PAXIDORM TABLETS 25MG

NightAid Tablets
Diphenhydramine Hydrochloride

H0014-4

Ambe Limited

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
ÐÐ Keep this leaflet. You may need to read it again.
ÐÐ Ask your pharmacist if you need more information or advice.
ÐÐ 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.
ÐÐ You must talk to a doctor or pharmacist if your symptoms worsen or do not improve.
This leaflet contains the following information.
1. What NightAid Tablets are and what are they used for?
2. What you need to know before you use NightAid Tablets
3. How to use NightAid Tablets
4. Possible side effects
5. How to store NightAid Tablets
6. Contents of the pack and other information
1. What NightAid Tablets are and what are they used
for?
NightAid Tablets contain the following active
ingredient: Diphenhydramine hydrochloride.
Diphenhydramine hydrochloride is an antihistamine
which works by blocking the body’s response to
histamine, which is an agent responsible for causing
allergic responses such as hay fever, stings and rashes.
Histamine is also involved in the brain’s waking
system so diphenhydramine hydrochloride can help
alleviate temporary sleeplessness.
2. What you need to know before you use NightAid
Tablets
Do not use NightAid Tablets:
•• if you are allergic to diphenhydramine hydrochloride or any of the ingredients listed in section 6 of
this leaflet
•• if you have a peptic ulcer
•• if you have a blockage between your stomach and
small intestine.
Warnings and precautions
Talk to your doctor or pharmacist before taking
NightAid Tablets:
•• if you suffer from myasthenia gravis (abnormal
muscle function)
•• if you suffer from seizures or have epilepsy
•• if you asthma, bronchitis or Chronic Obstructive
Pulmonary Disease (COPD)
•• if you have narrow-angle glaucoma
•• if you have an enlarged prostate
•• if you have difficulty urinating
•• if you have moderate to severe liver or kidney
problems
•• if you are elderly, particularly if you also suffer
from confusion.
This medicine is for short term use. It may not work
as well if you use it continuously. If your symptoms
persist, see your doctor for advice.

Other medicines and NightAid Tablets:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including:
•• Other antihistamines including those used on your
skin and in cough and cold medicines
•• Tranquillisers or anxiolytics (sedatives) used to
treat anxiety e.g. diazepam
•• Hypnotics (e.g. nitrazepam) used to help you sleep
better
•• Monoamine oxidase inhibitors (MAOIs) for depression (e.g. phenelzine) or if you have stopped taking an MOAI within the last two weeks
•• Metoprolol (a beta blocker) used to treat high
blood pressure, angina, irregular heart beat or
overactive thyroid
•• Venlafaxine used to treat depression
•• Anticholinergics which relax smooth muscles
and are used for example in Parkinson’s disease,
irritable bowel syndrome and incontinence e.g.
procyclidine, trihexyphenidyl, atropine, oxybutynin, fesoterodine
•• Tricyclic antidepressants (e.g. imipramine, amitriptyline).
NightAid Tablets with alcohol:
While taking NightAid Tablets avoid alcoholic drink.
Pregnancy and breast-feeding:
Do not take NightAid Tablets if you are pregnant or
breast-feeding.
Driving and using machines:
This medicine causes drowsiness and sedation and
may also cause dizziness, blurred vision, disturbance
in attention and slower reaction times. Do not drive or
operate machinery while you are affected in this way.
NightAid Tablets contain lactose and sucrose:
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.

3. How to use NightAid Tablets
Always use this medicine exactly as described in this
leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not
sure. The recommended dose is:
For use as a temporary sleep aid:
Adults: 1 or 2 tablets to be taken at bedtime or after
retiring when sleep is not readily achieved.
Do not take a repeat dose in the same night.
Not recommended as a sleep aid in children under
16 years of age.
For the treatment of hay fever, stings, rashes and
other minor allergies:
Adults and children over 12 years: 1 or 2 tablets
three or four times a day or as prescribed by a doctor.
Not recommended for children under 12 years of
age.
If you take more NightAid Tablets than you should:
Seek medical attention as soon as possible. When
seeking medical advice you should, if possible, take
the medicine and this leaflet with you provided it
doesn’t cause a delay.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur STOP TAKING the tablets
IMMEDIATELY and contact your doctor, as these may
be signs of an allergic reaction:
•• Difficulty breathing or shortness of breath, swelling of the face, mouth or throat
•• Rash, hive (itchy, raised red weals).
If you notice any of the following effects tell your doctor straightaway:
•• Faster heartbeat, irregular heartbeat
•• Fits, difficulty making or controlling movements.
Tell your doctor, pharmacist or nurse if you suffer
from any of the following other effects:
Common effects (may affect up to 1 in 10 people):
•• Sedation, drowsiness, dizziness, unsteadiness,
disturbance, inattention
•• Dry mouth
•• Fatigue.
Other effects (frequency not known – cannot be
estimated from the data available):
•• Palpitations (feeling your heartbeat)
•• Headache, tingling or numbness (pins and needles)
•• Depression, sleep disturbances
•• Confusion, excitation e.g. increased energy, restlessness, nervousness (the elderly are more likely
to experience these effects)
•• Difficulty urinating or inability to pass urine
•• Thicker bronchial mucus

•• Blurred vision
•• Feeling or being sick, stomach problems
•• Muscle twitching.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard or search for MHRA Yellow
Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store NightAid Tablets
Keep this medicine out of the sight and reach of
children. Store below 25°C. Do not use this medicine
after the expiry date which is stated on the carton and
blister pack. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What NightAid Tablets contain:
The active substance is diphenhydramine hydrochloride, 25mg. The other ingredients are: lactose, corn
starch, povidone, magnesium stearate, Opaseal (polyvinyl acetate phthalate, ethyl acetate and stearic acid),
sucrose, calcium carbonate, talc, acacia, titanium
dioxide E171, Opalux Pink AS 1537 (E127 erythrosine),
Opaglos 6000 (carnauba wax, beeswax), silicone fluid.
What NightAid Tablets look like and the contents
of the pack:
NightAid Tablets are pink, sugar coated, tablets and
are supplied in packs of 8, 16 or 20 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
The marketing authorisation holder is:
Norma Chemicals Ltd.,
51-53 Stert Street, Abingdon,
Oxfordshire, OX14 3JF, UK.
The EEA site of batch release is:
Surepharm Services Ltd.,
Bretby Business Park,
Burton upon Trent, DE15 0YZ, UK.
or
Wasdell Packaging Ltd.,
Euroway Industrial Estate,
Blagrove, Swindon, Wiltshire, SN5 8YW, UK
This Leaflet was last revised in September 2017
PL00386/5008R