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DIPHENHYDRAMINE 50MG TABLETS

Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE / DIPHENHYDRAMINE HYDROCHLORIDE

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Package leaflet: Information for the user
Diphenhydramine 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 Diphenhydramine 50mg Tablets are and what are they used for
2. What you need to know before you take Diphenhydramine 50mg Tablets
3. How to take Diphenhydramine 50mg Tablets
4. Possible side effects
5. How to store Diphenhydramine 50mg Tablets
6. Contents of the pack and other information
1. What Diphenhydramine 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, Diphenhydramine 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 Diphenhydramine 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 in your stomach or gut (for example, because of an ulcer).
 if you have a Phaeochromocytoma
 if you know you have a problem with ‘QT interval prolongation’
 if you have or had a cardiovascular disease or if your heart rate is very low
 if you have low salt levels in your body (e.g. low level of potassium or of magnesium)
 if you are taking certain medicines for heart rhythm problems or medicines that may affect
the heart rhythm
 if anyone in your close family has died suddenly of heart problems


Warnings and precautions
Seek medical advice if sleeplessness persists, as insomnia may be a sign of serious underlying
medical illness.
Cases of dependence and / or abuse have been reported in young people. Signs of this occurring
should be reported to a doctor.
Talk to your doctor or pharmacist before taking these tablets:
 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 muscle weakness, epilepsy or seizure disorders.
Skin allergy testing: do not take these tablets in the 3 days before skin tests for allergy. They
may interfere with the results.
If your sleeping difficulties persist, talk to your doctor or pharmacist.
Do not take these tablets for more than 7 days without consulting a doctor. Diphenhydramine
50mg Tablets may get less effective if you take them continuously.

Children and adolescents
Do not use in children or adolescents under the age of 18 years.
Other medicines and Diphenhydramine 50mg Tablets



Do not take these tablets together with medicines that can produce a change in heart
rhythm. If you are not sure, please consult your doctor before taking any.
Do not take other antihistamines together with these tablets, including those used on
the skin, or in cough and cold medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including medicines obtained without a prescription. It’s especially important to
mention:





Certain antidepressants: tricyclics or monoamine oxidase inhibitors (MAOIs) that you
have used within the last two weeks
atropine (used to dilate pupils of the eyes)
medicines which make you drowsy.

Taking Diphenhydramine 50mg Tablets with food, drink and alcohol
Do not drink alcohol while using these tablets.
Pregnancy, breast‐feeding and fertility
Do not take Diphenhydramine 50mg Tablets if you are pregnant or breast‐feeding. If you think
you may be pregnant or are planning to have a baby, ask your doctor for advice before taking
these tablets.
Driving and using machines
Do not drive or operate machinery. These tablets are intended to produce sleepiness or
drowsiness soon after the dose is taken.
Diphenhydramine 50mg Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, ask your
doctor before taking this medicine.

3. How to take Diphenhydramine 50mg Tablets
Always take 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 for Adults aged 18 years and over:
Swallow 1 tablet with water 20 minutes before you go to bed.
Not to be used by children under 18 years.
Elderly patients or patients with liver or kidney problems should consult their doctor before
taking this medicine.




Do not take more than the recommended dose.
Do not take extra tablets if you wake up in the night.
Do not take for more than 7 days without consulting a doctor.

If you take more Diphenhydramine 50mg Tablets than you should:
Contact your doctor or casualty department.
If you forget to take Diphenhydramine 50mg Tablets
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time
as described in this leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Diphenhydramine 50mg Tablets can have side effects, but not everybody gets
them.
Common (may affect up to 1 in 10 people)
 The most common side effects are: tiredness, drowsiness, reduced attention,
unsteadiness, dizziness or a dry mouth.
Not known (frequency cannot be estimated from the available data)
 Allergic reactions (such as rash, shortness of breath and swelling), blurred vision,
palpitation (feeling your heart beat) or irregular heartbeat.
 Muscle twitching, convulsions, headache or pins and needles.
 Also nausea (feeling sick), vomiting (being sick), thicker bronchial mucus and difficulty
passing urine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Diphenhydramine 50mg Tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the EXP date shown on the pack. The expiry date refers to the last
day of that month.
Store below 25oC
Store in the original packaging in order to protect from light and moisture.
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 Diphenhydramine 50mg Tablets contains
- Active ingredients: Each tablet contains Diphenhydramine Hydrochloride 50 mg.
- Other ingredients: Anhydrous lactose, microcrystalline cellulose, maize starch, stearic
acid and colloidal anhydrous silica.
What Diphenhydramine 50mg Tablets look like and contents of the pack

Diphenhydramine 50mg Tablets are white to off white, 15mm in length, oblong capsule shaped
tablets embossed with “N50” logo on both sides packed into UPVC/PVdC blister packs with a
heat sealable aluminium foil.
They are available in packs of 4, 8, 10, 16 and 20 tablets. Not all packs will be marketed.
Marketing Authorisation Holder
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road
LONDON, SW1V 2SA
United Kingdom
Manufacturer
Wrafton Laboratories Ltd, Wrafton, Braunton, North Devon, EX33 2DL, U.K.
This leaflet was last revised in 01/2017.

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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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