PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Accord 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Generic medicine
Please 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 questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Ciprofloxacin Accord is and what it is used for
What you need to know before taking Ciprofloxacin Accord
How to take Ciprofloxacin Accord
Possible side effects
How to store Ciprofloxacin Accord
Contents of the pack and other information

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

Ciprofloxacin Accord contains as its active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against specific strains of bacteria.
Adults
Ciprofloxacin Accord is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or sinus infections
urinary tract infections
genital tract infections in men and women
genital infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
prevention of infections caused by the bacterium Neisseria meningitidis
exposure to inhaled anthrax

Ciprofloxacin may be used to manage patients with a low white blood cell count (neutropenia) who develop fever suspected to be due to a bacterial infection.
If you have a severe infection or an infection caused by more than one type of bacteria, you will likely be prescribed additional antibiotic treatment alongside 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 with cystic fibrosis
complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
exposure to inhaled anthrax

Ciprofloxacin Accord may also be used to treat other specific severe infections in children and adolescents, when deemed necessary by the physician.

2. What you need to know before taking Ciprofloxacin Accord

Do not take Ciprofloxacin Accord if:

you are allergic to the active substance, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Accord).

Warnings and precautions
Before taking Ciprofloxacin Accord
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Ciprofloxacin Accord, if you have previously experienced any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Before taking Ciprofloxacin Accord, consult your doctor if:

you have ever had kidney problems, as your treatment may need to be adjusted
you suffer from epilepsy or other neurological disorders
you have had tendon problems during a previous treatment with antibiotics such as Ciprofloxacin Accord
you have diabetes, as there may be a risk of hypoglycaemia when using ciprofloxacin
you have myasthenia gravis (a type of muscle weakness), as symptoms may worsen
you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin
you have heart problems. Caution is required when using Ciprofloxacin Accord if you are born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called "bradycardia"), have weak heart function (heart failure), have a history of heart attack (myocardial infarction), are female or elderly, or are taking other medicines that cause changes in the ECG (see section Other medicines and Ciprofloxacin Accord).
you have been diagnosed with enlargement or "bulging" of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).

For the treatment of certain genital tract infections, your doctor may prescribe another
antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days
of treatment, consult your doctor.
While taking Ciprofloxacin Accord
Inform your doctor immediately if, during treatment with Ciprofloxacin Accord,
any of the following conditions occur. Your doctor will decide whether it is necessary to stop
treatment with Ciprofloxacin Accord.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). Even after the first dose, there is a small chance you may experience a severe allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In this case, stop taking Ciprofloxacin Accord and contact your doctor immediately.
Severe, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including ciprofloxacin tablets, have been associated with very rare but serious adverse effects, some of which are long-lasting (lasting months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, tickling, numbness, or burning (paresthesia), sensory disturbances including impaired vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these adverse effects after taking Ciprofloxacin Accord, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering an antibiotic from another class.
If your vision is impaired or if your eyes appear to be affected in any other way, consult an ophthalmologist immediately.
Rarely, joint pain and swelling, or inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Ciprofloxacin Accord. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin Accord, contact your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In case of seizures, stop taking Ciprofloxacin Accord and contact your doctor immediately.
You may experience psychiatric reactions even when taking quinolone antibiotics for the first time, including Ciprofloxacin Accord. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Accord. In rare cases, depression or psychosis may lead to suicidal thoughts and self-harming behaviours, such as suicide attempts or completed suicide (see section 4: Possible side effects). If depression, psychosis, or suicidal thoughts or behaviours occur, contact your doctor immediately.
Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycaemia) or a decrease in blood sugar levels below normal, possibly leading to loss of consciousness (hypoglycaemic coma) in severe cases (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood glucose levels should be closely monitored.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop treatment with Ciprofloxacin Accord and contact your doctor immediately to prevent permanent nerve damage.
Hypoglycaemia has been very commonly reported in diabetic patients, especially in the elderly population. If this occurs, contact your doctor immediately.
Diarrhoea may develop while you are taking antibiotics, including Ciprofloxacin Accord, or even several weeks after you have stopped taking the medicine. If diarrhoea worsens or becomes persistent, or if you notice blood or mucus in your stools, stop treatment with Ciprofloxacin Accord immediately, as this may be life-threatening. Do not take medicines that block or slow intestinal movement and contact your doctor.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Accord if you are required to provide a blood or urine sample for testing.
If you have kidney problems, inform your doctor, as you may require a dosage adjustment.
Ciprofloxacin Accord may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach discomfort, stop taking Ciprofloxacin Accord and contact your doctor immediately.
Ciprofloxacin Accord may reduce the number of white blood cells and may reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of localized infection such as sore throat/pain in the throat/mouth or urinary problems, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.
During treatment with Ciprofloxacin Accord, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight or artificial UV light, for example in sunbeds.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Accord, have been
associated with very rare but serious adverse effects, some of which are prolonged (lasting months
or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, numbness, or burning (paresthesia), sensory organ disturbances such as altered vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these adverse effects after taking Ciprofloxacin Accord, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Other medicines and Ciprofloxacin Accord:
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take Ciprofloxacin Accord with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin Accord).
Interactions between the following medicines and Ciprofloxacin Accord are known.
Taking Ciprofloxacin Accord with these medicines may affect the therapeutic effect of these medicines. It may also increase the likelihood of side effects.
Inform your doctor if you are taking:

Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin 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)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson's disease)
phenytoin (for epilepsy)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
metoclopramide (for nausea or vomiting)
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.
zolpidem (for sleep disorders)

Ciprofloxacin Accord may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g., for erectile dysfunction)
agomelatine (for depression)

Some medicines reduce the effect of Ciprofloxacin Accord. Inform your doctor if you are
taking or intend to take:

antacids
omeprazole
mineral supplements
sucralfate
a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take Ciprofloxacin Accord approximately two hours before or no sooner than four hours after taking them.

Taking Ciprofloxacin Accord with food and drink
Unless otherwise directed, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages when taking the tablets, as they may affect the absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 using Ciprofloxacin Accord during pregnancy.
Do not take Ciprofloxacin Accord while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to the infant.
Driving and using machines
Ciprofloxacin Accord may reduce your alertness. Some neurological adverse events may occur. Therefore, make sure you know how you react to Ciprofloxacin Accord before driving or operating machinery. If you have any doubts, consult your doctor.
Ciprofloxacin Accord contains lactose monohydrate
Ciprofloxacin Accord contains lactose monohydrate (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Ciprofloxacin Accord

Your doctor will explain exactly how much Ciprofloxacin Accord you should take, how often, and for how long. This will depend on the type and severity of the infection you have.
Inform your doctor if you have kidney problems, as a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer in the case of severe infections.
Always take the medicine exactly as prescribed by your doctor. Consult your doctor or pharmacist if you are unsure about the number of tablets to take or how to take Ciprofloxacin Accord.
a. Swallow the tablets with plenty of fluid.
b. Do not chew or crush the tablets. If you are unable to swallow the tablet, inform your doctor so that they can prescribe a more suitable formulation for you.
c. Try to take the tablets at the same time each day.
d. You may take the tablets with meals or between meals. Calcium consumed during a meal does not significantly affect absorption. However, do not take Ciprofloxacin Accord with dairy products such as milk or yoghurt, or with calcium-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids while taking Ciprofloxacin Accord.

If you take more Ciprofloxacin Accord than you should
➢ If you take more than the prescribed dose, contact your doctor immediately. If possible, bring the tablets or the pack with you to show your doctor.

If you forget to take Ciprofloxacin Accord
If you forget to take Ciprofloxacin Accord and:
➢ There are 6 hours or more until your next scheduled dose, take the missed dose as soon as possible. Then take the next dose at the usual time.
➢ There are less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin Accord
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop treatment too early, the infection may not be completely cured, and infection symptoms may return or worsen. You may also develop antibiotic resistance.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following section lists the most serious side effects you can recognize on your own:
Stop taking Ciprofloxacin Accord and contact your doctor immediately to consider alternative antibiotic treatment if you notice any of the following serious side effects:

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

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

Seizures (see section 2: Warnings and precautions)

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

Severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell, fainting, or dizziness upon standing (anaphylactic reaction/shock) (see section 2: Warnings and precautions)
Muscle weakness, tendon inflammation which may lead to tendon rupture, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
A severe, life-threatening skin rash, usually presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genitals, which may progress to widespread blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis)

Not known (frequency cannot be estimated from available data)

Unusual sensation of pain, burning, tingling, numbness, or muscle weakness in the extremities (neuropathy, see section 2: Warnings and precautions)
Drug reaction causing skin rashes, fever, internal organ inflammation, blood abnormalities, and systemic illness (DRESS syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP, Acute Generalized Exanthematous Pustulosis)

Other side effects observed during treatment with Ciprofloxacin Accord are listed below, grouped by their frequency:

Common (may affect up to 1 in 10 people)

Nausea, diarrhoea
Joint pain and joint inflammation in children

Uncommon (may affect up to 1 in 100 people)

Fungal superinfections
High concentration of eosinophils, a type of white blood cells
Decreased appetite
Hyperactivity or restlessness
Headache, dizziness, sleep disturbances, or taste alterations
Vomiting, abdominal pain, digestive problems such as stomach discomfort (dyspepsia/heartburn) or flatulence
Increased levels of certain substances in the blood (transaminases and/or bilirubin)
Skin rash, itching, or hives
Reduced kidney function
Joint pain in adults
Muscle and bone pain, feeling of malaise (asthenia), or fever
Increased alkaline phosphatase in the blood (a certain substance in the blood)

