Nytol One-A-Night 50 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diphenhydramine hydrochloride

Available from:

Chefaro Ireland DAC

ATC code:

R06AA; R06AA02

INN (International Name):

Diphenhydramine hydrochloride

Dosage:

50 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Aminoalkyl ethers; diphenhydramine

Authorization status:

Marketed

Authorization date:

2017-05-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nytol One‐A‐Night 50mg Tablets
Diphenhydramine Hydrochloride
READ ALL OF THIS LEAFLET BEFORE YOU START TAKING THIS MEDICINE BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has
told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better, or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What Nytol One‐A‐Night 50mg Tablets are and what are they used
for
2. What you need to know before you take Nytol One‐A‐Night 50mg
Tablets
3. How to take Nytol One‐A‐Night 50mg Tablets
4. Possible side effects
5. How to store Nytol One‐A‐Night 50mg Tablets
6. Contents of the pack and other information
1. WHAT NYTOL ONE‐A‐NIGHT 50MG TABLETS ARE AND WHAT ARE THEY USED
FOR
THESE TABLETS ARE USED TO RELIEVE TEMPORARY SLEEPING DIFFICULTIES.
The active ingredient is diphenhydramine hydrochloride, an
antihistamine that causes sleepiness
or drowsiness. Temporary difficulties in getting a good night's sleep
can be caused by various
problems such as stress, jet lag or personal problems such as
bereavement. In sleep problems of
this type, Nytol One‐A‐Night 50mg tablets have been shown to help
people to fall asleep faster
and to have a longer and deeper sleep. You must talk to a doctor after
7 days if you do not feel
better, or if you feel worse.
You should not drive or operate machinery for at least 8 hours after
taking the tablet.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NYTOL ONE‐A‐NIGHT 50MG
TABLETS
DO NOT TAKE THESE TABLETS:

IF YOU HAVE EVER HAD AN ALLERGIC REACTION to diphenhydramine
hydrochloride or to any of the
other ingredients (listed in Section 6)

if you have an OBSTRUCTION

Summary of Product characteristics

Health Products Regulatory Authority
03 December 2021
CRN00C94P
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nytol One-A-Night 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg Diphenhydramine Hydrochloride (equivalent
to 43.8 mg Diphenhydramine base)
Excipients with known effect: 168.75 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
A white to off white, 15 mm in length, oblong capsule-shaped tablet,
embossed with “N50” logo on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nytol One-A-Night 50 mg Tablets are indicated as a symptomatic aid to
the relief of temporary sleep disturbance in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
One tablet to be taken 20 minutes before going to bed, or as directed
by a physician. Do not exceed the maximum dose of one
tablet in 24 hours.
_Elderly_
The product should only be given to the elderly if the benefits for
the patient outweigh the potential risks (see section 4.4).
_Renal and Hepatic Impairment_
In patients with moderate to severe renal or hepatic impairment, a
lower dose might be required (see section 4.4).
_Paediatric population_
Nytol One-A-Night 50mg Tablets should not be used in children under 18
years.
Method of administration Oral administration only.
Do not exceed the stated dose or frequency of dosing. The product
should not be taken for more than 7 days without
consulting a doctor.
4.3 CONTRAINDICATIONS
Nytol One-A-Night 50 mg Tablets are contraindicated in patients who
are hypersensitive to the active substance
(diphenhydramine hydrochloride) or to any of the excipients listed in
section 6.1.
Nytol One-A-Night 50mg Tablets are also contraindicated in patients
with the following conditions:

Stenosing peptic ulcer

Pyloroduodenal obstruction

Phaeochromocytoma
Health Products Regulatory Authority
03 December 2021
CRN00C94P
Page 2 of 6

Known acquired or congenital QT interval prolongation

Kno