Clarithromycin Sandoz 25 mg/ml granules for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Clarithromycin Sandoz 25 mg/ml granules for oral suspension

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Clarithromycin Sandoz is and what it is used for
2. What you need to know before taking Clarithromycin Sandoz
3. How to take Clarithromycin Sandoz
4. Possible side effects
5. How to store Clarithromycin Sandoz
6. Contents of the pack and other information

1. What Claritromycin Sandoz is and what it is used for

Clarithromycin is an antibiotic that belongs to the macrolide group of antibiotics. Clarithromycin stops the growth of certain bacteria.

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

It is important to follow your doctor's instructions regarding dose, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Clarithromycin is used to treat:

• throat and sinus infections,
• otitis media in children,
• lower respiratory tract infections, such as bronchitis and pneumonia,
• skin and soft tissue infections,
• gastric ulcer caused by the bacterium Helicobacter pylori.

2. What you need to know before taking Clarithromycin Sandoz

Do not take Clarithromycin Sandoz

• if you are allergic to clarithromycin, macrolide antibiotics, or any of the other ingredients of this medicine (listed in section 6),
• if you or a family member has a history of heart rhythm disturbances (ventricular arrhythmia, including Torsades de Pointes) or an abnormal electrocardiogram (ECG, electrical recording of the heart), known as "long QT syndrome",
• if you have severe hepatic impairment and kidney problems at the same time,
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalemia or hypomagnesemia),
• if you are taking:
• ticagrelor, ivabradine, or ranolazine (for angina or to reduce the risk of myocardial infarction or stroke),
• ranolazine (used to treat angina),
• ergotamine, dihydroergotamine (medicines used to treat migraine),
• oral midazolam (for anxiety or to help you sleep),
• cisapride and domperidone (gastric medicines),
• pimozide (an antipsychotic),
• terfenadine, astemizole (antihistamines used for hay fever),
• lovastatin, simvastatin (medicines that lower cholesterol levels),
• a medicine containing lomitapide,
• colchicine (to treat gout),
• other medicines known to cause serious disturbances in heart rhythm.

Warnings and precautions

Talk to your doctor or pharmacist before taking clarithromycin

• if you have impaired liver or kidney function,
• if you are allergic to lincomycin or clindamycin (antibiotics),
• if you develop severe or prolonged diarrhea (pseudomembranous colitis) during or after taking clarithromycin, contact your doctor immediately. Inflammation of the colon (pseudomembranous colitis) has been reported with nearly all antibacterial agents, including clarithromycin,
• if you have myasthenia gravis, a rare disease causing muscle weakness,
• if you have diabetes,
• if you have or have had heart problems, or
• if you have previously taken clarithromycin repeatedly or for a long period of time.

Other medicines and Clarithromycin Sandoz

Tell 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 Sandoz must not be taken with ergot alkaloids, astemizole, terfenadine, cisapride, domperidone, pimozide, ticagrelor, ranolazine, colchicine, certain medicines used to treat high cholesterol, and medicines known to cause serious disturbances in heart rhythm (see section "Do not take Clarithromycin Sandoz").

Some medicines may affect how clarithromycin works or vice versa. These medicines are:

Clarithromycin may increase the effect of the following medicines:

• ibrutinib (a medicine used to treat chronic lymphocytic leukemia),
• alprazolam, triazolam, intravenous or oral (oromucosal) midazolam (for anxiety or to help you sleep),
• digoxin, verapamil, amlodipine, diltiazem (medicines for the heart),
• theophylline (an anti-asthma medicine),
• warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (used as anticoagulants),
• atorvastatin, rosuvastatin (medicines that lower cholesterol levels),
• cyclosporine, sirolimus, tacrolimus (immunosuppressants),
• carbamazepine, phenytoin, valproate (medicines used to treat epilepsy),
• cilostazol (used to improve blood circulation in the legs),
• insulin and other medicines used to treat diabetes (such as nateglinide, repaglinide),
• methylprednisolone (corticosteroid used for anti-inflammatory treatment),
• omeprazole (a gastric medicine),
• sildenafil, tadalafil, vardenafil (medicines used to treat erectile dysfunction),
• tolterodine (for treatment of overactive bladder),
• vinblastine (a medicine used to treat cancer),
• medicines with risk of affecting hearing, especially aminoglycosides such as gentamicin or neomycin (a group of antibiotics).

