Description

Product Overview

What Ciprofloxacin 250mg Tablets are and what they are used for

Ciprofloxacin 250mg Tablets are an antibiotic. Ciprofloxacin Tablets are used for the treatment of severe bacterial infections.

Adults
Ciprofloxacin tablets are used in adults to treat the following bacterial infections:

• respiratory tract, urinary tract, genital tract infections in men and women, stomach and intra-abdominal infections, skin and soft tissue, bone and joint infections
• long lasting or recurring ear or sinus 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 are 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.

What you need to know before you take Ciprofloxacin 250mg Tablets

Do NOT take Ciprofloxacin 250mg Tablets if you or your child:

• have a known allergic reaction to ciprofloxacin or any of the ingredients in Ciprofloxacin 250mg Tablets, listed in Section 6, or other quinolone antibiotics.
• taking tizanidine (see section2: Taking other medicines).

Take special care with Ciprofloxacin 250mg Tablets

Before starting treatment: talk to your doctor before taking this medicine if any of the precautions and warnings mentioned below are or were applicable to you (or to your child) in the past

• convulsions (seizures, fits), epilepsy or another problem affecting your brain or spine
• heart problems: Caution should be taken when using this kind of medicine, if you were born with or have a family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low levels 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 Taking other medicines)
• has a history of tendon disorders
• myasthenia gravis (a particular type of muscle weakness)
• significant kidney impairment. Your doctor will check your kidney function
• glucose-6-phosphate dehydrogenase deficiency (disease of the red blood cells based on a hereditary enzyme deficiency). If you or someone in your family suffers from the disease then taking ciprofloxacin may lead to a destruction of red blood cells occur causing anaemia. Signs of anaemia are a feeling of weakness and in more severe cases, breathlessness and pale skin.

During or after treatment:
talk to your doctor if any of the following occur

• severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even after 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
• 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
• temporary pain and inflammation of the tendons, in particular of the Achilles (heel) tendon. This medicine may cause these side effects, particularly if you are older or take medicine of the steroid group, such as hydrocortisone. 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. If you experience these symptoms rest the sore leg and consult your doctor immediately. Avoid any unnecessary exercise as this might increase the risk of 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
• symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens stop taking Ciprofloxacin and contact your doctor immediately
• severe and continuous diarrhoea during treatment, possibly with blood and mucus. Consult your doctor immediately, since you may have a severe inflammation of the large intestine. In rare cases this condition may be life-threatening
• increased skin sensitivity to sunlight or UV light. You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation. If exposure to sunlight is inevitable you should use sun cream to protect yourself. If you experience a fever, rash, itching or small red spots on the skin, you should consult your doctor immediately since the treatment may be discontinued
• 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
• decreased resistance to infection: 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
• crystalluria, (presence of crystals in the urine with discomfort when passing urine). Consult your doctor as your urine needs to be tested. Furthermore, you should drink a sufficient amount of liquid (about 1.5-2 litres per day)
• 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
• Tuberculosis test (Mycobacterium). Ciprofloxacin may cause a false test result.

Other medicines and Ciprofloxacin 250mg Tablets.

Make sure you have told your doctor or pharmacist about any other medicines that you or your child may be taking, including any bought without a prescription.

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”).

If Ciprofloxacin 250mg Tablets and one of the following medicines are given at the same time, special care must be taken.

Tell your doctor if you are taking:
• Vitamin K antagonists (e.g. warfarin) 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 and clozapine (antipsychotics)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)
• glibenclamide (for diabetes)
• anti-arrhythmics: medicines that can alter your heart rhythm (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)
• 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 taking them.

Ciprofloxacin 250mg Tablets with food and drink
Large amounts of dairy products particularly milk or yoghurt may slow down ciprofloxacin uptake, therefore ciprofloxacin should be taken 1 to 2 hours before or at least 4 hours after these products.

Surgical procedures
Tell your doctor that you are taking ciprofloxacin because pain relief and sedative medicines administered prior to surgery can also be affected by ciprofloxacin.
If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe another medicine or to adjust the dose of Ciprofloxacin 250mg Tablets or the other medicine.
It is advisable never to use several medicines at the same time without consulting your doctor first.

Pregnancy
You must not take Ciprofloxacin during pregnancy. Consult your doctor if you are pregnant or planning to become pregnant. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding
Ciprofloxacin is passed into human breast milk. You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant. Consult your doctor if you are breast-feeding your child. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Ciprofloxacin can reduce your attention. If you suffer from dizziness, do not drive or operate machines, which require your full concentration.

