Clopixol 10mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Zuclopenthixol dihydrochloride

Dostopno od:

Lundbeck Ltd

Koda artikla:

N05AF05

INN (mednarodno ime):

Zuclopenthixol dihydrochloride

Odmerek:

10mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04020100; GTIN: 5702157108800

Navodilo za uporabo

Package leaflet: Information for the user
Clopixol
®
10mg Tablets
(zuclopenthixol dihydrochloride)
The name of your medicine is Clopixol 10mg Tablets but will be
referred to as Clopixol Tablets throughout this leaflet. Please
note that this leaflet also contains information about other
strengths such as Clopixol 2mg and Clopixol 25mg Tablets.
In this leaflet:
1.
What Clopixol Tablets are and what they are used for
2.
What you need to know before you take Clopixol Tablets
3.
How to take Clopixol Tablets
4.
Possible side effects
5.
How to store Clopixol Tablets
6.
Further information
1.
What Clopixol Tablets are and what they are used for
Clopixol Tablets contain the active substance zuclopenthixol and
belong to a group of medicines known as antipsychotics (also
called neuroleptics).
These medicines act on nerve pathways in specific areas of the
brain and help to correct certain chemical imbalances in the
brain that are causing the symptoms of your illness.
Clopixol Tablets are used for the treatment of schizophrenia and
other psychoses.
Your doctor, however, may prescribe Clopixol Tablets for
another purpose. Ask your doctor if you have any questions
about why Clopixol Tablets have been prescribed for you.
2.
What you need to know before you take Clopixol
Tablets
Do not take Clopixol Tablets
•
If you are allergic to zuclopenthixol, other thioxanthene drugs
or antipsychotic drugs or any of the other ingredients of this
medicine (listed in section 6).
•
If you are feeling less alert than usual, or are drowsy or
sleepy or have serious problems with your blood circulation
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Clopixol
Tablets:
•
If you have a heart condition, including an irregular heart
beat (such as a slower heart beat); have had a recent heart
attack or have problems that cause ankle swelling or
shortness of breath
•
If you have severe breathing problems (such as asthma or
bronchitis)
•
If you have liver, kidney or thyroid problems
•
If you suffer from epilepsy

Lastnosti izdelka

OBJECT 1
CLOPIXOL TABLETS 2, 10 AND 25MG
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
1. Name of the medicinal product
Clopixol 2 mg film-coated tablets
Clopixol 10 mg film-coated tablets
Clopixol 25 mg film-coated tablets
2. Qualitative and quantitative composition
2 mg film-coated tablets
Each tablet contains 2 mg zuclopenthixol (as dihydrochloride)
10 mg film-coated tablets
Each tablet contains 10 mg zuclopenthixol (as dihydrochloride)
25 mg film-coated tablets
Each tablet contains 25 mg zuclopenthixol (as dihydrochloride)
Excipients with known effect:
Lactose monohydrate
Hydrogenated castor oil.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
2 mg: Round, biconvex, pale red, film-coated tablet.
10 mg: Round, biconvex, light red-brown, film-coated tablet.
25 mg: Round, biconvex, red-brown, film-coated tablet.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of psychoses, especially schizophrenia.
4.2 Posology and method of administration
Posology
_Adults_
The dosage range is 4-150 mg/day in divided doses. The usual initial
dose is 20-30 mg/day (sometimes
with higher dosage requirements in acute cases), increasing as
necessary. The usual maintenance dose is
20-50 mg/day.
Maximum dosage per single dose is 40 mg.
When transferring patients from oral to depot antipsychotic treatment,
the oral medication should not be
discontinued immediately, but gradually withdrawn over a period of
several days after administering the
first injection.
_Older patients_
In accordance with standard medical practice, initial dosage may need
to be reduced to a quarter or half
the normal starting dose in the frail or older patients.
_Paediatic population_
Clopixol is not indicated for use in children due to lack of clinical
experience.
_Patients with renal impairment_
Clopixol can be given in usual doses to patients with reduced renal
function. Where there is renal failure
dosage should be reduced to half the normal dosage.
_Patients with hepatic i