CLARITROMICINA 500 mg Powder For Concentrate For Infusion Solution

Зміст інструкції

1. Claritromicina Tillomed 500 mg powder for concentrate for solution for infusion
   1. What is Claritromicina Tillomed and what is it used for
   2. What you need to know before using Claritromicina Tillomed
   3. How Claritromicina Tillomed is administered
   4. Possible side effects
   5. How to store Claritromicina Tillomed
   6. Package contents and other information

Claritromicina Tillomed 500 mg powder for concentrate for solution for infusion

Claritromicina

Equivalent medicine

Read this leaflet carefully before you are given 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, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1.What Claritromicina Tillomed is and what it is used for
• 2.What you need to know before you are given Claritromicina Tillomed
• 3.How Claritromicina Tillomed is given
• 4.Possible side effects
• 5.How to store Claritromicina Tillomed
• 6.Contents of the pack and other information

1. What is Claritromicina Tillomed and what is it used for

Claritromicina Tillomed contains clarithromycin. Claritromicina Tillomed belongs to a
group of medicines known as macrolide antibiotics. Antibiotics inhibit the growth of
bacteria (pathogens) that cause infections.
Claritromicina Tillomed is indicated whenever an intravenous antibiotic
(injection into a vein) is needed to treat severe infections or, alternatively, if the patient is unable
to swallow tablets.
It is used to treat the following infections:

• 1. chest infections, such as bronchitis and pneumonia
• 2. throat and nasal sinus infections
• 3. skin and soft tissue infections

Claritromicina Tillomed is indicated in adults and adolescents aged 12 years and over.

2. What you need to know before using Claritromicina Tillomed

You must not be given Claritromicina Tillomed
if

• you are allergicto clarithromycin, to other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6);
• you are taking medicines called ergot alkaloids (e.g. ergotamine or dihydroergotamine) in tablets, or use ergotamine inhalers for migraine;
• you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or domperidone or cisapride (for stomach disorders) or pimozide (for psychiatric disorders) as the combination of these medicines can sometimes cause serious changes in heart rhythm. Consult your doctor for advice on alternative medicines;
• you are taking other medicines that are known to cause serious changes in heart rhythm;
• you are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to reduce cholesterol levels (a type of fat) in the blood);
• you are taking midazolam orally (a sedative);
• you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia);
• you suffer from severeliver disease with kidney disease;
• you, or someone in your family, has a history of heart rhythm disorders (ventricular cardiac arrhythmias, including torsade de pointes) or an abnormality on the electrocardiogram (ECG, electrical recording of the heart) called “long QT syndrome”;
• you are taking medicines called ticagrelor or ranolazine (to reduce the risk of heart attack, to treat chest pain or angina);
• you are taking colchicine (for the treatment of gout);
• you are taking a medicine containing lomitapide.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
Claritromicina Tillomed if:

• you have heart problems (e.g. coronary heart disease, heart failure or abnormally slow heart rate)
• you suffer from liver or kidney problems
• you suffer from or are prone to fungal infections (e.g. thrush)
• you are pregnant or breastfeeding

Use in children
Claritromicina Tillomed is not suitable for use in children under 12 years of age.
Other medicines and Claritromicina Tillomed
Youmust not be given Claritromicina Tillomed if you are taking any of the
medicines listed in the previous paragraph “You must not be given Claritromicina
Tillomed”.
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines as it may be necessary to adjust the dose or
perform regular tests:

• digoxin, quinidine or disopyramide (medicines for the heart)
• ibrutinib or vinblastine (for cancer treatment)
• aprepitant (for nausea and vomiting during cancer treatment)
• warfarin or other anticoagulant medicines for example dabigatran, rivaroxaban, apixaban, edoxaban (medicines to thin the blood)
• eletriptan (for migraine)
• carbamazepine, valproate, phenobarbital or phenytoin (medicines for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, used to reduce cholesterol levels (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition that causes the breakdown of

muscle tissue that can cause kidney damage) and the signs of myopathy (muscle pain
or muscle weakness) must be monitored.

• bromocriptine (for Parkinson's disease)
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (medicines to reduce blood glucose levels)
• gliclazide or glimepiride (sulphonylureas used in the treatment of type II diabetes)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam or midazolam for oral mucosa or intravenously (sedative medicines)
• cilostazol (for circulation problems)
• methadone (used in the treatment of opioid dependence)
• methylprednisolone (a corticosteroid)
• cyclosporine, sirolimus and tacrolimus (immunosuppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (antiviral medicines used to treat HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used to treat some bacterial or fungal infections)
• alofantrine (for malaria)
• tolterodine (for overactive bladder)
• verapamil, amlodipine or diltiazem (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or for pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs))
• St John's wort (a herbal remedy used to treat depression)
• quetiapine, ziprasidone or other medicines for mental disorders
• other macrolide medicines, such as erythromycin
• lincomycin and clindamycin (lincosamides - a type of antibiotic)
• hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines in combination with clarithromycin may increase the possibility of an abnormal heart rhythm and other serious heart-related side effects.
• corticosteroids, administered orally, by injection or inhaled (used to help suppress the body's immune system - useful in the treatment of a wide range of conditions)
• esobarbitone (anaesthetic)

Tell your doctor if you are taking oral contraceptives and you experience diarrhoea or vomiting, as
you may need to take additional contraceptive precautions such as using a
condom.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or if you are
breastfeeding, ask your doctor or pharmacist for advice before you are given
this medicine because the safety of clarithromycin during pregnancy or
breastfeeding is unknown.
Clarithromycin should only be used during pregnancy or breastfeeding after
careful assessment of the benefit/risk ratio by the doctor.

