Ciprofloxacin 2 Mg/Ml Solution For Infusion

Document: leaflet MAH GENERIC_PL 00289-1412 change

Package leaflet: Information for the patient

Ciprofloxacin 2 mg/ml solution for infusion Ciprofloxacin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor pharmacist or nurse.

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ciprofloxacin 2 mg/ml solution for infusion is and what it is used for

2. What you need to know before you are given Ciprofloxacin 2 mg/ml solution for infusion

3. How Ciprofloxacin 2 mg/ml solution for infusion is given

4. Possible side effects

5. How to store Ciprofloxacin 2 mg/ml solution for infusion

6. Contents of the pack and other information

1. What Ciprofloxacin 2 mg/ml solution for infusion is and what it is used for

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

Adults

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

• respiratory tract infections

• long lasting or recurring ear or sinus infections

• urinary tract infections

• infections of the testicles

• genital organ infections in women

• gastro-intestinal tract infections and intra-abdominal infections

• skin and soft tissue infections

• bone and joint infections

• to treat infections in patients with a very low white blood cell count (neutropenia)

• to prevent infections in patients with a very low white blood cell count (neutropenia)

• anthrax inhalation exposure.

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

Children and Adolescents

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

• lung and bronchial infections in children and adolescents suffering from cystic fibrosis

• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)

• anthrax inhalation exposure.

Ciprofloxacin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you are given Ciprofloxacin 2 mg/ml Solution for infusion

You must not be given Ciprofloxacin:

• if you are allergic to ciproflzacin, to other quinolone drugs or any of the other ingredients of this medicine (listed in section 6).

• if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin 2 mg/ml solution for unfusion).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Ciprofloxacin 2 mg/ml solution for

infusion:

• if you have ever had kidney problems because dose adjustment may be needed

• if you suffer from epilepsy or other neurological conditions

• if you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin

• if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin

• if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.

• if you have heart problems. Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart) , have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ’bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2: Other medicines and Ciprofloxacin 2 mg/ml solution for infusion).

• if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with ciprofloxacin.

For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to

ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While under treatment with Ciprofloxacin 2 mg/ml solution for infusion

Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin. Your

doctor will decide whether treatment with Ciprofloxacin needs to be stopped.

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin will have to be stopped.

• Pain and swelling in the joints, and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflamation and ruptures of tendons may occur even within the first 48 hours of treatment or up to several months after discontinuation of

Ciprofloxacin therapy. At the first sign of any pain or inflammation Ciprofloxacin will have to be stopped, rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture.

• If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

• You may experience psychiatric reactions after first administration of ciprofloxacin, in rare cases leading to suicidal thoughts/ideas. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts or completed suicide. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

• You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Ciprofloxacin and contact your doctor immediately.

Hypoglycemia has been reported most often in diabetic patients, predominantly in elderly population. If this happens, contact your doctor immediately.

• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin, or even several weeks after you have stopped using them. If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin /.../ treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see section 4: possible side effects).

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

• Tell the doctor or laboratory staff that you are taking Ciprofloxacin if you have to provide a blood or urine sample.

• Ciprofloxacin may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin must be stopped immediately.

• Ciprofloxacin may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

• Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

• if your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see section 4: possible side effects).

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

Do not use Ciprofloxacin together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see section 2: "You must not be given Ciprofloxacin ").

The following medicines are known to interact with Ciprofloxacin in your body. Using Ciprofloxacin together with these medicines can influence the therapeutic effect of these medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

• Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anti-coagulants (to thin the blood)

• probenecid (for gout)

• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

• theophylline (for breathing problems)

• tizanidine (for muscle spasticity in multiple sclerosis)

• olanzapine (an antipsychotic)

• clozapine or olanzapine (an antipsychotic)

• duloxetine (for treatment of depression)

• ropinirole (for Parkinson’s disease)

• phenytoin (for epilepsy)

• ciclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

• metroclopramide (for treatment of nausea and vomiting)

• omeprazole (for acid reflux, chronic heartburn)

• other medicines that can alter your heart rhythm; medicines that belong to the group if anti-arrythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Ciprofloxacin may increase the levels of the following medicines in your blood:

• pentoxifylline (for circulatory disorders)

• caffeine

• duloxetine (for depression, diabetic nerve damage or incontinence)

• glibenclamide (for diabetes)

• lidocaine (for heart conditions or anaesthetic use)

• sildenafil (used for treatment of erectile dysfunction or high blood pressure in the blood vessels in the lungs).

