250 mg, 500 mg, and 750 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, or nurse.
  • 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 includes any possible side effects not listed in this leaflet (see section 4).

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

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

Ciprofloxacin Accord 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.

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

Adults

Ciprofloxacin Accord 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
  • genital infections in women
  • infection in the gastrointestinal tract and infection in the abdomen
  • the infection you in the skin and soft tissues
  • skeletal and joint infections
  • to prevent infection caused by Neisseria meningitidis
  • if you are exposed 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 that is thought to be caused by 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 Accord.

Children and young people

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

  • lung and tracheal infections in children and adolescents suffering from cystic fibrosis
  • complicated urinary tract infections, including infection that has reached the kidneys ( pyelonephritis )
  • if you are exposed to anthrax bacteria via the respiratory tract

Ciprofloxacin Accord can also be used to treat serious infections in children and adolescents when the doctor deems it necessary.

2. What you need to know before using Ciprofloxacin Accord

Do not take Ciprofloxacin Accord if you:

  • is allergic to the active substance, other quinolone medicines or any of the other ingredients of this medicine (listed in section 6)
  • taking tizanidine (see section 2: Other medicines and Ciprofloxacin Accord)

Warnings and cautions

Before taking Ciprofloxacin Accord

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

Tell your doctor if you:

  • have ever had kidney problems because your treatment may need to be adjusted
  • have epilepsy or another neurological disease
  • have experienced tendon problems during previous treatment with an antibiotic similar to Ciprofloxacin Accord
  • if you have diabetes, as ciprofloxacin may cause a risk of hypoglycemia
  • have myasthenia gravis (a type of muscle weakness), as the symptoms may worsen
  • previously had an abnormal heart rhythm ( arrhythmia )
  • if you or someone in your family has a known one has glucose -6-phosphate dehydrogenase deficiency (G6PD), as there is a risk of you getting anemia from ciprofloxacin
  • have 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 Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis).

Caution should be exercised when using this type of medicine if you are born with or if someone in your family has QT interval prolongation , (this can be seen on the 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 previously had a heart attack (heart attack), you are a woman or elderly with heart problems, or are taking other medicines that result in abnormal ECG changes (see section: Other medicines and CiprofloxacinAccord). If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.

In the treatment of certain genital infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If symptoms do not improve within 3 days, consult your doctor.

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

During treatment with Ciprofloxacin Accord

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

  • Severe, sudden allergic reaction (anaphylactic reaction / shock, angioedema ). Even after the first dose, there is a small risk that you will experience a severe allergic reaction with the following symptoms: tightness in the chest, dizziness, nausea, feeling dizzy, or feeling dizzy when you stand up. If this happens, stop taking Ciprofloxacin Accord and contact your doctor immediately.
  • If your vision deteriorates or your eyes are affected in any other way , contact an ophthalmologist 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 Accord. At the first sign of pain or inflammation in a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking CiprofloxacinAccord, consult a doctor, and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you have 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 Accord and contact your doctor immediately.
  • You may experience psychiatric reactions the first time you take CiprofloxacinAccord. If you suffer from depression or psychosis, your, your symptoms may become worse under treatment with Ciprofloxacin Accord. In rare cases, depression or psychosis can turn into suicidal thoughts, suicide attempts, or suicide. If this happens, stop taking Ciprofloxacin Accord 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 Accord and contact your doctor immediately to prevent the development of any lasting condition.
  • Hypoglycemia has been reported mainly in diabetic patients, especially in the elderly. If this happens to you, contact a doctor immediately.
  • Diarrhea can occur while you are taking antibiotics, including CiprofloxacinAccord, or even several weeks after you stop taking them. If it becomes severe or persistent or if you notice blood or mucus in your stool, stop taking CiprofloxacinAccord immediately as it may be life-threatening. Do not take medicines that stop or reduce bowel movements and consult a doctor.
  • Tell your doctor or laboratory staff that you are taking Ciprofloxacin Accord 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 Accord may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching, or tightness in the stomach, stop taking Ciprofloxacin Accord and contact a doctor immediately.
  • Ciprofloxacin Accord 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 symptoms of infection such as soreness in the throat/throat/mouth or problems with the urine, you should contact a 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.
  • Tell your doctor if you or any of your family members have glucose -6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing ciprofloxacin anemia.
  • Your skin becomes more sensitive to sunlight or ultraviolet light (UV) when you take Ciprofloxacin Accord. Avoid exposing yourself to strong sunlight and artificial UV light such as tanning beds.

