Cipro

Cipro is an antibiotic intended for the treatment of infectious diseases of bacterial origin. It belongs to the fluoroquinolone family and has antibacterial activity against a large number of strains. Medicine is indicated in adults for the treatment of the following infections:

• Respiratory tract infections
• ENT infections
• Kidney and urinary tract infections
• Certain infections of the genital tract
• Gastrointestinal infections
• Peritoneal infections, including pelvic infections
• Skin and soft tissue infections
• Bone and joint infections

Prevention and treatment of anthrax following inhalation of anthrax bacilli (Bacillus anthracis). The efficacy of Cipro in anthrax has been demonstrated in animal models.

Cipro may also be used for the prevention of meningococcal meningitis following close contact with patients suffering from this disease.

What Does Cipro Contain?

Active ingredients:

• 1 film-coated tablet Cipro 250 mg contains 250 mg ciprofloxacin
• 1 film-coated tablet Cipro 500 mg contains 500 mg ciprofloxacin
• 1 film-coated tablet Cipro 750 mg contains 750 mg ciprofloxacin

Excipients:

• Excipients for tablet manufacture

Packaging Is Available On The Market

250 mg and 500 mg film-coated tablets: packs of 10 and 20 film-coated tablets (scored, breakable).

750 mg film-coated tablets: packs of 20 film-coated tablets (scored, breakable).

Uses

It is up to your doctor to determine the dose and duration of treatment. Only if you follow these instructions carefully will you obtain maximum benefit from treatment with Cipro.

Do not stop treatment prematurely, even if you feel better. The symptoms of the disease often disappear before the infection is completely healed.

If the treatment is not continued long enough or stopped prematurely, the disease may flare up again.

Swallow the tablets without chewing them with liquid. Avoid chewing the tablets because of their unpleasant taste. Always take the film-coated tablets at the same time if possible. The tablets can be taken with or without meals. Taking them on an empty stomach speeds up absorption of the active ingredient into the body. Do not take Cipro tablets with dairy products, such as milk or yoghurt, or with drinks rich in mineral salts (e.g. calcium-enriched orange juice), as resorption is impaired and effectiveness reduced.

If you miss a dose of Cipro and it is more than 6 hours before your next scheduled dose, take the missed dose immediately. Then take your next dose at the usual time. If it is less than 6 hours before the next scheduled dose, do not take the missed dose. Then take the next dose at the usual time.

Do not take a double dose to make up for missed doses.

Dosage

Depending on the severity of the illness, the sensitivity of the germ and the site of infection, your doctor will prescribe one of the following dosages:

Adults

Film-coated tablets (single/daily doses)

Simple infections of the upper and lower urinary tract

• 2 × 250 mg to
• 2 × 500 mg

Acute uncomplicated cystitis in non-menopausal women

• 500 mg single dose

Serious urinary tract infections (depending on severity)

• 2 × 500 mg to
• 2 × 750 mg

Gonococcal urethritis and cervicitis

• 500 mg as a single dose

Genital tract infections

• 2 × 500 mg to
• 2 × 750 mg

Respiratory tract infections (e.g. bronchitis), otitis media

• 2 × 500 mg to
• 2 × 750 mg

Infections of the digestive tract

• 2 x 500 mg

Pelvic infections including pelvis

• 2 × 500 mg to
• 2 × 750 mg

Skin and soft tissue infections

• 2 × 500 mg to
• 2 × 750 mg

Bone and joint infections

• 2 × 500 mg to
• 2 × 750 mg

Serious infections (e.g. osteomyelitis, inflammation of the outer ear, respiratory infections in cystic fibrosis)

• 2 × 750 mg

Prevention of meningococcal meningitis

• 500 mg single dose

In the case of uncomplicated infections of the efferent urinary tract, a 3-day course of treatment is recommended.

The duration of treatment for the usual indications is set by the doctor. It generally lasts from 7 to 14 days, and up to 3 months in the case of severe infections.

If the symptoms of gonorrhoea (e.g. discharge) do not disappear within a few days, the doctor should be consulted for a check-up to rule out a concomitant infection with germs that have not been eradicated by the single dose.

Children and adolescents during growth

Children and adolescents should not take Cipro during growth.

Exceptions

Treatment of acute infectious flare-ups in patients with cystic fibrosis.

• Cystic fibrosis is an inherited metabolic disease resulting in increased production of excessively viscous secretions from the bronchial and digestive glands;
• complicated urinary tract infections refractory to other therapies;
• anthrax.

