natgillin/translations-raw huggingface dataset:
се на метформин, особено при онези, чиито бъбреци не работят правилно
particularly those whose kidneys are not working properly
- замъглено виждане, дължащо се на подуване (или течност) в задната част на окото.
- blurred vision due to swelling (or fluid) in the back of the eye.
СЪХРАНЕНИЕ НА COMPETACT
HOW TO STORE COMPETACT
Не използвайте Competact след срока на годност отбелязан върху картонената кутия и блистера.
Do not use Competact after the expiry date which is stated on the carton and blister.
6.
26 6.
Какво съдържат таблетките Competact Активните съставки са 15 mg пиоглитазон (като хидрохлорид) и 850 mg метформин хидрохлорид.
What Competact Tablets contain The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
Другите съставки са микрокристална целулоза, повидон (K30), кроскармелоза натрий, мaгнезиев стеарат, хипромелоза, макрогол 8000, талк и титанов диоксид.
The other ingredients are, microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.
Как изглеждат таблетките Competact и какво съдържа опаковката Таблетките Competact са бели до почти бели, продълговати, изпъкнали, филмирани таблетки, с изпъкнало релефно означение ‘ 15 / 850 ’ от едната страна и ‘ 4833M ’ oт другата.
What Competact Tablets look like and contents of the pack Competact tablets are white to off white, oblong, convex, film-coated tablets embossed ‘ 15 / 850’ on one face and ‘ 4833M’ on the other.
Таблетките се доставят в блистерни опаковки, съдържащи 14, 28, 30, 50, 56, 60, 90, 98 или 180 таблетки.
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 60, 90, 98 or 180 tablets.
Притежател на разрешението за употреба и производител Притежател на разрешението за употреба:
Marketing Authorisation Holder and Manufacturer Marketing authorisation holder:
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, Обединеното кралство.
Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, United Kingdom.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I- 28065 Cerano (NO), Италия.
Takeda Italia Farmaceutici SpA, Via Crosa, 86, I-28065 Cerano (NO), Italy.
België/ Belgique/ Belgien Takeda Global R & D Centre (Europe), Royaume- Uni Tél/ Tel: + 44 (0) 20 3116 8953
België/ Belgique/ Belgien Takeda Global R & D Centre (Europe), Royaume-Uni Tél/ Tel: + 44 (0)20 3116 8953
Luxembourg/ Luxemburg Takeda Global R & D Centre (Europe), Royaume- Uni Tél/ Tel: + 44 (0) 20 3116 8954
Luxembourg/ Luxemburg Takeda Global R & D Centre (Europe), Royaume-Uni Tél/ Tel: + 44 (0)20 3116 8954
България Takeda Global R & D Centre (Europe), Обединеното кралство Teл.: +44 (0) 20 3116 8000
България Takeda Global R & D Centre (Europe), Обединеното кралство Teл.: +44 (0)20 3116 8000
Magyarország Takeda Global R & D Centre (Europe), Nagy- Britannia Tel.: +44 (0) 20 3116 8000
Magyarország Takeda Global R & D Centre (Europe), Nagy-Britannia Tel.: +44 (0)20 3116 8000
29 Danmark Takeda Global R & D Centre (Europe), Storbritannien Tlf: + 44 (0) 20 3116 8952
Danmark Takeda Global R & D Centre (Europe), Storbritannien Tlf: + 44 (0)20 3116 8952
Tel: +31 (0) 30 60 25 800
Tel: +31 (0) 30 60 25 800
Deutschland Takeda Pharma GmbH Tel: + 49 (0) 241 941- 0
Deutschland Takeda Pharma GmbH Tel: + 49 (0) 241 941-0
Eesti Österreich Eli Lilly Holdings Limited Eesti filiaal Tel: +3726441100
Eesti Eli Lilly Holdings Limited Eesti filiaal Tel: +3726441100
Takeda Pharma Ges m. b. H.
Österreich Takeda Pharma Ges m. b. H.
Ελλάδα ΦΑΡΜΑΣΕΡΒ- ΛΙΛΛΥ Α. Ε. Β. Ε.
Ελλάδα ΦΑΡΜΑΣΕΡΒ -ΛΙΛΛΥ Α .Ε .Β .Ε.
Polska Takeda Global R & D Centre (Europe), Wielka Brytania Tel.: +44 (0) 20 3116 8000
Polska Takeda Global R & D Centre (Europe), Wielka Brytania Tel.: +44 (0)20 3116 8000
España Lilly S. A.
