250 mg, 500 mg, 750 mg film-coated tablets ciprofloxacin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

What Ciprofloxacin Hexal is and what it is used for

Ciprofloxacin Hexal contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic in the group of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

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

  • respiratory infections
  • prolonged or recurrent ear or sinus infections
  • urinary tract infections
  • infection in the genitals of men and women
  • infection in the gastrointestinal tract and infection in the abdomen
  • skin and soft tissue infections
  • the infection you in the skeleton and joints
  • to prevent infection caused by Neisseria meningitidis
  • exposure to anthrax bacteria via the respiratory tract

Ciprofloxacin can be used in the treatment of patients with low white blood cell count( neutropenia ) who have a fever suspected of being due to a bacterial infection .

If you have a serious infection or one that is caused by more than one type of bacterium, you may be prescribed additional antibiotic treatment in addition to Ciprofloxacin Hexal.

Children and young people

Ciprofloxacin Hexal is used in children and adolescents, under the supervision of a medical specialist, to

treat the following bacterial infections:

  • acute lung infections in children and adolescents suffering from cystic fibrosis
  • complicated urinary tract infections, including infection that has reached the kidneys ( pyelonephritis )
  • exposure to anthrax bacteria via the respiratory tract (suspected or confirmed)

Ciprofloxacin Hexal can also be used to treat other particularly serious infections in children and adolescents when your doctor deems it necessary.

Ciprofloxacin contained in Ciprofloxacin Hexal may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Ciprofloxacin Hexal

Do not use Ciprofloxacin Hexal

  • if you are allergic to ciprofloxacin or other quinolone medicines or any of the other ingredients of this medicine (listed in section 6)
  • if you are being treated with tizanidine (see section 2: Other medicines and Ciprofloxacin Hexal).

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin Hexal, if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

Talk to your doctor before using Ciprofloxacin Hexal:

  • if you have ever had kidney problems because your treatment may need to be adjusted
  • if you suffer from epilepsy or another neurological disease
  • if you have experienced tendon problems during previous treatment with an antibiotic similar to Ciprofloxacin Hexal
  • if you are diabetic because you may experience hypoglycemia while taking ciprofloxacin
  • if you have myasthenia gravis (a type of muscle weakness), as the symptoms may worsen
  • if you have heart problems. Caution should be exercised when using ciprofloxacin:
    • if you have a congenital long QT interval or if this is in the family (which can be seen on heart film, ECG )
    • if the salt content in the blood is not in balance (especially in the case of low levels of potassium or magnesium in the blood)
    • if you have a very slow heart rate ( bradycardia )
    • if you have heart failure
    • if you have had a heart attack (heartbeat)
    • if you are a woman or older
    • if you are taking other medicines that cause abnormal changes in the heart film (see section 2: Other medicines and Ciprofloxacin Hexal).
  • if you or a family member are deficient in glucose -6-phosphate dehydrogenase (G6PD) because you may develop anemia while taking ciprofloxacin
  • if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel)
  • if you have had an aortic dissection (a rupture in the aortic wall)
  • if someone in your family has or has had an aortic aneurysm or aortic dissection or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, or vascular Ehlers-Danlos syndrome, or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis).

If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.

When treating certain genital infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin . If there is no improvement in symptoms after 3 days of treatment, you should consult a doctor.

Antibiotics quinolone can cause an increase over your normal blood sugar levels ( hyperglycemia ) or a decrease in your normal blood sugar levels, which in severe cases can cause loss of consciousness (hypoglycaemic coma ) (see section 4). This is important for patients with diabetes. If you have diabetes, your blood sugar should be monitored carefully.

During treatment with Ciprofloxacin Hexal

Tell your doctor immediately if any of the following occur during treatment with Ciprofloxacin Hexal. Your doctor will decide if you need to stop taking CiprofloxacinHexal.

