Rowatanal Cream

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Levomenthol; Bismuth subgallate; Zinc oxide

Disponível em:

Rowa Pharmaceuticals Limited

Código ATC:

C05AX; C05AX04

DCI (Denominação Comum Internacional):

Levomenthol; Bismuth subgallate; Zinc oxide

Dosagem:

2 / 8 /1 gram/100gram

Forma farmacêutica:

Cream

Tipo de prescrição:

Product not subject to medical prescription

Área terapêutica:

Other agents for treatment of hemorrhoids and anal fissures for topical use; zinc preparations

Status de autorização:

Marketed

Data de autorização:

1996-05-09

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
ROWATANAL
® CREAM
MENTHOL 1G/100G, BISMUTH SUBGALLATE 2G/100G, ZINC OXIDE 8G/100G
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor,
pharmacist or nurse 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 Rowatanal® is and what it is used for
2. What you need to know before you use Rowatanal®
3. How to use Rowatanal®
4. Possible side effects
5. How to store Rowatanal®
6. Contents of the pack and other information 1 WHAT ROWATANAL® IS AND WHAT IT IS USED FOR
Rowatanal® is used to relieve the pain and itching associated with
internal and
external haemorrhoids (piles), pruritus (symptoms of itching) and
irritation around
the back passage and other related conditions. It has antiseptic and
astringent
(cleansing) properties. It relieves the intense itching and burning
sensation
associated with haemorrhoids.
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 USE ROWATANAL®
DO NOT USE ROWATANAL® IF YOU:
• are allergic to menthol, bismuth subgallate, zinc oxide or any of
the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
• Talk to your doctor or pharmacist before using Rowatanal® if your
piles are
bleeding or have been present for some time.
If the condition persists or worsens you should also consult your
doctor.
OTHER MEDICINES AND ROWATANAL®
Tell your doctor or pharmacist if you are taking, have recently taken
or might take
any other medicines, including medicines obtained without a
p

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rowatanal Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 g contains Bismuth Subgallate 2g, Zinc Oxide 8g, Menthol 1g.
Excipients with known effect
Each 100g contains 20g wool fat, glycerol and 0.3g
parahydroxybenzoates.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A light yellow, smooth cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an adjunct in the symptomatic relief of uncomplicated haemorrhoids
and anal irritation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of Administration: Rectal Perianal.
RECOMMENDED DOSAGE SCHEDULE
_Adults only_
The cream should be applied 2-3 times daily and after defaecation. For
internal haemorrhoids use the cannula nozzle
provided.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Haemorrhoids or rectal bleeding are an indication to seek the
doctor’s advice. If your condition persists or worsens, you
should also seek your doctor’s advice.
Glycerol may have a slight laxative effect and wool fat may cause
local skin reactions (e.g. contact dermatitis).
Parahydroxybenzoates may cause allergic reactions (possibly delayed).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.6 FERTILITY, PREGNANCY AND LACTATION
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