Document: Ciprofloxacin Mylan film-coated tablet ENG PL change

• Ciprofloxacin Mylan film-coated tablet PL
• Ciprofloxacin Mylan film-coated tablet ENG PL

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Package leaflet: Information for the patient

Ciprofloxacin Mylan100 mg film-coated tablets

Ciprofloxacin Mylan 250 mg film-coated tablets

Ciprofloxacin Mylan 500 mg film-coated tablets

Ciprofloxacin Mylan 750 mg film-coated tablets

ciprofloxacin

Read all of this leaflet carefully before you start taking 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 or pharmacist.

- 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 or pharmacist. 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 take Ciprofloxacin Mylan

3. How to take Ciprofloxacin Mylan

4. Possible side effects

5. How to store Ciprofloxacin Mylan

6. Contents of the pack and other information

1. What Ciprofloxacin Mylanisand what it is used for

Ciprofloxacin Mylan, contains the active substance ciprofloxacin, which is an antibiotic belonging to the fluoroquinolone family. 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

• genital tract infections in men and women

• gastro-intestinal tract infections and intra-abdominal infections

• skin and soft tissue infections

• bone and joint infections

• to prevent infections due to the bacterium Neisseria meningitidis

• anthrax inhalation exposure

Ciprofloxacin may also be used to treat patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be caused by bacterial infection.

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

2. What you need to know before you take Ciprofloxacin Mylan

Do not take Ciprofloxacin Mylan:

• if you are allergic to ciprofloxacin, to other quinolone drugs (such as moxifloxacin, norfloxacin, ofloxacin or nalidixic acid) 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 Mylan’)

Warnings and precautions

Talk to your doctor or pharmacist before taking Ciprofloxacin Mylan if you:

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

• suffer from epilepsy (fits) or other neurological conditions that predispose you to fits

• have a history of tendon problems during previous treatment with quinolone antibiotics such as ciprofloxacin

• have diabetes, because you may experience hypoglycaemia when taking this medicine

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

• have heart problems. Caution should be taken when using ciprofloxacin, 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’).

• 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 taking Ciprofloxacin Mylan

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

Other medicines and Ciprofloxacin Mylan

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

You musttell 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.

The following medicines are known to interact with Ciprofloxacin Mylan in your body. Taking Ciprofloxacin Mylan together with these medicines can influence the therapeutic effect of those medicines. It can also increase the chance of you getting 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)

• olanzapine (an antipsychotic)

• clozapine (an antipsychotic)

• ropinirole (for Parkinson’s disease)

• phenytoin (for epilepsy)

• metoclopramide (for nausea and vomiting)

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

Ciprofloxacin Mylan may increasethe levels of the following medicines in your blood and your doctor may need to adjust your dose. Tell your doctor if you are taking or wish to take:

• pentoxifylline (for circulatory disorders)

• caffeine

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

• lidocaine given as an injection (for heart conditions or an anaesthetic often used in surgical procedures)

• sildenafil (for impotence)

• agomelatine

• zolpidem

Some medicines reducethe effect of Ciprofloxacin Mylan. Tell your doctor if you are taking or wish to take:

• antacids (for indigestion)

• omeprazole (for gastric reflux often known as heartburn, stomach or intestinal ulcers)

• mineral supplements

• sucralfate (for stomach ulcers)

• medicines used to bind phosphate and reduce phosphate levels in the blood (e.g. sevelamer or lanthanum carbonate)

• medicines or supplements containing calcium, magnesium, aluminium or iron

• didanosine (used to treat HIV infection)

If these medicines must be taken, take Ciprofloxacin Mylan about two hours before or no sooner than four hours after them.

Ciprofloxacin Mylanwith food and drink

Ciprofloxacin Mylan is best taken on an empty stomach but it can be taken with or without food. Unless you take Ciprofloxacin Mylan during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the medicine.

Pregnancy and breast feeding

Pregnancy

It is preferable to avoid the use of Ciprofloxacin Mylan during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

Breast-feeding

Do not take Ciprofloxacin Mylanduring breast feeding because ciprofloxacin is passed into breast milk and can be harmful for your baby.

Driving and using machines

Ciprofloxacin Mylan may make you feel dizzy, less alert and affect your reaction time. 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 or pharmacist.

