Ciproxin Solution for Infusion 2mg/ml

Main information

  • Trade name:
  • Ciproxin Solution for Infusion 2mg/ml, 100ml
  • Dosage:
  • 2 milligram(s)/millilitre
  • Pharmaceutical form:
  • Solution for infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Ciproxin Solution for Infusion 2mg/ml, 100ml
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Fluoroquinolones; ciprofloxacin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA1410/028/006
  • Authorization date:
  • 20-12-1988
  • Last update:
  • 21-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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Package leaflet: Information for the patient

Ciproxin Solution for Infusion 2mg/ml, 100ml, 200ml

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 or pharmacist.

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 or pharmacist. This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

What Ciproxin is and what it is used for

What you need to know before you are given Ciproxin

How to use Ciproxin

Possible side effects

How to store Ciproxin

Contents of the pack and other information

1.

What Ciproxin is and what it is used for

Ciproxin 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

Ciproxin 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 intra-abdominal 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 given

additional antibiotic treatment in addition to Ciproxin.

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Children and adolescents

Ciproxin 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

Ciproxin 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 Ciproxin

You must not be given Ciproxin:

if you are allergic to the active substance, 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 Ciproxin)

Warnings and precautions

Talk to your doctor before you are given Ciproxin

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

Ciproxin.

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 Ciproxin).

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 anemia 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.

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While under treatment with Ciproxin

Tell your doctor immediately, if any of the following occurs

during treatment with Ciproxin

. Your doctor

will decide whether treatment with Ciproxin 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

Ciproxin 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

Ciproxin therapy. At the first sign of any pain or inflammation stop taking Ciproxin, 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 seizure happens, stop

taking Ciproxin and contact your doctor immediately.

You may experience symptoms of

neuropathy

such as pain, burning, tingling, numbness and/or

muscle weakness. If this happens, stop taking Ciproxin and contact your doctor immediately.

You may experience

psychiatric reactions

after first administration of ciprofloxacin. If you suffer

from

depression

psychosis

, your symptoms may become worse under treatment with Ciproxin.

In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or

completed suicide. If this happens, 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 Ciproxin, 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, stop taking Ciproxin and contact your doctor 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

Ciproxin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

Tell the doctor or laboratory staff that you are taking Ciproxin if you have to provide a

blood or

urine sample

If you suffer from

kidney problems

, tell the doctor because your dose may need to be adjusted.

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Ciproxin 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, contact your doctor

immediately.

Ciproxin 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.

Other medicines and Ciproxin

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

Do not use Ciproxin together with tizanidine

, because this may cause side effects such as low blood

pressure and sleepiness (see Section 2:

You must not be given Ciproxin

The following medicines are known to interact with Ciproxin in your body. Using Ciproxin 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.

zolpidem (for sleep disorders)

Ciproxin 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 anesthetic use)

sildenafil (e.g for erectile dysfunction)

agomelatine (for depression)

Ciproxin with food and drink

Food and drink does not affect your treatment with Ciproxin.

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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 Ciproxin during pregnancy.

Do not take Ciproxin during breast-feeding because ciprofloxacin is excreted in breast milk and can be

harmful for your child.

Driving and using machines

Ciproxin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure

you know how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, talk to

your doctor.

Ciproxin contains sodium

Ciproxin Solution for Infusion 2mg/ml contains 154mmol sodium per litre. The 100ml bottle contains

15.4mmol sodium (equivalent to 354mg sodium, 900mg sodium chloride) and the 200ml bottle 31 mmol

sodium (equivalent to 708mg sodium, 1800mg sodium chloride). To be taken into consideration by

patients on a controlled sodium diet.

3.

How to use Ciproxin

Your doctor will explain to you exactly how much Ciproxin 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 Ciproxin and

30 minutes for 200 mg Ciproxin. Administering the infusion slowly helps prevent immediate side effects

occurring.

Remember to drink plenty of fluids while you are taking this medicine.

