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CIPROFLOXACIN 250 MG/5 ML GRANULES AND SOLVENT FOR ORAL SUSPENSION

Active substance(s): CIPROFLOXACIN / CIPROFLOXACIN / CIPROFLOXACIN

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ciproxin® 250 mg/5 ml granules and solvent for oral suspension /
Ciprofloxacin 250 mg/5 ml granules and solvent for oral suspension
(ciprofloxacin)
This product is available using either of the above names but will be referred to as Ciproxin
throughout the following leaflet.
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.
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
1.
2.
3.
4.
5.
6.

What Ciproxin is and what it is used for
What you need to know before you take Ciproxin
How to take 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
 to prevent infections due to the bacterium Neisseria meningitidis
 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.
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 take Ciproxin
Do not take 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 taking 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 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 taking Ciproxin
Tell your doctor immediately, if any of the following occurs while taking 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 small chance that you may experience a severe
allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick
or faint, or experiencing dizziness when standing up. If this happens, stop taking
Ciproxin and contact your doctor immediately.
 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 the first time you take Ciproxin. If you
suffer from depression or 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 taking antibiotics, including Ciproxin, or even
several weeks after you have stopped taking 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 when taking
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.
 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 take Ciproxin together with tizanidine, because this may cause side effects such
as low blood pressure and sleepiness (see Section 2: Do not take Ciproxin).
The following medicines are known to interact with Ciproxin in your body. Taking Ciproxin
together with these medicines can influence the therapeutic effect of those 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 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)
 metoclopramide (for nausea and vomiting)
 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 anaesthetic use)
 sildenafil (e.g. for erectile dysfunction)
 agomelatine (for depression)
Some medicines reduce the effect of Ciproxin. Tell your doctor if you take or wish to take:
 antacids
 omeprazole
 mineral supplements
 sucralfate
 a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
 medicines or supplements containing calcium, magnesium, aluminium or iron
If these preparations are essential, take Ciproxin about two hours before or no sooner than
four hours after them.
Ciproxin with food and drink
Unless you take Ciproxin during meals, do not eat or drink any dairy products (such as milk
or yoghurt) or drinks with added calcium when you take the suspension, as they may affect
the absorption of the active substance.
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 sucrose
If you are sucrose intolerant, please consult your doctor before taking Ciproxin 250 mg/5 ml
granules and solvent for oral suspension. As Ciproxin contains 1.4 g sucrose per 5-ml
measuring spoonful, this has to be taken into consideration in terms of daily intake,
particularly if you are on a diabetic diet to control your blood sugar level. This product can
be harmful to teeth.
3. How to take Ciproxin
Your doctor will explain to you exactly how much Ciproxin you will have to take 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.
The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure how to take Ciproxin.
Preparing and taking the suspension
Use only after reconstitution: the small amber bottle contains granules of ciprofloxacin. Add
them to the solvent in the larger white bottle
1.

The product comes in 2 bottles, a small amber bottle and a
larger white bottle. The small amber bottle contains granules
which you add to the solvent in the larger white bottle.

2.

Open both bottles. Press down the child-proof cap and turn it
to the left.

3.

Empty the small amber bottle containing the granules into the
opening of the larger white bottle with the solvent. Do not add
any water to the solvent. Discard the empty small amber
bottle.

4.

Close the white bottle with the solvent and added granules,
turn it on its side and shake vigorously for about 15 seconds.

5.
6.