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

Inflammation of the bowel (colitis) associated with antibiotic use (may be fatal in very rare cases) (see section 2: Warnings and precautions)
Changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in levels of a blood clotting factor (platelets)
Allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions), increased blood sugar (hyperglycaemia)
Decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
Confusion, disorientation, anxiety reactions, unusual dreams, depression (which may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions), or hallucinations
Tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, or vertigo
Vision problems including double vision (see section 2: Warnings and precautions)
Tinnitus, hearing loss, or hearing problems
Rapid heartbeat (tachycardia)
Dilation of blood vessels (vasodilation), low blood pressure, or fainting
Shortness of breath, including asthma-like symptoms
Liver disorders, jaundice (cholestatic jaundice), or hepatitis
Light sensitivity (see section 2: Warnings and precautions)
Muscle pain, joint inflammation, increased muscle tone, or cramps
Kidney failure, blood or crystals in urine (see section 2: Warnings and precautions), inflammation of the urinary tract
Fluid retention or excessive sweating
Increased levels of the enzyme amylase

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

A specific type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal; and bone marrow suppression, which may also be fatal
Allergic reaction known as serum sickness-like reaction (see section 2: Warnings and precautions)
Psychiatric reactions (psychotic reactions which may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions)
Migraine, coordination problems, unsteady gait (gait disturbance), disturbance of the sense of smell (olfactory disturbances), pressure in the brain (increased intracranial pressure and pseudotumor cerebri)
Distortions in colour perception
Inflammation of blood vessel walls (vasculitis)
Pancreatitis
Liver cell death (hepatic necrosis), which very rarely leads to life-threatening liver failure (see section 2: Warnings and precautions)
Tiny subcutaneous haemorrhages (petechiae); various types of skin rashes
Worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Not known (frequency cannot be estimated from available data)

Abnormally fast heart rate, potentially fatal heart rhythm irregularities, changes in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, which records the heart's electrical activity)
Extreme excitement (mania) or feelings of extreme optimism and hyperactivity (hypomania), pustular skin rashes, effects on blood clotting (in patients treated with vitamin K antagonists)
Syndrome associated with impaired water excretion and low sodium levels (SIADH)
Loss of consciousness caused by severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and changes in hearing, vision, taste, and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via [national reporting system, e.g., "reazioni-avverse"]. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton, following
Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacin Accord contains
The active substance is ciprofloxacin hydrochloride.
Each film-coated tablet contains 250 mg of ciprofloxacin (as hydrochloride).
Each film-coated tablet contains 500 mg of ciprofloxacin (as hydrochloride).
Each film-coated tablet contains 750 mg of ciprofloxacin (as hydrochloride).
The other components are:
Tablet core: croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, macrogol, sodium dihydrogen citrate (E331 iii), and the colouring agent titanium dioxide (E171).

Description of the appearance of Ciprofloxacin Accord and package contents
Ciprofloxacin 250 mg film-coated tablets are film-coated, approximately 10 mm in diameter, biconvex, round tablets, white to off-white in colour, with 'AM' engraved on one side and smooth on the other side.
Ciprofloxacin 500 mg film-coated tablets are film-coated, approximately 17 mm long and 7.5 mm wide, biconvex with bevelled edges, capsule-shaped, white to off-white in colour, with 'CI' engraved on one side and smooth on the other side.
Ciprofloxacin 750 mg film-coated tablets are film-coated, approximately 19 mm long and 10 mm wide, biconvex with bevelled edges, capsule-shaped, white to off-white in colour, with 'CJ' engraved on one side and smooth on the other side.
Ciprofloxacin Accord is available in PVC/aluminium blisters.
Pack sizes: 6, 10, 12, 14, 16, 20, 28, 30, 50 and 100 tablets in blister packs.
(Not all pack sizes may be marketed.)

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice,
Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

This medicinal product is authorised in the European Economic Area Member States under the following names:

| 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 | | The Netherlands | Ciprofloxacine Accord 250/500/750 mg filmomhulde tabletten | | Sweden | Ciprofloxacin Accord |

This leaflet was last approved in 05/2023.

Medical advice / patient education
Antibiotics are used to treat infections caused by bacteria; they are not effective against viral infections.
If your doctor has prescribed antibiotics for you, you need them specifically for the illness you currently have.
Despite antibiotic treatment, some bacteria may survive or develop resistance. This phenomenon is known as antimicrobial resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You may even promote the development of resistance in bacteria, thereby delaying recovery or reducing the effectiveness of antibiotics, if you do not follow the following instructions:

Dosage
Timing
Duration of treatment

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed.
2 – Strictly follow all instructions given by your doctor.
3 – Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4 – Never give your antibiotics to other people; they may not be suitable for their condition.
5 – After completing your treatment, return any unused medicines to your pharmacy to ensure they are properly disposed of.