CLARITHROMYCIN BROWN & BURK 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Clarithromycin Brown & Burk 250 mg Film-Coated Tablets EFG

Clarithromycin Brown & Burk 500 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Clarithromycin Brown & Burk and what is it used for
2. What you need to know before taking Clarithromycin Brown & Burk
3. How to take Clarithromycin Brown & Burk
4. Possible side effects

5. Storage of Clarithromycin Brown & Burk

1. Package Contents and Additional Information

1. What is Clarithromycin Brown & Burk and what is it used for

Clarithromycin belongs to a group of medications called macrolide antibiotics. Antibiotics stop the growth of bacteria that cause infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as the flu or the common cold.

It is essential to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw away medications down the drain or in the trash.

Clarithromycin is indicated for adults and children over 12 years old and is used to treat the following bacterial infections:

1. Respiratory tract infections such as bronchitis and pneumonia.
2. Throat and sinus infections
3. Skin and soft tissue infections
4. Helicobacter pyloriinfection associated with duodenal ulcers

2. What you need to know before taking Clarithromycin Brown & Burk

Do not takeClarithromycin Brown & Burkif you:

• are allergicto clarithromycin, other macrolide antibiotics (such as erythromycin or azithromycin), or any of the other components of this medication (listed in section 6)
• are taking ergot alkaloids, ergotamine, or dihydroergotamine, or are using inhalers with ergotamine for migraines.
• are taking terfenadine or astemizole (commonly used for hay fever or allergies) or cisapride or domperidone (for stomach disorders) or pimozide (for mental health problems), as the combination of these medications can sometimes cause severe heart rhythm disturbances.
• are taking other medications known to cause severe heart rhythm disturbances.
• are taking lovastatin or simvastatin (used to reduce blood lipids such as cholesterol or triglycerides).
• are taking oral midazolam (a sedative).
• are taking a medication containing lomitapide
• have abnormally low potassium or magnesium levels in your blood (hypokalemia or hypomagnesemia).
• have any liver or kidney problems.
• You or a family member have a history of heart rhythm disorders (ventricular arrhythmia, including torsades de pointes) or electrocardiogram (ECG) abnormalities known as "long QT syndrome".
• are taking medications called ticagrelor, ivabradina, or ranolazina (for angina or to reduce the risk of heart attack or stroke).
• are taking colchicine (commonly used for gout).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Clarithromycin;

• if you have heart problems
• if you need intravenous midazolam;

if you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding. Inform your doctor immediately if you experience severe or persistent diarrhea during or after taking clarithromycin, as this can be a symptom of a more serious condition such as pseudomembranous colitis or Clostridium difficile-associated diarrhea. Colitis pseudomembranous has been reported with almost all antibacterial medications, including clarithromycin,

Stop taking this medication and inform your doctor immediately if you develop any symptoms of liver dysfunction, such as loss of appetite, yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal pain.

If you have liver or kidney problems, consult your doctor before taking Clarithromycin.

Children and Adolescents

Clarithromycin tablets are not suitable for use in children under 12 years old.

Other Medications and Clarithromycin Brown & Burk

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medications,

This is especially important if you are taking medications called:

• digoxin, disopyramide, or quinidine (medications for various heart problems). Your heart may need to be monitored (ECG) or blood tests may be necessary if you have taken clarithromycin with any medication used for heart problems.

• warfarin or any other anticoagulant, such as dabigatran, rivaroxaban, apixaban, or edoxaban (used to make blood more fluid). Blood tests may be necessary to check that your blood is clotting properly.
• omeprazol (medication for the treatment of indigestion and stomach ulcers), unless your doctor prescribes it for the treatment of Helicobacter pyloriinfection associated with duodenal ulcers.

• theophylline (medication for the treatment of respiratory problems such as asthma).
• triazolam, alprazolam, or intravenous midazolam (sedatives).
• cilostazol (medication for the treatment of poor blood circulation).
• carbamazepine, valproate, phenytoin, or phenobarbital (medications for the treatment of epilepsy).

Do not take Clarithromycin

with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, cimetidine, pimozide, ticagrelor, ranolazina, colchicine, some medications for high cholesterol (simvastatin, lovastatin), and medications known to cause severe heart rhythm disturbances (see "Do not take Clarithromycin Brown & Burk").

Pregnancy, Breastfeeding, and Fertility

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

The safety of Clarithromycin tablets during pregnancy and breastfeeding is unknown. Therefore, their use is not recommended during pregnancy and breastfeeding without carefully considering the benefits and risks. Clarithromycin is excreted in breast milk.