Dosage in cystic fibrosis accompanied by acute infectious outbreaks

In children and adolescents (5-17 years) suffering from cystic fibrosis, the recommended dosage for acute infectious outbreaks is 20 mg of ciprofloxacin per kg of body weight, taken orally twice daily, 12 hours apart. The daily dose should not exceed 2 × 750 mg (oral). The recommended duration of treatment is 10-14 days.

Dosage for complicated urinary tract infections

In children and adolescents (5-17 years) with complicated urinary tract infections, the recommended dose is 2 x 10 - 20 mg of ciprofloxacin per kg of body weight, divided into 2 single doses 12 hours apart. Do not exceed a daily dose of 2 x 750 mg. The recommended duration of treatment is 10-21 days.

There is no experience of dosing in children with impaired renal or hepatic function.

Dosage in cases of anthrax (children, adolescents and adults)

Treatment should begin immediately after suspected or confirmed inhalation of anthrax agents. The prevention and treatment of anthrax is usually initiated with an infusion of ciprofloxacin. Depending on the course of the disease, ciprofloxacin tablets may then be administered.

Adults: 2 times daily 1 film-coated tablet of Cipro 500 mg.

Children: 2 times daily 10-15 mg per kg of body weight; do not exceed the maximum single dose of 500 mg in children.

Duration of treatment: 60 days for the prevention and treatment of infections following inhalation of anthrax agents.

Side Effects

In general, Cipro may cause the following side effects (listed by frequency):

Common (affects 1 to 10 in 100 users)

Nausea, diarrhoea, digestive disorders and inappetence. Joint pain in children.

If severe and persistent diarrhoea occurs during or after treatment, you should consult your doctor immediately. Do not try to treat it yourself, e.g. with preparations that inhibit peristalsis (intestinal movement)!

Occasional (affects 1 to 10 users out of 1000)

Candidiasis ("thrush", an infection of the oral cavity, ENT tract or genitals caused by fungi), allergic reactions such as oedema of the skin (urticaria) and mucous membranes, rash, itching, fever, excitement, headache, drowsiness, insomnia, sleep disorders, taste disorders, vomiting, belching, bloating, abdominal and lower abdominal pain, fatigue, joint pain, kidney function disorders, non-specific general pain, malaise.

Rare (affects 1 to 10 in 10,000 users)

Allergic reactions such as breathing difficulties or asthmatic attacks; circulatory disturbances, e.g. increased heart rate, heart rhythm disturbances, fainting, hypotension or oedema; confusion, anxiety states, nightmares, depression (up to and including self-destructive behaviour, e.g. suicidal ideation and suicide or suicide attempts). and suicide or attempted suicide), hallucinations, dizziness, numbness or tingling in the arms and legs, tremors, shaking, convulsions (including epileptic seizures), visual disturbances, tinnitus, deafness, jaundice, hyperglycaemia (increased blood sugar), hypoglycaemia (decreased blood sugar), hepatitis (inflammation of the liver). Please inform your doctor immediately if you develop symptoms of hepatitis. Early signs of hepatitis include fatigue, weakness, malaise, inappetence, nausea or vomiting. Other symptoms are yellowing of the eyes (conjunctiva), skin or a discoloured stool.

Other rare side effects: photosensitivity, pustules, blistering, skin discolouration, pain in the arms and legs, twitching, backache, muscle pain, muscle hardening, crystalluria (crystallisation of the active substance in the kidneys (see "What precautions should be taken when taking Cipro?") and sweating.

Very rare (affects less than 1 in 10,000 users)

Allergic reactions up to and including anaphylactic shock. In the event of hypersensitivity reactions, please contact your doctor immediately.

Bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially fatal). Symptoms of a bullous skin reaction include severe disturbance of general condition, high temperature, painful pustules in the mouth, throat and genital area, severe conjunctivitis.

Other very rare side-effects: psychosis (up to and including self-destructive behaviour, e.g. suicidal ideation and suicide or suicidality). Other very rare side-effects: psychoses (up to and including self-destructive behaviour, e.g. suicidal ideation and suicide or attempted suicide), coordination disorders, migraine, loss of sense of smell (generally reversible when treatment is stopped), abnormal colour perception, double vision, hearing problems (especially in the high-frequency region), stabbing pain, high blood pressure, vasculitis (pustules with crusting), hot flushes, chest pain, inflamed tendons, partial or total rupture of tendons, particularly the Achilles tendon, hesitant gait, general feeling of weakness, inflammation of the pancreas (pancreatitis). Tell your doctor immediately if you notice any signs of pancreatitis (severe abdominal cramps, nausea, vomiting). In patients with myasthenia gravis, worsening of symptoms has been observed.

