Ciprofloxacin 2mg/Ml Solution For Infusion
Executant: Promotion&Design Prospect: Ciprofloxacine engleza Format deschis propus: 430x305 mm Format inchis propus: 215x152 mm Suport: offset alb 60 gr Tipar: negru fata verso
• Visual colour distortions
• Skin eruptions or rashes (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Worsening ofthe symptoms of myasthenia gravis
Not known (frequency cannot be estimated from the available data):
• Changes in your heart rhythm
• Pustular rash
• Difficulty with blood clotting, particularly if you are being treated with medicines called Vitamin K antagonists
Some people develop thrush (an infection of the vagina, mouth or skin) whilst they are taking antibiotics. You can get treatment for thrush from your doctor and treatment for vaginal thrush can be obtamed from your pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also reportside effects directly via the Yellow Card Scheme at: www.mlira.gov.uk/yellowcard . By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOWTO STORE CIPROFLOXACIN INFUSION
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP": The expiry date refers to the last day of that month.
Store in the original package to protect from light. Do not refrigerate or freeze.
This medicine does not require any special storage precautions.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Ciprofloxacin Infusion contains
The active substance is ciprofloxacin (as ciprofloxacin lactate).
The other ingredients are lactic acid, glucose monohydrate, hydrochloric acid concentrated for pH adjustment and water for injections.
What Ciprofloxacin Infusion looks like and contents of the pack
Solution for infusion.
Ciprofloxacin is a clear, nearly colourless to slightly yellowish solution.
Ciprofloxacin Infusion is available in 100 ml or 200 ml PVC bags. The 100 ml bag contains 200 mg ciprofloxacin and the 200 ml bag contains 400 mg ciprofloxacin.
Pack sizes of 10 and 50 100 ml bags.
Pack sizes of 10 and 30 200 ml bags.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Infomed Fluids SRL 50 Theodor Pallady Blvd District 3 032266 Bucharest Romania
Tel:+40 21345 0222 Fax:+4021 345 3185 E-mail: office@mfomedfluids.ro
in the Member States of the EE A under the following names:
Ciprofloxacin 2 mg/ml Solution for Infusion Ciprofloxacin Infomed Infusionslosung 2 mg/ml Ciprofloxacina Infomed Cyprofloksacyna Infomed Cipro Inf 2 mg/ml solu(ie perfuzabila
Ciprofloksacin Infomed Fluids 2 mg/ml raztopina za infundiranje
This medicinal product is authorised
United Kingdom Germany Italy Poland Romania Slovenia
This leaflet was last revised in 04/2016
The following information is intended for healthcare professionals only:
Ciprofloxacin Infusion should not be mixed with injection solutions (e.g. penicillins, heparin solutions) which are chemically or physically unstable at its pH of 3.5 - 4.6. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products and should always be administered separately.
This medicinal product is for single use only.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ciprofloxacin 2 mg/ml Solution for Infusion
Ciprofloxacin 200 mg/100 ml and 400 mg/200 ml
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 or pharmacist.
• This medicine has been prescribed for you. DO NOT pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ciprofloxacin Infusion is and what it is used for
2. What you need to know before you are given Ciprofloxacin Infusion
3. How Ciprofloxacin Infusion is given
4. Possible side effects
5. How to store Ciprofloxacin Infusion
6. C ontents of the pack and other information_
1. WHAT CIPROFLOXACIN INFUSION IS AND WHAT IT IS USED FOR
Ciprofloxacin Infusion contains either 200 mg ciprofloxacin/100 ml of solution or 400 mg ciprofloxacin/200 ml of solution.
The active substance is ciprofloxacin and the other ingredients are listed in section 6.
C iprofloxacin is one of a group of medicines called antibiotics, which work by killing the bacteria that cause infections. C iprofloxacin is used to treat:
In adults
• Lung infections such as pneumonia
• Infections of the ears or sinuses
• Infections of the bladder and kidneys
• Infections of the genital organs including gonorrhoea (a sexually transmitted disease)
• Infections in the abdomen (tummy) such as travellers' diarrhoea
• Infections of the skin or the tissue under the skin
• Infections in the bones and j obits
• Infections that have spread to the blood
• Infection following exposure to anthrax In children and adolescents:
• Lung infections in children and teenagers who have cystic fibrosis.
• Infections of the bladder and kidneys
• Infection following exposure to anthrax
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CIPROFLOXACIN INFUSION!
You must not be given Ciprofloxacin Infusion:
• if you are allergic to ciprofloxacin, to any other quinolone antibiotic, or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Infusion)
If you are unsure about these, ask your doctor.
