections: cellulitis (only with the intravenous injection formulation), candidiasis (fungal infection), vaginal infection.
• Blood disorders: decreased white blood cell count.
• Immune system disorders: 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, somnolence, tremor.
• Ear and balance: vertigo, hearing problems, tinnitus.
• Cardiac disorders: cardiac arrest and cardiac rhythm disturbances (atrial fibrillation) (both effects, only with the intravenous injection formulation), QT interval prolongation (an electrocardiogram indicator of potential ventricular arrhythmias), extrasystoles (premature heartbeat compared to normal heart rate, only with the intravenous injection formulation), palpitations (irregular heartbeats).
• Respiratory disorders: asthma (difficulty breathing, chest tightness, and nocturnal or early morning cough, only with the intravenous injection formulation), pulmonary embolism (blockage of the pulmonary artery causing one-sided chest pain, cough, and breathing difficulty, only with the intravenous injection formulation).
• Gastrointestinal disorders: oesophagitis (only with the intravenous injection formulation), gastro-oesophageal reflux disease (oesophageal damage causing burning sensation, chronic cough), gastric mucosal inflammation (gastritis), oral mucosal inflammation, tongue inflammation, constipation, dry mouth, belching, flatulence.
• Hepatic disorders: increased alanine aminotransferase (liver enzyme), increased aspartate aminotransferase (another liver enzyme).
• Skin: bullous dermatitis (blistering skin eruptions, only with the intravenous injection formulation), pruritus, urticaria (edematous, red, and intensely itchy skin lesions).
• Musculoskeletal disorders: musculoskeletal stiffness (only with the intravenous injection formulation).
• Renal disorders: increased serum creatinine and serum urea (both effects indicating impaired kidney function, only with the intravenous injection formulation).
• Laboratory tests: abnormal albumin-globulin ratio (only with the intravenous injection formulation).

The following have been observed with frequency not known (frequency cannot be estimated from available data):

• Infections: pseudomembranous colitis (diarrhoea that may become severe), erysipelas (skin redness of variable extent that may cause pain, itching, and fever).

• Blood disorders: decreased neutrophil count (a type of white blood cell), decreased platelet count.

• Immune system disorders: anaphylactic reaction (generalized allergic reaction), angioedema (swelling beneath the skin).

• Psychiatric disorders: psychotic disorder, confusion, depersonalization, depression, disorientation, hallucinations, hypnagogic hallucinations (attenuated perception of external stimuli).

• Nervous system: seizures, decreased or loss of taste sensation, olfactory disturbance, loss or decreased sense of smell, tingling, numbness, or burning sensations in hands, feet, arms, or legs.

• Ear: deafness.

• Cardiac disorders: torsades de pointes (a type of ventricular tachycardia), ventricular tachycardia (accelerated heartbeat exceeding 100 beats per minute with at least 3 consecutive irregular beats).

• Vascular disorders: haemorrhage.

• Digestive disorders: acute pancreatitis (acute inflammation of the pancreas), tongue discoloration, tooth discoloration.

• Hepatic disorders: liver failure, hepatocellular jaundice (yellowing of the skin and eyes).

• Skin: Stevens-Johnson syndrome (widespread blistering and skin peeling, mainly affecting genital, oral, and trunk areas), acute generalized exanthematous pustulosis (widespread scaly red rash with subcutaneous bumps and blisters, accompanied by fever, mainly localized in skin folds, trunk, and upper limbs), and toxic epidermal necrolysis (widespread blistering and skin peeling, particularly around the mouth, nose, eyes, and genitals, causing widespread skin detachment (more than 30% of body surface), flu-like symptoms with skin rash, fever, gland swelling, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) [drug reaction with eosinophilia and systemic symptoms (DRESS)], acne. If any of these reactions occur, treatment with clarithromycin must be stopped immediately and a doctor should be consulted for appropriate management.

• Musculoskeletal disorders: rhabdomyolysis (muscle breakdown that may lead to kidney damage), myopathy (muscle disease of multiple causes).

• Renal disorders: kidney failure, interstitial nephritis (inflammation of renal tubules).

• Laboratory tests: increased international normalized ratio (calculation to detect blood coagulation), prolonged prothrombin time (indicates blood coagulation deficiency), and abnormal urine colour.

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.

Following marketing of the medicine, reports of central nervous system effects (e.g. somnolence and confusion) have been received with concomitant use of clarithromycin and triazolam. Patient monitoring is advised.

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

Adverse effects in children and adolescents:

Clinical trials with paediatric clarithromycin suspension have been conducted in children aged 6 months to 12 years. Therefore, children under 12 years of age should take paediatric clarithromycin suspension. There are insufficient data to recommend a dosage regimen for the intravenous clarithromycin formulation in patients under 12 years of age.

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 other patients with impaired immune systems, treated with the highest doses of clarithromycin over long periods for mycobacterial infections, it is often difficult to distinguish adverse effects possibly associated with clarithromycin administration from those caused by the disease itself or other conditions associated with AIDS.

