Clarithromycin Tilmomed

Italy
Brand name Clarithromycin Tilmomed
Form powder for concentrate for infusion solution
Active substance / Dosage
CLARITHROMYCIN LACTOBIONATE
Prescription type Restricted prescription – non-repeatable, dispensable on hospital or specialist prescription
ATC code
J01FA09
Registration number 048727
Manufacturer TILLOMED ITALIA SRL

Table of Contents

PACKAGE LEAFLET

Package leaflet: Information for the user

Clarithromycin Tillomed 500 mg powder for concentrate for solution for infusion

Clarithromycin
Generic medicine
Please read this leaflet carefully before this medicine is administered to you
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 experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Claritromycin Tillomed contains clarithromycin. Claritromycin Tillomed belongs to a group of medicines known as macrolide antibiotics. Antibiotics inhibit the growth of bacteria (pathogenic) that cause infections.
Claritromycin Tillomed is indicated whenever an intravenous antibiotic (injection into the vein) is required to treat serious infections or, alternatively, when 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 sinus infections
  3. skin and soft tissue infections

Claritromycin Tillomed is indicated in adults and adolescents aged 12 years and older.

2. What you need to know before using Claritromycin Tillomed

Do not take Claritromycin Tillomed
if

  • you are allergic to 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 tablet form, or using ergotamine inhalers for migraine;
  • you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or domperidone or cisapride (for stomach problems) 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 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 levels of cholesterol (a type of fat) in the blood);
  • you are taking midazolam by mouth (a sedative);
  • you have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia);
  • you have severe liver disease with kidney disease;
  • you, or someone in your family, have a history of heart rhythm disorders (cardiac ventricular arrhythmias, including torsade de pointes) or an abnormal 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
Claritromycin Tillomed if:

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

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

  • digoxin, quinidine, or disopyramide (medicines for the heart);

  • ibrutinib or vinblastine (for the treatment of cancer);

  • aprepitant (for nausea and vomiting during cancer treatment);

  • warfarin or other anticoagulant medicines such as 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 levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolysis (a condition that causes breakdown of muscle tissue which may lead to kidney damage), and signs of myopathy (muscle pain or muscle weakness) should be monitored.

  • bromocriptine (for Parkinson's disease);

  • nateglinide, pioglitazone, repaglinide, rosiglitazone, or insulin (medicines to reduce blood glucose levels);

  • gliclazide or glimepiride (sulfonylureas used in the treatment of type II diabetes);

  • theophylline (used in patients with breathing difficulties such as asthma);

  • triazolam, alprazolam, or midazolam administered orally or intravenously (sedative medicines);

  • cilostazol (for circulation problems);

  • methadone (used in opioid dependence treatment);

  • 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 certain bacterial or fungal infections);

  • halofantrine (for malaria);

  • tolterodine (for overactive bladder);

  • verapamil, amlodipine, or diltiazem (for high blood pressure);

  • sildenafil, vardenafil, and tadalafil (for erectile dysfunction in adult males or for pulmonary arterial hypertension (high blood pressure in the blood vessels of the lungs));

  • St John's wort (an herbal product used to treat depression);

  • quetiapine, ziprasidone, or other medicines for mental disorders;

  • other macrolide antibiotics, such as erythromycin;

  • lincomycin and clindamycin (lincosamides – a type of antibiotic);

  • hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis or to treat or prevent malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythm and other serious heart-related side effects.

  • corticosteroids, administered orally, by injection, or inhaled (used to suppress the body’s immune system – useful in treating a wide range of conditions);

  • secobarbital (an anaesthetic).

Inform your doctor if you are taking oral contraceptives and 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, think you may be pregnant, planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine, as the safety of clarithromycin
during pregnancy or breastfeeding is not known.
Clarithromycin should only be used during pregnancy or breastfeeding after careful evaluation of
the benefit-risk balance by your doctor.
Driving and using machines
Claritromycin Tillomed may cause dizziness or drowsiness. If you experience these symptoms, do
not drive, operate machinery, or perform any activity requiring alertness.
Claritromycin Tillomed contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, therefore it is essentially “sodium-free”.

3. How Claritromycin Tillomed is administered

Claritromycin Tillomed is prepared by the doctor or nurse by dissolving the powder contained in the vial with sterile water. The resulting solution is then added to a larger volume of sterile water. Claritromycin Tillomed is administered to you slowly through a needle into a vein over a period of at least one hour.

The recommended dose of Claritromycin Tillomed for adults, elderly patients, and adolescents over 12 years of age is 1 g per day, divided into two 500 mg doses, for 2–5 days. The doses should be given 12 hours apart. Your doctor will calculate the correct dose for you.

For patients receiving ritonavir, the daily dose must not exceed 1 g of clarithromycin.

In patients with impaired renal function, the daily dose must be reduced.

Claritromycin Tillomed must not be administered to children under 12 years of age. Your doctor will prescribe another suitable medicine for your child.

If a child accidentally ingests this medicine, contact a doctor immediately.

If you are given more Claritromycin Tillomed than you should

Since Claritromycin Tillomed is administered by a doctor, overdose is unlikely, but symptoms may include vomiting and stomach pain.

