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

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important for 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 you will find information about: 
1. What Ciprofloxacin Krka is and what it is used for 
2. What you need to know before you use Ciprofloxacin Krka 
3. How to use Ciprofloxacin Krka 
4. Possible side effects 
5. How to store Ciprofloxacin Krka 
6. Contents of the pack and other information 

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

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

Adults

Ciprofloxacin Krka 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 Krka.

Children and young people

Ciprofloxacin Krka 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

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

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

2. What you need to know before you use Ciprofloxacin Krka

Do not use Ciprofloxacin Krka

– if you are allergic to ciprofloxacin, 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 Krka”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Ciprofloxacin Krka.

Before treatment with Ciprofloxacin Krka

Tell your doctor:

  1. if you have ever had kidney problems because your treatment may need to be adjusted
  2. if you suffer from epilepsy or another neurological disease
  3. if you have experienced tendon problems during previous treatment with an antibiotic similar to Ciprofloxacin Krka
  4. 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)
  5. if you have had an aortic dissection (a rupture in the aortic wall)
  6. 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 arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis)
  7. if you are diabetic because there is a risk of you getting hypoglycemia from ciprofloxacin
  8. have myasthenia gravis (a type of muscle weakness)
  9. if you have heart problems. Caution should be exercised when using this type of medicine if you are born with or if someone in your family has a prolonged QT interval (this can be seen on the ECG, electronic recording of the work of the heart), has a disturbance in the salt balance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia ), have a weak heart ( heart failure ), have previously had a heart attack (heart attack), you are a woman or elderly or are taking other medicines that cause abnormal ECG changes (see section 2 “Other medicines and Ciprofloxacin Krka”).
  10. if you or a family member are deficient in glucose -6-phosphate dehydrogenase (G6PD) because you are at risk of developing ciprofloxacin anemia.

You should not take antibacterial fluoroquinolone/quinolone medicines, including Ciprofloxacin Krka 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.

To treat 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.

During treatment with Ciprofloxacin Krka

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

  • 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 or fainting, or dizziness when you get up. If this happens, stop taking Ciprofloxacin Krka 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 rupture of tendons can occur within the first 48 hours after starting treatment but also up to several months after treatment with Ciprofloxacin Krka has ended. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking CiprofloxacinKrka, consult a doctor, and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.
  • If you suffer from epilepsy or other neurological diseases 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 Krka and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take CiprofloxacinKrka. If you suffer from depression or psychosis, your, your symptoms may become worse under treatment with Ciprofloxacin Krka. If this happens, stop taking Ciprofloxacin Krka 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 Krka and contact your doctor immediately to prevent the development of any lasting condition.
  • 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 diabetesIf you have diabetes, your blood sugar should be monitored carefully.
  • Diarrhea can occur while you are taking antibiotics , including Ciprofloxacin Krka, 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 CiprofloxacinKrka immediately as this can be life-threatening. Do not take any medicine that stops or reduces bowel movements, and consult your doctor.
  • If your vision becomes worse, or if your eyes are affected in any other way, contact an ophthalmologist immediately.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Krka if you are going to have a blood or urine sample.
  • Tell your doctor if you have kidney problems as the dose may need to be adjusted.
  • Ciprofloxacin Krka can cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching or tension in the stomach, stop taking Ciprofloxacin Krka and contact your doctor immediately.
  • Ciprofloxacin Krka can 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 sample will be taken to check for a possible decline in white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin Krka. Avoid exposure to strong sunlight and artificial UV light such as tanning beds.
  • Antibacterial fluoroquinolone/quinolone drugs, including Ciprofloxacin Krka, have been linked to 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 tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disturbances in the form of impaired vision, taste, smell and hearing, depression, impaired memory, extreme fatigue, and severe sleep problems.
  • If you get any of these side effects after taking Ciprofloxacin Krka, talk to a doctor straight away before starting treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.

Other medicines and Ciprofloxacin Krka

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

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

It is known that the following medicines interact with Ciprofloxacin Krka in your body. Taking Ciprofloxacin Krka 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 ( 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 )
  • clozapine, olanzapine (antipsychotics)
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • ciclosporin (prevent rejection of transplanted organs)
  • other medicines that can change your heart rhythm: medicines that belong to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), certain antidepressants ( tricyclic antidepressants ), certain bactericides (which belong to the group macrolides er), certain drugs for mental illness.

