CALCICHEW-D 500/10 Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Available from:
Takeda UK Limited
ATC code:
A12AX
INN (International Name):
CALCIUM CARBONATE, CHOLECALCIFEROL CONCENTRATE (POWDER FORM)
Dosage:
500/10
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Calcium, combinations with other drugs
Authorization status:
Authorised
Authorization number:
PA1547/007/003
Authorization date:
2014-01-06

Package leaflet: Information for the user

Calcichew-D

Forte 500 mg/400 IUfilm-coated tablets

calcium/colecalciferol(vitamin D

)

Read allofthisleafletcarefullybeforeyou starttaking thismedicinebecauseitcontains important

information foryou.

Alwaystakethis medicine exactlyasdescribed in this leafletorasyourdoctororpharmacisthave told you.

- Keep this leaflet. You mayneed to read itagain.

- Askyourpharmacistifyou need more information oradvice.

- Ifyou getanyside effects,talkto yourdoctororpharmacist. This includesanypossibleside effects

notlisted inthis leaflet.See section 4.

What is in this leaflet:

1. WhatCalcichew-D

Fortefilm-coated tabletsareand whattheyareused for

2. Whatyou need to knowbeforeyou takeCalcichew-D

Forte film-coated tablets

3. Howto takeCalcichew-D

Forte film-coated tablets

4. Possible side effects

5. Howto storeCalcichew-D

Forte film-coated tablets

6. Contents ofthe packand otherinformation

1. WhatCalcichew-D

3 Forte film-coated tabletsis and what itis used for

Calcichew-D

Forte film-coated tabletsarefilm-coatedtablets containingcalciumand vitamin D3, which

both are importantsubstancesin bone formation.Calcichew-D

Forte film-coated tabletsareused in the

prevention and treatmentofcalciumand vitamin Ddeficiencyin the elderly, and as asupplementto specific

treatmentofosteoporosis.

2. What you need to knowbeforeyou takeCalcichew-D

3 Forte film-coated tablets

Do not takeCalcichew-D

3 Forte film-coated tablets:

- ifyou have excessive amounts ofcalciumin the blood orin the urine.

- ifyou have severekidneyproblems

- ifyou havekidneystones.

- ifyou haveexcessive amounts ofvitamin Din the blood.

- ifyou are allergic to calcium, vitamin D, oranyofthe otheringredients ofthis medicine (listed in

section 6).

Warnings and precautions

Talk to your doctororpharmacistbeforetakingCalcichew-D

3 Forte film-coated tablets

- ifyou are onlong-termtreatment, especiallyifyou alsotake diuretics(used in treatmentofhigh blood

pressure oroedema)orcardiacglycosides(used to treatheartdisorders).Pleaseconsultyourdoctor.

- ifyou have sarcoidosis(an immune systemdisorderwhich maycauseincreased levels ofvitamin Din

the body). Please consultyourdoctor.

- ifyouhave osteoporosis and are unable to move around. Please consultyourdoctor.

- ifyou take otherproducts containingvitamin D.Additionaldoses ofcalciumandvitamin Dshould be

taken underclosemedicalsupervision.

Other medicinesandCalcichew-D

3 Forte film-coated tablets

Tellyourdoctororpharmacistifyou are taking,have recentlytakenormighttakeanyothermedicines.

Calciumcarbonate mayinterfere with the absorptionoftetracyclines(a type ofantibiotics)iftaken atthe

same time. Forthis reason, tetracycline preparations should be taken atleast2 hours before or4-6 hours

afterintake ofCalcichew-D

Forte film-coated tablets.

Medicinescontainingbisphosphonates(used to treatosteoporosis)should be taken atleastonehourbefore

intake ofCalcichew-D

Forte film-coated tablets.

Calciumcan reduce the effectoflevothyroxine(used to treatthyroid deficiency). For this reason,

levothyroxine should be taken atleastfourhours before orfourhoursafterCalcichew-D

Forte film-coated

tablets.

