Gastro-Soothe Forte

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Hyoscine butylbromide 20 mg;  ;  
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Hyoscine butylbromide 20 mg
Dosage:
20 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Hyoscine butylbromide 20 mg     Excipient: Colloidal silicon dioxide Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Methylcellulose Microcrystalline cellulose Purified talc Purified water Sodium starch glycolate Titanium dioxide
Prescription type:
Restricted
Manufactured by:
Alchem International Ltd
Therapeutic indications:
For the relief of stomach ache and pain due to cramps or spasm.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVDC/PVC/Al foil - 10 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization number:
TT50-7482/1
Authorization date:
2014-02-11

Read the complete document

Consumer Medicine Information

Gastro-Soothe & Gastro-Soothe Forte

Hyoscine butylbromide

What is in this leaflet

This leaflet answers some common questions about Gastro-Soothe & Gastro-Soothe Forte

tablets. It does not contain all available information. It does not take the place of talking to

your doctor or pharmacist. Keep this information with your tablets. You may need to read it

again later.

To find out more about Gastro-Soothe & Gastro-Soothe Forte

You should ask your doctor or pharmacist if you have any questions about your medicine or if

you have any concerns about taking Gastro-Soothe or Gastro-Soothe Forte.

What Gastro-Soothe & Gastro-Soothe Forte are used for

Gastro-Soothe & Gastro-Soothe Forte anticholinergic medicines. Anticholinergic medicines

relieve pain caused by stomach and bowel cramps by helping your digestive system to relax.

Always consult your doctor or pharmacist if the pain does not improve within 48 hours or if

pain worsens after treatment.

Before taking Gastro-Soothe or Gastro-Soothe Forte

When not to take Gastro-Soothe or Gastro-Soothe Forte

take

Gastro-Soothe

Gastro-Soothe

Forte

allergic

hyoscine

butylbromide or any of the other ingredients in Gastro-Soothe or Gastro-Soothe Forte. These

ingredients are listed in full at the end of this leaflet (See Ingredients).

If you are uncertain as to whether you have such an allergy you should raise this concern with

your doctor or pharmacist.

Do not take Gastro-Soothe or Gastro-Soothe Forte if you have myasthenia gravis, glaucoma,

porphyria or a condition of the bowel known as megacolon.

Seek advice from your doctor or pharmacist if you have, or have had, a prostate or heart

condition. This is because Gastro-Soothe & Gastro-Soothe Forte should not be used in some

types of prostate disease and a certain type of heart complaint.

Gastro-Soothe & Gastro-Soothe Forte should not be used when there is a blockage in the

stomach or bowel, or in certain conditions when there is reduced bowel activity. These

conditions are best explained by your doctor or pharmacist.

You should never take Gastro-Soothe or Gastro-Soothe Forte after the EXPIRY DATE on the

product packaging.

Before you start taking Gastro-Soothe & Gastro-Soothe Forte

Ask your doctor or pharmacist to discuss with you the things you ought to know before taking

Gastro-Soothe & Gastro-Soothe Forte, particularly if you have not taken it before.

Before taking Gastro-Soothe or Gastro-Soothe Forte you must tell your doctor or pharmacist if

you are taking any other medicines, obtained with or without a doctor's prescription. In

particular you should tell your doctor or pharmacist if you are taking:

metoclopramide, quinidine or amantadine

any medicine which contains antihistamines (commonly used to treat allergies)

any medicine for the treatment of emotional disorders, heart disease or respiratory

disease

any other medicine for the treatment of this or another stomach or bowel condition

It is important to discuss this with your doctor or pharmacist because Gastro-Soothe &

Gastro-Soothe Forte may not work as well in the presence of some other medicines or side

effects may be increased.

Pregnancy

Special care is recommended during pregnancy, particularly in the first three months.

Ask for your doctor's advice if you are pregnant, or likely to become pregnant during your

course of medication.

Breastfeeding

Special care is recommended if you are breastfeeding as no studies have been conducted in

nursing women.

Ask for your doctor's advice if you are breastfeeding or likely to breastfeed during the course

of your medication.

Children

Gastro-Soothe & Gastro-Soothe Forte tablets are not recommended for use in children under

6 years of age.

Ability to drive or operate machinery

In rare cases, Gastro-Soothe & Gastro-Soothe Forte may cause drowsiness. If affected, do

not drive or operate machinery.

Alcohol

Do not drink alcohol while on Gastro-Soothe or Gastro-Soothe Forte. Alcohol may increase

the chance of side effects of this medicine such as drowsiness.

