Boots Sleepeaze 25mg Tablets

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.

1. What Sleepeaze 25 mg Tablets are and what they are used for
2. What you need to know before you take Sleepeaze 25 mg Tablets
3. How to take Sleepeaze 25 mg Tablets
4. Possible side effects
5. How to store Sleepeaze 25 mg Tablets
6. Contents of the pack and other information

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, this medicine has been shown to help sufferers to fall asleep faster, have a longer and deeper sleep, and to wake up feeling rested in the morning.

Do not take this medicine for more than 2 weeks without consulting your doctor.

• if you have ever had an allergic reaction to diphenhydramine hydrochloride or 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).

Talk to your doctor or pharmacist before taking this medicine:

• 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 myasthenia gravis, epilepsy or seizure disorders
• If your sleeping difficulties persist, talk to your doctor or pharmacist
• Stop taking Sleepeaze 25mg Tablets at least 3 days before any allergy skin testing, as it may interfere with the results.
• This medicine may get less effective if you use it continuously.

Talk to your doctor or pharmacist before taking these tablets if you are taking any prescribed medicines; particularly tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs prescribed for depression) within the last two weeks, atropine (used to dilate pupils of the eyes) or medicines which make you drowsy. Do not take Sleepeaze 25mg Tablets together with medicines that can produce a change in heart rhythm called QT prolongation which is seen by electrocardiogram (ECG). If you are not sure, please consult your doctor before taking this medicine. Avoid the use of other antihistamines including those used on your skin and in cold and cough medicines, while taking this medicine.

Do not drink alcohol while using this medicine.

Talk to your doctor before taking this medicine if you are pregnant, trying to become pregnant, or breast-feeding.

Do not drive or operate machinery. This medicine is intended to produce sleepiness or drowsiness soon after the dose is taken.

If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor before taking this medicine.

Contact your doctor or casualty department.

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.

• Faster heartbeat, irregular heartbeat
• Fits, difficulty making or controlling movements.

Common side effects (may affect up to 1 in 10 people):

• Sedation, drowsiness, dizziness, unsteadiness, inattention
• Dry mouth
• Fatigue

Other side effects (frequency not known – cannot be estimated from the data available):

• Palpitations (feeling your heartbeat)
• Headache, tingling or numbness (pins and needles)
• 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
• Reduced sense of touch
• An irresistible urge to move your legs and other limbs (restless leg syndrome)

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 or search for MHRA Yellow Card in Google Play or Apple App store.

By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance: Each tablet contains Diphenhydramine Hydrochloride 25 mg.
• The other ingredients are: Anhydrous lactose, microcrystalline cellulose, maize starch, stearic acid and silicon dioxide.

Packs of Sleepeaze 25 mg Tablets contain 4, 8, 16, 20 or 24 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder is

and all enquiries should be sent to this address.