Active ingredients: Oxybutynin
Oxybutynin Hydrochloride Mylan Generics 5 mg tablets
Why is Oxybutynin used? What is it for?
Oxybutynin hydrochloride belongs to two groups of medicines called "antispasmodics" and "anticholinergics".
Oxybutynin hydrochloride works by helping to reduce bladder muscle spasms. It is these spasms that cause you to feel the need to urinate often. Therefore oxybutynin has the effect of relaxing the bladder muscles, so the bladder can hold more urinating and the frequent urge to urinate is reduced. Therefore oxybutynin hydrochloride tablets can be used to treat conditions in which you are unable to control your bladder normally. The reason this occurs may not be known or may be caused by a disorder affecting the nerves of the bladder.
Oxybutynin hydrochloride can be used in adults and children aged 5 years and over to treat:
- Loss of urine control (urinary incontinence)
- Increased need and urgency to urinate
- Bedwetting, when other treatments have not been successful
Contraindications When Oxybutynin should not be used
Do not take Oxybutynin Hydrochloride Mylan Generics
- if you are allergic to oxybutynin or any of the other ingredients of this medicine (listed in section 6)
- if you have difficulty urinating
- if you have a serious condition called ulcerative colitis, or if you notice blood or mucus in your stool
- if you suffer from a lazy bowel, if you are constipated or if you have bowel problems (the bowel is blocked, punctured or not working properly)
- if you suffer from a condition that causes muscle weakness (Myasthenia gravis)
- if you suffer from glaucoma (increased pressure in the eye)
- if you have heart disease which causes fast or irregular beats
- if you have been told that you have a condition where the brain tissue is hardened (cerebral sclerosis).
Precautions for use What you need to know before taking Oxybutynin
Talk to your doctor or pharmacist before taking Oxybutynin Hydrochloride Mylan Generics tablets:
- if you are elderly (65 years or older), as you may be more sensitive to the effects of Oxybutynin Hydrochloride Mylan Generics
- if the person taking the medicine is a child (use is not recommended for under 5 years of age)
- if you have heart or blood vessel disease or if you suffer from high blood pressure
- if you have an irregular heartbeat and / or an increased or rapid heartbeat
- if you suffer from liver, kidney or bowel disease
- if you suffer from a condition affecting the nervous system
- if you have an overactive thyroid (hyperthyroidism)
- if you have a fever or live in a hot environment, because oxybutynin may increase the risk of hyperthermia
- if you have an enlarged prostate
- if you suffer from indigestion or heartburn caused by a disease called "hiatal hernia"
- if you have a urinary tract infection, this should be treated before starting treatment with oxybutynin.
Tell your doctor if any of these apply to you.
Interactions Which drugs or foods can modify the effect of Oxybutynin
Other medicines and Oxybutynin Hydrochloride Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, herbal remedies or any of the following medicines:
- antihistamines to relieve allergy symptoms
- other medicines called anticholinergics or antimuscarinics, such as some medicines to treat irritable bowel syndrome, asthma or incontinence, mobility disorders or movement disorders associated with Parkinson's disease
- medicines to treat depresson, eg. amitriptyline, imipramine or dosulepin (tricyclic antidepressants)
- medicines to treat mental illness, eg. clozapine, phenothiazines, butyrophenones
- medicines for nausea and vomiting, eg. metoclopramide, domperidone
- medicines containing atropine
- disopyramide or quinidine, digitalis used to treat irregular heart rhythms
- dipyridamole, used to prevent blood clots and strokes
- medicines to prevent certain virus infections or to treat Parkinson's disease, eg. levodopa, biperidene, procyclidine, amantadine
- medicines that dissolve on the tongue, eg. glyceryl trinitrate (GTN) tablets for angina, because oxybutynin hydrochloride can cause dry mouth so the tablets may not dissolve properly
- digoxin, used to treat heart problems
- medicines to treat myasthenia gravis, eg. neostigmine or pyridostigmine
- medicines to treat HIV infection, eg ritonavir, indinavir or saquinavir
- ketoconazole or itraconazole, used to treat fungal infections
- clarithromycin or telithromycin, used to treat bacterial infections.
Taking Oxybutynin Hydrochloride Mylan Generics with food, drink and alcohol
Oxybutynin Hydrochloride Mylan Generics can be taken on an empty stomach but is best taken with food or milk if it causes stomach problems. Drinking alcoholic beverages can increase drowsiness caused by oxybutynin.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Oxybutynin should only be used in pregnancy if the benefits to the mother outweigh the risks to the baby. Talk to your doctor first. You should not breastfeed while taking oxybutynin as small amounts of oxybutynin hydrochloride can pass into breast milk.
