Ciprofloxacin Stada 500 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ciprofloxacin Stada 500 mg film-coated tablets EFG

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 and must not be given to other people, even if they have the same symptoms as you. It may harm them.
If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ciprofloxacino Stada is and what it is used for

Ciprofloxacino Stada is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by eliminating bacteria that cause infections. It is only effective against specific strains of bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Adults

Ciprofloxacin 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
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
prevention of infections caused by the bacterium Neisseria meningitidis
inhalational anthrax exposure

Ciprofloxacin may also be used to treat patients with low white blood cell counts (neutropenia) who have 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 may be given additional antibiotic treatment alongside ciprofloxacin.

Children and adolescents

Ciprofloxacin is used in children and adolescents, under specialized 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)
inhalational anthrax exposure

Ciprofloxacin may also be used for the treatment of severe infections in children and adolescents when considered necessary.

2. What you need to know before taking Ciprofloxacino Stada

Do not take Ciprofloxacino Stada:

if you are allergic to the active substance, to other quinolones or to any of the other components of this medicine (listed in section 6)
if you are taking tizanidine (see section 2 “Other medicines and Ciprofloxacino Stada”)

Warnings and precautions

Before starting this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Consult your doctor before starting Ciprofloxacino Stada:

if you have ever had kidney problems, as your treatment may need adjustment
if you suffer from epilepsy or other neurological conditions
if you have a history of tendon problems during previous treatment with antibiotics such as ciprofloxacin
if you are diabetic, as you may be at risk of hypoglycaemia with ciprofloxacin
if you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
if you have heart problems. Caution is required when administering ciprofloxacin if you have been born with or have a family history of QT interval prolongation (seen on ECG, the electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium and magnesium), have a very slow heart rate (known as bradycardia), have a weak heart (cardiac arrest), have a history of heart attacks (myocardial infarction), are female or elderly, or are taking other medicines that cause abnormal changes in the ECG (see section 2 “Other medicines and Ciprofloxacino Stada”)
if you know that you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin
if you have been diagnosed with enlargement or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
if you have previously experienced aortic dissection (tearing of the aortic wall)
if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves)
if you have a family history of aortic dissection or aneurysm, 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 or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection))

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

During treatment with this medicine

Inform your doctor immediately if any of the following occur while taking ciprofloxacin. Your doctor will decide whether treatment with ciprofloxacin should be discontinued.

Severe and sudden allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose you may experience a severe allergic reaction with the following symptoms: chest tightness, dizziness, nausea or fainting, or feeling dizzy upon standing. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.
Serious, disabling, long-lasting and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for 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 pricking, tingling, pins and needles, numbness or burning (paraesthesia), sensory disturbances such as decreased vision, taste, smell or hearing, depression, memory loss, extreme fatigue and severe sleep disturbances.

If you experience any of these adverse effects after taking ciprofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, possibly considering the use of an antibiotic from another class.

Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping ciprofloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking ciprofloxacin, contact your doctor and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
If you experience a sudden and severe pain in the abdomen, chest or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department.

The risk may increase if you are receiving systemic corticosteroid treatment.

If you suddenly develop dyspnoea, especially when lying down, or notice swelling in your ankles, feet or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.
If you suffer from epilepsy or another neurological condition, such as cerebral ischaemia or stroke, you may experience central nervous system-related adverse effects. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.
Rarely, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms. If this occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
You may experience psychiatric reactions the first time you take ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts or completed suicide. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.
Quinolone antibiotics may cause an increase in your blood sugar levels above normal (hyperglycaemia), or a decrease in blood sugar levels below normal, which in severe cases may lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.
Diarrhoea may develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhoea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking ciprofloxacin immediately, as this could be life-threatening. Do not take medicines that stop or delay intestinal movements and consult your doctor.
While taking ciprofloxacin, inform your doctor or laboratory staff if you need to undergo a blood or urine test.
Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach pain, stop taking ciprofloxacin immediately and contact your doctor without delay.
Ciprofloxacin may cause a decrease in white blood cell count and possibly reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of local infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible low white blood cell count (agranulocytosis). It is important that you inform your doctor about your medication.
Your skin may become more sensitive to sunlight or ultraviolet (UV) light while taking ciprofloxacin. Avoid exposure to intense sunlight or artificial UV light, such as tanning booths.
Consult an ophthalmologist immediately if your vision worsens or if you experience any eye problems.

Other medicines and Ciprofloxacino Stada

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

Do not take ciprofloxacin at the same time as tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 “Do not take Ciprofloxacino Stada”).

The following medicines are known to interact with ciprofloxacin in your body. Taking ciprofloxacin at the same time as these medicines may affect their therapeutic effect and may also increase the likelihood of adverse 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)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin diseases, rheumatoid arthritis and organ transplants)
other medicines that may alter your 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.

Ciprofloxacin may increase blood levels of the following medicines:

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

Some medicines decrease the effect of ciprofloxacin. 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 approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacino Stada with food and drink

Although you may take ciprofloxacin with meals, do not consume any dairy products (such as milk or yoghurt) or drinks fortified with calcium at the same time as the tablets, as they may affect the absorption of the active substance.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using ciprofloxacin during pregnancy.

Do not take ciprofloxacin while breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin may reduce your level of alertness. Some neurological effects may occur. Therefore, make sure you know how you react to ciprofloxacin before driving or operating machinery. If in doubt, consult your doctor.

