Azithromycin tablets 250 mg spc

Always consult your doctor or pharmacist before taking Azithromycin. This medication is a macrolide antibiotic, prescribed to treat bacterial infections. A standard dose is 250mg once daily, but the dosage and duration vary depending on the specific infection and your individual health. Be sure to follow your doctor’s instructions precisely.

The Summary of Product Characteristics (SPC) for Azithromycin 250mg tablets contains comprehensive details regarding its use, including indications, contraindications, warnings, precautions, adverse reactions, and dosage information. Review this document carefully for complete understanding.

Common side effects can include diarrhea, nausea, vomiting, and abdominal pain. Serious, though less frequent, side effects may involve allergic reactions, such as skin rashes or swelling. Seek immediate medical attention if you experience a severe allergic reaction. Proper storage is vital: keep the tablets in a cool, dry place away from direct sunlight.

Drug interactions are possible. Inform your doctor about all medications you currently take, including over-the-counter drugs and herbal remedies, to avoid potential complications. Pregnancy and breastfeeding require special considerations; discuss Azithromycin use with your doctor if you are pregnant, planning pregnancy, or breastfeeding. Do not exceed the prescribed dosage. Complete the entire course of treatment even if you feel better to prevent recurrence of the infection.

Azithromycin Tablets 250mg SPC: A Detailed Overview

Consult your doctor or pharmacist before taking Azithromycin, especially if you have liver or kidney problems, heart rhythm issues, or a history of allergic reactions to antibiotics. This medication is not suitable for everyone.

Dosage and Administration

The standard dosage for adults is typically 500mg on day one, followed by 250mg daily for four days. Children’s dosages vary significantly based on weight and the specific infection being treated; always follow your doctor’s prescribed regimen precisely. Swallow tablets whole with water. Do not crush or chew them.

Common Side Effects

Many patients experience mild side effects, such as nausea, diarrhea, or stomach upset. These are usually temporary and resolve without intervention. However, report any severe or persistent side effects, including abdominal pain, vomiting, or allergic reactions (skin rash, itching, swelling) to your physician immediately.

Interactions and Precautions

Azithromycin may interact with certain medications, such as anticoagulants (blood thinners) and some heart medications. Inform your healthcare provider about all medications, supplements, and herbal remedies you are currently taking. Pregnancy and breastfeeding should be discussed with your doctor before starting Azithromycin. Alcohol consumption should be approached cautiously as it might worsen side effects.

Storage

Store Azithromycin tablets in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children. Discard any expired medication according to local guidelines.

Missed Dose

If you miss a dose, take it as soon as you remember unless it’s almost time for your next dose. Do not double the dose to make up for a missed one. Consult your pharmacist if you have any uncertainty regarding missed doses.

Further Information

This overview provides a summary and should not replace professional medical advice. The full Summary of Product Characteristics (SPC) should be consulted for complete details and information specific to your region and regulatory approval. Always consult your physician or pharmacist with any questions or concerns about your medication.

Contraindications

Do not take Azithromycin if you have a known hypersensitivity to azithromycin or any macrolide antibiotic. Pregnant or breastfeeding women should only use this medication under close medical supervision.

What is Azithromycin and its Uses?

Azithromycin is a macrolide antibiotic. Doctors prescribe it to treat various bacterial infections.

Common uses include: treating bacterial infections of the lungs (like pneumonia), throat (like tonsillitis), skin, and genitals (like chlamydia).

Specific conditions treated with azithromycin include: bronchitis, pharyngitis, sinusitis, and certain sexually transmitted infections.

Remember: Azithromycin only targets bacterial infections. It’s ineffective against viral infections like the common cold or flu. Always consult your doctor before taking any medication.

Important Note: Azithromycin can cause side effects, including nausea, diarrhea, and abdominal pain. Inform your physician of any allergies or existing health conditions before starting treatment.

Dosage and Administration Guidelines

Swallow Azithromycin tablets whole with water. Avoid crushing or chewing them.

Adults (≥18 years):

The usual dosage for adults is 500 mg on the first day, followed by 250 mg daily for four more days. For some infections, a different dosage regimen may be prescribed by your doctor. Always follow your doctor’s specific instructions.

