Clarithromycin Altan

Package leaflet: Information for the user

Claritromycin Altan 500 mg powder for solution for infusion

Clarithromycin
Generic medicine
Read all of this leaflet carefully before using this medicine.

• 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Claritromycin Altan is and what it is used for
2. What you need to know before using Claritromycin Altan
3. How to use Claritromycin Altan
4. Possible side effects
5. How to store Claritromycin Altan
6. Contents of the pack and other information

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

Claritromicina Altan contains the active substance clarithromycin, which is an antibiotic belonging to a group of medicines known as "macrolide antibiotics". Antibiotics inhibit the growth of bacteria (germs) that cause infections.
Claritromicina Altan is indicated whenever an intravenous antibiotic (injection into the vein) is needed to treat severe infections or, alternatively, if the patient is unable to swallow tablets.
It is used to treat infections such as:

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

Claritromicina Altan is indicated in adults and children aged 12 years and older.

2. What you need to know before using Clarithromycin Altan

Do not use Clarithromycin Altan

• if you are allergic to clarithromycin, to other types of macrolide antibiotics, such as erythromycin or azithromycin, or to any of the other ingredients of this medicine
• if you are taking medicines called ergot alkaloids in tablet form (e.g. ergotamine or dihydroergotamine) or if you are using ergotamine by inhalation for migraine
• if you are taking ticagrelor, ivabradine or ranolazine (for angina or to reduce the risk of heart attack or stroke)
• if you are taking colchicine (for the treatment of gout)
• if you are taking terfenadine or astemizole (medicines widely used for hay fever or allergies) or cisapride or domperidone (medicines used for stomach disorders) or pimozide (a medicine used for mental health problems), because combining these medicines with clarithromycin may sometimes cause serious heart rhythm disturbances. Consult your doctor, who will advise you on alternative medicines
• if you are taking other medicines known to cause serious heart rhythm disturbances
• if you are taking lovastatin or simvastatin (HMG-CoA inhibitors commonly known as statins, used to reduce cholesterol levels (a type of fat) in the blood)
• if you are taking midazolam (a sedative)
• if you are taking a medicine containing lomitapide
• if you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia)
• if you suffer from severe hepatic insufficiency associated with renal damage, or if someone in your family has a history of heart rhythm disorders (ventricular arrhythmia including torsades de pointes), or abnormalities on the electrocardiogram (ECG, electrical recording of the heart) known as "long QT syndrome"

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clarithromycin Altan

• if you have heart problems (e.g. heart disease, heart failure, unusually slow heartbeat)
• if you have liver or kidney problems
• if you have, or are prone to, fungal infections (e.g. oral thrush)
• if you are pregnant or breastfeeding

Use in children and adolescents
Claritromycin Altan is not suitable for children under 12 years of age.
Other medicines and Clarithromycin Altan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.

• Ibrutinib (for the treatment of cancer)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins and used to lower cholesterol levels (a type of fat) in the blood). Statins may cause rhabdomyolysis (a condition causing breakdown of muscle tissue which can lead to kidney damage), and signs of myopathy (muscle pain or muscle weakness) should be monitored.
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)
• gliclazide or glimepiride (sulfonylureas used in the treatment of type II diabetes)
• methadone (used in the treatment of opioid dependence)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used to treat certain bacterial infections)
• verapamil, amlodipine, diltiazem (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for erectile dysfunction in adult men or for use in pulmonary arterial hypertension (high blood pressure in the blood vessels of the lung))
• quetiapine or other antipsychotic medicines
• other macrolide antibiotics
• lincomycin and clindamycin (lincosamides, a type of antibiotic)
• St. John’s Wort (for the treatment of depression)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (antiviral drugs used in the treatment of HIV)
• Fluconazole (for the treatment of fungal infections)
• Warfarin or any other anticoagulant, e.g. dabigatran, rivaroxaban, apixaban, edoxaban (used to thin the blood)

This is also important if you are taking medicines called:

• hydroxychloroquine or chloroquine (used for the treatment of conditions including rheumatoid arthritis or for the treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other adverse effects affecting the heart
• corticosteroids, administered orally, by injection or by inhalation (used to help suppress the body's immune system – this is useful in the treatment of a wide range of conditions)

