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In this leaflet:
1. What Surnox tablets is and what it is used for
2. Before you take Surnox tablets
3. How to take Surnox tablets
4. Possible side effects
5. Storing Surnox tablets
Surnox tablets
Ofloxacin (I.N.N.)
Each tablet contains 200 mg. ofloxacin as its active ingredient.
The other ingredients are:
Ingredients of the tablet core: Maize starch, Lactose, Hyprolose, Carmellose, Magnesium stearate.
Ingredients of the tablet coating: Hydroxypropyl methylcellulose, Titanium dioxide (E171), Talc, Macrogol 8000.
The manufacturer is:
Aventis Pharma Specialités
1. WHAT SURNOX TABLETS IS AND WHAT IT IS USED FOR
Ofloxacin, the active ingredient of Surnox belongs to a group of medicines called fluoroquinolones, a type of antibacterial agent (antibiotic) with bactericidal activity.
Surnox tablets is used in adults to treat infections due to bacteria against which this medicine is active. The infections which are susceptible to treatment with Surnox are:
- Acute, chronic or relapsing lower respiratory tract infections (bronchitis).
- Pneumonias (in the case of community-acquired pneumococcal pneumonia, Surnox is not the medication of first-choice).
- Chronic and recurrent ear, nose and throat (ENT) infections; however the administration of SURNOX is not recommended for the treatment of acute tonsillitis.
- Skin and soft tissue infections.
- Enteric and biliary tract infections.
- Infections of the genital and urinary tract (including gonorrhoea).
- Gynecological infections.
- Bone and joint infections.
2. BEFORE YOU TAKE SURNOX TABLETS
Do not take SURNOX TABLETS
- If you are hypersensitive (allergic) to ofloxacin or any of the other ingredients of SURNOX tablets.
- If you suffer from epilepsy or any central nervous system disorder which may cause convulsions (such as cerebrocranial injuries, cerebrovascular accident...).
- In patients with a history of tendon disorders related to treatment with an antibiotic of the fluoroquinolone class.
- If you suffer from glucose-6-phosphate deficiency.
- If you are pregnant or think you could be or if you are breastfeeding a baby.
Surnox tablets is only intended for adults and must not be given to children or growing teenagers as there is a risk of damage to the cartilage of their growing bones.
If you have any questions consult your doctor or pharmacist.
Take special care with SURNOX Tablets:
- Tell your doctor immediately if you have severe, persistent and / or bloody diarrhoea during or after treatment with Surnox tablets. This may be a sign of a serious bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics and it may be necessary to stop treatment with Surnox and start specific therapy.
- Surnox tablets should be used with caution if you are predisposed to convulsions (fits) or if in the past you have experienced brain damage, or if you are taking fenbufen and similar non steroidal anti-inflammatory medicines or theophylline (medications that decrease convulsant threshold) because the risk of getting "fits" (convulsions) may be increased.
- As occurs with other quinolones Surnox tablets may in rare cases cause pain and inflammation in tendons (tendinitis), particularly in elderly patients or in patients taking corticosteroids (anti-inflammatory medicines like cortisone and similar medicines). If you experience any tendon complaints whilst or shortly after taking the Surnox tablets, rest the affected limb to avoid tendon damage and seek medical advice immediately as treatment discontinuation may be necessary.
- Do not stay out in strong sunlight for unnecessarily long periods and do not use a sun lamp or solarium while you are taking Surnox. This is because some patients may become more sensitive to light whilst taking the tablets.
Pregnancy
Consult your doctor or pharmacist before taking any medication.
Before starting the treatment, inform your doctor if you are pregnant or suspect that you could be pregnant because the safety of Surnox product for use in human pregnancy has not been established.
Lactation
Consult your doctor or pharmacist before taking any medication.
If you are breastfeeding, Surnox should not be taken because ofloxacin, the active ingredient of this medication is excreted in breast milk.
Effects on the ability to drive and use machinery:
Due to the possibility of the appearance of adverse effects such as: dizziness, drowsiness or visual disturbances Surnox tablets may impair your ability to carry certain activities, such as driving a vehicle or operating machinery.
Use in children:
Children and growing teenagers must not be given Surnox as there is a risk of damage to the cartilage of joints in the growing subject.
Use in the elderly:
No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal function.
Taking other medications:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Surnox tablets should be taken at least within two hours of aluminium and magnesium containing antacids, or medications used in the treatment of anemia (iron salts) or medications that protect the wall of the stomach (sucralfate) since they may reduce ofloxacin serum level and therefore also reduce the efficacy of your medicine.
You should inform your doctor if you are taking Surnox concomitantly with oral anticoagulants because he /she should monitor your blood coagulation, as it is possible that an increase in anticoagulant effect occurs.
The concomitant treatment of Surnox with medications such as theophylline (medications used to treat respiratory problems), fenbufen or similar non steroidal anti-inflammatory drugs (used to treat pain and inflammation) is not recommended as it is possible that the convulsant threshold decrease and that the risk of getting convulsions may be increased.
3. HOW TO TAKE SURNOX Tablets
Follow these instructions when taking this medication unless advised otherwise by your doctor.
Remember to take your medication.
Surnox tablets should be swallowed with plenty of liquid (a glass of water). It may be taken before or after a meal.
Your doctor will inform you of the duration of your treatment with Surnox. Do not discontinue treatment before the period recommended by your doctor.
If you have the impression that the effect of Surnox is too strong or too weak, inform your doctor or pharmacist.
