QUINOLOX MONOPRISE

200 MG · film-coated tablet · box 2 tablets pellicule

Reference dated : 2017-12-18. Confirm price and availability with a pharmacist.

Public price

39,00 MAD

What is this medicine?

French reference leaflet: OFLOXACINE BIOGARAN 200 mg, comprimé pelliculé sécable. Confirm indications in Morocco with a pharmacist.

Pharmacotherapeutic class: Fluoroquinolones - ATC code: J01MA01. OFLOXACINE BIOGARAN is an antibiotic from the quinolone family, from the fluoroquinolone group. The active substance is ofloxacine. It acts by killing the bacteria responsible for infections. It is active only against certain strains of bacteria. OFLOXACINE BIOGARAN is indicated for the treatment of the following bacterial infections: · certain urinary tract infections (bladder and kidney infections); · certain genital tract infections in men and women (for example: gonorrhea, a sexually transmitted disease); · certain bone and joint infections; · certain respiratory tract infections; · certain sinus infections; · certain skin infections; · in case of exposure to anthrax. (See section 2 "What is the information you need to know before taking OFLOXACINE BIOGARAN 200 mg, film-coated scored tablet?").

Full clinical reference

Additional sections are available in French. Read the original document; the information concerns the French reference product.

Uses

MONOFLOCET 200 mg, film-coated tablet is indicated in the treatment of the following bacterial infections (see section 4.4 and 5.1). MONOFLOCET should be used only when the antibiotics usually recommended for the treatment of these infections are deemed inappropriate. Particular attention should be paid to the available information on bacterial resistance to ofloxacin before initiating treatment.

Official recommendations regarding the appropriate use of antibacterials should be taken into account.

In adults

MONOFLOCET 200 mg film-coated tablet is indicated as a single-dose treatment of uncomplicated acute cystitis in non-menopausal adult women.

Pregnancy and breastfeeding

Pregnancy

Based on limited data in humans, the use of fluoroquinolones during the first trimester of pregnancy has not been associated with an increased risk of major malformations or other adverse effects on pregnancy outcomes. Animal studies have shown articular cartilage lesions in immature animals, but no teratogenic effect. Therefore, ofloxacin should not be used during pregnancy (see section 4.3).

Furthermore, for reasons of efficacy, single-dose treatments are not suitable for the management of urinary tract infections in pregnant women.

Breastfeeding

Ofloxacin is excreted in breast milk in small amounts. Due to the risk of arthropathy and other serious toxicities in the breastfed child, breastfeeding should be discontinued during treatment with ofloxacin (see section 4.3).

Driving

Reactions (for example dizziness/vertigo, drowsiness, visual disturbances) may impair the patient's ability to concentrate and react, and therefore constitute a risk in situations where these abilities are of particular importance (for example driving a vehicle or using a machine).

Adverse effects

The information below is based on data from clinical trials and on long-term experience acquired after marketing.