How to take Ciprofloxacin 250mg Tablets

You should follow your doctor’s instructions and check the pharmacist’s label for how many tablets to take, and when. The usual doses for different types of infections treated with Ciprofloxacin 250mg Tablets are given below as a guide:

Respiratory tract infections 1 or 2 tablet twice a day for 7 to 14 days.
Acute, uncomplicated cystitis 1 tablet twice a day for 3 days.
Pyelonephritis 1 or 2 tablet twice a day for 7 to 14 days.
Prostatitis 2 tablets twice a day for up to 28 days
Severe gastroenteritis 2 tablets twice a day for 3 to 7 days.
Skin and soft tissue infections 2 tablets twice a day for 5 to 10 days.
Bone and joint infections 2 or 3 tablets twice a day for 4 to 6 weeks or longer.
Severe systemic infections 2 or 3 tablets twice a day.
Acute, uncomplicated gonorrhea a single dose of 1 or 2 tablets.

The actual dose may be adjusted to take into account your age, severity of infection and how well your kidneys are working. If you have a severe infection and serious kidney problems your doctor may take regular blood samples to check your recovery and ensure you are receiving the correct dose. Ideally these tablets should be swallowed whole with a glass of water. These tablets can be taken at any time, with or without food. Taking the tablets on an empty stomach will speed up the uptake, whilst dairy products such as milk or yoghurt may slow down the uptake of ciprofloxacin in the stomach.

If you take more Ciprofloxacin 250mg Tablets than you should
If you take more than you should, or in the event of an overdose, seek medical advice immediately and, if possible, take any remaining tablets or this leaflet with you to show the doctor.

If you forget to take Ciprofloxacin 250mg Tablets
If you forget to take your medicine take the missed dose as soon as possible and then continue as normal. 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 the forgotten one.

If you stop taking Ciprofloxacin 250mg Tablets
You should continue to take these tablets for as long as directed by your doctor. It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Common side effects (between 1 and 10 in every 100 people are likely to get these):
• nausea, diarrhoea
• joint pains in children

Uncommon side effects (between 1 and 10 in every 1,000 people are likely to get these):
• fungal superinfections
• a high concentration of eosinophils, a type of white blood cell.
• loss of 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 amount of certain substances in the blood (transaminase and/or bilirubin)
• rash, itching or hives
• joint pain in adults
• poor kidney function

Rare side effects (between 1 and 10 in every 10,000 people are likely to get these):
• inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Take special care with Ciprofloxacin 250mg Tablets)
• 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 levels (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: Take special care with Ciprofloxacin 250mg Tablets)
• eyesight problems including double vision (diplopia))
• ringing in the ear (tinnitus), temporary hearing loss (particularly high frequencies)
• increased heart rate (tachycardia)
• widening of blood vessel (vasodilation), low blood pressure, or fainting
• shortness of breath (dyspnoea) including asthmatic symptoms, swelling of the voice box (larynx) with difficulties in breathing (larynx oedema)

Very rare side effects (less than 1 in every 10,000 people are likely to get these):
• 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: Take special care with Ciprofloxacin 250mg Tablets)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal – serum sickness) (see Section 2: Take special care with Ciprofloxacin 250mg Tablets)
• mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2 Take special care with Ciprofloxacin 250mg Tablets)
• migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure)
• 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: Take special care with Ciprofloxacin 250mg Tablets)

Frequency not know (cannot be estimated from the available data)

• trouble associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the extremities
• 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 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.

How to store Ciprofloxacin 250mg Tablets

Keep your tablets in a safe place out of the sight and reach of children.
Do not store above 25°C and keep in the original container.
Do not use after the expiry date which is stated on the label after ‘Exp (MM/YY)’.
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.

Contents of the pack and other information

What Ciprofloxacin 250mg Tablets contain:
Each tablet contains ciprofloxacin hydrochloride equivalent to 250mg ciprofloxacin. Your tablets also contain maize starch, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 400 and titanium dioxide (E171).Ciprofloxacin – Taj Dearob Pharma | Ciprofloxacin 250mg Tablets are an antibiotic. Ciprofloxacin Tablets are used for the treatment of severe bacterial infections.
Ciprofloxacin – Taj Dearob Pharma | Ciprofloxacin 250mg Tablets are an antibiotic. Ciprofloxacin Tablets are used for the treatment of severe bacterial infections.
Ciprofloxacin – Taj Dearob Pharma | Ciprofloxacin 250mg Tablets are an antibiotic. Ciprofloxacin Tablets are used for the treatment of severe bacterial infections.