Superdrug One-A-Night Sleep Aid 50mg Tablets.
VANTAGE
SLEEP AID 50MG TABLETS
(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.
I* 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 p. Storing the medicine 6. Further information
A WHAT THIS MEDICINE IS FOR
fv/antage Sleep Aid 50mg Tablets contain diphenhydramine hydrochloride which belongs to a ^group of medicines called sedating antihistamines, which help you to sleep.
p"hese tablets are for short term use to help you sleep.
BEFORE YOU TAKE THE MEDICINE
Do not take Vantage Sleep Aid 50mg Tablets 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
p suffer from narrow angle glaucoma (increased pressure in the eye) p suffer from prostate trouble
• suffer from porphyria (a rare inherited blood disease) p you are pregnant or breastfeeding.
Talk to your doctor or pharmacist before taking Vantage Sleep Aid 50mg Tablets if you:
• have liver or kidney disease
|» have bronchitis or chronic obstructive pulmonary disease (COPD)
|» have other types of glaucoma (see above)
• have difficulty in passing urine
p have myasthenia gravis (a muscle dysfunction)
• suffer from fits (e.g. epilepsy)
p have a condition called tinnitus, which causes ringing in the ears - the medicine may make L your tinnitus worse.
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
Taking other medicines:
This medicine may not be suitable if you are taking certain other medicines. Talk to your doctor or pharmacist before taking Vantage Sleep Aid 50mg Tablets if you are taking any of the following:
• monoamine oxidase inhibitors (for depression), or if you have taken them in the last 14 days
• 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)
• medicines called Beta-blockers (usually for heart problems)
• any other medicines.
If you are unsure about any medicines you are taking please consult your pharmacist or doctor.
Pregnancy and breastfeeding:
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.
If you or anyone takes too much: An overdose is dangerous. Talk to your 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.,
pi 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.
• Headache
• Muscle movements which are unintentional or hard to coordinate
• Stomach problems and discomfort, vomiting
• Low blood pressure; fast, slow or irregular heart beat
• Confusion, depression
• Liver problems
• Sleep disturbances, tremors, seizures (fits), sweating
• Muscle pain and stiffness, pins and needles, muscle twitching, unsteadiness
• 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).
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.
M 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
[71 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., Wrafton, Braunton, Devon, EX33 2DL, United Kingdom.
Manufacturer:
Galpharm International Ltd., Elmhirst Park,
Middle Field Road, Barnsley, South Yorkshire,
S75 4LS, United Kingdom.
Text revised: January 2014.
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