Ciprofloxacin Normon 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciprofloxacin Normon 2 mg/ml solution for infusion EFG

Read the entire leaflet carefully before you start using 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may 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 using Ciprofloxacin Normon
3. How to use Ciprofloxacin Normon
4. Possible adverse effects
5. How to store Ciprofloxacin Normon
6. Contents of the pack and other information

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

Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family.

The active substance is ciprofloxacin. Ciprofloxacin works by eliminating bacteria that cause infections. It is only effective against specific strains of bacteria.

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

It is important that you follow your doctor's instructions regarding dosage, dosing 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 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 testicles.
• Infections of the female genital organs.
• Gastrointestinal and intra-abdominal infections.
• Skin and soft tissue infections.
• Bone and joint infections.
• Treatment of infections in patients with a very low white blood cell count (neutropenia).
• Prevention of infections in patients with a very low white blood cell count (neutropenia).
• Inhalational anthrax exposure.

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may receive 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.

Ciprofloxacin Normon 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 use Ciprofloxacin Normon

Do not use Ciprofloxacin Normon

• If you are allergic to ciprofloxacin, to other quinolones, or to any of the other components of this medicine (listed in section 6).
• If you are taking tizanidine (see section 2: Use of other medicines).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Ciprofloxacin Normon.

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

Inform your doctor if:

• You have ever had kidney problems, as your treatment may need adjustment.
• You have epilepsy or other neurological conditions.
• You have a history of tendon problems during previous treatment with antibiotics such as ciprofloxacin.
• You have myasthenia gravis (a type of muscle weakness).
• You have a history of abnormal heart rhythms (arrhythmias).
• You have been diagnosed with an enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm).
• You have previously experienced an aortic dissection (tear in the wall of the aorta).
• You have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• 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, known hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

While being treated with Ciprofloxacin Normon

Inform your doctor immediately if any of the following occur during treatment with Ciprofloxacin Normon. Your doctor will decide whether treatment with Ciprofloxacin Normon needs to 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 symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. If this occurs, inform your doctor immediately, as administration of Ciprofloxacin Normon must be stopped.

• Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years of age), 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 swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you experience sudden, severe pain in the abdomen or back, 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 suddenly develop 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 central nervous system-related adverse effects. If this occurs, stop taking Ciprofloxacin Normon and contact your doctor immediately.

• You may experience psychiatric reactions after the first dose of ciprofloxacin. If you have depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Normon. If this occurs, stop taking Ciprofloxacin Normon 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.

• Diarrhea may develop during antibiotic use, including Ciprofloxacin Normon, or even several weeks after stopping treatment. If it becomes severe or persistent, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Normon must be stopped immediately, as it may be life-threatening. Do not take medications that stop or delay intestinal movements.

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

• While taking Ciprofloxacin Normon, inform your doctor or laboratory staff if you need to undergo blood or urine tests.

• Ciprofloxacin Normon 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 Normon immediately.

• Ciprofloxacin Normon may reduce white blood cell count and possibly decrease 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, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

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

• Your skin may become more sensitive to sunlight or ultraviolet (UV) light during treatment with Ciprofloxacin Normon. Avoid exposure to strong sunlight or artificial UV light, such as tanning beds.

• Quinolone antibiotics may cause an increase in 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.

Serious, disabling, prolonged, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory decline, 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, considering also the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Normon

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Do not use 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 use Ciprofloxacin Normon”).

The following medicines are known to interact with Ciprofloxacin Normon in your body. If Ciprofloxacin Normon is taken at the same time as these medicines, it may affect their therapeutic effect or increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• 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)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin Normon may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine

Taking Ciprofloxacin Normon with food and drinks

Food and drinks do not affect your treatment with Ciprofloxacin Normon.

Pregnancy and breastfeeding

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

Do not use Ciprofloxacin Normon during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

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

Ciprofloxacin Normon contains sodium

This medicine contains 354 mg of sodium (main component of table/cooking salt) in each 100 ml of solution. This corresponds to 17.7% of the maximum recommended daily sodium intake for an adult.

3. How to use Ciprofloxacino Normon

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

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 be longer for severe infections.

Your doctor will administer each dose by slow intravenous infusion into the bloodstream. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacino Normon, and 30 minutes for 200 mg of Ciprofloxacino Normon. Slow administration of the infusion helps prevent immediate adverse reactions.

Remember to drink plenty of fluids while taking Ciprofloxacino Normon.