Driving and using machines
Do not drive or operate machinery if you experience dizziness or blurred vision while using Oxybutynin Hydrochloride Mylan Generics tablets.
Oxybutynin Hydrochloride Mylan Generics contains lactose
If you have been told by your doctor that you have an "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Oxybutynin: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
Taking this medicine
Swallow the tablets with a glass of water on an empty stomach. If the tablets cause stomach problems, take them with a meal or with milk.
Get regular check-ups at your dentist because oxybutynin causes dry mouth which can increase the risk of tooth deterioration.
Adults
The starting dose is one 2.5 mg Oxybutynin Hydrochloride tablet two or three times a day. The recommended dose is one Oxybutynin Hydrochloride Mylan Generics 5 mg tablet two or three times a day. Your doctor may increase this dose to a maximum of 5 mg four times a day.
Elderly patients
Use a lower 2.5 mg dose of Oxybutynin Hydrochloride Mylan Generics twice a day initially, as the elderly and debilitated patients may be more sensitive to the effects of this medicine. Your doctor may increase this dose to a maximum of one Oxybutynin Hydrochloride Mylan 5 mg tablet twice a day.
Use in children and adolescents
Do not give this medicine to children under 5 years of age. For children over 5 years of age, the recommended starting dose is 2.5 mg Oxybutynin Hydrochloride Mylan Generics twice a day. Your doctor may increase this dose up to to a maximum of one tablet of Oxybutynin Hydrochloride Mylan Generics 5 mg two or three times a day. Give your child the last dose just before bedtime.
Overdose What to do if you have taken an overdose of Oxybutynin
If you take more Oxybutynin Hydrochloride Mylan Generics than you should
If you take more Oxybutynin Hydrochloride Mylan Generics than you should, contact your doctor or go straight to the emergency room of a hospital. Take your medicine with you. Taking too much Oxybutynin Hydrochloride Mylan Generics can be very dangerous. He may become very restless or agitated, red or dizzy or lightheaded. Heartbeats can become very rapid, irregular or energetic. He may have trouble breathing or drowsiness or go into a coma.
If you forget to take Oxybutynin Hydrochloride Mylan Generics
If you forget a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the forgotten dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Oxybutynin Hydrochloride Mylan Generics
Keep taking Oxybutynin Hydrochloride Mylan Generics until your doctor tells you to stop. Do not stop taking your medicine just because you feel better.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Oxybutynin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In some cases these effects may go away if your doctor reduces your dose. If you get any of these serious side effects, stop taking this medicine straight away and get medical help right away:
Common (may affect up to 1 in 10 people):
- if you have problems or difficulties passing urine
Not known (frequency cannot be estimated from the available data)
- if you have a severe allergic reaction with swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
- if you sweat a little, this can cause hyperthermia (overheating) in hot environments which can cause heat stroke.
- if increased pressure in the eye (glaucoma). If you notice a sudden change in your vision, see an ophthalmologist immediately
- if you have urinary tract infections (symptoms may include pain or burning when urinating)
- Convulsions
Other side effects
Very Common (may affect more than 1 in 10 people)
Headache, dizziness, sleepiness, dry mouth, dry skin, constipation, feeling sick
Common (may affect up to 1 in 10 people)
Feeling confused, dry eyes, flushing of the face (more common in children than adults), diarrhea, being unwell.
Uncommon (may affect up to 1 in 100 people)
Decreased appetite, loss of appetite, difficulty swallowing, stomach problems
Not known (frequency cannot be estimated from the available data)
Feeling restless, agitated, nightmares, feeling anxious, paranoia or hallucinating (seeing, feeling or hearing things that are not real), learning difficulties, perception and logic. Elderly patients are more sensitive to these side effects.
Other possible side effects include changes in vision, blurred vision.
Fast or irregular heartbeat, stomach discomfort and heartburn which usually occurs after meals or during the night and which can get worse when leaning forward (gastroesophageal reflux), impotence, allergic skin reactions such as rash, itching or increased sensitivity of the skin to the sun (photosensitivity).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Blisters: Store in the original package in order to protect from light.
Bottles: Keep the container tightly closed to protect from light.
Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Composition and pharmaceutical form
What Oxybutynin Hydrochloride Mylan Generics contains
- The active ingredient is oxybutynin hydrochloride 5 mg.