27 España Lilly S. A.
Suomi/ Finland Oy Eli Lilly Finland Ab Puh/ Tel: +358 (0) 9 8545250
Suomi/ Finland Oy Eli Lilly Finland Ab Puh/ Tel: +358 (0)9 8545250
Sverige Takeda Global R & D Centre (Europe), Storbritannien Tel: + 44 (0) 20 3116 8951
Sverige Takeda Global R & D Centre (Europe), Storbritannien Tel: + 44 (0)20 3116 8951
Дата на последно одобрение на листовката 28 юли 2006
This leaflet was last approved on {date}
EMEA/ H/ C/ 171
EMEA/ H/ C/ 171
ЕВРОПЕЙСКИ ДОКЛАД ЗА ОБЩЕСТВЕНА ОЦЕНКА (EPAR) COMTAN
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Предлага се под формата на кафяво- оранжеви таблетки от 200 mg.
It is available as brown-orange tablets (200 mg).
Comtan се използва за лечение на пациенти с болест на Паркинсон.
Comtan is used to treat patients with Parkinson’ s disease.
Болестта на Паркинсон е прогресиращо мозъчно заболяване, което причинява треперене, забавяне на движенията и мускулна ригидност (скованост).
Parkinson’ s disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Comtan се прилага като допълнение към леводопа (в комбинация леводопа и бензеразид или леводопа и карбидопа), когато пациентът има „ флуктуации ” към края на периода между две дози от лекарството.
Comtan is used together with levodopa (either a combination of levodopa and benserazide or a combination of levodopa and carbidopa) when the patient is having ‘ fluctuations ’ towards the end of the period between two doses of their medication.
Те се свързват с намаляване на ефектите на леводопа, когато пациентът изпитва внезапни преходи от състояние “ ON ” и способност за се движи към състояние “ OFF ” и затруднения при движение.
They are linked with a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘ on’ and able to move, and being ‘ off ’ and having difficulties moving about.
Не трябва да се използва с комбинации, които са с „ контролирано освобождаване ” (когато леводопа се освобождава бавно в продължение на няколко часа след приложението).
It should not be used with combinations that are ‘ modified release’ (when the levodopa is released slowly over a few hours).
При пациенти с болест на Паркинсон мозъчните клетки, които произвеждат невротрансмитера допамин, започват да умират и количеството на допамин в мозъка намалява.
The patients then lose their ability to control their movements reliably.
Тогава пациентите губят способност да контролират уверено движенията си.
The active substance in Comtan, entacapone, works to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Активното вещество в Comtan, ентакапон, възстановява нивата на допамин в онези части на мозъка, които контролират движенията и координацията.
It only works when it is taken with levodopa, a copy of the neurotransmitter dopamine that can be taken by mouth.
То действа само когато се приема с леводопа – копие на 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Entacapone blocks an enzyme that is involved in the break down of levodopa in the body called 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
В резултат леводопа остава активен по- дълго.
As a result, levodopa remains active for longer.
Това помага да се подобрят симптомите на болестта на Паркинсон, например скованост и забавяне на движенията.
This helps to improve the symptoms of Parkinson’ s disease, such as stiffness and slowness of movement.
Как е проучен Comtan? Comtan е изследван при общо 376 пациенти с болест на Паркинсон в две шестмесечни проучвания, които измерват ефектите от добавянето на Comtan или плацебо (сляпо лечение) към комбинацията на пациента от леводопа и карбидопа или от леводопа и бензеразид.
Comtan has been studied in a total of 376 patients with Parkinson’ s disease, in two six-month studies that measured the effects of adding Comtan or placebo (a dummy medicine) to the patient’ s combination of levodopa and carbidopa or levodopa and benserazide.
Основната мярка за ефективност е продължителността на “ ON ” времето (когато леводопа контролира симптомите на болестта на Паркинсон) след първата доза леводопа сутринта в първото проучване и в продължение на един ден във второто проучване.
The main measure of effectiveness was the time spent in the ‘ on’ state (the time when levodopa is controlling the symptoms of Parkinson’ s disease) after the first levodopa dose of the morning in the first study, and over one day in the second study.
Comtan е по- ефективен от плацебо и в двете проучвания.
Comtan was more effective than placebo in both studies.
При първото проучване добавянето на Comtan увеличава “ ON ” времето с 1 час и 18 минути в сравнение с добавянето на плацебо.
