Claritromicina sandoz 25 mg/ml granulado para suspension oral

Package Insert: Information for the Patient

Claritromycin Sandoz 25 mg/ml Granule for Oral Suspension

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

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

Claritromicinaisa macrolide antibiotic.Claritromicina inhibits the growth of certain bacteria.

Claritromicina is used to treat:

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

Do not take Claritromicina Sandoz

• if you areallergicto clarithromycin, macrolide antibiotics, or any of the other ingredients in this medication (listed in section 6),
• if you or a family member has a history ofheart rhythm disorders(ventricular arrhythmia, includingTorsades de Pointes),or abnormal electrocardiogram (ECG, heart electrical recording),known as “long QT syndrome”,
• if you havesevere liver failureandkidney problemsat the same time,
• if you have abnormally low levels ofpotassium or magnesium in your blood (hypokalemia or hypomagnesemia),
• if you are taking:
• ticagrelor, ivabradina, or ranolazine(for angina or to reduce the risk of heart attack or stroke),
• ranolazine(used to treat angina),
• ergotamine,dihydroergotamine(medications for migraine treatment),
• midazolam oral(for anxiety or to help sleep),
• cisaprideanddomperidone(gastrointestinal medication),
• pimozide(antipsychotic),
• terfenadine, astemizole(hay fever, antihistamines),
• lovastatin, simvastatin(medications that lower cholesterol levels),
• an oral medication containinglomitapida,
• colchicine(for gout treatment),
• other medications known to cause severe heart rhythm disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to take clarithromycin

• if you havereduced liver or kidney function,
• if you areallergic to lincomycin or clindamycin(antibiotics),
• if you developsevere or prolonged diarrhea(pseudomembranous colitis) while taking or after taking clarithromycin, consult your doctor immediately. Pseudomembranous colitis has been reported with almost all antibacterial medications, including clarithromycin,
• if you havemyasthenia gravis, a rare disease that causes muscle weakness,
• if you havediabetes,
• if you have or have hadheart problemsor,
• if you have used clarithromycin previously on multiple occasions or for a long period of time.

Other medications and Claritomicina Sandoz

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

Do not take Claritromicina Sandoz with ergot alkaloids, astemizole, terfenadine, cisaprida, domperidone, pimozide, ticagrelor, ranolazine, colchicine, some medications for high cholesterol, and medications known to cause severe heart rhythm disorders (see section “Do not take Claritromicina Sandoz”).

Some medications may affect the use of clarithromycin or vice versa. These medications are:

Claritromicina may increase the effect of the following medications:

• ibrutinib (medication for chronic lymphocytic leukemia),
• alprazolam, triazolam,midazolam intravenous or oral (oromucosal) (for anxiety or to help sleep),
• digoxina, verapamil, amlodipine, diltiazem (heart medications),
• theophylline (antiasmatic),
• warfarin or any other anticoagulant, e.g., dabigatran, rivaroxaban, apixaban, edoxaban (used as an anticoagulant),
• atorvastatin, rosuvastatin (medications that lower cholesterol levels),
• ciclosporin, sirolimus, tacrolimus (immunosuppressants),
• carbamazepine, phenytoin, valproate (medications for epilepsy treatment),
• cilostazol (used to improve blood circulation in the legs),
• insulin and other medications for diabetes treatment (such as nateglinide, repaglinide),
• prednisolone (cortisone for anti-inflammatory treatment),
• omeprazole (gastrointestinal medication),
• sildenafil, tadalafil, vardenafil (medications for erectile dysfunction treatment),
• tolterodine (for overactive bladder treatment),
• vinblastine (medication for cancer treatment),
• medications that may affect hearing, especially aminoglycosides such as gentamicin or neomycin (group of antibiotics).

The effect of Claritromicina Sandoz and the following medications may increase when taken concomitantly:

• atazanavir, saquinavir (medications for HIV treatment),
• itraconazole (medication for fungal infections).