Organ system class	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1 000 to < 1/100)	Rare (≥ 1/10 000 to < 1/1 000)	Very rare (< 1/10 000)	Uncertain frequency (cannot be estimated from the available data)
Infections and infestations		Fungal infections, Bacterial resistance
Blood and lymphatic system disorders				Anemia, Hemolytic anemia, Leucopenia, Eosinophilia, Thrombocytopenia	Agranulocytosis, Bone marrow failure
Immune system disorders			Anaphylactic reaction, Anaphylactoid reaction, Angioedema*	Anaphylactic shock, Anaphylactoid shock
Metabolism and nutrition disorders			Anorexia, Hypoglycemic coma (see section 4.4).		Hypoglycemia in diabetic patients treated with hypoglycemics,* Hyperglycemia.
Psychiatric disorders 1		Agitation, Sleep disorders, Insomnia	Psychotic disorders (for example hallucination), Anxiety, Confusional state, Nightmares, Depression, Delirium, Memory disorders.		Psychotic disorders and depression endangering the patient themselves, notably suicidal ideation or suicide attempts*, Nervousness
Nervous system disorders 1		Dizziness, Headache	Somnolence, Paresthesias, Dysgeusia, Parosmia.	Peripheral sensory neuropathy, Peripheral sensorimotor neuropathy, Convulsions, Extrapyramidal symptoms or other muscle coordination disorders	Tremor, Dyskinesia, Ageusia, Syncope, Benign intracranial hypertension (pseudotumor cerebri)
Eye disorders 1		Eye irritation	Visual disorders		Uveitis
Ear and labyrinth disorders 1		Vertigo		Tinnitus, Hearing loss	Hearing difficulties
Cardiac disorders **			Tachycardia		Ventricular arrhythmias, Torsades de pointes (events observed mostly in patients presenting risk factors for QT interval prolongation), QT interval prolongation confirmed by ECG (see sections 4.4 and 4.9).
Vascular disorders **			Hypotension
Respiratory, thoracic and mediastinal disorders		Cough, Nasopharyngitis	Dyspnea, Bronchospasm		Allergic pneumonia, Severe dyspnea
Gastro-intestinal disorders		Abdominal pain, Diarrhea, Nausea, Vomiting	Enterocolitis, sometimes haemorrhagic	Pseudomembranous colitis*	Dyspepsia, Flatulence, Constipation, Pancreatitis
Hepatobiliary disorders			Elevation of liver enzymes (ALAT, ASAT, LDH, gamma-GT and/or alkaline phosphatases), Increase in blood bilirubin	Cholestatic jaundice	Hepatitis which can be severe. Cases of serious liver injury, notably cases of acute liver failure, sometimes fatal, have been reported with ofloxacin, mainly in patients suffering from underlying liver conditions. *
Skin and subcutaneous tissue disorders		Pruritus, Rash	Urticaria, Hot flushes, Hyperhidrosis, Pustular eruption	Erythema multiforme, Toxic epidermal necrolysis, Photosensitization reaction*, Drug eruption, Vascular purpura, Vasculitis, which can exceptionally lead to skin necrosis	Stevens-Johnson syndrome, Acute generalized exanthematous pustulosis, Drug eruption, Lyell syndrome, Stomatitis, Exfoliative dermatitis
Musculoskeletal and systemic disorders and bone disorders 1			Tendinitis	Arthralgia, Myalgia, Tendon rupture (for example, Achilles tendon) which can occur within 48 hours after the start of treatment and can be bilateral	Rhabdomyolysis and/or myopathy, Muscle weakness, Muscle tear, Muscle rupture, Ligament rupture, Arthritis, Possible worsening of myasthenia *
Renal and urinary tract disorders			Increase in serum creatinine	Acute renal failure	Acute interstitial nephritis
Congenital, familial and genetic disorders					Porphyria attacks in patients with porphyria
General disorders and administration site conditions 1					Fatigue, Fever, Pain (including back, chest and extremity pain)

*see section 4.4

** Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ruptures), and regurgitation/insufficiency of one of the heart valves have been reported in patients receiving fluoroquinolones (see section 4.4).

1 Very rare cases of serious, persistent (lasting several months or years), disabling and potentially irreversible adverse effects, affecting various sensory organ systems, sometimes multiple (notably effects of a tendinitis type, tendon rupture, arthralgia, extremity pain, gait disorders, neuropathies associated with paresthesias, depression, fatigue, memory disorders, sleep disorders and disorders of hearing, vision, taste and smell), have been reported in association with the use of quinolones and fluoroquinolones, sometimes independently of pre-existing risk factors (see section 4.4).

Pediatric population

In children: arthropathies ( see section 4.4 ).

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/ .

Read the French reference

Hospital price

24,30 MAD

Type

Generic

Therapeutic class

FLUOROQUINOLONE

References and update dates

CNOPS Referentiel des medicaments · 2017-12-18

Product and price reference

Base de données publique des médicaments (France) · 2026-09-29 · Licence Ouverte

Read medical reference

This information is informational and must be confirmed by a pharmacist or doctor. Do not change medicine or dosage based only on this page.

Price history

Reference price recorded since 2017-12-18: 39,00 MAD

Referenced presentations and strengths