Phloroglucinol ELC 80mg orodispersible tablets

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

PHLOROGLUCINOL DIHYDRATE

可用日期:

ELC GROUP s.r.o. Pobrezni 394/12, Karlin 186 00 Prague 8, Czech Republic

ATC代码:

A03AX12

INN（国际名称）:

PHLOROGLUCINOL DIHYDRATE 80 mg

药物剂型:

ORODISPERSIBLE TABLET

组成:

PHLOROGLUCINOL DIHYDRATE 80 mg

处方类型:

OTC

治疗领域:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

授权状态:

Authorised

授权日期:

2019-08-20

资料单张

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHLOROGLUCINOL ELC 80 MG ORODISPERSIBLE TABLETS
phloroglucinol dihydrate
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 has 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 if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What
Phloroglucinol ELC
is and what it is used for
2.
What you need to know before you take
Phloroglucinol ELC
3.
How to take
Phloroglucinol ELC
4.
Possible side effects
5.
How to store
Phloroglucinol ELC
6.
Contents of the pack and other information
1.
WHAT
PHLOROGLUCINOL ELC IS AND WHAT IT IS USED FOR
Phloroglucinol ELC belongs to a group of medicines known as
antispasmodic.
This medicine is indicated in the treatment of pain caused by spasms
(cramps) in the intestines, biliary
tract, bladder and uterus.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHLOROGLUCINOL ELC
DO NOT TAKE PHLOROGLUCINOL ELC:
•
if you are allergic to phloroglucinol dihydrate or any of the other
ingredients of this
Medicine (listed in section 6).
•
if you are suffering from phenylketonuria (hereditary disease detected
at birth), due to the presence of
aspartame.
If in doubt, ask the advice of your doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Phloroglucinol ELC.
OTHER MEDICINES AND PHLOROGLUCINOL ELC
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
Avoid combining Phloroglucinol ELC with major analgesics(medicines
used to relieve pain) such

产品特点

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1.
NAME OF THE MEDICINAL PRODUCT
Phloroglucinol ELC 80 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 80 mg phloroglucinol dihydrate.
Excipients with known effect
Each tablet contains 182.45 mg lactose monohydrate and 2 mg aspartame.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet. White to off-white, round, uncoated tablets
plain on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of pain associated with functional
gastrointestinal tract and bile duct
disorders.
•
Treatment of acute painful spasmodic urinary tract problems: renal
colic.
•
Symptomatic treatment of painful spasmodic gynaecological problems.
•
Adjuvant treatment of contractions during pregnancy in combination
with rest.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The dose is 2 tablets to be taken when the pain occurs, to be repeated
if there are severe spasms
with a minimum interval of 2 hours between each dose without exceeding
6 tablets per 24 hours.
The active substance is a symptomatic treatment. In case of
persistence of symptoms, the treatment
should be reassessed.
_Paediatric population _
In children over 2 years, the dose is 1 tablet to be taken when the
pain occurs, to be repeated if
there are severe spasms with a minimum interval of 2 hours between the
previous dose without
exceeding 2 tablets per 24 hours.
The efficacy in children under 2 years of age has not been
established.
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Method of administration
Oral use.
In adults, the tablets may be taken by dissolving them under the
tongue without water or after
dissolving them in water.
In children, they must be dissolved in a glass of water before being
taken. The reconstituted solution
should be drunk immediately.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
In patients with phenylketonuria as this medicinal product contai