Ciprofloxacin 250mg Film-Coated Tablets
~
~
o
package leaflet: INFORMATION FOR THE USER
Ciprofloxacin 250mg Film-Coated Tablets Ciprofloxacin 500mg Film-Coated Tablets
Ciprofloxacin hydrochloride
(Referred to as Ciprofloxacin Tablets in the remainder of the leaflet)
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 Tablets are and what they are 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
i. what ciprofloxacin tablets are and
WHAT THEY ARE USED FOR
The name of your medicine is Ciprofloxacin Tablets. The active ingredient in your medicine is ciprofloxacin hydrochloride.
Ciprofloxacin hydrochloride belongs to a group of medicines called quinolone antibiotics, which are used to treat infections caused by certain types of bacteria.
Adults
Ciprofloxacin Tablets are used in the following conditions:
• respiratory infections, such as those to the windpipe or lungs, including pneumonia
• worsening of a breathing condition known as Chronic Obstructive Pulmonary Disease by a bacterial infection
• respiratory infections in patients with cystic fibrosis, including a lung condition known as bronchiectasis
• serious ear infections, which last a long time or recur
• worsening of sinus infections caused by certain bacteria
• kidney and bladder infections
• infections to male or female genitals including gonorrhoea, or swelling of the testicles
• infections of the stomach and intestine
• infections of the skin, soft tissue, bones or joints
• treatment or prevention of infections in patients with low white blood cell count (neutropenia)
• prevention of infections due to bacteria causing meningitis (such as Neisseria meningitides)
• treatment of exposure to anthrax
• treatment of severe infections or those caused by more than one type of bacterium.
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 conditions:
• respiratory infections in patients who have cystic fibrosis caused by certain bacteria (Pseudomonas aeroginosa)
• serious kidney and bladder infections, including a condition called pyelonephritis
• exposure to anthrax
• other severe infections if a doctor considers it necessary.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ciprofloxacin tablets
Do not take Ciprofloxacin Tablets If you:
• are allergic (hypersensitive) to ciprofloxacin hydrochloride, to other quinolone antibiotics or to any of the other ingredients in this medicine (see section 6)
• are taking a medicine called tizanidine, used in the treatment of multiple sclerosis.
Warnings and Precautions
Talk to your doctor before taking Ciprofloxacin Tablets if you:
• have ever had kidney problems, because your treatment may need to be adjusted
• suffer from epilepsy or other neurological conditions
• have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Tablets
• are diabetic because you may experience a risk of hypoglycaemia (low blood sugar) with Ciprofloxacin Tablets
• have myasthenia gravis (a type of muscle weakness), because symptoms can be aggravated
• have a history of heart problems. Caution should be taken when using this kind of medicine, 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 Other medicines and Ciprofloxacin Tablets).
• 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, angioedema). 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
• Pain and swelling in the Joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. At the first sign of any pain or inflammation stop taking Ciprofloxacin Tablets 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, such as seizures (fits). If this happens, stop taking Ciprofloxacin Tablets and contact your doctor Immediately
• 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. If this happens, stop taking Ciprofloxacin Tablets and contact your doctor immediately
• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. lf this happens, stop taking Ciprofloxacin Tablets and contact your doctor immediately
• Hypoglycaemia (low blood sugar) 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 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 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 Tablets if you have to provide a blood or urine sample
• 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, stop taking Ciprofloxacin Tablets and 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
• 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.
• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
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).
Tell your doctor if you are taking any of the following medicines:
• vitamin K antagonists (e.g. warfarin, acenocoumarol or fluindione) or other medicines used to thin the blood
• probenecid, used to treat gout
• methotrexate, used to treat certain types of cancer, psoriasis, or rheumatoid arthritis
• theophylline, used to treat asthma
• clozapine or olanzapine, used to treat certain mental health problems
• ropinirole, used to treat Parkinson's disease
• tizanidine, used in the treatment of multiple sclerosis
• phenytoin, used to treat epilepsy
• metoclopramide (for nausea and vomiting)
• ciclosporin, an immunosuppressant used 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, used to treat sleeping problems
Ciprofloxacin Tablets may increase the levels of the following medicines in your blood:
• pentoxifylline, used to treat circulatory disorders
• caffeine medicines or products, used to improve alertness
• duloxetine (for depression, diabetic nerve damage or incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g. for erectile dysfunction)
• agomelatine, used to treat depression
Some medicines reduce the effect of Ciprofloxacin Tablets. Tell your doctor if you take or wish to take:
• antacids used to reduce the acid in the stomach
• omeprazole
• mineral supplements
• sucralfate, used to treat ulcers in the gut
• medicines that reduce the amount of phosphate in the blood (e.g, sevelamer, used to treat severe kidney problems)
• medicines (e.g. didanosine, used to treat HIV) or food supplements containing calcium, magnesium, aluminium, or iron.
Taking Ciprofloxacin Tablets with food and drink
Do not eat or drink any dairy products or drinks containing calcium whilst you are taking Ciprofloxacin Tablets.
Pregnancy and breast-feeding
You should not use Ciprofloxacin Tablets if you are pregnant, planning to get pregnant, or are breastfeeding.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Ciprofloxacin Tablets may make you feel less alert. If affected, do not drive or operate machinery.
3. how to take ciprofloxacin tablets
Always take Ciprofloxacin Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Your doctor will decide on your dose depending on the condition you are being treated for. The dose in children will also depend on their weight. Your treatment will usually last between 1 day and 6 months and will depend on the condition being treated.
Swallow the tablets with plenty of water. Do not chew.
• Take the tablets around the same time every day
• Take the tablets at mealtimes or between meals. Do not take Ciprofloxacin Tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).
