Cenox Tablet Composition, Use, Dose, Side Effect

Cenox is a tablet containing ciprofloxacin. It is manufactured in India by Medibios laboratories ltd but marketed in Nigeria by Elbe pharma Nigeria ltd.

Cenox

Composition Of Cenox Tablet

The active substance is 500mg of ciprofloxacin. Each film-coated tablet contains Ciprofloxacin Hydrochloride equivalent to Ciprofloxacin 500 mg.

Excipients: Microcrystalline cellulose, Colloidal Silicon Dioxide, Starch, sodium Starch Glycolate, Croscarmellose sodium, Purified Talc, Magnesium stearate, Hymoxypropyl methylcellulose, Propylene glycol, Ethyl cellulose and Titanium dioxide.

What Cenox tablets Is And What It Is Used For

Cenox tablets contain the active substance ciprofloxacin hydrochloride. Ciprofloxacin hydrochloride is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin hydrochloride works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

Cenox tablets are used in adults to treat the following bacterial infections:

• Respiratory tract infections

• Long lasting or recurring ear or sinus infections

• Urinary tract infections

• Genital tract infections in men and women

• Gastro-intestinal tract infections and intra-abdominal infections

• Skin and soft tissue infections

• Bone and joint Infections

• To prevent infections due to the bacterium Neisseria meningitidis

• Anthrax inhalation exposure

Ciprofloxacin hydrochloride may be used in patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection.

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Cenox.

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Children And Adolescents

Cenox tablets are used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:

• Lung and bronchial infections in children and adolescents suffering from cystic fibrosis

• Complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)

• Anthrax inhalation exposure

Cenox may also be used to treat other specific severe infections in children medical doctors consider necessary.

What You Need To Know Before You Take Cenox Tablets

Do not take Cenox tablets:

• if you are allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this medicine

• if you are taking tizanidine

Warnings And Precautions

Before taking this medicine;

You should not take fluoroquinolone/quinolone antibacterial medicines, including Cenox tablets, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone. In this situation, you should inform your medical doctor as soon as possible.

Talk To Your medical doctor Before Taking Cenox

• If you have ever had kidney problems because your treatment may need to be adjusted

• If you suffer from epilepsy or other neurological conditions.

• If you have a history of tendon problems during previous treatment with antibiotics such as Cenox tablets.

• If you are diabetic because you may experience a risk of hypoglycemia with ciprofloxacin hydrochloride.

• If you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated.

• If you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).

• If you have experienced a previous episode of aortic dissection (a tear in the aorta wall).

• If you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfa syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).

• If you have heart problems. Caution should be taken when using ciprofloxacin hydrochloride, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes.

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• If you are a member of your family, you are known to have a deficiency in glucose 6-phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin hydrochloride. For the treatment of some genital tract infections, your medical doctor can prescribe another antibiotic in addition to ciprofloxacin hydrochloride. If there is no improvement in symptoms after 3 days of treatment, consult your medical doctor.

While Taking Cenox Tablets

Tell your medical doctor immediately if any of the following occurs while taking Cenox tablets. Your medical doctor will decide whether treatment with Cenox tablets needs to be stopped:

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Cenox tablets and contact your medical doctor immediately.

• Prolonged, disabling and potentially irreversible serious side effects. Fluoroquinolone/quinolone antibacterial medicines, including Cenox tablets, have been associated with very rare but serious side effects, some of them being long lasting (continuing months or years), disabling or potentially irreversible. This includes tendon, muscle and joint pain of the upper and lower limbs, difficulty in walking, abnormal sensations such as pins and needles, lingling, tickling, numbness or burning (paraesthesia), sensory disorders including impairment of vision, taste and smell, and hearing depression, memory impairment, severe fatigue, and severe sleep disorders. If you experience any of these side effects after taking Cenox tablets, contact your medical doctor immediately prior to continuing treatment. You and your medical doctor will decide on continuing the treatment, considering also an antibiotic from another class.

