Ciprofloxacin Orion 250 mg film-coated tablets, Ciprofloxacin Orion 500 mg film-coated tablets, Ciprofloxacin Orion 750 mg film-coated tablets

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.

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

What Ciprofloxacin Orion is and what it is used for

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

Adults

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

  • respiratory infections
  • prolonged or recurrent ear or sinus infections
  • urinary tract infections
  • infection is in the testicles
  • infection is in the abdomen of women
  • infection in the gastrointestinal tract and infection in the abdomen
  • skin and soft tissue infections
  • infection you in the skeleton and joints
  • to treat infection in patients with low white blood cell count ( neutropenia )
  • to prevent infection in patients with low white blood cell count ( neutropenia )
  • to prevent infection caused by the bacterium Neisseria meningitidis
  • exposure to anthrax bacteria via the respiratory tract (suspected or confirmed exposure).

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 Orion.

Children and young people

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

  • infection in the lungs and bronchus 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 Orion can also be used to treat other especially serious infections in children and adolescents when your doctor deems it necessary.

Ciprofloxacin contained in Ciprofloxacin Orion 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 Orion

Do not use Ciprofloxacin Orion

  • 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 Orion).

Warnings and cautions

Talk to your doctor or pharmacist before taking Ciprofloxacin Orion:

  • You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin Orion, if you have previously had any serious side effectsfrom taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.
  • if you have ever had kidney problems because your treatment may need to be adjusted
  • if you suffer from epilepsy or other neurological disease
  • if you have experienced tendon problems during previous treatment with an antibiotic similar to Ciprofloxacin Orion
  • if you are diabetic
  • if you have myasthenia gravis (a type of muscle weakness)
  • if you have a history of abnormal heart rhythm ( arrhythmia or QT prolongation ) or heart problems
  • 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 Takayasus arteritis, giant cell arteritis, Behçet’s disease , high blood pressure , or known atherosclerosis)
  • if you or a family member are deficient in glucose -6-phosphate dehydrogenase (G6PD).

Caution should be exercised when using Ciprofloxacin Orion, if you were born with or if someone in your family has QT prolongation (seen on ECG , electrical activity in the heart), has an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), has a very slow heart rhythm (so-called bradycardia ), has a weak heart ( heart failure ), has had a heart attack (heart attack), if you are a woman or elderly, or if you are taking other medicines that cause abnormal ECG -changes (see section 2: Other medicines and Ciprofloxacin Orion).

During treatment with Ciprofloxacin Orion

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

  • If you feel a sudden, severe pain in your stomach, chest or back , you should immediately go to an emergency room.
  • Severe, sudden allergic reaction (anaphylactic reaction / shock, angioedema ). Even with the first dose , there is a small risk that you will have a severe allergic reaction with the following symptoms: chest tightness, dizziness, malaise or fainting or dizziness when you get up. If this happens, stop taking Ciprofloxacin Orion 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 stopping treatment with Ciprofloxacin Orion. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder or knee), stop taking CiprofloxacinOrion, 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 other 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 Orion and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take CiprofloxacinOrion. In rare cases, depression or psychosis can lead to suicidal ideation, suicide attempt or completed suicide. If this happens, stop taking CiprofloxacinOrion 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 Orion and contact your doctor immediately to prevent the development of a possible permanent condition.
  • Long-term, debilitating and potentially persistent serious side effects: 
     Antibacterial fluoroquinolone / quinolone medicines, including CiprofloxacinOrion, 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 Orion, talk to your doctor immediately before starting any treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .
  • You may experience symptoms of low blood sugar ( hypoglycaemia ): rapid heartbeat ( tachycardia ), sweating, hunger, shaking hands, irritability. If this happens, contact your doctor immediately. Low blood sugar has been reported mainly for diabetic patients, especially among the elderly population.
  • Diarrhea can occur while you are taking antibiotics or even several weeks after you stop taking them. If this becomes serious or persistent, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin Orion immediately as this can be life threatening. Do not take medicines that stop or reduce bowel movements.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Orion if you are going to have a blood or urine sample.
  • Tell your doctor if you suffer from kidney problems as the dose of CiprofloxacinOrion may need to be adjusted.
  • Ciprofloxacin Orion may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching or tenderness in the stomach, stop taking Ciprofloxacin Orion and contact your doctor immediately.
  • If your vision becomes worse  or if  your eyes are affected  in any other way , contact an ophthalmologist immediately.
  • Ciprofloxacin Orion may cause a decrease in the number of white blood cells and your resistance to infection may be reduced. If you get an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local infection symptoms 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 drug treatment.
  • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when you take Ciprofloxacin Orion. Avoid exposure to strong sunlight or artificial UV light such as tanning beds.

