Ciprofloxacin 100mg Film-Coated Tablets
Please Note:
The applicant has been made aware that the frequency of undesirable effects listed in the Package Leaflet (as approved during the recent MR Renewal) does not correspond to the SmPC.
A revised version of the Package Leaflet has been submitted to the RMS for consideration. The changes proposed by the applicant are highlighted in the following Leaflet text.
Ciprofloxacin Merck NM 100 mg / 250 mg / 500 mg / 750 mg film-coated tablets
ciprofloxacin
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Ciprofloxacin Merck NM tablets are and what they are used for
2. Before you take Ciprofloxacin Merck NM tablets
3. How to take Ciprofloxacin Merck NM tablets
4. Possible side effects
5. How to store Ciprofloxacin Merck NM tablets
6. Further information.
The name of your medicine is Ciprofloxacin Merck NM 100mg, 250 mg, 500 mg and 750 mg film-coated tablets (referred to as Ciprofloxacin tablets in this leaflet).
1. What Ciprofloxacin tablets are and what they are used for
Your medicine comes as a film-coated tablet containing the active ingredient ciprofloxacin (as the hydrochloride monohydrate). Ciprofloxacin is an antibiotic used to treat a variety of different infections. These include infections of the skin, soft tissue (eg. leg ulcers), bone and respiratory system (chest infections such as pneumonia, bronchitis). Ciprofloxacin tablets can also be used for infections such as septicaemia (infection in the blood), gonorrhoea, prostate infections, urinary tract and gut infections. It can also be given to treat infection in patients with a weak immune system and to prevent infection in adults and children exposed to anthrax. Ciprofloxacin tablets can also be given to children and adolescents (aged 5 - 17 years) with cystic fibrosis to treat a chest infection.
Ciprofloxacin, which is contained in Ciprofloxacin tablets, may also be authorised to treat other illnesses, which are not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have further questions and always follow their instructions.
2. Before you take Ciprofloxacin tablets Do not take Ciprofloxacin tablets:
- if you are allergic (hypersensitive) to Ciprofloxacin or any of the other tablet ingredients
- if you have suffered an allergic reaction whilst taking a similar medicine (e.g. Norfloxacin)
- if you have a history of tendon (muscle) disorders e.g. tendonitis or ruptured tendons
- if you are under 18 years old (unless you have cystic fibrosis or have been exposed to anthrax).
- if you are taking tizanidine, for treatment of muscle spasms
Take special care with Ciprofloxacin tablets:
- if you have epilepsy
- if you have a condition affecting the nervous system eg. suffered a stroke, brain injury
- if you have or there is a family history of glucose-6-phosphate dehydrogenase deficiency
- if you have myasthenia gravis (a condition causing weak muscles)
- if you need an operation.
Avoid exposure to strong sunlight or UV light during treatment with Ciprofloxacin.
Ciprofloxacin should only be used for treatment in children for cystic fibrosis or to prevent infection following suspected expose to anthrax.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. In particular, inform your doctor if you are taking any of the following medicines:
■ Sucralfate (to treat ulcers), antacids or medicine containing iron, zinc, magnesium, aluminium or calcium (Ciprofloxacin should be taken either 2 hours before or at least 4 hours after)
■ Theophylline, for asthma
■ Medicine containing caffeine
■ Pentoxifylline, to treat poor circulation
■ Painkillers called NSAIDs (non-steroidal anti-inflammatory drugs) e.g. Ibuprofen
■ Ciclosporin, an anti-rejection medicine
■ Warfarin, to thin the blood, as your Warfarin dose may need adjusting
■ Glibenclamide, an antidiabetic medicine
■ Probenecid, to treat gout
■ Metoclopramide, an anti-sickness medicine
■ Mexiletine, to treat a heart condition
■ Phenytoin, for epilepsy
■ Ropinirole, to treat Parkinson’s disease
■ medicine containing Didanosine (DDI) (Ciprofloxacin should be taken either 2 hours before or at least 4 hours after)
■ Methotrexate, to treat cancer
■ Clozapine, for mental illness
■ Tizanidine, for muscle spasms
■ Tacrine, to treat symptoms of Alzheimer’s disease
■ Duloxetine, to treat depression
Taking Ciprofloxacin tablets with food and drink
Do not take with milk as the effect of Ciprofloxacin can be lowered if taken at the same time as dairy products (e.g. milk, yogurt) or liquid food supplements. Ciprofloxacin may make you feel less alert, particularly when taken with alcohol.