If you take more Ciprofloxacin Tablets than you should
If you or anybody else, including a child, takes too many Ciprofloxacin Tablets, contact your nearest hospital casualty department immediately. Always take the remaining tablets in the pack, and this leaflet with you. Symptoms of overdose include dizziness, shaking, headaches, feeling tired, fits, seeing things that are not there, feeling confused, tummy pain, kidney and liver problems, crystals or blood in the urine.
You will be monitored to ensure your kidneys are working properly and that you are not dehydrated.
If you forget to take Ciprofloxacin Tablets
If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed.
If you stop taking Ciprofloxacin Tablets
Do not stop taking this medicine without talking to your doctor first, even if you begin to feel better. If you stop taking this medicine too soon, the symptoms of the infection may return or get worse. You may also develop a resistance to the medicine if you stop taking it too soon.
If you have any further questions on the use of Ciprofloxacin Tablets, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Ciprofloxacin Tablets can cause side effects, although not everybody gets them.
The following side effects may be experienced:
If you experience any of the following, stop taking Ciprofloxacin Tablets and seek medical help immediately:
• severe allergic reaction (symptoms include difficulty in breathing or dizziness, rapid swelling of the mouth, lips and tongue)
• severe skin rashes with fever, blistering or peeling of the skin around the mouth, eyes, nose and genitals
• liver problems (symptoms include loss of appetite, yellowing of the skin or eyes, dark coloured urine) that can lead to life-threatening liver failure
• 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
Other side effects may include:
Common side effects (can affect 10 in every 100 people):
• being or feeling sick, diarrhoea
• joint pain in children.
Uncommon side effects (can affect between 1 and 10 in every 1,000 people):
• fungal infections
• increased number of white cells, protein and salts in the blood, shown in blood tests
• loss of appetite, hyperactivity or agitation
• headache, dizziness, sleeping problems, or problems with taste
• being sick, tummy pain, stomach upset or wind
• rash, itching, hives (red, raised, itchy bumps)
• joint, muscle or bone pain in adults
• kidney problems
• generally feeling unwell, or having a fever.
Rare side effects (can affect 10 in every 10,000 people):
• swollen bowel (symptoms include severe or persistent diarrhoea, stomach pain and blood in your stools). This can be fatal in very rare cases (see section 2: Take special care with Ciprofloxacin Tablets)
• blood cell count changes shown in blood tests, or blood clotting problems
• increased or decreased blood sugar levels, shown in blood tests
• feeling confused, disorientated, anxious, depressed, or having strange dreams or seeing things that are not there
• pins and needles, changes in your vision or sense of taste, touch, smell or hearing, including ringing in the ears
• shaking, feeling dizzy, fits (seizure), especially if you
suffer from epilepsy or other neurological conditions (see section 2: Take special care)
• increased or rapid heartbeat
• widening of blood vessels leading to low blood pressure, causing fainting or dizziness
• shortness of breath
• liver disorders: jaundice or hepatitis
• sensitivity to light (see section 2: Take special care with Ciprofloxacin Tablets)
• muscle pain, swollen joints, increased muscle tone, muscle cramp
• painful kidneys (pain in the lower back and tummy), kidney failure, blood or crystals in the urine
• swelling under the skin or excessive sweating.
Very rare side effects (can affect 1 in every 10,000 people):
• a reduction in the number of red and white blood cells or platelets in the blood (shown in blood tests), or decreased ability of the body to make blood cells, all of which can be fatal (see section 2: Take special care with Ciprofloxacin Tablets)
• mental health problems, such as depression or psychosis (see section 2: Take special care with Ciprofloxacin Tablets)
• headaches, migraine, coordination problems, unsteady walk, sense of smell problems
• difficulty in seeing colours
• muscle weakness, worsening of the symptoms of myasthenia gravis (a disease that causes muscle weakness or tiredness).
Frequency Not known (cannot be estimated from the available data)
• pain, burning, tingling, numbness and/or weakness in arms and legs (see section 2, Take special care with Ciprofloxacin Tablets)
• irregular heart beat
• 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).
• feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)
• hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms
• 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, 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 tablets
Keep this medicine out of the sight and reach of children
• Do not store above 25°C
• Store in the original packaging
• Do not take Ciprofloxacin Tablets after the expiry date stated on the packaging. The expiry date refers to the last day of the 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 Tablets contain
The active ingredient is ciprofloxacin hydrochloride.
Each Ciprofloxacin 250 mg Film-coated Tablet contains 250 mg of ciprofloxacin hydrochloride.
Each Ciprofloxacin 500 mg Film-coated Tablet contains 500 mg of ciprofloxacin hydrochloride.
The other ingredients are:
Tablet core: microcrystalline cellulose, crospovidone, colloidal anhydrous silica, magnesium stearate. Film-coating: hypromellose, macrogol 400 and titanium dioxide (E171).
What Ciprofloxacin Tablets look like and the contents of the pack
Ciprofloxacin 250mg Tablets are white or yellowish, scored, 11 mm round, biconvex, film-coated tablets marked C250.
Ciprofloxacin 500mg Tablets are white or yellowish, scored, 18x8mm oblong, biconvex, film-coated tablets marked C500.
Each strength of tablet is available in blister strips of aluminium /PVC in a cardboard outer container in pack sizes of 10, 20 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
|
Product name |
Reference number |
|
Ciprofloxacin 250 mg Film-Coated Tablets |
29831/0310 |
|
Ciprofloxacin 500 mg Film-Coated Tablets |
29831/0309 |
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 10/2016.
101774/9
Code : PB/Drugs/1802-OSP
Twockhardt