Driving and Using Machines

Clarithromycin may cause dizziness, vertigo, confusion, and disorientation. Do not drive or use machinery if you experience these symptoms.

Clarithromycin Brown & Burk contains sodium

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

3. How to take Clarithromycin Brown & Burk

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dose

For respiratory tract, skin, and soft tissue infections:

Adults and adolescents (12 years and older):

The usual dose of Clarithromycin for adults is 250 mg, twice a day, for 6-14 days, e.g., one 250 mg Clarithromycin tablet in the morning and one in the early evening.

Your doctor may increase the dose for more severe infections to Clarithromycin 500 mg, twice a day.

For the treatment of Helicobacter pyloriinfections associated with duodenal ulcers (adults):

There are several effective treatment combinations for Helicobacter pyloriin which Clarithromycin tablets are taken with one or two other medications.

The normal treatment duration is 6 to 14 days

These combinations include:

1. Triple Therapy

Clarithromycin (500 mg) twice a day, lansoprazole 30 mg twice a day, and amoxicillin 1,000 mg twice a day

1. Triple Therapy

Clarithromycin (500 mg) twice a day, lansoprazole 30 mg twice a day, and amoxicillin 400 mg twice a day.

1. Triple Therapy

Clarithromycin (500 mg) twice a day, omeprazole 40 mg twice a day, and amoxicillin 1,000 mg twice a day or metronidazole 400 mg twice a day

1. Triple Therapy

Clarithromycin (500 mg) twice a day and amoxicillin 1,000 mg twice a day and omeprazole 20 mg daily.

1. Dual Therapy

Clarithromycin (500 mg) three times a day, with 40 mg of omeprazole once a day

The treatment combination you receive may be slightly different from the above. Your doctor will decide which treatment combination is most suitable for you. If you are unsure about the tablets you should take or for how long you should take them, please consult your doctor.

Patient with kidney problems:

If you have severe kidney problems, your doctor may need to reduce the dose to half, i.e., 250 mg per day or 250 mg twice a day in severe infections, and limit treatment to a maximum of 14 days.

How to take Clarithromycin

Orally.

This medication should be taken with a sufficient amount of liquid (e.g., a glass of water)

Use in children under 12 years

Do not administer these tablets to children under 12 years old. Your doctor will prescribe a more suitable medication.

If you take more Clarithromycin Brown & Burk than you should

If you have accidentally taken more tablets in a day than your doctor indicated, or if a child has accidentally swallowed several tablets, contact your doctor or the nearest emergency service immediately.

Overdose may cause abdominal pain and vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Clarithromycin Brown & Burk

If you forget to take clarithromycin, continue treatment with the normal recommended dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Clarithromycin Brown & Burk

Do not stop taking your medication because you feel better. If you stop taking clarithromycin too soon, you may not have eliminated all the bacteria causing the infection, and it could recur.

If you have any further questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, clarithromycin can cause adverse effects, although not all people suffer from them.

If any of the following cases occur during treatment, stop taking these tablets immediately and inform your doctor:

• severe or prolonged diarrhea, which may present with blood or mucus. Diarrhea may occur two months after treatment with clarithromycin, in which case you should continue consulting your doctor. This can be a symptom of a severe intestinal inflammation.
• skin rash, difficulty breathing, fainting, or swelling of the face and throat. This is a sign that you have developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, abdominal pain on palpation, or loss of appetite. These can be signs that the liver is not functioning properly.
• severe skin reactions such as blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome / toxic epidermal necrolysis). A red and scaly rash with bumps under the skin and blisters (pustular exanthema); the frequency of this adverse effect is considered unknown (cannot be estimated from the available data). Rare allergic skin reactions that cause serious diseases with ulcers of the mouth, lips, and skin that cause serious diseases with skin rash, fever, and inflammation of internal organs (DRESS).
• muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue to break down, which can result in kidney damage).
• rapid or irregular heartbeat,
• pancreatitis, which causes severe abdominal and back pain,

Other possible adverse effects:

Frequent adverse effects (may affect up to 1 in 10 people):

• difficulty sleeping (insomnia);
• changes in taste;
• headache;
• stomach problems such as nausea, vomiting, abdominal pain, indigestion, or diarrhea;
• abnormal liver function test results;
• skin rash, excessive sweating, redness.
• hives,
• vasodilation.

