Lorazepam 2.5mg Tablets
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LORAZEPAM 1 mg AND 2.5 mg TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet.You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What LORAZEPAM tablets are for
2. Before you take LORAZEPAM tablets
3. How to take LORAZEPAM tablets
4. Possible side effects
5. How to store LORAZEPAM tablets
6. Further information
WHAT LORAZEPAM TABLETS ARE FOR
LORAZEPAM belongs to a group of medicines called the benzodiazepines. It is used for the short-term relief of severe or disabling anxiety, insomnia (difficulty in sleeping) due to anxiety or before dental or surgical procedures.
If you are not sure why you have been prescribed these tablets then please ask your doctor.
BEFORE YOU TAKE LORAZEPAM TABLETS
Do not take LORAZEPAM
• If you are allergic to LORAZEPAM, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other benzodiazepines
• If you have severe liver, lung or breathing problems
• if you have muscle weakness sometimes causing difficulty breathing (myasthenia gravis)
• If you suffer from breathing problems when you are asleep (sleep apnoea)
• If you suffer from mental health problems, irrational fears (phobias) or obsessions.
Take special care with LORAZEPAM
Tell your doctor before you take this medicine if you
• have a history of alcohol or drug abuse
• suffer from depression or a personality disorder
• have any problems with your liver, lungs or kidneys
• have weak or tired muscles
• suffer from an inherited iron disorder (porphyria).
Medicines such as LORAZEPAM may lead to addiction. Any risk is more likely with high doses, prolonged treatment or if you have a history of alcohol or drug abuse.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how LORAZEPAM tablets work:
• Medicines for depression or mental health problems such as Olanzapine
• Sodium oxybate to reduce daytime sleepiness or sudden loss of muscle strength
• Disulfiram or Lofexidine for drug dependence
• Medicines to relieve pain or anaesthetics
• Medicines for epilepsy such as Phenytoin or barbiturates
• Levodopa to treat Parkinson's disease
• Medicines for high blood pressure
• Muscle relaxants such as Baclofen orTizanidine
• Rifampicin to treat bacterial infections
• Ritonavir to treat viral infections
• Cimetidine to treat stomach ulcers
• Antihistamines for allergies
• Theophylline for asthma
• Medicines to increase urine production.
AVOID ALCOHOL when taking LORAZEPAM.
If you go into hospital or have treatment for other conditions, tell the doctor that you are taking LORAZEPAM.
Pregnancy and breast-feeding
Do not take LORAZEPAM tablets if you pregnant, planning a pregnancy or breast-feeding unless your doctor has advised you to take them.
Driving and using machines
LORAZEPAM can make you feel drowsy or less alert. If affected do not drive or operate machinery. Avoid alcohol as it can increase these effects.
Important information about some of the ingredients of LORAZEPAM
If you know you have an intolerance to lactose or other sugars contact your doctor before taking LORAZEPAM.
HOW TO TAKE LORAZEPAM TABLETS
Always take LORAZEPAM tablets exactly as your doctor has told you. Take this medicine by mouth. When taking LORAZEPAM tablets try to make sure you sleep well for 7-8 hours per night.
Dosage
Your doctor will decide your dose and length of treatment, as it depends on your condition. Remember LORAZEPAM is for short-term use to reduce the risk of addiction.
Adults:
Anxiety
Typical dose is 1-4 mg daily in divided doses.
Insomnia due to anxiety
Typical dose is 1-2 mg at bedtime.
Elderly or debilitated (those that are weak or feeble):Typically require half the adult dose.
Patients with liver or kidney problems also require smaller doses. Follow your doctor's advice.
Children: Not recommended for children.
If you take more LORAZEPAM than you should
Contact your doctor or pharmacist immediately. Show them the package. Symptoms of an overdose include drowsiness, confusion, difficulty in controlling movements or low blood pressure.
If you forget to take LORAZEPAM
Don't worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
If you stop taking LORAZEPAM
The risk of withdrawal symptoms is greater. Your doctor will gradually reduce your dose.
Withdrawal symptoms may include headache, sweating, diarrhoea, muscle pain, tension, extreme anxiety, depression, hallucinations, fits or sensitivity to light, noise or touch.
POSSIBLE SIDE EFFECTS
Like all medicines, LORAZEPAM can cause side effects, although not everybody gets them.
Common side effects:
• drowsiness, light-headedness, reduced alertness, numbed emotions, muscle weakness
• confusion or difficulty in controlling movements (especially in the elderly).
These effects often occur at the start of the treatment and usually disappear with continued treatment.
Less common side effects:
• headache, dizziness, temporary memory loss
• skin rashes, stomach upsets
• low blood pressure
• problems with your vision, difficulty in speaking
• difficulty passing urine
• changes in your sex drive.
Rare side effects:
• excitement, restlessness
• nightmares, hallucinations, depression
• aggressive outbursts, mood swings
• blood disorders causing bleeding or bruising
• yellowing of the skin and whites of the eyes (jaundice).
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
HOWTO STORE LORAZEPAM TABLETS
Keep out of the reach and sight of children.
Do not store above 25°C. Store in the original package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on the package or container.The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.These measures will help to protect the environment.
FURTHER INFORMATION
What LORAZEPAM tablets contain
The active ingredient in LORAZEPAM 1 mg and 2.5 mg tablets is lorazepam.The other ingredients are lactose, microcrystalline cellulose, talc, sodium starch glycollate and magnesium stearate. LORAZEPAM 2.5 mg tablets also contain erythrosine (E127).
What LORAZEPAM tablets look like and contents of the pack
LORAZEPAM 1 mg tablets are round white tablets with the marking MP60 on one side.
LORAZEPAM 2.5 mg tablets are pink capsule shaped tablets with the marking MP61 on one side and a break line engraved on the other.
The tablets come in blisters packs and containers of 14, 15, 21, 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited, 15 Runnelfield, Harrow on the Hill, Middlesex HA1 3NY
Manufacturer
Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex BN3 3LW or
DDSA Pharmaceuticals Limited, Chatfield Road, off York Road, London SW11 3SE
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last approved in 07/2008
LOR0060-61/0001 &00025T/LEA007
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TEVA UK LIMITED