- The other ingredients are: lactose monohydrate, microcrystalline cellulose, calcium stearate, indigo carmine E 132.
What Oxybutynin Hydrochloride Mylan Generics looks like and contents of the pack
The 5 mg tablets are blue, round, marked "OB / 5" on one side and "G" on the other side. The 5 mg tablets can be divided into equal doses.
Oxybutynin hydrochloride Mylan Generics is available in plastic bottles or blister packs of 20, 30, 50, 60, 84, 90, 100, 250 (bottles only) and 500 (bottles only) tablets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OXIBUTININ HYDROCHLORIDE MYLAN GENERICS 5 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg of oxybutynin hydrochloride per tablet.
Excipients with known effect: each tablet contains 145.4 mg of lactose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablet.
Blue, round and biconvex uncoated tablets, marked on one side with OB, score 5, and on the other side with the letter G. The tablet can be divided into equal parts.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Urinary incontinence, urgent and frequent urination in conditions of bladder instability. This may be due to idiopathic instability of the detrusor muscle (urgent motor incontinence) or to neurogenic disorders of the bladder (detrusor hyperflexia) in conditions such as multiple sclerosis and spina bifida.
Pediatric population
Oxybutynin hydrochloride is indicated in children over 5 years of age for:
• Urinary incontinence, urgent and frequent urination in conditions of bladder instability, caused by idiopathic overactive bladder or neurogenic disorders of the bladder (detrusor overactivity);
• Nocturnal enuresis associated with detrusor overactivity, in association with non-drug therapy, when other treatments have not been successful.
04.2 Posology and method of administration
Dosage
Adult patients
The starting dose is 2.5 mg three times a day but, if necessary, the lowest effective dose for a satisfactory clinical response can be used. The usual dose is 5 mg twice or thrice a day. This can be increased up to a maximum dosage of 5 mg four times a day to achieve a clinical response provided that side effects are tolerated.
Elderly patients
Since the elimination half-life may be increased in elderly subjects, a starting dose of 2.5 mg twice daily may be adequate, particularly if the patient is debilitated. This dose can be increased up to 5 mg twice daily. to obtain a clinical response, provided that side effects are well tolerated.
Pediatric population
Children (over 5 years of age)
Neurogenic instability of the bladder: the usual dose is 2.5 mg twice a day. This dose can be increased up to 5 mg two or three times a day to achieve a clinical response, provided that side effects are well tolerated.
Nocturnal enuresis: the usual dose is 2.5 mg twice a day. This dose can be increased up to 5 mg two or three times a day to achieve a clinical response, provided that side effects are tolerated.
The last dose should be given before bedtime.
Children (under 5 years of age)
Use is not recommended.
Method of administration
Oxybutynin hydrochloride tablets are for oral use and can be taken with a glass of water on an empty stomach. The tablets can also be taken with meals or with milk if stomach irritation occurs.
04.3 Contraindications
Hypersensitivity to oxybutynin hydrochloride or to any of the excipients listed in section 6.1.
Patients with bladder flow obstruction as urinary retention may be aggravated.
Patients with gastrointestinal obstruction, including paralytic ileus and intestinal atony.
Patients with toxic megacolon, severe ulcerative colitis, myasthenia gravis, narrow angle glaucoma or reduced depth of the anterior chamber, tachyarrhythmia and cerebral sclerosis.
Patients with frequent urination problems or nocturia due to heart or kidney failure.
04.4 Special warnings and appropriate precautions for use
Treatment with Oxybutynin hydrochloride tablets should be reconsidered after a period of 4-6 weeks, as normal bladder function may be restored in some patients.
Oxybutynin hydrochloride tablets should not be used to treat stress or exertion incontinence.
Oxybutynin hydrochloride tablets should be used with caution in debilitated elderly and children, who may be more sensitive to the effects of oxybutynin, and in patients with autonomic neuropathy, severe gastrointestinal, hepatic or renal motility disorders (see section 4.3 ).
Administration of oxybutynin hydrochloride tablets may aggravate the symptoms of hyperthyroidism, coronary artery disease, congestive heart failure, cardiac arrhythmias, tachycardias, hypertension and prostatic hypertrophy.
Because oxybutynin can reduce sweating, patients being treated may be at risk of hyperthermia in the event of a high ambient temperature or fever.
In the presence of urinary tract infections, the patient should be treated with appropriate antibacterial therapy.
Chronic use can lead to the development of dental caries, periodontal disease, thrush and oral disorders as a result of reduced or inhibited salivation.