The effectofquinolone antibioticsmaybe reduced iftaken atthe same time as calcium. Take quinolone

antibioticstwo hours before orsix hours aftertakingCalcichew-D

Fortefilm-coated tablets

Calciumsalts maydecreasethe absorption ofiron, zinc andstrontiumranelate. Consequentlyiron, zinc or

strontiumranelate preparations should be takenatleasttwo hours before orafterCalcichew-D

Forte film-

coated tablets.

Othermedicinesthatmayinfluenceorbe influencedbyCalcichew-D3Forte film-coated tabletsare:tiazide

diuretics(used in treatmentofhigh blood pressure and oedema)and cardiacglycosides(used to treatheart

disorders).

Orlistat(used to treatobesity)maydisturbthe absorption offat-soluble vitamins,e.g. vitamin D3.

Calcichew-D

Fortefilm-coated tabletswith food and drink

Calcichew-D

Forte film-coated tabletscan be taken with orwithoutfood and drink.

Pregnancy,breast-feedingandfertility

Ifyou are pregnantorbreast-feeding, thinkyou maybe pregnantorare planningto have ababy, askyour

doctororpharmacistbefore takingthis medicine.

Pregnancy

Duringpregnancythe dailyintake should notexceed 1500 mgcalciumand 600 IUvitamin D. Askyour

doctororpharmacistforadvice.Calcichew-D

Forte film-coated tabletscan be used duringpregnancy, in

caseofcalciumand vitamin Ddeficiency.

Breast-feeding

Calcichew-D

Forte film-coated tabletscan beused duringbreastfeeding.Calciumand vitamin D

pass into

breastmilk. This should be considered when givingadditionalvitamin Dto the child.

Driving and using machines

No studieson the effects on the abilityand use ofmachineshave been performed.An effectis however

unlikely.

Calcichew-D

3 Forte film-coated tabletscontains sorbitolandsucrose.

Calcichew-D

Forte film-coated tabletscontainssorbitoland sucrose. Ifyou have been told byyourdoctor

thatyou have an intolerance to some sugars, contactyourdoctorbefore takingthis medicinalproduct.May

be harmfulto the teeth.

3. Howto takeCalcichew-D

3 Forte film-coated tablets

Always takethis medicineexactlyasyourdoctorhastold you.Checkwith yourdoctororpharmacistifyou

are notsure.

Dosage:

Therecommendeddoseis onetablettwicedaily.The tabletmaybe swallowed orchewed.

Ifyou takemoreCalcichew-D

3 Forte film-coated tabletsthanyou should

Ifyou mayhave taken moreCalcichew-D

Forte film-coated tabletsthan you should, talkto yourdoctoror

pharmacistimmediately.

Ifyou forgetto takeCalcichew-D

3 Forte film-coated tablets

Do nottake adouble doseto make up fora forgotten tablet.

4. Possibleside effects

Like allmedicines,this medicinecan causeside effects, although noteverybodygets them.

Uncommonside effects(mayaffectup to 1 in 100 people):):Excessive amounts ofcalciumin the blood or

in the urine mayoccurwith large doses.

Rareside effects(mayaffectup to 1 in 1,000 people):constipation, flatulence, nausea, gastric pain,

diarrhoea.

Veryrareside effects(mayaffectup to 1 in 10,000 people):itchingandrashand dyspepsia.Milk-alkali

syndrome(also called Burnett’s syndrome andusuallyonlyseen when excessive amounts ofcalciumhave

been ingested), symptoms are frequenturge to urinate, headache,lossofappetite, nausea orvomiting,

unusualtirednessorweakness, alongwith elevated levels ofcalciumin the blood and kidneyimpairment.

Frequency notknown(cannotbe estimated fromthe available data):Hypersensitivityreactions such as

swellingofthe face, tongue, lips (angioedema)orswellingofthe throat(laryngealoedema).

Ifyou have impaired renalfunction, you maybe atriskofincreased amounts ofphoshate in the blood, renal

stone formation and increased amounts ofcalciumin the kidneys.

