Tarivid 200mg Film Coated Tablets

  • Name:

    Tarivid 200mg Film Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Ofloxacin

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/02/20

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Summary of Product Characteristics last updated on medicines.ie: 3/2/2020

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 February 2020 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 of the Summary of Product Characteristics (SmPC) and Section 4 of the Patient Information Leaflet (PIL) for Tarivid IV (ofloxacin hydrochloride) 2 mg/ml solution for infusion (PA 540/76/002) and Tarivid (ofloxacin) 200 mg film-coated tablets (PA 540/76/003), with regards to dysglycemia, psychotic reactions, memory impairment and delirium.

Updated on 3 February 2020 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Updated on 31 May 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 31 May 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Minor update to Section 4.4 ‘Patients with history of psychotic disorder’

Introduction of benign intracranial hypertension adverse event in Section 4.8

Updated on 24 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 24 April 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4         Special warnings and special precautions for use

  • Aortic aneurysm and dissection
    Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
    Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).
    In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.

     

Updated on 4 April 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 4 April 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.         Clinical Particulars

4.1       Therapeutic indications

 

Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent.  It is effective in vitro against a wide range of Gram-negative and Gram-positive organisms.  It is indicated for the treatment of the following infections when caused by sensitive organisms:

 

The following indications are restricted to adults:

 

Respiratory tract: Acute, chronic or recurrent respiratory tract infections (bronchitis) caused by Haemophilus influenzae or other Gram-negative or multi-resistant pathogens, as well as by Staphylococcus aureus.  In respiratory tract infection ofloxacin is not recommended as first-line therapy for the treatment of pneumococcal pneumonia.  Streptococcus pneumoniae is the most frequent pathogen responsible for community acquired pneumonia.

In acute exacerbations of chronic obstructive pulmonary disease including chronic bronchitis Tarivid should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for treatment of these infections.

 

In community acquired pneumonia Tarivid should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

 

Urinary tract:

Tarivid is indicated in adults for the treatment of the following bacterial infections (see sections 4.4 and 5.1):

•           Acute pPyelonephritis and complicated urinary tract infections

•           Bacterial pProstatitis, epididymo-orchitis

•           Pelvic inflammatory disease, in combination with other antibacterial agentstreatment

 

In uncomplicated cystitis Tarivid should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

 

In urethritis Tarivid should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

 

In complicated skin and soft tissue infections Tarivid should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

 

 

For the below-mentioned infections Tarivid should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections (see section 4.4).

•           Uncomplicated cystitis

•           Urethritis

  • Skin and soft-tissue infections
     
    Tarivid tablets are also indicated for infection prophylaxis of bacterial infection in neutropenic patients.

 

4.4       Special warnings and special precautions for use

 

  • The use of ofloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolones containing products (see section 4.8). Treatment of these patients with ofloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
     
  • Prolonged, disabling and potentially irreversible serious adverse drug reactions
           Very rare cases of prolonged (continuing months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors. Ofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.

 

 

  • Tendinitis and tendon rupture
     
    Tendinitis, rarely observed with quinolones, may occasionally lead to rupture involving Achilles tendon in particular. Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with ofloxacin and have been reported up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in patients aged over 60 years and in patients using corticosteroids..   Furthermore, as transplanted patients are at increased risk of tendinitis, caution is recommended when fluoroquinolones are used in this population. The daily dose should be adjusted in elderly patients based on creatinine clearance (see section 4.2). Close monitoring of these patients is therefore necessary if they are prescribed ofloxacin. All patients should consult their physician if they experience symptoms of tendinitis. If tendinitis is suspected, or at the first signs of pain or inflammation, treatment with ofloxacin must be halted immediately.  Appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon (see sections 4.3 and 4.8).
    Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids. Therefore, concomitant use of corticosteroids should be avoided.
    At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with ofloxacin should be discontinued and alternative treatment should be considered. The affected limb(s) should be appropriately treated (e.g. immobilisation). Corticosteroids should not be used if signs of tendinopathy occur.
     
