Prometazin Actavis 25 mg Filmdragerad tablett

Šalis: Švedija

kalba: švedų

Šaltinis: Läkemedelsverket (Medical Products Agency)

Veiklioji medžiaga:

prometazinhydroklorid

Prieinama:

Actavis Group PTC ehf.

ATC kodas:

R06AD02

INN (Tarptautinis Pavadinimas):

promethazine

Dozė:

25 mg

Vaisto forma:

Filmdragerad tablett

Sudėtis:

prometazinhydroklorid 25 mg Aktiv substans

Recepto tipas:

Receptbelagt

Produkto santrauka:

Förpacknings: Blister, 2 tabletter; Blister, 4 tabletter; Blister, 8 tabletter; Blister, 12 tabletter; Blister, 16 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 100 tabletter

Autorizacija statusas:

Godkänd

Leidimo data:

2016-11-03

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Prometazin Actavis 25 mg film-coated tablets
promethazine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS INPORTANT
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 in 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.
WHAT IS IN THIS LEAFLET
1.
What Prometazin Actavis is and what it is used for
2.
What you need to know before you take Prometazin Actavis
3.
How to take Prometazin Actavis
4.
Possible side effects
5.
How to store Prometazin Actavis
6.
Content of the pack and other information
1.
WHAT PROMETAZIN ACTAVIS IS AND WHAT IT IS USED FOR
Prometazin Actavis contains a medicine called promethazine
hydrochloride. It belongs to a group of
medicines called phenothiazines. It works by blocking the natural
substance histamine in your body that
causes itching during an allergic reaction. This medicine also has a
sedative effect.
Prometazin Actavis can be used in the following situations:
-
short-term treatment of sleep disorders
-
short-term treatment of anxiety symptoms
-
to help you feel more relaxed before an operation or a dental
procedure
-
to treat or stop motion sickness (e.g. sea sickness)
-
to treat itchiness of the skin and allergies
-
to treat or stop you feeling sick and dizzy
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROMETAZIN ACTAVIS
DO NOT TAKE PROMETAZIN ACTAVIS
-
if you are allergic to promethazine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
-
if you are taking a medicine for depression belonging to a group of
medicines called monoamine
oxidase inhibitors (MAOIs). Also, do not take Prometazin Actavis if
you have stopped taki

Prekės savybės

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
.
NAME OF THE MEDICINAL PRODUCT
Prometazin Actavis 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of promethazine hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White coloured, oval shaped, 9.8 x 6.2 mm biconvex, film-coated
tablets debossed with "C25" on one
side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Short-term treatment of sleep disorders
-
Symptomatic short-term treatment of anxiety
-
Premedication in surgical and dental practice
-
Motion sickness
-
Allergic reactions of different origins
-
Pruritus
-
Nausea and vertigo (morning sickness, Ménière's disease, nausea
after radium treatment and
anaesthetics)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prometazin Actavis should be used at the lowest effective dose and for
the shortest possible treatment
period. The recommended dose should not be exceeded (see also section
4.4).
SYMPTOMATIC SHORT-TERM TREATMENT OF ANXIETY:
_Adults:_
25-50 mg, 1-3 times a day.
SHORT-TERM TREATMENT OF SLEEP DISORDERS:
_Adults:_
25-50 mg 1-2 hours before bedtime.
Sometimes this dose can lead to residual morning drowsiness, which
disappears after a few days
continuous medication, In many cases, a lower dose will give adequate
effect. In more severe cases,
the dose is increased.
_Children 5-12 years-of-age: _
25 mg 1-2 hours before bedtime.
Usually, the hypnotic effect decreases with continuous use. In more
severe cases of sleep disorder,
intermittent medication may be necessary (a break every third or
fourth night).
Elderly people can usually take promethazine continuously as a
hypnotic.
Patients with some form of lesion will rarely tolerate high doses.
2
MOTION SICKNESS:
_Adults: _
25 mg, 1-2 hours before the trip or alternatively the evening before
the trip. If needed, two
extra doses can be taken within a 24-hour period.
ALLERGIC CONDITIONS:
_Adults:_
25-50 mg at night;
PREMEDICATION: