100 mg, 250 mg, 500 mg, 750 mg film-coated tablets
Ciprofloxacin
What Ciprofloxacin Mylan is and what it is used for
Ciprofloxacin Mylan contains the active substance ciprofloxacin which is an antibiotic within the group fluoroquinolones . Ciprofloxacin works by killing bacteria that cause infections. It only acts on specific strains of bacteria.
Adults
Ciprofloxacin Mylan 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 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 an infection caused by more than one type of bacterium , you may be prescribed additional antibiotic treatment in addition to ciprofloxacin .
Children and young people
Ciprofloxacin Mylan 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 you have reached the kidneys ( acute pyelonephritis )
- exposure to anthrax bacteria via the respiratory tract
Ciprofloxacin can also be used to treat other particularly serious infections in children and adolescents when your doctor deems it necessary.
Ciprofloxacin contained in Ciprofloxacin Mylan may also be authorized 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.
What you need to know before you take Ciprofloxacin Mylan
Do not take Ciprofloxacin Mylan
- if you are allergic to ciprofloxacin or other quinolone medicines (such as moxifloxacin, norfloxacin, ofloxacin or nalidixic acid) 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 Mylan”)
Warnings and cautions
Before taking this medicine
You should not take antibacterial fluoroquinolone / quinolone medicines, including Ciprofloxacin Mylan, 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.
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.
Talk to your doctor or pharmacist before using Ciprofloxacin Mylan if you:
- have ever had kidney problems because your treatment may need to be adjusted
- suffers from epilepsy (seizures) or other neurological disease
- have experienced tendon problems during previous treatment with quinolone antibiotics similar to ciprofloxacin
- have diabetes
- have myasthenia gravis (a type of muscle weakness), as the symptoms may worsen
- or a family member has a glucose -6-phosphate dehydrogenase deficiency (G6PD), as there is a risk of you getting anemia from ciprofloxacin .
- have heart problems. Caution should be exercised when using ciprofloxacin if you are born with or if someone in your family has prolonged QT intervals, (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 potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia ), have a weak heart ( heart failure ), have had a heart attack (heart attack), you are a woman or elderly or are taking other medicines that result in abnormal ECG changes (see section 2 “Other medicines and Ciprofloxacin Mylan”).
- has been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel)
- have had an aortic dissection (a rupture in the aortic wall)
- has someone in your family who 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 experience a sudden severe pain in the abdomen, 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 symptoms do not improve within 3 days, consult your doctor.
When you take this medicine
Tell your doctor immediately if any of the following occur during treatment with Ciprofloxacin Mylan. Your doctor will decide if you need to stop taking CiprofloxacinMylan.
- Long-term, debilitating and potentially lasting serious side effect is antibacterial fluoroquinolones – / quinolone drugs, including Ciprofloxacin Mylan has been associated with rare but serious side effect is, some of these have been long-term (up to months or years), debilitating or possibly permanent. This includes pain in tendons, muscles and joints in arms and legs, difficulty walking, abnormal sensations such as, ant crawls, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disorders in the form of impaired vision, taste and smell and hearing , depression, impaired memory, extreme fatigue and severe sleep disorders.
If you get any of these side effects after taking Ciprofloxacin Mylan , 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. - 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 Mylan and contact your doctor immediately.
- Pain and swelling in the joints and inflammation or rupture of tendons can occur in rare cases. The risk increases if you are older (over 60 years), have undergone an organ transplant, have kidney problems or if you are being treated with corticosteroids . Inflammation and tendon rupture can occur within the first 48 hours of treatment but also up to several months after stopping treatment with Ciprofloxacin Mylan. At the first sign of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop taking CiprofloxacinMylan, consult a doctorand rest the painful area. Avoid unnecessary movements, as it may increase the risk of 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 Mylan and contact your doctor immediately.
- You may experience psychiatric reactions the first time you take CiprofloxacinMylan. If you suffer from depression or psychosis, your , your symptoms may become worse under treatment with Ciprofloxacin Mylan. In rare cases, depression or psychosis can lead to suicidal ideation, a suicide attempt, or completed suicide. If this happens, stop taking Ciprofloxacin Mylan and contact your doctor immediately.
- In rare cases, you may experience symptoms of nerve damage ( neuropathy )such as pain, burning sensation, tingling, numbness and / or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking CiprofloxacinMylan and contact your doctor immediately to prevent the development of a possible permanent condition.