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

Antibacterial fluoroquinolone/quinolone drugs, including Ciprofloxacin Accord, 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 experience any of these side effects after taking Ciprofloxacin Accord, talk to your doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic .

Other medicines and Ciprofloxacin Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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

It is known that the following medicines interact with Ciprofloxacin Accord in your body. Taking Ciprofloxacin Accord with these medicines may affect the way these medicines work. It can also increase the risk of side effects.

Tell your doctor if you are taking

  • Vitamin K antagonist (eg warfarin or other anticoagulants (thins the blood))
  • probenecid (for gout )
  • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis )
  • theophylline (for respiratory problems)
  • tizanidine (for muscle cramps in multiple sclerosis )
  • olanzapine (an antipsychotic)
  • clozapine (a medicine for mental illness)
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • cyclosporine (for skin diseases, rheumatism, and organ rejection)
  • omeprazole (metoclopramide (antiemetic and antiemetic)
  • glibenclamide (medicine for diabetes )
  • other drugs that may alter the heart rhythm: drugs belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, and ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the macrolide group, and certain antipsychotics).

Ciprofloxacin Accord may increase the levels of the following agents in your blood:

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, diabetic nerve disease, or incontinence )
  • lidocaine (for heart disease or as an anesthetic)
  • sildenafil (for erection problems)
  • agomelatine
  • zolpidem

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

  • medicines that reduce stomach acid (antacids)
  • mineral supplements
  • medicines for a peptic ulcer (sucralfate)
  • drugs that reduce phosphate levels in the blood (eg sevelamer in kidney problems)
  • medicines or supplements containing calcium, magnesium, aluminum, or iron.

If it is important that you take these medicines, Ciprofloxacin Accord should be taken about 2 hours before you take them or at the earliest 4 hours after.

Ciprofloxacin Accord with food and drink

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

Pregnancy and breastfeeding

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

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

Driving and using machines

Ciprofloxacin Accord may make you feel less alert. Some neurological side effects may occur. 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 Accord contains lactose monohydrate (a type of sugar)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to use Ciprofloxacin Accord

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

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

The treatment usually lasts for 5 to 21 days, but may take longer for serious infections. Always take the tablets according to your doctor’s instructions. If you are not sure how many tablets to take or how to take Ciprofloxacin Accord, ask your doctor or pharmacist.

a. Swallow the tablets together with plenty of liquid. Do not chew the tablets as they do not taste good.

b. Try to take the tablets at the same time each day.

c. You can take the tablets at mealtime or between meals. Taking calcium as part of a meal does not affect your uptake. However, Ciprofloxacin Accord tablets should not be taken with dairy products such as milk or yogurt or with fortified fruit juices (eg calcium-fortified orange juice).

Remember to drink plenty of fluids while taking Ciprofloxacin Accord.

If you forget to use Ciprofloxacin Accord

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. It is very important that you complete the treatment.

If you stop using Ciprofloxacin Accord

It is important that you complete the treatment even if you start to feel better after a few days. If you stop taking the 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.

Contact your doctor immediately if you experience any of the following serious side effects are :

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

  • Severe, sudden allergic reaction with symptoms such as tightness of the chest, dizziness, nausea, fainting or if you feel dizzy when you get up (an anaphylactic reaction / shock, angioedema , see section 2).


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

  • Muscle pain and/or weakness, inflammation of the joints and joint pain, increased muscle tension and cramps, inflammation of tendons or tendon rupture, especially in the large tendon on the back of the heel (heel tendon). See section 2.
  • An infection with symptoms such as fever with severe general deterioration, or fever with local infectious symptoms such as sore throat/pharynx or difficulty urinating ( agranulocytosis, see section 2).
  • Severe skin damage (skin detachment of the epidermis and superficial mucous membranes) ( toxic epidermal necrolysis ).
  • An extremely severe allergic reaction with skin rash usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes such as genitals ( Stevens-Johnson syndrome ).

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

  • Abnormal feelings of pain, burning sensation, tingling, numbness, or muscle weakness in the arms and legs ( neuropathy, see section 2).
  • A drug reaction that causes rash, fever, inflammation of internal organs, altered blood picture, and systemic disease (DRESS syndrome, AGEP- acute generalized exanthematous pustulosis ).

Other side effects are :

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

  • nausea, diarrhea
  • joint pain in children.

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

  • fungal infections
  • a high concentration of eosinophils, a type of white blood cell
  • 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
  • poor kidney function
  • joint pain in adults
  • 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 )
  • elevated blood sugar  hyperglycaemi )
  • decreased blood sugar ( hypoglycemia ) (see section 2, Precautions)
  • confusion, disorientation, anxiety, strange dreams, depression (may lead to suicidal ideation, a suicide attempt or suicide), or hallucinations
  • ant crawling, unusual sensation, decreased skin sensitivity, tremors, seizures (see section 2: Warnings and precautions), or dizziness
  • vision problems (including 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), urinary tract infection
  • accumulation of fluid in the body (swelling) or pronounced sweating
  • elevated levels of enzyme et amylase.

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

  • decreased number of a special type of red blood cells ( hemolytic anemia ); 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 (a psychotic reaction that may lead to suicidal ideation, suicide attempt, or suicide) (see section 2: Warnings and precautions)
  • migraine, altered coordination ability, unsteady gait, altered sense of smell (olfactory disorder), pressure on the brain ( intracranial pressure )
  • altered color vision
  • inflammation of the walls of blood vessels ( vasculitis )
  • 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.

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

  • abnormally fast heartbeat, life-threatening irregular heartbeat, change in heartbeat (called “prolongation of QT interval”, this can be seen on the ECG, electronic recording of the work of the heart)
  • very elated feeling (mania) or overactivity and feeling of great optimism ( hypomania )
  • pustular rash
  • effect on blood coagulation
  • conditions with decreased fluid secretion resulting in 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 Accord

Keep out of 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.

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 hydrochloride.

Other ingredients are:

Tablet core: croscarmellose sodium, microcrystalline cellulose, povidone, magnesium stearate.

Film coating: hypromellose, lactose monohydrate, macrogol, sodium citrate dihydrate (E331 iii), and the dye titanium oxide (E171) ( see section 2 for Important information on some of the ingredients of Ciprofloxacin Accord ).

What the medicine looks like and contents of the pack

Ciprofloxacin 250 mg film-coated tablets are white to off-white, round, approximately 10 mm in diameter, biconvex, film-coated tablets marked “AM” on one side and unmarked on the other.

Ciprofloxacin 500 mg film-coated tablets are white to off-white, approximately 17.5 mm long and 7.5 mm wide, capsule-shaped, biconvex, tablets with beveled edges marked “CI” on one side and unmarked on the other.

Ciprofloxacin 750 mg film-coated tablets are white to off-white, approximately 19 mm long and 10 mm wide, capsule-shaped, biconvex, tablets with bevelled edges marked “CJ” on one side and unmarked on the other.

Ciprofloxacin Accord is available in PVC / Alu blister packs.

Pack sizes: 6, 10, 12, 14, 16, 20, 28, 30, 50 and 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Limited

Sage House, 319 Pinner Road

North Harrow, Middlesex

HA1 4HF, UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice,

Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Muhammad Nadeem

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