Medication Guide App

CIPROXIN TABLETS 500MG

Active substance: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE

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5. How to store Ciproxin

S1431 LEAFLET Ciproxin 20140520

Advice/medical education



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.

If your doctor has prescribed antibiotics, you need them precisely
for your current illness.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.

Despite antibiotics, some bacteria may survive or grow. This
phenomenon is called resistance: some antibiotic treatments
become ineffective.



If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of your pharmacist.

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:



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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antibiotics are used to cure bacterial infections. They are ineffective
against viral infections.

-

The name of your medicine is Ciproxin Tablets 500mg but will be
referred as Ciproxin throughout the following patient information
leaflet.

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)

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Warnings and precautions

duration of treatment



Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.



schedules

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.


6. Contents of the pack and other information

Consequently, to preserve the efficacy of this drug:

What Ciproxin contains

1 - Use antibiotics only when prescribed.



Each tablet contains 500mg of the active ingredient
ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).

2 - Strictly follow the prescription.



The tablets also contain microcrystalline cellulose, maize
starch, crospovidone, colloidal silicon dioxide, magnesium
stearate, hypromellose 2910, macrogol 4000 and titanium
dioxide (E171).

3 - Do not re-use an antibiotic without medical prescription, even if
you want to treat a similar illness.



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

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.

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.

2. What you need to know before you take Ciproxin
4. Possible side effects

What Ciproxin looks like and contents of the pack
Ciproxin is a white, capsule-shaped tablet marked Bayer on one
side and with a score-line and CIP 500 on the other.

Do not take Ciproxin:




dosages

-

CIPROXIN TABLETS 500mg
(ciprofloxacin hydrochloride)

2. What you need to know before you take Ciproxin

S1431 LEAFLET Ciproxin 20140520

3. How to take Ciproxin
5. How to store Ciproxin
6. Contents of the pack and other information

Ciproxin is available as blister packs of 10 or 20 tablets.

1. What Ciproxin is and what it is used for

Product Licence holder

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.
Ciproxin is used in adults to treat the following bacterial infections:

Manufacturer
This product is manufactured by Bayer Pharma AG, Leverkusen,
Germany.
POM

PL No: 19488/1431

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.



respiratory tract infections

While taking Ciproxin



long lasting or recurring ear or sinus infections



urinary tract infections

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.



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

genital tract infections in men and women





gastro-intestinal tract infections and intra-abdominal infections

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.



Hypoglycemia has been reported most often in diabetic
patients, predominantly in elderly population. If this happens,
contact your doctor immediately.

Adults



skin and soft tissue infections

Leaflet revision date: 20 May 2014



bone and joint infections

Ciproxin is a registered trade mark of Bayer AG, Germany.



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.



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.

Some medicines reduce the effect of Ciproxin. Tell your doctor if
you take or wish to take:





antacids



omeprazole



mineral supplements



sucralfate

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





a polymeric phosphate binder (e.g. sevelamer or lanthanum
carbonate)

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





medicines or supplements containing calcium, magnesium,
aluminium or iron

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.

If these preparations are essential, take Ciproxin about two hours
before or no sooner than four hours after them.



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.

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 tablets, as they may affect the absorption of the
active substance.

If you stop taking Ciproxin

Very rare:

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.

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)

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

-

mental disturbances (psychotic reactions potentially leading to
thoughts of suicide, suicide attempts, or completed suicide)
(see Section 2: Warnings and precautions)

may affect up to 1 in 10 people

-

migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory disorders),
pressure on the brain (intracranial pressure and pseudotumor
cerebri)

If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects

-

nausea, diarrhoea

-

joint pains in children
-

visual colour distortions

Uncommon:

-

inflammation of the wall of the blood vessels (vasculitis)

may affect up to 1 in 100 people
Pregnancy and breast-feeding

-

pancreatitis

-

fungal superinfections

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.

-

-

a high concentration of eosinophils, a type of white blood cell

death of liver cells (liver necrosis) very rarely leading to lifethreatening liver failure

-

decreased appetite

-

It is preferable to avoid the use of Ciproxin during pregnancy.

