Doxylamine Krka 15 mg film-coated tablets

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

DOXYLAMINE SUCCINATE

Dostupno od:

KRKA DD Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenia

ATC koda:

R06AA09

INN (International ime):

DOXYLAMINE SUCCINATE 15 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

DOXYLAMINE SUCCINATE 15 mg

Tip recepta:

POM

Područje terapije:

ANTIHISTAMINES FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2018-06-21

Uputa o lijeku

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DOXYLAMINE KRKA 15 MG FILM-COATED TABLETS
doxylamine hydrogen succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor or pharmacist if you do not feel better or
if you feel worse after 5
days.
WHAT IS IN THIS LEAFLET
1.
What Doxylamine Krka is and what it is used for
2.
What you need to know before you take Doxylamine Krka
3.
How to take Doxylamine Krka
4.
Possible side effects
5.
How to store Doxylamine Krka
6.
Contents of the pack and other information
1.
WHAT DOXYLAMINE KRKA IS AND WHAT IT IS USED FOR
The use of this medicine is recommended in occasional insomnia in
adults.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXYLAMINE KRKA
DO NOT TAKE DOXYLAMINE KRKA
-
if you are allergic to doxylamine, to antihistamines or any of the
other ingredients of this
medicine (listed in section 6),
-
if you have a history of acute glaucoma (increased pressure in the
eye),
-
if you have difficulty urinating in men (due to prostatic or other
problems),
-
if you are a child or adolescent under 18 years of age.
If you have any doubts, you must seek advice from your doctor or
pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Doxylamine Krka.
Insomnia (sleeplessness) may have a variety of causes that do not
necessarily require taking a
medication.
This medicine should be used with caution in the elderly because of
the risk of cognitive impairment,
somnolence (sleepiness), slow respon

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Doxylamine Krka 15 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 15 mg doxylamine hydrogen succinate.
Excipient(s) with known effect
Each film-coated tablet contains 95.00 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pale purple-grey to purple-grey, oval, biconvex, one side scored
film-coated tablets. Tablet dimension:
8.5 mm x 5.5 mm. The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Occasional insomnia in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended dosage is from 7.5 to 15 mg daily (½ to 1 tablet
daily). It may be increased to 30
mg daily (2 tablets daily), if necessary.
_In the elderly, renal or hepatic impairment: _
It is recommended to decrease the dosage.
Method of administration
For oral use.
A single dose per day in the evening, 15 to 30 minutes before going to
bed.
Swallow the tablet with some water.
Duration of treatment
The duration of treatment is 2 to 5 days.
If insomnia persists for more than 5 days, treatment should be
re-evaluated.
4.3
CONTRAINDICATIONS
Known hypersensitivity to the active substance, to antihistamines, or
to any of the excipients listed in
section 6.1.
Personal or family history of acute glaucoma caused by the closure of
the iridocorneal angle
Urethroprostatic disorders with a risk of urinary retention
Children and adolescents under 18 years of age
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
Insomnia may have a variety of causes that do not necessarily require
taking a medication.
Like other hypnotic or sedative drugs, doxylamine succinate is likely
to aggravate a pre-existing sleep
apnoea syndrome (increasing the number and duration of apnoeas).
The risk of abuse and drug dependence is low; however, cases of abuse
and drug dependence have
been reported. The occurrence of signs