In the first study, adding Comtan increased the ‘ on’ time by 1 hour and 18 minutes more than adding placebo.
При второто проучване “ ON ” времето се увеличава 35 минути, сравнено с плацебо.
In the second study, the ‘ on’ time was increased by 35 minutes compared with placebo.
Най- честите нежелани реакции при Comtan (наблюдавани при 1 до 10 на 100 пациенти) са дискинезия (неконтролирани движения), гадене (позиви за повръщане) и безвредна промяна в цвета на урината.
The most common side effects with Comtan (seen in between 1 and 10 patients in 100) are dyskinesia (uncontrollable movements), nausea (feeling sick) and harmless urine discoloration.
Comtan не трябва да се прилага при пациенти със: • чернодробни заболявания; • феохромоцитом (тумор на надбъбречната жлеза); • анамнеза за малигнен невролептичен синдром (опасно нарушение на нервната система, обикновено причинено от антипсихотични лекарства) или рабдомиолиза (разрушаване на мускулните влакна).
Comtan should not be used in patients with: • liver disease; • phaeochromocytoma (a tumour of the adrenal gland); • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Comtan не трябва да се използва като допълнение към други лекарства, принадлежащи към групата на „ инхибиторите на моноаминоксидазата ” (вид антидепресанти).
Comtan should not be used together with other medicines that belong to the group ‘ monoamine oxidase inhibitors ’ (a type of antidepressant).
За пълна информация вижте Кратката характеристика на продукта (също част от EPAR).
See the Summary of Product Characteristics (also part of the EPAR) for full details.
Комитетът по лекарствените продукти за хуманна употреба (CHMP) решава, че ползите от Comtan са по- големи от рисковете като допълнение към стандартните лекарствени продукти, съдържащи леводопа/ бензеразид или леводопа/ карбидопа, за употреба при пациенти с болест на Паркинсон и моторните флуктуации при изчерпване на дозата, които не могат да бъдат стабилизирани с тези комбинирани дозови режими.
The Committee for Medicinal Products for Human Use (CHMP) decided that Comtan’ s benefits are greater than its risks as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Comtan 200 mg
Comtan 200 mg film-coated tablets
200 mg
Each film-coated tablet contains 200 mg entacapone.
:
Excipients:
1, 82 mg
Each tablet contains 1.82 mg sucrose.
.
For a full list of excipients, see section 6.1.
-
Film-coated tablet
“ Comtan ”,
Brownish-orange, oval, biconvex film-coated tablet with “ Comtan ” engraved on one side.
4. 1
4.1 Therapeutic indications
!
Entacapone is indicated as an adjunct to standard preparations of levodopa/ benserazide or levodopa/ carbidopa for use in adult patients with Parkinson’ s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
"
4.2 Posology and method of administration
,
The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
200 mg
Posology One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose.
200 mg
The maximum recommended dose is 200 mg ten times daily, i. e.
000 mg
2,000 mg of entacapone.
levodopa
Entacapone enhances the effects of levodopa.
.
If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
: '
Hence, patients who are taking standard levodopa/ benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
.
Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment.
5. 2).
However, for patients who are receiving dialysis therapy, a longer 2 dosing interval may be considered (see section 5.2).
4. 3.
Hepatic impairment: see section 4.3.
:
Elderly:
: (
Children:
18
Comtan is not recommended for use in children below age 18 due to lack of data on safety and efficacy.
)
Method of administration Entacapone is administered orally and simultaneously with each levodopa/ carbidopa or levodopa/ benserazide dose.
,
Entacapone can be taken with or without food (see section 5.2).
(
4.3 Contraindications
/
- Hypersensitivity to the active substance or to any of the excipients.
/
- Hepatic impairment.
5. 2).
- Phaeochromocytoma.
4. 3
- Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B)
!
inhibitors (e. g. phenelzine, tranylcypromine).
"
- Concomitant use of a selective MAO-A inhibitor plus a selective MAO-B inhibitor and
MAO- B) (
entacapone (see section 4.5).
.
- A previous history of neuroleptic malignant syndrome (NMS) and/ or non-traumatic
4. 5).
rhabdomyolysis.
'
4.4 Special warnings and precautions for use
$&
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson’ s disease.
/
In individual cases, only some of these symptoms and/ or findings may be evident.
(
When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/ or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
(
Thus, entacapone should be administered cautiously to patients being treated with medicinal products metabolised by catechol-O- methyl transferase (COMT), e. g. rimiterole, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine (see also section 4.5).
