CIPROFLOXACIN 2 MG / ML SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

Patient leaflet - CIPROFLOXACIN 2 MG / 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 are given 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.

The name of your medicine is Ciprofloxacin 2 mg / mL Solution for infusion

In the rest of this leaflet Ciprofloxacin 2 mg / mL Solution for infusion is called Ciprofloxacin.

What is in this leaflet:

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

1. what ciprofloxacin is and what it is used for

Ciprofloxacin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

Ciprofloxacin is used in adults to treat the following bacterial infections:

respiratory tract infections
long lasting or recurring ear or sinus infections
urinary tract infections (acute pyelonephritis, bacterial prostatitis)
genital tract infections in men and women
gastro-intestinal tract infections and intra-abdominal infections
skin and soft tissue infections
infections of the bones and joints
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 given additional antibiotic treatment in addition to Ciprofloxacin.

Children and adolescents

Ciprofloxacin 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 (acute pyelonephritis)
anthrax inhalation exposure

Ciprofloxacin 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 are given ciprofloxacin

Do not take Ciprofloxacin:

if you are allergic to ciprofloxacin, to other quinolone drugs or any of the other ingredients of this medicines (listed in section 6)
if you are taking tizanidine (see Section 2: “Other medicines and Ciprofloxacin”)

Warnings and precautions

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

Talk to your doctor, pharmacist or nurse before you are given Ciprofloxacin:

if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm)
if you have experienced a previous episode of aortic dissection (a tear in the aorta wall)
if you have been diagnosed with leaking heart valves (heart valve regurgitation)
if you have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such

as Marfan syndrome or Ehlers- Danlos syndrome, Turner syndrome, Sjogren’s syndrome [an inflammatory autoimmune disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, high blood pressure, or known atherosclerosis, rheumatoid arthritis [a disease of the joints] or endocarditis [an infection of the heart]).

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
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. 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 2: “Other medicines and Ciprofloxacin”)
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:

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.

If you feel sudden, severe pain in your abdomen, chest or back, which can be symptoms of aortic aneurysm and dissection, go immediately to an emergency room. Your risk may be increased if you are being treated with systemic corticosteroids.
If you start experiencing a rapid onset of shortness of breath, especially when you lie down flat in your bed, or you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (sensation of rapid or irregular heartbeat), you should inform a doctor immediately.
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 inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping of Ciprofloxacin therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin, rest contact your doctor and 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 receiving 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 receiving Ciprofloxacin and contact your doctor immediately.
You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Ciprofloxacin and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.
Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels (hyperglycaemia), or lowering of your blood sugar levels below normal levels, potentially

leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.

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. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
Tell the doctor or laboratory staff that you are receiving Ciprofloxacin if you have to provide a blood or urine sample.
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, Ciprofloxacin must be stopped immediately.
Ciprofloxacin 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.

Prolonged, disabling and potentially irreversible serious side effects

Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Ciprofloxacin, contact your doctor immediately prior to continuing treatment. You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.

If you suffer from kidney problems, tell the doctor because your dose may need to be adjusted.

Other medicines and Ciprofloxacin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not use Ciprofloxacin together with tizanidine , because this may cause side effects such as low blood pressure and sleepiness (see Section 2: “Do not take Ciprofloxacin” ).

The following medicines are known to interact with Ciprofloxacin in your body. Using Ciprofloxacin 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 anti-coagulants (to thin the 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)
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

Ciprofloxacin 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)

Ciprofloxacin with food and drink

Food and drink does not affect your treatment with Ciprofloxacin.

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 you receive this medicine. It is preferable to avoid the use of Ciprofloxacin during pregnancy. You must not receive Ciprofloxacin during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Ciprofloxacin contains sodium

This medicine contains 707.70 mg sodium (main component of cooking/table salt) in 200 mL. This is equivalent to 35.39 % of the recommended maximum daily dietary intake of sodium for an adult. Appropriate consideration should be taken when administering this product to children. Talk to your doctor or pharmacist if you need one dose of 400 mg or more bags/bottles of 200 mL on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

3. how to use ciprofloxacin

Your doctor will explain to you exactly how much Ciprofloxacin 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

The following information is intended for medical or healthcare professionals only:

Ciprofloxacin 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 and 30 minutes for 200 mg Ciprofloxacin. 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.

Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Administering the infusion slowly helps prevent immediate side effects occurring. Remember to drink plenty of fluids while you are receiving this medicine.

