2 mg / ml Infusion solution 
Ciprofloxacin (as hydrogen sulphate)

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, nurse or healthcare professional.
  • If you get any side effects, talk to your doctor, pharmacist, nurse or healthcare professional. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ciprofloxacin Fresenius Kabi is and what it is used for 
2. What you need to know before you get Ciprofloxacin Fresenius Kabi 
3. How to use Ciprofloxacin Fresenius Kabi 
4. Possible side effects 
5. How to take Ciprofloxacin Fresenius Kabi Store 
6. Contents of the packaging and other information

What Ciprofloxacin Fresenius Kabi is and what it is used for

Ciprofloxacin Fresenius Kabi contains the active substance ciprofloxacin . Ciprofloxacin is an antibiotic in the fluoroquinolone group. Ciprofloxacin works by killing bacteria that cause infections. It only acts on specific strains of bacteria.

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

  • respiratory infections
  • prolonged or recurrent ear or sinus infections
  • urinary tract infections
  • infection is in the testicles
  • infection is in the abdomen of women
  • infection in the gastrointestinal tract and infection in the abdomen
  • skin and soft tissue infections
  • infection you in the skeleton and joints
  • to treat infection in patients with very low white blood cell count ( neutropenia )
  • to prevent infection in patients with very low white blood cell count ( neutropenia)
  • exposure to anthrax bacteria via the respiratory tract

If you have a serious infection or one that is caused by more than one type of bacterium , you may be prescribed additional antibiotic treatment in addition to Ciprofloxacin Fresenius Kabi.

Children and adolescents 
Ciprofloxacin Fresenius Kabi is used in children and adolescents, under the supervision of a medical specialist, to treat the following bacterial infections:

  • acute lung infections in children and adolescents suffering from cystic fibrosis
  • complicated urinary tract infections, including infection that has reached the kidneys ( pyelonephritis )
  • exposure to anthrax bacteria via the respiratory tract (suspected or confirmed)

Ciprofloxacin Fresenius Kabi can also be used to treat other particularly serious infections in children and adolescents when your doctor deems it necessary.

Ciprofloxacin contained in Ciprofloxacin Fresenius Kabi may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Ciprofloxacin Fresenius Kabi

You should not be given Ciprofloxacin Fresenius Kabi

  • if you are allergic to ciprofloxacin , other quinolone medicines or any of the other ingredients of this medicine (listed in section 6)
  • if you are being treated with tizanidine (see section 2 Other medicines and Ciprofloxacin Fresenius Kabi)

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin Fresenius Kabi, if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

Before treatment with Ciprofloxacin Fresenius Kabi , tell your doctor, pharmacist, nurse or healthcare professional:

  • if you have ever had kidney problems because your treatment may need to be adjusted
  • if you have epilepsy or other neurological disease
  • if you have had late problems during previous treatment with any antibioticsimilar to Ciprofloxacin Fresenius Kabi
  • if you are diabetic because there is a risk of getting hypoglycaemia (too low blood sugar) from ciprofloxacin .
  • if you have myasthenia gravis (a type of muscle weakness) as the symptoms may worsen
  • if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel).
  • if you have had an aortic dissection (a rupture of the aortic wall).
  • if someone in your family has or has had an aortic aneurysm or aortic dissection or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, or vascular Ehlers-Danlos syndrome , or vascular diseases such as Takayasus arteritis, giant cell arteritis, Behçet’s disease , high blood pressure , or known atherosclerosis).
  • if you have heart problems. Caution should be exercised when using this type of medicine if you, or someone in your family, have a congenital prolonged QT interval (seen on ECG , electrical activity in the heart), disturbance of the salt balance in the blood (especially low levels of potassium or magnesium ), has a very slow heart rhythm (so-called bradycardia ), has a weak heart ( heart failure ), has had a heart attack (heart attack), if you are a woman or elderly or if you are taking other medicines that cause abnormal ECG changes (see section 2 Other medicines and Ciprofloxacin Fresenius Kabi).
  • if you feel a sudden, severe pain in your stomach, chest or back, you should immediately go to an emergency room.
  • if you or a family member are deficient in glucose -6-phosphate dehydrogenase (G6PD) because you are at risk of developing ciprofloxacin anemia .