Cipro may also alter the blood count.

Following the marketing of ciprofloxacin, cases of peripheral nervous system disorders have been reported (pain, burning, tingling, numbness and/or weakness of the limbs), as well as cases of acute cardiac rhythm disorders and irregular heartbeat. In the event of the appearance of cardiac arrhythmias, the doctor treating the patient should be informed immediately.

The use of fluoroquinolone antibiotics has been associated with very rare cases of long-lasting (several months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, pain in the limbs, difficulty walking, unusual sensations such as tingling, pins and needles, tickling, burning, numbness or pain in the joints, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory disorders, as well as deterioration in hearing, sight, taste and smell, disorders of the central or peripheral nervous system or muscular disorders, in some cases independently of the existence of risk factors.

Cases of widening and weakening of the aortic wall or tearing of the aortic wall (aneurysms and dissections), which may rupture and be fatal, and leakage of heart valves have been reported in patients receiving fluoroquinolone therapy.

Precautions

Ciprofloxacin may cause serious adverse reactions affecting different organ systems which may occur simultaneously. These side effects include tendonitis and tendon rupture, joint pain, neuropathic symptoms and psychiatric reactions. These adverse reactions may occur within hours or weeks of taking Cipro and may affect patients of any age, as well as patients without pre-existing risk factors.

Please discuss this with your doctor before taking Cipro:

• if you have been diagnosed with a dilated or "bulging" large blood vessel (aneurysm of the aorta or peripheral aneurysm of a large vessel).
• if you have previously suffered an aortic dissection (a tear in the wall of the main artery).
• if you have been diagnosed with heart valve leakage (heart valve regurgitation).
• if there have been cases of aortic aneurysm or aortic dissection or congenital valve disease in your family or if other risk or predisposing factors (which favour) aortic aneurysm and aortic dissection are known (e.g. connective tissue diseases such as Marfan's syndrome, Ehlers Danlos syndrome, Turner's syndrome, Sjögren's syndrome (an inflammatory autoimmune disease), Takayasu's arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (an infection of the heart).

In addition, if you suddenly experience severe pain in your stomach, chest or back, which may be symptoms of aortic aneurysm and dissection, go immediately to the nearest emergency department.

Your risk may be increased if you are being treated with systemic corticosteroids.

If you begin to experience rapid shortness of breath, particularly when lying flat on your bed, or if you notice swelling of your ankles, feet or abdomen, or a new onset of heart palpitations (a sensation of rapid or irregular heartbeats), you should inform a doctor immediately.

Like certain other antibiotics, Ciprofloxacin causes an abnormality in cardiac activity (a prolongation of the QT interval) visible on the ECG (electrocardiogram = electronic recording of the heart's activity). You should therefore inform your doctor if you suffer from heart problems (e.g. heart failure, myocardial infarction or a "slow heartbeat" (bradycardia)), sodium imbalances, particularly in the event of a drop in blood potassium or magnesium levels (hypokalaemia or hypomagnesaemia) and/or if you are taking other medicines likely to cause changes in the ECG. Women and elderly patients may be more sensitive to treatment.

If you experience severe and persistent diarrhoea during or after treatment, you should inform your doctor or pharmacist immediately. This is pseudomembranous colitis. This intestinal condition, triggered by antibiotic treatment, may be life-hreatening and requires immediate and appropriate treatment. When such diarrhoea occurs, avoid taking medicines that inhibit peristalsis (intestinal movement).

Please inform your doctor if you suffer from liver failure. Cases of liver disease leading to total liver failure have been described in association with Ciprofloxacin. Symptoms include lack of appetite, jaundice (yellowing of the skin, mucous membranes and sclera), dark coloured urine, itching or pain in the abdomen. If you notice these symptoms, please stop taking Cipro and contact your doctor immediately.

Skin sensitivity and allergic reactions may occur after the first dose. In very rare cases, anaphylactic reactions may progress to life-threatening shock. Hypersensitivity may be manifested by the following symptoms: skin rash, oedema (swelling of the skin and/or mucous membranes), tightness in the chest, dizziness, nausea or risk of fainting or feeling dizzy on rising. In these cases, Cipro should be discontinued immediately and medical treatment (e.g. treatment for shock) should be instituted.

During treatment with Cipro, avoid excessive exposure to sunlight or solarium visits, as unpleasant reddening or inflammation of the skin (photosensitisation) may occur in sensitive patients.

Ciprofloxacin may trigger photosensitivity reactions in rare cases. These patients should avoid excessive exposure to sunlight while taking ciprofloxacin. If this is not possible, they should apply sunblock cream with a high sun protection factor, and wear clothing that covers the arms and legs, and possibly a hat for the face.

In patients with known brain damage, particularly those with epileptic seizures or other neurological conditions, particular care should be taken when administering Cipro.

Psychiatric reactions (e.g. nervousness, agitation, insomnia, anxiety states, nightmares, paranoid thoughts, confusion, tremor, hallucinations and depression) may occur after the first dose of Cipro. If you suffer from depression or psychosis, your symptoms may worsen under treatment with Cipro and in rare cases progress to self-destructive behaviour.

Cipro, like other fluoroquinolone antibiotics, may trigger convulsive seizures or lower the convulsive threshold. If seizures occur, treatment with this drug should be discontinued. Consult your doctor if you suffer from epilepsy or other disorders of the central nervous system (e.g. lowered convulsive threshold, history of epileptic seizures, reduced cerebral circulation, altered cerebral structure or stroke). In these cases, Cipro, like other medicines in this class, should be used with caution.

During treatment with fluoroquinolones such as Cipro, damage to the peripheral nervous system may occur. Such neuropathy may manifest rapidly. Symptoms of nerve damage may include pain, burning, tingling, numbness and/or weakness. If you experience these symptoms, please stop taking Cipro and contact your doctor immediately. In this way, the possible risk of irreversible nerve damage can be reduced.

If you have myasthenia gravis (a muscle disease), Cipro should be used with caution as symptoms may worsen.

Fluoroquinolone/quinolone antibiotics have been associated with very rare but serious side effects, some of which were persistent (lasting months or years), life-altering or possibly permanent. These side effects include tendon, joint and muscle pain in the upper and lower limbs, difficulty walking, unusual sensations such as tingling, pins and needles, tickling, numbness or burning (paresthesia), sensory disturbances including impaired vision, taste, smell and hearing, depression, memory impairment, severe fatigue and sleep disturbance.

If you notice any of these side effects while taking Cipro, consult your doctor immediately before continuing treatment. You and your doctor will decide whether treatment should be continued with an antibiotic from another group of active ingredients.

In very rare cases, Cipro may cause tendon inflammation and rupture - mainly of the Achilles heel. The risk is higher if you are elderly (over 60), have had an organ transplant, suffer from kidney problems, are being treated simultaneously with corticosteroids or are involved in strenuous physical activity. Tendon inflammations and ruptures can occur as early as 48 hours after the start of treatment, but can also occur several months after the end of treatment. Tell your doctor if you suffer from or have suffered from tendon problems. If you develop symptoms of tenosynovitis (e.g. painful swelling of the ankle, wrist, elbow, shoulder or knee), contact your doctor immediately and immobilise the affected limb to prevent tendon damage. Avoid any unnecessary movement that could increase the risk of tendon rupture.

During treatment with Cipro, ensure that you have sufficient fluid intake, otherwise crystallisation of the active substance in your urine may occur.

In the event of renal insufficiency, the dosage may need to be adjusted. Your doctor will adjust the dose if necessary.

Patients suffering from glucose-6-phosphate dehydrogenase deficiency (a hereditary disease) or with a family history of this deficiency tend to have haemolytic reactions (i.e. excessive lysis of red blood cells) when taking fluoroquinolones. Caution should therefore be exercised when treating these patients with Cipro.

Taking Cipro and other medicines

Please let your doctor know if you are using any medications that could disrupt your ECG. This includes specific drugs for heart rhythm disorders, certain antidepressants, some antibiotics, and psychotropic medications.

Do not take iron-based preparations at the same time as medicines to treat gastric hyperacidity containing calcium, aluminium or magnesium hydroxide, sevelamer or lanthanum (active ingredients intended for the treatment of high blood phosphorus levels), as they reduce the effect of Cipro. The same applies to sucralfate, another substance also containing aluminium, which is used to treat gastric ulcers. Cipro should be administered at least 1-2 hours before or 4 hours after these preparations, to allow sufficient absorption by the body.

Please tell your doctor if you are taking anticoagulants (e.g. warfarin, acenocoumarol, phenprocoumon) and theophylline-based products (anti-asthma drugs, also known as aminophylline) at the same time. The side effects of anticoagulants and theophylline may be more pronounced.