If you stop receiving Ciprofloxacin , 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 further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. POSSIBLE SIDE-EFFECTS

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

Common:

may affect up to 1 in 10 people

nausea, diarrhoea, vomiting
joint pains in children
local reaction at the injection site, rash
temporary increased amounts of substances in the blood (transaminases)

Uncommon:

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)
decreased appetite
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
eyesight problems including double vision
loss of hearing
rapid heartbeat (tachycardia)
expansion of the blood vessels (vasodilation), low blood pressure
abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind
liver disorders, increased amounts of one substance in the blood (bilirubin), jaundice (cholestatic icterus)
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:

may affect up to 1 in 1,000 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, bone

marrow depression which may also be fatal (see Section 2: “Warnings and precautions”)

allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see Section 2: “Warnings and precautions”)
increased blood sugar (hyperglycemia)
decreased blood sugar (hypoglycaemia) (see Section 2: “Warnings and precautions”)
anxiety reaction, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), mental disturbances (psychotic reactions potentially leading

to thoughts of suicide, suicide attempts, or completed suicide) (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
hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure
sensitivity to light (see Section 2: “Warnings and precautions”), small, pin-point bleeding under the skin (petechiae)
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”)

blood or crystals in the urine (see Section 2: “Warnings and precautions”), urinary tract inflammation
excessive sweating
increased levels of the enzyme amylase

Very rare:

may affect up to 1 in 10,000 people

a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis)
severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which can be fatal (see Section 2: “Warnings and precautions”)
disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure and pseudotumor cerebri) ,,
visual colour distortions
various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see Section 2: “Warnings and precautions”)

Not known

frequency cannot be estimated from the available data

troubles associated with the nervous system such unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy) (see section 2: “Warnings and precautions”)
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)
Syndrome associated with impaired water excretion and low levels of sodium (SIADH)
Loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.
A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms,

AGEP Acute Generalised Exanthematous Pustulosis).

Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.

Cases of an enlargement and weakening of the aortic wall or a tear in the aortic wall (aneurysms and dissections), which may rupture and may be fatal, and of leaking heart valves have been reported in patients receiving fluoroquinolones. See also section 2.

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

For UK: Yellow Card Scheme, Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

For IE: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: ; E-mail:.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store ciprofloxacin

Keep this medicine out of the sight and reach 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 below 25°C. Do not refrigerate or freeze as crystals may form if the medicine gets too cold. If you see crystals in your medicine, do not use the medicine and tell your doctor, nurse or pharmacist immediately. Keep your medicine in the outer container in order to protect from light. Overwrapped bottles: Keep the bottles in the outer pouch in order to protect from light. To be used immediately after removing from the pouch. Bottles without overwrapping should be kept in the carton in order to protect from light. To be used immediately after removing from the carton. Open the bottle and/or bag and use the medicinal product straight away. This is a single dose container. No special precautions are required during the normal 60-minute infusion period.

Your medicine should not be mixed with certain other medicines that may also be given by infusion. Please ask your doctor, nurse or pharmacist if you want any more information about this. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. contents of the pack and other information

What Ciprofloxacin contains

– The active substance is ciprofloxacin (as lactate).

Each 100 mL contains 200 mg (milligram) of ciprofloxacin.

Each 200 mL contains 400 mg (milligram) of ciprofloxacin.

– The other ingredients are Lactic acid, Sodium Chloride, Hydrochloric Acid (for pH adjustment) and Water for Injections.

What Ciprofloxacin looks like and contents of the pack

Solution for infusion. This means it is ready to give to you in a plastic bag or bottle as an intravenous or IV infusion (drip).

Each bag or bottle of Ciprofloxacin contains 100 mL or 200 mL of your medicine.

100mL bags come in cartons of 10.

200 mL bags come in cartons of 5.

Bottles:

Each 100mL bottle is placed in a metalized plastic pouch. Packs of 10 or 20 bottles are available.

Alternatively:

100 mL bottles are placed in carton. Packs of 1, 10 or 20 bottles are available.

Each 200 mL bottle is placed in a metalized plastic pouch. Packs of 5, 10 or 20 bottles are available.

Alternatively:

200 mL bottles are placed in carton. Packs of 1, 5, 10 or 20 bottles are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Noridem Enterprises Ltd, Evagorou and Makariou, Mitsi Building 3, Office 115, 1065 Nicosia, Cyprus.

Manufacturer: DEMO S.A. PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece, T: +30 210 8161802, F: +30 210 8161587

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Ciprofloxacin 2 mg / mL Solution for infusion

Ireland: Ciprofloxacin 2 mg / mL Solution for infusion

Spain: Ciprofloxacino KERN PHARMA 2 mg/ml solucion para perfusion EFG

Greece: Ciprofloxacin/Noridem, AidAupa yia Eyxuaq 2 mg/ml

Austria: Ciprofloxacin Noridem 2 mg/ml Infusionslosung

Germany: Ciprofloxacin 2mg/ml Infusionslosung

This leaflet was last revised in 12/2020.

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: – dosage – schedules – duration of treatment

Consequently, to preserve the efficacy of this medicinal product:

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.