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CIPROFLOXACIN 750 MG FILM COATED TABLETS

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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Ciprofloxacin 250 mg film-coated tablets
Ciprofloxacin 500 mg film-coated tablets
Ciprofloxacin 750 mg film-coated tablets
Ciprofloxacin hydrochloride

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 Ciprofloxacin is and what it is used for
2. What you need to know before you take Ciprofloxacin
3. How to take Ciprofloxacin
4. Possible side effects
5. How to store Ciprofloxacin
6. Contents of the pack and other information
1. What Ciprofloxacin is and what it is used for
Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family.
The active substance is ciprofloxacin. Ciprofloxacin works by killing
bacteria that cause infections. It only works with specific strains of
bacteria.
Adults
Ciprofloxacin is used in adults to treat the following bacterial
infections:
• respiratory tract infections
• long lasting or recurring ear or sinus infections
• urinary tract infections
• genital organ 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 Ciprofloxacin.
Children and adolescents
Ciprofloxacin is used in children and adolescents, under specialist
medical supervision, to treat the following bacterial infections:
• lung and bronchial infections in children and adolescents
suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have
reached the kidneys (pyelonephritis)
• anthrax inhalation exposure
Ciprofloxacin may also be used to treat other specific severe
infections in children and adolescents when your doctor considered
this necessary.
2. What you need to know before you take Ciprofloxacin
Do not take Ciprofloxacin:
• if you are allergic to ciprofloxacin, to other quinolone drugs or any
of the other ingredients of this medicine (listed in section 6).
• if you are taking tizanidine (see Section 2: Other medicines and
Ciprofloxacin)
Warnings and precautions
Talk to your doctor or pharmacist before taking Ciprofloxacin.
• if you have ever had kidney problems because your treatment
may need to be adjusted
• if you suffer from epilepsy or other neurological conditions.
• if you have a history of tendon problems during previous
treatment with antibiotics such as Ciprofloxacin
• if you are diabetic because you may experience a risk of
hypoglycaemia with ciprofloxacin.
• if you have myasthenia gravis (a type of muscle weakness)
because symptoms can be exacerbated.
• If you have heart problems. Caution should be taken when using
Ciprofloxacin, if you were born with or have family history of
prolonged QT interval (seen on ECG, electrical recording of the
heart), have salt imbalance in the blood (especially low level of
potassium or magnesium in the blood), have a very slow heart
rhythm (called ‘bradycardia’), have a weak heart (heart failure),
have a history of heart attack (myocardial infarction), you are
female or elderly or you are taking other medicines that result
in abnormal ECG changes (see section 2: Other medicines and
Ciprofloxacin).
• if you or a member of your family is known to have a deficiency
in glucose-6-phosphate dehydrogenase (G6PD), since you may
experience a risk of anaemia with ciprofloxacin.
For the treatment of some genital tract infections, your doctor can
prescribe another antibiotic in addition to ciprofloxacin. If there is no
improvement in symptoms after 3 days of treatment, please consult
your doctor.
While taking ciprofloxacin
Tell your doctor immediately, if any of the following occurs while
taking Ciprofloxacin. Your doctor will decide whether treatment
with Ciprofloxacin 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 Ciprofloxacin 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 therapy. At
the first sign of any pain or inflammation stop taking Ciprofloxacin
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 and contact your doctor
immediately.
• You may experience psychiatric reactions the first time you
take Ciprofloxacin. If you suffer from depression or psychosis,
your symptoms may become worse under treatment with
Ciprofloxacin. In rare cases, depression or psychosis can
progress to thoughts of suicide, suicide attempts, or completed
suicide. If this happens, stop taking Ciprofloxacin 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.
• You may experience symptoms of neuropathy such as pain,
burning, tingling, numbness and/or weakness. If this happens,
stop taking Ciprofloxacin and contact your doctor immediately.
• If your eyesight becomes impaired or if your eyes seem to be
otherwise affected, consult an eye specialist immediately. (see
section 4. Possible side effects).

