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DIPHENHYDRAMINE HYDROCHLORIDE TABLETS 25mg & 50mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
In this leaflet:
1. What Diphenhydramine Hydrochloride Tablets are and what they are used for
2. Before you take Diphenhydramine Hydrochloride Tablets
3. How to take Diphenhydramine Hydrochloride Tablets
4. Possible side effects
5. How to store Diphenhydramine Hydrochloride Tablets
6. Further information
1. What Diphenhydramine Hydrochloride Tablets are and what they are used for
Diphenhydramine hydrochloride is an antihistamine with sedative properties which induces drowsiness or sedation. It works by reducing the time needed to fall asleep and increases the depth and quality of sleep.
This medicine is used to aid relief of temporary sleep disturbance (difficulties sleeping).
2. Before you take Diphenhydramine Hydrochloride Tablets
Do not take these tablets if you:
• are allergic to diphenhydramine, or any of the other ingredients listed in section 6
• have a peptic ulcer
• have a blockage between your stomach and small intestine.
Check with your doctor before taking these tablets if you:
• suffer from seizures or have epilepsy
• have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)
• have narrow angle glaucoma
• suffer from myasthenia gravis (abnormal muscle function)
• have an enlarged prostate
• have difficulty urinating
• have moderate to severe liver or kidney problems
• are elderly, particularly if you also suffer from confusion.
Taking other medicines:
Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, even those you have bought without prescription. In particular, you should inform your doctor if you are taking:
• other anti-histamines 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 MAOI 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
• anti-muscarinics which relax smooth muscles and are used for example in Parkinsons Disease, irritable bowel syndrome and incontinence e.g. procyclidine, trihexyphenidyl, atropine, oxybutinin, fesoterodine
• tricyclic antidepressants (e.g. imipramine, amitriptyline).
Other special warnings:
This medicine is for short term sleeping problems. It may not work as well if you use it continuously. If your problems with sleeping persist, see your doctor for advice.
Alcohol:
Do not drink alcohol if you are taking this medicine.
Pregnancy and breast feeding:
If you are pregnant, think you may be pregnant or are breast feeding, consult your doctor before taking this medicine. Effects on driving or operating machinery:
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.
Important information about an ingredient of Diphenhydramine Hydrochloride Tablets:
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Diphenhydramine Hydrochloride Tablets
Swallow the tablets whole with water.
Always take this medicine exactly as stated on the label. The label will tell you how many tablets to take and how often. If you are not sure, ask your doctor or pharmacist.
The usual dose for adults and children aged 16 years and over is:
25mg strength tablets: Take two tablets 20 minutes before going to bed.
50mg strength tablets: T ake one tablet 20 minutes before going to bed.
Do not exceed the stated dose.
Do not use in children under 16 years of age.
If you have taken too many tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
4. Possible side effects
Like all medicines, Diphenhydramine 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:
• 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.
The following side effects have also been reported:
Common effects (may affect up to 1 in 10 people):
• sedation, drowsiness, dizziness, unsteadiness, disturbance in attention
• dry mouth
• fatigue.
Other effects:
• faster heartbeat, palpitations (feeling your heartbeat), irregular heartbeat
• fits, headache, tingling or numbness (pins and needles), difficulty making or controlling movements
• 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, 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 Diphenhydramine Hydrochloride Tablets
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Keep this medicine in the pack provided and protect from light and moisture.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Diphenhydramine Hydrochloride tablets are available in 2 strengths. Each tablet contains either 25 mg or 50 mg diphenhydramine hydrochloride, as the active ingredient. They also contain the inactive ingredients lactose, maize starch, pregelatinised maize starch and magnesium stearate.
What the medicine looks like:
The tablets are white and round and available in pack sizes of 16 and 20 tablets (not all sizes may be marketed.) Who makes this medicine and holds the Product Licence:
The product licence holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.
Manufactured by Surepharm Services Limited, Unit 2H, Bretby Business Park, Ashby Road East, Burton Upon T rent, Staffs, DE15 0YZ.
Date leaflet revised: December 2013
If you would like this leaflet in a different format please contact the licence holder at the above address.