-

hyperactivity or agitation
headache, dizziness, sleeping problems, or taste disorders

-

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

vomiting, abdominal pain, digestive problems such as stomach
upset (indigestion/heartburn), or wind

-

Other medicines and Ciproxin

Do not take Ciproxin during breast-feeding because ciprofloxacin is
excreted in breast milk and can be harmful for your child.

-

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)

Driving and using machines

-

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).

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.

increased amounts of certain substances in the blood
(transaminases and/or bilirubin)

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)

-

rash, itching, or hives

-

joint pain in adults

Not known:

-

poor kidney function

frequency cannot be estimated from the available data

-

pains in your muscles and bones, feeling unwell (asthenia), or
fever

-

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.

-

increase in blood alkaline phosphatase (a certain substance in
the blood)

troubles associated with the nervous system such as pain,
burning, tingling, numbness and/or weakness in extremities
(peripheral neuropathy and polyneuropathy)

-

Tell your doctor if you suffer from kidney problems because your
dose may need to be adjusted.

Rare:

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)



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.

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)

3. How to take Ciproxin

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.



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)

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



cyclosporin (for skin conditions, rheumatoid arthritis and in
organ transplantation)

If you take more Ciproxin than you should



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)



sildenafil (e.g. for erectile dysfunction)

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).

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.

-

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)

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 (see details below). By reporting
side effects, you can help provide more information on the safety of
this medicine.

-

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

-

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

Yellow Card Scheme

pins and needles, unusual sensitivity to stimuli of the senses,
decreased skin sensitivity, tremors, seizures (see Section 2:
Warnings and precautions), or giddiness

Malta

-

eyesight problems including double vision

The Medicines Authority

-

tinnitus, loss of hearing, impaired hearing

Post-Licensing Directorate

-

rapid heartbeat (tachycardia)

203 Level 3, Rue D'Argens

-

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

-

lidocaine (for heart conditions or anaesthetic use)



a. Swallow the tablets with plenty of fluid. Do not chew the tablets
because they do not taste nice.

may affect up to 1 in 1,000 people

United Kingdom
Website: www.mhra.gov.uk/yellowcard

ADR Reporting

GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

5. How to store Ciprofloxacin Tablets

S1431 LEAFLET Ciprofloxacin 20140520

Advice/medical education



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not take the tablets after the date shown on the pack.

If your doctor has prescribed antibiotics, you need them precisely
for your current illness.



If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist for safe disposal. Only keep them
if your doctor tells you to.

Despite antibiotics, some bacteria may survive or grow. This
phenomenon is called resistance: some antibiotic treatments
become ineffective.

If the tablets become discoloured or show any other signs of
deterioration, please seek the advice of your pharmacist.

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:




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.

-

schedules

-

Consequently, to preserve the efficacy of this drug:
1 - Use antibiotics only when prescribed.



2 - Strictly follow the prescription.

The tablets also contain microcrystalline cellulose, maize
starch, crospovidone, colloidal silicon dioxide, magnesium
stearate, hypromellose 2910, macrogol 4000 and titanium
dioxide (E171).

3 - Do not re-use an antibiotic without medical prescription, even if
you want to treat a similar illness.

Ciprofloxacin Tablets are available as blister packs of 10 or 20
tablets.
Product Licence holder

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

Do not take Ciprofloxacin Tablets:


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
Ciprofloxacin Tablets)

Warnings and precautions



Keep this leaflet. You may need to read it again.



Talk to your doctor before taking Ciprofloxacin Tablets

If you have any further questions, ask your doctor or
pharmacist.



if you have ever had kidney problems because your treatment
may need to be adjusted.

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 suffer from epilepsy or other neurological conditions.



if you have a history of tendon problems during previous
treatment with antibiotics such as Ciprofloxacin Tablets.



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 Tablets).



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.



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 Ciprofloxacin Tablets is and what it is used for

4 - Never give your antibiotic to another person; maybe it is not
adapted to her/his illness.

