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The active ingredient is ciprofloxacin.
Each film-coated tablets contains:
ciprofloxacin (DOE) (hydrochloride) ……………………………………500-750mg.
The excipients are: croscarmellose sodium, microcrystalline cellulose, colloidal anhydrous silica, maize starch, sodium lauryl sulfate, magnesium stearate, talc, hypromellose, titanium dioxide, macrogol 400.
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WHAT IS CIPRO
Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets comes in tablets. Each package contains 10 or 20 scored tablets.
Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets belongs to a group of antibiotics known as quinolones.
Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets is indicated for the treatment of infections caused by ciprofloxacin sensitive bacteria, such as:
- Respiratory tract infections (including cystic fibrosis and carbuncle)
- Ear and throat infections
- Urinary tract and genital infections (genitourinary)
- Abdominal infections (including carbuncle)
- Blood infections (systemic)
- Bone and joint infections (osteoarticular)
- Skin and soft tissue infections
- Infections of the gall bladder
Cipro - ciprofloxacin cinfa ® is also indicated for the prevention of carbuncle.
BEFORE TAKING CIPRO
Do not take Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets:
- If you are allergic to ciprofloxacin or other quinolone antibiotics or to any other ingredients of this medication.
- You experience any type of pain or inflammation around the calf area, in particular Achilles tendon. If this occurs, patients should discontinue ciprofloxacin treatment, rest completely and inform their doctor immediately.
- You suffer impaired renal function, as your doctor should adjust the dosage.
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Take special care with Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets if:
- You suffer or have suffered epileptic fits and / or convulsions; altered blood flow, or have suffered thrombosis and / or cerebral haemorrhage.
- You are older than 65 and are being treated with anti-inflammatory medications (corticosteroids), tendon inflammation and rupture may occur with quinolone antibiotics. At the first sign of pain or inflammation, patients should discontinue ciprofloxacin treatment and rest the affected limbs.
- You develop severe and persistent diarrhoea, whilst you are taking your tablets, or after stopping your tablets, you should consult your doctor immediately as you may be suffering from a special type of colitis called pseudomembranous colitis, which can lead to a fatal outcome.
- You have a family history of or actual defects in glucose-6-phosphate dehydrogenase (genetic or acquired metabolic disorder).
- During treatment with this medication, patients should avoid exposure to UV radiation and exposure to excessive sunlight, if done so you should protect your skin appropriately.
- If you suffer from myasthenia gravis, Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets should be used with precaution.
Consult your doctor, if you have experienced any of the above symptoms.
Pregnancy and lactation:
Consult your doctor or pharmacist before taking any medication.
Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets is not recommended during pregnancy or lactation.
Driving and using machines:
Treatment with Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets may impair the patient's ability to drive or to operate machinery. This risk is increased during the first days of treatment, particularly when taken with alcohol and if dosage of this medication is increased, therefore you should not drive or operate dangerous machinery in any of these situations.
Taking other medications:
Inform your doctor or pharmacist if you are taking or have recently taken any other medications including those you have bought without a prescription.
Some medications may affect the action of ciprofloxacin, such as:
- Antacids, iron, sucralfate and calcium, didanosine, oral nutritional solutions and dairy products: the simultaneous administration of these medications with ciprofloxacin may reduce the effect of ciprofloxacin: Therefore ciprofloxacin should be administered 1 to 3 hours before or 4 hours after the above-mentioned medications.
- Theophylline, caffeine or pentoxifylline: increased plasma levels of these medications have been observed following concurrent administration with ciprofloxacin, therefore the risk of adverse effects of these medications also increases.
- Non-steroidal anti-inflammatory drugs (NSAIs): the administration of these medications (except for acetylsalicylic acid) in combination with very high doses of quinolones can provoke convulsions.
- Cyclosporin (medication used to prevent transplant rejection): may alter kidney function when administered simultaneously with ciprofloxacin.
- Warfarin (medication used to thin the blood and prevent blood clots), glibenclamide (medication used to treat diabetes), phenytoin (medication used in the treatment of epilepsy), ropinirole (medication used in the treatment of Parkinson's disease): when taken concomitantly with ciprofloxacin, the effects of these medications may increase.
- Probenecid (medication used in the treatment of gout), metoclopramide (medication used in the treatment of nausea and vomiting): when taken together with ciprofloxacin, it may increase the ciprofloxacin serum concentrations and therefore, increase the effects of this medication.