Reporting ofside effects

Ifyou getanyside effects, talkto yourdoctor, pharmacistornurse. This includesanypossible side effects

notlisted in this leaflet.You can also reportside effects directlyto HPRAPharmacovigilance, Earlsfort

Terrace, IRL-Dublin 2;Tel:+353 1 6764971; Fax:+353 1 6762517. Website:www.hpra.ie;E-mail:

medsafety@hpra.ie. Byreportingside effects you can help provide more information on the safetyofthis

medicine.

5. Howto storeCalcichew-D

3 Forte film-coatedtablets

Do notstore above25

C. Keep the containertightlyclosedin orderto protectfrommoisture.

Keepthis medicineoutofthe sightand reachofchildren.

Do notusethis medicineafterthe expirydate which is stated on thelabel.The expirydate refers to the last

dayofthatmonth.

Donotthrowanymedicinesvia wastewaterorhousehold waste. Askyourpharmacisthowtothrowaway

medicinesyouno longeruse. These measureswillhelp to protectthe environment.

6. Contentsofthe pack and other information

WhatCalcichew-D

3 Forte film-coated tabletscontains

- The active substancesare500 mgcalcium(ascalciumcarbonate)and 400 IUvitamin D

(equivalent

to10microgramscholecalciferol).

- The otheringredientsare

- tabletcore:sorbitolE420, mannitol, acesulfame potassium, flavouring(lemon),croscarmellose

sodium, microcrystallinecellulose, magnesiumstearate,maltodextrin, tocopherol-rich extract,all-rac-

alpha-tocopherol, sucrose,modifiedmaize starch, mediumchain triglycerides, sodiumascorbate and

anhydrous colloidalsilica

- film-coating:talc, hypromellose, propyleneglycol.

WhatCalcichew-D

3 Forte film-coated tabletslooks like andcontents ofthe pack

Calcichew-D

Forte film-coated tabletsarewhite/offwhite,ovalfilm-coatedtablets.

Packsizes:

20, 30, 50, 60, 90, 100, 120,180 and 250tablets. Notallpacksizesmaybe marketed.

Marketing Authorisation Holder

TakedaUKLimited

Building3

GloryPark

GloryParkAvenue

Wooburn Green

BUCKS

HP10 0DF

UK

Manufacturer

Takeda Pharma A/S

Langebjerg1

DK-4000 Roskilde

Denmark

or

TakedaPharma AS

Jaama 55B

63308 Põlva

Estonia

or

TakedaGmbH

Lehnitzstr. 70-98

DE-16515 Oranienburg

Germany

Thismedicinal productis authorised in the Member StatesoftheEEAunder the following names:

Austria: Cal-D-or500 mg/400 I.E.-Filmtabletten

Belgium: SteovitD3500 mg/400 I.E., filmomhulde tabletten

Denmark:Calcichew-D3ForteFlex

Estonia: CalcigranForte 500 mg/400 IUfilm-coated tabletsFlex

Finland: CalcichewD

Fortesitruuna 500 mg/10mikrog–kalvopäällysteinentabletti

Greece: CalcioralD

, 500 mg+ 10 µg(400 IU),επικαλυμμένομελεπτόυμένιοδισκίο

Ireland: Calcichew-D

Forte 500 mg/400 IUFilm-coated Tablets

Latvia: CalcigranForteFlex500 mg/400 IUSVapvalkotās tabletesLithuania: CalcigranForte

Flex500 mg/400 TVplėvele dengtos tabletės

Luxembourg:SteovitD3500 mg/400 U.I., comprimé pelliculé

Netherlands:Calci-Chew D3 FLEX500 mg/400 I.E.

