Document: leaflet MAH GENERIC_PL 04569-1057 change

• leaflet MAH GENERIC_PL 04569-1057
• leaflet MAH GENERIC_PL 04569-1058

---

Package leaflet: Information for the user

Ciprofloxacin Mylan 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.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours

•    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 Mylan is and what it is used for

2.    What you need to know before you are given Ciprofloxacin Mylan

3.    How to use Ciprofloxacin Mylan

4.    Possible side effects

5.    How to store Ciprofloxacin Mylan

6.    Contents of the pack and other information

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

Ciprofloxacin Mylan 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 Mylan 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 Mylan.

Children and adolescents Ciprofloxacin Mylan 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 Mylan 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 Mylan

You must not be given Ciprofloxacin Mylan if you are:

•    allergic to ciprofloxacin, to other quinolone drugs or any of the other ingredients of this medicine (listed in section 6)

•    taking tizanidine (see section 2: Other medicines and Ciprofloxacin Mylan).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Ciprofloxacin Mylan 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 Mylan).

Tell your doctor if you:

•    have ever had kidney problems because your treatment may need to be adjusted

•    suffer from epilepsy or other neurological conditions

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

•    are diabetic because you may experience a risk of low-blood sugar levels (hypoglycaemia) with ciprofloxacin.

•    have myasthenia gravis (a type of muscle weakness)

While under treatment with Ciprofloxacin Mylan

Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin Mylan. Your doctor will decide whether treatment with Ciprofloxacin Mylan needs to be stopped.

•    Severe, sudden allergic reaction (an anaphylactic reaction/shock, angino-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 Mylan 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. At the first sign of any pain or inflammation Ciprofloxacin Mylan will have to be stopped, rest the painful area. Avoid any unnecessary exercise as this might increase the risk of a tendon rupture. Tendon inflammation and ruptures may occur even up to several months after you stop taking Ciprofloxacin Mylan.

•    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 Mylan and contact your doctor immediately.

•    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 Mylan. You may have thoughts of killing or harming yourself. If this happens, stop taking Ciprofloxacin Mylan 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 Mylan and contact your doctor immediately.

•    If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist 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 Mylan, 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 Mylan treatment will have to be stopped immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

•    Tell the doctor or laboratory staff that you are taking Ciprofloxacin Mylan

if you have to provide a blood or urine sample.

•    Ciprofloxacin Mylan 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 Mylan must be stopped immediately.

•    Ciprofloxacin Mylan 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 Mylan. Avoid exposure to strong sunlight or artificial UV light such as sunbeds.

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

You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Do not use Ciprofloxacin Mylan 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 Mylan if you are).

The following medicines are known to interact with Ciprofloxacin Mylan in your body. Using Ciprofloxacin Mylan 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:

•    Warfarin, acenocoumarol, phenprocoumon, 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)

•    clozapine (an antipsychotic)

•    ropinirole (for Parkinson's disease)

•    phenytoin (for epilepsy)

•    ciclosporin (an immunosuppressant)

•    glibenclamide (for diabetes) Ciprofloxacin Mylan may increase the level of the following substances in the blood:

•    pentoxifylline (for circulatory disorders)

•    duloxetine (for depression, anxiety and pain)

•    olanzapine (an antipsychotic)

•    lidocaine given as an injection (an anaesthetic often used in surgical procedures)

•    sildenafil (for impotence)

•    caffeine

•    agomelatine

•    zolpidem

Ciprofloxacin Mylan with food and drink

Food and drink does not affect your treatment with Ciprofloxacin Mylan.

Pregnancy and breast-feeding

It is preferable to avoid the use of Ciprofloxacin Mylan during pregnancy. Tell your doctor if you are planning to get pregnant.

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

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

Ciprofloxacin Mylan contains 5 g of glucose per 100 ml of solution for infusion.

Ciprofloxacin Mylan contains 10 g of glucose per 200 ml of solution for infusion.

This should be taken into account in patients with diabetes mellitus.

3. How to use Ciprofloxacin Mylan

Your doctor will explain to you exactly how much Ciprofloxacin Mylan 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 Mylan and 30 minutes for 200 mg Ciprofloxacin Mylan. Administering the infusion slowly helps prevent immediate side effects occurring.

Remember to drink plenty of fluids while you are taking Ciprofloxacin Mylan.

If you use more Ciprofloxacin Mylan than you should

If you are concerned that you may have been given too much ciprofloxacin, talk to your doctor or nurse immediately.

A symptomatic treatment and a monitoring of the electrical activity of your heart as well as your kidney function should be undertaken.

_ ------------------------

The following information is intended for healthcare professionals only

Ciprofloxacin Mylan 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 Mylan and 30 minutes for 200 mg Ciprofloxacin Mylan. 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.

PR778816

The following effects can be observed: dizziness, tremor, headache, fits, seeing, feeling or hearing things that are not there (hallucinations), giddiness, abdominal pain, liver disorders, kidney disorders such as crystals or blood in the urine.