In isolated cases, when medicines that lower blood sugar (anti-diabetics), such as glibenclamide and glimepiride, are taken at the same time, their effects may be more marked, leading to a drop in blood sugar levels (hypoglycaemia).

If ciprofloxacin is taken at the same time as methotrexate, an active substance which blocks certain cellular chemical mechanisms and inhibits the growth of a particular type of cell, the efficacy of methotrexate may be increased, making it necessary to monitor treatment carefully.

Simultaneous treatment with ciprofloxacin and duloxetine (active ingredient in the treatment of depression) may also increase the efficacy of duloxetine.

The efficacy of the following active ingredients may be increased when taken simultaneously with ciprofloxacin:

• clozapine (active ingredient in the treatment of mental disorders),
• ropinirol (active ingredient in the treatment of restless legs),
• sildenafil (active ingredient in the treatment of erectile dysfunction),
• olanzapine (active ingredient in the treatment of schizophrenia),
• tizanidine (active ingredient in the treatment of severe seizures)
• agomelatine (active ingredient in the treatment of depression).

Tizanidine and agomelatine should not be taken concomitantly with Cipro.

Caution should also be exercised when taking coffee and medicines containing caffeine, as well as pentoxifylline (active ingredient in the treatment of circulatory disorders).

The efficacy of phenytoin (active ingredient in the treatment of epilepsy) may be affected when Cipro is taken concomitantly.

Cipro should not be taken concomitantly with zolpidem (active ingredient in the treatment of insomnia), as the efficacy of zolpidem may be affected.

According to animal experiments, the combination of very high doses of fluoroquinolones (antibiotics which also include Cipro) with certain fever-reducing, pain-relieving and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs, "NSAIDs") may cause convulsions. If you are receiving treatment with Cipro, you should not take these medicines unless specifically instructed to do so by your doctor.

Isolated cases of temporary impairment of renal function have been observed when Cipro is taken at the same time as cyclosporine (the active ingredient used after organ transplants). If concomitant treatment with Cipro and a cyclosporine-based preparation proves necessary, your doctor will prescribe close monitoring of renal function (generally 2 × per week).

You should also tell your doctor if you are taking any of the following active ingredients, as these may affect the effectiveness of ciprofloxacin:

• probenecid (active ingredient in the treatment of gout)
• metoclopramide (active ingredient in the treatment of heartburn and irritated stomach)
• omeprazole (active ingredient in the reduction of gastric acidity)
• tacrolimus (active ingredient in the prevention of rejection after organ transplantation).

Ciprofloxacin should not be taken at the same time as dairy products or calcium-rich foods (e.g. milk, yoghurt, calcium-enriched fruit juice), as the absorption of ciprofloxacin may be reduced. However, the absorption of ciprofloxacin is not influenced by the calcium content of a normal meal.

Due to different individual reactions, some people may experience a reduction in their ability to drive or operate machinery. The concomitant use of alcohol increases this effect.

Please inform your doctor or pharmacist if:

• you suffer from any other illness
• you have allergies
• you are already taking other medicines or using other medicines externally (even if you are self-medicating).

When Should Cipro Not Be Taken/Used?

You should not use Cipro, if you have previously experienced a serious adverse reaction when using quinolones/fluoroquinolones. In this case, you should consult your doctor as soon as possible.

Patients who are allergic to ciprofloxacin, to other quinolone antibiotics (gyrase inhibitors) or to any of the excipients should not take Cipro.

Based on the results of animal studies, damage to articular cartilage during the growth period cannot be completely ruled out. Therefore, children and adolescents during the growth period should not receive Cipro. With the exception of treatment of acute infectious outbreaks in patients with cystic fibrosis.

Cystic fibrosis is an inherited metabolic disease resulting in increased production of excessively viscous secretions from the bronchial and digestive glands;

• anthrax;
• complicated urinary tract infections refractory to other therapies.

Evaluation of safety data from adolescent patients with cystic fibrosis, complicated urinary tract infections or anthrax has not revealed any irreversible damage to joints and cartilage.

Patients treated with tizanidine (an active substance for the treatment of severe seizures) or agomelatine (an active substance for the treatment of depression) should not receive Cipro at the same time.

Alcohol

Alcohol consumption (in moderation) is not contraindicated during treatment with Cipro.

Taking alcohol with antibiotics does not affect their effectiveness. However, like antibiotics, alcohol is difficult to digest, which can increase the risk of side effects such as stomach aches and nausea. Moderate consumption is preferable.

Pregnancy and Breastfeeding

Cipro must not be used during pregnancy or when breast-feeding. Exception: anthrax.