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GALPHARM ONE A NIGHT NIGHTCALM 50MG TABLETS

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE

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Transcript
EXTRA STRENGTH SLEEP AID
(Diphenhydramine Hydrochloride)
PATIENT INFORMATION LEAFLET
Read this leaflet carefully because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information
or advice.
• You must contact a doctor if your symptoms
worsen or do not improve.
IN THIS LEAFLET:
1. What this medicine is for
2. Before you take the medicine
3. How to take the medicine
4. Possible side effects
5. Storing the medicine
6. Further information
WHAT THIS MEDICINE IS FOR
Extra Strength Sleep Aid contains diphenhydramine
hydrochloride which belongs to a group of
medicines called sedating antihistamines, which
help you to sleep. These tablets are for short term
use to help you sleep.
BEFORE YOU TAKE THE MEDICINE
Do not take Extra Strength Sleep Aid if you:
• are allergic to diphenhydramine or any of the
other ingredients in the tablets (listed in Section 6).
• have asthma
• have a stomach ulcer, or obstruction of the gut
or bladder
• suffer from narrow angle glaucoma (increased
pressure in the eye)
• suffer from prostate trouble
• suffer from porphyria (a rare inherited blood
disease).
• you are pregnant or breastfeeding.
Talk to your doctor or pharmacist before
taking Extra Strength Sleep Aid if you:
• have liver disease
• have bronchitis or chronic obstructive pulmonary
disease (COPD)
• have other types of glaucoma (see above)
• have difficulty in passing urine
• have myasthenia gravis (a muscle dysfunction)
• suffer from fits
• suffer from tinnitus as this medicine may make
your tinnitus worse.

Taking other medicines:
This medicine may not be suitable if you are taking
certain other medicines. Talk to your doctor or
pharmacist before taking Extra Strength Sleep
Aid if you are taking any of the following:
• medicines used to treat depression called
monoamine oxidase inhibitors
• other medicines used to treat depression or
anxiety (for example sedatives, hypnotics,
tranquillizers, tricyclic antidepressants)
• other antihistamines (these medicines are often
used to relieve allergies or hayfever)
• any other medicines
If you are unsure about any medicines you are taking
please consult your pharmacist or doctor
Pregnancy and breast feeding:
Do not take the tablets if you are pregnant or
breastfeeding.
Taking this medicine with food and drink
Avoid drinking alcohol while taking these tablets.
Driving and using machines
This product causes drowsiness soon after taking,
so you should not drive or operate machinery for at
least 8 hours after taking a tablet.
Important information about some of the
ingredients of this medicine:
The tablets contain lactose. If you have been told
by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this
medicinal product.
HOW TO TAKE THE MEDICINE
Age

Dose and how often to take

Adults and
children over
16 years

Take ONE tablet 20 minutes
before going to bed. Swallow
the tablet with a glass of water.
Don’t take a second tablet in
the same night.

Do not give to children under 16 years.
Remember: the tablets are for short term use only.
If you continue to have sleeping problems consult
your doctor. Do not take the tablets continuously
as they may become less effective.
DO NOT EXCEED THE STATED DOSE
If you or anyone takes too much: An overdose
is dangerous. Talk to a doctor straight away, or
contact your nearest hospital casualty department
if you take more than the stated dose. Take the
carton and this leaflet with you.
Further information overleaf.

POSSIBLE SIDE EFFECTS
Most people take these tablets without any problems,
but they can have side effects, like all medicines.
Side effects are more likely to occur in the elderly.
Serious side effects
Stop taking the tablets and go to your doctor
or casualty department IMMEDIATELY if:
• you get any swelling of the face, lips, tongue or
throat
• you have any difficulty swallowing or breathing
• you get any skin rash.
The above symptoms may mean you are having a
severe allergic reaction to this medicine.
Other side effects that may occur are listed below.
If you experience any of these symptoms, you feel
unwell or notice any unusual effects while taking
these tablets talk to your doctor or pharmacist.
• Unexpected bleeding or bruising. This may be a
sign of very rare changes in the blood.
• Headache
• Muscle movements which are unintentional or
hard to coordinate
• Stomach problems and discomfort, vomiting
• Low blood pressure; fast, slow or irregular
heart beat
• Sensitivity to light
• Confusion, depression
• Blood and liver problems
• Sleep disturbances, tremors, seizures (fits),
sweating
• Muscle pain and stiffness, pins and needles,
muscle twitching, unsteadiness
• Hair loss
• Urinary retention and difficulty passing urine
• Tinnitus
• Urticaria (hives)
• Reduced sense of touch or sensation
• Restlessness, excitability and reduced attention
• Increased energy
• Thicker bronchial mucus
The following side effects are mild and wear off
about 8 hours after taking the medicine:
• Blurred vision, dizziness, drowsiness, feeling
groggy, nervousness
• Dry mouth
• Nausea (feeling sick)

STORING THE MEDICINE
Do not store above 25°C.
Store in the original package. Keep container in
outer carton.
Do not use after the expiry date printed on the carton
and blister foil.
Keep all medicines out of the reach and sight
of children.
FURTHER INFORMATION
What is in this medicine:
The active ingredient is: Diphenhydramine
hydrochloride 50mg in each tablet.
Other ingredients are: Lactose, maize starch and
magnesium stearate.
What this medicine looks like and contents of
the pack:
The tablets are white and marked with "DX" on one
side and plain on the other.
The tablets are available in packs containing 6, 8,
10, 12, 14, 16, 20, 24 or 30 tablets (not all pack
sizes may be marketed).
Marketing Authorisation Holder: Galpharm
Healthcare Ltd, Upper Cliffe Road, Dodworth
Business Park, Dodworth, South Yorkshire S75 3SP
Manufacturer: Galpharm International Ltd, Upper
Cliffe Road, Dodworth Business Park, Dodworth,
South Yorkshire S75 3SP
Leaflet revised: February 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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