.
Entacapone is always given as an adjunct to levodopa treatment.
3
Hence, the precautions valid for 3 levodopa treatment should also be taken into account for entacapone treatment.
.
Entacapone should be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension.
,
The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated.
,,
Entacapone in association with levodopa has been associated with somnolence and episodes of sudden sleep onset in patients with Parkinson’ s disease and caution should therefore be exercised when driving or operating machines (see also section 4.7).
!
For patients experiencing diarrhoea, a follow-up of weight is recommended in order to avoid potential excessive weight decrease.
.
Pathological gambling, increased libido and hypersexuality have been reported in Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa.
%
For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
, 4. 5).
Comtan tablets contain sucrose.
,
4.5 Interaction with other medicinal products and other forms of interaction
,
Pharmacokinetic interaction with benserazide has not been studied.
,
Caution should be exercised when these medicinal products are used concomitantly with entacapone (see also sections 4.3 and 4.4).
5- 10%.%
Entacapone may be used with selegiline (a selective MAO-B inhibitor), but the daily dose of selegiline should not exceed 10 mg.
.
Entacapone and iron preparations should be taken at least 2– 3 hours apart (see section 4.8).
4. 2
According to in vitro studies, significant displacement is not anticipated at therapeutic concentrations of the medicinal products.
4. 8).
Thus, control of INR is recommended when entacapone treatment is initiated for patients receiving warfarin.
)
4.6 Pregnancy and lactation
!
As there is no experience in pregnant women, entacapone should not be used during pregnancy.
!
Women should not breast-feed during treatment with entacapone.
,.
4.7 Effects on ability to drive and use machines
.
Therefore, caution should be exercised when driving or using machines.
,
Patients being treated with entacapone in association with levodopa and presenting with somnolence and/ or sudden sleep onset episodes must be instructed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e. g. operating machines) until such recurrent episodes have resolved (see also section 4.4).
Comtan
4.8 Undesirable effects
,
Urine may be discoloured reddish-brown by entacapone, but this is a harmless phenomenon.
&
In clinical studies the most common adverse reactions leading to discontinuation of entacapone treatment have been gastrointestinal symptoms (e. g. diarrhoea, 2.5%) and increased dopaminergic adverse reactions of levodopa (e. g. dyskinesias, 1.7%).
-
Dyskinesias (27%), nausea (11%), diarrhoea (8%), abdominal pain (7%) and dry mouth (4.2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo.
.
Some of the adverse reactions, such as dyskinesia, nausea, and abdominal pain, may be more common with the higher doses (1,400 to 2,000 mg per day) than with the lower doses of entacapone.
,
The following adverse drug reactions, listed below in Table 1, have been accumulated both from clinical studies with entacapone and since the introduction of entacapone into the market.
4. 5
Table 1* Adverse drug reactions 5 Nervous system disorders
(& * +
Very common:
+ & '#
Common:
,
Dyskinesia Parkinsonism aggravated, dizziness, dystonia, hyperkinesia
+
Gastrointestinal disorders
& '- (,
Very common:
(& * +
Common:
(
Nausea Diarrhoea, abdominal pain, dry mouth, constipation, vomiting Anorexia Colitis
&
Renal and urinary disorders
.
Very common:
.
Urine discoloration
!,
Skin and subcutaneous tissue disorders
!,
Rare:
MAO- A
Very rare:
COMT (
Not known:
.
Erythematous or maculopapular rash Urticaria Skin, hair, beard and nail discolorations
,,
General disorders and administration site conditions
:,
Common:
(
Very rare
,
Fatigue, sweating increased, fall Weight decrease
(
Hepatobiliary disorders
4. 3
Rare:
4. 4).
Not known:
)
Hepatic function tests abnormal Hepatitis with mainly cholestatic features (see section 4.4)
(10 mg.
Psychiatric disorders
MAO- B
Common:
4. 8).
Very rare:
II
Insomnia, hallucinations, confusion, paroniria Agitation
)
Very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
,
Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
!
Parkinson’ s disease patients treated with dopamine agonists and other dopaminergic treatments such as entacapone in association with levodopa, especially at high doses, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, which were generally reversible upon reduction of the dose or treatment discontinuation.
,
Isolated cases of NMS have been reported following abrupt reduction or discontinuation of entacapone and other dopaminergic treatments.
&
Isolated cases of rhabdomyolysis have been reported.
in vitro!!