  • Peripheral neuropathy


    Sensory or sensorimotor peripheral neuropathy has been reported in patients receiving fluoroquinolones, including ofloxacin, which can be rapid in its onset. Ofloxacin should be discontinued if the patient experiences symptoms of neuropathy. This would minimize the possible risk of developing an irreversible condition (see Section 4.8). 
    Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones. Patients under treatment with ofloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition. (see section 4.8)

 

  1. 4.8    Undesirable Effects

Psychiatric disorders**

 

 

Agitation,

Sleep disorder,

Insomnia

 

Psychotic disorder (for e.g. hallucination),

Anxiety,

Confusional state,

Nightmares,

Depression

 

Psychotic disorder and depression with self-endangering behaviour including suicidal ideation or suicide attempt (see Section 4.4)

Nervousness

Nervous system disorders**

 

Dizziness,

Headache

Somnolence,

Paraesthesia,

Dysgeusia,

Parosmia

Peripheral sensory neuropathy*

Peripheral sensory motor neuropathy*

Convulsion*,

Extra-pyramidal symptoms or other disorders of muscular coordination

Tremor Dyskinesia Ageusia Syncope

Eye disorders**

 

Eye irritation

Visual disturbance

 

Uveitis

Ear and labyrinth disorders**

 

Vertigo

 

Tinnitus,

Hearing loss

Hearing impaired

 

 

Musculoskeletal and Connective tissue disorders**

 

 

Tendonitis

Arthralgia,

Myalgia,

Tendon rupture (e.g. Achilles tendon) which may occur within 48 hours of treatment start and may be bilateral.

Rhabdomyolysis and/or Myopathy,

Muscular weakness which may be of special importance in patients with myasthenia gravis,

Muscle tear, muscle rupture

Ligament rupture

Arthritis

Renal and Urinary disorders

 

 

Blood creatinine increased

Acute renal failure

Acute interstitial nephritis

Congenital and familial/genetic disorders

 

 

 

 

Attacks of porphyria in patients with porphyria

General disorders and administration site conditions**

 

 

 

 

Asthenia Pyrexia

Pain (including pain in back, chest, and extremities)

 

* postmarketing experience[HKP1] 

 

**Very rare cases of prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses (including reactions such as tendonitis, tendon rupture, arthralgia, pain in extremities, gait disturbance, neuropathies associated with paraesthesia, depression, fatigue, memory impairment, sleep disorders, and impairment of hearing, vision, taste and smell) have been reported in association with the use of quinolones and fluoroquinolones in some cases irrespective of pre-existing risk factors (see Section 4.4).


 

Updated on 28 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder

Updated on 27 March 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Urinary tract: Tavanic Tarivid is indicated in adults for the treatment of the following bacterial infections (see sections 4.4 and 5.1):

For the below-mentioned infections Tavanic Tarivid should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections (see section 4.4).

•           Uncomplicated cystitis

•           Urethritis

  •       Skin and soft-tissue infections

Tarivid tablets are also indicated for infection prophylaxis in neutropenic patients.

Skin and soft tissue infection.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

 

4.2       Posology and method of administration

General dosage recommendations: Tarivid tablets are to be swallowed with sufficient amount of liquids.  They may be taken on an empty stomach or with meals.  Concomitant administration with antacids should be avoided (see section 4.5 : Interactions).  Ofloxacin should be administered approximately 2 hours apart from antacids. The dose of ofloxacin is determined by the type and severity of the infection.  The dosage range for adults with normal renal function is 200 mg to 800 mg daily.  A daily dose of  Uup to 400 mg may be given as a single dose., In this case, it is preferabley to administer ofloxacin in the morning.  Daily doses of more than 400mg must be divided into two separate doses and be given approximately equal intervals.

Dosage Posology in adults patients with renal insufficiency:

 

When creatinine clearance cannot be measured, it can be estimated with reference to the serum creatinine level using the following Cockcroft's formula for adults:

                                                                                    weight(kg) x (140 -age in years)

Men:                         ClCr (ml/min) =                        ---------------------------------------

                                                                                   72 x serum creatinine (mg/dl)

                     or

                                                                                   weight(kg) x (140 -age in years)

                                 ClCr (ml/min) =                        --------------------------------------

                                                                                   0.814 x serum creatinine (µmol/l)

Women:                    ClCr (ml/min) =                        0.85 x (above value)
Posology in hepatic insufficiency Impaired liver function: the excretion of ofloxacin may be reduced in patients with severe renal liver function disorders (e.g. cirrhosis of the liver and ascites).

