Hydrochlorothiazide Orion 12,5 mg Tablett

País: Suécia

Língua: sueco

Origem: Läkemedelsverket (Medical Products Agency)

Ingredientes ativos:

hydroklortiazid

Disponível em:

Orion Corporation

Código ATC:

C03AA03

DCI (Denominação Comum Internacional):

hydrochlorothiazide

Dosagem:

12,5 mg

Forma farmacêutica:

Tablett

Composição:

hydroklortiazid 12,5 mg Aktiv substans; laktosmonohydrat Hjälpämne

Tipo de prescrição:

Receptbelagt

Resumo do produto:

Förpacknings: Blister, 10 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 90 tabletter; Blister, 98 tabletter; Blister, 100 tabletter

Status de autorização:

Avregistrerad

Data de autorização:

2017-08-25

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
HYDROCHLOROTHIAZIDE ORION 12.5 MG AND 25 MG TABLETS
hydrochlorothiazide
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.
WHAT IS IN THIS LEAFLET
1.
What Hydrochlorothiazide Orion is and what it is used for
2.
What you need to know before you take Hydrochlorothiazide Orion
3.
How to take Hydrochlorothiazide Orion
4.
Possible side effects
5.
How to store Hydrochlorothiazide Orion
6.
Contents of the pack and other information
1.
WHAT HYDROCHLOROTHIAZIDE ORION IS AND WHAT IT IS USED FOR
Hydrochlorothiazide is a diuretic and antihypertensive drug. The
reduction in the blood pressure is
partly due to the diuretic effect, but probably also that some of the
blood vessels (arterioles) are
widened and hereby the resistance in the blood vessels are lowered.
HYDROCHLOROTHIAZIDE ORION TABLETS ARE USED TO TREAT:
-
high blood pressure
-
fluid retention in the body (oedema).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYDROCHLOROTHIAZIDE ORION
DO NOT TAKE HYDROCHLOROTHIAZIDE ORION
-
if you are allergic (hypersensitive) to hydrochlorothiazide, other
thiazides or sulfonamides or
any of the other ingredients of this medicine (listed in section 6)
-
if you have severely reduced kidney function
-
if you have severely reduced liver function
-
if you have or have had gout.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Hydrochlorothiazide
Orion tablets:
-
if you have coronary heart disease
-
if you have diabetes
-
if you have an impaired kidney function
-
if you have an impaired liver f

Características técnicas

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Hydrochlorothiazide Orion 12.5 mg tablets
Hydrochlorothiazide Orion 25 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Hydrochlorothiazide Orion 12.5 mg tablets_
Each tablet contains 12.5 mg hydrochlorothiazide.
Excipient with known effect
Lactose monohydrate. Each tablet contains 50.5 mg lactose monohydrate.
_Hydrochlorothiazide Orion 25 mg tablets_
Each tablet contains 25 mg hydrochlorothiazide.
Excipient with known effect
Lactose monohydrate. Each tablet contains 101 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
_Hydrochlorothiazide Orion 12.5 mg tablets_
White, round tablets with a diameter of 6 mm and a one-sided score
notch.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
_Hydrochlorothiazide Orion 25 mg tablets_
White, round tablets with a diameter of 8 mm and a one-sided score
notch.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Hypertension.
-
Oedema associated with heart failure.
-
Oedema caused by other conditions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily dose should preferably be taken in the morning.
Adults
Hypertension
The recommended dose is 12.5–50 mg per day initially. The lowest
possible maintenance dose should
be used especially as the blood pressure lowering effect is not dose
dependent.
2
Hydrochlorothiazide Orion can be combined with other antihypertensive
agents and potentiate the
effect of these so the doses should be adjusted accordingly.
Oedema
The recommended dose is 25–50 mg or in severe cases 75–100 mg per
day initially. The lowest
possible maintenance dose should be used. A satisfactory effect during
maintenance therapy can be
achieved by intermittent dosing e.g. every two to three days.
Hydrochlorothiazide Orion can be combined with other antihypertensive
agents and potentiate the
effect of these so the doses should