2 mg / ml Infusion solution 
ciprofloxacin

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

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you. Do not give it to others. It may harm them, even if they show symptoms similar to yours.
  • If you get any side effect, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Ciprofloxacin Villerton is and what it is used for 
2. What you need to know before you use Ciprofloxacin Villerton 
3. How to use Ciprofloxacin Villerton 
4. Possible side effects 
5. How to store Ciprofloxacin Villerton 
6. Contents of the packaging and other information 

What Ciprofloxacin Villerton is and what it is used for

Ciprofloxacin Villerton is an antibiotic in the group of fluoroquinolones. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

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

  • respiratory infections
  • long-term 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
  • the 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 Villerton.

Children and young people

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

  • lung and tracheal 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

Ciprofloxacin Villerton can also be used to treat other especially serious infections in children and adolescents when the doctor deems it necessary.

What you need to know before you use Ciprofloxacin Villerton

Do not take Ciprofloxacin Villerton

  • if you are allergic (hypersensitive) to the active substance or to other quinolone medicines or to any of the other ingredients of Ciprofloxacin Villerton (see section 6)
  • if you are being treated with tizanidine (see section 2: Taking other medicines)

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin Villerton 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 Villerton

Tell your doctor if you

  • have ever had kidney problems because your treatment may need to be adjusted
  • suffers from epilepsy or another neurological disease
  • have experienced tendon problems during previous treatment with antibioticssuch as Ciprofloxacin Villerton
  • have myasthenia gravis (a type of muscle weakness)
  • previously had an abnormal heart rhythm ( arrhythmia )
  • 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 in 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)

During treatment with Ciprofloxacin Villerton

Tell your doctor immediately if any of the following occur during treatment with Ciprofloxacin VillertonYour doctor will decide if your treatment with CiprofloxacinVillerton 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, feeling dizzy, feeling uncomfortable or weak, or experiencing dizziness when you get up. If this happens, you should contact a doctor immediately as the administration of Ciprofloxacin Villerton must be stopped.
  • 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 tendon rupture can occur within the first 48 hours after starting treatment but also up to several months after stopping treatment with Ciprofloxacin Villerton. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking CiprofloxacinVillerton, consult a physician, and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you suffer from epilepsy or another neurological disease such as decreased blood flow to the brain or stroke, you may experience side effects related to the central nervous system. If this happens, stop taking Ciprofloxacin Villerton and contact your doctor immediately.
  • You may experience psychiatric reactions thefirst time you take CiprofloxacinVillerton. If you suffer from depressionor psychosis, your symptoms may get worse during treatment with Ciprofloxacin Villerton. If this happens, stop taking Ciprofloxacin Villerton 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 Villerton and contact your doctor immediately to prevent the development of any lasting condition.
  • Antibiotics quinolone can cause an increase in your normal blood sugar levels ( hyperglycemia ) or a decrease in your normal blood sugar levels, which in severe cases can cause loss of consciousness (hypoglycaemic coma ) (see section 4). This is important for patients with diabetes. If you have diabetes , your blood sugar should be monitored carefully.
  • Diarrhea can occur while you are taking antibiotics, including CiprofloxacinVillerton, or even several weeks after you stop taking them. If diarrhea becomes severe or persistent or if you notice blood or mucus in your stools, tell your doctor. Treatment with Ciprofloxacin Villerton must be stopped immediately as this can be life threatening. Do not take medicines that stop or reduce bowel movements and consult a doctor.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Villerton if you are going to have a blood or urine sample.
  • Ciprofloxacin Villerton may cause liver damageIf you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching, or soreness in the stomach, you must immediately stop taking Ciprofloxacin Villerton.
  • Ciprofloxacin Villerton can cause a decrease in the number of white blood cellsand your resistance to infection may be reducedIf you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor immediately. A blood sample will be taken to check for a possible decrease in white blood cells ( agranulocytosis ). It is important to inform your doctor about your medicine.
  • Tell your doctor if you or a family member have glucose -6-phosphate dehydrogenase (G6PD) deficiency as you may be at risk of developing ciprofloxacin anemia.
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) during treatment with Ciprofloxacin Villerton. Avoid exposure to strong sunlight or artificial UV light such as tanning beds.
  • If your vision becomes worse, or if your eyes are affected in any other way, contact an ophthalmologist immediately.
  • If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.

