Ciprofloxacin 2mg/Ml Solution For Infusion
Package leaflet: Information for the user
Ciprofloxacin 2 mg/ml Solution for Infusion
Ciprofloxacin
Read all of this leaflet carefully before you start taking 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 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.
What is in this leaflet:
1. What Ciprofloxacin 2 mg/ml Solution for Infusion is and what it is used for
2. What you need to know before you are given Ciprofloxacin 2 mg/ml Solution for Infusion
3. How to use Ciprofloxacin 2 mg/ml Solution for Infusion
4. Possible side effects
5. How to store Ciprofloxacin 2 mg/ml Solution for Infusion
6. Contents of the pack and other information
1. What Ciprofloxacin 2 mg/ml Solution for Infusion is and what it is used for
Ciprofloxacin 2 mg/ml Solution for Infusion is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.
Adults
Ciprofloxacin 2 mg/ml Solution for Infusion is used in adults to treat the following bacterial infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections.
• genital tract infections in men and women
• gastro-intestinal tract infections and intraabdominal infections
• skin and soft tissue infections
• bone and joint infections
• anthrax inhalation exposure
Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.
If you have a severe infection or one that is caused by more than one type of bacterium, you may be iven additional antibiotic treatment in addition to iprofloxacin 2 mg/ml Solution for Infusion.
Children and adolescents
Ciprofloxacin 2 mg/ml Solution for Infusion is used in children and adolescents under specialist medical supervision, to treat the following bacterial infections:
• lung and bronchial infections in children and adolescents suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• anthrax inhalation exposure
Ciprofloxacin 2 mg/ml Solution for Infusion may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.
2. What you need to know before you take Ciprofloxacin 2 mg/ml Solution for Infusion
You must not be given Ciprofloxacin 2 mg/ml Solution for Infusion:
- if you are allergic to the active substance ciprofloxacin, to other quinolone drugs 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 2 mg/ml Solution for Infusion )
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Ciprofloxacin 2 mg/ml Solution for Infusion
• if you have ever had kidney problems because your treatment may need to be adjusted
• if you suffer from epilepsy or other neurological conditions if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin 2 mg/ml Solution for Infusion,
• if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin.
if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.
• if you have heart problems (arrythmias). Caution should be taken when using Ciprofloxacin, if you were born with or have family history of prolonged QT interval (seen 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 Other medicines and Ciprofloxacin 2 mg/ml Solution for Infusion).
• If you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
While under treatment with Ciprofloxacin 2 mg/ml Solution for Infusion
Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin 2 mg/ml Solution for Ihfusion. Your doctor will decide whether treatment with Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion 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 Ciprofloxacin therapy. At the first sign of any pain or inflammation Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide If this happens, stop taking Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion, 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 2 mg/ml Solution for Infusion treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• Tell the doctor or laboratory staff that you are taking Ciprofloxacin 2 mg/ml Solution for Infusion if you have to provide a blood or urine sample.
• Ciprofloxacin 2 mg/ml Solution for Infusion 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, Ciprofloxacin 2 mg/ml Solution for Infusion must be stopped immediately.
• Ciprofloxacin 2 mg/ml Solution for Infusion 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.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin 2 mg/ml Solution for Infusion. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
• If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.
Other medicines and Ciprofloxacin 2 mg/ml Solution for Infusion:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are taking other medicines that can alter your heart rhythm:
• medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.
Do not use Ciprofloxacin 2 mg/ml Solution for Infusion 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 2 mg/ml Solution for Infusion if you are").
The following medicines are known to interact with Ciprofloxacin 2 mg/ml Solution for Infusion in your body. Using Ciprofloxacin 2 mg/ml Solution for Infusion together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.
Tell your doctor if you are taking:
• Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin blood)
• probenecid (for gout)
• methotrexate, (for certain types of cancer, psoriasis, rheumatoid arthritis).
• theophylline, (for breathing problems)
• tizanidine, (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy).
• cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
Ciprofloxacin 2 mg/ml Solution for Infusion may increase the levels of the following medicines in your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or incontinence)
• I idocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
Taking Ciprofloxacin 2mg/ml Solution for Infusion with food and drink
Food and drink does not affect your treatment with Ciprofloxacin 2 mg/ml Solution for Infusion.
Pregnancy and breast-feeding
It is preferable to avoid the use of Ciprofloxacin 2 mg/ml Solution for Infusion during pregnancy. Tell your doctor if you are planning to get pregnant.
Do not take Ciprofloxacin 2 mg/ml Solution for Infusion during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Driving and using machines
Ciprofloxacin 2 mg/ml Solution for Infusion may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin 2 mg/ml Solution for Infusion before driving a vehicle or operating machinery. If in doubt, talk to your doctor.
Important information about some of the ingredients of Ciprofloxacin 2 mg/ml Solution for Infusion
This medicinal product contains 177/354/708 mg (7.7/15.4/30.8 mmol) sodium per 50/100/200 milliliter of solution.
To be taken into consideration by patients on a controlled sodium diet.
3. How to take Ciprofloxacin 2mg/ml Solution for Infusion
Your doctor will explain to you exactly how much Ciprofloxacin 2 mg/ml Solution for Infusion you will be given as well as how often and for how long.
This will depend on the type of infection you have and how bad it is.
Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.
Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin 2 mg/ml Solution for Infusion and30 minutes for 200 mg Ciprofloxacin 2 mg/ml Solution for Infusion. Administering the infusion slowly helps prevent immediate side effects occurring.
Remember to drink plenty of fluids while you are taking Ciprofloxacin 2mg/ml Solution for Infusion.
If you stop your course of Ciprofloxacin 2 mg/ml Solution for Infusion
> It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.
If you have any more questions about the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
See your doctor immediately if you notice any of the following side effects during treatment with Ciprofloxacin, which may be serious, and for which you may need urgent medical treatment:
• 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 2 mg/ml Solution for Infusion will have to be stopped.
• Muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tone and cramping, inflammation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions).
• Sudden onset of a severe rash or blistering or peeling skin, which may be associated with a high fever and joint pains. These may indicate severe, sometimes life-threatening reactions (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Psychiatric reactions after first administration of ciprofloxacin. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin 2 mg/ ml Solution for Infusion. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciprofloxacin 2 mg/ml Solution for Infusion and contact your doctor immediately.
• Symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If
this happens, stop taking Ciprofloxacin 2 mg/ ml Solution for Infusion and contact your doctor immediately.
• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin 2 mg/ml Solution for Infusion, 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 2 mg/ml Solution for Infusion treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• Ciprofloxacin 2 mg/ml Solution for Infusion 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, Ciprofloxacin 2 mg/ml Solution for Infusion must be stopped immediately.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
Other side effects may occur. If any of the following occurs during treatment with Ciprofloxacin.
Tell your doctor as soon as possible.
Common side effects (may affect up to 1 in 10 people):
- nausea, vomiting
- joint pains in children
- local reaction at the injection site, rash
- temporary increased amounts of substances in the blood (transaminases)
Uncommon side effects (may affect up to 1 in
100 people):
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood cloting factor (thrombocytes)
- loss of appetite (anorexia)
- hyperactivity, agitation, confusion, disorientation, hallucinations
- headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, seizures (see Section 2: Warnings and precautions), giddiness
- loss of nearing
- rapid heartbeat (tachycardia)
- expansion of the blood vessels (vasodilation), low blood pressure
- abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind
- itching, hives
- joint pain in adults
- poor kidney function, kidney failure
- pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention
- increase in blood alkaline phosphatase (a certain substance in the blood)
Rare side effects (may affect up to 1 in 1000 people):
- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see Section 2: Warnings and precautions)
- changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bonemarrow depression which may also be fatal (see Section
2: Warnings and precautions)
- increased blood sugar (hyperglycemia)
- decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)
- decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders)
- tinnitus, impaired hearing
- fainting, inflammation of the blood vessel (vasculitis)
- shortness of breath including asthmatic symptoms
- pancreatitis
- sensitivity to light (see Section 2: Warnings and precautions), small, pin-point bleeding under the skin (petechiae)
- blood or crystals in the urine (see Section 2: Warnings and precautions), urinary tract inflammation
- excessive sweating
Very rare side effects (may affect up to 1 in
10000 people):
- 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 (gait disturbance), pressure on the brain (intracranial pressure and pseudotumor cerebri)
- visual colour distortions
- muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)
Frequency not known (cannot be estimated from the available data)
- Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called 'prolongation of QT interval', seen on ECG, electrical activity of the heart)
- pustular rash
- influence on blood clotting (in patients treated with Vitamin K antagonists)
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 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 Ciprofloxacin 2 mg/ml Solution for Infusion
Keep out of the sight and reach of children.
