Diarrhoea Relief 2mg capsules

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Loperamide hydrochloride

Verfügbar ab:

Herbal Concepts Ltd

ATC-Code:

A07DA03

INN (Internationale Bezeichnung):

Loperamide hydrochloride

Dosierung:

2mg

Darreichungsform:

Oral capsule

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 01040200; GTIN: 5039290000822

Gebrauchsinformation

• If you have IBS, which has previously been diagnosed by a
doctor, but you notice any of the following new symptoms:
-
If you are 40 years or over and it is some time since your
last attack of IBS, or if the symptoms are different this time
-
If you have recently passed blood from the bowel
-
If you have severe constipation
-
If you are feeling sick or being sick
-
If you have lost your appetite or lost weight, especially if
losing weight without trying
-
If you have difficulty or pain on passing urine
-
If you have a fever
-
If you have recently travelled abroad
Other important information
Diarrhoea is a common symptom of a number of serious
conditions in the stomach and bowel.
If your diarrhoea lasts for a long time or keeps returning, talk
to your doctor.
This medicine only treats the symptoms of diarrhoea and
should not be taken for long periods of time.
Diarrhoea can cause the body to lose large amounts of fluids,
which need replacing by drinking more fluid than usual.
When your body loses more fluid than normal, the amount of
salts (electrolytes) in your body also changes and this can cause
dehydration and electrolyte imbalance. This can be treated
using a type of medicine called ‘oral rehydration treatment’,
which helps to bring the fluid and salt levels back to normal.
Your pharmacist may recommend that you take this rehydration
treatment, especially if you are elderly.
Driving and using machines:
dizziness, sleepiness or tiredness. If affected, you should not
drive, operate machinery or take part in activities where such
symptoms may put you or others at risk.
These capsules may cause
Information about some of the ingredients in this medicine:
The colour ponceau 4R (E124) in this medicine may cause
allergic reactions.
If you take other medicines
Before you take these capsules, make sure that you tell your
pharmacist about ANY other medicines you might be using at
the same time, particularly the following:
• Ritonavir (used to treat HIV)
• Quinidine (for heart rhythm problems), gemfibrozil (for

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tillomed Diarrhoea Relief (Loperamide Hydrochloride) 2mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains loperamide hydrochloride 2mg.
Excipient with known effect: Each capsule contains 127mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Grey-dark green coloured hard gelatin size 3 capsules, filled with a
homogeneous
white to off white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children over 12
years.
For the symptomatic treatment of acute episodes of diarrhoea
associated with Irritable
Bowel Syndrome in adults aged 18 years and over following initial
diagnosis by a
doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ACUTE DIARRHOEA
_Adults and children over 12 years: _
The initial dose is two capsules (4mg), followed by one capsule (2mg)
after every
loose stool.
The maximum daily dose should not exceed six capsules (12mg).
SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED WITH
IRRITABLE
BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER
Two capsules (4mg) to be taken initially, followed by 1 capsule (2mg)
after every
loose stool, or as previously advised by your doctor. The maximum
daily dose should
not exceed 6 capsules (12mg).
_ _
_Paediatric population _
Loperamide is contraindicated in children less than 12 years of age.
_Elderly: _
No dose adjustment is required for the elderly.
_Renal impairment: _
No dose adjustment is required for patients with renal impairment.
_Hepatic impairment_:
Although no pharmacokinetic data are available in patients with
hepatic impairment,
loperamide should be used with caution in such patients because of
reduced first pass
metabolism. (See section 4.4).
METHOD OF ADMINISTRATION
For oral use.
The capsules should be taken with liquid.
4.3
CONTRAINDICATIONS
This medicine is contraindicated:
•
hypersensitivity to the active substance or to