Ciprofloxacin Krka

Patient Information Leaflet

Ciprofloxacin Krka 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Ciprofloxacin Krka is and what it is used for
2. What you need to know before taking Ciprofloxacin Krka
3. How to take Ciprofloxacin Krka
4. Possible side effects
5. How to store Ciprofloxacin Krka
6. Contents of the pack and other information

1. What Ciprofloxacin Krka is and what it is used for

Ciprofloxacin Krka is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against certain strains of bacteria.

Adults
Ciprofloxacin Krka is used in adults to treat the following bacterial infections:

• Respiratory tract infections
• Long-lasting or recurrent ear or paranasal sinus infections
• Urinary tract infections
• Genital infections in men and women
• Gastrointestinal and intra-abdominal infections
• Skin and soft tissue infections
• Bone and joint infections
• To prevent infections caused by the bacterium Neisseria meningitidis
• Exposure to inhalation of anthrax spores

Ciprofloxacin may be used to treat patients with low blood cell counts (neutropenia) who have fever suspected to be due to a bacterial infection.
If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin Krka.

Children and adolescents
Ciprofloxacin Krka is used in children and adolescents, under specialist supervision, to treat the following bacterial infections:

• Lung and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• Exposure to inhalation of anthrax spores

Ciprofloxacin Krka may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the doctor.

2. What you should know before taking Ciprofloxacin Krka

Do not take Ciprofloxacin Krka

• if you are allergic to ciprofloxacin, to other quinolones, or to any of the excipients of this medicine (listed in section 6)
• if you are taking tizanidine (see section 2: “Other medicines and Ciprofloxacin Krka”).

Warnings and precautions
Consult your doctor or pharmacist before taking Ciprofloxacin Krka
Before taking Ciprofloxacin Krka
Inform your doctor:

• if you have kidney problems, as your treatment may need to be adjusted
• if you suffer from epilepsy or other neurological disorders
• if you have had tendon problems during previous treatment with antibiotics such as Ciprofloxacin Krka
• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
• if you have previously experienced episodes of aortic dissection (a tear in the aortic wall)
• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, or known atherosclerosis)
• if you are diabetic, as you may be at risk of hypoglycaemia with ciprofloxacin
• if you suffer from myasthenia gravis (a type of muscle weakness)
• if you have heart problems. Caution is advised when using this type of medicine if you were born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), if you have a very slow heart rate (called 'bradycardia'), if you have a weak heart (heart failure), if you have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause ECG changes (see section 2, "Other medicines and Ciprofloxacin Krka").
• if you—or a member of your family—know you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia during treatment with ciprofloxacin. You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin Krka, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such case, inform your doctor as soon as possible.

For the treatment of certain genital tract infections, your doctor may 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 Krka
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Krka. Your doctor will decide whether treatment should be discontinued.

• A severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, angioedema). There is a rare possibility of a severe and sudden allergic reaction even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, lightheadedness when standing. In such case, stop treatment with Ciprofloxacin Krka and contact your doctor immediately.
• Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin Krka. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin Krka, contact your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
• If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.
• If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. In such case, stop treatment with Ciprofloxacin Krka and contact your doctor immediately.
• Psychiatric reactions may occur the first time you take Ciprofloxacin Krka. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Krka. In such case, stop treatment with Ciprofloxacin Krka and contact your doctor immediately.
• Symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such case, stop treatment with Ciprofloxacin Krka and inform your doctor immediately to prevent permanent nerve damage.
• Quinolone antibiotics may cause blood sugar levels to rise above your normal levels (hyperglycaemia) or fall below your normal levels, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
• During treatment with antibiotics, including Ciprofloxacin Krka, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, you must stop taking Ciprofloxacin Krka immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor.
• If your vision deteriorates or if you think your eyes have a problem, consult an ophthalmologist immediately.
• Inform your doctor or laboratory staff that you are taking Ciprofloxacin Krka if you need to have blood or urine tests.
• If you have kidney problems, inform your doctor, as your dose may need to be adjusted.
• Ciprofloxacin Krka may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking Ciprofloxacin Krka and contact your doctor immediately.
• Ciprofloxacin Krka may cause a reduction in the number of white blood cells, which may lead to decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in your general condition, or fever with symptoms of localized infection such as sore throat, pain in the throat or mouth, or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
• During treatment with Ciprofloxacin Krka, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as sunbeds.
• Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Krka, have been associated with very rare but serious adverse effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
• If you experience any of these adverse effects after taking Ciprofloxacin Krka, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Krka
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin Krka together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: “Do not take Ciprofloxacin Krka”)
The following medicines interact with Ciprofloxacin Krka in the body. Taking Ciprofloxacin Krka together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
Inform your doctor if you are taking:

• vitamin K antagonists (warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• cyclosporine (to reduce the body’s immune response)
• other medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

Ciprofloxacin Krka may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (an antidepressant)
• lidocaine (a local anaesthetic)
• sildenafil (for erectile dysfunction)
• agomelatine
• zolpidem

Certain medicines reduce the effect of Ciprofloxacin Krka. Inform your doctor if you are taking or intend to take:

• antacids
• omeprazole (for ulcers)
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g. sevelamer)
• medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take Ciprofloxacin Krka approximately two hours before or no sooner than four hours after taking them.