Warnings and precautions
Talk to your doctor before treatment with Ciprofloxacin Infusion:
• if you have ever had kidney problems because your treatment may need to be adjusted
• if you have ever had fits or you have epilepsy or any other condition related to your brain
• if you have had problems with your tendons following use of a quinolone antibiotic
• if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacm
• ifyouoramemberofyourfamilyisknowntohaveadeficiencyinglucose-6-phosphatedehydrogenase(G6PD),since you may experience a risk of anaemia with ciprofloxacin
• if you have a condition known as “myasthenia gravis” (a rare disorder of the nervous system that causes muscle weakness)
• if you have or have had any heart problems. Caution should be taken when using Ciprofloxacin if you were bom with or have a family history of
prolonged QT interval (see on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood) have a very slow heart rhythm (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprofloxacm Infusion)
If you have a genital tract infection your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in your symptoms after 3 days of treatment, please see your doctor.
Other medicines and Ciprofloxacin Infusion
Do not use Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: You must not be given Ciprofloxacin Infusion).
Please tell your doctor if you are taking any of the following medicines as they may interact with ciprofloxacm and lead to side-effects:
• anticoagulants (used to thin the blood) such as warfarin, acenocoumarol, phenprocoumon or fluindione
• glibenclamide (for diabetes)
• ciclosporin (used for skin conditions, rheumatoid arthritis and after organ or bone marrow transplants)
• phenytoin (for epilepsy)
• methotrexate (used to treat some tumours, psoriasis and rheumatoid arthritis)
• theophylline (for asthma)
• probenecid (for gout)
• ropinirole (for Parkinson's disease)
• tizanidme (for muscle spasticity in multiple sclerosis)
• olanzapine (anantipsychotic)
• clozapine (an antipsychotic)
• omeprazole (for indigestion, acid reflux and peptic ulcers)
• any other medicines that can alter your heart rhythm: medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilidejbutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics
C iprofloxacin may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
While you are having treatment with Ciprofloxacin Infusion
Tell your doctor immediately if any of the following occurs during treatment with Ciprofloxacin. Your doctor will decide whether treatment with Ciprofloxacin needs to be stopped.
• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin will have to be stopped.
• Pain and swelling in the joints, and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflammation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of C iprofloxacin therapy. At the first sign of any pain or inflammation C iprofloxacin will have to be stopped, rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.
• If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.
• You may experience psychiatric reactions after first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciprofloxacin and contact your doctor immediately
• Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin. You should not sunbathe or use UV tanning lamps because there is an increased risk of skin burning. You should avoid becoming dehydrated.
• Tell the doctor or laboratory staff that you are taking C iprofloxacin if you have to provide a blood or urine sample.
• Ciprofloxacin can interfere with results of laboratory tests for tuberculosis. If you are going to have a test for tuberculosis, make sure that your doctor or nurse knows that you are taking ciprofloxacin.
• Ciprofloxacin may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, C iprofloxacin must be stopped immediately.
• C iprofloxacin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
• If you suffer from kidney problems, tell your doctor because your dose may need to be adjusted.
Ciprofloxacin Infusion with food and drink
Ciprofloxacin Infusion may be taken with food or drink.
You should avoid becoming dehydrated by drinking lots of fluids e.g. water.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid the use of Ciprofloxacin Infusion during pregnancy.
C iprofloxacin Infusion should not be given during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin Infusion may make you feel less alert, dizzy or confused, particularly if taken with alcohol. Make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If you are affected, you should not drive or operate machinery.
Ask your doctor if you are unsure.
Ciprofloxacin Infusion contains glucose
This medicine contains 5 g glucose per 100 ml of infusion solution. This should be taken into account in patients with diabetes mellitus.
3. HOW CIPROFLOXACIN INFUSION IS GIVEN
Ciprofloxacin is given by slow inj ection (infusion) through a vein into the bloodstream over 30-60 minutes.
Your doctor will calculate the dose of C iprofloxacin Infusion and how long you will need to be treated. This depends upon the type of your infection.
Adults and the elderly:
The usual dose is 400 mg given 2 or 3 times a day.
If you have severe kidney problems, your doctor may give you lower doses.
The usual length of treatment is 7 to 14 days, but it may be longer if your infection is more severe. It is important that you are given a complete course of treatment, even if you begin to feel better after a few days, otherwise your symptoms may return.
Children and adolescents:
F or the treatment of a lung infection in cystic fibrosis, the usual dose is 10 mg/kg given three times a day.
The maximum daily dose is 1200 mg.
The infusion should be given over 60 minutes. The length of treatment is usually 10-14 days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS 1
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects soon after receiving the infusion, tell your doctor or nurse immediately or go to the casualty department at your nearest hospital. These are very serious side effects. 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 or you may need to go back to hospital.