Norway: CalcigranForte 500 mg/400 IEtabletter, filmdrasjerte

Poland: OrocalD

Tab

Sweden: Calci-D

Citron 500 mg/400 IE filmdragerad tablett

UK: Calcichew-D

500 mg/400IUCaplets

Thisleafletwas lastrevisedin10/2015

<Detailed information on this medicine is available on the web site ofMA/Agency

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Calcichew-D

Forte 500 mg / 400 IU Film-coated Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Calcium carbonate equivalent to 500 mg calcium

Cholecalciferol concentrate (powder form) equivalent to 400 IU (10 microgram ) cholecalciferol (vitamin D

Excipients with known effect:

Sorbitol (E420), 154 mg

Sucrose, 0.7 mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet

Oval, white/off white, film-coated tablets. May have hardly visible grey spots.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Prevention and treatment of vitamin D and calcium deficiency in the elderly.

Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatment of patients who are at risk of

vitamin D and calcium deficiency.

4.2 Posology and method of administration

Posology

Adults and elderly

One tablet twice daily.

Special Patient Populations

Paediatric population:

Calcichew-D3 Forte 500mg/400 IU Film-coated tablets is not intended for use in children.

Impaired renal function:

Calcichew-D3 Forte 500mg/400 IU Film-coated tablets should not be used in patients with severe renal impairment

(see section 4.3).

Impaired hepatic function:

No dose adjustment is required

Method of Administration

Oral. The tablet should be swallowed or chewed.

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4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Severe renal impairment (glomerular filtration rate < 30 ml/min/1.73m

Diseases and/or conditions resulting in hypercalcaemia and/or hypercalcuria

Renal calculi (nephrolithiasis)

Hypervitaminosis D

4.4 Special warnings and precautions for use

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through

measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with

cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of

hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

Calcium carbonate with cholecalciferol tablets should be used with caution in patients with hypercalcaemia or signs of

impaired of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue

calcification should be taken into account.

During concomitant treatment with other sources of vitamin D and/or medications or nutrients (such as milk)

containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome with subsequent kidney function

impairment. In these patients serum calcium levels should be followed and renal function should be monitored.

Calcichew-D3 Forte Film-coated tablets should be prescribed with caution to patients suffering from sarcoidosis, due to

the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to

the calcium content in serum and urine.

Calcichew-D3 Forte Film-coated tablets should be used cautiously in immobilised patients with osteoporosis due to

increased risk of hypercalcaemia.

Calcichew-D3 Forte Film-coated tablets contains sorbitol (E420) and sucrose. Patients with rare hereditary problems of

fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this

medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Thiazide diuretics reduce the urinary excretion of calcium,

therefore,

due to increased risk of hypercalcaemia,

serum

calcium should be regularly monitored during concomitant use of thiazide diuretics.

Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this

reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake

of calcium carbonate.

Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients

should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

If a bisphosphonate is used concomitantly, this preparation should be administered at least one hour before the intake of

Calcichew-D3 Forte 500mg/ 400 IU Film-coated tablets since gastrointestinal absorption may be reduced.

The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine

absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone

antibiotics should be taken two hours before or six hours after intake of calcium.

Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. Consequently, iron, zinc or strontium

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ranelate preparations should be taken at least two hours before or after Calcichew-D3 Forte 500mg/ 400 IU Film-coated

tablets.

Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (e.g. vitamin D

4.6 Fertility, pregnancy and lactation

Pregnancy

Calcichew-D3 Forte 500mg/400 IU Film-coated tablets can be used during pregnancy, in case of a calcium and vitamin

D deficiency. During pregnancy the daily intake should not exceed 2500 mg calcium and 4000 IU vitamin D. Studies in

animals have shown reproductive toxicity of high doses of vitamin D (see section 5.3). In pregnant women, overdoses

of calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the

developing foetus. There are no indications that vitamin D at therapeutic doses is teratogenic in humans.

Breast-feeding

Calcichew-D3 Forte 500mg/400 IU Film-coated tablets can be used during breast-feeding. Calcium and vitamin D3

pass into breast milk. This should be considered when giving additional vitamin D to the child.

4.7 Effects on ability to drive and use machines

Calcichew-D3 Forte 500mg/400 IU Film-coated tablets have no known influence on ability to drive and use machines.