• agomelatine (for depression)

• zolpidem (for insomnia)

Ciprofloxacin 2 mg/ml solution for infusion with food and drink

Food and drink does not affect your treatment with Ciprofloxacin.

Pregnancy and breast-feeding

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 preferable to avoid the use of Ciprofloxacin during pregnancy.

Do not take Ciprofloxacin during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving and using machines

Ciprofloxacin may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

Ciprofloxacin 2mg/ml solution for infusion contains glucose

Ciprofloxacin 2 mg/ml solution for infusion contains 5000 mg glucose monohydrate per 100 ml solution for infusion. This should be taken into account in patients with diabetes mellitus.

3. How Ciprofloxacin 2 mg/ml solution for infusion is given

Your doctor will explain to you exactly how much Ciprofloxacin 2 mg/ml solution for infusion you will be given as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

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

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

Your doctor will give you each dose by slow infusion through a vein into your bloodstream. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin 2 mg/ml solution for infusion and 30 minutes for 200 mg Ciprofloxacin 2mg/ml solution for infusion. Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking this medicine.

If you stop your course of Ciprofloxacin 2 mg/ml solution for infusion

It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

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

4. Possible side effects

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

Serious side effects

Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin 2 mg/ml solution for infusion:

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema).

Even with the first dose, there is a rare chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing. If this happens, tell your doctor immediately since the administration of Ciprofloxacin 2 mg/ml solution for infusion will have to be stopped.

• You may experience psychiatric reactions after first administration of ciprofloxacin.

If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin 2 mg/ml solution for infusion. In rare cases, depression or psychosis can progress to thoughts of suicide, suicide attempts, or completed suicide. If this happens, stop taking Ciprofloxacin 2 mg/ml solution for infusion and contact your doctor immediately.

• Muscle pain and/or weakness, inflamation of the joints and joint pain, increased muscle tone and cramping, inflamation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) - see section 2.

• You may experience symptoms of neuropathy such as unusual feelings of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) - see section 2. If this happens, stop taking Ciprofloxacin 2 mg/ml solution for infusion and contact your doctor immediately.

• Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin 2 mg/ml solution for infusion, or even several weeks after you have stopped using them. If it becomes severe or persistant or you notice that your stool contains blood or mucus tell your doctor immediately. Ciprofloxacin treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately (see section 2: What you need to know before you are given Ciprofloxacin 2 mg/ml solution for infusion).

Other side effects

The following side effects have been reported at the approximate frequencies shown:

Common (may affect up to 1 in 10 people):

- nausea, diarrhoea, vomiting

- joint pains in children

- local reaction at the injection site, rash

- temporary increased amounts of substances in the blood (transaminases)

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

- allergic swelling (oedema)

- fungal superinfections

- a high concentration of eosinophils, a type of white blood cell, increased or decreased amounts of a blood cloting factor (thrombocytes)

- loss of appetite (anorexia)

- hyperactivity, agitation, confusion, disorientation, hallucinations

- headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, seizures (see section 2: Warnings and precautions), giddiness (vertigo)

- eyesight problems

- loss of hearing

- rapid heartbeat (tachycardia)

- expansion of the blood vessels (vasodilation), low blood pressure

- abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), wind

- liver disorders, increased amounts of substances in the blood (bilirubin), jaundice (cholestatic icterus)

- itching, hives

- j oint pain in adults

- poor kidney function, kidney failure

- pains in your muscles and bones, feeling unwell (asthenia), fever, fluid retention

- increase in blood alkaline phosphatase (a certain substance in the blood).