Pregnancy and breast feeding
Ciprofloxacin tablets should not be taken by pregnant or breast feeding mothers. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Ciprofloxacin may make you feel less alert, do not drive or operate machines until you know how you react.
Important information about some of the ingredients of Ciprofloxacin tablets
Tell your doctor if you know you are allergic to any of the tablet’s ingredients.
3. How to take Ciprofloxacin tablets
Always take Ciprofloxacin exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important that you complete the course of treatment as directed by your doctor even if you feel better. The dose to be taken will depend on the type of infection to be treated.
Swallow the tablets with a full glass of water.
Tell your doctor if you feel your symptoms are not improving, if you suffer from severe diarrhoea or notice blood in your stools. He may wish to change your medicine.
The following doses may be given for specific infections:
Adults:
Bronchitis, pneumonia, a prostate infection or severe gut infection - The usual dose is 500 mg of Ciprofloxacin twice daily.
Urinary tract infections - To treat cystitis a dose of 100 mg or 250 mg of Ciprofloxacin twice daily may be given.
Gonorrhoea - A single dose of 250 mg or 500 mg of Ciprofloxacin may be given.
Severe skin, soft tissue (e.g. leg ulcers) and osteomyelitis, septicaemia - The usual dose ranges from 500 mg to 750 mg of Ciprofloxacin twice daily.
Infection in patients with weak immune system - To treat an infection the usual dose ranges from 500 mg to 750 mg of Ciprofloxacin twice daily. Your doctor may prescribe this along with another antibiotic.
Anthrax: The recommended dose is 500 mg twice daily.
Elderly: Elderly patients should be given the lowest dose possible to treat the infection.
Children and adolescents (aged 5-17 years): Ciprofloxacin tablets should not be given to children except to treat cystic fibrosis patients or for the treatment of Anthrax.
Chest infections in cystic fibrosis patients: To treat a chest infection the usual dose is 40 mg/kg divided into two doses a day.
Anthrax: The recommended dose is 15mg/kg body weight twice daily, with a maximum daily dose of 1000 mg.
If you have kidney problems, severe liver problems or are a dialysis patient, and need Ciprofloxacin to treat a severe infection, your doctor may reduce the dose and how often you take your medicine.
Some patients may need regular blood tests to check the level of Ciprofloxacin in their blood.
If you take more Ciprofloxacin than you should, contact your doctor or local accident and emergency department immediately.
If you forget to take a dose of Ciprofloxacin tablets, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose, take the next dose on time. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Ciprofloxacin tablets can cause side effects, although not everybody gets them.
If you suffer from any of the following stop taking your medicine and go to your doctor at once:
■ Itchy skin, feel wheezy, difficulty breathing
■ Skin rashes which may be severe.
You may be allergic to your medicine.
