ALFU 10 Milligram Tablet Prolonged Release

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
ALFUZOSIN HYDROCHLORIDE
Available from:
Milpharm Limited
ATC code:
G04CA01
INN (International Name):
ALFUZOSIN HYDROCHLORIDE
Dosage:
10 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Alpha-adrenoreceptor antagonists
Authorization status:
Authorised
Authorization number:
PA1050/022/001
Authorization date:
2014-08-08

Package leaflet: Information for the user

Alfu

10 mg prolonged-release tablets

alfuzosine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet

What Alfu is and what it is used for

What you need to know before you take Alfu

How to take Alfu

Possible side effects

How to store Alfu

Contents of the pack and other information

1.

What Alfu

is and what it is used for

Alfu belongs to a group of medicines called alpha-1-blockers.

Alfu is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia. This is a condition

where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (benign). It

occurs most often in older men.

The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine

to the outside of the body). With age, the prostate gland may grow and press the urethra making it

smaller. This may cause problems with urination such as frequent urination and difficulty in passing

urine.

Alfu works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so

makes it easier to pass urine.

2.

What you need to know before you take Alfu

Do not take Alfu

if you are allergic to alfuzosine or the other ingredients of this medicine (listed in section 6).

Symptoms of an allergic reaction include: a rash, swelling of your lips, throat, or tongue,

difficulty in swallowing or breathing.

If you are allergic (hypersensitive) to alfuzosin-equivalent substances (such as terazosin,

doxazosin).

If you have, or have had in the past, low blood pressure when standing up from a sitting or lying

position (the medical term for this is orthostatic hypotension). It can make you feel dizzy, light-

headed or faint when you stand or sit up quickly.

If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See section

below on ‘Other medicines and Alfu. In case of doubt please ask your pharmacist or doctor.

If you have liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Alfu if:

You have severe kidney problems.

You have a heart disease.

You have chest pain (angina).

You are known to have an abnormality of electrocardiogram (ECG ), called “QT prolongation”

Other medicines and Alfu

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

medicines.

Do not take Alfu if you are taking:

Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or

phenoxybenzamine.

Check with your doctor or pharmacist before taking your medicine if:

In the past, you have had a large fall in blood pressure while taking an alpha-blocker (this could

include previous use of alfuzosin). See paragraph immediately above for examples of other alpha-

blockers.

You are taking a medicine for high blood pressure, as you may get dizzy, weak or start sweating

within a few hours of taking this medicine. If this happens, lie down until the symptoms have

completely gone. Tell your doctor as the dose of your medicine may be changed.

You are taking medicines for chest pain or angina (nitrates).

You are taking medicines for fungal infections (such as ketoconazole, itraconazole).

You are taking medicines for HIV (such as ritonavir).

You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).

You are taking medicines for treatment of depression (such as nefazodone).

Operations while taking Alfu

If you are going to have an operation that needs a general anaesthetic, tell your doctor you are

taking Alfu before the operation. This is because it can be dangerous as it can lower your blood

pressure.

If you are undergoing eye surgery because of cataract (cloudiness of the lens) please inform your

eye specialist before the operation that you are using or have previously used Alfu. This is

because Alfu may cause complications during the surgery which can be managed if your

specialist is prepared in advance.

Alfu

with food and drink and alcohol

Take Alfu after a meal.

Pregnancy, breast-feeding and fertility

This section does not apply as alfuzosine is only used by men.

Driving and using machines

You may feel dizzy and weak while taking Alfu. Adverse reactions such as dizziness and asthenia

may occur essentially at the beginning of treatment. If this happens do not drive or operate any tools

or machines.

3.

How to take Alfu

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

Swallow your tablets whole with plenty a fluid (for instance a glass of water).

Do not break, crush or chew your tablets. This can affect the release of your medicine into the

body

Take this medicine after a meal

The first dose should be taken at bedtime.

Use in children

Alfu is not recommended for children.

Adults:

The usual dose is one Alfu 10 mg prolonged release tablet once a day.