Driving and using machines
Claritromicina Tillomed can cause dizziness or drowsiness. If you experience these effects do not
drive, use machines and do not perform any activity that requires attention.

Claritromicina Tillomed contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, therefore it is
essentially “sodium-free”.

3. How Claritromicina Tillomed is administered

Claritromicina Tillomed is prepared by the doctor or nurse by dissolving the powder
contained in the vial in sterile water. The resulting solution is added to a larger
volume of sterile water. Claritromicina Tillomed is administered to you slowly
through a needle into a vein for at least one hour.
The recommended dose of Claritromicina Tillomed for adults, the elderly and adolescents over
12 years of age is 1 g per day, divided into two doses of 500 mg each, for 2-5 days.
The doses should be taken 12 hours apart. The doctor will calculate the correct
dose for you.
For patients undergoing treatment with ritonavir, the daily dose should not exceed 1 g of
clarithromycin.
In patients with impaired renal function, the daily dose must be reduced.
Claritromicina Tillomed should not be administered to children under 12 years of age. The
doctor will prescribe another appropriate medicine for your child.
If a child accidentally ingests this medicine, contact your doctor immediately.

If you are given more Claritromicina Tillomed than you should
Since Claritromicina Tillomed is administered by a doctor, an overdose is
unlikely, but symptoms may include vomiting and stomach pain.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, Claritromicina Tillomed can cause side effects, although not everyone gets them.
If you experience any of the following symptoms at any time during treatment, inform your
doctor immediately as it may be necessary to stop it:

• severe or prolonged diarrhea, which may contain blood or mucus. Diarrhea may occur within two months of treatment with clarithromycin; in this case, you should still contact your doctor.
• skin rash, difficulty breathing, fainting or swelling of the face, tongue, lips, eyes and throat. This is a sign of a possible development of an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, soft abdomen or loss of appetite. These may be signs of inflammation or liver dysfunction.
• 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 the formation of pustules and blisters (pustular exanthematous reaction). The frequency of this side effect is unknown (cannot be defined based on available data).
• rare allergic reactions that cause serious illnesses associated with ulceration of the mouth, lips and skin, causing severe pathologies with rash, fever and inflammation of internal organs (DRESS).
• condition of muscle pain or weakness known as rhabdomyolysis (a condition that causes muscle tissue breakdown that can cause kidney damage). Other side effects include:Common: (may affect up to 1 in 10 people)
• inflammation, sensitivity or pain at the injection site
• sleep disturbances
• altered taste
• headache
• vasodilation
• stomach problems such as feeling unwell, vomiting, abdominal pain, indigestion, diarrhea
• excessive sweating

Uncommon: (may affect up to 1 in 100)

• high fever
• swelling, redness or itching of the skin
• oral or vaginal “thrush” (a fungal infection)
• inflammation of the stomach and intestines
• reduction in platelet levels (platelets help stop bleeding)
• reduction in white blood cells (leukopenia)
• reduction in neutrophils (neutropenia)
• stiffness
• chills
• increased number of eosinophils (white blood cells involved in the immune response)
• exaggerated immune response to a foreign agent
• lack or loss of appetite
• anxiety, nervousness
• drowsiness, fatigue, dizziness or tremors
• involuntary muscle movements
• vertigo
• ringing in the ears or hearing loss
• chest pain or changes in heart rhythm such as palpitations or irregular heartbeat
• asthma: lung disease associated with narrowing of the airways, making breathing difficult
• nosebleeds
• blood clot causing a sudden blockage in a pulmonary artery (pulmonary embolism)
• inflammation of the lining of the throat (esophagus) or stomach
• anal pain
• swelling, constipation, flatulence, belching
• dry mouth
• condition in which bile (fluid produced by the liver and stored in the gallbladder) cannot flow from the gallbladder to the duodenum (cholestasis)
• skin inflammation characterized by the presence of blisters filled with fluid, itchy and painful rash
• muscle spasms, muscle pain or loss of muscle tissue If you suffer from myasthenia gravis (a condition in which muscles weaken and tire easily), clarithromycin may worsen these symptoms.
• increased abnormal values in blood tests of liver and kidney function and increased values in blood tests
• feeling of weakness, fatigue and lack of energy

Not known: (frequency cannot be defined on the basis of available data)