Tell your doctor if you are taking oral contraceptive pills 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 and breastfeeding is not known.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Claritromycin Altan may cause dizziness and drowsiness. Make sure you do not experience these side effects before driving, operating machinery or doing anything that requires alertness. Claritromycin Altan contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to use Claritromycin Altan

Claritromycin Altan is administered to you intravenously by a doctor or nurse, by dissolving the powder contained in the vial with sterile water.
The resulting solution is added to a larger volume of sterile fluid.
Claritromycin Altan is administered slowly through a needle into a vein over a period of at least one hour.
The recommended daily dose of intravenous clarithromycin in adults and children aged 12 years and older is 1000 mg/day, divided into two equal doses of 500 mg each, infused over 60 minutes after appropriate dilution.
Adults: The recommended dose is 1 gram per day, divided into two 500 mg doses, appropriately diluted as described below.
Children aged over 12 years: As for adults.
Children under 12 years of age: The use of Claritromycin Altan 500 mg powder for infusion is not recommended in children under 12 years of age.
Elderly patients: As for adults.
Renal impairment: In patients with renal impairment who have a creatinine clearance of less than 30 ml/min, the dose of clarithromycin should be reduced to half the normally recommended dose.
Hepatic impairment: Clarithromycin must not be used in patients with severe hepatic insufficiency associated with renal impairment.

Method of administration
Claritromycin Altan must be administered into one of the larger proximal veins as an intravenous infusion over 60 minutes, using a solution concentration of approximately 2 mg/ml.

If you use more Claritromycin Altan than you should
Since Claritromycin Altan is administered by a doctor, overdose is unlikely. However, symptoms may include vomiting and stomach pain.

If you forget to use Claritromycin Altan
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Claritromycin Altan can cause side effects, although not everybody 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 treatment:

• severe or prolonged diarrhoea, which may contain blood or mucus. Diarrhoea may occur more than two months after treatment with clarithromycin, in which case you should still contact your doctor.
• skin rash, difficulty breathing, fainting, or swelling of the face, tongue, lips, eyes, and throat. These are signs that you may have developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, painful abdomen, or loss of appetite. These are signs that your liver may be inflamed and not functioning properly.
• severe skin reactions such as painful blistering of the skin, mouth, lips, eyes, and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• red, scaly rash with subcutaneous bumps and blisters (symptoms of exanthematous pustulosis). The frequency of this side effect is not known (cannot be estimated from available data).
• rare skin allergic reactions causing a serious illness with ulceration of the mouth, lips, and skin, leading to a severe condition with rash, fever, and inflammation of internal organs (DRESS).
• muscle pain or weakness known as rhabdomyolysis (a condition causing breakdown of muscle tissue which may lead to kidney damage).

Other side effects
Common side effects (may affect up to 1 in 10 people):

• inflammation, tenderness, or pain at the injection site
• difficulty sleeping
• changes in taste sensation
• headache
• dilation of blood vessels
• stomach problems such as nausea, vomiting, stomach ache, indigestion, diarrhoea, increased sweating

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

• high temperature
• swelling, redness, or itching of the skin
• oral or vaginal thrush (a fungal infection)
• inflammation of the stomach and intestine
• decreased platelet levels in the blood (platelets help stop bleeding)
• decreased white blood cells (leucopenia)
• decreased neutrophils (neutropia)
• stiffness
• chills
• increased eosinophils (white blood cells involved in immunity)
• exaggerated immune response to a foreign agent
• lack of appetite or 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 of a pulmonary artery (pulmonary embolism)
• inflammation of the lining of the oesophagus (oesophagitis) and stomach lining
• anal pain
• bloating, constipation, flatulence, belching
• dry mouth
• condition in which bile (a 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 rashes
• muscle spasms, muscle pain, or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which muscles become weak and tire easily), clarithromycin may worsen these symptoms.
• abnormal increase in kidney and liver function test values and increased blood test values
• feeling weak, tired, and lacking energy