- Diarrhea can occur while you are taking antibiotics , including CiprofloxacinMylan, 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 Mylan 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.
- Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin Mylan. Avoid exposure to strong sunlight and artificial UV light such as tanning beds.
- Tell your doctor or laboratory staff that you are taking Ciprofloxacin Mylan if you are going to have a blood or urine sample.
- If you have kidney problems , tell your doctor. Your dose may need to be adjusted.
- Ciprofloxacin Mylan may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin and whites of the eyes), dark urine, itching or tension in the stomach, you should stop taking Ciprofloxacin Mylan and contact your doctor immediately.
- Ciprofloxacin Mylan 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.
Other medicines and Ciprofloxacin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
- Do not take Ciprofloxacin Mylan with tizanidine (for muscle spasm in multiple sclerosis or spinal cord injury or disease) as it may cause side effects such as low blood pressure and fatigue (see section 2 “What you need to know before taking Ciprofloxacin Mylan”).
You must tell your doctor if you are taking other medicines that may alter your heart rhythm, medicines that belong to the antiarrhythmic group (eg quinidine , hydroquinone, disopyramide , amiodarone , sotalol, dofetilide, ibutilide), tricyclic antidepressants , certain bactericides ( belonging to the group macrolides er), certain antipsychotics.
It is known that the following medicines interact with Ciprofloxacin Mylan in your body. Taking Ciprofloxacin Mylan with these medicines may affect the therapeutic effect of these medicines. It can also increase the risk of you getting side effects .
Tell your doctor if you are taking:
- Vitamin K antagonist (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)
- olanzapine (an antipsychotic )
- clozapine (an antipsychotic )
- ropinirole (for Parkinson’s disease )
- phenytoin (for epilepsy )
- metoclopramide (for nausea and vomiting)
- cyclosporine (for skin diseases, rheumatism and organ transplantation)
Ciprofloxacin Mylan may increase the levels of the following substances in your blood and your doctor may need to adjust your dose . Tell your doctor if you are taking or want to take:
- pentoxifylline (for circulatory disorders)
- caffeine
- duloxetine (for depression, anxiety, pain, (diabetic nerve disease) or incontinence )
- lidocaine given as an injection (for heart problems or as a local anesthetic commonly used in surgery )
- sildenafil (for impotence )
- agomelatine
- zolpidem
Some medicines may reduce the effect of Ciprofloxacin Mylan. Tell your doctor if you are taking or want to take:
- antacids (for indigestion)
- omeprazole (for acid reflux, heartburn, stomach or intestinal ulcers)
- mineral supplements
- sucralfate (for stomach ulcers )
- medicines used to bind phosphate or reduce phosphate levels in the blood (eg sevelamer or lanthanum carbonate)
- medicines or supplements containing calcium , magnesium , aluminum or iron
- didanosine (used to treat HIV )
If you need to take these medicines, take Ciprofloxacin Mylan about 2 hours before or at the earliest 4 hours after them.
Ciprofloxacin Mylan with food and drink
Ciprofloxacin Mylan is best taken on an empty stomach, but it can be taken with or without food. Unless you are taking Ciprofloxacin Mylan during a meal, do not eat or drink any dairy product (such as milk or yoghurt) or calcium supplements when taking the tablets as it may affect the uptake of the medicine.
Pregnancy and breastfeeding
Pregnancy
It is best to avoid taking Ciprofloxacin Mylan during pregnancy. 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.
Breast-feeding
Do not take Ciprofloxacin Mylan while breast-feeding as ciprofloxacin passes into breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Mylan may make you feel dizzy, less alert and may affect your reaction time. Do not drive or use machines until you know how you react to CiprofloxacinMylan. If you are not sure, talk to your doctor or pharmacist.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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.
3. How to use Ciprofloxacin Mylan
Your doctor will explain to you exactly how much Ciprofloxacin Mylan 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 have 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 Ciprofloxacin Mylan.
Method of administration
- To be swallowed: Swallow the tablets together with plenty of liquid. Do not chew the tablets as they do not taste good.
- Ciprofloxacin Mylan 250 mg, 500 mg and 750 mg tablets have a score. The notch is only there to help you break the tablet if you have difficulty swallowing the entire tablet.
- Try to take the tablets at the same time each day.
