Ciprofloxacin Alter 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Alter 500 mg film-coated tablets EFG

Ciprofloxacin

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any 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, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ciprofloxacin Alter is and what it is used for
2. What you need to know before taking Ciprofloxacin Alter
3. How to take Ciprofloxacin Alter
4. Possible side effects
5. How to store Ciprofloxacin Alter
6. Contents of the pack and other information

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

Ciprofloxacin Alter is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. It 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 dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Adults

Ciprofloxacin Alter is used in adults to treat the following bacterial infections:

• Respiratory tract infections.
• Long-lasting or recurrent ear or sinus infections.
• Urinary tract infections.
• Male and female genital tract infections.
• 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 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 Alter.

Children and adolescents

Ciprofloxacin Alter 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.

This medicine 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 Ciprofloxacin Alter

Do not take Ciprofloxacin Alter

• If you are allergic (hypersensitive) to the active substance, to other quinolones or to any of the other components of this medicine (see section 6).
• If you are taking tizanidine (see section 2: Taking Ciprofloxacin Alter with other medicines).

Warnings and precautions

Before starting this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin Alter, 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.

Talk to your doctor before starting this medicine

• If you have ever had kidney problems, as your treatment may need adjustment.
• If you have epilepsy or other neurological conditions.
• If you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Alter.
• If you have myasthenia gravis (a type of muscle weakness).
• If you have heart problems. Caution is required when administering ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on ECG, the heart's electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium and magnesium in the blood), have a very slow heart rate (known as bradycardia), have a fragile heart (cardiac arrest), have a history of heart attacks (myocardial infarction), are a woman or elderly, or are taking other medicines that cause abnormal ECG changes (see section 2: Taking Ciprofloxacin Alter with other medicines).
• If you have been diagnosed with an enlargement or a "lump" 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 aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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 situations occur. Your doctor will decide whether treatment 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 serious allergic reaction with the following symptoms: chest tightness, dizziness, nausea or fainting, or feeling dizzy when standing up. If this happens, do not take any more Ciprofloxacin Alter and contact your doctor immediately.
• Serious, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin Alter, 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 pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disturbances.
• If you experience any of these adverse effects after taking Ciprofloxacin Alter, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the use of an antibiotic from another class.
• In rare cases, 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even up to several months after stopping treatment with Ciprofloxacin Alter. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin Alter, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
• If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical attention immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you develop sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or experience palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.
• If you have epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience central nervous system-related adverse effects. If this occurs, stop taking this medicine and contact your doctor immediately.
• In rare cases, 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 happens, stop taking Ciprofloxacin Alter and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• You may experience psychiatric reactions the first time you take this medicine. If you have depression or psychosis, your symptoms may worsen during treatment with this medicine. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. If this occurs, stop taking this medicine and contact your doctor immediately.
• Quinolone antibiotics may cause an increase in your blood sugar level above normal (hyperglycemia), or a decrease in your blood sugar level below normal, which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar level should be carefully monitored.
• Diarrhea may develop while taking antibiotics, including this medicine, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking this medicine immediately, as this could be life-threatening. Do not take medicines that stop or delay intestinal movements and consult your doctor.
• While taking this medicine, inform your doctor or laboratory staff if you need to undergo a blood or urine test.
• This medicine 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 Alter immediately and consult your doctor immediately.
• If you have kidney problems, inform your doctor, as your dose may need adjustment.
• This medicine may cause a decrease in white blood cell count and may therefore 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 to inform your doctor about this medicine.
• Inform your doctor if you or a family member has a confirmed glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.
• Your skin may become more sensitive to sunlight or ultraviolet (UV) light while taking this medicine. Avoid exposure to intense sunlight or artificial UV light such as tanning beds.
• Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.

Taking Ciprofloxacin Alter with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

Do not take Ciprofloxacin Alter at the same time as tizanidine, as this could cause adverse effects such as low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin Alter).

The following medicines are known to interact with this medicine in your body. Taking this medicine together with these medicines may affect their therapeutic effect or increase the likelihood of adverse effects.

Tell 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.

This medicine 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 anesthetic use)
• sildenafil (e.g., for erectile dysfunction)

Some medicines decrease the effect of this medicine. Inform your doctor if you are taking or plan 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 this medicine approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacin Alter with food and drink

Although you may take this medicine 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 and breastfeeding

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

It is preferable to avoid using this medicine during pregnancy.

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

Driving and using machines

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

3. How to take Ciprofloxacin Alter

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

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

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

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the tablets exactly as prescribed by your doctor. If you have any doubts about how many tablets of Ciprofloxacin Alter to take and how to take them, ask your doctor or pharmacist for clarification.

1. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
2. Try to take the tablets at the same time each day.
3. You may take the tablets with or between meals. Calcium taken as part of a meal will not seriously affect absorption of the medicine. However, do not take Ciprofloxacin Alter tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

If you take more Ciprofloxacin Alter 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, indicating the medicine and the amount ingested.

If you forget to take Ciprofloxacin Alter

Take the missed dose as soon as you remember, and 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. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin Alter

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 antibiotic resistance.

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.

Frequent: 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 (fungal infections)
• elevated concentration 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 of malaise (asthenia) or fever
• increased blood alkaline phosphatase (a blood substance)

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 count (leucopenia, leucocytosis, 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)
• 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, deterioration of hearing
• 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 the 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 decrease in blood cell count (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), a decrease in 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, serum sickness with risk of death) (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), disturbances in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure and pseudotumour cerebri)
• visual distortions of colours
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• death of liver cells (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 and polyneuropathy)
• abnormally rapid heart rate, life-threatening irregular heart rhythm, disturbance in heart rhythm (known as “prolongation of the QT interval”, observed on ECG, electrical activity of the heart)
• pustular rash
• effect on blood clotting (in patients treated with vitamin K antagonists)
• syndrome associated with deficient water excretion and low sodium concentrations (SIADH)
• loss of consciousness due to a severe decrease in 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-term (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, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts), as well as 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 may 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 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 Alter

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin Alter

• The active substance is Ciprofloxacin. Each tablet contains 250 mg of ciprofloxacin (as hydrochloride).
• The other components are: Core: microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), crospovidone, colloidal anhydrous silica, and magnesium stearate. Coating: hypromellose, titanium dioxide (E-171), and glycerol triacetate.

Appearance of the product and contents of the pack

Ciprofloxacin Alter 250 mg film-coated tablets are white, biconvex, film-coated tablets, marked with a break line on one side.

Each pack contains 14 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

Date of the most recent revision of this leaflet: March 2025

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

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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. Nevertheless, some bacteria may survive or grow despite antibiotic treatment. 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, thereby delaying your recovery or reducing antibiotic effectiveness if you do not comply with:

• the dose
• the schedule
• the duration of treatment

Therefore, to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed by a doctor.
2. Follow the prescription exactly.
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 another person; they may not be suitable for their condition.
5. After completing a course of treatment, return all unused medicines to the pharmacy to ensure they are properly disposed of.