Ciprofloxacin Hikma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Hikma 2 mg/ml, solution for infusion

Ciprofloxacin
Read this leaflet carefully before using this medicine

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT CIPROFLOXACIN HIKMA IS AND WHAT IT IS USED FOR

Ciprofloxacin Hikma contains the active substance ciprofloxacin. Ciprofloxacin Hikma is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. It is effective only against certain strains of bacteria.

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

• respiratory tract infections
• long-lasting or recurrent ear or paranasal 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
• exposure to inhalation of anthrax spores

Ciprofloxacin may be used to treat patients with low white blood cell counts (neutropenia) and fever believed to be due to bacterial infection.
If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin Hikma.

Children and adolescents
Ciprofloxacin Hikma is used in children and adolescents, under specialist 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)
• exposure to inhalation of anthrax spores

Ciprofloxacin Hikma may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the doctor.

2. WHAT YOU SHOULD KNOW BEFORE USING CIPROFLOXACIN HIKMA

Do not use CIPROFLOXACIN HIKMA:

• if you are allergic to ciprofloxacin, to other quinolone antibiotics, or to any of the other ingredients of this medicine (listed in section 6)
• if you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Hikma)

Warnings and precautions
Talk to your doctor or nurse before using Ciprofloxacin Hikma.
Speak with your doctor before taking Ciprofloxacin Hikma:

• if you have kidney problems, as your treatment may need to be adjusted
• if you suffer from epilepsy or other neurological disorders.
• if you have had tendon problems during a previous treatment with antibiotics such as Ciprofloxacin Hikma.
• if you are diabetic, as you may experience hypoglycaemia with ciprofloxacin.
• if you have myasthenia gravis (a type of muscle weakness), as symptoms may worsen.
• if you have heart problems. Caution is advised if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heartbeat (called bradycardia), have a weak heart (heart failure), have a history of heart attacks (myocardial infarction), are a woman or elderly, or are taking other medicines that cause abnormal changes in the ECG (see section 2 “Other medicines and Ciprofloxacin Hikma”).
• if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.
• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, known high blood pressure, or atherosclerosis).

If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.
For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
During treatment with Ciprofloxacin Hikma
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Hikma. Your doctor will decide whether treatment with Ciprofloxacin Hikma should be discontinued.

• A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility of a severe and sudden allergic reaction even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, dizziness upon standing. In this case, stop treatment with Ciprofloxacin Hikma and contact your doctor immediately.
• Occasionally, Ciprofloxacin Hikma may cause joint and tendon pain and tendinitis, especially if you are elderly or receiving corticosteroid treatment. Inflammation and rupture of tendons may occur within the first 48 hours of treatment or up to several months after stopping treatment with Ciprofloxacin Hikma. At the first sign of pain or inflammation, stop taking Ciprofloxacin Hikma and rest the affected area. Avoid any unnecessary physical activity, as this may increase the risk of tendon rupture.
• If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. In this case, stop treatment with Ciprofloxacin Hikma and contact your doctor immediately.
• Psychiatric reactions may occur the first time you take Ciprofloxacin Hikma. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Hikma and, in rare cases, may progress to suicidal thoughts, suicide attempts, or suicide.

In this case, stop treatment with Ciprofloxacin Hikma and contact your doctor immediately.

• You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness and/or weakness. In this case, stop treatment with Ciprofloxacin Hikma and contact your doctor immediately.

Hypoglycaemia has been reported more frequently in diabetic patients, particularly in elderly patients. If this occurs, contact your doctor immediately.

• During treatment with antibiotics, including Ciprofloxacin Hikma, or even several weeks afterwards, you may develop diarrhoea. If it worsens or persists, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Hikma must be stopped immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
• Inform your doctor or laboratory staff that you are taking Ciprofloxacin Hikma if you are undergoing blood or urine tests.
• Ciprofloxacin Hikma may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, Ciprofloxacin Hikma must be stopped immediately.
• Ciprofloxacin Hikma may cause a reduction in the number of white blood cells, which may lead to decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with signs of localized infection such as sore throat, throat or mouth pain, or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
• If you have kidney problems, inform your doctor, as your dosage may need to be reduced.
• During treatment with Ciprofloxacin Hikma, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
• If you notice a weakening of vision or feel that your eyes are affected, consult an eye specialist immediately.

Other medicines and CIPROFLOXACIN HIKMA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not use Ciprofloxacin Hikma together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take").
The following medicines interact with Ciprofloxacin Hikma in the body. Taking Ciprofloxacin Hikma together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
Inform your doctor if you are taking:

• vitamin K antagonists (e.g.: warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (which thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis or 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)
• cyclosporine (for certain skin conditions, rheumatoid arthritis, and used in organ transplantation)
• 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.

