Ciprofloxacin Normon 250 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciprofloxacin Normon 250 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, 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 you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Ciprofloxacin Normon is an antibiotic that belongs to the group of quinolones. It works by killing bacteria that cause infections.

Ciprofloxacin Normon is used to treat the following types of bacterial infections:

• Infections of the ear, nose, and throat (e.g., sinusitis, tonsillitis)
• Respiratory tract infections (e.g., bronchitis, pneumonia)
• Urinary tract infections (e.g., cystitis, pyelonephritis)
• Genital infections (e.g., gonorrhea, prostatitis)
• Gastrointestinal infections (e.g., infectious diarrhea)
• Skin and soft tissue infections
• Bone and joint infections
• Infections in patients with low white blood cell count (neutropenia)
• Complicated infections caused by specific bacteria, such as Pseudomonas aeruginosa

Ciprofloxacin Normon may also be used to prevent and treat infections caused by Bacillus anthracis (anthrax) in certain situations.

The active substance is ciprofloxacin (as hydrochloride).

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

Adults

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

• respiratory tract infections,
• long-lasting or recurrent ear or sinus infections,
• urinary tract infections,
• infections of the male and female genital tract,
• 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 a low white blood cell count (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 Normon.

Children and adolescents

Ciprofloxacin Normon 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 Ciprofloxacino Normon

Do not take Ciprofloxacino Normon

• 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: Use with other medicines).

Warnings and precautions

Before starting this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacino Normon, 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 taking Ciprofloxacino Normon

• if you have ever had kidney problems, as your treatment may need dose 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 Ciprofloxacino Normon,
• 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 prolonged QT interval (seen on ECG, the electrical recording of the heart), if you have an imbalance of blood salts (especially low levels of potassium and magnesium in the blood), if you have a very slow heart rate (known as bradycardia), if you have a weak heart (cardiac arrest), if you have a history of heart attacks (myocardial infarction), if you are female or elderly, or if you are taking other medicines that cause abnormal changes in the ECG (see section 2: Use with other medicines).
• if you have been diagnosed with an 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 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 autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, 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.

Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.

While taking 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 when standing up. If this happens, do not take any more Ciprofloxacino Normon 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 may be 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 disorders.

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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping ciprofloxacin. At the first sign of tendon pain or inflammation (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 sudden, severe abdominal or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may be increased if you are receiving systemic corticosteroid treatment.

If you begin to experience sudden shortness of breath, especially when lying down, or notice swelling in your ankles, feet or abdomen, or develop palpitations (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 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 levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal, which in severe cases may lead to loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels 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 this medicine immediately and consult your doctor.

• 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 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 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 to inform your doctor about this medicine.

• Inform your doctor if you or a family member has a confirmed glucose-6-phosphate dehydrogenase deficiency (G6PD), as this may increase the 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.

Use of Ciprofloxacino Normon with other medicines

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

Do not take Ciprofloxacino Normon 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 Ciprofloxacino Normon).

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 and may also increase the risk of adverse effects.

Tell your doctor if you are taking

• vitamin K antagonists (e.g., warfarin) 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),
• clozapine (an antipsychotic),
• olanzapine (an antipsychotic),
• ropinirole (for Parkinson's disease),
• phenytoin (for epilepsy),
• metoclopramide (for nausea and vomiting),
• cyclosporine (for skin diseases, rheumatoid arthritis, and organ transplants),
• other medicines that may affect 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 wish to take:

• antacids,
• omeprazole,
• mineral supplements,
• sucralfate,
• a polymeric phosphate binder (e.g., sevelamer),
• medicines or supplements containing calcium, magnesium, aluminium or iron.

If these preparations are essential, take this medicine approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacino Normon 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 with added calcium at the same time as the tablets, as they may interfere with the absorption of the active substance.

Pregnancy and breastfeeding

It is preferable to avoid using this medicine during pregnancy. Inform your doctor if you plan to become pregnant.

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 or operating machinery. If in doubt, consult your doctor.

Ciprofloxacino Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Ciprofloxacin Normon

Take this medication exactly as prescribed by your doctor. The dosage and duration of treatment depend on the type of infection being treated.

• Oral administration: Swallow the tablet whole with a full glass of water. Do not crush, chew, or break the tablet.
• Take Ciprofloxacin Normon at least 2 hours before or 6 hours after taking any antacids, sucralfate, metal cations (such as iron, zinc, magnesium, aluminum), or multivitamins containing minerals, as these can interfere with absorption.
• It can be taken with or without food. However, avoid consuming dairy products (e.g., milk or yogurt) or calcium-fortified juices alone with the medication, as they may reduce its effectiveness.
• Drink plenty of fluids while taking this medicine unless otherwise directed by your doctor.

