Medica RCP |Accotim 250mg | Indications | Side Effects | Composition | Route | all.price

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Products » Items » Accotim 250mg

Contraindicated
Teratogenic

Contraindicated

Accotim 250mg :
Type	Medicine Authorised
Originator	Temodal Capsules 250mg
Agent	Mediterranean Pharmaceutical Company
Distributor	Mediterranean Pharmaceutical Company
Laboratory	Accord HealthCare
Responsible Party	Accord Healthcare Limited
Origin	UK
Manufacturer	Accord healthcare Limited
Manufacturing Type	G
Origin	UK
ATC	L01AX03

Accotim 250mg :

Oral

Accotim 250mg :

L Antineoplastic and immunomodulating agents

L01 Antineoplastic agents

L01A Alkylating agents

L01AX Other Alkylating agents

L01AX03 Temozolomide

Accotim 250mg :

Temozolomide : 250mg

Accotim 250mg :

Adults : Malignant glioma 200mg/m²/day for 5 days of a 28 day cycle treatment

Accotim 250mg :

Colloidal silica anhydrous (colloidal silicon dioxide) (Aerosil 200) (E551) Anti-caking

◼

Lactose anhydrous*

Sodium carboxymethyl starch

Stearic acid (E570) Thickeners and Stabilizers

Tartaric acid (E334)

* Excipient with known effect

Hazard Level
◼ Major
◼ Moderate
◼ Minor
◼ Safe

Accotim 250mg :

Gelatin

Titanium dioxide (E171) (CI 77891)

Water

Accotim 250mg :

Black iron oxide (E172i) CI 77499

Potassium hydroxide

Propylene glycol * (E 1520)

Shellac (E904)

Accotim 250mg :

Revision Date : 27/05/2015

Frequency	Percentage
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
Unknown	Cannot be Estimated

Effect	Frequency
Abdominal distension	Uncommon
Abdominal pain	Common
Abnormal behaviour	Uncommon
Affect lability	Common
Agitation	Uncommon
Alopecia	Very Common
ALT increased	Common
Amenorrhoea (amenorrhea)	Uncommon
Amnesia	Uncommon
Anaemia	Common
Anaphylactic reactions	Very rare
Angioedema (Angioneurotic oedema) (Quincke oedema)	Very rare
Anxiety	Common
Apathy	Uncommon
Aphasia	Common
Aplastic anemia	Very rare
Arthralgia (Pain joint) (Joint ache)	Common
AST increased	Uncommon
Asthenia	Common
Ataxia	Uncommon
Back pain	Uncommon
Balance disorder	Common
Blood alkaline phosphatase increased	Uncommon
Bone marrow failure	Not known
Breast pain	Uncommon
Bronchitis	Uncommon
Cerebral haemorrhage	Uncommon
Chills	Common
Cholestasis	Uncommon
Cognitive disorder	Uncommon
Condition aggravated	Uncommon
Confusional state	Common
Constipation	Very Common
Coordination abnormal	Uncommon
Cough	Common
Cytomegalovirus infection	Uncommon
Deafness	Uncommon
Decreased appetite	Very Common
Deep vein thrombosis	Common
Depressed level of consciousness	Common
Depression	Common
Dermatitis	Common
Dermatitis exfoliative	Very rare
Diabetes insipidus	Uncommon
Diarrhoea (Diarrhea)	Common
Diplopia	Common
Disturbance in attention	Common
Dizziness	Common
Dry eye	Uncommon
Dry mouth (Xerostomia)	Common
Dry skin	Common
Dysguesia (taste perversion) (Taste abnormality) (Taste disturbance)	Common
Dyspepsia	Common
Dysphagia	Common
Dyspnoea (dyspnea)	Common
Dysuria (Micturition painful)	Uncommon
Erectile dysfunction	Uncommon
Erythema	Common
Erythema multiforme	Very rare
Extrapyramidal disorder	Uncommon
Eye pain	Uncommon
Face oedema	Common
Faecal incontinence	Uncommon
Fatigue	Very Common
Febrile neutropenia (Neutropenic fever)	Common
Flushing	Uncommon
Gait disturbance	Uncommon
Gamma-GT increased	Uncommon
Gastroenteritis	Uncommon
Gastrointestinal disorders	Uncommon
Haemorrhage	Common
Haemorrhoids	Uncommon
Hallucination	Uncommon
Headache	Very Common
Hemianopia	Uncommon
Hemiparesis	Common
Hemiplegia	Uncommon
Hepatic enzyme increased	Common
Hepatic failure (Hepatic insufficiency) (Liver failure)	Uncommon
Hepatitis	Uncommon
Hepatitis B	Uncommon
Herpes simplex	Common
Herpes zoster	Uncommon
Hot flush	Uncommon
Hyperacusis	Uncommon
Hyperaesthesia	Uncommon
Hyperbilirubinaemia	Uncommon
Hyperglycaemia	Common
Hyperhidrosis	Uncommon
Hypersensitivity	Common
Hypertension	Uncommon
Hypoacusis	Common
Hypoesthesia	Uncommon
Hypokalaemia	Uncommon
Infection	Common
Infection reactivation	Uncommon
Influenza-like illness	Uncommon
Insomnia	Common
Interstitial pneumonitis	Very rare
Leucopenia (Leukopenia)	Common
Liver injury	Uncommon
Lyell Syndrome (Toxic epidermal necrolysis)	Very rare
Lymphopenia	Very Common
Malaise	Common
Memory impairment	Common
Menorrhagia	Uncommon
Muscle weakness	Common
Musculoskeletal pain	Common
Myalgia	Common
Myelodysplastic syndrome	Very rare
Myeloid leukaemia	Very rare
Myopathy	Uncommon
Nasal congestion	Uncommon
Nausea	Very Common
Nervous system disorder	Common
Neuropathy peripheral	Common
Neutropenia	Very Common
Oedema	Common
Oedema peripheral	Common
Opportunistic infections	Rare
Oral candidiasis	Common
Otalgia (Earache) (Ear pain)	Uncommon
Otitis media	Uncommon
Pain	Common
Palpitations	Uncommon
Pancytopenia	Uncommon
Paraesthesia (paresthesia)	Common
Parosmia	Uncommon
Petechiae	Uncommon
Pharyngitis	Common
Photosensitivity reaction	Uncommon
Pigmentation disorder	Uncommon
Pneumocystis jirovecii pneumonia	Rare
Pneumonia	Uncommon
Pneumonitis	Very rare
Pollakiuria (Urinary frequency)	Common
Pruritus	Common
Pulmonary embolism	Uncommon
Pulmonary fibrosis	Very rare
Pyrexia	Common
Radiation injury	Common
Respiratory failure	Very rare
Seizures	Very Common
Sensory disturbance	Uncommon
Sinusitis	Uncommon
Skin exfoliation (Flaking skin)	Uncommon
Skin rash	Very Common
Somnolence	Common
Speech disorder	Common
Status epilepticus	Uncommon
Stevens-Johnson syndrome	Very rare
Stomatitis	Common
Thirst	Uncommon
Thrombocytopenia (Thrombopenia)	Very Common
Tinnitus	Common
Tongue discolouration	Uncommon
Tooth disorder	Uncommon
Tremor	Common
Upper respiratory tract infection	Uncommon
Urinary incontinence	Common
Urticaria	Very rare
Vaginal haemorrhage	Uncommon
Vaginal infection	Uncommon
Vertigo	Uncommon
Vision blurred	Common
Visual acuity reduced	Uncommon
Visual disturbance	Uncommon
Visual field defect	Common
Vomiting	Very Common
Weight decreased (Weight loss)	Common
Weight increased (weight gain)	Uncommon
Wound infection	Common

