Active ingredient
- ciprofloxacin hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0022.
Ciprofloxacin 250mg & 500 mg film-coated tablets
Package leaflet: Information for the patient
Ciprofloxacin 250mg and 500mg Film-Coated Tablets
Ciprofloxacin Hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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.
1. What Ciprofloxacin tablets are and what they are used for
Ciprofloxacin tablet 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 are used in adults to treat the following bacterial infections:
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:
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 tablets
Do not take 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,
If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
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.
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:
Ciprofloxacin can increase the levels of the following medicines in your blood:
Some medicines reduce the effect of Ciprofloxacin tablets. Tell your doctor if you take or wish to take:
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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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.
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 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 on 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.
Serious side effects
Stop taking Ciprofloxacin tablets and see a doctor or go to a hospital straight away if you notice any of the following serious side effects- you may need urgent medical attention:
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Other side effects
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Not known (frequency cannot be estimated from the available data)
Very rare cases of long lasting (up to months or years) or permanent adverse drug reactions, such as tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.
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 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 use this medicine after the expiry date, which is stated on the blister or carton after “EXP”: The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 to protect the environment.
6. Contents of the pack and other Information
What Ciprofloxacin tablets contain
The active substance is ciprofloxacin.
Other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, talc, colloidal anhydrous silica, sodium starch glycolate (type A), hypromellose, macrogol 400 and titanium dioxide (E171).
Ciprofloxacin tablets come in two strengths containing 250mg and 500mg of ciprofloxacin.
What Ciprofloxacin tablets look like and contents of the pack
Ciprofloxacin 250 mg Film-coated Tablets are white, round film-coated tablets debossed with ‘250’ on one side and plain on the other side.
Each tablet contains 250 mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride).
Ciprofloxacin 500 mg Film-coated Tablets are white, caplet-shaped film-coated tablets debossed with ‘500’ on one side and plain on the other side.
Each tablet contains 500 mg of the active ingredient ciprofloxacin (as ciprofloxacin hydrochloride).
The tablets are available as blister packs of 1, 8, 10, 14, 16, 20, 28, 32 or 100 tablets.
Not all pack sizes may be marketed.
The marketing authorisation holder and manufacturer
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in April 2019.
Advice/medical education
Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness. Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:
Consequently, to preserve the efficacy of this drug:
1) Use antibiotics only when prescribed.
2) Strictly follow the prescription.
3) Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
4) Never give your antibiotic to another person; maybe it is not adapted to her/his illness.
5) After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.
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