Ciprofloxacin Mylan contains glucose and sorbitol

Ciprofloxacin Mylan tablets contain polydextrose (glucose and sorbitol). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ciprofloxacin Mylan.

3. How to take Ciprofloxacin Mylan

Your doctor will explain to you exactly how much Ciprofloxacin Mylan you will have to take 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 have kidney problems because your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Mylan.

Route and method of administration

• For oral use. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.

• Ciprofloxacin Mylan 250 mg, 500 mg and 750 mg tablets have a score line. The score line is only there to help you break the tablet if you have difficulty swallowing the tablet whole.

• Do try to take the tablets at around the same time every day.

• You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprofloxacin Mylan tablets with dairy products such as milk or yoghurt or with fortified fruit-juices (e.g. orange juice containing added calcium).

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

If you take more Ciprofloxacin Mylan than you should

If you take more tablets than you should, get medical help immediately. Take the remaining tablets and the container with you to show the doctor.

The following effects may be observed: dizziness, tremor, headache, tiredness, fits, seeing, feeling or hearing things that are not there (hallucinations), confusion, abdominal pain, liver problems, kidney problems, crystals or blood in the urine.

If you forget to take Ciprofloxacin Mylan

Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Be sure to complete your course of treatment.

If you stop taking Ciprofloxacin Mylan

It is important that you finish the course of treatmenteven if you begin to feel better after a few days. If you stop taking 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 or pharmacist.

4. Possible side effects

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

Stop taking Ciprofloxacin Mylan and contact your doctor immediately if you notice any of the following serious side effects:

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

• muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tone and cramping, inflammation of the tendons or tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• increased number of infections, causing fever, severe chills, sore throat or mouth ulcers (due to decreased number of white blood cells in the blood) (see Section 2 ‘While taking Ciprofloxacin Mylan')

• depression, or very rarely, psychotic reactions (potentially leading to thoughts of suicide, suicide attempts or completed suicide) (see Section 2 ‘While taking Ciprofloxacin Mylan’)

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

• a widespread rash with blisters around the mouth, nose, eyes, genitals or body

• pus-filled blisters and skin rash

• skin rash which may blister and has central dark spots surrounded by a paler area with darker ring around the edge

• a widespread rash with extensive peeling of the skin

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

• unusual feelings of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• abnormal heart rhythm (seen on ECG) (see Section 2 ‘Warnings and precautions’)

Other side effects may include:

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

• feeling sick (nausea), diarrhoea

• joint pain in children

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

• fungal superinfections

• increased number of white blood cells (eosinophilia, leukocytosis)

• decreased appetite

• hyperactivity or agitation

• headache, dizziness, sleeping problems, taste disorders

• vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind

• increased amounts of certain substances in the blood (transaminases and/or bilirubin)

• rash, itching or hives

• joint pain in adults

• poor kidney function

• pains in your muscles and bones (e.g. back pain, chest pain, pain in extremities), unusual weakness (asthenia), fever

• increase in a certain substance in the blood (alkaline phosphatase)

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

• severe or persistent diarrhoea that may contain blood or mucous (colitis) (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• reduced number of red blood cells which causes weakness or breathlessness and may make the skin pale (anaemia)

• unexpected bruising or bleeding for longer than normal (thrombocytopenia)

• increased number of blood platelets (thrombocytaemia)

• increased blood sugar (hyperglycaemia)

• decreased blood sugar (hypoglycaemia – see section 2 ‘Warnings and precautions’ and ‘While taking Ciprofloxacin Mylan’)

• confusion, disorientation, anxiety reactions, strange or abnormal dreams or hallucinations (seeing, feeling or hearing things that are not there)

• seizures, fits or convulsions (including prolonged or repeated fits without any recovery in between) (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• tingling or numbness of the hands or feet, pins and needles (paraesthesia), unusual sensitivity to stimuli of the senses (dysaesthesia), decreased sense of touch, sensation or skin sensitivity (hypoaesthesia), tremors

• giddiness, spinning sensation (vertigo)

• eyesight problems such as difficulties telling colours apart, blurred or double vision (see section 2 ‘While taking Ciprofloxacin Mylan’)

• buzzing, hissing, whistling, ringing or other persistent noise in the ears (tinnitus), loss of hearing, impaired hearing

• rapid heartbeat (tachycardia)

• expansion of blood vessels (vasodilation), low blood pressure, fainting

• shortness of breath, including asthmatic symptoms

• liver disease, including inflammation of the liver (hepatitis), with symptoms such as loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching or tenderness of the stomach. Very rarely, death of liver cells (liver necrosis) which may lead to liver failure (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• sensitivity to light (see Section 2 ‘While taking Ciprofloxacin Mylan’)

• kidney failure (symptoms like feeling sick (nausea), loss of appetite, weakness, little or no urine), blood or crystals in the urine (see Section 2 ‘While taking Ciprofloxacin Mylan’), urinary tract inflammation

• fluid retention or excessive sweating

• increased levels of the enzyme amylase

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

• other allergic reactions with symptoms that include fever, swelling, skin rash and enlargement of the lymph nodes (serum sickness)

• damaged red blood cells, which causes weakness or breathlessness with yellowing of the skin and whites of the eyes

• inflammation of the pancreas (pancreatitis) which causes severe upper stomach pain, often with feeling sick (nausea) and being sick (vomiting)

• migraine, changes in coordination, unsteady walk (gait disturbance), changes in sense of smell (olfactory disorders), increased pressure on the brain (intracranial pressure or pseudotumour cerebri)

• inflammation of the wall of the blood vessels (vasculitis)

• small, pin-point bleeding under the skin (petechiae)

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

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

• increased blood clotting time in patients treated with Vitamin K antagonist (used for preventing blood clots, e.g. warfarin)

• alteration of the heart rhythm (called ‘prolongation of QT interval’ and seen on ECG) (see Section 2 ‘Warnings and precautions’)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via [to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin Mylan

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 blister or carton after ‘EXP’: The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Mylan contains

The active substance is ciprofloxacin. Each tablet contains 100 mg, 250 mg, 500 mg or 750 mg of ciprofloxacin (as ciprofloxacin hydrochloride).

The other ingredients of the tablets are cellulose microcrystalline, maize starch, crospovidone, starch pregelatinised, silica colloidal anhydrous and magnesium stearate. The film-coating contains hypromellose, titanium dioxide (E171), glucose and sorbitol (polydextrose), glycerol triacetate and macrogol.

What Ciprofloxacin Mylan looks like and contents of the pack

Ciprofloxacin Mylan 100 mg tablets are white, round film-coated tablets marked ‘CF’ on one side and ‘G’ on the other side.

Ciprofloxacin Mylan 250 mg are white, round film-coated tablets marked ‘CF scoreline 250’ on one side and ‘G’ on the other side.

Ciprofloxacin Mylan 500 mg are white capsule-shaped film-coated tablets and marked ‘CF scoreline 500’ on one side and ‘G’ on the other.

Ciprofloxacin Mylan 750 mg are white capsule-shaped film-coated tablets and marked ‘CF scoreline 750’ on one side and ‘G’ on the other.

Ciprofloxacin Mylan 100 mg tablets are available in blister packs of 6, 10, 12, 14, 16, 20, 100 and 120 tablets.

Ciprofloxacin Mylan 250 mg, 500 mg, 750 mg tablets are available in blister packs of 1, 6, 8, 10, 12, 14, 16, 20, 100 and 120 tablets.

Ciprofloxacin Mylan tablets are available in bottles of 6, 10, 12, 14, 16, 20, 100 and 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: [To be completed nationally]

Manufacturer: [To be completed nationally]

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

Austria - Ciprofloxacin "Arcana"

Belgium - Ciprofloxacine Mylan

Germany - Ciprodura

Greece - Ciprofloxacin/Mylan

Italy - Ciprofloxacina Mylan Generics

Luxembourg - Ciprofloxacine Mylan

Netherlands - Ciprofloxacine Mylan

Portugal - Ciprofloxacina Mylan

Sweden - Ciprofloxacin Mylan

UK - Ciprofloxacin

This leaflet was last revised in: 2016-10-05

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 which may lead to some antibiotic treatments becoming 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 follow the prescribed:

• dosages

• 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; as it may not be appropriate for her/his illness.

5 - After completion of treatment, return all unused drugs to your pharmacist to ensure they will be disposed of correctly.