2. What you need to know before you take Ciprofloxacin Tablets

5 - After completion of treatment, return all unused drugs to your
chemist’s shop to ensure they will be disposed of correctly.

4. Possible side effects

What Ciprofloxacin Tablets look like and contents of the pack
Ciprofloxacin Tablets are white, capsule-shaped tablets marked
Bayer on one side and with a score-line and CIP 500 on the other.

The name of your medicine is Ciprofloxacin Tablets 500mg but will
be referred as Ciprofloxacin Tablets throughout the following patient
information leaflet.

duration of treatment

What Ciprofloxacin Tablets contain



CIPROFLOXACIN TABLETS 500mg
(ciprofloxacin hydrochloride)

2. What you need to know before you take Ciprofloxacin
Tablets



dosages

6. Contents of the pack and other information
Each tablet contains 500mg of the active ingredient
ciprofloxacin (as ciprofloxacin hydrochloride monohydrate).

PACKAGE LEAFLET: INFORMATION FOR THE USER

Antibiotics are used to cure bacterial infections. They are ineffective
against viral infections.

3. How to take Ciprofloxacin Tablets
5. How to store Ciprofloxacin Tablets
6. Contents of the pack and other information

S1431 LEAFLET Ciprofloxacin 20140520

1. What Ciprofloxacin Tablets is and what it is used for
Ciprofloxacin Tablets 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.

This product is manufactured by Bayer Pharma AG, Leverkusen,
Germany.
POM

PL No: 19488/1431

Leaflet revision date: 20 May 2014



respiratory tract infections

While taking Ciprofloxacin Tablets



long lasting or recurring ear or sinus infections



urinary tract infections

Tell your doctor immediately, if any of the following occurs while
taking Ciprofloxacin Tablets. Your doctor will decide whether
treatment with Ciprofloxacin Tablets needs to be stopped.

genital tract infections in men and women



gastro-intestinal tract infections and intra-abdominal infections



Manufacturer

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

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.



Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

skin and soft tissue infections



bone and joint infections



to prevent infections due to the bacterium Neisseria
meningitidis



anthrax inhalation exposure

Adults



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 Ciprofloxacin
Tablets 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 Ciprofloxacin
Tablets therapy. At the first sign of any pain or inflammation
stop taking Ciprofloxacin Tablets 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 Ciprofloxacin Tablets and contact your
doctor immediately.



You may experience psychiatric reactions the first time you
take Ciprofloxacin Tablets. If you suffer from depression or
psychosis, your symptoms may become worse under
treatment with Ciprofloxacin Tablets. In rare cases, depression
or psychosis can progress to thoughts of suicide, suicide
attempts, or completed suicide. If this happens, stop taking
Ciprofloxacin Tablets and contact your doctor immediately.



You may experience symptoms of neuropathy such as pain,
burning, tingling, numbness and/or weakness. If this happens,
stop taking Ciprofloxacin Tablets and contact your doctor
immediately.



Hypoglycemia has been reported most often in diabetic
patients, predominantly in elderly population. If this happens,
contact your doctor immediately.

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 Tablets.
Children and adolescents
Ciprofloxacin Tablets is used in children and adolescents, under
specialist medical supervision, to treat the following bacterial
infections:


lung and bronchial infections in children and adolescents
suffering from cystic fibrosis



complicated urinary tract infections, including infections that
have reached the kidneys (pyelonephritis)



anthrax inhalation exposure

Ciprofloxacin Tablets may also be used to treat other specific
severe infections in children and adolescents when your doctor
considered this necessary.





Diarrhoea may develop while you are taking antibiotics,
including Ciprofloxacin Tablets, 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
Ciprofloxacin Tablets immediately, as this can be lifethreatening. Do not take medicines that stop or slow down
bowel movements and contact your doctor.

Some medicines reduce the effect of Ciprofloxacin Tablets. Tell
your doctor if you take or wish to take:

Tell the doctor or laboratory staff that you are taking
Ciprofloxacin Tablets 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.



