Clarithromycin 500 Mg Powder For Solution For Infusion
PIL-572UK_CLAR_V5_PIL-572UK_CLAR_V1 19/01/2015 09:44 Page 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clarithromycin 500mg Powder for Solution for Infusion
Pharmacode
Clarithromycin
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do NOT pass it on to others.
It may harm them even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
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What is in this leaflet:
1. What Clarithromycin Infusion is and what it is used for
2. What you need to know before you are given Clarithromycin Infusion
3. How Clarithromycin Infusion is given
4. Possible side effects
5. How to store Clarithromycin Infusion
6. Contents of the pack and other information
The name of your medicine is “Clarithromycin 500mg Powder for Solution for Infusion" (referred to as Clarithromycin Infusion throughout this leaflet).
1. WHAT CLARITHROMYCIN INFUSION IS AND WHAT IT IS USED FOR_
Your medicine contains the active substance clarithromycin, which is one of a group of medicines called “macrolide antibiotics". These are used to kill the bacteria or 'germs' that cause infections.
Your doctor has decided to give you Clarithromycin Infusion to treat:
• A chest infection such as bronchitis or pneumonia
• A throat or sinus infection
• A skin or soft tissue infection.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE QVEN CLARITHROMYCIN INFUSION
You should not be given Clarithromycin Infusion if:
• you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6)
• you have a history of heart rhythm problems
• you have low levels of potassium in your blood
• you have severe liver failure as well as kidney problems
• you are taking certain other medicines -see "Other medicines and Clarithromycin Infusion ".
If you are unsure, talk to your doctor or nurse.
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before treatment with Clarithromycin
Infusion:
• if you are pregnant
• if you have severe kidney problems
• if you have liver problems
• if you have "myasthenia gravis" (resulting in muscle weakness)
• if you have heart disease , a slow heart beat or a history of heart rhythm problems.
Other medicines and Clarithromycin Infusion
Do not take Clarithromycin Infusion if you are taking any of the following medicines:
• ergotamine or dihydroergotamine (for migraine headaches)
• cisapride (for stomach problems)
• terfenadine or astemizole (for hayfever or allergies)
• pimozide (for schizophrenia)
• simvastatin or lovastatin (used to reduce cholesterol)
• ticagrelor or ranolazine (for heart problems and angina)
• colchicine (usually taken for gout).
Tell your doctor or nurse if you are taking any of the following medicines:
• rifampicin, rifapentine (antibiotics)
• fluconazole or itraconazole (anti-fungals)
• cilostazol (for poor circulation)
• digoxin, disopyramide or quinidine (medicines for certain heart conditions)
• warfarin (used to "thin" the blood)
• carbamazepine, phenobarbital, valproate or phenytoin (for epilepsy)
• theophylline (used to treat asthma)
• alprazolam, triazolam or midazolam (make you feel sleepy before an operation)
• cyclosporine (suppresses the immune system)
• zidovudine (anti-viral agent)
• ritonavir, efavirenz, nevirapine, atazanavir, saquinavir,etravirine (anti-HIV medicine)
• rifabutin (used to treat some infections)
• tacrolimus and sirolimus (for organ transplants)
• methylprednisolone (a corticosteroid)
• omeprazole (for stomach ulcers and indigestion)
• sildenafil, tadalafil, and vardenafil (for erectile dysfunction)
• vinblastine (for treatment of cancer)
• aminoglycoside antibiotics (e.g. gentamycin, neomycin)
• statins (used to reduce cholesterol)
• tolterodine (for urinary incontinence)
• verapamil, amlodipine, diltiazem (for high blood pressure and angina)
• insulin, nateglinide, pioglitazone, repaglinide and rosiglitazone (used for diabetes)
• the herbal remedy, St. Johns Wort.
Tell your doctor or nurse if you are taking, have recently taken or might take other medicines.
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you must tell your doctor or nurse before you are given this medicine.
Driving and using machines
After taking this medicine, you may suffer dizziness, vertigo, confusion, and disorientation. If these side effects occur, you should not drive or use machines.
3. HOW CLARITHROMYCIN INFUSION IS GIVEN
Clarithromycin Infusion will usually be given by a doctor or nurse by an intravenous infusion ('drip').
The infusion is prepared by dissolving the powder in sterile water. The solution obtained is added to a larger volume of sterile liquid, and this is then infused (like being given a blood transfusion) into one of your veins for at least an hour.
Adults
The usual dose is 1 gram per day given in two doses, for 2-5 days.
Patients with kidney problems may be given a smaller dose.
The correct dose will be decided by your doctor.
Children and adolescents under 18 years
should not be given Clarithromycin Infusion.
If you have any further questions on the use of this medicine, ask your doctor, phamacist or nurse.
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INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only.
Instructions for use and handling:
Reconstitute each vial of Clarithromycin 500mg Powder for Solution for Infusion with 10ml sterile water for injections (final volume: 10.75ml). The reconstituted solution can be diluted in 250ml of the following diluents:
• 0.9% sodium chloride solution
• 5% dextrose solution
• 5% dextrose in 0.3% or 0.45% sodium chloride solution
• 5% dextrose in Ringers solution
• 5% dextrose in Ringers Lactate solution.