Shake it vigorously for about 15 seconds before each dose.
Enter the expiry date after reconstitution (= reconstitution date + 14 days) in the
relevant field on the white solvent bottle. The reconstituted suspension is stable for no
more than 14 days even when stored in a refrigerator
7. Do try to take the suspension at around the same time every day.
8. Always use the measuring spoon provided. The full spoon will give you a dose of 250
mg Ciproxin.
9. Do not chew the granules present in the suspension, simply swallow them
10. A glass of water may be taken after taking the dose.
11. You can take the suspension at mealtimes or in between meals. Any calcium you take
as part of a meal will not seriously affect uptake. However, do not take Ciproxin with
dairy products such as milk or yoghurt or with fortified fruit-juice (e.g. calcium-fortified
orange-juice).
Remember to drink plenty of fluids while you are taking this medicine.
If you take more Ciproxin than you should
If you take more than the prescribed dose, get medical help immediately. If possible, take
the oral suspension or the box with you to show the doctor.
If you forget to take Ciproxin
Take the normal dose as soon as possible and then continue as prescribed. However, if it
is almost time for your next dose, do not take the missed dose and continue as usual. Do
not take a double dose to make up for a forgotten dose. Be sure to complete your course of
treatment.
If you stop taking 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 taking 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:
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:
Rare (may affect up to 1 in 1,000 people)
 Seizure (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/shock) (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
 joint pain and joint inflammation in children
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
 decreased appetite
 hyperactivity or agitation
 headache, dizziness, sleeping problems, or taste disorders
 vomiting, abdominal pain, digestive problems such as stomach upset
(indigestion/heartburn), or wind
 increased amounts of certain substances in the blood (transaminases and/or bilirubin)
 rash, itching, or hives
 poor kidney function
 pains in your muscles and bones, feeling unwell (asthenia), or fever
 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),
increased or decreased amounts of a blood clotting factor (thrombocytes)
 allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous
membranes (angio-oedema) (see Section 2: Warnings and precautions)
 increased blood sugar (hyperglycaemia)




decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)
confusion, disorientation, anxiety reactions, strange dreams, depression (potentially
leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2:
Warnings and precautions), or hallucinations
 pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity,
tremors, or giddiness
 eyesight problems including double vision (see Section 2: Warnings and precautions)
 tinnitus, loss of hearing, impaired hearing
 rapid heartbeat (tachycardia)
 expansion of blood vessels (vasodilation), low blood pressure, or fainting
 shortness of breath, including asthmatic symptoms
 liver disorders, jaundice (cholestatic icterus), or hepatitis
 sensitivity to light (see Section 2: Warnings and precautions)
 kidney failure, blood or crystals in the urine, urinary tract inflammation
 fluid retention or 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); a drop in the number of red and white blood cells and platelets
(pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal
 allergic reaction called serum sickness-like reaction (see Section 2: Warnings and
precautions)
 mental disturbances (psychotic reactions potentially leading to thoughts of suicide,
suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)
 migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of
smell (olfactory disorders), pressure on the brain (intracranial pressure and
pseudotumor cerebri)
 visual colour distortions
 inflammation of the wall of the blood vessels (vasculitis)
 pancreatitis
 death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure (see
Section 2: Warnings and precautions)
 small, pin-point bleeding under the skin (petechiae); 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)
 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 the Yellow
Card Scheme, Website: 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 Ciproxin
 Keep out of the sight and reach of children.
 Do not use this medicine after the expiry date, which is stated on the carton and bottles
after “EXP”: The expiry date refers to the last day of that month.
 When reconstituted, the ready-to-use oral suspension is stable only for 14 days when
stored either at ambient temperatures up to 30°C or in a refrigerator (2°C-8°C). After
this time, the reconstituted oral suspension should not be taken. Protect the
reconstituted oral suspension from freezing.
Granules:
 Do not store above 25°C.
Solvent:
 Do not store above 25°C.
 Protect from freezing. Avoid inverted storage.
 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.
 If your medicine becomes discoloured or show signs of any deterioration, consult your
doctor or pharmacist who will tell you what to do
6. Contents of the pack and other information
What Ciproxin contains
The active substance is ciprofloxacin.
1 measuring spoonful (approx 5.0 ml suspension) provides approx. 250 mg ciprofloxacin.
1/2 measuring spoonful (approx 2.5 ml suspension) provides approx. 125 mg ciprofloxacin.
The other ingredients are:
Granules: hypromellose, magnesium stearate, polyacrylate dispersion 30 %, polysorbate
20, povidone.
Solvent: Soya lecithin, medium chain triglycerides, strawberry flavour, sucrose, purified
water.
What Ciproxin looks like and contents of the pack
Granules and solvent for oral suspension.
Pack size:
One amber glass bottle containing 7.95 g white to slightly yellow granules and one white
HDPE bottle containing 93 ml of strawberry flavoured white to slightly yellow solvent. The
pack is provided with a blue plastic graduated measuring spoon.
PL: 15814/1160
POM
Manufactured by Bayer Healthcare Manufacturing S.r.l., Garbagnate Milanese, Italy.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
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
Leaflet revision and issue date (Ref.): 10.02.2017.
Ciproxin is a registered trademark of Bayer AG, Germany.

To request a copy of this leaflet in Braille, large
print or audio please call 01923 332 796.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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