4.9 Overdose
,
The acute symptoms and signs in these cases of overdose included confusion, decreased activity, somnolence, hypotonia, skin discolouration and urticaria.
2C9 in vitro (
Management of acute overdose is symptomatic.
5. 2),
5.
18% [CI90 11- 26%].%
PHARMACOLOGICAL PROPERTIES
13% [CI90 6- 19%].
5.1 Pharmacodynamic properties
,
Pharmacotherapeutic group: other dopaminergic agents, ATC code:
INR.
NO4BX02.
4. 6
6 Entacapone belongs to a new therapeutic class, catechol-O-methyl transferase (COMT) inhibitors.
, 1, 7%).
This leads to a higher levodopa AUC.
#
COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
(27%),
The results are given in Table 2.
2
Table 2:
4. 4)
Daily ON time (Mean ± SD)
:
Study I:
(41/ 10);
Daily On time (h) Baseline
(41/ 100, < 1/ 10);
Entacapone (n=85) 9.3±2.2
(41/ 1 000, < 1/ 100); (
Placebo (n=86) 9.2±2.5
16 000 mg. /
Difference
NO4BX02.
Week 8-24
(COMT).,
10.7±2.2
COMT. - -.
9.4±2.6
. 1
1 h 20 min (8.3%) CI95% 45 min, 1 h 56
II -
Study II:
1h 20 min (8, 3%) CI95% 45 min, 1 h 56
Proportion of daily On time (%) Baseline
(n=103)
Entacapone (n=103) 60.0±15.2
#%) (n=102)
Placebo (n=102) 60.8±14.0
60, 0±15, 2
Difference
60, 8±14, 0
Week 8-24
66, 8±14, 5
66.8±14.5
62, 8±16, 80
62.8±16.80
0%
4.5% (0 h 35 min) CI95% 0.93%, 7.97%
!
There were corresponding decreases in OFF time.
I.
The% change from baseline in OFF time was – 24% in the entacapone group and 0% in the placebo group in study I.
– 5%.
The corresponding figures in study II were – 18% and – 5%.
8 5. 2
5.2 Pharmacokinetic properties
(
General characteristics of the active substance Absorption There are large intra- and interindividual variations in the absorption of entacapone.
200 mg. "
The peak concentration (Cmax) in plasma is usually reached about one hour after ingestion of a 200 mg entacapone tablet.
35%
The bioavailability of entacapone is about 35% after an oral dose.
20
Distribution After absorption from the gastrointestinal tract, entacapone is rapidly distributed to the peripheral tissues with a distribution volume of 20 litres at steady state (Vdss).
30
Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
800 ml/ min.
The total clearance of entacapone is about 800 ml/ min.
,
At therapeutic concentrations,
.
7 entacapone does not displace other extensively bound substances (e. g. warfarin, salicylic acid, phenylbutazone, or diazepam), nor is it displaced to any significant extent by any of these substances at therapeutic or higher concentrations.
)
Metabolism A small amount of entacapone, the (E)-isomer, is converted to its (Z)-isomer.
95% AUC
The (E)-isomer accounts for 95% of the AUC of entacapone.
5%.
The (Z)-isomer and traces of other metabolites account for the remaining 5%.
(CYP1A2,
Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 ∼ 4 µM).
CYP2A6, CYP2D6, CYP2E1, CYP3A
Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section 4.5).
CYP2C19) (
It is estimated that 80– 90% of the dose is excreted in faeces, although this has not been confirmed in man.
80- 90% 10- 20%
Approximately 10– 20% is excreted in urine.
(95%)
The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
1
Of the metabolites found in urine only about 1% have been formed through oxidation.
!
However, a longer dosing interval may be considered for patients who are receiving dialysis therapy.
.
5.3 Preclinical safety data
,
Regarding reproduction toxicity, decreased foetal weight and a slightly delayed bone development were noticed in rabbits at systemic exposure levels in the therapeutic range.
(2
Tablet core Microcrystalline cellulose Mannitol Croscarmellose sodium Hydrogenated vegetable oil Magnesium stearate
(E172) * (E172)
8 Film-coating Hypromellose Polysorbate 80 Glycerol 85% Sucrose Yellow iron oxide (E172) Red iron oxide (E172) Titanium dioxide (E171)
- (E171)
6.2 Incompatibilities
+ / (+
Not applicable.
3
3 years
% #
This medicinal product does not require any special storage conditions.