Black

P15

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Ciprofloxacin

Package leaflet: Information for the user

Ciprofloxacin

Pharmacode position may change as per the supplier’s m/c requirement

• Diarrhoea may develop while you are taking antibiotics, including
Ciprofloxacin, 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
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 Ciprofloxacin
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 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 and contact your doctor immediately.
• Ciprofloxacin may cause a reduction in the number of white blood
cells and your resistance to infection may be decreased. If
you experience an infection with symptoms such as fever and
serious deterioration of your general condition, or fever with local
infection symptoms such as sore throat/pharynx/mouth or urinary
problems you should see your doctor immediately. A blood test
will be taken to check possible reduction of white blood cells
(agranulocytosis). It is important to inform your doctor about your
medicine.
• Your skin becomes more sensitive to sunlight or ultraviolet
(UV) light when taking Ciprofloxacin. Avoid exposure to strong
sunlight, or artificial UV light such as sunbeds.
Other medicines and Ciprofloxacin
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Ciprofloxacin can increase the level of the following substances in
the blood: Agomelatine, Zolpidem.
Do not take Ciprofloxacin together with tizanidine, because this
may cause side effects such as low blood pressure and sleepiness
(see Section 2: “Do not take Ciprofloxacin “).
The following medicines are known to interact with Ciprofloxacin
in your body. Taking Ciprofloxacin 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 anti-coagulants
(to thin the blood)
• theophylline (for breathing problems)
• phenytoin ( for epilepsy)
• probenecid ( for gout)
• ropinirole ( for Parkinson’s disease)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid
arthritis)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• 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 antiarrhythmics (e.g. quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide,
ibutilide), tricyclic antidepressants, some antimicrobials (that
belong to the group of macrolides), some antipsychotics.
Ciprofloxacin may increase the levels of the following medicines in
your blood:
• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage or
incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
Some medicines reduce the effect of Ciprofloxacin. 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 Ciprofloxacin about two
hours before or no sooner than four hours after them.
Ciprofloxacin with food and drink
Unless you take Ciprofloxacin 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 Ciprofloxacin during pregnancy.
Tell your doctor if you are pregnant or planning to become pregnant.
Do not take Ciprofloxacin during breast feeding because
ciprofloxacin is excreted in breast milk and can be harmful for your
child.
Driving and using machines
Ciprofloxacin may make you feel less alert. Some neurological
adverse events can occur. Therefore, make sure you know how
you react to Ciprofloxacin before driving a vehicle or operating
machinery. If in doubt, talk to your doctor.
3. How to take Ciprofloxacin
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
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. Take the tablets exactly as your doctor has told
you. Ask your doctor or pharmacist if you are not sure how many
tablets to take and how to take Ciprofloxacin.
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 Ciprofloxacin 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
Ciprofloxacin.
If you take more Ciprofloxacin 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 Ciprofloxacin
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.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
If you suffer from any of the following symptoms, stop taking
Ciprofloxacin and contact your doctor or go to your nearest
emergency department immediately:
• muscle pain and/or weakness, inflammation of the joints and joint
pain, increased muscle tone and cramping, inflammation of the
tendons or tendon rupture, particularly affecting the large tendon
at the back of the ankle (Achilles tendon) (see section 2).
• unusual feelings of pain, burning tingling, numbness or muscle
weakness in the extremities (neuropathy) (see section 2).
Common side effects (may affect up to 1 in 10 people):
- nausea, diarrhoea
- joint pains in children
Uncommon side effects (may affect up to 1 in 100 people):
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite (anorexia)
- 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)
Rare side effects (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 complete 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)
- 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 side effects (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 lifethreatening liver failure
- small, pin-point bleeding under the skin (petechiae); various skin
eruptions or rashes (for example, the potentially fatal StevensJohnson syndrome or toxic epidermal necrolysis)
- worsening of the symptoms of myasthenia gravis (see Section 2:
Warnings and precautions)
Not known (frequency cannot be estimated from the available data)
- 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)
- Feeling highly excited (mania) or feeling great optimism and
overactivity (hypomania), hypersensitivity reaction called DRESS
(Drug Reaction with Eosinophilia and Systemic Symptoms)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects (see details below). By reporting side
effects you can help provide more information on the safety of this
medicine.
The United Kingdom
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 Ciprofloxacin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
carton and blister after EXP. The expiry date refers to the last day of
that month.
This medicinal product does not require any special storage
conditions.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Ciprofloxacin contains
- The active substance is ciprofloxacin (as hydrochloride).
Each film-coated tablet contains 250 mg ciprofloxacin (as
hydrochloride).
Each film-coated tablet contains 500 mg ciprofloxacin (as
hydrochloride).
Each film-coated tablet contains 750 mg ciprofloxacin (as
hydrochloride).
- The other ingredients are:
Tablet core: Cellulose microcrystalline, sodium starch glycolate
(Type A), povidone (K 30), silica, colloidal anhydrous,
magnesium stearate.
Film coating: Hypromellose, titanium dioxide (E 171), macrogol
400.
What Ciprofloxacin looks like and contents of the pack
Film- coated tablet.
Ciprofloxacin 250 mg film-coated tablets
White to off white, round shaped (diameter 11.1 mm), film coated
tablets, with a score line on one side and debossed with ‘F’ and ‘23’
with a score line in between on the other side. The tablet can be
divided into equal doses.
Ciprofloxacin 500 mg film-coated tablets
White to off white, capsule shaped, film coated tablets, with a score
line on one side and debossed with ‘F22’ on the other side. The
tablet can be divided into equal doses. The size is 18.2 mm x
8.1 mm
Ciprofloxacin 750 mg film-coated tablets
White to off white, capsule shaped, film coated tablets, debossed
with ‘C’ on one side and ‘93’ on the other side. The size is 22.3 mm
x 8.2 mm
Ciprofloxacin film-coated tablets are available in PVC/PVdCAluminum foil blister pack.
Pack sizes: 1, 8, 10, 14, 16, 20 and 100 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This medicinal product is authorised in the Member States of
the EEA under the following names:
Belgium:
Ciprofloxacine AB 250 mg/ 500 mg/ 750 mg,
filmomhulde tabletten
Bulgaria:
Ципрофлоксацин Ауробиндо 250 mg
/ 500 mg/ 750 mg Филмирана таблетки
Latvia:
Ciprofloxacin Aurobindo 500 mg apvalkotās
tabletes
Lithuania:
Ciprofloxacin Aurobindo 500 mg plėvele
dengtos tabletės
Luxemburg:
Ciprofloxacin AB 250 mg/ 500 mg/ 750 mg,
filmomhulde tabletten/ Filmtabletten
The Netherlands:
Ciprofloxacine Aurobindo 250 mg/ 500 mg/
750 mg, filmomhulde tabletten
Portugal:
Ciprofloxacina Aurobindo
Romania:
Ciprofloxacina Aurobindo 250 mg/ 500 mg/
750 mg comprimate filmate
Spain:
CIPROFLOXACINO AUROBINDO 250 mg/
500 mg/ 750 mg comprimidos recubiertos
con pelicula EFG
The United Kingdom: Ciprofloxacin 250 mg/ 500 mg/ 750 mg filmcoated tablets
This leaflet was last revised in 08/2016.
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.

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If you stop taking Ciprofloxacin
It is important that you finish the course of treatment even if you
begin to feel better after a few days. If you stop 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 on the use of this medicine, ask
your doctor or pharmacist.

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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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