Clarithromycin 500mg Powder for Solution for Infusion should be administered into one of the larger proximal veins as an IV infusion over 60 minutes, using a solution concentration of about 2mg/ml. Clarithromycin should not be given as a bolus or an intramuscular injection.
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| 4. POSSIBLE SIDE EFFECTS
Like all medicines, Clarithromycin Infusion can cause side effects, although not everybody gets them.
If you get any of the following side effects soon after receiving this medicine, tell your doctor or nurse immediately. If you get them, you may have had a serious allergic reaction or other type of reaction to this medicine. You may need urgent medical attention:
• skin rash and itching
• peeling, blistering or crusting of the skin
• ulcers on the skin or in the mouth
• any sudden wheeziness, difficulty in breathing
• yellow colouration of the skin or the eyes (jaundice)
• anorexia, dark urine, tender abdomen (signs of liver disease).
If you develop severe or prolonged diarrhoea, which may have blood or mucus in it, tell your doctor or nurse immediately.
Other side effects that can occur are as follows:
Very common side effects (probably
affecting more than 1 in 10 patients)
• inflammation and swelling at the site of injection.
Common side effects (probably affecting fewer than 1 in 10 patients)
• rash
• increased sweating
• nausea (feeling sick), vomiting (being sick), tummy pain, and diarrhoea
• pain at the site of injection
• headache
• taste perversion
• changes in liver function tests
• widening of blood vessels (causing redness)
• difficulty sleeping
Uncommon side effects (probably affecting fewer than 1 in 100 patients)
• infections e.g. vaginal infections, fungal infections, gastroenteritis
• cellulitis (bacterial infection of the skin).
• changes in the number of white blood cells
• increased number of blood platelets
• allergic reactions (see above)
• anorexia, decreased appetite
• anxiety, nervousness
• screaming
• loss of consciousness
• abnormal muscle movements
• dizziness
• drowsiness
• tremor
• vertigo
• hearing problems
• "ringing" in the ears
• heart attack
• changes in heart rhythm
• palpitations
• asthma
• nose bleed
• blockage of pulmonary artery
• inflammation of the esophagus
• acid reflux
• inflammation of stomach lining
• rectal pain
• mouth or lip sores
• tongue inflamed
• abdominal bloating
• constipation
• dry mouth
• wind, belching
• build up of bile in the liver
• hepatitis
• increased liver enzymes
• dermatitis
• itching (pruritis)
• nettle rash (hives)
• red rash with swelling
• muscle spasms and stiffness
• muscle pain
• increased levels of creatinine and urea in the blood
• generally feeling unwell
• fever
• weakness
• chest pain, chills, tiredness (fatigue)
• altered protein levels in the blood
• increased levels of certain enzymes in the blood.
Side effects occurring with unknown frequency
• severe or prolonged diarrhoea, which may contain blood or mucus (see above)
• skin infections
• reduced number of blood platelets
• reduced number of white blood cells
• reduced blood sugar levels
• hallucinations (seeing things), bad dreams
• confusion, change in sense of reality, and panicking
• loss of sense of taste or smell
• deafness
• inflamed eyes
• fast heart rate
• blood taking longer to clot after a cut to the skin
• convulsions (fits)
• inflammation of the pancreas
• tooth or tongue discolouration
• liver failure and jaundice (see above)
• acne
• rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis (which causes severe illness with ulceration of the mouth, lips and skin)
• rare allergic reaction which causes swelling of the face or throat
• progressive muscle weakness
• loss of muscle tissue
• kidney failure
• inflammation of kidney
• abnormal urine colour.
• pins and needles.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CLARITHROMYCIN INFUSION_
Keep this medicine out of the sight and reach of children.
Do not use Clarithromycin Infusion after the expiry date which is printed on the label and carton after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Your doctor, pharmacist or nurse will know how to store Clarithromycin Infusion properly.
6 CONTENTS OF THE PACK AND OTHER INFORMATION
What Clarithromycin Infusion contains
• The active substance is Clarithromycin 500mg
• The other ingredient is Lactobionic acid.
What Clarithromycin Infusion looks like and contents of the pack:
Clarithromycin Infusion is a vial containing a white to off-white powder.
Each vial contains 500mg clarithromycin.
Each carton contains 1 or 5 vials.
Marketing Authorisation Holder:
Ibigen Srl.
Via Fossignano, 2, 04011 Aprilia (LT), Italy Manufacturer:
Laboratorios Alcala Farma S.L., Madrid, Spain This leaflet was last revised in 01/2015.
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For single use only. The vial and any unused solution should be disposed of in accordance with local requirements.
Storage precautions: Store below 25°C Shelf life:
Unopened vial: 48 months.
Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 5 - 25°C when reconstituted in 10ml water for injections, and for 6 hours (at 25°C) or 24 hours (at 5°C) once diluted in 250ml of appropriate diluent.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.