The effect of Clarithromycin Sandoz and the following medicines may increase when taken together:

• atazanavir, saquinavir (medicines used to treat HIV),
• itraconazole (a medicine used to treat fungal infections).

If your doctor has advised you to take clarithromycin together with any of the medicines listed above, your doctor may need to monitor you carefully.

The following medicines may reduce the effect of Clarithromycin Sandoz:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, etravirine, nevirapine (medicines used to treat HIV),
• phenytoin, carbamazepine, phenobarbital (antiepileptics),
• St. John’s wort.

This is also important if you are taking medicines called:

• hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as clarithromycin may increase the risk of abnormal heart rhythms and other serious adverse effects affecting the heart.
• corticosteroids, administered orally, by injection, or by inhalation (used to suppress the immune system; this is useful in treating a wide variety of diseases).

Please note

Ritonavir (an antiviral) and fluconazole (an antifungal) may increase the effect of clarithromycin.

Clarithromycin may reduce the effect of zidovudine (an antiviral). To avoid this, it is recommended to leave a 4-hour interval between taking these medicines.

The combined use of clarithromycin with digoxin, quinidine, disopyramide, or verapamil (medicines for the heart) or other macrolide antibiotics may cause cardiac arrhythmias.

Concomitant use of clarithromycin with disopyramide may cause a drop in blood sugar levels (hypoglycemia).

Pregnancy and breastfeeding

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.

Driving and Using Machines

Sandoz Clarithromycin generally does not affect the ability to drive or operate machinery, but it may cause adverse reactions such as dizziness, confusion, and disorientation. If you experience these adverse effects, do not drive or operate machinery, or engage in any activities in which you or others could be at risk. Visual disturbances and blurred vision may impair the patient's ability to drive or operate machinery.

Sandoz Clarithromycin contains sucrose and sodium.

This medicine contains 2.4 g of sucrose per 5 ml of reconstituted suspension. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. This should be taken into account in patients with diabetes mellitus.

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

3. How to take Claritromycin Sandoz

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

The dispensing conditions indicated on your prescription will tell you the dose and frequency with which you should take this medicine. Please read it carefully. The dose prescribed by your doctor will depend on the type and severity of the infection you have. In addition, it depends on your renal function. Your doctor will explain this to you.

Adults and adolescents:

The recommended dose is 10 ml twice daily.

For severe infections or gastric ulcers caused by Helicobacter pylori, the usual dose is 20 ml twice daily.

Children from 6 months to 12 years of age:

The daily dose is calculated according to the child's body weight.

The following table will provide you with a dosing guide:

Body weight (kg)	Age (years)	Dosage (ml) twice daily
8 - 11	1 - 2	2.5
12 - 19	2 - 4	5
20 - 29	4 - 8	7.5
30 - 40	8 - 12	10

Children weighing less than 8 kg should take a dose of 0.3 ml/kg twice daily.

Duration of treatment

Your doctor will determine how long you should take clarithromycin; usually between 5 and 14 days. Do not stop treatment on your own initiative, for example, because you or your child feel better. If treatment is stopped too early, the infection may return.

Instructions for use

Clarithromycin is usually taken twice a day, once in the morning and once in the evening.

It can be taken with or without food.

Clarithromycin may leave a bitter taste in the mouth after taking it. This can be avoided by eating or drinking something immediately after administration.

How to measure the dose

A 5 ml syringe, marked at 2.5, 3.75 and 5 ml, is included in the package. It comes with an adapter that fits onto the bottle. To measure the medicine dose:

• shake the bottle,
• place the adapter into the neck of the bottle,
• insert the tip of the syringe into the adapter,
• invert the bottle,
• pull the plunger to measure the required dose,
• return the bottle to upright position, remove the syringe, leave the adapter in the bottle and close.

Always remember to shake the bottle before measuring each dose.

Instructions for administering the dose using the syringe:

• always ensure the child is in an upright position,
• carefully place the tip of the syringe into the child's mouth, directing it towards the inside of the cheek,
• slowly push the syringe plunger: do not administer too quickly,
• allow time for the child to swallow the medicine.

Alternatively, empty the measured dose from the syringe into a spoon for your child to take the medicine.

How to prepare this medicine

Your doctor or pharmacist will have prepared the medicine for you. To open the bottle, you need to remove the child-resistant cap by pressing down and then turning.

If you need to prepare this medicine yourself, carefully fill the bottle with cold water, taking care not to exceed the mark. Then, shake the bottle well. Next, add more water up to the mark on the bottle and shake again.

The suspension only needs to be prepared once, at the beginning of treatment.

If you take more Claritromycin Sandoz than you should

If you have taken more Claritromycin Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken.

The most common symptoms associated with overdose are gastrointestinal disturbances.

If you forget to take Claritromycin Sandoz

If you forget to take a dose, continue with the treatment as your doctor has instructed. Do not take a double dose to make up for forgotten doses.

If you stop taking Claritromycin Sandoz

It is important to take this medicine exactly as your doctor has told you. Do not stop treatment suddenly without first talking to your doctor, otherwise your symptoms may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

If any of the following occur, stop taking the medicine and consult your doctor immediately or go to the nearest hospital:

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

• allergic reactions such as sudden difficulty breathing, speaking or swallowing, swelling of the lips, face and neck, extreme dizziness or collapse, itching, papular skin rash,
• irregular heartbeat (change in the heart's electrical activity),
• risk of blood clotting due to increased platelet levels,
• blistering dermatitis.

Serious adverse effects of unknown frequency (cannot be estimated from available data):

• fever, sore throat, more frequent infections, caused by a shortage of white blood cells (agranulocytosis),
• rash, fever, blood abnormalities (which may be signs of a hypersensitivity syndrome called DRESS),
• yellowing of the skin and eyes, nausea, loss of appetite, slight yellowing of the skin and eyes, abnormal liver blood test results (signs of liver problems),
• severe, prolonged or bloody diarrhoea with stomach pain or fever. This may be a symptom of a serious intestinal infection. Your doctor may stop treatment. Do not take medicines that reduce intestinal motility,
• severe pain in the abdomen and back, caused by inflammation of the pancreas,
• high or low urine output, drowsiness, confusion and nausea, caused by kidney inflammation,
• severe skin rash or intense itching, especially if blisters appear and swelling occurs in the eyes, mouth or genital organs,
• unusual bruising or bleeding caused by low platelet levels,
• irregular or rapid heartbeat,
• red, scaly rash with bumps under the skin and blisters (acute generalized exanthematous pustulosis).

These are serious adverse effects. You may require urgent medical attention.

Other possible adverse effects

Consult your doctor if you experience any of the following adverse effects:

Frequent (may affect up to 1 in 10 people)

• headache,
• changes in taste sensation (e.g. metallic or bitter taste),
• abdominal pain, feeling unwell, diarrhoea, indigestion,
• difficulty sleeping,
• abnormal liver function test results,
• rash,
• excessive sweating,
• dilation of blood vessels.

Uncommon (may affect up to 1 in 100 people)

• decreased levels of white blood cells in the blood,
• inflammation of the stomach and intestines,
• decreased neutrophil levels (neutropenia),
• increased eosinophils (white blood cells involved in immunity),
• involuntary muscle movements,
• increased liver enzymes in the blood,
• fungal infection (candidiasis),
• infections, for example in the vagina,
• decreased or loss of appetite,
• anxiety, nervousness, screaming,
• dizziness, tremor, drowsiness, fainting,
• sensation of spinning, hearing loss, ringing in the ears (tinnitus),
• awareness of your heartbeat,
• chest pain or changes in heart rhythm, such as palpitations or irregular heartbeats,
• inflammation of the stomach lining, constipation, gas, dry mouth, burping,
• itching, hives, red blistering rash,
• muscle spasms,
• fever and weakness,
• muscle spasms, muscle pain or loss of muscle tissue. If your child has myasthenia gravis (a condition in which muscles become weak and tire easily), clarithromycin may worsen these symptoms,
• anal pain,
• asthma: lung disease associated with narrowing of the airways, making breathing difficult,
• nosebleeds,
• blood clot causing sudden blockage in a pulmonary artery (pulmonary embolism),
• inflammation of the lining of the throat (oesophagus) and of the stomach mucosa,
• increased blood tests showing abnormal kidney and liver function and elevated blood test values.

Frequency not known (cannot be estimated from available data)

• discoloration of teeth and tongue,
• bacterial infections of the skin and underlying tissues,
• disturbances in the sense of smell, loss of smell or taste,
• deafness,
• acne,
• depression,
• muscle pain or weakness,
• abnormal urine color,
• nightmares, disorientation, confusion, lack of awareness, feeling unwell or hearing things that are not real, loss of contact with reality, feeling loss of identity, mania (feeling of euphoria or overexcitement),
• seizures, tingling and numbness of the skin,
• bleeding,
• vision problems (blurred vision),
• visual disturbances.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle after CAD/EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C.

After reconstitution: do not store above 25°C.

The suspension may be used up to 14 days after preparation.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Clarithromycin Sandoz 25 mg/ml granules for oral suspension

• The active substance is clarithromycin. 5 ml of reconstituted oral suspension contains 125 mg of clarithromycin.
• The other components are: poloxamer 188, povidone K 30, hypromellose, macrogol 6000, titanium dioxide (E171), methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate, glyceryl monostearate, polysorbate 80, sucrose, maltodextrin (contains corn starch), potassium sorbate, anhydrous colloidal silica, xanthan gum, fruit flavor (natural and artificial flavor, including maltodextrine, modified starch and maltol).

Appearance of the product and contents of the container

White to beige granules in HDPE bottles of 60 ml, 120 ml or 240 ml with a child-resistant closure system (press + turn) made of polypropylene (PP) and a tamper-evident ring, and a PE/PP oral syringe (5 ml) marked at 2.5 ml, 3.75 ml and 5.0 ml and/or a PP measuring spoon marked at 1.25 ml, 2.5 ml and 5.0 ml.

Container sizes:

One bottle containing 27.3 g of granules for oral suspension, to prepare 40 ml of suspension (amount of water required: 23.6 ml) or

34.1 g of granules for oral suspension, to prepare 50 ml of suspension (amount of water required: 29.5 ml) or

41.0 g of granules for oral suspension, to prepare 60 ml of suspension (amount of water required: 35.4 ml) or

47.8 g of granules for oral suspension, to prepare 70 ml of suspension (amount of water required: 41.3 ml) or

54.6 g of granules for oral suspension, to prepare 80 ml of suspension (amount of water required: 47.2 ml) or

68.3 g of granules for oral suspension, to prepare 100 ml of suspension (amount of water required: 59.0 ml) or

81.9 g of granules for oral suspension, to prepare 120 ml of suspension (amount of water required: 70.8 ml) or

Double pack of 2 x 60 ml for oral suspension: 2 x 41 g of granules for oral suspension, each to prepare 2 x 60 ml of oral suspension (amount of water required: 2 x 35.4 ml each).

1, 2, 5, 10, 20, 30, 40, 50 and 100 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

or

Novartis Pharmaceuticals S.R.L

Livezeni Street no 7A

Targu Mures

Romania

Date of the most recent revision of this leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

---

The following information is intended for healthcare professionals only:

To prepare the suspension, fill the bottle with the following amounts of water:

• For 40 ml bottles, add 23.6 ml of water,
• For 50 ml bottles, add 29.5 ml of water,
• For 60 ml bottles, add 35.4 ml of water,
• For 70 ml bottles, add 41.3 ml of water,
• For 80 ml bottles, add 47.2 ml of water,
• For 100 ml bottles, add 59.0 ml of water,
• For 120 ml bottles, add 70.8 ml of water.

Shake the bottle well after adding water. After reconstitution with water, the resulting product is a white or beige suspension.