Older patients (> 65 years):

The usual dose is one Alfu 10 mg prolonged release tablet once a day. The dose does not need to be

adjusted for elderly (over 65 years).

Patients with mild to moderate kidney problems

Your dose does not need to be adjusted for mild to moderate kidney problems.

If you take more Alfu

than you should

Contact your doctor or your local hospital Accident and Emergency department straight away. Tell

the doctor how many tablets you have taken. Lie down as much as possible to help stop the side

effects. Do not try to drive to the hospital yourself.

If you forget to take Alfu

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next

tablet as directed.

If you stop taking Alfu

Keep taking your tablets, even if your symptoms improve. Only stop if your doctor tells you to. The

symptoms are better controlled if you continue taking the same dose of this medicine.

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

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Chest pain (angina)

Normally, this only happens if you have had angina before.

If you get chest pain stop taking your

tablets and contact a doctor or go to a hospital immediately

. This happens in less than 1 in 10,000

people.

Allergic reactions

You could notice symptoms of angioedema, such as a red and lumpy skin rash, swelling (on the

eyelids, face, lips, mouth and tongue), difficulty breathing or swallowing.

These are symptoms of an allergic reaction.

If this happens, stop

taking your tablets and contact a

doctor or go to a hospital immediately

. This happens in less than 1 in 10,000 people.

Other side effects include:

Common (affects less than 1 in 10 people)

Feeling dizzy

Headache

Feeling sick (nausea)

Stomach pain

Weakness or tiredness

Uncommon (affects less than 1 in 100 people)

Feeling dizzy, lightheaded, or faint when you stand or sit up quickly.

Fast heart beat (tachycardia)

Chest pain

Runny nose, itching, sneezing, and stuffy nose.

Diarrhoea

Rashes and itching

Water retention (may cause swollen arms or legs)

Hot flushes.

Additional side effects (frequency not known) which may occur are:

If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy),

the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the

procedure.

Irregular and fast heart beat

Decrease in white blood cells. Signs may include more frequent infections, sore throat or mouth

ulcers.

Low numbers of blood platelets. Signs may include bleeding from your gums and nose, bruising,

prolonged bleeding from cuts, rash (pinpoint red spots called petechia).

Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites

of your eyes.

If you are undergoing eye surgery because of cataract (cloudiness of the lens) and are using or

have previously used Alfu, the pupil may dilate poorly and the iris (the coloured circular part of

the eye) may become floppy during the procedure. This only occurs during the operation and it is

important for the eye specialist to be aware of this possibility as the operation may need to be

performed differently (see section

“Operations while taking Alfu”

Abnormal, often painful, persistent erection of the penis unrelated to sexual activity (priapism).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side

effects not listed in this leaflet. You can also report side effects directly via www.imb.ie. By reporting

side effects you can help provide more information on the safety of this medicine.

5.

How to store Alfu

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label, carton, bottle 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. These measures will help protect the environment.

6.

Contents of the pack and other information

What Alfu

contains

The active substance is alfuzosine hydrochloride. Each prolonged-release tablet contains 10 mg

alfuzosine hydrochloride.

The other ingredients

Tablet Core:

Hypromellose (E464)

,

hydrogenated vegetable oil

,

povidone (K-30) (E1201)

,

calcium hydrogen phosphate anhydrous

,

carbomer, silica colloidal anhydrous (E551)

,

magnesium stearate (E572).

Film-coating:

Hypromellose (E464)

,

propylene glycol

,

titanium dioxide (E 171).

The tablet has a prolonged effect which means that after taking the active substance is not released

immediately but gradually from the tablet and therefore acts longer.

What Alfu looks like and contents of the pack

Prolonged-release tablet

White to off-white round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on

other side.

Alfu tablets are available in clear PVC/PVdC Aluminium blister packs and white opaque round HDPE

bottles containing silica gel .