• Pain and swelling in the joints and inflammation or rupture of tendons may occur rarely. Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids. Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Cenox tablets therapy. At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Cenox tablets, contact your medical doctor and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.

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• If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.

• If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If a seizure happens, stop taking Cenox tablets and contact your medical doctor immediately.

• You may rarely experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness especially in the feet and legs or hands and arms. If this happens, stop taking Cenox and inform your medical doctor immediately in order to prevent the development of potentially irreversible conditions.

• You may experience psychiatric reactions the first time you take Cenox tablets. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Cenox tablets. In rare cases, depression or psychosis can lead to thoughts of suicide, suicide attempts, or completed suicide. If this happens, contact your medical doctor immediately.

• Quinolone antibiotics may cause an increase of your blood sugar levels above normal levels (hyperglycaemia) or lowering of your blood sugar levels below normal levels, potentially leading to loss of consciousness (hypoglycemic coma) in severe cases. This is important for people who have diabetes. If you suffer from diabetes, your blood sugar should be carefully monitored.

• Diarrhea may develop while you are taking antibiotics, including Cenox tablets, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Cenox tablets and contact your medical doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.

• If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Cenox tablets. Avoid exposure to strong sunlight, or artificial UV light such as sunbeds.

• Tell the medical doctor or laboratory staff that you are taking Cenox tablets if you have to provide a blood or urine sample.

• If you suffer from kidney problems, tell the medical doctor because your dose may need to be adjusted.

• Cenox tablets may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, contact your medical doctor immediately.

• Cenox tablets may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat, pharynx/mouth or urinary problems you should see your medical doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your medical doctor about your medicine.

Taking Other Medicines And Cenox Tablets

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

Do not take Cenox tablets together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness.

The following medicines are known to interact with Cenox tablets in your body. Taking Cenox tablets together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

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Tell your medical doctor if you are taking:

• Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood)

• probenecid (for gout) (to thin the blood)

• probenecid (for gout)

• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

• theophylline (for breathing 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)

• cyclosporin (for skin conditions, rheumatoid arthritis and in organ transplantation)

• other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmic (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

• zolpidem (for sleep disorders)

Cenox tablets may increase the levels of the following medicines in your blood:

• pentoxifylline (for circulatory disorders)

• caffeine

• duloxetine (for depression, diabetic nerve damage or incontinence)

• lidocaine (for heart conditions or anesthetic use)

• sildenafil (e.g., for erectile dysfunction) agomelatine (for depression)

Some medicines reduce the effect of Cenox tablets. Tell your medical doctor if you take or wish to take:

• antacids

• omeprazole

• mineral supplements

• sucralfate

• a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)

• medicines or supplements containing calcium, magnesium, aluminum or iron

If these preparations are essential, take Cenox about two hours before or no sooner than four hours after them.

Cenox tablets With Food And Drink

Unless you take a Cenox tablet during meals, do not eat or drink any dairy products such as milk or yogurt) or drinks.

Pregnancy And Breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant or planning to have a baby, ask your medical doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of cenox tablets during pregnancy.

Do not take Cenox tablets during breastfeeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

Driving And Using Machines

Cenox tablets may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to cenox tablets before driving a vehicle or operating machinery. If in doubt, talk to your medical doctor.

How To Take Cenox Tablets

Your medical doctor will explain to you exactly how many cenox tablets you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your medical doctor if you suffer from kidney problems because your dose may need to be adjusted. The treatment usually lasts from 5 to 21 days but may take longer for severe infections. Always take this medicine exactly as your medical doctor has told you. Check with your medical doctor or pharmacist if you are not sure how many tablets to take and how to take Cenox tablets.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.

b. Try to take the tablets at around the same time every day.

c. You can take the tablet at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Canox tablets with dairy products such as milk or yogurt or with fortified fruit.

Remember to drink plenty of fluids while you are taking this medicine.

