Nytol One-A-Night

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE

Available from:

Omega Pharma Limited 1st Floor, 32 Vauxhall Bridge Road, London SW1V 2SA, United Kingdom

ATC code:

R06AA02

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg

Pharmaceutical form:

TABLET

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-08-16

Patient Information leaflet

PROFILE KEYS:
150mm
139.7mm
THIS CODE READ
IN THIS DIRECTION
12mm
12mm
3mm
40mm Lead in to First bar
150mm
139.7mm
THIS CODE READ
IN THIS DIRECTION
12mm
12mm
3mm
9mm
9mm
First bar
Last bar
40mm Lead in to First bar
First bar
Last bar
Pharma Code
Copy/Text Free
MG TABLETS
DIPHENHYDRAMINE HYDROCHLORIDE
2. What you need to know before you take
Nytol One-A-Night
DO NOT TAKE NYTOL ONE-A-NIGHT:
•
IF YOU HAVE EVER HAD AN ALLERGIC REACTION to
diphenhydramine hydrochloride or any of the other
ingredients (listed in Section 6)
•
if you have an OBSTRUCTION IN YOUR STOMACH OR GUT (for
example, because of an ulcer).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Nytol One-A-Night:
•
if you have ASTHMA, BRONCHITIS or Chronic Obstructive
Pulmonary Disease (COPD)
•
if you have NARROW-ANGLE GLAUCOMA (a form of raised
pressure in the eye)
•
if you have an ENLARGED PROSTATE or URINARY RETENTION
•
if you have moderate to severe LIVER or KIDNEY DISEASE
•
if you have MYASTHENIA GRAVIS, EPILEPSY or SEIZURE
DISORDERS.
•
If your SLEEPING DIFFICULTIES persist, talk to your doctor
or pharmacist.
•
Nytol One-A-Night may get less effective if you use it
continuously.
OTHER MEDICINES AND NYTOL ONE-A-NIGHT
Talk to your doctor or pharmacist before taking these
tablets if you are taking any prescribed medicines;
particularly TRICYCLIC ANTIDEPRESSANTS, MONOAMINE OXIDASE
INHIBITORS (MAOIs prescribed for DEPRESSION) within the
last two weeks, atropine (used to dilate pupils of the
eyes) or medicines which make you DROWSY. Avoid the
use of OTHER ANTIHISTAMINES including those used on your
skin and in cold and cough medicines, while taking this
medicine.
NYTOL ONE-A-NIGHT WITH FOOD, DRINK AND ALCOHOL
DO NOT DRINK ALCOHOL while using Nytol One-A-Night.
PREGNANCY, BREAST FEEDING AND FERTILITY
Talk to your doctor before taking Nytol
One-A-Night if you are pregnant, trying to
become pregnant, or breast feeding.
DRIVING AND USING MACHINES
DO NOT DRIVE OR OPERATE MACHINERY.
Nytol One-A-Night is intended to produc

Summary of Product characteristics

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Nytol One-A-Night.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nytol One-A-Night contains 50mg Diphenhydramine Hydrochloride per
tablet.
3
PHARMACEUTICAL FORM
Tablets to be taken orally.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
An aid to the relief of temporary sleep disturbance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
One tablet to be taken 20 minutes before going to bed, or as directed
by a physician.
Do not exceed the stated dose or frequency of dosing.
Do not use in children under 16 years.
This medication should not be used continuously for more than 2 weeks
without
consulting a doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1 Nytol One-A-Night is contraindicated in in those with the
following conditions:
stenosing peptic ulcer, pyloroduodenal obstruction.
Page 2 of 7
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Nytol One-A-Night should be used with caution in patients with
myasthenia gravis,
epilepsy or seizure disorders, narrow-angle glaucoma, prostatic
hypertrophy, urinary
retention, asthma, bronchitis and chronic obstructive pulmonary
disease (COPD),
moderate to severe hepatic impairment and moderate to severe renal
impairment.
Tolerance may develop with continuous use. Seek medical advice if
sleeplessness persists, as insomnia may be a symptom of serious
underlying
medical illness.
This medication should not be used continuously for more than 2 weeks
without
consulting a doctor.
May increase the effects of alcohol, therefore alcohol should be
avoided.
Avoid use of other antihistamine-containing preparations, including
topical
antihistamines and cough and cold medicines.
Use with caution in the elderly, who are more likely to experience
adverse
effects. Avoid use in elderly patients with confusion.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase
deficiency or glucose-galactose malabsorp