Common side effects (Seen in more than 1 in 100 patients but less than 1 in 10) include:
• feeling or being sick
• abdominal pain or wind
• dizziness
• feeling tired
• notice a tremor
• fever
Uncommon side effects (seen in more than 1 in
• palpitations
• blood changes e.g. changes in white blood cell count
• unusual bruising or bleeding of the skin
• hiccups
• infections
• difficulty sleeping
• changes in taste or smell
Rare side effects (seen in more than 1 in 10,000
• severe diarrhoea with blood and mucus
• fainting or fits
• serious allergic reaction which causes swelling of the face or throat
• anxiety or distress
• depression
• a tingling in the hands and feet
• ringing in the ears
• hearing changes
• a racing heart beat
• dark urine and pale stools
• sweating
• pain passing urine or blood in the urine
Very rare side effects (seen in less than 1 in 10, •—difficulty sleeping •—sweating •—fits
•—anxiety or distress •—depression
• taste, smell or hearing changes •—eyesight changes
•—unusual bruising or bleeding of the skin •—yellowing of the skin or whites of the eyes •—liver problems
• dark urine
•— swollen ankles
• diarrhoea, stomach upset
• loss of appetite
• headache
• agitated or confused
• itchy skin, skin rash
1000 patients but less than 1 in 100) include:
• swelling or pain in the joints
• anaemia
• chest pain and breathlessness (in some cases caused by a blood clot in the lungs)
• nose bleeds or coughing up spots of blood
• muscle spasm
• liver problems
patients but less than 1 in 1,000) include:
• abdominal pain with sickness
• low blood pressure
• back pain
• muscle cramps
• a raised blood sugar level
• nightmares or hallucinations
• eyesight changes
• swollen ankles
• hot flushes
• yellowing of the skin or whites of the eyes
• skin sensitivity to light
• kidney problems
000 patients) include:
•—a tingling in the hands and feet
• loss of muscle co-ordination
• severe headache •—nightmares
•—hallucinations
• ringing in the ears
• loss of muscle control in the face and mouth
• severe skin reactions, ©washes or hives •—hives
• yellowing of the skin or whites of the eyes •—pale stools
• migraine
• a racing heart beat or other changes in heart rhythm
•—a raised blood sugar level •—pain passing urine or blood in the urine
• skin sensitivity to light
• inflammation of blood vessels, often with skin rash
• hot flushes
• high blood pressure
• inflamed tendon sheath
• swollen or torn Achilles tendons (the elderly and patients already taken a corticosteroid are more prone)
• weakness
• serum sickness-like reaction causing rashes, fever and joint pain
Very rarely patients may notice changes in their mood or behaviour which in some cases can lead to patients wanting to harm themselves. This can occur after the first dose of Ciprofloxacin. If you experience these effects stop taking the medicine and speak to your doctor.
In a few patients with myasthenia gravis taking Ciprofloxacin, the condition seems to have worsened.
Ciprofloxacin may also affect blood liver enzymes, bilirubin and urea levels. These effects can be seen from a blood test.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Ciprofloxacin tablets
Keep all medicines out of the reach and sight of children.
Do not use Ciprofloxacin tablets after the expiry date which is stated on the label / carton after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater 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 What Ciprofloxacin tablets contain
- The active substance is ciprofloxacin hydrochloride monohydrate (equivalent to ciprofloxacin)
- The other ingredients are microcrystalline cellulose, maize starch, crospovidone, pregelatinised starch, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), polydextrose, glycerol triacetate and macrogol.
What Ciprofloxacin tablets look like and contents of the pack
Ciprofloxacin tablets are white, film-coated tablets. The 100 mg tablets are round and marked "CF" on one side and “G” on the other; the 250 mg tablets are round and marked “CF | 250” on one side and “G” on the other. The 500 mg tablets are capsule-shaped and marked “CF | 500” on one side and “G” on the other; the 750 mg tablets are capsule-shaped and marked “CF | 750” on one side and “G” on the other.
Ciprofloxacin 100 mg tablets are available in blister packs of 6, 10, 12, 14, 16, 20, 100, 120 tablets. Ciprofloxacin 250 mg, 500 mg, 750 mg tablets are available in blister packs of 1, 6, 8, 10, 12, 14,
16, 20, 100, 120 tablets.
Ciprofloxacin tablets are available in bottles of 6, 10, 12, 14, 16, 20, 100, 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Merck NM AB Box 230 33 104 35 Stockholm Sweden
Manufacturer:
Merck Farma y Quimica SA, E-08100 Mollet del Valles, Barcelona, Spain. This leaflet was last revised in 2008-01-29
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