Ciprofloxacin Normon 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciprofloxacin Normon 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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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 adverse 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 and what it is used for

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 is effective only 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 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 starting to take Ciprofloxacin Normon

Do not take Ciprofloxacin 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 of other medicines).

Warnings and precautions

Before starting to take this medicine

You must not take antibacterial medicines containing fluoroquinolones or quinolones, including Ciprofloxacin 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 starting to take Ciprofloxacin 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 Ciprofloxacin 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 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 weakened heart (cardiac arrest), 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 of 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 (heart valve regurgitation).
• 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, arterial 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.

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

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 risk that even with the first dose you may experience a severe allergic reaction, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. If this happens, do not take any more Ciprofloxacin 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 have been 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 reduced vision, taste, smell or hearing, depression, memory loss, 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.

• 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 or even several months after stopping ciprofloxacin treatment. 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 the onset of 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.

• 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 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 must be carefully monitored.

• Diarrhea may develop while you are taking antibiotics, including this medicine, or even several weeks after you have stopped taking 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 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 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 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 Ciprofloxacin Normon with other medicines

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

Do not take Ciprofloxacin 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 Ciprofloxacin Normon).

The following medicines are known to interact with this medicine in your body. Taking this medicine at the same time as these medicines may affect their therapeutic effect and may also increase the likelihood 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 alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide group), and some antipsychotics.

This medicine may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders),
• caffeine,
• duloxetine (for depression, diabetic polyneuropathy, 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),
• 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 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 fortified with calcium at the same time as taking the tablets, as they may affect the absorption of the active substance.

Pregnancy and breastfeeding

It is preferable to avoid using this medicine during pregnancy. Inform your doctor if you are planning 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 a vehicle or operating machinery. If in doubt, consult your doctor.

Ciprofloxacin 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 medicine exactly as your doctor has told you.
• Swallow the tablets whole with a full glass of water (to reduce the risk of irritation of the esophagus). Do not crush or chew the tablets.
• Ciprofloxacin Normon can be taken with or without food. However, take it at the same time each day to maintain consistent levels of the medicine in your body.
• Drink plenty of fluids while taking this medicine, unless otherwise directed by your doctor.

Important:

• Do not stop taking Ciprofloxacin Normon early, even if you feel better. Stopping early may allow bacteria to continue growing and may lead to a return of infection or resistance to antibiotics.
• If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a forgotten one.
• Do not take more than the prescribed dose.

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

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 between 5 and 21 days, but may be longer for severe infections. Take the tablets exactly as prescribed by your doctor. 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 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 Normon than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 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, and then continue with 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 return or worsen. You may also develop resistance to the antibiotic.

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.

Frequent adverse effects (may affect up to 1 in 10 people):

• nausea, diarrhoea,
• joint pain in children.

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

• fungal superinfections (fungal infections),
• 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 (may 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, anaemia), increase or decrease in levels of blood clotting factor (thrombocytes),
• allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angioedema),
• increased blood sugar (hyperglycaemia),
• 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, reduced 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 (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: 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),
• mental 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 disturbances), disturbances in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure),
• visual colour distortions,
• inflammation of the blood vessel walls (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):

• nervous system disorders such as pain, burning, tingling, numbness and/or weakness in the limbs,
• abnormally fast heart rate, life-threatening irregular heart rhythm, disturbance in heart rhythm (known as “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 inadequate water excretion and low sodium levels (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-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, reduced memory and concentration, mental health problems (such as sleep disorders, anxiety, panic attacks, depression and suicidal ideation), and reduced 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 who have received 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 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

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

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

Store in the original packaging to protect from light.

No special storage conditions required.

Keep the container tightly closed to protect from moisture.

Do not dispose of unused medicines via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer required. These measures will help protect the environment.

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 packaging, after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Ciprofloxacin Normon

• The active substance is ciprofloxacin. Each tablet contains 500 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, methacrylic acid copolymer type A and propylene glycol (E-1520).

Appearance of the product and contents of the pack

Film-coated tablets, white or slightly cream-coloured, elongated, 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 review 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 (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) at http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging.

You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62300/P_62300.html.

Medical advice / patient education

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

If your doctor has prescribed you 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, thereby delaying your recovery or reducing the effectiveness of antibiotics, if you do not comply with:

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

Therefore, in order 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 appropriate for their condition.
5. After completing a treatment, return any unused medicines to the pharmacy, to ensure they are properly disposed of.