Other medicines and Ciprofloxacin Orion

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

Tell your doctor if you are taking other medicines that can change your heart rhythm at the same time: medicines belonging to the group of antiarrhythmics (eg quinidine , hydroquinidine, disopyramide , amiodarone , sotalol, dofetilide, ibutilide), tricyclic antidepressants , certain bactericides (such as belongs to the group macrolides er), certain antipsychotics.

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

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

Tell your doctor if you are taking:

  • oral anticoagulants ( oral blood thinners such as warfarin , acenocoumarin, fenprocoumon or fluindione)
  • probenecid (for gout )
  • methotrexate (for certain types of cancer, psoriasis , rheumatoid arthritis )
  • theophylline (in case of breathing problems)
  • clozapine or olanzapine (for psychosis )
  • ropinirole (in Parkinson’s disease )
  • phenytoin (for epilepsy )
  • medicines that prolong the QT interval (certain antiarrhythmic and antidepressants, macrolides and antipsychotics)
  • cyclosporine (prevention of rejection after organ transplants, in severe skin conditions (atopic eczema ) and psoriasis )
  • metoclopramide (for nausea)
  • glibenclamide (in diabetes ).

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

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (in case of depression)
  • lidocaine (local anesthetic)
  • sildenafil (for erection problems)
  • agomelatin
  • zolpidem.

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

  • antacids (in case of too much acid in the stomach)
  • omeprazole (in case of too much acid in the stomach and heartburn)
  • 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 Orion about two hours before or no earlier than four hours after them.

Ciprofloxacin Orion with food, drink and alcohol

Be careful not to take Ciprofloxacin Orion with dairy products (such as milk or yoghurt) or drinks with calcium supplements as it may affect the absorption of ciprofloxacin .

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.

You should preferably avoid taking Ciprofloxacin Orion during pregnancy. Tell your doctor if you are planning to become pregnant.

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

Driving and using machines

Ciprofloxacin Orion 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 CiprofloxacinOrion. 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.

Ciprofloxacin Orion contains ciprofloxacin

3. How to use Ciprofloxacin Orion

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 Orion 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 can last for a longer time in case of serious infection . 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 and how to take Ciprofloxacin Orion.

  1. Swallow the tablets together with plenty of liquid. Do not chew the tablets as they taste bad.
  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 Orion 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 Orion.

If possible, take your tablets or pack and see your doctor.

If you forget to use Ciprofloxacin Orion

Take the usual dose as soon as possible and then continue as prescribed. However, if it is soon time for your next dose , do not take the missed dose but 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 Orion

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.

Stop taking Ciprofloxacin Orion and contact your doctor immediately if you experience any of the following serious side effects , which may be rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people) or occurring in an unknown number of persons (has been reported):

  • severe allergic reactions (allergic edema , angioedema , serum sickness, severe hypersensitivity reaction called DRESS, anaphylactic reaction or anaphylactic shock , which may be life threatening). Symptoms include rash, sudden swelling of the skin and mucous membranes, difficulty breathing, wheezing, swelling of the lips, tongue and throat or of the body, fainting, difficulty swallowing, fever, enlargement of the lymph nodes .
  • widespread rash with blisters and flaky skin (may be symptoms of potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis ).
  • severe skin rash in the form of blisters ( acute generalized exanthematous pustulosis ).
  • severe and persistent diarrhea may be symptoms of inflammation of the intestine ( colitis ) associated with antibiotic use (may be life-threatening in very rare cases).
  • inflammation of the pancreas ( pancreatitis ) which causes severe pain in the upper abdomen, often accompanied by nausea and vomiting.
  • yellow skin and eyes, itchy dark urine and pale stools, abdominal pain and chronicfatigue can be symptoms of severe liver damage.
  • seizures, seizures or convulsions (including prolonged or repeated seizures without recovery in between)
  • pain, burning sensation, tingling, numbness and / or muscle weakness in the arms and legs can be symptoms of neuropathy
  • mental disorders (depression or psychotic reactions which can lead to suicidal thoughts or suicide attempts).
  • tendonitis, tendon rupture (especially the heel tendon on the back of the heel).
  • abnormally fast heartbeat, life-threatening irregular heartbeat, change in heartbeat
  • severe deterioration of your general condition with high and persistent fever (may be symptoms of a serious blood disease, bone marrow depression or aggravation of infection ).

