500 mg film-coated tablets 
ciprofloxacin

Read all of this leaflet carefully before you start taking 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 SUN is and what it is used for 
2. What you need to know before taking Ciprofloxacin SUN 
3. How to take Ciprofloxacin SUN 
4. Possible side effects 
5. How to store Ciprofloxacin SUN 
6. Contents of the packaging and other information 

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

Ciprofloxacin SUN contains the active substance ciprofloxacin . Ciprofloxacin is an antibiotic that belongs to the group of fluoroquinolones  Ciprofloxacin works by killing bacteria that cause you infections . Ciprofloxacin acts only on specific strains of bacteria.

Adults

Ciprofloxacin 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
  • 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 to treat 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 SUN.

Children and young people

Ciprofloxacin SUN is used in children and adolescents, under the supervision of a medical specialist, to treat the following bacterial infections:

  • lung and respiratory 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 SUN can also be used to treat other particularly serious infections in children and adolescents when your doctor deems it necessary.

What you need to know before you take Ciprofloxacin SUN

Do not take Ciprofloxacin SUN

  • 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 SUN)

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin SUN, 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 taking Ciprofloxacin SUN

  • 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 of 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 arteritis, giant cell arteritis, Behçet’s disease , high blood pressure , or known atherosclerosis).
  • 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 SUN
  • if you have diabetes because there is a risk that your blood sugar level will drop along with ciprofloxacin .
  • If you have myasthenia gravis (a type of muscle weakness) then the symptoms may worsen
    • if you have heart problems. Caution should be exercised when using ciprofloxacin if you are born with or if someone in your family has a prolonged QT interval , (this can be seen on ECG electronic recording of heart work), has a disturbance in the salt balance in the blood (especially low levels of potassiumor 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), are you a woman or elderly, or are taking other medicines that cause abnormal ECG changes (see section 2 : “Other medicines and Ciprofloxacin SUN”).
  • if you or a family member have a glucose -6-phosphate dehydrogenase deficiency (G6PD), as you may be at risk of developing ciprofloxacin anemia .

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

For the treatment of certain genital infections , your doctor may prescribe an additional antibiotic in addition to ciprofloxacin . If symptoms have not improved after 3 days of treatment, consult a doctor.

When you take this medicine

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

  • 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 feeling dizzy when you get up. If this happens, stop taking Ciprofloxacin SUN 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 SUN. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking CiprofloxacinSUN, 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 SUN and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take CiprofloxacinSUN. If you suffer from depression or psychosis, your , your symptoms may become worse under treatment with Ciprofloxacin SUN. In rare cases, depression or psychosis can lead to suicidal ideation, suicide attempt or completed suicide. If this happens, stop taking Ciprofloxacin SUN 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 SUN and contact your doctor immediately to prevent the development of any permanent condition.
  • Long-term, debilitating and potentially lasting serious side effects antibacterial fluoroquinolone/quinolone drugs, including Ciprofloxacin SUN, 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 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 SUN, talk to your doctor immediately before starting treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .
  • Low blood sugar has been reported most often in diabetic patients, mainly in the elderly. If this happens, contact your doctor immediately.
  • Diarrhea can occur while you are taking antibiotics , including Ciprofloxacin SUN, 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 CiprofloxacinSUN 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 deteriorates or if your eyes are affected in any other way, consult an ophthalmologist immediately (see section 4: Possible side effects).
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin SUN. Avoid exposure to strong sunlight and artificial UV light such as tanning beds.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin SUN if you are going to have a blood or urine sample.
  • If you have kidney problems , tell your doctor as your dose may need to be adjusted.
  • Ciprofloxacin SUN may 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 SUN and contact your doctor immediately.
  • Ciprofloxacin SUN 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 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.
  • 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.

Other medicines and Ciprofloxacin SUN

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

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

It is known that the following medicines interact with Ciprofloxacin SUN in your body. Taking Ciprofloxacin SUN 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 , acenocoumarol, 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)
  • cyclosporine (for the treatment of skin diseases, rheumatoid arthritis and in organ transplantation).
  • other drugs that may alter the heart rhythm: drugs belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone , sotalol, dofetilide, ibutilide), tricyclic antidepressants , certain antibiotics(belonging to the macrolide group ), certain antipsychotics.

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

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • gelatin (for depression)
  • zolpidem (sleeping pill)
  • duloxetine (for depression, diabetic nerve damage or incontinence )
  • lidocaine (for heart disease or for local anesthesia )
  • sildenafil (for erectile dysfunction ( impotence )).

Some medicines may reduce the effect of Ciprofloxacin SUN. 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 SUN film-coated tablets about 2 hours before or no earlier than 4 hours after them.

Ciprofloxacin SUN with food and drink

Unless you are taking Ciprofloxacin SUN 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 SUN during pregnancy.