Ciprofloxacin Tablets 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 Ciprofloxacin Tablets and contact your doctor
immediately.



Ciprofloxacin Tablets 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.



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 Ciprofloxacin Tablets about
two hours before or no sooner than four hours after them.
Ciprofloxacin Tablets with food and drink
Unless you take Ciprofloxacin Tablets 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.

If you stop taking Ciprofloxacin Tablets

Very rare:

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.

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)

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

-

mental disturbances (psychotic reactions potentially leading to
thoughts of suicide, suicide attempts, or completed suicide)
(see Section 2: Warnings and precautions)

may affect up to 1 in 10 people

-

migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory disorders),
pressure on the brain (intracranial pressure and pseudotumor
cerebri)

If you have any further questions about the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects

-

nausea, diarrhoea

-

joint pains in children
-

visual colour distortions

Uncommon:

-

inflammation of the wall of the blood vessels (vasculitis)

may affect up to 1 in 100 people
Pregnancy and breast-feeding

-

pancreatitis

-

fungal superinfections

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.

-

-

a high concentration of eosinophils, a type of white blood cell

death of liver cells (liver necrosis) very rarely leading to lifethreatening liver failure

-

decreased appetite

-

It is preferable to avoid the use of Ciprofloxacin Tablets during
pregnancy.

-

hyperactivity or agitation

-

headache, dizziness, sleeping problems, or taste disorders

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)

-

vomiting, abdominal pain, digestive problems such as stomach
upset (indigestion/heartburn), or wind

-

Other medicines and Ciprofloxacin Tablets

Do not take Ciprofloxacin Tablets during breast-feeding because
ciprofloxacin is excreted in breast milk and can be harmful for your
child.

-

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

increased amounts of certain substances in the blood
(transaminases and/or bilirubin)

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)

Driving and using machines

-

rash, itching, or hives

-

joint pain in adults

Not known:

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

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

-

poor kidney function

frequency cannot be estimated from the available data

-

pains in your muscles and bones, feeling unwell (asthenia), or
fever

-

-

increase in blood alkaline phosphatase (a certain substance in
the blood)

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)



Your skin becomes more sensitive to sunlight or ultraviolet
(UV) light when taking Ciprofloxacin Tablets. Avoid exposure to
strong sunlight, or artificial UV light such as sunbeds.

The following medicines are known to interact with Ciprofloxacin
Tablets in your body. Taking Ciprofloxacin Tablets 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)





3. How to take Ciprofloxacin Tablets
Your doctor will explain to you exactly how much Ciprofloxacin
Tablets 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 Ciprofloxacin
Tablets.

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)

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 (see details below). By reporting
side effects, you can help provide more information on the safety of
this medicine.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets
because they do not taste nice.

-

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

b. Do try to take the tablets at around the same time every day.

-

increased blood sugar (hyperglycaemia)

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 Ciprofloxacin Tablets tablets with
dairy products such as milk or yoghurt or with fortified fruit
juices (e.g. calcium-fortified orange juice).

-

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

Yellow Card Scheme

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

-

metoclopramide (for nausea and vomiting)

Malta

cyclosporin (for skin conditions, rheumatoid arthritis and in
organ transplantation)

pins and needles, unusual sensitivity to stimuli of the senses,
decreased skin sensitivity, tremors, seizures (see Section 2:
Warnings and precautions), or giddiness

If you take more Ciprofloxacin Tablets than you should

-

eyesight problems including double vision

The Medicines Authority

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.

-

tinnitus, loss of hearing, impaired hearing

Post-Licensing Directorate

-

rapid heartbeat (tachycardia)

203 Level 3, Rue D'Argens

-

expansion of blood vessels (vasodilation), low blood pressure,
or fainting

If you forget to take Ciprofloxacin Tablets

-

shortness of breath, including asthmatic symptoms

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.

-

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

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 Tablets 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)

United Kingdom
Website: www.mhra.gov.uk/yellowcard

ADR Reporting

GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

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.

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