Important: Continue taking the medication for the full prescribed length of time, even if symptoms improve before the course is completed. Stopping the medication too early may result in the return of infection and increase the risk of antibiotic resistance.

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.

For further details, refer to the full instructions provided by your healthcare provider or the patient information leaflet included in the package.

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will explain precisely 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 your doctor has instructed. If you have any doubts about how many Ciprofloxacin Normon tablets to take and how to take them, ask your doctor or pharmacist for clarification.

• 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 Normon tablets with dairy products such as milk or yogurt, or with mineral-fortified fruit juices (e.g., calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

If you have taken more Ciprofloxacin Normon 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 ingested.

If you forget to take Ciprofloxacin Normon

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.

Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin Normon

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 worsen again. You may also develop antibiotic resistance.

If you have any further questions about the use of this product, 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 adverse effects (may affect up to 1 in 10 people):

• nausea, diarrhea,
• joint pain in children.

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

• fungal superinfections (due to fungi),
• elevated levels of eosinophils, a type of white blood cell,
• loss of appetite (anorexia),
• 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 alkaline phosphatase in blood (a substance measured in blood).

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

• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2: Special warnings and precautions for use with Ciprofloxacin Normon),
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in levels of blood clotting factor (platelets),
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema),
• increased blood sugar (hyperglycemia),
• 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: Special warnings and precautions for use with Ciprofloxacin Normon) or dizziness,
• vision problems (including double vision),
• tinnitus (ringing in the ears), hearing loss, worsening of hearing,
• 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: Special warnings and precautions for use with Ciprofloxacin Normon),
• muscle pain, joint inflammation, increased muscle tone or cramps,
• kidney failure, blood or crystals in urine (see section 2: Special warnings and precautions for use with Ciprofloxacin Normon), inflammation of the urinary tract,
• fluid retention or excessive sweating,
• increased concentrations of amylase enzyme.

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

• a specific type of decreased blood cell count (hemolytic anemia), 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: Special warnings and precautions for use with Ciprofloxacin Normon),
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with risk of death – serum sickness) (see section 2: Special warnings and precautions for use with Ciprofloxacin Normon),
• psychiatric disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or completed suicides) (see section 2: Special warnings and precautions for use with Ciprofloxacin Normon),
• migraine, coordination disorder, unsteadiness when walking (gait disorders), disturbances in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure),
• visual distortions of colors,
• inflammation of the walls of blood vessels (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: Special warnings and precautions for use with Ciprofloxacin Normon), worsening of symptoms of myasthenia gravis (see section 2: Special warnings and precautions for use with Ciprofloxacin Normon).

Frequency not known (cannot be estimated from available data):

• nerve system-related problems such as pain, burning, tingling, numbness, and/or weakness in the limbs,
• abnormally fast heart rate, life-threatening irregular heartbeat, disturbance in heart rhythm (called “prolongation of the QT interval”, observed on ECG, heart activity),
• pustular rash,
• effects 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 (hypoglycemic 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, mental health problems (such as 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 may be fatal, and heart valve insufficiency have been reported in patients who have received 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciprofloxacin Normon

Store below 25°C. Keep the container tightly closed to protect from light and moisture. Keep out of the reach and sight of children. Do not store above 30°C. Do not use after the expiry date stated on the container. Keep the medicinal product in its original packaging to protect from light. Keep the bottle closed. Keep away from direct sunlight. Keep away from moisture. Keep in a dry place. Keep away from children. Do not use after the expiration date. Keep the container tightly closed. Do not store above 30°C. Keep below 25°C.

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

No special storage conditions are required.

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

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

6. Contents of the container and additional information

Composition of Ciprofloxacin Normon

• The active substance is ciprofloxacin. Each tablet contains 250 mg of ciprofloxacin (hydrochloride).
• The other components (excipients) are: microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), povidone, magnesium stearate, talc, titanium dioxide (E-171), macrogol 6000, ammonium methacrylate copolymer type A and propylene glycol (E-1520).

Appearance of the product and contents of the pack

Film-coated tablets, white or slightly cream-colored, round, biconvex, and scored on one side. Each pack contains 1 or 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the most recent revision of this leaflet: December 2020

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton.

You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62299/P_62299.html

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 you specifically need them for your current illness.

Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: some 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 follow:

• 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. Strictly follow the prescription.
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 treatment, return all unused medicines to the pharmacy, to ensure they are properly disposed of.