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PACKAGE LEAFLET:

INFORMATION FOR THE USER

Ciprofloxacin 250 mg,

500 mg and 750 mg Tablets

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 further questions, please ask your doctor or your 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, pharmacist or nurse. 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 is it 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.    Contents of the pack and other information

The name of this medicine is Ciprofloxacin 250 mg, 500 mg or 750 mg Film-coated Tablets.

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

Ciprofloxacin belongs to a group of antibiotics called fluoroquinolones. It works by killing some types of bacteria that can cause infections.

Ciprofloxacin is used to treat bacterial infections including:

•    Lung infections such as pneumonia

•    Infections of the bladder and kidneys

•    Severe gastro-enteritis

•    Infections in the abdomen around the gut

•    Infections of the gall bladder and bile

•    Infections of the skin and spreading infections under the skin

•    Infections in the womb and tubes leading to the ovaries and in the area around these organs

•    Infections of the genital organs, including gonorrhoea (a sexually transmitted disease) and inflammation of the prostate gland in men

•    Infections in the bones and joints

•    Infections that have spread to the blood

•    Infections in people who have poor immunity to infections

•    Prevention of infections after surgery on the gut or after procedures that involve passing cameras (endoscopes) into the gut or other organs

Ciprofloxacin Tablets may also be used for treating lung infections in children (aged five years or older) and teenagers who have cystic fibrosis.

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

Do not take Ciprofloxacin Tablets:

•    If you are allergic to ciprofloxacin, 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

Talk to your doctor, pharmacist or nurse 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.

•    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.

•    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.

•    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.

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 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)

•    agomelatine

•    zolpidem.

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.

Pregnancy and breastfeeding

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 during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

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Driving or using machines

Ciprofloxacin may make you feel less alert.

Some neurological adverse events can occur. Therefore, make sure that you know how you react to Ciprofloxacin Tablets before driving or operating machinery.

3.    How to take Ciprofloxacin Tablets

You should always take this medicine as prescribed by your doctor. Do not take more than the doctor told you to. Read and follow the instructions on the pharmacist’s label. If you’re not sure about anything please ask your doctor or pharmacist.

The dose you are prescribed will depend on the type and severity of your infection. The usual dose range in adults is 100 mg to 750 mg twice a day. Your doctor will tell you how long your treatment with ciprofloxacin will last.

In lung infections it is usual to use 250 mg or 500 mg twice a day for up to two weeks.

In infections of the bladder and kidneys the dose may be as low as 100-250 mg twice a day for only three days or as high as 500 mg twice a day for up to two weeks (or even four weeks for certain infections of the prostate gland in men).

In gonorrhoea infections that have not spread beyond the lower genital organs in men or women, a single dose of 250-500 mg may be enough.

For other infections 500 mg twice a day is the usual dose, but 750 mg twice a day may be used for more severe infections.

For the treatment of lung infections in cystic fibrosis patients (aged 5 to 17 years), the dose is 20 mg/kg twice a day for up to two weeks. The maximum daily dose in this age group is 1500 mg.

To prevent infections after gut surgery or after endoscopy (see above), 750 mg is usually given 1 to 1% hours before the procedure.

If you are elderly or have kidney problems your doctor may give you a single daily dose or a lower dose.

Also, special dosing instructions are needed if you are on haemodialysis or having CAPD (continuous ambulatory peritoneal dialysis) to treat kidney problems. In these cases, it is very important to follow your doctor’s instructions carefully.

•    Swallow the tablets with plenty of fluid drink e.g. water. Do not chew the tablets. The tablets can be taken before, with or after food. You should avoid eating yoghurt or drinking milk at the same time as you take a tablet as this will reduce the effect. You should either take ciprofloxacin 1-2 hours before eating or drinking dairy products or avoid eating and drinking these products for four hours after taking ciprofloxacin.

•    There are also several medicines that should not be taken at the same time as ciprofloxacin. See under Other medicines and Ciprofloxacin Tablets.

•    Space the doses as evenly as possible throughout the day.

•    It is important that you keep taking Ciprofloxacin Tablets until the prescribed course is finished. Do not stop taking the tablets just because you feel better. If you stop too soon, the infection may start up again.

•    If you still feel unwell at the end of your prescribed course of treatment, tell your doctor.

If you forget to take Ciprofloxacin Tablets at the right time, take them as soon as you remember. Do not take a double dose to make up for forgotten individual doses.

If you have taken more Ciprofloxacin Tablets than you

should, drink plenty of water and consult your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so your doctor will know what you have taken.

4.    Possible side effects

Like all medicines, this medicine can have side effects.

If any of the following happen, stop taking Ciprofloxacin Tablets and tell your doctor immediately or go to the casualty department at your nearest hospital.