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

4. Possible side effects

Like all medicines, Claritromycin Tillomed can cause side effects, although not everyone experiences them.
If you develop any of the following symptoms at any time during treatment, inform your doctor immediately, as treatment may need to be stopped:

  • severe or prolonged diarrhoea, which may contain blood or mucus. Diarrhoea may occur up to two months after 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. These may be signs of a possible allergic reaction.
  • yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, soft abdomen, or loss of appetite. These may indicate inflammation or impaired liver function.
  • severe skin reactions such as painful blisters on the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction known as Stevens-Johnson syndrome/toxic epidermal necrolysis);
  • a red, scaly rash with pustule and blister formation (exanthematous pustulosis). The frequency of this adverse effect is unknown (cannot be estimated from available data).
  • rare allergic reactions causing serious conditions associated with ulceration of the mouth, lips, and skin, leading to severe disorders with skin rash, fever, and inflammation of internal organs (DRESS).
  • a condition of muscle pain or weakness known as rhabdomyolysis (a condition causing breakdown of muscle tissue which may lead to 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 nausea, vomiting, abdominal pain, indigestion, diarrhoea
  • excessive sweating

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

  • high fever
  • swelling, redness, or itching of the skin
  • oral or vaginal thrush (a fungal infection)
  • inflammation of the stomach and intestines
  • reduced platelet levels (platelets help stop bleeding)
  • reduced white blood cells (leucopenia)
  • reduced neutrophils (neutropia)
  • stiffness
  • chills
  • increased eosinophil count (white blood cells involved in immune response)
  • exaggerated immune response to an external agent
  • loss of appetite
  • anxiety, nervousness
  • drowsiness, fatigue, dizziness, or tremors
  • involuntary muscle movements
  • dizziness
  • ringing in the ears or hearing loss
  • chest pain or changes in heart rhythm such as palpitations or irregular heartbeat
  • asthma: a 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) or stomach
  • anal pain
  • bloating, 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 fluid-filled blisters, itchy and painful rash
  • muscle spasms, muscle pain, or loss of muscle tissue
    If you have myasthenia gravis (a condition in which muscles become weak and tire easily), clarithromycin may worsen these symptoms.
  • abnormally increased values in blood tests for liver and kidney function and increased blood test values
  • feeling of weakness, fatigue, and lack of energy

Not known: (frequency cannot be estimated from available data)

  • colon infection
  • bacterial infection of the outer layers of the skin
  • reduced number of certain blood cells (which may increase the risk of infections or the risk of bruising or bleeding)
  • confusion, disorientation, hallucinations (seeing things), altered sense of reality, panic, depression, abnormal dreams or nightmares, and manic episodes (feelings of excitement or over-excitement)
  • seizures (epileptic fits)
  • paraesthesia, more commonly known as "pins and needles"
  • loss of taste or smell or inability to smell properly
  • hearing loss (usually reversible after stopping the medicine)
  • disturbances in heart rhythm (torsades de pointes, ventricular tachycardia)
  • bleeding (haemorrhage)
  • inflammation of the pancreas
  • change in the colour of the tongue or teeth
  • acne
  • changes in levels of substances produced by the kidneys, kidney inflammation, 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, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 Clarithromycin Tillomed

Keep this medicine out of the sight and reach of children.
The physician and the hospital pharmacist are responsible for the proper storage, use, and
disposal of Clarithromycin Tillomed.
Do not use this medicine after the expiry date stated on the label and on the carton after "EXP.".
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Reconstituted solution: chemical and physical in-use stability 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 in-use stability has been demonstrated for 6 hours at
20-25 °C and for 24 hours at 2-8 °C.
From a microbiological standpoint, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions of in-use storage prior to use are the responsibility of the user and should not exceed the times indicated above for chemical and physical in-use stability.
Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

6. Pack contents and other information

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

Description of the appearance of Claritromycin Tillomed and pack contents
Claritromycin Tillomed is a white to off-white lyophilized powder for concentrate for solution for infusion, supplied in a 15 ml transparent type I glass vial closed with a grey bromobutyl rubber stopper with two cuts and sealed with a blue child-resistant aluminium cap.
Claritromycin Tillomed is available in single packs containing 1 vial.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Tillomed Italia S.r.l.
viale Richard 1, Torre A
20143, Milan
Italy

Manufacturers:
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 European Economic Area countries under
the following names:
Germany Clarithromycin Tillomed 500 mg Powder for a concentrate for solution for infusion
Italy Claritromycin Tillomed
Austria Clarithromycin Tillomed 500 mg Powder for a concentrate for solution for infusion
Czech Republic Clarithromycin Tillomed
Poland Klarytromycyna Tillomed

This leaflet was last updated on
___________________________________________________________________________

The following information is intended for healthcare professionals only.

For complete prescribing information, refer to the Summary of
Product Characteristics.
Route of administration
For dosage information, refer to the Summary of Product Characteristics.
Clarithromycin must not be administered as an intravenous bolus or by intramuscular injection.
Clarithromycin should be administered via intravenous infusion over a period of 60 minutes into one of the larger proximal veins, using a solution concentration of approximately 2 mg/ml.

Preparation for use
Reconstitution (step 1)
Prepare the initial clarithromycin solution by adding 10 ml of sterile water for injections to the vial.
Shake until the contents of the vial are completely 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 prior to administration: dextrose 50 g/ml (5%) in Ringer's lactate solution, dextrose 50 mg/ml (5%), Ringer's lactate, dextrose 50 mg/ml (5%) in 3 mg/ml sodium chloride (0.3%) solution, 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%) solution, 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 PRIOR TO ADMINISTRATION.
Any unused medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.