Histalix Syrup

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL

Available from:

SIMRU Global Holdings Limited The Black Church, St. Mary’s Place, Dublin 7, D07 P4AX , Ireland

ATC code:

R05FB02

INN (International Name):

AMMONIUM CHLORIDE 135 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml MENTHOL 1.1 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

AMMONIUM CHLORIDE 135 mg/5ml DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml MENTHOL 1.1 mg/5ml

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-04-13

Patient Information leaflet

H0155-4
PATIENT INFORMATION LEAFLET
HISTALIX SYRUP
Diphenhydramine Hydrochloride 14 mg / 5 ml
Ammonium Chloride 135 mg / 5 ml
Levomenthol 1.1 mg / 5 ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
You must contact a doctor if your symptoms worsen or do not
improve.
•
If any side effect becomes more serious, or if you notice any side
effect not listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. WHAT HISTALIX SYRUP IS AND WHAT DOES IT DO?
2. WHAT SHOULD I KNOW BEFORE USING HISTALIX SYRUP?
3. HOW DO I USE HISTALIX SYRUP?
4. DOES HISTALIX SYRUP HAVE ANY SIDE EFFECTS?
5. HOW DO I STORE HISTALIX SYRUP?
6. FURTHER INFORMATION
1.WHAT HISTALIX SYRUP IS AND WHAT DOES IT DO?
The name of your medicine is Histalix Syrup.
It is for the symptomatic relief of troublesome cough associated with
upper
respiratory tract congestion. It may also be used to aid restful
sleep.
The syrup contains the active ingredients diphenhydramine
hydrochloride,
ammonium chloride and levomenthol. Diphenhydramine Hydrochloride
is an antihistamine that is used to provide relief from the effects of
an
allergy. Ammonium chloride is an expectorant that helps loosen phlegm
and catarrh. Levomenthol relieves the discomfort of congestion and
also
provides a cooling effect in mouth and throat.
2.WHAT SHOULD I KNOW BEFORE USING HISTALIX SYRUP?
YOU SHOULD NOT USE THIS MEDICINE IF YOU:
•
Are sensitive to any of the ingredients (full list provided in Section
6).
•
Are taking or have taken monoamine oxidase inhibitors (MAOI) (a
treatment for depression) within the previous 14 days.
•
Are under 12 years old.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE IF YOU:
•
Suffer from glaucoma.
•
Have difficulty urinating.
•
Have a cough with a lot of mucus.
•
Suffer from an enlarged prostate.
•
Have asthma.
•
Have any disorder of the liver.
IS IT SAFE TO

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Histalix Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains :-
Diphenhydramine HCl BP 14.00 mg
Ammonium Chloride BP 135.00 mg
Menthol BP 1.10 mg
3 PHARMACEUTICAL FORM
Oral Syrup
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the oral symptomatic relief of troublesome cough associated with
upper
respiratory tract congestion and aids restful sleep.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One to two 5ml spoonfuls to be taken every 4 hours
To aid sleep the patient may start with two 5ml spoonfuls at bedtime
followed by two
5ml spoonfuls every 6 hours.
Not suitable for children under 12 years.
Do not take more than 4 doses (1 dose = two 5ml spoonfuls) in 24
hours.
Do not exceed the stated dose.
4.3 CONTRAINDICATIONS
•
Hypersensitivity to any of the ingredients.
•
Children below 12 years of age.
•
Patients on monoamine oxidase inhibitor therapy within previous 14
days (see
Section 4.5).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not combine with other treatments for coughs and colds.
Histalix syrup should be used with caution in patients with the
following conditions:
prostatic hypertrophy, urinary retention, susceptibility to ‘closed
angle’ glaucoma and
hepatic disease.
Histalix Syrup may cause drowsiness.
Seek medical advice when suffering from chronic or persistent cough
and when also
suffering from asthma, and acute asthmatic attack or where cough is
accompanied by
excessive secretions.
Keep out of the reach and sight of children.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
•
Additive CNS depressant effects with alcohol and other CNS depressants
including barbiturates, hypnotics, opiod analgesics, anxiolytic
sedatives and anti-
psychotics.
•
Additive anti-muscarinic effects with other drugs of similar
properties such as
atropine and some anti-depressants.
•
Not to be taken in patients taking monoamine oxidase inhibitors
(MAOIs) or
within
14 of stopping treatment as there