Very serious side effects How many people may be affected:
May affect up to 1 in 10 people taking this medicine. May affect up to 1 in 1,000 people taking this medicine
May affect up to 1 in 1,000 people taking this medicine May affect up to 1 in 1,000 people taking this medicine
Frequency cannot be estimated from the available data
Skin rash and itching
Any sudden wheeziness, difficulty in breathing swelling of the eyelids, face or lips
Yellow colouration of the skin or the eyes
Muscle pain and/or weakness, swelling of the joints and joint pain, tightening of the muscles and cramping, pain or swelling of the tendons, which may indicate torn tendons, particularly at the back of the ankle (the Achilles' tendon) - see section 2: While you are having treatment with Ciprofloxacin Infusion
Unusual feelings of pain, burning, tingling, numbness or weakness in the muscles of your arms and legs (neuropathy) - see section 2: While you are having treatment with Ciprofloxacin Infusion
You should also tell your doctor immediately and stop taking ciprofloxacin if you notice:
May affect up to 1 in 1,000 people
May affect up to 1 in 1,000 people
Severe diarrhoea with bleeding or mucous
A feeling that you want to physically harm yourself.
The following side effects may also occur:
Very common side effects (may affect more than 1 in 10people taking this medicine):
• None have been reported.
Common side effects (may affect up to 1 in 10people taking this medicine)'.
• Nausea (feeling sick), vomiting (being sick), diarrhoea.
• Joint pains in children
• Swelling and soreness at the injection site
• Temporary increased amounts of substances in the blood (transaminases)
Uncommon side effects (may affect up to 1 in 100people taking this medicine):
• Fungal infections (such as thrush, see below)
• Loss of appetite (including anorexia)
• Hyperactivity, agitation, confusion, disorientation, hallucinations
• Headache, dizziness, sleeping problems, taste disorders
• Changes in sensitivity of the skin, phis and needles, fits (see Section 2: While you are having treatment with C iprofloxacin Infusion)
• Eyesight problems including double vision
• Loss of hearing
• Fast heartbeat (palpitations)
• Expansion of the bloodvessels (vasodilation), low blood pressure
• Stomach pain, digestive problems such as stomach upset (including indigestion/heartburn), wind
• Problems with your liver, including short-term liver problems, increased amounts of a substance called bilirubin in your blood, yellowing of the skin and eyes (jaundice)
• Hives
• Problems with your kidneys, kidney failure
• Pains in your muscles and bones, including your joints, weakness, fever, fluid retention
• Ahigh concentration of eosinophils, a type ofwhite blood cell, increased or decreased amounts of a blood clotting factor (thrombocytes)
• hicreased amounts of a substance called alkaline phosphatase in your blood Rare side effects (may affect up to 1 in 1,000people taking this medicine)'.
• Inflammation in the intestine (colitis), linked to antibiotic use (can be fatal in rare cases) (see Section 2: While you are having treatment with Ciprofloxacin Infusion)
• Hot flushes, inflammation of the bloodvessels (vasculitis), fainting
• Anxiety, nightmares, depression, having strange or suicidal thoughts (see Section 2: While you are having treatment with Ciprofloxacin Infusion)
• Reduced skin sensitivity, migraine, loss of the sense of smell, tremor
• Ringing in the ears (tinnitus), problems with your hearing
• Sensitivity to light (see Section 2: While you are having treatment with Ciprofloxacin Infusion), increased risk of sunburn, small pin-point bleeding under the skin (petechiae)
• Problems with your liver, including hepatitis and death of liver cells (liver necrosis) which may very rarely lead to life-threatening liver failure
• Problems with your kidneys
• hicreases in some types of cells in your blood or in the cells that help blood to clot
• Decreases mall types of blood cells, including a drop in the number of red and white blood cells (called pancytopenia) which may be fatal (See Section 2: While you are having treatment with Ciprofloxacin Infusion)
• Changes in some blood proteins that are needed for normal clotting
• Anaemia that is due to breaking up of red blood cells and causes yellowing of the skin and eyes
• Bone marrow depression, which can be fatal (See Section 2: While you are having treatment with Ciprofloxacin Infusion)
• Allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), serum sickness, severe allergic reaction including anaphylactic reaction, anaphylactic shock which can be life-threatening (see Section 2: While you are having treatment with Ciprofloxacin Infusion)
• Shortness of breath
• Pancreatitis
• hicreased blood sugar (hyperglycemia)
• Decreased blood sugar (hypoglycemia) (see Section 2: Warnings and precautions)
• Blood or crystals in your urine
• Excessive sweating
• hicreased levels of the enzyme amylase
Very rare side effects (may affect up to 1 in 10,000 people taking this medicine):
• A special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis)
• Disturbed coordination, unsteady walk, problems caused by pressure on the brain