See also section 2: Warnings and Precautions.

Other side effects:

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

Less common side effects are (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 ( agitation )
  • headache, dizziness, sleep problems or taste changes
  • vomiting, abdominal pain, digestive problems such as upset stomach (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,
  • weakness ( asthenia ) or fever
  • increase in alkaline phosphatases in the blood (a special substance in the blood).

Rare side effects are (may affect up to 1 in 1000 people):

  • changes in blood value ( leukopenia , leukocytosis , neutropenia , anemia ), increased or decreased amount of blood coagulation factor ( platelets )
  • elevated blood sugar ( hyperglycaemia )
  • decreased blood sugar ( hypoglycaemia )
  • confusion, disorientation, anxiety, strange dreams, depression or hallucinations
  • ant crawling, unusual sensation, decreased sensitivity of the skin, tremors or dizziness
  • vision problems including double vision
  • tinnitus, hearing loss, hearing loss
  • rapid heartbeat, ( tachycardia )
  • dilated blood vessels ( vasodilation ), low blood pressure or fainting
  • shortness of breath including asthmatic symptoms
  • hepatic impairment, jaundice (cholestatic jaundice) or hepatitis
  • photosensitivity
  • muscle pain, inflammation in the joints, increased muscle tension or cramping
  • kidney failure , blood or crystals in the urine, kidney inflammation
  • fluid retention or pronounced sweating
  • elevated levels of enzyme et amylase

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

  • decreased number of a special type of red blood cell ( hemolytic anemia )
  • migraine , altered coordination, unsteady gait (gait disturbance), 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 )
  • small punctate hemorrhages under the skin ( petechiae )
  • muscle weakness, worsening of the symptoms of myasthenia gravis

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

  • ventricular arrhythmia and torsades de pointes tachycardia (heart rhythm changes, has mainly been reported in patients at high risk of prolonged QT interval )
  • increase in INR (International Normalized Ratio) value that measures the blood’s ability to coagulate (in patients treated with vitamin K antagonists )
  • very elated feeling (mania) or overactivity and feeling of great optimism ( hypomania )
  • conditions 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 ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effectsdirectly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

75103 Uppsala

www.lakemedelsverket.se

5. How to store Ciprofloxacin Orion

This medicine does not require any special storage instructions.

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 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. One tablet contains 250 mg, 500 mg or 750 mg ciprofloxacin as ciprofloxacin hydrochloride.
  • The other ingredients in the tablet core are microcrystalline cellulose, sodium starch glycolate (type A), povidone, silica ( colloidal , anhydrous) and magnesium stearate.
  • The other ingredients in the film coating are hypromellose, macrogol and titanium dioxide (E171).

What the medicine looks like and contents of the pack

250 mg film-coated tablet: White to off-white, round, film-coated tablets with a notch on both sides. One side embossed with “F” and “23” on each side of the notch. The tablet can be divided into two equal doses .

500 mg film-coated tablet: White to off-white, capsule-shaped, film-coated tablets with a notch on one side and debossed with “F22” on the other side. The tablet can be divided into two equal doses .

750 mg film-coated tablet: White to off-white, capsule-shaped, film-coated tablets debossed with “C” on one side and “93” on the other side.

Ciprofloxacin Orion is available in PVC / PVdC / aluminum foil blister packs.

Pack sizes:

250 mg tablets: 10 and 20 tablets

500 mg tablets: 10, 20 and 50 tablets

750 mg tablets: 10, 20, 30, 50 and 100 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

02200 Espoo

Finland

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:

medinfo@orionpharma.com 

Muhammad Nadeem

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