Ciprofloxacino Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Ciprofloxacin Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will explain exactly how much ciprofloxacin you should take, how often, and for how long. This will depend on the type and severity of your infection.

Inform your doctor if you have kidney problems, as your dose may need to be adjusted.

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections. Always follow your doctor's instructions precisely. If you have any doubts about how many tablets of ciprofloxacin to take and how to take them, consult your doctor or pharmacist.

Swallow the tablets with plenty of liquid. Do not chew the tablets as they have an unpleasant taste.
Try to take the tablets at the same time each day.
You may take the tablets with or between meals. Calcium consumed as part of a meal will not significantly affect the absorption of the medicine. However, do not take ciprofloxacin tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (for example, calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

If you take more Ciprofloxacin Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Ciprofloxacin Stada

Take the missed dose as soon as possible, then continue your treatment as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one. Be sure to complete the full course of treatment.

If you stop taking Ciprofloxacin Stada

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 taking this medicine too early, your infection may not be completely cured and symptoms may return or worsen. You may 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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

nausea, diarrhoea
joint pain in children

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

fungal superinfections (due to fungi)
elevated levels of eosinophils, a type of white blood cell
decreased appetite
hyperactivity or agitation
headache, dizziness, sleep disturbances or taste disorders
vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence
increased levels of certain substances in the blood (transaminases and/or bilirubin)
skin rash, itching or hives
joint pain in adults
impaired kidney function
muscle and bone pain, feeling unwell (asthenia) or fever
increased alkaline phosphatase in blood (a substance measured in blood)

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

inflammation of the intestine (colitis) associated with antibiotic use (may be fatal in very rare cases) (see section 2 “Warnings and precautions”)
changes in blood cell count (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in levels of blood clotting factor (platelets)
allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2 “Warnings and precautions”)
confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, suicide attempts, or completed suicides), or hallucinations
tingling and numbness sensations, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, seizures (see section 2 “Warnings and precautions”), or dizziness
vision problems (including double vision)
tinnitus (ringing in the ears), hearing loss, hearing impairment
increased heart rate (tachycardia)
dilation of blood vessels (vasodilation), decreased blood pressure, or fainting
difficulty breathing, including asthmatic symptoms
liver disorders, jaundice (cholestatic jaundice), hepatitis
sensitivity to light (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 concentrations of amylase enzyme

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

a specific type of decreased blood cell count (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), decreased levels of red and white blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also with risk of death (see section 2 “Warnings and precautions”)
severe allergic reactions (anaphylactic reaction or anaphylactic shock, with risk of death – serum sickness) (see section 2 “Warnings and precautions”)
mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts, or completed suicides) (see section 2 “Warnings and precautions”)
migraine, coordination disorder, unsteadiness when walking (gait disorders), disorders of the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure and pseudotumour cerebri)
visual colour distortions
inflammation of the blood vessel wall (vasculitis)
pancreatitis
liver cell death (hepatic necrosis), which very rarely leads to liver failure with risk of death
small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with risk of death or toxic epidermal necrolysis)
muscle weakness, tendon inflammation, tendon rupture – especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”), worsening of symptoms of myasthenia gravis (see section 2 “Warnings and precautions”)

Frequency not known (cannot be estimated from available data)

nervous system disorders such as pain, burning, tingling, numbness, and/or weakness in the limbs (peripheral neuropathy or polyneuropathy)
abnormally fast heart rate, irregular and life-threatening heart rhythm, disturbance in heart rhythm (known as “QT interval prolongation”, observed on ECG, electrical activity of the heart)
pustular rash
effect on blood clotting (in patients treated with vitamin K antagonists)
feeling extremely excited (mania) or feeling overly optimistic and hyperactive (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
syndrome associated with insufficient water excretion and low sodium levels (SIADH – Syndrome of Inappropriate Antidiuretic Hormone Secretion)
loss of consciousness due to severely low blood sugar levels (hypoglycaemic coma). See section 2.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, reduced memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and potentially be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciprofloxacin Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin Stada

The active substance is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).
The other components are: crospovidone, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, magnesium stearate. The components of the film coating are: hypromellose, titanium dioxide (E-171), and triacetin.

Appearance of the product and contents of the pack

Ciprofloxacin Stada 500 mg are film-coated, capsule-shaped, white tablets, scored on one side. The score line is intended to facilitate breaking the tablet for ease of swallowing, but not to divide it into equal doses.

Each pack contains 1, 14, or 500 (hospital pack) film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain

Date of the most recent review of this leaflet: December 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

Medical advice / patient education

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

If your doctor has prescribed antibiotics, it is because they are specifically needed for your current illness.

Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: certain antibiotic treatments become ineffective.

Improper use of antibiotics increases resistance. Even you can contribute to making bacteria more resistant—and thus delay your recovery or reduce antibiotic effectiveness—if you do not follow:

the prescribed dose,
the dosing schedule,
the duration of treatment.

Therefore, to maintain the effectiveness of this medicine:

Use antibiotics only when prescribed by a doctor.
Strictly follow the prescription.
Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
Never give your antibiotics to another person; they may not be suitable for their condition.
After completing a course of treatment, return all unused medicines to the pharmacy to ensure they are properly disposed of.