Lorazium Tablets
PATIENT INFORMATION LEAFLET
Lorazium Tablets 1 and 2.5 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF LORAZIUM.
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST.
What is in Lorazium tablets?
The active ingredient of Lorazium is lorazepam BP.
Lorazium 1 mg tablets contain 1.0 mg lorazepam BP and are white tablets.
Lorazium 2.5 mg tablets contain 2.5 mg lorazepam BP and are pink capsule-shaped tablets marked LOR 2.5 and scored. Lorazium tablets also contain the ingredients microcrystalline cellulose, lactose, talc, sodium starch glycollate, and magnesium stearate. Lorazium 2.5mg tablets in addition contain the colour E127.
Both strengths of Lorazium tablets are available in containers of 100 and 500 and in blister-packs of 28 tablets.
Lorazium belongs to a group of medicines, the
benzodiazepines, that slow down the nervous system and are known as Central Nervous System (CNS) depressants.
The name and address of the Product Licence holder of Lorazium tablets is Chelonia Healthcare Limited,
11 Boumpoulinas, 3rd Floor, 1060 Nicosia, Cyprus
The name and address of the manufacturer of Lorazium tablets is
DDSA Pharmaceuticals Ltd.,
Chatfield Road, off York Road, London SW11 3SE.
Why have you been prescribed Lorazium?
Lorazium is used for the short-term relief (2-4 weeks only) of nervousness or tension which is disabling or which can cause unacceptable distress, either on its own or together with trouble in falling asleep or in sleeping known as insomnia. Lorazium is also used for premedication for dental and surgical procedures.
Before taking this medicine
Before taking this medicine tell your doctor if you have ever had unusual or allergic reactions to Lorazium (Lorazepam) or other benzodiazepines. Also tell your doctor or pharmacist if you are allergic to any other substances, such as foods, preservatives or dyes.
The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor if you have any other medical problems, particularly if you suffer from depression.
This medicine will add to the effects of alcohol and other medicines that slow down the Central Nervous Systems (CNS), possibly causing drowsiness. Some examples of CNS depressants are antihistamines (medicines for hayfever and other allergies), sedatives, tranquillisers, sleeping medicines, pain relieving medicines, barbiturates, medicines for seizures, muscle relaxants, anaesthetics (including some dental anaesthetics).
Tell your doctor if you suffer from Myasthesia Gravis; severe breathing problems; the sleep apnoea problem; liver disease.
How and when to use Lorazium
Take this medicine by mouth and only in the doses prescribed by your doctor. Do not take more of it and do not take it more often or for a longer time than your doctor ordered.
When your doctor decides that treatment should be stopped, then Lorazium will be withdrawn gradually; even then symptoms such as headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability, depression, nervousness, insomnia, sweating and diarrhoea may occur.
If you feel this medicine is not working as well after you have taken it for a short time (1-2 weeks) do not increase the dose, instead check with your doctor.
If you miss a dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose.
Adults dosage:
Your doctor will prescribe a suitable dose for your condition.
Children:
Not recommended for Children.
Overdose
If you think you may have taken an overdose of this medicine, and particularly if you have also taken other Central Nervous System depressants (including alcohol) you should obtain emergency help at once. Tell the doctor in charge, or the nurse or pharmacist, that you are taking this medicine and also tell them whether you have taken other medicines or alcohol. Take any remaining tablets in their original container with you so they may be identified.
With overdose you will become drowsy, mentally confused, lethargic and experience loss of balance, muscle weakness, lowered blood pressure and rarely coma and very rarely death.
What side effects can Lorazium have?
When Lorazium has been combined during treatment with CNS depressants, sedative effects of these are likely to be intensified.
Along with its needed effects, the medicine may cause some unwanted effects, which may persist into the next day. Common amongst these include drowsiness, sedation, fatigue, headache, unsteadiness and difficulty with balance when walking.
Other adverse effects are rare and include drowsiness, sedation, blurring of vision, aggressive outbursts of anger, excitement and confusion may be experienced.
Other rare effects include: lowering of blood pressure, stomach upset, skin rashes, headache, dizziness, inability to pass urine, changes in sexual desire, different types of anaemia, yellowing of the skin and whites of eyeballs (jaundice).
If the above occur check with your doctor at once, as he may wish to discontinue using the drug.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
Driving and using machines
Lorazium can affect your ability to drive and use machines as it may make you sleepy or dizzy. Please remember that alcohol may intensify these effects and should be avoided during treatment.
Do not drive or use machines while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
• However, you would not be committing an offence if:
- Lorazium has been prescribed to treat a medical or dental problem and;
- you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;
- it was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Use in pregnancy
Do not take this medicine if you are pregnant, might become pregnant, or are breast-feeding. If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, and breathing and feeding difficulties. If this medicine is taken regularly in late pregnancy, your baby may develop withdrawal symptoms.
Storing your medicine
Keep out of the sight and reach of children.
Keep your medicine in a dry place, below 25°C in a well-closed container.
If your doctor tells you to stop the treatment, return any remaining tablets to the pharmacist. Only keep the medicine if the doctor tells you to.
On the label you will find the words "Expiry Date" followed by numbers indicating the month and year. This is the date when the medicine is no longer fit for use. Do not use the medicine after this date, but return it to your doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours. This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.
Lorazium Tablets 1 mg Product Licence PL 33414/0056 Lorazium Tablets 2.5 mg Product Licence PL 33414/0057
This leaflet was revised in July 2014.