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CIPROFLOXACIN 750MG FILM-COATED TABLETS

Active substance(s): CIPROFLOXACIN HYDROCHLORIDE

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Package leaflet: Information for the user
Ciprofloxacin 250 mg Film-Coated Tablets
Ciprofloxacin 500 mg Film-Coated Tablets
Ciprofloxacin 750 mg Film-Coated Tablets
Ciprofloxacin
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 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
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 tract infections in men and women
 gastro-intestinal tract infections and intra-abdominal infections
 skin and soft tissue infections
 bones or 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 fromcystic 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 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”)

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-6phosphate 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.
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.

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 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.

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“).
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.
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.
Tell your doctor if you or a member of your family is known to have a deficiency in glucose6- phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with
ciprofloxacin.

Other medicines and Ciprofloxacin

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

ciclosporin (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.
glibenclamide (for treating diabetes)
agomelatine (for treating depression)

zolpidem (for the treatment of insomnia and some brain disorders)

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 tohave a baby, ask
your doctor or pharmacist for advice before takingthis medicine.
It is preferable to avoid the use of Ciprofloxacin during pregnancy.
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
Your doctor will explain to you exactly how much Ciprofloxacin 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.
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 this medicine.
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.
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 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.
A few people may develop very serious side effects. If you experience any of the following
symptoms, tell your doctor immediately:








swelling of the face, hands, lips, tongue or throat, difficulty swallowing or breathing
severe skin rash with blistering or bleeding of the lips, skin, nose, mouth, eyes and genitals
severe diarrhoea, sometimes with blood or mucus
inflammation of the tendons or a ruptured tendon
fits or seizures
unusual feelings of pain, burning, tingling, numbness or muscle weakness
yellowing of the skin or eyes, dark urine, tenderness in the abdomen or weight loss.

If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye
specialist immediately (see section 2: What you need to know before you take Ciprofloxacin).
The following side effects have been reported at the approximate frequencies shown:
Common (may affect up to 1 in 10 people):
 nausea, diarrhoea
 joint pain in children.
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
agitation
headache, dizziness, sleeping problems or, taste disorders
vomiting, abdominal pain, digestive problems
(indigestion/heartburn), or wind

such

as

stomach

upset

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):
 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)
 decreased blood sugar (hypoglycaemia) (see Section 2: “Warnings and precautions”)
 increased blood sugar (hyperglycaemia)



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, hearing loss or impairment













rapid heart beat (tachycardia)
expansion of blood vessels (vasodilatation), low blood pressure, or fainting
shortness of breath, (including asthmatic symptoms)
liver disorders, jaundice (yellowing of the skin and whites of the eyes) or hepatitis
sensitivity to light (see section 2: “Warnings and precautions”)
muscle pain
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 culminating in suicidal thoughts or
suicide attempts and 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):

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






(hypomania), hypersensitivity reaction called DRESS (Drug Reaction with
Eosinophilia and Systemic Symptoms)
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)

Reporting of side effects
If you get 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 Ciprofloxacin
Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to
the last day of that month.
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 monohydrate)
The other ingredients are croscarmellose sodium, colloidal silicon dioxide, magnesium stearate,
hypromellose 6cp (E464), magnesium stearate (E572), microcrystalline cellulose (E460), sodium
starch glycolate A, povidone, propylene glycol, talc, titanium dioxide (E171).
What Ciprofloxacin looks like and contents of the pack:
(Manufacturer = MicroLabs Ltd)
- 250 mg: White, biconvex, round film-coated tablets, debossed “CIP breakline 250” on one side
and plain on the other.
OR*
(Manufacturer = Kemwell Biopharma Pvt Ltd)
- 250 mg: White, biconvex, round film-coated tablets debossed with a breakline on one side and
plain on the other.
(Manufacturer = MicroLabs Ltd)
- 500 mg: White, oval-shaped film-coated tablets, debossed “CIP breakline 500” on one side and
plain on the other.
OR*
(Manufacturer = Kemwell Biopharma Pvt Ltd)
- 500 mg: White, oval-shaped film-coated tablets debossed with a breakline on one side and plain
on the other.
(Manufacturer = Microlabs Ltd or Kemwell Biopharma Pvt Ltd)
- 750 mg: White, oval-shaped film-coated tablets, debossed “CIP breakline 750” on one side and a
breakline on the other.
 The product is available in pack sizes of 10, 12, 20, 30, 50, 100 or 160 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: TEVA UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
Pharmachemie B.V., Haarlem, The Netherlands.
OR*
TEVA UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: December 2015
PL 00289/0493-0495
* Only the details of the current manufacturing site and corresponding tablet descriptions will be
included in the printed version of the PIL

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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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