  • Severe, sudden allergic reaction (anaphylactic reaction / shock, angioedema ). Even after the first dose , there is a small risk that you will experience a severe allergic reaction with the following symptoms: tightness in the chest, dizziness, nausea or fainting or dizziness when you get up. If this happens, stop taking Ciprofloxacin Hexal and contact your doctor immediately.
  • In rare cases, pain and swelling in the joints and inflammation or rupture of tendons can occur. The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems or if you are being treated with cortisone ( corticosteroids ). Inflammation and tendon rupture can occur within the first 48 hours after starting treatment but also up to several months after stopping treatment with Ciprofloxacin Hexal. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking CiprofloxacinHexal, consult a doctor and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you suffer from epilepsy or another neurological disease such as decreased blood flow to the brain or stroke, you may experience side effects related to the central nervous system. If this happens, stop taking Ciprofloxacin Hexal and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take CiprofloxacinHexal. In rare cases, depression or psychosis can lead to suicidal ideation, a suicide attempt, or completed suicide. If you suffer from depression or psychosis, your , your symptoms may become worse under treatment with Ciprofloxacin Hexal. If this happens, stop taking Ciprofloxacin Hexal and contact your doctor immediately.
  • In rare cases, you may experience symptoms of nerve damage ( neuropathy )such as pain, a burning sensation, tingling, numbness and / or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Ciprofloxacin Hexal and contact your doctor immediately to prevent the development of a possible permanent condition.
  • Hypoglycemia has been reported mainly in diabetic patients, especially in the elderly. If this happens, consult a doctor immediately.
  • Diarrhea can occur while you are taking antibiotics, including CiprofloxacinHexal, or even several weeks after you stop taking them. If this becomes severe or persistent or if you notice blood or mucus in your stools, stop taking CiprofloxacinHexal immediately as this can be life-threatening. Do not take any medicine that stops or reduces bowel movements and contact your doctor.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Hexal if you are going to have a blood or urine sample.
  • Tell your doctor if you suffer from kidney problems as the dose may need to be adjusted.
  • Ciprofloxacin Hexal may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching or tightness in the stomach, stop taking Ciprofloxacin Hexal and contact your doctor immediately.
  • Ciprofloxacin Hexal may cause a decrease in the number of white blood cells and your resistance to infection may be reduced . If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local symptoms of infection such as sore throat / throat / mouth or urinary incontinence, contact your doctor immediately. A blood test will be taken to check for a possible decrease in white blood cells ( agranulocytosis ). It is important to inform your doctor about your medicine.
  • If your vision gets worse , or if your eyes are affected in any other way while you are taking Ciprofloxacin Hexal, contact an ophthalmologist immediately.
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin Hexal. Avoid exposure to strong sunlight and artificial UV light such as tanning beds.

Long-term, debilitating, and potentially lasting serious side effect s

Antibacterial fluoroquinolone/quinolone drugs, including Ciprofloxacin Hexal, have been associated with very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabling, and possibly permanent. This includes pain in the tendons, muscles, and joints of the arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste, smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders.

If you get any of these side effects after taking Ciprofloxacin Hexal, talk to your doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.

Other medicines and Ciprofloxacin Hexal

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

Do not take Ciprofloxacin Hexal with tizanidine as it may cause side effects such as low blood pressure and fatigue (see section 2: Do not use Ciprofloxacin Hexal).

It is known that the following medicines interact with Ciprofloxacin Hexal in your body. Taking Ciprofloxacin Hexal with these medicines may affect the therapeutic effect of these medicines. It can also increase the risk of experiencing side effects.

Tell your doctor if you are taking:

  • Vitamin K antagonists (eg warfarin, acenocoumarin, phenprocoumon, or fluindione) or other anticoagulants (dilutes the blood)
  • probenecid (for gout )
  • methotrexate (for certain types of cancer, psoriasis , rheumatoid arthritis )
  • theophylline (for respiratory problems)
  • tizanidine (for muscle spasticity in multiple sclerosis )
  • olanzapine (an antipsychotic )
  • clozapine (an antipsychotic )
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • metoclopramide (for nausea and vomiting)
  • ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplantation)
  • Other drugs that can affect your heart rhythm:
    • medicines belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
    • tricyclic antidepressants
    • certain antibiotics belonging to the group macrolide s
    • certain psychosis medications.

Ciprofloxacin Hexal may increase the levels of the following substances in your blood:

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, diabetic nerve disease, or incontinence )
  • lidocaine (for heart problems or anesthesia)
  • sildenafil (eg for erection problems)
  • agomelatine
  • zolpidem.