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

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression)
  • lidocaine (local anesthetic)
  • sildenafil (for erectile dysfunction )
  • agomelatine
  • zolpidem

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

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

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

Ciprofloxacin Krka with food and drink

Unless you are taking Ciprofloxacin Krka 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, breastfeeding and fertility

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 Krka during pregnancy. Tell your doctor if you are planning to become pregnant.

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

Driving and using machines

Ciprofloxacin Krka may make you feel less alert. Some neurological side effects may occur. Do not drive or use machines until you know how you react to CiprofloxacinKrka. 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 increased vigilance. 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.

Ciprofloxacin Krka contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to use Ciprofloxacin Krka

Always use 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 Krka 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. Take the tablets 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 CiprofloxacinKrka.

  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. HoweverCiprofloxacin Krka 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 Ciprofloxacin Krka.

If you forget to use Ciprofloxacin Krka

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 Krka

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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

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

  • fungal infections
  • a high concentration of eosinophils, a type of white blood cell
  • loss of appetite ( anorexia )
  • 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)
  • decreased blood sugar ( hypoglycemia ) (see Section 2: Precautions)
  • confusion, disorientation, anxiety, strange dreams, depression, or hallucinations
  • ant crawling, unusual sensation, decreased skin sensitivity, tremors, seizures (see section 2: “Warnings and precautions”), dizziness
  • vision problem (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
  • abnormal levels of coagulation factor (prothrombin) or elevated levels of enzymes 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 (psychotic reaction) (see section 2: “Warnings and caution”)
  • migraine, altered coordination, unsteady gait, altered sense of smell (olfactory disorder), pressure on the brain ( intracranial pressure )
  • 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 heartbeat, life-threatening irregular heartbeat, change in heartbeat (called QT interval prolongation, this can be seen on the ECG, electronic recording of heart work)
  • rash with blisters
  • increased risk of bleeding (in patients treated with blood-thinning drugs)
  • very exciting feeling (mania) or feeling of excessive optimism or overactivity ( hypomania )
  • hypersensitivity reaction called DRESS (drug reaction with eosinophilia and systemic symptoms)
  • condition 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 Krka

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

Store in the original package. Sensitive to light.

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

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 (as hydrochloride monohydrate)
  • Ciprofloxacin Krka 250 mg film-coated tablet:1 film-coated tablet contains 291.0 mg ciprofloxacin hydrochloride monohydrate equivalent to 250 mg ciprofloxacin. Ciprofloxacin Krka 500 mg film-coated tablet:1 film-coated tablet contains 582.0 mg ciprofloxacin hydrochloride monohydrate equivalent to 500 mg ciprofloxacin. Ciprofloxacin Krka 750 mg film-coated tablet:1 film-coated tablet contains 873.0 mg ciprofloxacin hydrochloride monohydrate equivalent to 750 mg ciprofloxacin.
  • The other ingredients are croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, sodium starch glycolate (type A), povidone, and magnesium stearate in the tablet core and hypromellose, propylene glycol, talc, and titanium dioxide (E171) in the film coating.See section 2 “Ciprofloxacin Krka contains sodium”.

What the medicine looks like and the contents of the pack

250 mg film-coated tablets are white, round, smooth on one side, with a notch on the other side. The tablet can be divided into equal doses.

500 mg film-coated tablets are white, oval, smooth on one side, with a notch on the other side. The tablet can be divided into equal doses.

750 mg film-coated tablets are white, oval, with notches on both sides of the tablet. The tablet can be divided into equal doses.

All strengths of the tablet are available in cartons of 10, 20, 30, or 100 film-coated tablets packed in blister cards (1, 2, 3, or 10 blister cards with 10 film-coated tablets per card), 500 mg is also available in cartons of 6 film-coated tablets (1 blister card with 6 film-coated tablets) and 16 film-coated tablets (2 blister cards with 8 film-coated tablets) and 750 mg in a carton of 12 film-coated tablets (2 blister cards with 6 film-coated tablets). The tablets are also available in hospital packs of 50 film-coated tablets (10 blister cards with 5 film-coated tablets per card).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm,

Manufacturer:

KRKA, dd, Novo Mesto, Šmarješka Cesta 6, 8501 Novo Mesto, Slovenia

Muhammad Nadeem

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