DIPHENHYDRAMINE HYDROCHLORIDE TABLETS 50MG
Active substance(s): DIPHENHYDRAMINE HYDROCHLORIDE
The recommended dose is:
Adults and children over 16 years:
Take one tablet 20 minutes before going to bed.
Do not exceed the stated dose.
Use in children:
Do not use in children under 16 years of age.
This medicine is for oral use. Swallow the tablets whole with water.
If you take more tablets than you should
If you take too much of this medicine it is likely to result in effects similar to those listed
below in section 4 Possible Side Effects. Other effects may include dilated pupils, fever,
flushing, agitation, shaking, movement disorder, seeing or hearing things that are not
real or ECG changes. A large overdose may cause abnormal muscle breakdown which
can lead to kidney problems, fits, delirium, loss of contact with reality, irregular heartbeat,
coma or cardiovascular collapse.
Talk to your doctor or pharmacist if you take too many tablets. Take the medicine pack
If you have any further questions on the use of this medicine, ask your doctor or
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
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, hives (itchy, raised red weals}.
If you notice any of the following effects tell your doctor straightaway:
• fever, chills, sore throat, infections. These may be signs of a blood disorder
• 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 in attention
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
feeling or being sick, stomach problems
Reporting of side effects
If you get any side effects, talk to your doctor, 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. By reporting side effects you
can help provide more information on the safety of this medicine.
5. How to store this medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton or
blister after "EXP". The expiry date refers to the last day of that month.
Keep this medicine in the pack provided and protect from light and moisture.
Do not use this medicine if you notice any change in the appearance of the tablets.
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 this medicine contains
The active substance is diphenhydramine hydrochloride. Each tablet contains 50 mg
diphenhydramine hydrochloride. The other ingredients are lactose, maize starch,
pregelatinised maize starch and magnesium stearate.
What this medicine looks like and contents of the pack
The tablets are white, round tablets and are available in pack sizes of 16 and 20 tablets
(not all sizes may be marketed.)
Marketing Authorisation Holder:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane,
Overton, Hants, RG25 3ED.
Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road East,
Burton Upon Trent, Staffs, DE15 OYZ.
This leaflet was last revised in February 2016
If you would like this leaflet in a different format please contact the marketing
authorisation holder at the above address.
Clearly mark any amendments on one proof and return to MPS
Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our client's brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
Measure bar should be 150mm at 100% scale
Careway MAX STRENGTH SLEEP AID 50mg TABLETS PIL • Process Black
146 x 315mm
O Keyline-does not print
• Pharmacode Area-does not print
Min. Point Size 9pt
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.