If you stop your course of Ciproxin,

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 about the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

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

The following section contains the most serious side effects that you can recognize yourself:

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Stop taking Ciproxin and contact your doctor immediately

in order to consider another antibiotic

treatment if you notice any of the following serious side effects:

Uncommon

(may affect up to 1 in 100 people)

Seizure (see Section 2: Warnings and precautions)

Rare

(may affect up to 1 in 1,000 people)

Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or

faint, or experience dizziness when standing up (anaphylactic shock) (see Section 2: Warnings and

precautions)

Tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon)

(see Section 2: Warnings and precautions)

Very rare

(may affect up to 1 in 10,000 people)

Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or

faint, or experience dizziness when standing up (anaphylactic reaction) (see Section 2: Warnings

and precautions)

Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon,

particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2:

Warnings and precautions)

A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat,

nose, eyes and other mucous membranes such as genitals which may progress to widespread

blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Not known

(frequency cannot be estimated from the available data)

Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities

(neuropathy) (see Section 2: Warnings and precautions)

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).

Other side effects which have been observed during treatment with Ciproxin are listed below by how

likely they are:

Common

(may affect up to 1 in 10 people)

nausea, diarrhoea, vomiting

joint pain and joint inflammation 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)

joint pain in adults

fungal superinfections

a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a

blood clotting 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, giddiness

eyesight problems including double vision

loss of hearing

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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

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)

muscle pain, inflammation of the joints, increased muscle tone and cramping

inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very 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

allergic reaction, allergic swelling (oedema), rapid swelling of the skin and mucous membranes

(angiooedema) (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 (see

Section 2: Warnings and precautions)

sensitivity to light (see Section 2: Warnings and precautions), small, pin-point bleeding under the

skin (petechiae)

blood or crystals in the urine, 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) (see Section 2: Warnings and precautions)

allergic reaction called serum sickness-like reaction (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

worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

Not known

(frequency cannot be estimated from the available data)

feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

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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)

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 HPRA Pharmacovigilance, Earlsfort

Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:

medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this

medicine.

5.

How to store Ciproxin

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 and the bottle after "EXP": The

expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light. Do not refrigerate or freeze.

At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature

(15 °C - 25 °C).

Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (15 °C to

25 °C). From a microbiological point of view, unless the method of opening and mixing with co-infusion

solutions precludes the risk of microbial contamination, the product should be used immediately. If not

used immediately, in-use storage times and conditions are the responsibility of the user.

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 Ciproxin contains

The active substance is ciprofloxacin.

Each glass bottle with 100 mL infusion solution contains 200 mg of ciprofloxacin.

Each glass bottle with 200 mL infusion solution contains 400 mg of ciprofloxacin.

The other ingredients are: lactic acid solution 20%, sodium chloride, hydrochloric acid concentrated, water

for injections

What Ciproxin looks like and contents of the pack

Solution for infusion

Clear, nearly colourless to slightly yellowish solution.

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Pack sizes of 1, 5 or 40 bottles containing 100 mL of solution for infusion each

Pack sizes of 1 or 5 bottles containing 200 mL of solution for infusion each

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Product Authorisation Holder:

Bayer Limited

The Atrium,

Blackthorn Road,

Dublin 18.

Manufacturer:

Bayer Pharma AG,

D-51368 Leverkusen,

Germany

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

Austria:

Ciproxin

Belgium:

Ciproxine

Cyprus

Ciproxin

France:

Ciflox

Germany:

Ciprobay

Greece:

Ciproxin

Ireland:

Ciproxin

Italy:

Ciproxin

Luxembourg:

Ciproxine

Malta:

Ciproxin

Portugal:

Ciproxina

Slovenia:

Ciprobay

United Kingdom:

Ciproxin

This leaflet was last revised in [To be inserted upon approval]

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:

dosage

schedules

duration of treatment

Consequently, to preserve the efficacy of this drug:

1 - Use antibiotics only when prescribed.

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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

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The following information is intended for medical or healthcare professionals only

Ciproxin 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 Ciproxin and 30 minutes for 200 mg Ciproxin.

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.