Ciprofloxacin Krka with food and drink
Unless otherwise instructed, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified drinks at the same time as taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin Krka during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take Ciprofloxacin Krka while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Krka may impair your ability to concentrate. As neurological adverse events may occur, check how you react to Ciprofloxacin Krka before driving a vehicle or operating machinery. If in doubt, discuss with your doctor.
Ciprofloxacin Krka contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Ciprofloxacina Krka

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacina Krka you should take, how often, and for how long. This will depend on the type and severity of your infection.
Inform your doctor if you have kidney problems, as a dose adjustment may be necessary.
The treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
Always take the tablets exactly as directed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacina Krka.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacina Krka tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with Ciprofloxacina Krka.
If you take more Ciprofloxacina Krka than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, take the tablets or the pack with you to show the doctor.
If you forget to take Ciprofloxacina Krka
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.
If you stop taking Ciprofloxacina Krka
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, the infection may not be completely cured, and symptoms may return or worsen. You may also develop antibiotic resistance.
If you have any questions about 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.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Common: may affect up to 1 in 10 people

• nausea, diarrhoea
• joint pain in children

Uncommon: may affect up to 1 in 100 people

• fungal superinfections
• high concentration of eosinophils, a type of white blood cells
• loss of appetite (anorexia)
• hyperactivity, agitation
• headache, dizziness, sleep disturbances, taste disturbances
• vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, urticaria
• joint pain in adults
• reduced kidney function
• muscle and bone pain, malaise (asthenia), fever
• increased alkaline phosphatase in the blood (a certain substance present in the blood)

Rare: may affect up to 1 in 1,000 people

• inflammation of the bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: "Warnings and precautions")
• changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
• allergic reaction, swelling (oedema), sudden swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycaemia)
• decreased blood sugar (hypoglycaemia) (see section 2: "Warnings and precautions")
• confusion, disorientation, anxious reaction, unusual dreams, depression, hallucinations
• tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (see section 2: "Warnings and precautions"), dizziness
• visual disturbances (diplopia)
• tinnitus, hearing loss, decreased hearing
• rapid heartbeat (tachycardia)
• dilation of blood vessels (vasodilation), low blood pressure, fainting
• shortness of breath, including symptoms of asthma
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• sensitivity to light (see section 2: "Warnings and precautions"), muscle pain, joint inflammation, increased muscle tone, cramps
• kidney failure, blood or crystals in the urine (see section 2: "Warnings and precautions"), inflammation of the urinary tract
• fluid retention, excessive sweating
• abnormal levels of a coagulation factor (prothrombin), increased levels of the enzyme amylase

Very rare: may affect up to 1 in 10,000 people

• a particular type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal (see section 2: "Warnings and precautions")
• severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: "Take special care with Ciprofloxacin Krka")
• mental disorders (psychotic reactions) (see section 2: "Warnings and precautions")
• migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure on the brain (intracranial hypertension)
• distortions in colour perception
• inflammation of blood vessel walls (vasculitis)
• pancreatitis
• death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure
• pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
• muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: "Warnings and precautions"); worsening of symptoms of myasthenia gravis (see section 2: "Warnings and precautions")

Frequency not known: frequency cannot be estimated from the available data

• disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities (peripheral neuropathy and polyneuropathy)
• abnormally increased heart rate, potentially life-threatening irregular heartbeat, changes in heart rhythm (known as "prolongation of the QT interval", visible on ECG, electrical activity of the heart)
• pustular rash
• increased risk of bleeding (in patients treated with blood thinners)
• feeling of intense excitement (mania), or feeling of great optimism and hyperactivity (hypomania)
• hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
• syndrome associated with impaired water elimination and low sodium levels (SIADH)
• loss of consciousness due to severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting for months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin Krka

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacin Krka contains

• The active substance is ciprofloxacin (as monohydrate hydrochloride).
  Ciprofloxacin Krka 250 mg film-coated tablets: Each film-coated tablet contains 291.0 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of ciprofloxacin.
  Ciprofloxacin Krka 500 mg film-coated tablets: Each film-coated tablet contains 582.0 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of ciprofloxacin.
  Ciprofloxacin Krka 750 mg film-coated tablets: Each film-coated tablet contains 873.0 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of ciprofloxacin.
• The other excipients are: in the tablet core: croscarmellose sodium, anhydrous colloidal silica, microcrystalline cellulose, sodium carboxymethylstarch (Type A), povidone K-25 and magnesium stearate; in the coating: hypromellose, propylene glycol, talc and titanium dioxide (E171).

Description of the appearance of Ciprofloxacin Krka and package contents
The 250 mg film-coated tablets are white, round, coated, smooth on one side, with a break line on the opposite side. The tablet can be divided into equal doses.
The 500 mg film-coated tablets are white, oval, coated, smooth on one side, with a break line on the opposite side. The tablet can be divided into equal doses.
The 750 mg film-coated tablets are white, oval, coated, with a break line on both sides. The tablet can be divided into equal doses.
All strengths are available in packages of 10, 20, 30 and 100 film-coated tablets (1, 2, 3 or 10 blisters containing 10 tablets each). The 500 mg tablets are also available in packs of 6 tablets (1 blister of 6 tablets) and 16 tablets (2 blisters of 8 tablets each), and the 750 mg tablets in packs of 12 tablets (2 blisters of 6 tablets each). Tablets are also supplied in hospital packs of 50 tablets (10 blisters of 5 tablets each).

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local representative for Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milano, Italy

This medicinal product is authorized in the European Economic Area Member States under the following names: