Document: Ciprofloxacin Accord film-coated tablet ENG PL change

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Accord250 mg film-coated tablets

Ciprofloxacin Accord500 mg film-coated tablets

Ciprofloxacin Accord750 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 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 of the side effects, talk to your doctor or 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 Accord is and what it is used for

Ciprofloxacin Accord 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 Accord 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 prevent infections due to the bacterium Neisseria meningitidis

• anthrax inhalation exposure

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a 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 Accord.

Children and adolescents

Ciprofloxacin Accord 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 Accord 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 knowbefore you use Ciprofloxacin Accord

Do not take Ciprofloxacin Accord if you are:

• allergic (hypersensitive) to the active substance, to other quinolone drugs or to any of the other ingredients of Ciprofloxacin Accord (see section 6).

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

Warnings and Precautions

Before taking CiprofloxacinAccord

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 Accord

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

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

• have a history of abnormal heart rhythms (arrhythmias)

• 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.

• 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 Other medicines and Ciprofloxacin Accord).

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 Accord

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

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up. If this happens, stop taking Ciprofloxacin Accord and contact your doctor immediately.

• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

• Pain or swelling in the joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. Inflammation and ruptures of tendons

may occur even within the first 48 hours of treatment or up to several months after discontinuation of Ciproxin therapy.At the first sign of any pain or inflammation stop taking Ciprofloxacin Accord and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.

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

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

• If you suffer from kidney problems, tell the doctor because your dose may need to be

adjusted.

Other medicines and Ciprofloxacin Accord:

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

Do not take Ciprofloxacin Accord together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see section 2: “Do not take Ciprofloxacin Accord ”)

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

Tell your doctor if you are taking:

• Vitamin K antagonists (e.g. warfarin) 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 (an antipsychotic)

• ropinirole (for parkinson’s disease)

• phenytoin ( for epilepsy)

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

• metoclopramide (for nausea or vomiting)

• omeprazole (for peptic ulcer or indigestion)

• glibenclamide (for diabetes)

• 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.

Ciprofloxacin Accord may increasethe levels of the following medicines in your blood:

• pentoxifylline (for circulatory disorders)

• caffeine

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

• lidocaine (for heart conditions or anesthetic use)

• sildenafil (e.g. for erectile dysfunction)

• agomelatine,

• zolpidem

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

• antacids

• mineral supplements

• sucralfate

• a polymeric phosphate binder (e.g. sevelamer)

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

If these preparations are essential, take Ciprofloxacin Accord about two hours before or no sooner than four hours after them.

Ciprofloxacin Accordwith food and drink

Unless you take Ciprofloxacin Accord during meals, do not eat or drink any dairy products (such as milk or yogurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.

Pregnancy and breast-feeding

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

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

Driving and using machines

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

CiprofloxacinAccord contains Lactose monohydrate

Ciprofloxacin Accord contains lactose monohydrate (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

3. How to take Ciprofloxacin Accord

Your doctor will explain to you exactly how much Ciprofloxacin Accord 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 suffer from 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. Take the tablets exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacin Accord.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste

nice.

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

c. 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 Accord with dairy

products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange

juice).

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

If you take more Ciprofloxacin Accordthan you should

If you forget to take Ciprofloxacin Accord

If youstop taking Ciprofloxacin Accord

If you have any more questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you experienceany of the following serious side effects:

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

Very rare (may affect up to 1 in 10,000 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.

• 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 (agranulocytosis, see section 2).

• Severe extensive skin damage (separation of the epidermis and superficial mucous membranes)(toxic epidermal necrolysis).

• A serious allergic reaction with rashes, usually in the form of blisters or ulcers in the mouth and eyes and other mucous membranes such as genitals (Stevens-Johnson syndrome).

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)

• A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS syndrome, AGEP Acute Generalised Exanthematous Pustulosis).

Otherside effects:

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

• nausea, diarrhoea

• Joint pains in children

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

• fungal superinfections

• a high concentration of eosinophils, a type of white blood cell

• loss of appetite (anorexia)

• hyperactivity or agitation

• headache, dizziness, sleeping problems, or 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

• poor kidney function

• joint pain in adults

• pains in your muscles and bones, feeling unwell (asthenia), or fever

• 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 very rare cases) (see section 2: Warnings and precautions)

• changes to the blood count (leukopenia, leucocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)

• increased blood sugar (hyperglycaemia)

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

• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), or hallucinations

• pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see section 2: Warnings and precautions), or giddiness

• eyesight problems including double vision

• tinnitus, loss of hearing, impaired hearing

• rapid heartbeat (tachycardia)

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

• shortness of breath, including asthmatic symptoms

• liver disorders, jaundice (cholestatic icterus), or hepatitis

• sensitivity to light (see section 2: Warnings and precautions)

• muscle pain, inflammation of the joints, increased muscle tone, or cramp

• kidney failure, blood or crystals in the urine (see section 2:Warnings and precautions), 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):

• a special type of reduced red blood cell count (haemolytic anaemia); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Warnings and precautions)

• mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts, or completed suicide) (see Section 2: Warnings and precautions)

• migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure)

• visual colour distortions

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

• pancreatitis

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

• small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes

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

• 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)

• feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)pustular rash influence on blood clotting (in patients with Vitamin K antagonists)

Reporting of side effects

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

5. How to storeCiprofloxacin Accord

Keep 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 medicinal product 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 to protect the environment.

6. Contents of the pack and other information

WhatCiprofloxacin Accordcontains

The active substance is Ciprofloxacin hydrochloride.

Theotheringredients arecroscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate. The tablet coating is made of hypromellose, lactose monohydrate, macrogol, Sodium citrate dihydrate (E331 iii) and the colouring agent titanium dioxide (E171) (see section 2 for Important information about some of the ingredients of Ciprofloxacin Accord).

What Ciprofloxacin Accord looks like and contents of the pack

Ciprofloxacin 250mg film-coated Tablets are white to off-white, round, biconvex film coated tablet with inscription ‘AM’ on one side and plain on the other side.

Ciprofloxacin 500mg film-coated Tablets are white to off-white, capsule shape, biconvex with beveled edge, film coated tablet with inscription ‘CI’ on one side and plain on other side.

Ciprofloxacin 750mg film-coated Tablets are white to off-white, capsule shape, biconvex with beveled edge, film coated tablet with inscription ‘CJ’ on one side and plain on other side.

Ciprofloxacin Accord are available in PVC/Alu blister.

Pack size: 6, 10, 12, 14, 16, 20, 28, 30, 50 and 100 tablets in blister.

(Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Accord Pharmaceuticals Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road,

North Harrow, Middlesex,

HA1 4HF, United Kingdom

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

Name of the Member State	Name of the medicinal product
Belgium	Ciprofloxacin Accord Healthcare 250/500/750 mg comprimés pelliculés/ filmomhulde tabletten / Filmtabletten
France	Ciprofloxacin Accord 250/500/750 mg comprimés pelliculés
Italy	Ciprofloxacina Accord
Netherlands (The)	Ciprofloxacine Accord 250/500/750 mg filmomhulde tabletten
Sweden	Ciprofloxacin Accord

This leaflet was last revised in 2016-03-30

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:

- 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; 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.