Do not use Ciprofloxacin 2 mg/ml Solution for Infusion after the expiry date which is stated on the carton after "EXP": The expiry date refers to the last day of that month.
Do not refrigerate or freeze.
Keep the container in the outer carton in order to protect from light.
Do not throw away any medicinesvia wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Ciprofloxacin 2 mg/ml Solution for Infusion contains
The active ingredient is ciprofloxacin (as ciprofloxacin lactate).
1 ml solution for infusion contains 2 mg of Ciprofloxacin (as lactate).
The other ingredients are: Lactic Acid (90%), Sodium Chloride, Hydrochloric Acid 1N, Water for Injections.
What Ciprofloxacin 2 mg/ml Solution for Infusion looks like and contents of the pack
Ciprofloxacin 2mg/ml Solution for Infusion is supplied in a transparent Type I glass vial with rubber stopper and aluminium cap. The appearance of the product is a clear yellowish to slightly yellow, odourless solution free from foreign bodies with a pH 3.9 - 4.5.
Pack sizes:
One vial with
50 ml solution for infusion contains 100 mg ciprofloxacin (as lactate).
100 ml solution for infusion contains 200 mg ciprofloxacin (as lactate).
200 ml solution for infusion contains 400 mg ciprofloxacin (as lactate).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder(s)
For United Kingdom:
Pharmathen S.A., 153 51, Pallini-Attiki, Greece tel.: +30.210.6665067 fax: +30.210.6666749 e-mail: info@pharmathen.com
For Greece
Pharmathen Hellas S.A., 153 51, Pallini, Attiki Tel.: +30 210 66 64 805 Fax: +30 210 66 64 804 E-mail: info@pharmathen.com
Manufacturer(s)
Pharmathen S.A., 153 51, Pallini-Attiki, Greece tel.: +30.210.6665067 fax: +30.210.6666749 e-mail: info@pharmathen.com
And
ANFARM HELLAS S.A., Sximatari Viotias, Sximatari Viotias 32009, Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
Greece Ladinin
United Kingdom Ciprofloxacin 2mg/ml Solution for Infusion
This leaflet was last revised in 09/2016.
Detailed information on this medicine is available on the web site of MA.
Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:
- dosages
- schedules
- duration of treatment
Consequently, to preserve the efficacy of this drug:
1 - Use antibiotics only when prescribed.
2 - Strictly follow the prescription.
3 - Do not re-use an antibiotic without medical
prescription, even if you want to treat a similar illness.
4 - Never give your antibiotic to another person;
maybe it is not adapted to her/his illness.
5 - After completion of treatment, return all unused
drugs to your chemist's shop to ensure they will be disposed of correctly.
The following information is intended for medical or healthcare professionals only:
Ciprofloxacin 2 mg/ml Solution for Infusion should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin 2 mg/ml Solution for Infusion and 30 minutes for 200 mg Ciprofloxacin 2 mg/ml Solution for Infusion. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.
Unless compatibility with other infusion solutions/ drugs has been confirmed, the infusion solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.
Incompatibility appears with all infusion solutions/ drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.9-4.5).
After intravenous initiation of treatment, the treatment can be continued orally as well.