Dalmane 30 mg Hard Capsules

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

FLURAZEPAM HYDROCHLORIDE

Tillgänglig från:

Mylan IRE Healthcare Limited

ATC-kod:

N05CD; N05CD01

INN (International namn):

FLURAZEPAM HYDROCHLORIDE

Dos:

30

Läkemedelsform:

Capsule, hard

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Benzodiazepine derivatives; flurazepam

Bemyndigande status:

Marketed

Tillstånd datum:

1977-04-01

Bipacksedel

PAGE 1 OF 7
PACKAGE LEAFLET
PAGE 2 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
DALMANE 15 AND 30 MG HARD CAPSULES
Flurazepam monohydrochloride
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.
The name of your medicine is Dalmane 15 mg or 30 mg hard capsules,
which will be called Dalmane capsules thoughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Dalmane capsules are and what they are used for
2.
What you need to know before you take Dalmane capsules
3.
How to take Dalmane capsules
4.
Possible side effects
5.
How to store Dalmane capsules
6.
Contents of the pack and other information
1.
WHAT DALMANE CAPSULES ARE AND WHAT THEY ARE USED FOR
Dalmane capsules contain the active ingredient flurazepam, which
belongs to a group of medicines called benzodiazepines.
Dalmane capsules are used for severe insomnia (sleeplessness).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALMANE CAPSULES
Do not take Dalmane capsules:
- If you have a condition called myasthenia gravis (very weak or tired
muscles)
- If you have severe breathing difficulties
- If you have sleep apnoea syndrome (breathing problems when asleep)
- If you have severe pulmonary insufficiency
- If you have severe liver disease
- If you have a mental illness
- If you are allergic to flurazepam
- If you are allergic to other similar drugs (benzodiazepines)
- If you are allergic to any of the other ingredients of Dalmane
capsules (listed in section 6). An allergic
reaction may include rash, itching, difficulty breathing or swelling
of the face, lips, throat or tongue.
WARNINGS

Produktens egenskaper

Health Products Regulatory Authority
26 November 2020
CRN00C1YD
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dalmane 30 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 30 mg flurazepam as flurazepam
monohydrochloride.
Excipients: Lactose monohydrate 97.7 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Capsules with opaque black cap and opaque grey body with 'ICN30'
printed in red on both cap and body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Insomnia_
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Insomnia_
Treatment should be as short as possible. Generally the duration of
treatment varies from a few days to two weeks with a
maximum, including tapering off process of four weeks.
In certain cases extension beyond the maximum treatment period may be
necessary; if so, it should not take place without
re-evaluation of the patient's status.
Treatment should be started with the lowest recommended dose. The
maximum dose should not be exceeded.
Health Products Regulatory Authority
26 November 2020
CRN00C1YD
Page 2 of 9
_ _
_Adults:_
The usual dosage is 15-30mg before retiring. 15mg is optimal for most
patients. Patients with severe insomnia may require
30mg but residual effects on awakening, associated with anxiolytic
effects, are more frequent at this dose.
_ _
_Older or debilitated patients:_
Older patients will be particularly susceptible to the adverse effects
of Dalmane.
The initial dose should not exceed 15mg. If organic brain changes are
present, the dosage of Dalmane should be reduced (see
section 4.4).
_ _
_Use in patients with hepatic and renal impairment:_
The dosage should be reduced in patients with renal or hepatic
impairment. Dalmane is contraindicated in patients with severe
hepatic failure (see sections 4.3 and 4.4.).
_Use in patients with chronic pulmonary insuff