Taking Gastro-Soothe & Gastro-Soothe Forte

How much to take

Gastro-Soothe 10 mg/tablet

Adults and children over 6 years: 2 tablets (two 10 mg tablets = 20 mg) four times a day

Gastro-Soothe Forte 20mg/tablet

Adults and children over 6 years: 1 tablet (20 mg) four times a day.

Tablets should be swallowed whole with a little fluid.

Ask your doctor or pharmacist for further information if they have advised you to take a

different dose.

Do not take Gastro-Soothe or Gastro-Soothe Forte for longer than 2-3 days at a time except

on the recommendation of a doctor.

If you forget to take a dose

If you miss a dose, take it as soon as you remember. However, if you remember when it is

almost time for your next dose, take only your usual dose at that time.

It is not necessary to finish taking all the tablets in the pack if you find you no longer have any

pain.

If you have taken too much Gastro-Soothe or Gastro-Soothe Forte

Seek medical advice if you have used more than the recommended or prescribed dose of

Gastro-Soothe or Gastro-Soothe Forte and you experience signs of overdose as listed below.

Signs of overdose may include drowsiness, dry mouth, difficulty passing urine, reddening of

the skin, decreased gastrointestinal tract movement, fast heart rate and sight disturbances.

Advice can be provided by a doctor, pharmacist or Poisons Information Centre (telephone

0800 POISON or 0800 764766).

Do not drive a car or operate machinery if you have taken more than the recommended or

prescribed dose of Gastro-Soothe or Gastro-Soothe Forte.

While you are taking Gastro-Soothe or Gastro-Soothe Forte

As mentioned previously, do not drink alcohol and tell your doctor or pharmacist if you begin

taking any other medicine while you are taking Gastro-Soothe or Gastro-Soothe Forte.

Cramps in the stomach or bowel may be temporary or may signal the presence of a more

serious problem. Always consult your doctor or pharmacist if the pain is severe or does not

improve within 48 hours of taking Gastro-Soothe or Gastro-Soothe Forte.

Side effects

You should be aware that all medicines carry some risks and that all possible risks may not

be known at this stage despite thorough testing.

Ask for the advice of your doctor or pharmacist if you have any concerns about the effects of

taking this medicine.

If side effects occur, they are usually mild when Gastro-Soothe or Gastro-Soothe Forte are

used at the recommended dose. Very occasionally, Gastro-Soothe or Gastro-Soothe Forte

tablets may cause:

dry mouth and fast heart rate

reduced sweating and difficulty with passing urine.

If these occur, they usually disappear when you stop taking the tablets.

Very rare but more serious side effects include:

allergic reactions, such as skin rashes, or swelling of the face

difficulty in breathing.

If these occur, seek medical advice or attention immediately.

Otherwise, tell your doctor or pharmacist as soon as possible if you experience any side

effects during or after using Gastro-Soothe or Gastro-Soothe Forte.

Unexpected effects, not listed above, can occur with any medicine. You should tell your

doctor or pharmacist if you notice anything unusual, during or after taking Gastro-Soothe or

Gastro-Soothe Forte.

After taking Gastro-Soothe or Gastro-Soothe Forte

Storage

Gastro-Soothe and Gastro-Soothe Forte should be kept in a cool, dry place where the

temperature stays below 30°C. For example, do not leave your tablets in a car or store them

in the bathroom. Heat and dampness will damage the tablets.

Keep Gastro-Soothe and Gastro-Soothe Forte tablets where children cannot reach them.

Disposal

After the expiry date has passed, any unused Gastro-Soothe or Gastro-Soothe Forte should

be returned to your pharmacist so that it can be disposed of safely.

Product Description

What the tablets look like

White sugar coated tablet plain on both the sides.

Gastro-Soothe is available in blister packs of 20 tablets.

Gastro-Soothe Forte is available in blister packs of 10 tablets

Ingredients

Each Gastro-Soothe tablet contains 10mg of hyoscine butylbromide.

Each Gastro-Soothe Forte tablet contains 20mg of hyoscine butylbromide

Lactose, maize starch, microcrystalline cellulose, methocel A4C, sodium starch glycolate,

colloidal anhydrous silica, magnesium stearate, hydroxy propyl methyl cellulose ,

polyethylene glycol, talc, titanium dioxide.

Who supplies this medicine

Distributed in New Zealand by:

AFT Pharmaceuticals Ltd

129 Hurstmere Road (Level 1)

Takapuna

AUCKLAND

Telephone: 09 488 0232

Email: customer.service@aftpharm.com

Date of information

October 2017

Read the complete document

Page 1 of 5

NEW ZEALAND DATA SHEET

1 GASTRO-SOOTHE

®

(Hyoscine-N-butylbromide 10mg film coated

tablet)

(Gastro-Soothe) 10 mg Hyoscine-N-butylbromide film coated tablet

GASTRO-SOOTHE FORTE

®

(Hyoscine-N-butylbromide 20mg film coated

tablet)

(Gastro-Soothe Forte) 20 mg Hyoscine-N-butylbromide film coated tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Gastro-Soothe

Each tablet contains 10 mg Hyoscine-N-butylbromide.

Gastro-Soothe Forte

Each tablet contains 20 mg Hyoscine-N-butylbromide.

For the list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

White, circular biconvex film coated tablet plain on both sides.

4 CLINICAL PARTICULARS

4.1

Therapeutic indications

Muscle spasm of the gastrointestinal tract.

4.2

Dose and method of administration

Gastro-Soothe and Gastro-Soothe Forte are for oral administration only.

Gastro-Soothe and Gastro-Soothe Forte should be swallowed whole with adequate water.

Gastro-Soothe 10 mg/tablet

Adults and children over 6 years: 2 tablets (two 10 mg tablets = 20 mg) four times a day.

Gastro-Soothe Forte 20 mg/tablet

Adults and children over 6 years: 1 tablet (20 mg) four times a day.

4.3

Contraindications

Gastro-Soothe & Gastro-Soothe Forte are contraindicated in myasthenia gravis, megacolon, and

narrow glaucoma. In addition, they should not be given to patients who have demonstrated prior

sensitivity to the product.

4.4

Special warnings and precautions for use

Gastro-Soothe and Gastro-Soothe Forte should be used with caution in conditions characterised by

tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it

may further accelerate the heart rate. Due to the risk of anticholinergic complications, caution should

be used in patients susceptible to intestinal or urinary outlet obstructions.

Page 2 of 5

Because of the possibility that anticholinergics may reduce sweating, Gastro-Soothe and Gastro-

Soothe Forte should be administered with caution to patients with pyrexia

Elevation of intraocular pressure may be produced by the administration of anticholinergic agents

such as Gastro-Soothe and Gastro-Soothe Forte in patients with undiagnosed and therefore untreated

narrow angle glaucoma. Therefore, patients should seek urgent ophthalmological advice in case they

should develop a painful, red eye with loss of vision whilst or after taking Gastro-Soothe and Gastro-

Soothe Forte.

4.5

Interaction with other medicines and other forms of interaction

The anticholinergic effect of tricyclic antidepressants, antihistamines, quinidine, amantadine and

disopyramide may be intensified by Gastro-Soothe & Gastro-Soothe Forte.

Concomitant treatment with dopamine antagonists such as metoclopramide may result in diminution

of the effects of both medicines on the gastrointestinal tract.

The tachycardic effects of beta-adrenergic agents may be enhanced by Gastro-Soothe & Gastro-

Soothe Forte.

4.6

Fertility, pregnancy and lactation

Pregnancy

Long experience has shown no evidence of ill effects during human pregnancy. Preclinical studies in

rats and rabbits did not show either embryotoxic or teratogenic effects. Hyoscine-N-butylbromide is

classified with medications that have been taken by only a limited number of pregnant women but

without an increase to the frequency of malformation or other direct or indirect harmful effects on the

human foetus having been observed. However, the usual precautions regarding the use of medicines at

this time, especially during the first trimester, should be observed

Lactation

Safety during lactation has not yet been established, however, adverse effects on the new born have

not been reported.

4.7

Effects on ability to drive and use machines

In rare cases Gastro-Soothe & Gastro-Soothe Forte may cause drowsiness, if affected, patients should

not drive or operate machinery.

4.8

Undesirable effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of Gastro-

Soothe and Gastro-Soothe Forte.

Adverse events have been ranked under headings of frequency using the following convention:

Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000,

<1/1000); very rare (<1/10000); not known – cannot be estimated from the available data.