Some medicines may reduce the effect of Ciprofloxacin Hexal. Tell your doctor if you are taking or want to take:

  • antacids
  • omeprazole
  • mineral supplements
  • sucralfate
  • phosphate-bound polymers (eg sevelamer or lanthanum carbonate)
  • medicines or supplements containing calcium, magnesium, aluminum or iron.

If these medicines are important to you, take Ciprofloxacin Hexal about 2 hours before or no earlier than 4 hours after them.

Ciprofloxacin Hexal with food and drink

Unless you are taking Ciprofloxacin Hexal during a meal, do not eat or drink any dairy product (such as milk or yoghurt) or drinks with calcium supplements while taking the tablets as it may affect the uptake of the active substance.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is best to avoid taking Ciprofloxacin Hexal during pregnancy.

Do not take Ciprofloxacin Hexal while you are breast-feeding as ciprofloxacin excreted in human milk and may be harmful to your baby.

Driving and using machines

Ciprofloxacin Hexal may make you feel less alert. Some neurological side effects may occur. Therefore, do not drive or use machines until you know how you react to Ciprofloxacin Hexal. If you are not sure, talk to your doctor.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Ciprofloxacin Hexal

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Your doctor will explain to you exactly how much Ciprofloxacin Hexal to take as well as how often and for how long. This depends on the type of infection you have and how serious it is.

Tell your doctor if you suffer from kidney problems as your dose may need to be adjusted.

The treatment usually lasts for 5 to 21 days, but may take longer for serious infections.

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure how many tablets to take or how to take CiprofloxacinHexal.

  1. Swallow the tablets together with plenty of liquid. Do not chew the tablets as they do not taste good.
  2. Try to take the tablets at the same time each day.
  3. You can take the tablets at mealtime or between meals. Taking calcium as part of a meal does not affect your uptake. However Ciprofloxacin Hexal tablets should not be taken with dairy products such as milk or yoghurt or with fortified fruit juice (eg calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

The tablet can be divided into equal doses.

If you forget to use Ciprofloxacin Hexal

Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to make up for a forgotten dose. Make sure to complete your cure.

If you stop using Ciprofloxacin Hexal

It is important that you complete the treatment regimen even if you start to feel better after a few days. If you stop taking this medicine too soon, your infection may be inadequately treated and the symptoms of infection may return or get worse. You may also develop resistance to the antibiotic.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • nausea, diarrhea
  • joint pain in children

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

  • fungal infections
  • a high concentration of eosinophils, a type of white blood cell
  • decreased appetite
  • hyperactivity or agitation
  • headache, dizziness, sleep problems, or taste changes
  • vomiting, abdominal pain, indigestion such as upset stomach (indigestion/heartburn) or gas in the stomach
  • increased amounts of certain substances in the blood ( transaminases and/or bilirubin )
  • rash, itching, or hives
  • joint pain in adults
  • poor kidney function
  • pain in muscles and bones, feeling sick ( asthenia ) or fever
  • increase in alkaline phosphatases in the blood (a special substance in the blood).

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

  • inflammation of the intestine ( colitis ) associated with antibiotic use (maybe fatal in very rare cases) (see section 2: Warnings and precautions)
  • changes in blood value ( leukopenia , leukocytosis, neutropenia, anemia ), increased or decreased amount of blood coagulation factor ( platelets )
  • allergic reaction, swelling ( edema ), or rapid swelling of the skin and mucous membranes ( angioedema )
  • elevated blood sugar (hyperglycemia)
  • low blood sugar hypoglycemia) (see section 2: Warnings and precautions)
  • confusion, disorientation, anxiety, strange dreams, depression (which can lead to suicidal thoughts, suicide attempts, or completed suicide), or hallucinations
  • ant crawling, unusual sensation, decreased skin sensitivity, tremors, seizures (see section 2: Warnings and precautions), dizziness
  • problems with vision, e.g. double vision
  • tinnitus, hearing loss, hearing loss
  • palpitations, ( tachycardia )
  • dilated blood vessels ( vasodilation ), low blood pressure or fainting
  • shortness of breath including asthmatic symptoms
  • hepatic impairment, jaundice (cholestatic jaundice), or hepatitis
  • photosensitivity (see section 2: Warnings and precautions)
  • muscle pain, inflammation in the joints, increased muscle tension or cramping
  • renal failure, blood or crystals in the urine (see section 2: Warnings and precautions), inflammation of the urinary tract
  • fluid retention or pronounced sweating
  • elevated levels of enzyme et amylase.