Long-term, debilitating, and potentially lasting serious side effect is 
antibacterial fluoroquinolones – / quinolone, including ciprofloxacin Do Fullerton has been associated with rare but serious side effects is. Some of these have been long-lasting (up to months or years), disabling, and possibly permanent. This includes pain in the tendons, muscles, and joints of the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste, smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders.

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

Before you take Ciprofloxacin Villerton:

Heart problems 
Caution should be exercised when using this type of medicine if you are born with or if someone in your family has QT interval prolongation (this can be seen on the ECG, electrical recording of heart work), has a disturbance in the salt balance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia ), have a weak heart ( heart failure ), have previously had a heart attack (heart attack), you are a woman or elderly or are taking other medicines that result in abnormal ECGs changes (see section Taking other medicines )

Pregnancy, breastfeeding, and fertility

It is best to avoid taking Ciprofloxacin Villerton during pregnancy. Tell your doctor if you are planning to become pregnant.

Do not take Ciprofloxacin Villerton while you are breast-feeding as ciprofloxacin isexcreted in human milk and may be harmful to your baby.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take Ciprofloxacin Villerton with tizanidine as it may cause side effectssuch as low blood pressure and drowsiness (see section 2: “ Do not take Ciprofloxacin Villerton ”)

It is known that the following medicines interact with Ciprofloxacin Villerton in your body. The use of Ciprofloxacin Villerton with these medicines may affect the therapeutic effect of these medicines. It can also increase the risk of experiencing side effects.

Tell your doctor if you are taking:

  • warfarin or other anticoagulants (thins the blood)
  • probenecid (for gout )
  • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis )
  • theophylline (for respiratory problems)
  • tizanidine (for muscle spasticity in multiple sclerosis )
  • clozapine (an antipsychotic )
  • olanzapine (an antipsychotic )
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • duloxetine (for depression, neuropathic pain , anxiety)

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

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • agomelatine (for depression)
  • zolpidem (treatment of sleep problems)

Driving and using machines

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

Important information about one of the ingredients of Ciprofloxacin Villerton

Ciprofloxacin Villerton contains 55 mg / ml glucose monohydrate. This should be considered in patients with diabetes mellitus .

How to use Ciprofloxacin Villerton

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 Villerton you will be given and 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 can last 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 Villerton and 30 minutes for 200 mg Ciprofloxacin Villerton. Slow administration of infusion one helps prevent immediate side effects are occurring.

Remember to drink plenty of fluids while taking Ciprofloxacin Villerton.

If you stop taking Ciprofloxacin Villerton

It is important that you complete the treatment 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 or pharmacist.

4. Possible side effects

Like all medicines, Ciprofloxacin Villerton can cause side effects, although not everybody gets them.

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.

Common side effects are (between 1 and 10 in every 100 people are expected to get them)

  • nausea, diarrhea
  • joint pain in children
  • the local reaction at the injection site, rash

Less common side effects are (between 1 and 10 to 1 000 people are expected to get them):

  • fungal infections
  • a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood coagulation factor ( platelets )
  • loss of appetite
  • hyperactivity, agitation
  • headache, dizziness, sleep problems, taste changes
  • dizziness
  • palpitations ( tachycardia )
  • dilated blood vessels ( vasodilation ), low blood pressure
  • abdominal pain, indigestion such as upset stomach (indigestion/heartburn) or gas in the stomach, vomiting
  • liver disease, increased levels of substances in the blood ( transaminases )
  • increased levels of a substance in the blood ( bilirubin ), jaundice (cholestatic jaundice)
  • itching , hives , rash,
  • joint pain in adults
  • poor kidney function, kidney failure
  • pain in muscles and bones, feeling of discomfort ( asthenia ), fever
  • increase in alkaline phosphatases in the blood (a special substance in the blood)

Rare side effects are (between 1 and 10 out of 10 000 people are expected to get them):