Frequency not known (frequency cannot be estimated from available data)

• inflammation of the colon
• bacterial infection of the outer layers of the skin
• reduction in levels of certain blood cells (which may make infections more likely or increase the risk of bruising or bleeding)
• confusion, disorientation, hallucinations (seeing things), altered sense of reality or panic, depression, unusual dreams or nightmares, and mania (feeling of euphoria or overexcitement)
• seizures (fits)
• paraesthesia, more commonly known as "pins and needles"
• loss of taste or smell or inability to correctly perceive odours
• type of heart rhythm disorder (torsades de pointes, ventricular tachycardia)
• bleeding (haemorrhage)
• inflammation of the pancreas
• discoloration 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 or puffiness 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 Altan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or label.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
For the reconstituted solution (500 mg in 10 ml of water for infusion): it can be stored for up to 24 hours at room temperature and up to 48 hours in the refrigerator (2°C-8°C). The final reconstituted solution (reconstituted solution for infusion added to 250 ml of diluent, respectively to each diluent mentioned) can be stored for up to 24 hours at room temperature (25°C) or up to 48 hours in the refrigerator (2°C-8°C). Reconstitution of the medicinal product may take up to 3 minutes.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Claritromycin Altan contains
The active substance is clarithromycin as clarithromycin lactobionate. Each vial contains 500 mg
of clarithromycin (equivalent to 739.5 mg of clarithromycin lactobionate).
1 ml contains 25 mg of clarithromycin (equivalent to 36.98 mg of clarithromycin lactobionate).
Excipients: lactobionic acid, sodium hydroxide and water for injections.

Description of the appearance of Claritromycin Altan and contents of the pack
Claritromycin Altan is a white to off-white powder for concentrate for solution for infusion.
Pack sizes: 1 vial.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide No. 6, Portal 2, 1st Floor, Office F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain

Manufacturer
Altan Pharmaceuticals, S.A.
Avda. de la Constitución, 198-199,
Polígono Industrial Monte Boyal, Casarrubios del Monte
45950 (Toledo) Spain
MEFAR ILAC SANAYII A.S.
Ensar Caddesi 20, Ramazanoglu Mahallesi - Kurtkoy, Istanbul,
Pendik - 34906 Turkey

THE FOLLOWING INFORMATION IS INTENDED EXCLUSIVELY FOR PHYSICIANS OR

HEALTHCARE PROFESSIONALS
The recommended daily dose of intravenous clarithromycin is 1000 mg/day, divided into two equal doses of 500 mg each, infused over a period of 60 minutes after appropriate dilution. Intravenous therapy may be administered for 2 to 5 days and, if appropriate, should be followed by oral clarithromycin therapy.
Reconstitute each vial with 10 ml of sterile water for injectable preparations. Reconstitution of the medicinal product may take up to 3 minutes.
The reconstituted solution may be diluted in 250 ml of one of the following diluents:

• Sodium chloride 9 mg/ml (0.9%) solution for infusion
• Dextrose 5 mg/ml (5%) solution
• Dextrose 0.05 mg/ml (5%) in a sodium chloride infusion solution (0.003 mg/ml (0.3%) or 0.0045 mg/ml (0.45%))
• Dextrose 0.05 mg/ml (5%) in Ringer's solution
• Dextrose 0.05 mg/ml (5%) in Ringer's lactate solution

After reconstitution/dilution, solutions should be visually inspected prior to use.
Only solutions that are clear and practically free from particles should be used.
The ready-to-use infusion solution must be administered into one of the larger proximal veins as a 60-minute intravenous infusion, using a solution concentration of approximately 2 mg/ml.
The medicinal product must not be administered as a bolus or by intramuscular injection.
For the reconstituted solution (500 mg in 10 ml of water for infusion): it may be stored for up to 24 hours at room temperature and up to 48 hours under refrigeration (2°C–8°C). The final diluted solution (reconstituted solution added to 250 ml of diluent, respectively for each diluent listed) may be stored for up to 24 hours at room temperature (25°C) or up to 48 hours under refrigeration (2°C–8°C). Reconstitution of the medicinal product may take up to 3 minutes.