Ciprofloxacin Hikma may increase the blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage, or incontinence)
• lidocaine (for heart conditions or anaesthetic use)
• sildenafil (e.g.: for erectile dysfunction)
• agomelatine
• zolpidem

Ciprofloxacin Hikma with food and drink
Food and drink do not affect treatment with Ciprofloxacin Hikma.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid using Ciprofloxacin Hikma during pregnancy.
Do not take Ciprofloxacin Hikma while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Hikma may affect your level of alertness. Since neurological adverse events may occur, check your response to Ciprofloxacin Hikma before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.
Ciprofloxacin Hikma contains sodium
If you are on a low-sodium diet, please note that 100 ml of Ciprofloxacin Hikma contains 15.4 mmol (equivalent to 354 mg) of sodium.

3. HOW TO USE CIPROFLOXACIN HIKMA

Your doctor will explain exactly how much Ciprofloxacin Hikma you should receive, how
frequently, 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 a dose adjustment may be necessary.
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. For
children, the infusion duration is 60 minutes. In adult patients, the infusion duration is 60
minutes for Ciprofloxacin Hikma 400 mg and 30 minutes for Ciprofloxacin Hikma 200 mg.
Administering the infusion slowly helps prevent the occurrence of immediate adverse
reactions.
Remember to drink plenty of fluids during treatment with this medicine.

If you interrupt treatment with Ciprofloxacin Hikma

• 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 early, the 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, consult your doctor or
pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, contact your doctor immediately
(see section 2 Warnings and Precautions):

• Sudden severe allergic reaction (an anaphylactic reaction/shock, angioedema).
• Joint pain and swelling, and tendinitis
• Adverse reactions affecting the central nervous system, if you have epilepsy or other neurological conditions
• Psychiatric reactions after the first dose of ciprofloxacin, if you have depression or psychosis
• Symptoms of neuropathy, such as pain, burning, tingling, numbness and/or weakness.
• Hypoglycemia if you are diabetic
• Severe or persistent diarrhea, or if you notice blood or mucus in your stools
• Loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach tenderness
• Infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth or urinary problems
• Loss of vision or other eye disorders.

Common (may affect up to 1 in 10 people):

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

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

• fungal superinfections
• high concentration of eosinophils, a type of white blood cells, increase or decrease in a blood coagulation factor (platelets)
• reduced appetite
• hyperactivity, restlessness, confusion, disorientation, hallucinations
• headache, dizziness, sleep disturbances, taste disturbances, tingling, unusual sensitivity to sensory stimuli, seizures (see section 2: Warnings and Precautions), feeling drowsy
• visual disturbances including double vision
• hearing loss
• rapid heartbeat (tachycardia)
• dilation of blood vessels (vasodilation), low blood pressure
• abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence
• liver disorders, increase in a substance in the blood (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• joint pain in adults
• reduced kidney function, kidney failure
• muscle and bone pain, malaise (asthenia), fever, fluid retention
• increased alkaline phosphatase in the blood (a certain substance in the blood)

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

• inflammation of the intestine (colitis) associated with antibiotic use (in rare cases may be fatal) (see section 2: Warnings and Precautions)
• changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), a decrease in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal, bone marrow suppression, which may also be fatal (see section 2: Warnings and Precautions)
• allergic reaction, allergic swelling (edema), acute swelling of the skin and mucous membranes (angioedema), severe allergic reaction (anaphylactic shock) which may be life-threatening (see section 2: Warnings and Precautions)
• increased blood sugar (hyperglycemia)
• decreased blood sugar (hypoglycemia) (see section 2: Warnings and Precautions)
• anxiety reaction, unusual dreams, depression (potentially leading to suicidal thoughts/ideation or suicide attempts and completed suicide), mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts or completed suicide) (see section 2: Warnings and Precautions)
• reduced skin sensitivity, tremor, migraine, disturbances in smell (olfactory disturbances)
• tinnitus, decreased hearing
• fainting, inflammation of blood vessels (vasculitis)
• shortness of breath, including symptoms of asthma
• pancreatitis
• hepatitis, liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
• sensitivity to light (see section 2: Warnings and Precautions), pinpoint bleeding under the skin (petechiae)
• pain and/or muscle weakness, joint inflammation, joint pain, increased muscle tone, cramps, tendon inflammation or tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and Precautions)
• blood or crystals in the urine (see section 2: Warnings and Precautions), inflammation of the urinary tract
• excessive sweating
• increased levels of the amylase enzyme