  • inflammation of the intestine ( colitis ) associated with antibiotic use (maybe fatal in rare cases) (see section 2: Take special care with Ciprofloxacin Villerton)
  • changes in blood counts ( leukopenia, leukocytosis, neutropenia, anemia ), decrease in red and white blood cells and platelets (pancytopenia), which can be fatal, bone marrow depression which can also be fatal (see section 2: Take special care with Ciprofloxacin Villerton)
  • allergic reaction, allergic swelling ( edema ), rapid swelling of the skin and mucous membranes ( angioedema ), severe allergic reaction (anaphylactic shock ) which may be life threatening (see section 2: Take special care with CiprofloxacinVillerton)
  • elevated blood sugar ( hyperglycaemia )
  • confusion, disorientation, hallucinations, anxiety, strange dreams, depression that may culminate in suicidal ideation/thoughts or suicide attempts or completed suicide, see section 2, mental disorders (psychotic reactions) (see section 2: Take special care with Ciprofloxacin Villerton)
  • decreased or unusual sensitivity to sensory stimuli, seizures including status epilepticus (see section 2: Take special care with Ciprofloxacin Villerton)
  • Decreased skin sensitivity, tremors, migraines, olfactory disorders (olfactory disorders)
  • problems with vision including double vision (diplopia)
  • hearing loss, tinnitus, hearing loss
  • fainting, inflammation of blood vessels ( vasculitis )
  • shortness of breath including asthmatic symptoms
  • pancreatitis
  • hepatitis, liver cell death (liver necrosis) which very rarely leads to life-threatening liver failure
  • photosensitivity (see section 2: Take special care with Ciprofloxacin Villerton), small punctate hemorrhages under the skin ( petechiae )
  • muscle pain, joint inflammation, increased muscle tension, cramping, tendon rupture – especially large tendon on the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacin Villerton)
  • blood or crystals in the urine (see section 2: Take special care with CiprofloxacinVillerton), urinary tract inflammation
  • excessive sweating, fluid retention
  • abnormal levels of a blood coagulation factor (prothrombin), increased levels of enzyme et amylase, a special type of reduced red blood cell count ( hemolytic anemia ), a dangerous decrease of a white blood cell type ( agranulocytosis )
  • severe allergic reaction ( anaphylactic reaction , anaphylactic shock , serum sickness) which may be fatal (see section 2: Take special care with CiprofloxacinVillerton)

Very rare side effects are (fewer than 1 in 10 000 people are expected to get them):

  • coordination disorder, unsteady gait (gait disorder), pressure on the brain ( intracranial pressure )
  • distortion of color vision
  • various skin conditions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis )
  • muscle weakness, tendonitis, worsening of myasthenia gravis symptoms (see section 2: Take special care with Ciprofloxacin Villerton)
  • abnormal levels of a blood coagulation factor (increased INR = International normalized ratio)

No known frequency (cannot be calculated from the available data)

  • Heart problems: Abnormal heart rhythm, life-threatening irregular heartbeat, altered heart rhythm (called “prolongation of QT interval et or torsades de pointes, which can be seen on the ECG (electrical activity of the heart)).
  • Problems related to the nervous system such as pain, burning, tingling, numbness, and/or weakness in the limb are
  • Acute generalized exanthemantous pustulosis (AGEP) (sterile pustules in the skin)
  • Feels very aroused (mania) or feels great optimism and overactivity ( hypomania ), hypersensitivity reaction called DRESS (drug reaction with eosinophilia and systemic symptoms)
  • State of reduced water excretion and low sodium levels (SIADH)
  • Loss of consciousness due to a severe decrease in blood sugar (hypoglycaemic coma ). See section 2. 

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.

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.

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 Villerton

Keep this medicine out of the sight and reach of children.

Do not store in the refrigerator or freezer.

Store the infusion bag in the foil until it is to be used. Sensitive to light. Use immediately after opening the bag. Discard leftover contents immediately after use.

Ciprofloxacin Villerton should be used before the expiry date which is stated on the bag. The expiration date is the last day of the specified month.

Do not use Ciprofloxacin Villerton if you notice visible deterioration.

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 lactate equivalent to 2 mg/ml ciprofloxacin.
  • The other ingredients are lactic acid, glucose monohydrate, and water for injections.

What the medicine looks like and contents of the pack

Ciprofloxacin Villerton is a clear solution, free from visible particles. 
It is packed in plastic bags, available in sizes 100 ml or 200 ml, which are wrapped in foil.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Villerton Invest SA 
Rue Edward Steichen, 14

2540 Luxembourg

LUXEMBOURG

Manufacturer:

Infomed Fluids SRL

50 Theodor Pallady Street

3rd District

Bucharest

Cod 032266

Romania

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

Mylan Hospital AS

PO Box 194, 1371

Asker, Norway

Muhammad Nadeem

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