If you stop your course of Ciprofloxacin Mylan

•    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 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.

You must contact your doctor immediately or go straight to your nearest hospital emergency department if you notice any of the following:

Uncommon: may affect up to 1 in 100 people

•    Joint pain;

•    Fungal superinfections;

•    Fits (seizures) (see section 2: Warnings and precautions);

•    Yellowing of the skin and/or eyes (cholestatic icterus) (see section 2: Warnings and precautions);

•    Poor kidney function, kidney disease where you pass little or no urine (kidney failure);

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

•    Muscle pain, inflammation of the joints, increased muscle tone and cramping or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions);

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

•    Diarrhea incl inflammation of the bowel (colitis) linked to antibiotic use (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);

•    Anxiety reaction, strange dreams, depression (which may lead to thoughts of harming or killing yourself), mental disturbances (psychotic reactions) (see section 2: Warnings and precautions);

•    Fainting;

•    Inflammation of the pancreas with symptoms including severe upper stomach pain, often with nausea and vomiting (pancreatitis);

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

•    Kidney disease in which inflammation of the area surrounding the tubules in the kidney occurs with symptoms like blood in urine;

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

•    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);

•    High blood pressure in the brain including symptoms like blurred vision (intracranial pressure and pseudotumor cerebri);

•    Various skin eruptions or rashes (e.g. the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis);

•    Worsening of the symptoms of myasthenia gravis (see section 2: Warnings and precautions);

•    Muscle weakness, inflammation of the tendons.

Not known: Frequency cannot be estimated from the available data

•    Hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms);

•    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);

•    Troubles associated with the nervous system such as unusual feelings of pain, burning, tingling, numbness and/ or muscle weakness in the extremities (peripheral neuropathy and polyneuropathy) (see section 2: Warnings and precautions).

Other possible side effects:

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

•    Nausea, diarrhoea, vomiting

•    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):

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

•    loss of appetite (anorexia)

•    hyperactivity, agitation, confusion, disorientation, seeing, feeling or hearing things that are not there (hallucinations)

•    headache, dizziness, sleeping problems, taste disorders, pins and needles, unusual sensitivity to stimuli of the senses, giddiness

•    eyesight problems (like seeing double) (See section 2: Warnings and precautions)

•    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 one substance in the blood (bilirubin),

•    itching, hives

•    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):

•    increased blood sugar (hyperglycemia)

•    decreased blood sugar (hypoglycaemia) (see Section 2: Warnings and precautions)

•    decreased skin sensitivity, tremor, migraine, disorder of sense of smell (olfactory disorders)

•    tinnitus, impaired hearing

•    inflammation of the blood vessel (vasculitis)

•    shortness of breath including asthmatic symptoms

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

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

•    excessive sweating

•    abnormal levels of a clotting factor (prothrombin), increased levels of the enzyme amylase

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

•    disturbed coordination, unsteady walk (gait disturbance),

•    visual colour distortions

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

•    blistered and reddened skin rash sometimes with a fever (Acute generalised exanthematous pustulosis)

•    increased clotting time in people taking warfarin or other oral anticoagulants (to thin the blood)

•    feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

IRELAND

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie UK

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

5.    How to store Ciprofloxacin Mylan

Do not store above 25°C.

Store in the outer overwrap in order to protect from light.

Do not refrigerate or freeze.

The opened bag should be used immediately.

Chemical and physical in-use stability has been demonstrated for 48 hours at 25°C.

From a microbiological point of view, the product should be used immediately.

If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

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 expiry date refers to the last day of that month.

Do not through 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 Mylan contains

The active substance is ciprofloxacin. Each bag of 100 ml contains 200 mg of ciprofloxacin

Each bag of 200 ml contains 400 mg of ciprofloxacin

The other ingredients are lactic acid (E270), glucose monohydrate, hydrochloric acid (E507) for pH adjustment and water for injections. What Ciprofloxacin Mylan looks like and contents of the pack Solution for infusion Ciprofloxacin Mylan is a sterile, clear and colourless to slightly yellow solution for infusion.

It is contained in a polyolefin bag overwrapped with both a polypropylene envelope and an opaque envelope.

Pack of 1, 10, 20 or 30 bags with an

integrated infusion set

Pack of 1, 10, 15 or 20 bags with an

integrated infusion set

Not all pack sizes may be marketed.

Marketing Authorisation Holder

For any information about this

medicine, please contact the Marketing

Authorisation Holder.

Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom. Manufacturer

Maco Production S.A.S. - rue Lorthiois, 59420 Mouvaux - France Or Mylan S.A.S - 117 allee des Parcs, 69800 Saint-Priest - France.

This medicinal product is authorised in the Member States of the EEA under the following names:

This leaflet was last revised in 06/2016.

Detailed information on this medicine is available on the web site of MHRA/HPRA 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

_ -------------------------

Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion 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.

778816    PR778816

v1/May 2015