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

Driving and using machines

Ciprofloxacin SUN 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 CiprofloxacinSUN. 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.

3. How to take Ciprofloxacin SUN

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 SUN 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 .

  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 SUN 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.

If you take more Ciprofloxacin SUN than you should

If you take more than the prescribed dose, seek medical help immediately. If possible, bring your tablets or pack and see your doctor.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital or the Poison Information Center on tel.

If you forget to take Ciprofloxacin SUN

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 taking Ciprofloxacin SUN

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.

Serious side effects are

Stop taking Ciprofloxacin tablets and see a doctor or hospital immediately if you notice any of the following serious side effects – you may need urgent medical attention:

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

  • allergic reaction, swelling ( edema ), or rapid swelling of the skin and mucous membranes ( angioedema )
  • inflammation of the intestine ( colitis ) associated with antibiotic use (may be fatal in very rare cases) (see section 2: Warnings and precautions)
  • hepatic impairment, jaundice (cholestatic jaundice) or hepatitis
  • decreased blood sugar ( hypoglycemia ) (see Section 2: Precautions)

Very rare: affects up to 1 in 10,000 people

  • severe allergic reactions ( anaphylactic reaction or anaphylactic shock , which may be fatal – serum sickness) (see section 2: Warnings and precautions)
  • small, punctate hemorrhages under the skin ( petechiae ); various skin conditions or rashes (for example, the potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis )
  • inflammation of the walls of blood vessels ( vasculitis )
  • inflammation of the pancreas that includes symptoms such as severe abdominal pain in the upper abdomen, often with nausea and vomiting ( pancreatitis )
  • muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tension and cramps, inflammation of the tendons or tendon rupture, especially affecting the large tendon on the back of the heel (heel tendon) – see section 2

No known frequency: can not be calculated from the available data

  • abnormally fast heartbeat, life-threatening irregular heartbeat, change in heartbeat (called “prolonged QT interval”, this can be seen on the ECG , electronic recording of heart work)
  • unusual feelings of pain, burning tingling, numbness and muscle weakness in the arms and legs ( neuropathy ) – see section 2
  • Loss of consciousness due to a severe decrease in blood sugar (hypoglycaemic coma ). See section 2.

Other side effects ar

Common (may affect up to 1 in 10 people)

  • nausea, diarrhea
  • joint pain in children

Uncommon (may affect up to 1 in 1,000 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 imagen
  • 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):

  • changes in blood value ( leukopenia , leukocytosis , neutropenia , anemia ), increased or decreased amount of blood coagulation factor ( platelets )
  • elevated blood sugar ( hyperglycaemia )
  • confusion, disorientation, anxiety, strange dreams, depression (may lead to suicidal ideation / thoughts or suicide attempts and completed suicide) or hallucinations
  • ant crawling, unusual sensation, decreased skin sensitivity, tremors, seizures (see section 2: Warnings and precautions), dizziness
  • vision problems including double vision hearing loss, hearing loss, hearing loss
  • palpitations, ( tachycardia )
  • dilated blood vessels ( vasodilation ), low blood pressure, or fainting
  • shortness of breath including asthmatic symptoms
  • photosensitivity (see section 2: Warnings and precautions)
  • 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 the enzyme 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)
  • mental disorder (psychotic reaction, which can lead to suicidal ideation, suicide attempt 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 pseudotumorcerebri)
  • distortion of color vision
  • liver cell death (liver necrosis) can in very rare cases lead to life-threatening liver failure

Unknown frequency (cannot be calculated from available data).

  • skin rash with blisters
  • effects on blood clotting ability (in patients treated with vitamin K antagonists )
  • very elated feeling (mania) or feeling of great optimism and overactivity ( hypomania )
  • severe hypersensitivity reaction called DRESS (drug reaction with eosinophilic and systemic symptoms)
  • condition of decreased water excretion and low sodium levels (SIADH)

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 SUN

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 carton or blister. 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.
  • The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate, talc, colloidal anhydrous silica, sodium starch glycolate (type A), hypromellose, macrogol 400 and titanium dioxide (E171).

What the medicine looks like and contents of the pack

Ciprofloxacin SUN 500 mg film-coated tablets are white, capsule-shaped and marked with ‘500’ on one side and smooth on the other side. Each tablet contains 500 mg of the active substance ciprofloxacin (as ciprofloxacin hydrochloride).

Pack sizes: 1, 8, 10, 14, 16, 20, 28, 32 and 100 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sun Pharmaceuticals Industries Europe BV,

Polarisavenue 87,

2132JH, Hoofddorp,

Netherlands

Manufacturer:

Sun Pharmaceutical Industries Europe BV, Polarisavenue 87, 2132JH, Hoofddorp, The Netherlands

Terapia SA, Fabricii 124, 400632 Cluj-Napoca, Cluj, Romania

Muhammad Nadeem

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