4.8 Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon

1/1,000 to <1/100), rare (

1/10,000 to <1/1,000), or very rare (<1/10,000), or not known (cannot be estimated from

the available data).

Immune system disorders

Not known: Hypersensitivity reactions such as angio-oedema or laryngeal oedema.

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare:

Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or

vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). Seen usually only in

overdose (see section 4.9).

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain, and diarrhoea.

Skin and subcutaneous tissue disorders

Very rare: Pruritus, rash and urticaria.

Other special population

Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. See section

4.4.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions to HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:

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

4.9 Overdose

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Symptoms

Overdose can lead to hypercalcaemia and hypervitaminosis D. Symptoms of hypercalcaemia may include anorexia,

thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polidipsia,

polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia

may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue

calcification.

Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali.

Treatment of hypercalcaemia:

Treatment is essentially symptomatic and supportive. The treatment with calcium and vitamin D must be discontinued.

Treatment with thiazide diuretics, and cardiac glycosides must also be discontinued (see section 4.5). Emptying of the

stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined

treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and

diuresis must be monitored. In severe cases, ECG and CVP should be followed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Mineral supplements Calcium combinations with vitamin D and/or other drugs.

ATC code: A12AX

Vitamin D

increases the intestinal absorption of calcium.

Administration of calcium and vitamin D3 counteracts the increase of parathyroid hormone (PTH) which is caused by

calcium deficiency and which causes increased bone resorption.

A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of two

calcium and vitamin D3 500 mg/400 IU chewable tablets for six months normalised the value of the 25-hydroxylated

metabolite of vitamin D3 and reduced secondary hyperparathyroidism and alkaline phosphatases.

An 18 month double-blind, placebo controlled study including 3270 institutionalised women aged 84+/- 6 years who

received supplementation of vitamin D (800 IU/day) and calcium phosphate (corresponding to 1200 mg/day of

elemental calcium), showed a significant decrease of PTH secretion. After 18 months, an "intent-to treat" analysis

showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0,004). A

follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group

(n=1176) and 178 in the placebo group (n=1127) (p<0,02).

5.2 Pharmacokinetic properties

Calcium

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed

dose.

Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and

teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content

is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other

anions, the remaining 40% being bound to proteins, principally albumin.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration

and calcium tubular reabsorption.

Cholecalciferol

Absorption: Vitamin D

is easily absorbed in the small intestine.

Distribution and biotransformation: Colecalciferol and its metabolites circulate in the blood bound to a specific

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globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycholecalciferol. It is then further

converted in the kidneys to the active form 1,25 dihydroxycolecalciferol. 1,25 dihydroxycolecalciferol is the metabolite

responsible for increasing calcium absorption. Vitamin D which is not metabolised is stored in adipose and muscle

tissues.

Elimination: Vitamin D

is excreted in faeces and urine.

5.3 Preclinical safety data

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is

further no information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Tablet core:

Sorbitol (E420)

Mannitol

Acesulfame potassium

Flavouring (lemon)

Croscarmellose sodium

Cellulose, microcrystalline

Magnesium stearate

Maltodextrin

Tocopherol-rich extract

All-rac-alpha-tocopherol

Sucrose

Modified maize starch

Triglycerides, medium-chained

Sodium ascorbate

Silica, colloidal anhydrous

Film-coating:

Talc

Hypromellose

Propylene glycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C. Keep the container tightly closed in order to protect from moisture.

6.5 Nature and contents of container

The film-coated tablets are packed in:

HDPE containers with HDPE screw caps: 20, 30, 50, 60, 90, 100, 120, 180 and 250 tablets

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Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements for disposal.

7 MARKETING AUTHORISATION HOLDER

Takeda UK Limited

Building 3, Glory Park

Glory Park Avenue,

Woodburn Green,

Buckinghamshire,

HP10 0DF

United Kingdom

8 MARKETING AUTHORISATION NUMBER

PA1547/007/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11th December 2009

Date of last renewal: 4th June 2013

10 DATE OF REVISION OF THE TEXT

November 2015

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