Immune system disorders

Uncommon: skin reactions (e.g. urticaria, pruritus)

Not known*: anaphylactic shock , anaphylactic reactions, dyspnoea, rash, erythema, other

hypersensitivity

Cardiac disorders

Uncommon: tachycardia

Gastrointestinal disorders:

Uncommon: dry mouth

Skin and subcutaneous tissue disorders

Uncommon: dyshidrosis

Page 3 of 5

Renal and urinary disorders

Rare: urinary retention

* This adverse reaction has been observed in post-marketing experience. With 95% certainty, the

frequency category is not greater than uncommon (3/1,368), but might be lower. A precise frequency

estimation is not possible as the adverse drug reaction did not occur in a clinical trial database of

1,368 patients.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked

to report any suspected adverse reactions https://nzphvc.otago.ac.nz/reporting/.

4.9

Overdose

Symptoms

Serious signs of poisoning following acute overdosage have not been observed in man. In case of

overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of skin,

tachycardia, inhibition of gastrointestinal motility, and transient visual disturbances may occur.

Therapy

In the case of oral poisoning, gastric lavage with activated charcoal should be followed by magnesium

sulphate (15%). Symptoms of Gastro-Soothe & Gastro-Soothe Forte overdosage respond to

parasympathomimetics. For patients with glaucoma, urgent ophthalmological advice should be sought

and pilocarpine should be given locally. If necessary, parasympathomimetics should be administered,

e.g. neostigmine 0.5-2.5 mg i.m. or i.v. cardiovascular complications should be treated according to

usual therapeutic principles. In case of respiratory paralysis: intubation, artificial respiration should be

considered. Catheterisation may be required for urinary retention. In addition, appropriate supportive

measures should be used as required.

For advice on the management of overdose please contact the National Poisons Centre on 0800

POISON (0800 764766).

5 PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Gastro-Soothe & Gastro-Soothe Forte exert a spasmolytic action on the smooth muscle of the

gastrointestinal, biliary and urinary tracts. As a quaternary ammonium derivative, hyoscine-N-

butylbromide does not enter the central nervous system. Therefore, anticholinergic side effects at the

central nervous system do not occur. Peripheral anticholinergic effects result from a ganglion-

blocking action within the visceral wall as well as from anti-muscarinic activity.

5.2

Pharmacokinetic properties

As a quaternary ammonium compound, hyoscine-N-butylbromide is highly polar and hence only

partially absorbed following oral (8%) administration and the systemic availability was found to be

less than 1%. Nevertheless, despite the briefly measurable low blood levels, hyoscine-N-butylbromide

and/or its metabolites have been observed at the sites of action.

The half-life of the terminal elimination phase t1/2γ is approximately 5 hours. The total clearance is

1.2 l/min, approximately half the clearance is renal. The main metabolites found in urine bind poorly

to the muscarinic receptor. Hyoscine-N-butylbromide does not pass the blood-brain barrier and

plasma protein binding is low.

Page 4 of 5

5.3

Preclinical safety data

In limited reproductive toxicity studies hyoscine butylbromide showed no evidence of teratogenicity

in rats at 200 mg/kg in the diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by subcutaneous

injection. Fertility in the rat was not impaired at doses of up to 200 mg/kg in the diet.

6 PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose, maize starch, microcrystalline cellulose, methocel A4C, sodium starch glycolate, colloidal

anhydrous silica, magnesium stearate, hydroxyl propyl methyl cellulose, polyethylene glycol, talc,

titanium dioxide

6.2

Incompatibilities

None stated.

6.3

Shelf life

36 months.

6.4

Special precautions for storage

Store below 30 °C

Store in a safe place out of the reach of children.

6.5

Nature and contents of container

Gastro-Soothe is available in

Tender blister pack of 20 tablets

OTC blister pack of 20 tablets.

Gastro-Soothe Forte is available in

OTC blister pack of 10 tablets

6.6

Special precautions for disposal

None stated.

7 MEDICINE SCHEDULE

Pharmacist only medicine

8 SPONSOR

AFT Pharmaceuticals Ltd

129 Hurstmere Road (Level 1)

Takapuna

AUCKLAND

Telephone: 09 488 0232

9 DATE OF FIRST APPROVAL

Gastro-Soothe: 5 November 2012

Gastro-Soothe Forte: 21 August 2014

Page 5 of 5

10 DATE OF REVISION OF THE TEXT

6 September 2017

SUMMARY TABLE OF CHANGES

Section changed

Summary Table of Changes

Information that anticholinergics may reduce sweating, medicine should be

administered with caution to patients with pyrexia added.

Updated undesirable effect to the most up-to-date information. Information on

reporting of suspected adverse reactions added.

Information on preclinical safety data added.

Information on shelf life added.

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