CIPROXIN 500 MG FILM-COATED TABLETS

Active substance: CIPROFLOXACIN

View full screen / Print PDF » Download PDF ⇩

Transcript
®

Ciproxin 500 mg film-coated
tablets
Ciprofloxacin 500 mg film-coated
tablets

2427
21.05.14[5]

-

(ciprofloxacin hydrochloride)
PATIENT INFORMATION LEAFLET
Your medicine is available using any one of the above names but will be
referred to as Ciproxin throughout the leaflet.
Ciproxin is also available in other strengths.

-

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. What Ciproxin is and what it is used for
2. What you need to know before you take Ciproxin
3. How to take Ciproxin
4. Possible side effects
5. How to store Ciproxin
6. 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 (hypersensitive) 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 you 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: 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 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 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, stop taking Ciproxin 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
Ciproxin and contact your doctor immediately.
Hypoglycaemia 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 immediately, as this can be life-threatening.
Do not take medicines that stop or slow down bowel movements and
contact your doctor.
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, stop taking Ciproxin and 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.
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.

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.
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)
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 the 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 tablets, 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.
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 many
tablets to take and how to take Ciproxin.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets because
they do not taste nice.
b. Do try to take the tablets at around the same time every day.

c. You can take the tablets at mealtimes or between meals. Any calcium
you take as part of a meal will not seriously affect uptake. However, do
not take Ciproxin tablets with dairy products such as milk or yoghurt or
with fortified fruit juices (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 your tablets 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.

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 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 CIPROXIN
Keep out of the sight and reach of children.
Do not use Ciproxin after the expiry date, which is stated on the blister and
carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
If the tablets become discoloured or show signs of any deterioration, you
should seek the advice of your pharmacist who will advise you what to do.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ciproxin contains
Each film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride).
Also contain maize starch, microcrystalline cellulose, povidone, colloidal
silicon dioxide, magnesium stearate, hydroxypropyl methylcellullose,
macrogol 4000 and titanium dioxide (E171).

Common:
may affect up to 1 in 10 people
- nausea, diarrhoea
- joint pains in children

What Ciproxin looks like and contents of the pack
Ciproxin tablets are oblong, nearly white to slightly yellowish tablets marked
with “CIP score 500” on one side and “BAYER” on the reverse side.
The tablets come in blister packs of 10 and 20.

Uncommon:
may affect up to 1 in 100 people
- 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
- joint pain in adults
- 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)

Manufacturer and Product Licence holder
Manufactured by Bayer Schering Pharma AG, D-51368, Leverkusen,
Germany and procured from the EU by Product Licence holder
Star Pharmaceuticals Ltd., Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.

Rare:
may affect up to 1 in 1,000 people
- 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)
- 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), or hallucinations
- pins and needles, unusual sensitivity to stimuli of the senses, decreased
skin sensitivity, tremors, seizures (see Section 2: Warnings and
Precautions), or giddiness
- eyesight problems including double vision
- 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)
- muscle pain, inflammation of the joints, increased muscle tone, or cramp
- kidney failure, blood or crystals in the urine (see Section 2: Warnings
and Precautions), 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 ); 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 (see Section 2: Warnings and Precautions)
- severe allergic reactions (anaphylactic reaction or anaphylactic shock,
which can be fatal - serum sickness) (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
- small, pin-point bleeding under the skin (petechiae); various skin
eruptions or rashes (for example, the potentially fatal Stevens-Johnson
syndrome or toxic epidermal necrolysis)
- muscle weakness, tendon inflammation, tendon rupture – especially of
the large tendon at the back of the ankle (Achilles tendon) (see Section
2: Warnings and Precautions); 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 as pain, burning,
tingling, numbness and/or weakness in extremities (peripheral
neuropathy and polyneuropathy)
- 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)

POM

PL 20636/2427

Leaflet revision and issue date: (Ref) 21.05.14[5]
Ciproxin is a trademark of Bayer Aktiengesellschaft.
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.

Expand view ⇕

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.

Hide
(web2)