Tesco Max Strength Sleep Aid 50 Mg Tablets
eCTD Office [http://www.ectdoffice.com]
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
I Careway MAX STRENGTH SLEEP AID 50 MG TABLETS (Diphenhydramine Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use 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.
What is in this leaflet:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What this medicine is and what it is used for
This medicine contains the active substance diphenhydramine hydrochloride which 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) in adults and children over 16 years of age.
2. What you need to know before you take this medicine
Do not take this medicine:
• if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
• if you have a peptic ulcer
• if you have a blockage between your stomach and small intestine.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
• if you suffer from myasthenia gravis (abnormal muscle function)
• if you suffer from seizures or have epilepsy
• if you have asthma, bronchitis or Chronic Obstructive Pulmonary Disease (COPD)
• if you have narrow angle glaucoma
• if you have an enlarged prostate
• if you have difficulty urinating
• if you have moderate to severe liver or kidney problems
• if you are elderly, particularly if you also suffer from confusion.
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.
Other medicines and Careway Max Strength Sleep Aid 50 mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following:
• other antihistamines 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
• antimuscarinics 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).
Careway Max Strength Sleep Aid 50 mg Tablets with alcohol
Do not drink alcohol if you are taking this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
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.
Careway Max Strength Sleep Aid 50 mg Tablets contain lactose
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 this medicine
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 is:
£
Adults and children over 16 years:
11 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 with you.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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:
• 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
• dry mouth
• fatigue.
Other effects:
• 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
• 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 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.
Manufacturer:
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.