- You can take the tablets at mealtime or between meals. Taking calcium as part of a meal does not affect your uptake.
- However , Ciprofloxacin Mylan 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 Mylan.
If you take more Ciprofloxacin Mylan than you should
If you take more tablets than you should, seek medical help immediately . Bring the remaining tablets and the package and show the doctor.
If you forget to take Ciprofloxacin Mylan
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 Mylan
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 antibiotics .
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 Mylan and contact your doctor immediately if you experience any of the following serious side effects:
Rare (may affect up to 1 in 1,000 people):
- severe, sudden allergic reaction , (see section 2 “During treatment with Ciprofloxacin Mylan”) with symptoms such as:- skin rash, itching , hives , pressure over the chest, dizziness, nausea, fainting or if you feel dizzy when you get up (an anaphylactic reaction / shock)- sudden swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing ( angioedema )
- muscle pain and / or muscle weakness, inflammation of the joints and joint pain, increased muscle tension and cramping, inflammation of the tendons or tendon rupture, especially in the large tendon at the back of the heel (heel tendon) (see section 2 “During treatment with Ciprofloxacin Mylan”)
- increased number of infections , which cause fever, severe chills, sore throat or cold sores (due to a decrease in the number of white blood cells in the blood) (see section 2 “During treatment with Ciprofloxacin Mylan”)
- depression, or very rarely, psychotic reactions (which may lead to suicidal ideation, suicide attempt or completed suicide) (see section 2 “During treatment with Ciprofloxacin Mylan”)
Very rare (may affect up to 1 in 10,000 people):
- severe skin reactions, such aswidespread rash with blisters around the mouth, nose, eyes, genitals or body- filled with blisters and rashes- skin rash, which can lead to blisters, and which has central dark spots surrounded by a lighter area with a dark ring around the edge- widespread rash with flaky skin
Has been reported (occurs in an unknown number of users):
- abnormal pain, burning sensation, tingling, numbness or muscle weakness in the arms and legs ( neuropathy ) (see section 2 “During treatment with CiprofloxacinMylan”)
- abnormal heart rhythm (seen on ECG ) (see section 2 “Warnings and precautions”)
- an allergic reaction with symptoms such as skin rash, fever, swollen lymph nodes abnormal blood test results (drug reaction with eosinophilia and systemic symptoms (DRESS)).
- Loss of consciousness due to a severe decrease in blood sugar (hypoglycaemic coma ). See section 2.
Other possible side effects:
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
- increased white blood cell count ( eosinophilia , leukocytosis )
- decreased appetite
- hyperactivity or restlessness
- headache, dizziness, sleep problems, 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, (eg back pain, chest pain, pain in arms and legs, feeling of weakness ( asthenia ), fever
- increase of a certain substance in the blood (alkaline phosphatases)
Rare (may affect up to 1 in 1,000 people):
- severe or persistent diarrhea that may contain blood or mucus ( colitis ) (see section 2 “During treatment with Ciprofloxacin Mylan”)
- decreased number of red blood cells that cause weakness or shortness of breath and can make the skin pale ( anemia )
- unexpected bruising or bleeding that lasts longer than normal ( thrombocytopenia)
- increased platelet count ( thrombocythemia )
- elevated blood sugar ( hyperglycaemia )
- low blood sugar ( hypoglycaemia – see section 2, “Warnings and precautions” and “During treatment with Ciprofloxacin Mylan”)
- confusion, disorientation, anxiety, strange or abnormal dreams or hallucinations (seeing, feeling or hearing things that do not exist)
- seizures or seizures (including prolonged or repeated seizures with no recovery in between) (see section 2 “During treatment with Ciprofloxacin Mylan”)
- tingling or numbness in the hands or feet, ant crawling ( paresthesia ) unusual sensation (dysesthesia), decreased sensation, feeling or tenderness of the skin ( hypesthesia ), tremors
- dizziness, giddiness ( vertigo )
- vision problems such as difficulty seeing differences in color, blurred vision or double vision (see section 2 “During treatment with Ciprofloxacin Mylan”)
- buzzing, hissing, whistling, ringing or other persistent sound in the ears ( tinnitus ), hearing loss, hearing loss
- rapid heartbeat ( tachycardia )
- dilation of blood vessels ( vasodilation ), low blood pressure or fainting,
- shortness of breath including asthmatic symptoms
- liver disease, including inflammation of the liver, with symptoms such as loss of appetite, yellowing of the skin and whites of the eyes, dark urine, itching or tenderness in the stomach. Very rare, hepatic cell death (liver necrosis) which may lead to liver failure (see section 2 “During treatment with Ciprofloxacin Mylan”)
- photosensitivity (see section 2 “During treatment with Ciprofloxacin Mylan”)
- renal failure (symptoms such as nausea, loss of appetite, weakness, little or no urine), blood or crystals in the urine (see section 2 “During treatment with Ciprofloxacin Mylan”), inflammation of the urinary tract.