These are very serious side effects. If you have them you may have had a serious allergic reaction or other type of reaction to ciprofloxacin. You may need urgent medical attention or hospitalisation.

-    Severe skin disorders including skin rash, itching, peeling, blistering or crusting (for example the potentially fatal Steven-Johnson syndrome or toxic epidermal necrolysis, Erythema multiforme, Acute generalised exanthematous pustulosis), small, pin point bleeding under the skin (petechiae)

-    Allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema), swelling of the face or throat, difficulty breathing (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)

-    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), worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

-    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)

-    Reduction in red blood cells due to extensive destruction of these cells (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 diarrhoea with bleeding or mucous.

-    Unusual feelings of pain, burning, tingling, numbness or muscle weakness in the extremities (peripheral neuropathy and polyneuropathy) (see Section 2: Warnings and precautions)

Other side effects have also been reported. These are shown below:

Common: may affect up to 1 in 10 people:

-    Nausea (feeling sick), diarrhoea

Uncommon: may affect up to 1 in 100 people:

-    Fungal super infections

-    Increased numbers of a type of blood cell called an eosinophil.

-    Vomiting (being sick), indigestion, decreased appetite, flatulence (wind), abdominal pain

-    Dizziness, headache, sleep problems, fever, feeling unwell (asthenia)

-    Hyperactivity or agitation

-    Disturbances in taste, increase in blood alkaline phosphatase (a certain substance in the blood)

-    Poor kidney function

-    Palpitations, itching or hives

-    Skin rashes and itching

-    Increased amount of certain substances in the blood (transaminase and/or bilirubin)

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 cell count (leukopenia, leukocytosis, neutropenia, anaemia), increased or deceased amounts of a blood clotting factor (thrombocytes)

-    Increases in blood sugar levels (hyperglycaemia) and decreases in blood sugar levels (hypoglycaemia)

-    Confusion, disorientation, anxiety reactions, strange dreams, hallucinations

-    Fluid retention or excessive sweating

-    Pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (See Section 2: Warnings and precautions)

-    Spinning sensation (vertigo), ringing in the ears (tinnitus), temporary loss of hearing, impaired hearing

-    Visual disturbances (diplopia)

-    Increased heart rate (tachycardia)

-    Widening of blood vessel (vasodilation), low blood pressure, fainting

-    Shortness of breath (dyspnoea), including asthmatic symptoms

-    Liver disorders, jaundice (cholestatic icterus), or hepatitis

-    Sensitivity to light (see Section 2: Warnings and precautions)

-    Sudden (acute) kidney failure, blood or crystals in the urine with discomfort when passing urine (crystalluria), increases in some blood chemicals that normally pass through the kidneys (see Section 2: Warnings and precautions), urinary tract inflammation

-    increased levels of the enzyme amylase

Very rare: and may affect up to 1 in 10,000 people.

-    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 (severe stomach pain)

-    Death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

Frequency not know:

-    Influence on blood clotting (in patients treated with Vitamin K antagonists)

-    Feeling highly excited (mania) or feeling great optimism and over-activity (hypomania)

-    Serious 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the 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 Tablets

•    Keep Ciprofloxacin Tablets out of the sight and reach of children

•    Do not take after the expiry date on the labelling

•    There are no special storage instructions, however, as with all medicines do not store Ciprofloxacin tablets anywhere too hot or damp

•    If you notice any visible signs of deterioration in the tablets, such as chipped, broken or discoloured tablets, take them to your pharmacist for advice before taking them

•    If you have any tablets left after taking all the doses prescribed for you, please return these to your pharmacist

6.    Contents of the pack and other information What Ciprofloxacin Tablets contains

•    The active ingredient is ciprofloxacin.

•    The other ingredients are lactose monohydrate, sodium starch glycollate, povidone, sodium stearyl fumarate and a coating consisting of methocel, polyethylene glycol and titanium dioxide (E171).

What Ciprofloxacin Tablets looks like and contents of the pack

Ciprofloxacin 250mg Film-coated Tablets are off-white, round, biconvex film coated tablets. Scored on one side and plain on the other.

Ciprofloxacin 500mg Film-coated Tablets are off-white, capsule shaped, biconvex film coated tablets. Scored on both the sides.

Ciprofloxacin 750mg Film-coated Tablets are off-white, capsule shaped, biconvex, film coated tablets.

The 250mg and 500mg tablets are available in blister packs of 10, 20 or 100 tablets.

The 750mg tablets are available as blister packs of 10 or 100 tablets.

Marketing Authorisation Holder and Manufacturer

Co-pharma Ltd Unit 4, Metro Centre,

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Tolpits Lane, Watford Hertfordshire, WD18 9SS United Kingdom

This leaflet was last revised in March 2016.

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