Uncommon adverse effects (may affect up to 1 in 100 people):

• fungal infections of the skin or vagina (candidiasis);
• change in white blood cell concentration in the blood (which can make infections more frequent);
• change in platelet levels in the blood (increased risk of bruising, bleeding, or blood clots);
• increase in the number of certain white blood cells (eosinophilia),
• allergic reactions;
• loss of appetite, anorexia
• anxiety, nervousness, screaming;
• fainting, dizziness, drowsiness, tremors, involuntary movements of the tongue, face, lips, or limbs;
• feeling of spinning (vertigo), ringing in the ears, hearing loss;
• changes in cardiac activity measured on the ECG, called "QT prolongation",
• strong and rapid heartbeats (palpitations), changes in heart rhythm or cardiac arrest;
• respiratory problems (asthma), nosebleeds;
• blood clots in the lungs;
• stomach problems, such as abdominal distension, constipation, gas (flatulence), belching, heartburn, or anal pain;
• inflammation of the stomach or esophagus (the tube that connects the mouth to the stomach);
• mouth pain, dry mouth, tongue inflammation;
• liver problems such as hepatitis or cholestasis that can cause yellowing of the skin (jaundice), pale stools, or dark urine;
• increased liver enzymes;
• itching, hives, skin inflammation;
• stiffness, pain, or muscle spasms;
• kidney problems such as elevated protein levels that are normally excreted by the kidneys or elevated kidney enzyme levels;
• fever, chills, weakness, fatigue, chest pain, or general feeling of discomfort;
• abnormal blood test results.

Unknown frequency (frequency cannot be estimated from the available data):

• inflammation of the intestine, from mild to severe (see "Serious adverse effects" above),

• skin and underlying tissue infection (erysipelas),
• severe decrease in certain white blood cells (agranulocytosis),
• reduced platelet count in the blood: signs may be bruising and bleeding

unusual,

• severe allergic reaction (anaphylactic reaction, see "Serious adverse effects" above),
• psychotic disorder, confusion, changes in sense of reality, depression, loss of orientation (disorientation), hallucinations (seeing things), abnormal dreams (nightmares), manic episodes;
• seizures;
• change or loss of sense of taste and/or smell;
• paresthesia (tingling and burning sensation in the skin, numbness, tingling sensation);
• deafness;
• bleeding;
• type of arrhythmia (Torsade de pointes, ventricular tachycardia);
• prolongation of blood coagulation time,
• pancreatitis;
• discoloration of the tongue, discoloration of the teeth;
• liver failure, jaundice (yellowing of the skin);
• severe skin diseases with discomfort, redness, peeling, and swelling (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, see "Serious adverse effects" above),
• acne;
• muscle disease (myopathy), rhabdomyolysis;

• kidney inflammation (which can cause ankle swelling or high blood pressure) or kidney failure.
• abnormal urine color
• Alteration of blood test results

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it 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.

5. Conservation of Clarithromycin Brown & Burk

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and blister, after "CAD". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofClarithromycin Brown & Burk

The active ingredient is clarithromycin.

Clarithromycin 250 mg: Each tablet contains 250 mg of clarithromycin

Clarithromycin 500 mg: Each tablet contains 500 mg of clarithromycin.

The other components are:

Core of the tablet:

Microcrystalline cellulose, sodium croscarmellose, povidone (PVPK-30), low-substitution hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate.

Coating of the tablet:

Hypromellose (E464), propylene glycol (E1520), titanium dioxide (E171), hydroxypropylcellulose (E463), sorbitan monooleate, quinoline yellow (E104), sorbic acid (E200), vanillin.

Product appearance and package contents

250 mg:

Film-coated tablets of bright yellow color, oval shape, biconvex, engraved with "C2" on one face and the other face smooth, approximately 16 mm long and 8.2 mm wide.

Clarithromycin 250 mg film-coated tablets are packaged in PVC/PVdC-Aluminum blisters and unit-dose blisters of 14 and 500 film-coated tablets

500 mg:

Film-coated tablets of pale yellow color, oval shape, biconvex, engraved with "C1" on one face and the other face smooth, approximately 19.2 mm long and 9 mm wide.

Clarithromycin 500 mg film-coated tablets are packaged in PVC/PVdC-Aluminum blisters and unit-dose blisters of 14, 21, and 500 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Brown & Burk IR Ltd

22 Northumberland Road,

Ballsbridge, Dublin 4,

Ireland

Manufacturer

Misom Labs Ltd

Malta Life Sciences Park

LS2.01.06 Industrial Estate

San Gwann, SGN 3000, Malta

Date of the last revision of thisprospectus: January 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/)}