Package size:

Blister pack: 30, 50 and 100 tablets

HDPE bottle pack: 30, 500 and 1000 tablets

Not all pack sizes may be marketed

Marketing Authorization Holder

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

United Kingdom

This leaflet was last revised in 06/2015.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Alfu 10 mg Prolonged-release Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Prolonged-release tablet.

White to off-white round (diameter 8.1 mm), biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on

other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Treatment of moderate to severe functional symptoms of benign prostate hyperplasia (BPH).

4.2 Posology and method of administration

Oral Use

The prolonged-release tablet should be taken whole with sufficient amount of fluid (e.g. a glass of water). The

prolonged-release tablets must not be crushed, chewed or divided (see section 4.4).

The first dose should be taken at bedtime. The prolonged-release tablet 10 mg should be taken immediately after the

same meal each day.

Adults:

The recommended dose is one 10 mg prolonged-release tablet daily.

Elderly patients (over the age of 65 years)

The recommended dose is the same as that for adults. Pharmacokinetic and clinical safety studies have shown that dose

adjustment is not necessary in the case of elderly patients.

Impaired renal function

Mild to moderate renal insufficiency (creatinine clearance > 30 ml/min): Dose reduction is usually not necessary (see

section 5.2).

Severe renal insufficiency

Alfuzosin 10 mg should not be given to patients with severely impaired renal function (creatinine clearance < 30

ml/min) as there are no clinical safety data available for this patient group (see section 4.4).

Hepatic insufficiency:

Alfuzosin, given as 10 mg prolonged-release tablets are contraindicated in patients with hepatic insufficiency.

Preparations containing a low dose of alfuzosin hydrochloride might be used in patients with mild to moderate hepatic

insufficiency as instructed in the corresponding product information.

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Paediatric population:

Efficacy of alfuzosin has not been demonstrated on children aged 2 to 16 years (see section 5.1). Therefore, alfuzosin is

not indicated for use in paediatric population.

4.3 Contraindications

Hypersensitivity to the alfuzosin hydrochloride, other quinazolines (e.g. terazosine, doxazosine) or to any of the

excipients listed in section 6.1

Previous history of orthostatic hypotension

Liver insufficiency

Combination with other alpha 1- blockers

4.4 Special warnings and precautions for use

Alfu 10 mg tablets should not be given to patients with severe renal impairment (creatinine clearance < 30 ml/min) in

view of the lack of clinical safety data in this group of patients.

Alfuzosin should be given with caution to patients who are on antihypertensive medication or nitrates.

In some subjects postural hypotension may develop, with or without symptoms (dizziness, fatigue, sweating) within a

few hours following administration. These effects are usually transient, occur in the beginning of treatment and do not

usually prevent the continuation of treatment.

Pronounced drop in blood pressure has been reported in post-marketing surveillance in patients with pre-existing risk

factors (such as underlying cardiac diseases and/or concomitant treatment with anti-hypertensive medication).

Care should be taken when alfuzosin is administered to patients who have had a pronounced hypotensive response to

another alpha1-blocker.

In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears

or worsens, alfuzosin should be discontinued.

As with all alpha-1-blockers, alfuzosin should be used with caution in patients with acute cardiac failure.

Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs

known to increase the QTc interval should be evaluated before and during the administration of alfuzosin

The ’Interoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract

surgery in some patients on or previously treated with tamsulosin. Isolated reports have also been received with other

alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural

complications during the cataract operation, current or past use of alpha-1 blockers should be made known to the

opthalmic surgeon in advance of surgery.

Patients should be warned that the tablet should be swallowed whole. Any other mode of administration, such as

crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to

inappropriate release and absorption of the drug and therefore possible early adverse reactions.

4.5 Interaction with other medicinal products and other forms of interaction

No pharmacodynamic or pharmacokinetic interactions have been observed in studies with healthy volunteers between

alfuzosin and the following drugs:

warfarin, digoxin, hydrochlorothiazide and atenolol.

Administration of general anaesthetics to a patient treated with alfuzosin may lead to blood pressure instability.

Combinations contra-indiacted

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Alpha-1 receptor blockers (see section 4.3)

Increased hypotensive effect. Risk of severe orthostatic hypotension.