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

  • decreased number of a special type of red blood cells ( hemolytic anemia ); a severe decline in a type of white blood cell ( agranulocytosis ); decrease in the number of red and white blood cells and platelets (pancytopenia), which can be fatal, and bone marrow depression which can also be fatal (see section 2: Warnings and precautions)
  • severe allergic reactions ( anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Warnings and precautions)
  • mental disorder (the psychotic reaction that can lead to suicidal thoughts, suicide attempts or completed suicide) (see section 2: Warnings and caution)
  • migraine, altered coordination, unsteady gait, altered sense of smell (olfactory disorder), pressure on the brain ( intracranial pressure and benign intracranial pressure increase)
  • distortion of color vision
  • inflammation of the walls of blood vessels ( vasculitis )
  • pancreatitis ( inflammation of the pancreas)
  • liver cell death (liver necrosis) can in very rare cases lead to life-threatening liver failure
  • small punctate hemorrhages under the skin ( petechiae ); various skin conditions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis )
  • muscle weakness, tendonitis, tendon rupture – especially the large tendon on the back of the heel (Achilles tendon) (see section 2: Warnings and caution), worsening of the symptoms of myasthenia gravis (see section 2: Warnings and caution).

Has been reported (occurs in an unknown number of users):

  • problems related to the nervous system such as pain, burning sensation, tingling, numbness, and/or weakness in the extremities ( peripheral neuropathy and polyneuropathy )
  • abnormally fast heart rate, life-threatening irregular heartbeat, changes in heart rate (prolonged QT interval seen on heart film, ECG, which measures the electrical activity of the heart)
  • rash with blisters
  • effect on blood clotting in patients treated with vitamin K antagonist s
  • very elated feeling (mania) or feeling of great optimism and overactivity ( hypomania )
  • severe hypersensitivity reaction called DRESS (drug reaction with eosinophilia and systemic symptoms).
  • conditions of decreased water excretion and low sodium levels (SIADH).
  • loss of consciousness due to a severe decrease in blood sugar (hypoglycaemic coma). See section 2.

In very rare cases, long-term (up to several months or years) or lasting side effects, such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and impaired hearing, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Ciprofloxacin Hexal

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

Do not use this medicine after the expiry date which is stated on the blister or on the carton after EXP. or EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ciprofloxacin.One film-coated tablet contains 250 mg ciprofloxacin (as hydrochloride monohydrate).One film-coated tablet contains 500 mg ciprofloxacin (as hydrochloride monohydrate).One film-coated tablet contains 750 mg of ciprofloxacin (as hydrochloride monohydrate).
  • The other ingredients are microcrystalline cellulose, sodium starch glycolate (type A), povidone 25000, anhydrous colloidal silica, stearic acid, magnesium stearate, croscarmellose sodium, hypromellose, macrogol 6000, talc, titanium dioxide (E 171).

What the medicine looks like and the contents of the pack

Ciprofloxacin Hexal 250 mg film-coated tablets are white, round, scored on one side and marked “cip 250” on one side.

Ciprofloxacin Hexal 500 mg film-coated tablets are white, oblong, scored on both sides and marked “cip 500” on one side.

Ciprofloxacin Hexal 750 mg film-coated tablets are white, oblong, scored on both sides and marked “cip 750” on one side.

Ciprofloxacin Hexal 250 mg film-coated tablets

6, 10, 12, 14, 20, 28 and 100 film-coated tablets in PVC / aluminum or PP / aluminum blister.

Hospital packs containing 20, 30, 50 (10 x 5) and 160 film-coated tablets.

Ciprofloxacin Hexal 500 mg film-coated tablets

10, 12, 14, 16, 20, 28, 50 (10 x 5) and 100 film-coated tablets in PVC / aluminum or PP / aluminum blister.

Hospital packs containing 20, 30, 100, 120 and 160 film-coated tablets.

Ciprofloxacin Hexal 750 mg film-coated tablets

10, 20 and 100 film-coated tablets in PVC / aluminum or PP / aluminum blister. Hospital packs containing 20, 30, 50 (10 x 5) and 160 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

SC Sandoz S: RL, 7A Livezeni Street, 540472 Targu Mures, Romania

Muhammad Nadeem

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