NOTENSYL SYRUP

Summary of Product Characteristics

1. Name of the medicinal product

Notensyl Tablets

Notensyl Syrup

2. Qualitative and quantitative composition

Each tablet of Notensyl contains Dicyclomine hydrochloride 10mg

Each 5ml of Notensyl Syrup contain Dicyclomine hydrochloride 10mg

3. Pharmaceutical form

Tablets , syrup

4. Clinical particulars

4.1 Therapeutic indications

Adjunctive therapy in irritable bowel syndrome, neurogenic bowel disturbance

4.2 Posology and method of administration

Route of administration: Oral

tablets

Adolescents and Adults (above 12 years): 10-20mg three times daily before or after meals.

Children (2-12 years): 10mg three times daily.

syrup

Adults

5-10 ml (10 - 20mg) three times daily before or after meals.

Children (2-12 years):

5ml (10mg) three times daily.

Children (6 months - 2 years)

2.5 ml (5mg) three or four times daily, 15 minutes before feeds. Do not exceed a daily dose of

40mg.

4.3 Contraindications

Tablets and syrup

Known idiosyncrasy to dicyclomine hydrochloride.

syrup

Infant under 6 months of age

Patients with rare heredity problems of fructose intolerance, glucose galactose

malabsorption or sucrase-isomaltase insufficiency should not take this medicine

4.4 Special warnings and precautions for use

Products containing dicyclomine hydrochloride should be used with caution in any patient with or

suspected of having glaucoma or prostatic hypertrophy.

Use with care in patients with hiatus hernia associated with reflux oesophagitis because

anticholinergic drugs may aggravate the condition.

There are reports of infants, 3 months of age and under, administered dicyclomine hydrochloride

syrup who have evidenced respiratory symptoms (breathing difficulty, shortness of breath,

breathlessness, respiratory collapse, apnoea) as well as seizures, syncope, asphyxia, pulse rate

fluctuations, muscular hypotonia and coma. The above symptoms have occurred within minutes

of ingestion and lasted 20-30 minutes. The symptoms were reported in association with

dicyclomine hydrochloride syrup therapy but the cause and effect relationship has neither been

disproved nor proved. The timing and nature of the reactions suggest that they were a

consequence of local irritation and/or aspiration, rather than to a direct pharmacological effect.

Although no causal relationship between these effects, observed in infants and dicyclomine

administration has been established, dicyclomine hydrochloride is contra-indicated in infants

under 6 months of age.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6. Pregnancy and lactation

Epidemiological studies in pregnant women with products containing dicyclomine hydrochloride

(at doses up to 40mg/day) have not shown that dicyclomine hydrochloride increases the risk of

foetal abnormalities if administered during the first trimester of pregnancy. Reproduction studies

have been performed in rats and rabbits at doses of up to 100 times the maximum

recommended dose (based on 60mg per day for an adult person) and have revealed no

evidence of impaired fertility or harm to the foetus due to dicyclomine. Since the risk of

teratogenicity cannot be excluded with absolute certainty for any product, the drug should be

used during pregnancy only if clearly needed.

It is not known whether dicyclomine is secreted in human milk. Because many drugs are

excreted in human milk, caution should be exercised when dicyclomine is administered to a

nursing mother.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Side-effects seldom occur with dicyclomine. However, in susceptible individuals, dry mouth,

thirst and dizziness may occur. On rare occasions, fatigue, sedation, blurred vision, rash,

constipation, anorexia, nausea and vomiting, headache and dysuria have also been reported.

Reporting of suspected adverse reactions

Side effects can be reported to the Ministry of Health using the online form for reporting side

effects in the Ministry of Health website www.health.gov.il or via the following link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@

moh.gov.il

4.9 Overdose

Symptoms of dicyclomine overdosage are headache, dizziness, nausea, dry mouth, difficulty in

swallowing, dilated pupils and hot dry skin. Treatment may include emetics, gastric lavage and

symptomatic therapy if indicated.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Dicyclomine hydrochloride relieves smooth muscle spasm of the gastrointestinal tract.

Animal studies indicate that this action is achieved via a dual mechanism;

(1) a specific anticholinergic effect (antimuscarinic at the ACh-receptor sites) and

(2) a direct effect upon smooth muscle (musculotropic).

5.2 Pharmacokinetic properties

After a single oral 20mg dose of dicyclomine hydrochloride in volunteers, peak plasma

concentration reached a mean value of 58ng/ml in 1 to 1.5 hours.

C labelled studies

demonstrated comparable bioavailability from oral and intravenous administration. The principal

route of elimination is via the urine.

5.3 Preclinical safety data

None stated.

6. Pharmaceutical particulars

6.1 List of excipients

Notensyl Tablets:

Lactose, Maize Starch, Povidone, Magnesium Stearate, Sorbitol Solution 70%

Notensyl Syrup

Liquid glucose 80%,Sorbitol Solution 70%, Glycerin, Ethanol 95%, Lemon Oil NO, Methyl

hydroxybenzoate, Sacchrin Sodium, Vanillaroma 200, Propyl hydroxybenzoate, Sunset Yellow

FDC Yellow No. 6, Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf life

Notensyl Tablets: 36 months

Notensyl Syrup: 30 months. Discard 2 months after opening

6.4 Special precautions for storage

6.5 Nature and contents of container

Notensyl Tablets: Blisters packs contains biconvex white tablet, 10 tablets per one blister. Pack

size: 20 tablets

Notensyl Syrup: Glass bottle of 110ml contains clear orange syrup

7. Marketing authorisation holder

CTS Chemical Industries Ltd.

Hakidma 3, Kiryat-Malachi

Israel

8. Marketing authorisation number(s)

Notensyl Tablets: 1178523254

Notensyl Syrup: 1178423253

9. Date of revision of the text

December 2015