If your doctor has recommended taking clarithromycin and one of the medications mentioned above at the same time, your doctor may need to monitor you closely.

The following medications may decrease the effect of Claritromicina Sandoz:

• rifampicin, rifabutin, rifapentine (antibiotics),
• efavirenz, etravirine, nevirapine (medications for HIV treatment),
• phenytoin, carbamazepine, phenobarbital (antiepileptic medications),
• St. John's Wort.

This is also important if you take medications called:

• 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 severe 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 variety of diseases).

Please note

Ritonavir(antiviral) andfluconazole(antifungal) may increase the effect of clarithromycin.

Claritromicina may decrease the effect ofzidovudine(antiviral). To avoid this, it is recommended that you leave a 4-hour interval between taking these medications.

The concomitant use of clarithromycin withdigoxin, quinidine, disopyramideorverapamil(heart medications) or othermacrolide antibioticsmay cause cardiac arrhythmias.

The concomitant use of clarithromycin withdisopyramidemay cause a decrease in blood sugar levels (hypoglycemia).

Pregnancyandlactation

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

Driving and operating machinery

Claritromicina Sandoz generally does not affect the ability to drive or operate machinery, but 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 activities that may put yourself or others at risk.Visual disturbances and blurred vision may affect the patient's ability to drive or operate machinery.

Claritromicina Sandoz contains saccharose and sodium.

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

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

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

The dispensing conditions indicated on your prescription will inform you of the dose and frequency at which you should take this medication. Please read it carefully. The prescribed dose by your doctor will depend on the type of infection you are suffering from and its severity. This also depends on your renal function. Your doctor will explain this to you.

Adultsand adolescents:

The recommended dose is 10 ml, twice a day.

For severe infections or gastric ulcers caused byHelicobacter pylorithe usual dose is 20 ml twice a day.

Childrenfrom 6 months to 12 years of age:

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

The following table will provide a dosage guide:

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

Treatment duration

Your doctor will inform you of the duration of treatment with clarithromycin, which is usually between 5 and 14 days. Do not stop treatment on your own initiative, for example, because you or your child feel better. If you stop treatment too early, the infection may recur.

Instructions for use

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

It can be taken with or without food.

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

How to measure the dose

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

• shake the bottle,
• put the adapter into the neck of the bottle,
• put the end of the syringe into the adapter,
• invert the bottle,
• pull the plunger to measure the required dose,
• put the bottle back in its normal position, remove the syringe, leave the adapter in the bottle, and close.

Remember to always shake the bottle before measuring each dose.

Instructions for administering the dose with a syringe:

• make sure the child is in a vertical position,
• put the end of the syringe into the child's mouth carefully. Point the syringe towards the inside of the cheek,
• press the plunger of the syringe slowly: do not administer it quickly,
• give the child time to swallow the medication.

Alternatively, empty the measured dose from the syringe into a spoon so that your child can take the medication.

How to prepare this medication

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

If you have to prepare this medication, you must fill the bottle with cold water carefully without exceeding the mark. Then, shake the bottle well. Then add more water up to the bottle mark and shake again.

You only need to prepare the suspension once, at the beginning of the process.

If you take more Claritromycin Sandoz than you should

If you have taken more Claritromycin Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

The most common symptoms that accompany an overdose are gastrointestinal disturbances.

If you forgot to take Claritromycin Sandoz

If you forget to take a dose, continue with the treatment in the same way that your doctor has indicated. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Claritromycin Sandoz

It is essential that you take the medication following your doctor's instructions. Do not interrupt your treatment abruptly without first speaking with your doctor. If the symptoms do not reappear.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects

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

Less common side 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 heart electrical activity),
• blood clotting risk, caused by an increase in platelet levels,
• dermatitis herpetiformis.