Your doctor will prescribe the lowest possible dose in order to achieve the desired effect.
Dosage for adults
The recommended dose of Surnox for adults is 2 tablets of 200 mg., twice daily in two divided doses (one tablet in the morning and the other one in the afternoon). This dose may be increased to 3 or 4 tablets daily in cases of severe infection or in patients with excess weight.
In patients with impairment of renal function the dosage should be adjusted by their doctor according to the degree of impairment:
- Mild or moderate renal insufficiency: 1 tablet of 200 mg. per day.
- Severe renal insufficiency: 1 tablet of 200 mg. every 2 days.
If you suffer severe hepatic dysfunction, like for example cirrhosis with ascites, the excretion of ofloxacin may be reduced therefore a maximum dose of 2 tablets per day should not be exceeded.
Duration of treatment is dependent on the response to treatment. Like all other medications with antimicrobial activity, treatment with SURNOX should continue during at least 3 days after the remission of fever and clinical symptoms. In most acute infections seven to ten days of treatment is sufficient.
According to the available results treatment with Surnox should not exceed 2 months duration.
If you take more Surnox tablets than you should:
If you take more Surnox than you should, immediately consult your doctor or pharmacist or go to the nearest hospital casualty department and take this patient information leaflet with you.
The signs to be expected following ofloxacin overdosage may be: dizziness, confusion, impairment of consciousness and convulsive seizures. Your doctor will carry out the usual measures to remove any unabsorbed ofloxacin. Symptomatic and supportive treatment should be implemented.
In the case of an overdose or accidental ingestion, contact your local poison control centre (Servicio de Informacion Toxicologica. Telephone: (91) 562 04 20) immediately.
If you miss a dose of Surnox tablets:
If you forget to take a dose do not take a double dose to make up for the missed dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Surnox tablets can have side effects but it is generally well tolerated.
General allergic reactions, skin reactions
Uncommon: itching, stinging of the eyes, irritative cough and skin rash.
Rare: general allergic reactions (anaphylactic / anaphylactoid reactions) with symptoms such as wheals, rash and itchy skin (urticaria), severe difficulty in breathing (dyspnoea / bronchospasm), hot flushes, sweating.
Very Rare: Hypersensitivity skin reactions such as photosensitivity (allergic skin reaction to sun and ultraviolet light), skin rash, erythema multiforme.
Isolated cases: severe blistering reactions of the skin and mucous membranes (Steven's Johnson syndrome) and severe difficulty in breathing.
Gastrointestinal and metabolism
Uncommon: pain in the abdominal region, diarrhoea, nausea, vomiting.
Rare: anorexia (loss of appetite), diarrhoea (in isolated cases diarrhoea may be haemorrhagic).
Very Rare: inflammation of the bowel with diarrhoea (pseudomembranous colitis).
Isolated cases: extreme decrease in blood sugar (hypoglycaemia) in diabetic patients treated with hypoglycaemic drugs.
Nervous system reactions
Uncommon: agitation, dizziness, headache, drowsiness, sleep disorders, insomnia.
Rare: nervous disorders such as hallucinations, anxiety, confusion, depression and somnolence, disorders of the peripheral nervous system like: paraesthesia (tingling feeling in the hands and feet), disturbances of taste and smell, vision disorders.
Very Rare: hearing disorders such as loss of hearing, convulsions, coordination disorders.
Isolated cases: behaviour disorders such as self-endangering behaviour.
Cardiovascular system reactions
Rare: abnormally low blood pressure (hypotension), abnormally rapid beating of the heart (tachycardia).
Muscles, bones and tendon reactions
Rare: tendon pain and inflammation (tendinitis)
Very Rare: Joint pain and muscle pain. Tendon rupture (for example, Achilles tendon), as occurs with other fluoroquinolones, this side effect may occur within 48 hours after starting treatment and may be bilateral.
Isolated cases: Muscle reactions with muscle cell damage (rhabdomyolysis). Muscular weakness which may be of special importance in patients with myasthenia gravis.
Liver reactions
Rare: increase in blood levels of liver enzymes.
Very Rare: cholestatic jaundice.
Isolated cases: Hepatitis which could be severe.
Renal side effects
Rare: an increase in serum creatinine.
Very Rare: Severe disturbances of kidney function.
Isolated cases: Inflammation of the kidney which may be due to allergic kidney reactions (interstitial nephritis).
Haematological reactions
Very Rare: decrease in red blood cells (anaemia), decrease in red blood cells due to blood cell damage (haemolytic anaemia), decrease in the number of white blood cells (leucopenia, eosinophilia) and decrease in the number of blood platelets (thrombocytopenia).
Isolated cases: severe decrease in the number of white blood cells (agranulocytosis), decrease in the number of all types of blood cells (pancytopenia), bone marrow depression.
Other reactions
Uncommon: development of resistant microorganisms and fungal growth.
Isolated cases: allergic lung reactions (allergic pneumonia) and appearance of attacks of porphyria in patients with porphyria (a very rare metabolic disease).
If you experience any other adverse reaction not mentioned in this patient information leaflet, consult your doctor or pharmacist.
5. STORING SURNOX Tablets
Keep Surnox tablets in a safe place, where children cannot reach or see it.
No special precautions are required, but it is recommended you keep Surnox tablets in the original box in a dry place.
Expiry:
Do not use Surnox tablets after the expiry date shown on the packaging.
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