Patients should immediately seek advice if they notice a "sudden loss of vision."
Particular caution should be exercised in patients with hiatal hernia associated with reflux oesophagitis, as anticholinergic drugs can aggravate this condition.
Pediatric population
Oxybutynin hydrochloride tablets are not recommended for use in children under 5 years of age due to insufficient data on safety and efficacy.
There is limited evidence supporting the use of oxybutynin in children with monosymptomatic nocturnal enuresis (unrelated to detrusor overactivity).
In children over 5 years of age, Oxybutynin hydrochloride tablets should be used with caution as they may be more sensitive to the effect of the product, particularly CNS and psychiatric adverse reactions.
Excipients
Oxybutynin hydrochloride contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Caution should be exercised if other anticholinergic agents are co-administered with oxybutynin hydrochloride tablets as potentiation of anticholinergic effects may occur.
Anticholinergic and antihistamine agents, tricyclic antidepressants, L-dopa, atropine, disopyramide and clozapine may lead to occasional cases of interaction, due to the possible potentiation of anticholinergic effects. Concomitant use may also cause confusion in the elderly.
Cases of interactions with amantadine, phenothiazines, butyrophenones and digitalis have occasionally been reported.
Oxybutynin can antagonize the gastrointestinal effects of metoclopramide and domperidone.
Sublingual nitrates may not dissolve under the tongue due to dry mouth, thus reducing the therapeutic effect.
By reducing gastric motility, oxybutynin can affect the absorption of other drugs.
04.6 Pregnancy and lactation
Pregnancy
Data from the use of oxybutynin in pregnant women are not adequate.
Animal studies have shown reproductive toxicity (see section 5.3). The potential risks for humans are unknown.
Oxybutynin should not be used during pregnancy unless considered strictly necessary.
Feeding time
In animals, oxybutynin has been found in breast milk and therefore the use of oxybutynin by lactating mothers is not recommended.
04.7 Effects on ability to drive and use machines
Oxybutynin hydrochloride tablets may cause drowsiness or blurred vision; patients should be informed of possible adverse effects on the ability to drive, use machines or perform hazardous work.
04.8 Undesirable effects
Psychiatric disorders
Cognitive effects (confusion, anxiety, paranoia, hallucinations) have been reported in elderly patients.
Anorexia,
restlessness,
nightmares.
Nervous system disorders
Headache,
dizziness
drowsiness,
convulsions.
Eye disorders
Mydriasis,
blurred vision,
intraocular hypertension and induction of glaucoma (narrow angle glaucoma),
dry eye.
Cardiac pathologies
Tachycardia,
cardiac arrhythmia.
Vascular pathologies
Facial redness (more pronounced in children than in adults).
Gastrointestinal disorders
Dry mouth,
constipation,
nausea,
abdominal discomfort,
diarrhea,
He retched,
gastrointestinal reflux.
Skin and subcutaneous tissue disorders
Dry skin.
Allergic reactions such as rash, urticaria, angioedema, photosensitivity have been reported.
Renal and urinary disorders
Problems with urination,
urinary retention.
Diseases of the reproductive system and breast
Impotence.
Reducing the dosage may decrease the incidence of some side effects.
Reporting of suspected adverse reactions The reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
04.9 Overdose
Symptoms
Symptoms of overdose are progressive from an "intensification of the undesirable effects of the Central Nervous System (from restlessness to excitement to psychotic behavior), to circulatory changes (flushing, reduction of blood pressure, circulatory insufficiency, etc.), respiratory failure, paralysis and coma.
Treatment
In the event of an overdose, take the following measures:
i) immediate gastric lavage;
ii) slow intravenous injection of 0.5-2.0 mg of physostigmine, repeated if necessary (after 5 minutes) up to a total of 5 mg. The recommended dose of physostigmine in children is 30 micrograms / kg by slow intravenous injection, repeated as needed (after 5 minutes) up to a total maximum of 2 mg.
Fever should be treated with ice packs or lukewarm water sponges.
For pronounced restlessness or excitement 10 mg of diazepam can be given intravenously.
For tachycardia, an intravenous injection of propranolol can be given.
Catheterization can be used to treat urinary retention.
Mechanical ventilation is required if paralysis of the respiratory muscles occurs.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drugs for frequent urination, enuresis and incontinence.
ATC code: G04BD04.
Oxybutynin has a direct antispasmodic effect on the smooth muscle of the detrusor muscle of the bladder.
