Ciprofloxacin Alter 750 mg film-coated tablets EFG: detailed information

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Alter 750 mg film-coated tablets EFG

Ciprofloxacin

Read all of this leaflet carefully before you start taking this medicine, because 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, because it may 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.

Contents of the leaflet

What Ciprofloxacin Alter is and what it is used for
What you need to know before taking Ciprofloxacin Alter
How to take Ciprofloxacin Alter
Possible side effects
How to store Ciprofloxacin Alter
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 the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

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.
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 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 if the infection is 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 suffer from 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 ciprofloxacin is administered if you were born with or have a family history of QT interval prolongation (seen on ECG, the heart's electrical recording), have an electrolyte imbalance in the blood (especially low levels of potassium and magnesium in the blood), have a very slow heart rate (known as bradycardia), have a weak heart (cardiac arrest), have a history of heart attacks (myocardial infarction), if you are a woman or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section 2: Taking Ciprofloxacin Alter with other medicines).
If you have been diagnosed with 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.

While being treated 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 severe allergic reaction with symptoms such as chest tightness, dizziness, nausea or fainting, or feeling dizzy upon standing. 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, tickling, numbness or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell and hearing, depression, memory decline, extreme fatigue and serious sleep disorders.
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.
Rarely, joint pain and swelling, and 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 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, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or the onset of 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 adverse effects related to the central nervous system. If this occurs, stop taking this medicine 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 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 you are 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 may 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 localized 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 this medicine.
Inform your doctor if you or a family member has a confirmed deficiency in glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.
Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking this medicine. Avoid exposure to intense sunlight or artificial ultraviolet 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

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

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 the therapeutic effect of these medicines. It may also increase the likelihood of experiencing adverse effects.

Tell your doctor if you are taking:

vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon or phenindione) 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 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 this medicine approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacin Alter with food and drinks

Although you may take this medicine with meals, do not consume any dairy products (such as milk or yoghurt) or drinks fortified with calcium 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 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 during 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 and severity of your infection.

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 Ciprofloxacin Alter tablets to take and how to take them, ask your doctor or pharmacist for clarification.

Swallow the tablets with a plentiful amount 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 Alter tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (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 possible, and then continue with your prescribed treatment. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a missed dose. Be sure to 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 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 experiences 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 problems or taste disturbances
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 blood parameter)

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 the levels of a blood coagulation 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, strange dreams, depression (potentially leading to suicidal thoughts, suicide attempts or completed suicides), or hallucinations
tingling and numbness sensations, unusual sensitivity to sensory stimuli, reduced 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 asthma-like 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 the enzyme amylase

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 the number of white and red 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, walking instability (gait disorders), disturbances in the sense of smell (olfactory disorders); increased 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 fast 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 drop 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-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 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, consult 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 stated on the packaging or blister, after “EXP”. The expiry date refers to the last day of the month indicated.

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

6. Package contents 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 glyceryl triacetate.

Appearance of the medicinal product and contents of the pack

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

Each pack contains 14 tablets.

Marketing Authorisation Holder and Manufacturer

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

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

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/

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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 necessary for your current illness. However, 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, thereby delaying recovery or reducing 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.
Follow the prescription exactly.
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 appropriate for their condition.
After completing a course of treatment, return all unused medicines to the pharmacy to ensure they are properly disposed of.