If you interrupt treatment with Ciprofloxacino 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 using this medicine too soon, 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, Ciprofloxacin Normon may cause adverse effects, although not everyone will experience them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Frequent adverse effects (may affect between 1 and 10 out of every 100 people):

• nausea, diarrhea, vomiting
• joint pain in children
• local reaction at the injection site, skin rash
• temporary increase in levels of substances in the blood (transaminases)

Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 people):

• fungal superinfections (infections caused by fungi)
• elevated levels of eosinophils, a type of white blood cell; increase or decrease in a blood coagulation factor (platelets)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep disturbances or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, seizures (see section 2: Take special care with Ciprofloxacin Normon), dizziness, sensation of vertigo
• vision problems
• hearing loss
• increased heart rate (tachycardia)
• dilation of blood vessels (vasodilation), decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/heartburn), flatulence
• impaired liver function, increased levels of a substance in the blood (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• joint pain in adults
• impaired kidney function, renal failure
• muscle and bone pain, feeling of malaise (asthenia), fever, fluid retention
• increased alkaline phosphatase in blood (a substance measured in blood)

Rare adverse effects (may affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2: Take special care with Ciprofloxacin Normon)
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), decreased levels of red blood cells, white blood cells, and platelets (pancytopenia) which may be life-threatening, bone marrow depression which may be life-threatening (see section 2: Take special care with Ciprofloxacin Normon)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes
• (angioedema), severe allergic reaction (anaphylactic shock) with risk of death (see section 2: Take special care with Ciprofloxacin Normon)
• increased blood sugar (hyperglycemia)
• anxiety reactions, strange dreams, depression, mental disturbances (psychotic reactions) (see section 2: Take special care with Ciprofloxacin Normon)
• decreased skin sensitivity, tremors, migraine, disturbances of the sense of smell
• tinnitus (ringing in the ears), hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthmatic symptoms
• pancreatitis
• hepatitis, death of liver cells (hepatic necrosis), which very rarely leads to liver failure with risk of death
• sensitivity to light (see section 2: Take special care with Ciprofloxacin Normon), nonspecific blister formation, small hemorrhages at points under the skin (petechiae)
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2: Take special care with Ciprofloxacin Normon)
• blood or crystals in the urine (see section 2: Take special care with Ciprofloxacin Normon), inflammation of the urinary tract
• excessive sweating
• abnormal levels of coagulation factor (prothrombin) or increased concentrations of the enzyme amylase

Very rare adverse effects (may affect less than 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)
• severe allergic reactions with risk of death (anaphylactic reaction or anaphylactic shock, serum sickness) which may be life-threatening (see section 2: Take special care with Ciprofloxacin Normon)
• coordination disorder, unsteadiness when walking (gait disturbances), increased pressure in the brain (intracranial pressure)
• visual distortions of colors
• various skin rashes or exanthems (e.g., the potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, worsening of symptoms of myasthenia gravis (see section 2: Take special care with Ciprofloxacin Normon)

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

• nervous system-related problems such as pain, burning, tingling, numbness and/or weakness in the limbs
• serious disturbances in heart rhythm, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with insufficient water excretion and low sodium concentrations (SIADH)
• loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma). See section 2.

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, decreased memory and concentration, mental health problems (such as sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://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 this medicine out of sight and reach of children.

Bags: Store below 30°C. Keep in the original packaging to protect from light. Do not freeze or refrigerate.

Since ciprofloxacin is sensitive to light, the overwrap of the bag should only be removed immediately before administration.

Discard if any changes are observed in the container or in the liquid it contains.

Do not use Ciprofloxacin Normon after the expiry date stated on the packaging 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Ciprofloxacin Normon

The active substance is ciprofloxacin.

Each 100 ml of solution contains 200 mg of ciprofloxacin as lactate.

Each 200 ml of solution contains 400 mg of ciprofloxacin as lactate.

The other components (excipients) are: lactic acid, sodium chloride, hydrochloric acid and water for injection.

Appearance of the product and contents of the pack

Infusion solution

Ciprofloxacin Normon infusion solution is a clear, colourless or slightly yellow solution.

It is supplied in plastic bags of 100 ml and 200 ml.

Marketing Authorisation Holder and Manufacturer

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

This leaflet was approved in December 2020

Medical advice/education

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

If your doctor has prescribed antibiotics, you need them specifically 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 and thus delay your recovery or reduce antibiotic effectiveness if you do not follow:

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

1. Therefore, to maintain the effectiveness of this medicine: Use antibiotics only when prescribed.
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.

The following information is intended only for physicians or healthcare professionals

Ciprofloxacin Normon must be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Normon, and 30 minutes for 200 mg of Ciprofloxacin Normon. Slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution may be administered directly or after mixing with another compatible infusion solution.

Unless compatibility with other infusion solutions or drugs has been confirmed, the infusion solution must be administered separately. Visual signs of incompatibility include, for example, precipitation, cloudiness, or colour change.

Ciprofloxacin Normon 2 mg/ml infusion solution is compatible with physiological saline solution, Ringer's solution, 5% and 10% dextrose solution, glucose-saline solution and 10% fructose solution. Once prepared, the solution should be used within 24 hours.

After starting intravenous treatment, therapy may be continued orally.

Detailed and up-to-date information on this medicinal product 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 on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/62646/P_62646.html.