To treat certain genital infections , your doctor may prescribe another antibiotic in addition to ciprofloxacin . If there is no improvement in symptoms after 3 days of treatment, you should consult a doctor.

During treatment with Ciprofloxacin Fresenius Kabi

Tell your doctor immediately if any of the following occur during treatment with Ciprofloxacin Fresenius Kabi. Your doctor will decide if treatment with Ciprofloxacin Fresenius Kabi needs to be stopped.

  • Severe, sudden allergic reaction (anaphylactic reaction / shock, angioedema ). Even after the first dose , there is a small risk that you will experience a severe allergic reaction with the following symptoms: tightness in the chest, dizziness or fainting or dizziness when you get up. If this happens, stop taking Ciprofloxacin Fresenius Kabi and contact your doctor immediately.
  • In rare cases, pain and swelling in the joints and inflammation or rupture of tendons can occur. The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems or if you are being treated with cortisone ( corticosteroids ). Inflammation and rupture of tendons can occur within the first 48 hours after starting treatment but also up to several months after treatment with Ciprofloxacin Fresenius Kabi has ended. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking CiprofloxacinFresenius Kabi, consult a doctor and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you suffer from epilepsy or other neurological disease such as decreased blood flow to the brain or stroke, you may experience side effects related to the central nervous system . If you get seizures, stop taking Ciprofloxacin Fresenius Kabi and contact your doctor immediately.
  • In rare cases, you may experience symptoms of nerve damage ( neuropathy )such as pain, a burning sensation, tingling, numbness and / or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Ciprofloxacin Fresenius Kabi and contact your doctor immediately to prevent the development of any permanent condition.
  • You may experience psychiatric reactions the first time you take CiprofloxacinFresenius Kabi. If you suffer from depression or psychosis, your , your symptoms may become worse under treatment with Ciprofloxacin Kabi. If this happens, stop taking Ciprofloxacin Fresenius Kabi and contact your doctor immediately.
  • Hypoglycaemia has been most commonly reported in diabetics, especially in elderly patients. If this happens, contact your doctor immediately.
  • Diarrhea can occur while you are taking antibiotics , including CiprofloxacinFresenius Kabi, or even several weeks after you stop taking them. If this becomes severe or persistent or if you notice blood or mucus in your stools, stop taking Ciprofloxacin Fresenius Kabi immediately as this can be life threatening. Do not take any medicine that stops or reduces bowel movements and contact your doctor.
  • If your vision becomes worse , or if your eyes are affected in any other way, contact an ophthalmologist immediately.
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin Fresenius Kabi. Avoid exposure to strong sunlight and artificial UV light such as tanning beds.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Fresenius Kabi for blood or urine tests .
  • Tell your doctor if you have kidney problems , as dose one may need to be adjusted.
  • Ciprofloxacin Fresenius Kabi can cause liver damage . If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching or tightness in the stomach, stop taking Ciprofloxacn Fresenius Kabi and contact your doctor immediately.
  • Ciprofloxacin Fresenius Kabi can cause a decrease in the number of white blood cells and your resistance to infection may be reduced . If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local symptoms of infection such as sore throat / throat / mouth or urinary incontinence, contact your doctor immediately. A blood sample will be taken to check for a possible decline in white blood cells (agranulocytosis). 
    It is important to inform your doctor about your medicine.

Long-term, debilitating and potentially persistent serious side effects: 
Antibacterial fluoroquinolone / quinolone drugs, including Ciprofloxacin Fresenius Kabi have been associated with very rare but serious side effects . Some of these have been long-lasting (up to months or years), disabling and possibly permanent. This includes pain in tendons, muscles and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disturbances in the form of impaired vision, taste, smell and hearing, depression , impaired memory, extreme fatigue and severe sleep problems.

If you experience any of these side effects after taking Ciprofloxacin Fresenius Kabi, talk to a doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .

Other medicines and Ciprofloxacin Fresenius Kabi

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Ciprofloxacin Fresenius Kabi with tizanidine as it may cause side effects such as low blood pressure and fatigue (see section 2: “ Do not take Ciprofloxacin Fresenius Kabi ”).

It is known that the following medicines interact with Ciprofloxacin Fresenius Kabi in your body. Taking Ciprofloxacin Fresenius Kabi with these medicines may affect the way these medicines work. It can also increase the risk of side effects .

Tell your doctor if you are taking:

  • Vitamin K antagonist (such as warfarin , acenocoumarol, fenprocumon or fluindione) or other anticoagulants (dilutes the blood)
  • probenecid (for gout )
  • methotrexate (for special types of cancer, psoriasis , rheumatoid arthritis )
  • theophylline (for respiratory problems)
  • tizanidine (for muscle spasticity in multiple sclerosis)
  • olanzapine (an antipsychotic )
  • clozapine (an antipsychotic )
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • ciclosporin (for skin conditions, rheumatoid arthritis and for organ transplantation)
  • other drugs that can affect your heart rhythm; medicines belonging to the group of antiarrhythmics (eg quinidine , hydroquinidine, disopyramide , amiodarone , sotalol, dofetilide, ibutilide), tricyclic antidepressants , certain bactericidal medicines (belonging to the group macrolides ), certain medicines for mental illness.
  • zolpidem (for insomnia)
  • metoclopramide (for nausea and vomiting)
  • omeprazole (for stomach ulcers )

Ciprofloxacin Fresenius Kabi may increase the levels of the following substances in your blood:

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, nerve damage due to diabetes or incontinence )
  • lidocaine (for heart conditions or as anesthesia)
  • sildenafil (eg for erection problems)
  • agomelatin
  • glibenclamide (for diabetes )

Ciprofloxacin Fresenius Kabi with food and drink

Food and drink do not affect your treatment with Ciprofloxacin Fresenius Kabi.

Pregnancy and breastfeeding

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 best to avoid taking Ciprofloxacin Fresenius Kabi during pregnancy.

Do not take Ciprofloxacin Fresenius Kabi while you are breast-feeding as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and using machines

Ciprofloxacin Fresenius Kabi may make you feel less alert. Some neurological side effects may occur. Do not drive or use machines until you know how you react to Ciprofloxacin Fresenius Kabi. If you are not sure, talk to your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ciprofloxacin Fresenius Kabi contains sodium

If you are on a diet low in sodium , you should take into account that 100 ml Ciprofloxacin Fresenius Kabi contains 15.1 mmol (= 347 mg) sodium .

How to use Ciprofloxacin Fresenius Kabi

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will explain to you exactly how much Ciprofloxacin Fresenius Kabi you will receive as well as how often and for how long. This depends on the type of infection you have and how serious it is.

Tell your doctor if you suffer from kidney problems as your dose may need to be adjusted.

The treatment usually lasts for 5 to 21 days, but may take longer for serious infections.

Your doctor will give each dose by slow infusion through a vein into your bloodstream. For children, the infusion lasts one to 60 minutes. For adult patients, the infusion time is 60 minutes for 400 mg Ciprofloxacin Fresenius Kabi and 30 minutes for 200 mg Ciprofloxacin Fresenius Kabi. Slow administration of infusion a help to prevent the adverse event is occurring.

Remember to drink plenty of fluids while taking Ciprofloxacin Fresenius Kabi.

If you get more Ciprofloxacin Fresenius Kabi than you should

If you take more Ciprofloxacin Fresenius Kabi than you should, you may experience dizziness, tremors, headaches, fatigue, stomach discomfort or confusion.

Tell your doctor or nurse if you experience any of these symptoms.

If a dose of Ciprofloxacin Fresenius Kabi is forgotten

You will not receive a double dose to make up for a forgotten dose .

If you stop taking Ciprofloxacin Fresenius Kabi.

  • It is important that you complete the treatment regimen even if you start to feel better after a few days. If you stop taking this medicine too soon, your infection may be inadequately treated and the symptoms of infection may return or get worse. You may also develop resistance to the antibiotic.