Children (<18 years):

Dosage for children depends on their weight and the specific infection. Your doctor will determine the appropriate dose and duration of treatment. Never administer medication to a child without a doctor’s prescription.

Specific Infections:

• Community-acquired pneumonia: The dosage may vary; consult your doctor for specific guidelines.
• Acute bacterial sinusitis: A doctor will determine the appropriate course of treatment.
• Uncomplicated skin and skin structure infections: Similar to pneumonia, dosage is determined by the prescribing physician.

Missed Dose:

1. Take the missed dose as soon as you remember, unless it’s almost time for your next dose.
2. Do not take a double dose to make up for a missed dose.
3. Consult your doctor if you miss multiple doses.

Important Considerations:

• Inform your doctor about all medications you are currently taking, including over-the-counter drugs and herbal supplements. Certain medications may interact with Azithromycin.
• Tell your doctor about any allergies you have, particularly to antibiotics.
• If you experience any adverse reactions, such as severe allergic reactions (difficulty breathing, swelling of the face, lips, tongue, or throat), stop taking the medication and seek immediate medical attention.
• This information does not replace professional medical advice. Always consult your doctor or pharmacist for personalized guidance.

Renal and Hepatic Impairment:

Dosage adjustments may be necessary for patients with kidney or liver problems. Your doctor will determine the appropriate dose based on your individual needs.

Contraindications and Precautions

Do not use Azithromycin if you have a known allergy to azithromycin, erythromycin, or any other macrolide antibiotic. This includes a history of severe allergic reactions like anaphylaxis.

Caution is advised if you have liver problems. Your doctor should monitor your liver function during and after treatment. Similar caution applies if you have kidney problems; dosage adjustments may be necessary.

Prolonged QT interval on electrocardiogram (ECG) is a concern, especially with pre-existing conditions or concomitant medications affecting the QT interval. Your doctor may order an ECG if this is a concern.

Azithromycin may interact negatively with certain medications, including but not limited to: ergotamine, dihydroergotamine, pimozide, cisapride, terfenadine, astemizole, and certain statins. Inform your doctor about all medications you are currently taking, including over-the-counter drugs and herbal supplements.

Use caution in patients with myasthenia gravis, as Azithromycin may worsen symptoms. This is also true for patients with known arrhythmias or heart conditions.

Condition	Precautions
Liver disease	Monitor liver function
Kidney disease	Dosage adjustment may be needed
Cardiac arrhythmias	ECG monitoring may be indicated
Myasthenia gravis	Monitor for symptom exacerbation

Always inform your healthcare provider of your complete medical history, including any allergies or underlying health conditions, before starting treatment with Azithromycin.

Possible Side Effects and Adverse Reactions

Azithromycin, while generally well-tolerated, can cause side effects. These vary in frequency and severity.

Gastrointestinal Issues

• Nausea is a common complaint, often mild and resolving without intervention.
• Diarrhea may occur; if severe or persistent, consult your doctor.
• Abdominal pain is possible, though usually not serious.
• Vomiting is less frequent than nausea.

Other Common Side Effects

• Headache: usually mild and transient.
• Dizziness: may affect balance; avoid driving or operating machinery if affected.

Less Frequent but Serious Side Effects

While rare, some serious reactions warrant immediate medical attention:

1. Severe allergic reactions (anaphylaxis): characterized by difficulty breathing, swelling of the face, lips, tongue, or throat, and hives. Seek immediate medical help.
2. Severe liver problems: symptoms include jaundice (yellowing of skin and eyes), dark urine, and abdominal pain. Contact your doctor immediately.
3. Prolonged QT interval (on electrocardiogram): This can lead to irregular heartbeats. This is more likely in people with existing heart conditions or those taking other medications that affect the heart rhythm. Report any palpitations or unusual heart sensations to your doctor.
4. Hearing problems: Ringing in the ears (tinnitus) or hearing loss are possible, though infrequent. Consult your doctor if you experience any hearing changes.

Reporting Side Effects

It’s crucial to report any unexpected or concerning side effects to your doctor or pharmacist. This helps monitor the safety of the medication.

Interactions

Azithromycin may interact with other medications. Always inform your doctor and pharmacist about all medications, supplements, and herbal remedies you are taking.