- Opiate premedicants (medications used for postoperative sedation): when taken together with ciprofloxacin, it may decrease the ciprofloxacin serum concentrations and therefore, decrease the effects of this medication.
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HOW TO TAKE CIPRO
The tablets are usually swallowed whole, without chewing with a small amount of fluid (for example, a glass of water) and preferably two hours before or after a meal.
You should drink plenty of water during every day of your treatment with this medication.
Follow these instructions unless told otherwise by your doctor.
Remember to take your medication.
Your doctor will indicate the dosage required and the duration of treatment with Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets.
Do not discontinue treatment before the recommended period, as the infection may not be totally cured.
The usual dose for adults is 1 tablet every 12 hours. In the case of treatment or prevention of carbuncle, the usual dose is 500 mg. orally every 12 hours.
In acute infections, the usual treatment period is 5 to 10 days. However, the treatment should continue for three days after the signs and symptoms of the infection have disappeared.
In the case of treatment or prevention of carbuncle, the usual treatment period is 60 days.
Elderly:
The dosage recommended is the same as for adults. The dosage should only be adjusted in the case of impaired renal function.
Children and adolescents (5 to 17 years):
The recommended dosage is 20 mg. / kg. orally every 12 hours. The maximum daily dose is 1500 mg. In the case of treatment or prevention of carbuncle, the recommended dose is 10-15 mg. / kg. orally every 12 hours.
Impaired hepatic function:
No adjustment of dosage is necessary in adults.
If you take more Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets than you should
The symptoms that may be experienced are: dizziness, tremor, headache, fatigue and confusion; as well as gastrointestinal discomfort and abnormalities of renal and hepatic function.
In the case of an overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital or contact your local poison centre (Servicio de Información Toxicológica (Telephone 91 562 04 20)).
If you forget to take a dose of Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets
If you forget to take a dose, take it as soon as you can and continue treatment as recommended. However, if it is almost time for your next dose, it is better not to take the missed dose, just take the next dose on time.
Do not take a double dose to make up for the missed dose.
POSSIBLE SIDE EFFECTS
Like all medicines, Cipro - ciprofloxacin cinfa ® 500 mg. film-coated tablets may have adverse effects.
The most frequently reported adverse reactions involve the gastrointestinal tract, the central nervous system and the skin.
The following adverse reactions have been observed:
Effects on the gastrointestinal tract
Common: nausea, vomiting, abdominal pain, flatulence and diarrhoea.
Rare: pseudomembranous colitis.
Effects on Central Nervous System
Common: dizziness, headache, fatigue, agitation and confusion.
On very rare occasions other reactions like insomnia, anxiety or sweating may be experienced.
Effects on sensory organs
Very rare: impaired sense of taste and smell and visual disturbances.
Skin and hypersensitivity reactions
Common: Skin reactions such as pruritus and rash.
On very rare occasions spots on the skin may appear. Other allergic reactions like swelling, respiratory difficulties, circulatory collapse, and impairment of renal and / or hepatic function.
Effects on the cardiovascular system
Uncommon: palpitation.
Very rare: swelling, feelings of suffocation, headache, fainting, and tachycardia.
Effects on the respiratory tract
Uncommon: respiratory difficulties, nasal bleeding, coughing and haemoptysis.
Effects on the locomotor apparatus
Uncommon: joint pain and swelling.
Very rare: muscular pains. In isolated cases: tendinitis (for example, Achilles tendon). Exacerbation of symptoms of myasthenia.
Effects on blood and blood components
Uncommon: blood component alterations (eosinophilia, leukopenia, anaemia, thrombocytopenia).
Very rare: other blood component alterations (leucocytosis, thrombocytosis, haemolytic anaemia, pancytopenia, agranulocytosis), altered prothrombin levels, hyperglycaemia, crystalluria or haematuria.
Other adverse reactions
Long-term and repeated use of ciprofloxacin can lead to superinfections with resistant bacteria or fungi.
If you experience any of these adverse effects you should inform your doctor. He/she will evaluate whether it is convenient or not to suspend treatment.
If you suffer from any other unusual or unexpected symptoms not mentioned in this leaflet, consult your doctor or pharmacist.
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STORAGE OF CIPRO
No special storage precautions are necessary.
Expiry
This medication should not be used after the expiry date indicated on the carton.
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