If you have any further questions on the use of this product, ask your doctor, pharmacist, nurse or healthcare professional.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following sections list the most serious side effects that you may recognize yourself:

Stop taking Ciprofloxacin Fresenius Kabi and contact your doctor immediatelyif you experience any of the following serious side effects so that other antibiotic treatments can be considered:

Uncommon (may affect up to 1 in 100 people):

  • Seizures (see section 2: Warnings and precautions)

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

  • Severe, sudden allergic reaction with symptoms such as pressure over the chest, dizziness, nausea, fainting or if you feel dizzy when you get up (anaphylactic shock) (see section 2: Warnings and precautions).
  • Tendon rupture, especially in the large tendon at the back of the heel (heel tendon) (see section 2: Warnings and precautions)

Very rare (may affect up to 1 in 10,000 users):

  • Severe, sudden allergic reaction with symptoms such as pressure over the chest, dizziness, nausea, fainting or if you feel dizzy when you get up (anaphylactic reaction) (see section 2: Warnings and precautions).
  • Muscle weakness, inflammation of the tendons that can lead to tendon rupture, especially in the large tendon on the back of the heel (heel tendon) (see section 2: Warnings and caution)
  • Severe life-threatening skin rash, usually in the form of blisters or sores in the mouth, pharynx, nose, eyes and other mucous membranes such as. genitals, which can develop into widespread blistering or skin loosening (Stevens-Johnson syndrome, toxic epidermal necrolysis ).

Unknown frequency (cannot be calculated from the available data):

  • Abnormal pain, burning sensation, tingling, numbness or muscle weakness in the arms and legs ( neuropathy ) (see section 2: Warnings and caution)
  • A drug reaction that causes skin rash, fever, inflammation of the internal organs, altered blood picture and systemic disease (DRESS, severe drug reaction with eosinophilia and systemic symptoms, AGEP, acute generalized exanthematous pustulosis ).
  • State of reduced water excretion and low sodium levels (SIADH)

Other side effects that have been observed during treatment with CiprofloxacinFresenius Kabi are listed below according to the frequency with which they occur:

Common side effects are (may affect up to 1 in 10 people)

  • nausea, diarrhea, vomiting
  • joint pain and joint inflammation in children
  • local reaction at the injection site, rash
  • temporary increase in certain substances in the blood ( transaminases )

Less common side effects are (may affect up to 1 in 100 people):

  • joint pain in adults
  • fungal infections
  • a high concentration of eosinophils , a type of white blood cell , increased or decreased amount of platelets ( platelets )
  • loss of appetite ( anorexia )
  • hyperactivity, agitation , confusion, disorientation, hallucinations
  • headache, dizziness, sleep problems, taste changes, ant crawls, abnormal sensitivity to sensory impressions, seizures (see section 2: Warnings and caution), dizziness
  • vision problem, including double vision
  • hearing loss
  • fast heartbeat ( tachycardia )
  • dilation of blood vessels ( vasodilation ), low blood pressure
  • abdominal pain, digestive problems such as upset stomach(indigestion / heartburn) or gas in the stomach
  • liver disease, increased levels of a substance in the blood ( bilirubin ), jaundice (cholestatic jaundice)
  • itching or hives
  • poor kidney function, kidney failure
  • muscle and skeletal pain, malaise , fever, fluid retention
  • increase in alkaline phosphatases in the blood (a special substance in the blood)

Rare side effects are (may affect up to 1 in 1,000 people):