In adult patients treated with total daily doses of 1,000 mg and 2,000 mg of clarithromycin, the most frequently observed adverse reactions were: nausea, vomiting, taste disturbance, abdominal pain, diarrhoea, skin rash, flatulence, headache, constipation, hearing disturbances, and elevated transaminases (which may indicate liver, pancreas, heart, or muscle involvement). Less frequently observed were dyspnoea, insomnia, and dry mouth. Incidences were similar in patients treated with 1,000 mg and 2,000 mg, but were generally 3 to 4 times more frequent in those receiving a total daily dose of 4,000 mg of clarithromycin.

In these immunocompromised patients, approximately 2% to 3% receiving daily doses of 1,000 mg or 2,000 mg of clarithromycin developed severely abnormal elevations in transaminase levels, as well as abnormally low white blood cell and platelet counts. A smaller percentage of patients in both dosage groups also had elevated blood urea nitrogen levels (which may indicate reduced kidney function). In patients receiving 4,000 mg daily, slightly higher incidences of abnormal values were observed for all parameters except white blood cell count.

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 the available data).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect 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

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

• Reconstituted solution (500 mg in 10 ml of water for injections): may be stored for 24 hours at room temperature and for 48 hours in the refrigerator (2ºC – 8ºC).
• Final reconstituted solution (reconstituted solution added to 250 ml of diluent, respectively for each diluent mentioned) may be stored for 24 hours at room temperature (25ºC) or for 48 hours in the refrigerator (2ºC – 8ºC).

Do not use Clarithromycin after the expiry date stated on the container or on the vial label. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition of Claritromycin Altan 500 mg

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

Appearance of the medicinal product and contents of the container

White to almost white powder or sediment for infusion solution in a glass vial.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st Floor, Prisma Building, Office F

28231 Las Rozas (Madrid), Spain

Manufacturer

Altan Pharmaceuticals, S.A.

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

45950 Casarrubios del Monte (Toledo), Spain

This leaflet was last reviewed in July 2025

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

INFORMATION FOR HEALTHCARE PROFESSIONALS:

Adults:

The recommended dose in adults and adolescents (12 to 18 years of age) is 1 g per day, divided into two equal doses, each administered by intravenous infusion after further dilution with an appropriate intravenous diluent, over a period of 60 minutes. Currently, there are no data to support the intravenous use of clarithromycin in children. Clarithromycin must not be administered as bolus injection or intramuscularly.

Elderly patients:

Same dose as in adults.

Dosing in patients with mycobacterial infections:

Although there are currently no data on the use of intravenous clarithromycin in immunocompromised patients, data are available on the use of oral clarithromycin in HIV-infected patients. For disseminated or localized infections (M. avium, M. intracellulare, M. chelonae, M. fortuitum, M. kansasii), the recommended treatment in adults is 1000 mg/day divided into two doses.

Intravenous treatment may be given for 2–5 days in severely ill patients and should be switched to oral clarithromycin treatment as soon as possible, as determined by the physician.

Renal impairment:

In patients with renal impairment and creatinine clearance less than 30 ml/min, the dose of clarithromycin should be reduced by half of the recommended dose.

Hepatic impairment:

Clarithromycin must not be administered to patients with severe hepatic impairment combined with renal impairment. (see section 4.3)

Paediatric population:

There are insufficient data to recommend a dosing regimen for intravenous clarithromycin formulation 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 medicinal product prior to administration

1. Prepare the initial clarithromycin solution (reconstituted solution) by adding 10 ml of sterile water for injection to the 500 mg vial. Gently rotate until complete dissolution is achieved, with no visible residue of undissolved macroparticles (this may take up to 5 minutes). Only sterile water for injection must be used, as other diluents may cause precipitation during reconstitution. Do not use diluents containing preservatives or inorganic salts.

Note: When the product is reconstituted as described 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. If stored at 2–8°C, it should be used within 48 hours.

2. Prior to administration, the reconstituted solution (500 mg in 10 ml of water for injection) should be added to 250 ml of one of the following diluents:

3. Sodium chloride 0.9%

4. Dextrose 5%

5. Dextrose in sodium chloride 0.3%

6. Dextrose 5% in sodium chloride 0.45%

7. Dextrose 5% in Ringer's lactate solution

8. Ringer's lactate solution.

The final diluted solution (the reconstituted solution added to 250 ml of the diluents listed above) should be used within 24 hours if stored at room temperature (25°C), or within 48 hours if stored refrigerated at 2–8°C.

Other drugs or chemical agents must not be added to the final mixture unless their effect on the physical and chemical stability of the solution has been determined.

From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user/administrator and normally should not exceed 24 hours at 2–8°C, unless dilution has been carried out under validated aseptic conditions.

PHARMACEUTICAL INCOMPATIBILITIES

None reported.

Overdose

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

Adverse reactions associated with overdose should be managed by rapid elimination of the unabsorbed drug and supportive care.

Clarithromycin levels are not expected to be significantly affected by hemodialysis or peritoneal dialysis.