Combinations to be taken into account

Antihypertensive drugs (see section 4.4)

Nitrates (see section 4.4)

Potent CYP3A4 inhibitors such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin

and nefazodone since alfuzosin blood levels are increased (see section 5.2)

Ketoconazole: Repeated 200 mg daily dosing of ketoconazole, for seven days resulted in a 2.1 fold increase in C

and a 2.5 fold increase in exposure of alfuzosin 10 mg OD when administered under fed conditions. Other parameters

such as t

and t

were not modified.

The increase in alfuzosin C

and AUC

(last)

following repeated 400 mg daily administration of ketoconazole was 2.3-

fold, and 3.2-fold , respectively (see section5.2).

See also section 4.4.

4.6 Fertility, pregnancy and lactation

In view of the area of indication this section is not applicable.

4.7 Effects on ability to drive and use machines

There are no data available on the effect on driving vehicles.

Adverse reactions such as dizziness and asthenia may occur essentially at the beginning of treatment. This has to be

taken into consideration when driving vehicles and operating machines.

4.8 Undesirable effects

Classification of expected frequencies:

Very common (

1/10), 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), not known (cannot be estimated from the available data).

Frequency

Common

Uncommon

Very rare

Not Known

Blood and

lymphatic

system disorders

Neutropenia,

thrombocytopenia

Cardiac

disorders

Tachycardia

Angina

pectoris in

patients with

pre-existing

coronary

artery disease

(see section

4.4)

Atrial fibrillation

Vascular

disorders

Hypotension

(postural),

flushing

Nervous system

disorders

Dizziness,

headache

Syncope,

Vertigo

Eye disorders

Intraoperative

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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in

this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;

Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie. By reporting side

effects you can help provide more information on the safety of this medicine.

4.9 Overdose

In case of overdosage, the patient should be hospitalized, kept in the supine position, and conventional treatment of

hypotension should take place.

In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on

vascular muscle fibres

Alfuzosin is highly protein-bound, therefore, dialysis may not be of benefit.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic category: alpha-adrenoreceptor antagonists. ATC code: G04C A01 Alfuzosin

Alfuzosin, a racemic compound, is an orally active quinazoline derivative that selectively blocks post-synaptic alpha-l-

receptors. In vitro studies have shown that the substance acts selectively on alpha-1-receptors in the trigone of the urine

bladder, the urethra and the prostate gland. The clinical symptoms of benign prostate hyperplasia are not only related to

the size of the prostate but also to the sympathicomimetic nerve impulses which through stimulation of the postsynaptic

alpha-receptors increase the tension of the smooth muscles of the lower urinary tract. Through treatment with alfuzosin

the smooth muscles relax as a result of which the urine flow improves.

The clinical evidence of the selective effect on the urinary tract is shown by the clinical efficacy and the good safety

profile in men treated with alfuzosin, including elderly patients and patients with hypertension.

Alfuzosin can result in

moderate antihypertensive effects.

floppy iris

syndrome

Respiratory,

thoracic and

mediastinal

disorders

Rhinitis

Gastrointestinal

disorders

Nausea,

abdominal pain

Diarrhoea

Vomiting

Skin and

subcutaneous

tissue disorders

Rash, pruritus

Urticaria,

angioedema

General

disorders and

administration

site conditions

Asthenia

Oedema, chest

pain

Hepatobiliary

disorders

Hepatocellular

injury, cholestatic

liver disease

Reproductive

system and

breast disorders

Priapism

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In men, alfuzosin improves the voiding of water by reducing urethral muscle tone and bladder outlet resistance, thereby

facilitating bladder emptying.

In patients treated with alfuzosin a lower frequency of acute urine retention was observed than in untreated patients.

In placebo-controlled studies in patients with benign prostate hyperplasia alfuzosin:

significantly increased maximum urine flow (Q

) in patients with Q

<15 ml/sec by an average of

30%. This

improvement was observed from the first dose;

a significantly reduced detrusor pressure and an increased volume, producing a strong desire to void,

a significantly reduced the residual urine volume.