Accotim 250mg :

Belgium

Cyprus

Czech Republic

Denmark

Finland

France

Germany

Greece

Iceland

Ireland

Italy

Lebanon

Norway

Spain

Sweden

Switzerland

The Netherlands

Form	Capsule, hard
Package Size	Box of 5
Strength	250mg
Public Price	13397927.13 L.L.
Stratum	C
NSSF	✔
Quarantine	✘
Reg. Number	168816/1
Submission date	28/11/2016
Registration Year	2017

P.P. =	Public Price
P/U =	Price Per Unit

Medicine Authorised

Accotim 250mg

P.P. : 13397927.13 LBP

( Box of 5 )

P/U: 2679585.43 LBP

Mediterranean Pharmaceutical Company

Accord HealthCare

Medicine Authorised

Tegozol Capsules 250mg

P.P. : 24856894.21 LBP

( Box of 5 )

P/U: 4971378.84 LBP

Droguerie Mercury

Hikma Pharmaceuticals

Medicine Authorised

Temodal Capsules 250mg

P.P. : 18516504.71 LBP

( Box of 5 )

P/U: 3703300.94 LBP

Abela Freres

MSD

Medicine Authorised

Temozolomide GP-Pharm 250mg

P.P. : 13397927.13 LBP

( Box of 5 )

P/U: 2679585.43 LBP

Mediterranean Pharmaceutical Company

GP-Pharm

Medicine Authorised

Accotim 100mg

Mediterranean Pharmaceutical Company

Accord HealthCare

Medicine Authorised

Accotim 20mg

Mediterranean Pharmaceutical Company

Accord HealthCare

Medicine Authorised

Accotim 5mg

Mediterranean Pharmaceutical Company

Accord HealthCare

Medicine Authorised

Tegozol Capsules 100mg

Droguerie Mercury

Hikma Pharmaceuticals

Medicine Authorised

Tegozol Capsules 20mg

Droguerie Mercury

Hikma Pharmaceuticals

Medicine Authorised

Tegozol Capsules 250mg

Droguerie Mercury

Hikma Pharmaceuticals

Medicine Authorised

Temodal Capsules 100mg

Abela Freres

MSD

Medicine Authorised

Temodal Capsules 20mg

Abela Freres

MSD

Medicine Authorised

Temodal Capsules 250mg

Abela Freres

MSD

Medicine Authorised

Temozolomide GP-Pharm 100mg

Mediterranean Pharmaceutical Company

GP-Pharm

Medicine Authorised

Temozolomide GP-Pharm 20mg

Mediterranean Pharmaceutical Company

GP-Pharm

Medicine Authorised

Temozolomide GP-Pharm 250mg

Mediterranean Pharmaceutical Company

GP-Pharm

Medicine Authorised

Temozolomide GP-Pharm 5mg

Mediterranean Pharmaceutical Company

GP-Pharm