Drug Interactions: What to Avoid

Avoid combining azithromycin with drugs that prolong the QT interval, such as certain antiarrhythmics (like quinidine or amiodarone) or some antidepressants. This combination increases the risk of dangerous heart rhythm disturbances.

Ergotamine and dihydroergotamine should not be taken concurrently with azithromycin. This combination can lead to ergotism, a serious condition characterized by vascular constriction and tissue damage.

Medications Affecting Liver Enzymes

Azithromycin is metabolized by the liver. Concurrent use with drugs that significantly affect liver enzymes (like rifampicin or carbamazepine) may alter azithromycin levels, necessitating careful monitoring or dose adjustment. Consult your doctor if you’re taking such medications.

Antacids and Other Interactions

Taking azithromycin with antacids may reduce its absorption. Separate the administration of these medications by at least two hours. Similar considerations apply to sucralfate.

Finally, always inform your doctor or pharmacist of all medications, including over-the-counter drugs and herbal remedies, you are taking before starting azithromycin treatment. This allows for the identification and management of potential drug interactions.

Storage and Handling Instructions

Store Azithromycin tablets below 25°C (77°F).

Protecting Your Medication

• Keep tablets in their original blister pack until ready to use. This protects them from moisture and light.
• Avoid extreme temperatures – both hot and cold.
• Don’t store in damp areas, such as bathrooms.

Disposal

Dispose of any unused tablets responsibly. Check local regulations for safe pharmaceutical waste disposal.

Handling Precautions

1. Always wash your hands before and after handling the medication.
2. Keep Azithromycin tablets out of reach of children and pets. Accidental ingestion can be dangerous.
3. If you notice any changes in the appearance of the tablets (e.g., discoloration, unusual odor), do not use them and contact your pharmacist.

Further Information

Consult your pharmacist or physician for additional storage and handling information specific to your situation.

Overdosage: Symptoms and Management

Seek immediate medical attention if you suspect an azithromycin overdose. Symptoms can include nausea, vomiting, and diarrhea. In severe cases, you might experience hearing loss, heart rhythm problems, or liver damage.

Treatment focuses on supportive care. This may involve inducing vomiting or using activated charcoal to absorb the drug. Monitoring vital signs, such as heart rate and blood pressure, is crucial. Specific treatments for organ damage may be necessary, depending on the severity of the overdose.

Contact your doctor or a poison control center immediately for guidance. Provide them with the amount of azithromycin ingested and the time of ingestion. This information assists medical professionals in providing the most appropriate care.

Close monitoring after an overdose is essential. Follow your doctor’s instructions meticulously to ensure a complete recovery. Regular follow-up appointments may be needed.

Patient Information Leaflet Summary

Take Azithromycin exactly as prescribed by your doctor. Swallow the tablets whole with a glass of water. Do not crush or chew them.

The usual dose for adults is 500mg on the first day, followed by 250mg daily for four more days. Your doctor may adjust this depending on your specific infection. Children’s dosages differ significantly; always follow your doctor’s instructions precisely.

Common side effects include diarrhea, nausea, vomiting, and abdominal pain. These usually are mild and temporary. However, report any severe or persistent side effects to your doctor immediately.

Azithromycin can interact with certain medications. Inform your doctor of all medications, including over-the-counter drugs and herbal remedies, you are currently taking.

Pregnancy and breastfeeding: Consult your doctor before taking Azithromycin if you are pregnant, breastfeeding, or planning to become pregnant.

Missed Dose: Take the missed dose as soon as you remember, unless it’s nearly time for your next dose. Never double up on doses.

Possible Side Effect	Action
Severe allergic reaction (difficulty breathing, swelling of face/lips/tongue)	Seek immediate medical attention.
Persistent diarrhea	Contact your doctor; this could indicate a serious infection.
Severe stomach pain	Contact your doctor.

Store Azithromycin tablets at room temperature, away from moisture and direct sunlight. Keep out of reach of children.

This summary does not replace the complete Patient Information Leaflet. Always read the full leaflet provided with your medication for complete details and instructions. Consult your doctor or pharmacist if you have any questions or concerns.