These urodynamic effects result in an improvement in lower urinary tract symptoms (LUTS), i.e. symptoms relating to

retention (irritating) and urine discharge (obstructive) which is clearly demonstrated.

Paediatric population

Alfuzosin is not indicated for use in the paediatric population (see section 4.2).

Efficacy of alfuzosin hydrochloride was not demonstrated in the two studies conducted in 197 patients 2 to 16 years of

age with elevated detrusor leak point pressure (LPP 40 cm H

O) of neurologic origin. Patients were treated with

alfuzosin hydrochloride 0.1 mg/kg/day or 0.2 mg/kg/day using adapted paediatric formulations.

5.2 Pharmacokinetic properties

Alfuzosin has linear pharmacokinetics in the therapeutic dosage range. The kinetic profile is characterised by large

inter-individual fluctuations in the plasma concentration. Absorption is increased when the medication is administered

after a meal.

Absorption

After the first dose (following a meal) the mean maximum plasma concentration was 7.72 ng/ml and the AUC

ng x h/ml (after a meal) and the t

was 6.69 hours (after a meal).

In steady state conditions (after a meal) the mean AUC over the dosage interval (AUC ) was 145 ng x h/ml, the mean

10.6 ng/ml and C

was 3.23 ng/ml.

Distribution

Plasma protein binding is approx. 90%. The distribution volume of alfuzosin in healthy test subjects is 2.5 l/kg. It has

been shown that the substance is distributed more in the prostate than in the plasma.

Elimination

The apparent elimination half-life is approximately 8 hours. Alfuzosin is largely metabolised in the liver (various

routes), the metabolites are eliminated by the kidneys and probably also via the bile, 75-91% of an oral dose is

eliminated in the faeces, 35% in unmodified form and the rest as metabolites, which indicates that some excretion via

the bile takes place. Around 10% of the dose is eliminated in unmodified form in the urine. None of the metabolites are

pharmacologically active.

Renal or hepatic impairment

The volume of distribution and clearance increases with reduced renal function, possibly owing to a decreased degree

of protein binding. The half-life, however, is unchanged. This change in the pharmacokinetic profile is not considered

clinically relevant. Therefore, this does not necessitate a dosing adjustment in patients with mild to moderate renal

insufficiency (see sections 4.2 and 4.4).

The half-life is prolonged in patients with severe hepatic insufficiency. The peak plasma concentration is doubled and

the bioavailability increases in relation to that in young, healthy volunteers. Alfuzosin 10 mg prolonged release tablets

are contraindicated in hepatic insufficiency (see section 4.3).

Elderly patients

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Compared to healthy middle-aged volunteers, the peak plasma concentration (C

) and bioavailability (AUC) are not

increased in elderly patients. The elimination half-life (t

) remains unchanged.

5.3 Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity, carcinogenic

potential or reproductive toxicity for males.

In vitro, alfuzosin prolonged the action potential duration and QT interval

duration at a clinically relevant concentration.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet Core:

Hypromellose (E464)

Hydrogenated vegetable oil

Povidone (K-30) (E1201)

Calcium hydrogen phosphate anhydrous

Carbomer

Silica colloidal anhydrous (E551)

Magnesium stearate (E572)

Film-coating:

Hypromellose (E464)

Propylene glycol

Titanium dioxide (E171)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Alfu tablets are available in clear PVC/PVdC Aluminium blister packs and white opaque round HDPE bottles

containing silica gel.

Package sizes:

Blister pack: 30, 50 & 100 tablets

HDPE bottle pack: 30, 500 & 1000 tablets

Not all pack sizes may be marketed

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6.6 Special precautions for disposal and other handling

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Milpharm Limited

Ares, Odyssey Business Park,

West End Road,

South Ruislip, RA4 6QD

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1050/022/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 8

August 2014

Date of last renewal: 9th January 2017

10 DATE OF REVISION OF THE TEXT

March 2017

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