- fluid retention or excessive sweating
- increased levels of enzyme and amylase
Very rare (may affect up to 1 in 10,000 people):
- other allergic reactions with symptoms such as fever, swelling, rash and enlargement of lymph nodes (serum sickness)
- damaged red blood cells which causes weakness and shortness of breath with yellowing skin and whites of the eyes
- inflammation of the pancreas ( pancreatitis ) which causes severe upper abdominal pain, often with nausea and vomiting.
- migraine , changes in coordination, unsteady gait, changes in sense of smell (olfactory disorder), increased pressure on the brain ( intracranial pressure or pseudotumor cerebri )
- inflammation of the walls of blood vessels ( vasculitis )
- small punctate hemorrhages under the skin ( petechiae )
- reddish-purple swelling on the shins, thighs and less commonly on the arms. Joint, muscle pain and fever may also occur (erythema nodosum)
- worsening of myasthenia gravis symptoms (see section 2 “Warnings and precautions”)
Has been reported (occurs in an unknown number of users):
- very excited feeling (mania) or a feeling of great optimism and overactivity ( hypomania )
- prolonged blood clotting time in patients taking vitamin K antagonists (used to prevent blood clots, such as warfarin
- altered heart rhythm (called “prolonged QT interval” and seen on ECG ) (see section 2 “Warnings and precautions”).
- conditions of decreased water excretion and low sodium levels (SIADH).
In very rare cases of long-term (up to several months or years) or permanent side effects , such as tendonitis, 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, taste and smell have been linked to treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-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 Mylan
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 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. Each tablet contains 100 mg, 250 mg, 500 mg or 750 mg ciprofloxacin (as ciprofloxacin hydrochloride).
The other ingredients in the tablets are cellulose, microcrystalline, corn starch, crospovidone, starch , pregelatinized, silica, colloidal , anhydrous, magnesium stearate. The film coating contains hypromellose, titanium dioxide (E171), polydextrose, glycerol triacetin and macrogol.
What the medicine looks like and contents of the pack
Ciprofloxacin Mylan 100 mg are white, round film-coated tablets, marked with “CF” on one side and “G” on the other.
Ciprofloxacin Mylan 250 mg are white, round, film-coated, scored tablets marked with “CF 250” on one side and “G” on the other side.
Ciprofloxacin Mylan 500 mg tablets are capsule-shaped, scored tablets, marked with “CF 500” on one side and “G” on the other side.
Ciprofloxacin Mylan 750 mg are capsule-shaped, scored tablets and marked with “CF 750” on one side and “G” on the other.
Ciprofloxacin Mylan 100 mg tablets are available in blister packs of 6, 10, 12, 14, 16, 20, 100 and 120 tablets.
Ciprofloxacin Mylan 250 mg, 500 mg and 750 mg tablets are available in blister packs of 1, 6, 8, 10, 12, 14, 16, 20, 100 and 120 tablets.
Ciprofloxacin Mylan tablets are available in cans of 6, 10, 12, 14, 16, 20, 100 and 120 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Mylan AB
Box 23033
104 35 Stockholm
Tel: 08-555 227 50
Fax: 08-555 227 51
Email: inform@mylan.se
Manufacturer:
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
McDermott Laboratories Ltd t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road,
Dublin 13, Ireland
Mylan Hungary Kft., H-2900 Komárom, Mylan utca 1, Hungary
This medicinal product is authorized under the European Economic Area under the names :
Austria: Ciprofloxacin “Arcana”
Belgium, Luxembourg, Netherlands: Ciprofloxacin Mylan
Greece: Ciprofloxacin / Mylan
Italy: Ciprofloxacina Mylan Generics
Portugal: Ciprofloxacina Mylan