It is recommended that Aa maximum daily dose of 400 mg of ofloxacion should be therefore not be exceeded, because of possible reduction of excretion.

Children: Contra-indicated in children and growing adolescents.

Elderly: Dosage may need to be reduced in accordance with renal or hepatic function.  Age in itself does not impose to adapt the dosage of ofloxacin. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly. (See section 4.4 QT interval prolongation).

Duration of therapy varies according to the course of the disease. Ofloxacin should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

 

4.3       Contra-indications

Ofloxacin must not be used

  • In patients hypersensitive to ofloxacin, other quinolones, or any of the excipients listed in section 6.1.

Severe bullous reactionscutaneous adverse reactions Cases

Diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with ofloxacin (including several weeks after treatment), may be symptomatic of pseudo-membranous colitis (CDAD)CDAD may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis (see section 4.8). It is therefore important to consider this diagnosis in patients who develop serious diarrhoea during or after treatment with ofloxacin. If pseudo-membranous colitis is suspected, ofloxacin must be stopped immediately.

In case of convulsive seizuresIf seizure develops, treatment with ofloxacin should be discontinued.

  • Tendinitis 

Tendinitis, rarely observed with quinolones, may occasionally lead to rupture involving Achilles tendon in particular. Tendinitis and tendon rupture, sometimes bilateral, may occur within 48 hours of starting treatment with ofloxacin and have been reported up to several months after discontinuation of treatment. The risk of tendinitis and tendon rupture is increased in patients aged over 60 years and in patients using corticosteroids..   Elderly patients are more prone to tendinitis.  The risk of tendon rupture may be increased by coadministration of corticosteroids.

If secondary infection occurs during therapy, appropriate measures should be taken.

  • Risks of resistance
    The prevalence of acquired resistance may vary geographically and over time for selected species. Therefore, local information on resistance is required; microbiological diagnosis with isolation of the pathogen and demonstration of its susceptibility should be sought, especially for severe infections or failure to respond to treatment.
  • QT interval prolongation
    Very rare Ccases of QT interval prolongation have been reported in patients taking fluoroquinolones including ofloxacin.
     DAs with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported with fluoroquinolones including ofloxacin., usually Iin diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g., glibenclamide) or with insulin, c. ases of hypoglycaemic coma have been reported. In these diabetic patients, careful monitoring of blood glucose is recommended (see Section 4.8).

Ofloxacin should be used with caution in patients with a history of psychotic disorder or in patients with psychiatric disease. Caution is recommended if the drug is to be used in psychotic patients or in patients with a history of psychiatric disease.

Coagulation tests, therefore,  should be monitored in patients treated with vitamin K antagonists. because of a possible increase in the effect of coumarin derivatives.

Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, and antipsychotics). (See section 4.4 QT interval prolongation).

  • Anticoagulant Therapy

with this combinationofloxacin and glibenclamide should be closely monitored.be monitored particularly closely.

See section 4.3 Contraindications).

Breast-feeding

Because Oofloxacin is excreted in human breast milk in small amounts. Because of the potential for arthropathy and other serious toxicity in the nursing infant, breast feeding should be discontinued during treatment with ofloxacin. , either breast-feeding or treatment of the mother must    be stopped because of the risk to the child.  (See Section 4.3 Contraindications).

(e.g. driving as car or operating a special machinemachinery).

 

Vascular disorders

applies only to the solution for infusion:

 

Phlebitis

 

Hypotension

 

applies only to the solution for infusion:

 

During infusion of ofloxacin, tachycardia and hypotension may occur. Such a decrease in blood pressure may, in very rare cases, be severe.

Respiratory, thoracic and mediastinal disorders

 

Cough,

Naso-pharyngitis

Dyspnoea,

Bronchospasm

 

Allergic pneumonitis,

Severe dyspnoea

Gastro-intestinal disorders

 

Abdominal pain,

Diarrhoea,

Nausea,

Vomiting

Enterocolitis, sometimes haemorrhagic

Pseudo-membranous colitis*

 

Dyspepsia Flatulence  Constipation Pancreatitis, stomatitis

Hepato-bilary disorders

 

 

 

Hepatic enzymes increased (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatase)

Blood bilirubin increased

Jaundice cholestatic

Hepatitis, which may be severe*,

Severe liver injury, including cases with acute liver failure, sometimes fatal, have been reported with ofloxacin, primarily in patients with underlying liver disorders (see section 4.4).