If You Take More Cenox tablets Than You Should

If you take more than the prescribed dose, get medical help immediately. If possible, take your tablets or the box with you to show the medical doctor.

If Forget To Take Cenox Tablets

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. Be sure to complete your course of treatment.

If You Stop Taking Cenox Tablets

It is important that you finish the course of treatment even if you begin to feel better after a few days. If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse. You might also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your medical doctor or pharmacist.

Possible Side Effects Of Cenox Tablet

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following section contains the most serious side effects that you can recognize yourself: Stop taking Cenox tablets and contact your medical doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects:

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

- Seizure

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

- Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction/shock)

- Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon)

- A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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Not known (frequency cannot be estimated from the available data)

- Unusual feelings of pain, burning tingling, numbness or muscle weakness in the extremities (neuropathy)

- A drug reaction that causes rash, fever, inflammation of internal organs, hematologic abnormalities and systemic illness (DRESS Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP Acute Generalized Exanthematous Pustulosis).

Other side effects which have been observed during treatment with Cenox are listed below by how likely they are:

Common (may affect up to 1 in 10 people)

- nausea, diarrhea joint pain and joint inflammation in children

Uncommon (may affect up to 1 in 100 people)

- joint pain in adults

- fungal superinfections

- a high concentration of eosinophils, a type of white blood cell

- decreased appetite

- hyperactivity or agitation

- headache, dizziness, sleeping problems, or taste disorders

- vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind

- increased amounts of certain substances in the blood (transaminases and/or bilirubin)

- rash, itching, or hives

- poor kidney function

- pains in your muscles and bones, feeling unwell (asthenia), or fever

- increase in blood alkaline phosphatase (a certain substance in the blood)

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

- muscle pain, inflammation of the joints, increased muscle tone and cramping

- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases)

- changes to the blood count (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased amounts of a blood clotting factor (thrombocytes)

- allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema)

- increased blood sugar (hyperglycemia)

- decreased blood sugar (hypoglycemia)

- confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to thoughts of suicide, suicide attempts, or completed suicide), or hallucinations

- pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, or giddiness, eyesight problems including double vision

- tinnitus, loss of hearing, impaired hearing

- rapid heartbeat (tachycardia)

- expansion of blood vessels (vasodilation), low blood pressure, or fainting

- shortness of breath, including asthmatic symptoms

- liver disorders, jaundice (cholesteric icterus), or hepatitis

- sensitivity to light

- Kidney failure, blood or crystals in the urine, urinary tract inflammation

- fluid retention or excessive seating

- increased levels of the enzyme amylase

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

- a special type of reduced red blood cell count (hemolytic anemia a dangerous drop in a type of white blood cells (agranulocytosis), a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, and bone marrow depression, which may also be fatal

- allergic reaction called serum sickness-like reaction

- mental disturbances (psychotic reactions potentially leading to thoughts of suicide, suicide attempts or complete suicide)

- migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders) pressure on the brain (intracranial pressure and pseudotumor cerebri)

- visual color distortion

- inflammation of the wall of the blood vessels (vasculitis)

- pancreatitis

- death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

- small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes

- worsening of the symptoms of myasthenia gravis

Not known (frequency cannot be estimated from the available data)

- syndrome associated with impaired water excretion and low levels of sodium (SIADH)

- feeling highly excited (mania) or feeling great optimism and overactivity (hypomania)

- abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called prolongation of QT interval, seen on ECG, electrical activity of the heart)

- influence on blood clothing (in patients treated with Vitamin K antagonists)

- loss of consciousness due to severe decrease in blood sugar levels (hypoglycemic coma).

Very rare cases of long lasting (up to months of years) or permanent adverse drug reactions, such an tendon inflammations, tendon rupture, joint pain, pain in the limbs, difficulty in walking, abnormal sensations such as pins and needles, tingling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment, as well as impairment of hearing, vision, and taste and smell have been associated with administration of quinolone and fluoroquinolone antibiotics, in some cases irrespective of pre-existing risk factors.