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

• a specific type of decrease in red blood cells (hemolytic anemia); a dangerous decrease in a type of white blood cells (agranulocytosis)
• severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which may be fatal (see section 2: Warnings and Precautions)
• coordination disorders, unsteady gait (gait disturbances), increased pressure in the brain (intracranial hypertension and pseudotumor cerebri)
• disturbances in color perception
• various types of skin rashes (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
• muscle weakness, tendon inflammation, worsening of symptoms of severe myasthenia gravis (see section 2: Warnings and Precautions)

Frequency not known (frequency cannot be estimated from the available data)

• Unusual sensations of pain, burning, tingling, numbness, and muscle weakness in the extremities (neuropathy) – see section 2
• abnormally increased heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as “prolongation of the QT interval”, documented by ECG, electrical activity of the heart)
• pustular rash
• effect on blood clotting (in patients treated with vitamin K antagonists)
• Feeling of excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania)
• Hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor or pharmacist. You can also report adverse reactions directly
via the website www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting adverse reactions, you can help provide more information
on the safety of this medicine.

5. HOW TO STORE CIPROFLOXACIN HIKMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.

• Do not refrigerate or freeze.
• Keep the vial/bag in its outer carton/outer aluminium bag until use to protect from light.

6. Package contents and other information

What Ciprofloxacina Hikma contains

• The active substance is ciprofloxacin lactate. Each 100 ml vial contains 200 mg of ciprofloxacin. Each 200 ml bag contains 400 mg of ciprofloxacin.
• The other components are lactic acid (E270), sodium chloride, hydrochloric acid (E507) for pH adjustment, and water for injections.

Description of the appearance of Ciprofloxacina Hikma and contents of the pack
Ciprofloxacina Hikma is a sterile, clear, colourless or pale yellow infusion solution.
The solution is contained in a transparent, colourless glass vial of type I or II with a volume of 100 ml and/or in a polypropylene infusion bag containing 200 ml of solution.

Marketing Authorization Holder and Responsible Lot Release Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.º 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
Tel: +351 219 608 410
Fax: +351 219 615 102
[email protected]
Marketing Authorization Holder in Italy: Hikma Italia SpA, Viale Certosa 10, 27100 Pavia

This medicinal product is authorized in the Member States of the European Union under the following names:
Austria: Ciprofloxacin Hikma 2 mg/ml solution for intravenous infusion
Germany: Ciprofloxacin Hikma 2 mg/ml Infusionslösung
Ireland: Truoxin I.V. 200 mg/100 ml & 400 mg/200 ml Solution for Infusion
Italy: Ciprofloxacina Hikma 2 mg/ml Soluzione per Infusione
United Kingdom: Ciprofloxacin Hikma 2 mg/ml Solution for Infusion
Netherlands: Ciprofloxacine Hikma 2 mg/ml Oplossing voor Intraveneuze Infusie

This Patient Information Leaflet was last approved on
The following information is intended for healthcare professionals only.
Visually inspect the solution before use and use only clear solutions free from particles.
The infusion contains no preservatives. For single use only. Any unused solution, vials and/or bags must be disposed of properly in accordance with local legal requirements.

Ciprofloxacina Hikma is compatible with the following solutions: isotonic sodium chloride solution, Ringer’s solution, Ringer’s lactate solution, glucose 50 mg/ml (5%) or 100 mg/ml (10%) solution, glucose 50 mg/ml (5%) with sodium chloride 2.25 mg/ml (0.225%) or 4.5 mg/ml (0.45%) solution, and 10% fructose solution. Compatibility with these solutions has been demonstrated at ciprofloxacin concentrations of 1 mg/ml. Chemical and physical stability has been demonstrated immediately after dilution, after 24 hours at 2–8°C, and after 24 hours at room temperature. Unless compatibility has been demonstrated, the infusion solution must always be administered separately.

Before administration, visually inspect the diluted solution for the presence of particulate matter or discoloration. Use only clear, colourless solutions.

Handling of glass vials
Ciprofloxacina Hikma 2 mg/ml may be infused directly via a suitable cannula or diluted with any of the fluids listed above.

Handling of plastic bags
Remove the bag from its outer protective packaging immediately before use. The outer packaging protects against moisture. The inner bag maintains the sterility of the product.

To open, tear the outer packaging at the perforation and remove the solution container. The plastic may appear slightly opaque due to moisture absorbed during the sterilization process. This is normal and does not affect the quality or safety of the solution. The opacity gradually diminishes. After removing the outer packaging, firmly compress the inner bag to ensure there are no small leaks. If any leakage is detected, sterility may be compromised and the solution must be discarded.

WARNING: Do not use plastic containers in series connections. Otherwise, gas embolism may occur due to residual air being drawn from the primary container before fluid administration from the secondary container is complete.