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

- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see section 2: Warnings and precautions)

- changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, bone-marrow depression which may also be fatal (see section 2: Warnings and precautions)

- allergic reaction, rapid swelling of the skin and mucous membranes (angiooedema), severe allergic reaction (anaphylactic shock) which can be life-threatening (see sSection 2: Warnings and precautions)

- increased blood sugar (hyperglycemia)

- anxiety reaction, strange dreams, depression which can lead to suicidal thoughts or suicide attempts, mental disturbances (psychotic reactions) (see section 2: Warnings and precautions)

- decreased skin sensitivity, tremor, seizures (including persistent brain seizure), migraine, disorder of sense of smell (olfactory disorders)

- tinnitus, impaired hearing

- fainting, inflammation of the blood vessel (vasculitis)

- shortness of breath including asthmatic symptoms

- pancreatitis

- hepatitis, death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

- sensitivity to light (see section 2: Warnings and precautions), small, pin-point bleeding under the skin (petechiae)

- muscle pain, inflammation of the joints, increased muscle tone, cramping, tendon rupture - especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)

- blood or crystals in the urine (see Section 2:Warnings and precautions), urinary tract inflammation

- excessive sweating

- increased levels of the enzyme amylase.

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

- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis )

- severe allergic reaction (anaphylactic reaction, serum sickness) which can be fatal (see section 2: Warnings and precautions.)

- disturbed coordination, unsteady walk (gait disturbance), pressure on the brain (intracranial pressure)

- visual colour distortions

- various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic

epidermal necrolysis)

- muscle weakness, tendon inflammation, worsening of the symptoms of myasthenia gravis (see section 2: Warnings and precautions.).

Not known (frequency cannot be estimated from the available data)

- troubles associated with the nervous system such as pain, burning, tingling, numbness and/ or weakness in extremities (peripheral neuropathy and polyneuropathy)

- abnormal fast heart rhythm, life- threatening irregular heart rhythm, alteration of the heart rhythm (called’prolongation of QT interval’, seen on ECG, electrical activity of the heart).

- pustular rash

- influence on blood clotting (in patients treated with Vitamin K antagonists).

- feeling highly excited (mania) or feeling great optimism and overactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms).

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE Ciprofloxacin 2 mg/ml solution for infusion

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 packaging after “Exp”. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Store the infusion bag in the overpouch until it is used in order to protect from light.

After first opening and / or following dilution, the solution should be used immediately.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ciprofloxacin 2 mg/ml solution for infusion contains

The active substance is ciprofloxacin (as lactate).

Each bag of 100 ml contains 200 mg of ciprofloxacin.

Each bag of 200 ml contains 400 mg of ciprofloxacin.

The other ingredients are glucose monohydrate, lactic acid, hydrochloric acid and water for injections.

What Ciprofloxacin 2 mg/ml solution for infusion looks like and contents of the pack

Ciprofloxacin 2mg/ml solution for infusion is an isotonic sterile, clear and colourless solution. The medicine is supplied to the hospital in plastic (polycine) infusion bags fitted with polypropylene infusion ports. The ports are sealed with a rubber stopper and a polypropylene snap-cap. The infusion bags are contained in an aluminium overpouch.

Pack sizes: 100 ml bags (200 mg ciprofloxacin) in packs of 1 or 10 bags 200 ml bags (400 mg ciprofloxacin) in packs of 1 or 10 bags Not all package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva UK Limited, Eastbourne, BN22 9AG

Manufacturer:

Teva Pharmaceutical Works Private Limited Company, H-2100, Godollo, Tancsics. M. u. 82., Hungary

PL 00289/1412

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

- dosage

- schedules

- duration of treatment

Consequently, to preserve the efficacy of this drug:

1. Use antibiotics only when prescribed.

2. Strictly follow the prescription.

3. Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4. Never give your antibiotic to another person; maybe it is not adapted to her/his illness.

5. After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.

The following information is intended for medical or healthcare professionals only:

Ciprofloxacin should be administered by intravenous infusion. For children, the infusion duration is 60 minutes. In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin and 30 minutes for 200 mg Ciprofloxacin. Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation. The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.

Unless compatibility with other infusion solutions/drugs has been confirmed the solution must always be administered separately. The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.

Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.5-4.6).

After intravenous initiation of treatment, the treatment can be continued orally as well.