  • muscle pain, inflammation in the joints, increased muscle tension, cramps
  • inflammation of the intestine ( colitis ) associated with antibiotic use (may be fatalin very rare cases) (see section 2: Warnings and precautions)
  • changes in blood levels ( leukopenia , leukocytosis , neutropenia , anemia ), decreased red and white blood cells and platelets (pancytopenia) which can be fatal, bone marrow depression, which can also be fatal (see section 2: Warnings and precautions)
  • allergic reaction , swelling ( edema ) or rapid swelling of the skin and mucous membranes ( angioedema ),
  • elevated blood sugar ( hyperglycaemia )
  • decreased blood sugar ( hypoglycemia ) (see Section 2: Precautions)
  • anxiety, strange dreams, depression (which may lead to suicidal ideation, suicide attempt or completed suicide), mental disorder (psychotic reaction which may lead to suicidal ideation, suicide attempt or completed suicide) (see section 2: Warning and caution)
  • decreased skin sensitivity, tremors, migraines , altered sense of smell (olfactory disorder)
  • tinnitus, hearing loss
  • fainting, inflammation of blood vessels ( vasculitis )
  • shortness of breath including asthmatic symptoms
  • pancreatitis
  • hepatitis , liver cell death (liver necrosis), can in very rare cases lead to life-threatening liver failure
  • photosensitivity (see section 2: Warnings and precautions), small punctate hemorrhages under the skin ( petechiae )
  • blood or crystals in the urine (see section 2: Warnings and precautions), inflammation of the urinary tract
  • excessive sweating
  • elevated levels of enzyme et amylase

Very rare side effects are (may affect up to 1 in 10,000 people):

  • decreased number of a special type of red blood cells ( hemolytic anemia ); a severe decline in a type of white blood cell ( agranulocytosis ), which can be fatal (see section 2: Warnings and precautions)
  • allergic reaction called serum sickness reaction (see section 2: Warnings and precautions)
  • altered coordination, unsteady gait (gait disturbance), pressure on the brain ( intracranial pressure and pseudotumor cerebri)
  • distortion of color vision
  • various skin conditions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis )
  • worsening of myasthenia gravis symptoms (see section 2: Warnings and precautions)

Unknown frequency (cannot be calculated from available data).

  • very excited mood (mania) or feeling of great optimism and overactivity ( hypomania )
  • abnormally fast heartbeat, life-threatening irregular heartbeat, change in heartbeat (prolonged QT interval , visible on ECG , electronic recording of heart work).
  • elevated INR (ie increased blood thinning effect) (in patients treated with vitaminK antagonists )

In very rare cases, long-term (up to several months or years) or lasting side effects , such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and impaired hearing, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Ciprofloxacin Fresenius Kabi

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 carton after EXP. The expiration date is the last day of the specified month.

  • Store in a cold place. Do not freeze.
  • Store the infusion bag in the outer bag until use. Sensitive to light.
  • Keep the infusion bottle in the outer carton until ready to use. Sensitive to light.

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. Contents of the packaging and other information

Content declaration

  • The active substance is ciprofloxacin (as hydrogen sulphate).
  • The other ingredients are sodium chloride, sulfuric acid, sodium hydroxide for adjustment, water for injections.

What the medicine looks like and contents of the pack

Ciprofloxacin Fresenius Kabi is a sterile , clear and colorless solution.

Ciprofloxacin Fresenius Kabi is packaged in a clear, flexible polyolefin bag with an aluminum outer bag (Freeflex bag) or in a polyethylene bottle (KabiPac).

Pack sizes 100 ml:

1, 5, 10, 12, 20, 30 or 40 bags.

1, 5, 10, 12, 20, 25, 30 or 40 bottles.

Pack sizes 200 ml:

1, 5, 10, 12, 20, 30 or 40 bags.

1, 5, 10, 12, 20, 30 or 40 bottles.

100 ml solution contains 200 mg ciprofloxacin .

200 ml solution contains 400 mg ciprofloxacin .

Not all pack sizes may be marketed

Marketing Authorization Holder and Manufacturer

Holder of approval for sale: 
Fresenius Kabi AB 
751 74 Uppsala 
Tel: 018-64 40 00 
Fax: 018-64 40 13

Manufacturer: 
Fresenius Kabi Norge AS 
Postboks 430 
N-1753 Halden 
Norge

Fresenius Kabi Polska Sp. z oo 
Wytwórnia Płynów Infuzyjnych 
99-300 Kutno 
Sienkiewicza 25 
Poland

Muhammad Nadeem

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