Severe side effects of unknown frequency(cannot be estimated from available data)

• fever, sore throat, increased frequency of infections, caused by a lack of white blood cells (agranulocytosis),
• eruption, fever, blood abnormalities (which may be signs of hypersensitivity syndrome, called DRESS),
• yellow discoloration of the skin and eyes, nausea, loss of appetite, mild yellow discoloration of the skin and eyes, abnormal liver function test results (signs of liver problems),
• prolonged or bloody diarrhea with stomach pain or fever. This may be a sign of a severe intestinal infection. Your doctor may stop treatment. Do not take medications that reduce intestinal movement,
• severe abdominal and back pain, caused by pancreatitis inflammation,
• high or low urine production, drowsiness, confusion, and nausea, caused by kidney inflammation,
• severe skin rash or intense itching, especially if blisters appear and inflammation 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 (generalized acute pustular psoriasis).

These are severe side effects. You may need urgent medical attention.

Other possible side effects

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

Common(may affect up to 1 in 10 people)

• headache,
• changes in taste (e.g. metallic or bitter taste),
• abdominal pain, feeling unwell, diarrhea, indigestion,
• difficulty sleeping,
• altered liver function test results,
• eruption,
• excessive sweating,
• vasodilation.

Less common(may affect up to 1 in 100 people)

• decrease in white blood cell count in blood,
• inflammation of the stomach and intestines,
• decrease in neutrophils (white blood cells involved in immunity),
• increase in eosinophils (white blood cells involved in immunity),
• involuntary muscle movements,
• increase in liver enzymes in blood,
• yeast infections (candidiasis),
• infections, for example in the vagina,
• decrease or loss of appetite,
• anxiety, nervousness, screaming,
• dizziness, tremors, drowsiness, fainting,
• sensation of spinning, hearing loss, ringing in the ears (tinnitus),
• feeling the heartbeat,
• chest pain or changes in heart rhythm, such as palpitations or irregular heartbeats,
• inflammation of the stomach lining, constipation, gas, dry mouth, belching,
• itching, urticaria, red, blistering rash,
• muscle spasms,
• fever and weakness,
• muscle spasms, muscle pain or muscle tissue loss. If your child has myasthenia gravis (a condition in which muscles weaken and tire easily), clarithromycin may worsen these symptoms,
• anal pain,
• asthma: a lung disease associated with narrowing of the airways, making breathing difficult,
• nasal bleeding,
• blood clot that causes a sudden blockage in a pulmonary artery (pulmonary embolism),
• inflammation of the esophagus lining and stomach mucosa,
• abnormal liver and kidney function test results and elevated blood tests.

Unknown frequency(cannot be estimated from available data)

• discoloration of teeth and tongue,
• bacterial skin and tissue infections,
• alterations in the sense of smell, loss of sense of smell or taste,
• hearing loss,
• acne,
• depression,
• muscle pain or weakness,
• abnormal urine color,
• nightmares, not knowing where you are, confusion, disorientation, feeling sick or hearing things that are not real, loss of contact with reality, feeling loss of identity, mania (feeling of euphoria or overexcitement),
• convulsions, tingling and numbness of the skin,
• bleeding,
• vision problems (blurred vision),
• vision alteration.

Reporting ofside effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the bottle after CAD/EXP. The expiration 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 can be used up to 14 days after preparation.

Medicines should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Claritromicina Sandoz 25mg/ml granulated for oral suspension

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

Appearance of the product and contents of the package

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

Packaging sizes:

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

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

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

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

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

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

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

Double packaging of 2 x 60 ml prepared for oral suspension: 2 x 41 g of granulated oral suspension each to prepare 2 x 60 ml of oral suspension each (required amount of water: 2 x 35.4 ml each).

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Lek Pharmaceuticals d.d.

Verovškova 57

1526 Ljubljana

Slovenia

or

Sandoz S.R.L.

Livezeni Street no 7A

Targu Mures

Romania

Last review date of this leaflet:May 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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The following information is only for healthcare professionals:

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 when adding the water. After reconstitution with water, the resulting product is a white or beige suspension.