GEBECIP – 500

(CIPROFLOXACIN TABLETS USP 500 MG)

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

What is in this leaflet

1. What CIPROFLOXACIN TABLETS is and what it is used for
2. What you need to know before you take CIPROFLOXACIN TABLETS
3. How to take CIPROFLOXACIN TABLETS
4. Possible side effects
5. How to store CIPROFLOXACIN TABLETS
6. Further information

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.
Adults
Ciprofloxacin Tablets 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 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CIPROFLOXACIN TABLETS
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

Before taking this medicine

You should not take fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin
Tablets, if you have experienced any serious adverse reaction in the past when taking a quinolone or
fluoroquinolone. In this situation, you should inform your doctor as soon as possible.

Talk to your doctor before taking Ciprofloxacin Tablets

• 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 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 been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm
or large vessel peripheral aneurysm).
• if you have experienced a previous episode of aortic dissection (a tear in the aorta wall).
• if you have a family history of aortic aneurysm or aortic dissection or other risk factors or
predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-
Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s disease,
high blood pressure, or known atherosclerosis).
• 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.

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 Tablets

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.

• 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.

• Prolonged, disabling and potentially irreversible serious side effects. Fluoroquinolone/ quinolone
antibacterial medicines, including Ciprofloxacin Tablets, have been associated with very rare but
serious side effects, some of them being long lasting (continuing months or years), disabling or
potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs,
difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, numbness or
burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing,
depression, memory impairment, severe fatigue, and severe sleep disorders. If you experience any of
these side effects after taking Ciprofloxacin Tablets, contact your doctor immediately prior to
continuing treatment. You and your doctor will decide on continuing the treatment considering also an
antibiotic from another class.

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is
increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney
problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may
occur within the first 48 hours of treatment and even up to several months after stopping of
Ciprofloxacin Tablets therapy. At the first sign of pain or inflammation of a tendon (for example in
your ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin Tablets, contact your doctor and
rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon
rupture.

• If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency
room.

• If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you
may experience side effects associated with the central nervous system. If seizure happens, stop taking
Ciprofloxacin Tablets and contact your doctor immediately.

• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling,
numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop
taking Ciprofloxacin Tablets and inform your doctor immediately in order to prevent the development
of potentially irreversible condition.

• 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, contact your doctor immediately.

• Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels
(hyperglycaemia), or lowering of your blood sugar levels below normal levels, potentially leading to
loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is important for
people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.

• 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 and contact your doctor
immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel
movements.

• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye
specialist immediately.

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

• 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, 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.

Other medicines and Ciprofloxacin Tablets

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

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).

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
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 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 •
zolpidem (for sleep disorders)

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) • agomelatine (for depression)

Some medicines reduce the effect of Ciprofloxacin Tablets. 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 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
 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 Tablets during pregnancy.
Do not take Ciprofloxacin Tablets during breast-feeding because ciprofloxacin is excreted in breast
milk and can be harmful for your child.

Driving and using machines

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.

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.
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 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 Tablets 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 Tablets
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 Tablets
It is important that you finish the course of treatment even if you begin to feel better after a few days. If
you stop taking this medicine too soon, your infection may not be completely cured and the symptoms
of the infection may return or get worse. You might also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following section contains the most serious side effects that you can recognize yourself:
Stop taking Ciprofloxacin Tablets and contact your doctor immediately in order to consider another
antibiotic treatment if you notice any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people) –
Seizure (see Section 2: Warnings and precautions)
Very rare (may affect up to 1 in 10,000 people)
- Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or
faint, or experience dizziness when standing up (anaphylactic reaction/shock) (see Section 2: Warnings
and precautions)
- Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly
affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and
precautions)
- A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose,
eyes and other mucous membranes such as genitals which may progress to widespread blistering or
peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Not known (frequency cannot be estimated from the available data)
- Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities
(neuropathy) (see Section 2: Warnings and precautions)
- A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities
and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute
Generalised Exanthematous Pustulosis).
Other side effects which have been observed during treatment with Ciprofloxacin Tablets are listed
below by how likely they are:
Common (may affect up to 1 in 10 people)
- nausea, diarrhoea
- joint pain and joint inflammation in children
Uncommon (may affect up to 1 in 100 people)
joint pain in adults
- fungal superinfections
- a high concentration of eosinophils, a type of white blood cell
- decreased appetite
- hyperactivity or agitation - headache, dizziness, sleeping problems, or taste disorders
- vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind
- increased amounts of certain substances in the blood (transaminases and/or bilirubin)
- rash, itching, or hives
- poor kidney function
- pains in your muscles and bones, feeling unwell (asthenia), or fever
- increase in blood alkaline phosphatase (a certain substance in the blood)

5. HOW TO STORE CIPROFLOXACIN TABLETS

Keep out of the sight and reach of children.
Do not use tablets after the expiry date which is printed after ‘Exp’ on the carton.
Do not store above 30°C. Keep the tablets in their original pack.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Micro crystalline cellulose BP

Maize Starch BP
Sodium lauryl Sulphate BP
Purified Water BP
Purified Talc BP
Colloidal Silicon dioxide BP
Magnesium Stearate BP
Sodium Starch glycolate BP
Colour: Titanium dioxide BP
Iso propyl alcohol BP
Dichloromethane BP

Marketing authorization holder

Company Name : GB PHARMA LIMITED
Address : 65 Chatsworth Road, London NW2 4BG
Country : United Kingdom
Phone : +44 (0)2088301057
Fax : + 44 (0) 2088304807
E-mail : [email protected]