 

Skin and subcutaneous tissue disorders

 

Pruritus,

Rash

Urticaria,

Hot flushes,

Hyperhidrosis

Pustular rash

Erythema multiforme,

Toxic epidermal necrolysis,

Photo-sensitivity reaction*,

Drug eruption

Vascular purpura,

Vasculitis, which can lead in exceptional cases to skin necrosis

Stevens-Johnson syndrome;

Acute generalized exanthemous pustulosis; drug rash

Stomatitis,

Exfoliative dermatitis

Musculoskeletal and Connective tissue disorders

 

 

Tendonitis

Arthralgia,

Myalgia,

Tendon rupture (e.g. Achilles tendon) which may occur within 48 hours of treatment start and may be bilateral.

Rhabdomyolysis and/or Myopathy,

Muscular weakness which may be of special importance in patients with myasthenia gravis,

Muscle tear, muscle rupture

Ligament rupture

Arthritis

Renal and Urinary disorders

 

 

Serum Blood creatinine increased

Acute renal failure

Acute interstitial nephritis

    1. Overdose
       
      The most important signs to be expected following acute overdoseage are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures, increases in QT interval as well as gastrointestinal reactions such as nausea and mucosal erosions. 

CNS effects including confusional state, convulsion, hallucination, and tremor have been observed in post marketing experience

In the event of overdose, symptomatic treatment should be implemented.

ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Antacids may be used for protection of gastric mucosa. A fraction of ofloxacin may be removed from the body with haemodialysis. Peritoneal dialysis and CAPD are not effective in removing ofloxacin from the body. No specific antidote exists.

The antibacterial spectrum of ofloxacin is as follows (the sensitivity to ofloxacin may vary, depending on the epidemiology and level of resistance in the country concerned.)

 

 

 

 

 

 

 

 

Updated on 29 January 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 28 January 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • Patients with rare hereditary disorders


    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
     
  • Aortic aneurysm and dissection
     
    Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
    Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis).
    In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
     
    4.5       Interaction with other medicinal products and other forms of interaction 

Updated on 30 June 2017 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

The application concerns a type II work-sharing variation for the assessment of a labelling update of all product information in relation to the warning on tendon disorders in transplant patients for levofloxacin and ofloxacin.

 

This safety variation updates Sections 4.4 and Section 2 of the SmPC and PILs respectively for both Tavanic (Levofloxacin) and Tarivid (Ofloxacin).

Updated on 30 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 23 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 December 2016 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Modification to UTI indication

Updated on 29 November 2016 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 16 March 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 7 November 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Bulk Type II variation to update sections 4.4, 4.5, 4.6 & 4.8 of the SmPC following the outcome of the PSUR and the final assessment report for Ofloxacin work-sharing procedure.

Updated on 19 December 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Bulk Type IB No C.I.3.a. to implement changes requested by the INB following PhVWP findings on use of Fluoroquinolones and risk of QT prolongation for Ofloxacin.

Updated on 25 November 2013 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 16 October 2012 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 21 September 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 has been updated to include 'T/A SANOFI'

Updated on 29 August 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change in the shelf-life or storage conditions of the finished product. Reduction to shelf life of the fiished product as packaged for sale.

Updated on 13 August 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.8 and 4.9 of SPC.

Updated on 18 July 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update Section 4.4, 4.5, 4.8,  following Type II safety variation approval and renewal changes.

Updated on 16 August 2007 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update
Section 6.5 - pack details
Section 10 - date of revision

Updated on 29 May 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Section 4.2    QT interval prolongation

Section 4.4    QT interval prolongation

Section 4.5    Sucralfate and Metal Cations added, QT interval prolongation and interference with drug tests for opiates

Section 4.8    Sensory or sensorimotor peripheral neuropathy

Section 9       Editorial rearrangement of text

Section 10     Updated

Updated on 15 March 2007 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update section 10 - Date of revision

Updated on 6 March 2006 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 5 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 April 2005 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 30 March 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 20 October 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 19 April 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)