Oxybutynin also inhibits the effects of acetylcholine on smooth muscle by blocking muscarinic receptors. Pharmacological modeling has established that affinity differences exist for muscarinic receptor subtypes.
Due to its pharmacodynamic properties, oxybutynin causes relaxation of the detrusor muscle of the bladder. Patients with unstable bladder show a greater degree of bladder distension and a lower incidence of spontaneous contractions of the detrusor muscle.
05.2 "Pharmacokinetic properties
Absorption
After oral administration, oxybutynin is rapidly absorbed from the gastrointestinal tract (tmax 0.5-1.4 hours).
The studies established a Cmax of 8-12 ng / ml after a dose of 5-10 mg in healthy young patients. Large variations in plasma concentrations were observed between subjects.
Distribution
Oxybutynin binds 83-85% to plasma albumin. The mean elimination half-life is 2 hours.
The elimination half-life may be increased in the elderly, particularly if they are debilitated.
Biotransformation
Oxybutynin is subject to extensive first pass metabolism, with an absolute systemic availability of 6.2%.
The major metabolite, desethyloxybutynin, is pharmacologically active. Many other metabolites are produced, including phenylcyclohexiglycolic acid, but they have no pharmacological activity.
Elimination
Urinary excretion was estimated to be less than 0.02% of the administered dose.
Oxybutynin is eliminated bioexponentially.
Repeated administration produces limited accumulation.
05.3 Preclinical safety data
Oxybutynin hydrochloride has been shown to have low acute toxicity.
Chronic toxicity has been associated with reduced food consumption, weight gain, tremors and nervousness; minor pathological changes in the liver and kidneys were observed in one species.
Preclinical studies did not suggest mutagenic or carcinogenic activity, nor adverse effects on fertility or reproductive function. No adverse effects were observed on gestation, birth and development of the offspring up to weaning.
No teratogenicity was observed at oral dose levels (rats - 20 mg / kg / day, rabbits - 48 mg / kg / day) which did not cause significant maternal toxicity; however, at maternally toxic doses of oxybutynin (100 mg / kg / day), a higher incidence of extra thoraco-lumbar ribs was observed in rat fetuses and in neonatal mortality.
Pre-clinical data reveal no special hazard for humans based on conventional studies of general toxicity, genotoxicity and carcinogenic potential, in addition to the information included in the other sections of the SmPC.
Embryo-fetal studies in pregnant rats showed cardiac malformations.
Additionally, higher dosages have been associated with extra thoraco-lumbar ribs and increased neonatal mortality. Reproductive toxicity occurred only simultaneously with general maternal toxicity. In the absence of exposure data, the relevance of these observations cannot be assessed.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate,
microcrystalline cellulose,
calcium stearate,
indigo carmine (aluminum lake) and 132.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Do not store above 25 ° C. Protect from light.
06.5 Nature of the immediate packaging and contents of the package
Polypropylene tablet container with child resistant polyethylene cap. Polyvinyl chloride (PVC) / aluminum foil blister packs.
Pack sizes: 20, 30, 50, 60, 84, 90, 100, 250 and 500 tablets - polypropylene container.
Pack sizes: 20, 30, 50, 60, 84, 90 and 100 tablets - blister.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Mylan S.p.A. - Via Vittor Pisani, 20 - 20124 Milan, Italy
08.0 MARKETING AUTHORIZATION NUMBER
Container 20 tablets 5 mg AIC n. 034261014 / M
Container 30 tablets 5 mg AIC n. 034261026 / M
Container 50 tablets 5 mg AIC n. 034261038 / M
Container 60 tablets 5 mg AIC n. 034261040 / M
Container 84 tablets 5 mg AIC n. 034261053 / M
Container 90 tablets 5 mg AIC n. 034261065 / M
Container 100 tablets 5 mg AIC n. 034261077 / M
Container 250 tablets 5 mg AIC n. 034261089 / M
Container 500 tablets 5 mg AIC n. 034261091 / M
Blister 20 tablets 5 mg AIC n. 034261103 / M
Blister pack of 30 tablets 5 mg AIC n. 034261115 / M
Blister 50 tablets 5 mg AIC n. 034261127 / M
Blister pack 60 tablets 5 mg AIC n. 034261139 / M
Blister 84 tablets 5 mg AIC n. 034261141 / M
Blister 90 tablets 5 mg AIC n. 034261154 / M
Blister pack of 100 tablets 5 mg AIC n. 034261166 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
April 2000
10.0 DATE OF REVISION OF THE TEXT
March 2014