• colon infection
• bacterial infection of the outermost layers of the skin
• reduction in the number of some blood cells (which can lead to an increased possibility of infections or the risk of bruising or bleeding)
• confusion, disorientation, hallucinations (seeing things), altered sense of reality or panic, depression, abnormal dreams or nightmares and manic episodes (feeling excited or overexcited)
• convulsions (seizures)
• paresthesia, more commonly known as “numbness and tingling”
• loss of taste or smell or inability to smell properly
• hearing loss (usually reversible after stopping the medicine)
• heart rhythm disorders (torsades de pointes, ventricular tachycardia)
• blood loss (hemorrhage)
• inflammation of the pancreas
• alteration of the color of the tongue or teeth
• acne
• changes in the levels of substances produced by the kidneys, inflammation of the kidneys or inability of the kidneys to function properly (you may notice fatigue, swelling of the face, abdomen, thighs or ankles or problems with urination)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through the national
reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store Claritromicina Tillomed

Keep this medicine out of the sight and reach of children.
The doctor and hospital pharmacist are responsible for the correct storage, use and
disposal of Claritromicina Tillomed.
Do not use this medicine after the expiry date which is stated on the label and on the pack
after “EXP.”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Reconstituted solution: chemical and physical stability in use has been demonstrated for 24 hours at 20-
25 °C and for 24 hours at 2-8 °C.
Reconstituted and diluted solution: chemical and physical stability in use has been demonstrated for 6 hours at
20-25 °C and for 24 hours at 2-8 °C.
From a microbiological point of view, unless the opening/reconstitution/dilution method
excludes the risk of microbial contamination, the product must be used
immediately. If not used immediately, the storage times and conditions
in use before use are the responsibility of the user and should not be longer than
the times indicated above for chemical and physical stability during use.
Unused medicine and waste derived from such medicine must be disposed of in
accordance with local regulations.

6. Package contents and other information

What Claritromicina Tillomed contains
The active ingredient is clarithromycin. Each vial contains 500 mg of clarithromycin (as
clarithromycin lactobionate).
The other component is 1N sodium hydroxide (for pH adjustment).

Description of the appearance of Claritromicina Tillomed and contents of the pack
Claritromicina Tillomed is a lyophilized powder for concentrate for solution for infusion
of colour from white to off-white, available in a 15 ml transparent tubular glass vial,
closed with a grey bromobutyl rubber stopper with two slits and sealed
with a blue child-resistant aluminium crimp.
Claritromicina Tillomed is available in a single pack containing 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milan
Italy
Manufacturer:
MIAS Pharma Limited
Suite 2, Stafford House, Strand Road
Portmarnock, Co. Dublin
Ireland
Tillomed Malta Limited
Malta Life Sciences Park,
LS2.01.06 Industrial Estate,
San Gwann, SGN 3000, Malta

This medicinal product is authorised in the Member States of the European Economic Area with
the following designation:
Germany Clarithromycin Tillomed 500 mg Pulver für ein Konzentrat zur
Herstellung einer Infusionslösung
Italy Claritromicina Tillomed
Austria Clarithromycin Tillomed 500 mg Pulver für ein Konzentrat zur
Herstellung einer Infusionslösung
Czech
Republic
Clarithromycin Tillomed
Poland Klarytromycyna Tillomed

This leaflet was last updated on
___________________________________________________________________________
The following information is intended exclusively for healthcare professionals.
For complete prescribing information, refer to the Summary of
Product Characteristics
Route of administration
For information on dosage, refer to the Summary of Product
Characteristics.

Clarithromycin must not be administered as a bolus or intramuscular injection.
Clarithromycin must be administered in one of the larger proximal veins by
intravenous infusion over a period of 60 minutes, using a solution concentration of
approximately 2 mg/ml.
Preparation for use
Reconstitution (step 1)
Prepare the initial clarithromycin 500 mg solution by adding 10 ml of sterile water for
injections to the vial.
Shake until the contents of the vial have dissolved.
Use only sterile water for injections as other diluents may
cause precipitation during reconstitution. Do not use diluents containing preservatives or
inorganic salts. Each ml contains 50 mg of clarithromycin.
Dilution (step 2)
The reconstituted solution (500 mg of clarithromycin in 10 ml of water for injections) must be added to at least 250 ml of one of the following diluents before
administration: dextrose 50 g/ml (5%) in Ringer’s lactate, dextrose 50 mg/ml
(5%), Ringer’s lactate, dextrose 50 mg/ml (5%) in 3 mg/ml sodium chloride
(0.3%), Normosol-M in dextrose 50 mg/ml (5%), Normosol-R in dextrose 50 mg/ml (5%),
dextrose 50 mg/ml (5%) in 4.5 mg/ml sodium chloride (0.45%) and 9 mg/ml sodium chloride (0.9%) solution.
1 ml of the infusion solution prepared in this way contains 2 mg of clarithromycin.
IMPORTANT: BOTH DILUTION STEPS (1 and 2) MUST BE COMPLETED
BEFORE USE.
Any unused medicinal product or waste material derived from such medicinal product must be disposed of in
accordance with local regulations.