Chlordiazepoxide 5mg Film-Coated Tablets
Package Leaflet: Information for the User Chlordiazepoxide 5mg & 10mg film-coated Tablets
Read all of this leaflet carefully before you starts taking this medicine because it contains important information for you.
- 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 only. Do not pass it on to others. It may harm them even if their signs of illness are the same as yours.
- 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.
What is in this leaflet:
1. What are Chlordiazepoxide film-coated Tablets and what they are used for
2. What you need to know before you take Chlordiazepoxide film-coated Tablets
3. How to take Chlordiazepoxide film-coated Tablets
4. Possible side effects
5. How to store Chlordiazepoxide film-coated Tablets
6. Contents of the pack and other information
1. What Chlordiazepoxide film-coated Tablets are and what they are used for
The active ingredient (which makes the tablets work) is chlordiazepoxide hydrochloride. It belongs to a group of drugs known as benzodiazepines and has a calming effect. Chlordiazepoxide film-coated Tablets are used for the short-term relief (2-4 weeks only) of severe or disabling anxiety occurring alone or along with sleeping problems, muscle spasm of varied causes and for the relief of symptoms of sudden alcohol withdrawal.
2. What you need to know before you take Chlordiazepoxide film-coated Tablets
Do not take Chlordiazepoxide Tablets if you:
• have had any unusual or allergic reactions to chlordiazepoxide, other benzodiazepine medicines or to any of the other ingredients in the tablets (see Section 6).
• have a disorder known as myasthenia gravis a condition where muscles become easily tired and weak leading to difficulty breathing
• have severe liver disease
• suffer from lung disease or breathing difficulties
• have a condition called sleep apnoea where you have difficulty breathing while asleep
• suffer from phobias or obsessive behaviour
• are suffering from a psychiatric illness or personality disorder (severe mental problems)
• are pregnant, planning a pregnancy or breast-feeding unless it is under the supervision of your doctor (see Pregnancy and breast-feeding below)
Warnings and precautions
Talk to your doctor or pharmacist before taking Chlordiazepoxide Tablets if you
are suffering or have suffered from a mental illness are pregnant or breast feeding have a decrease in mental
function as you should receive a lower dose.
• have a long term lung, liver or kidney disease
• have a history of alcohol or drug abuse
• suffer from depression or have recently suffered the death of a close friend or relative (because there is a risk of suicide in such patients)
Chlordiazepoxide Tablets relax the muscles, therefore elderly patients should take extra care when they get up in the night as there is a risk of falls and consequently of injuries including hip fractures.
Dependence
There is a risk of becoming reliant on this type of medicine (dependence) which increases with high doses, duration of treatment and in patients with a history of alcoholism and drug abuse. If dependence has developed, withdrawal symptoms will occur if you suddenly stop treatment. Treatment should therefore be gradually withdrawn. See Section 3, ‘If you stop taking Chlordiazepoxide Tablets’.
Tolerance
Chlordiazepoxide may not work as well in promoting sleep after repeated use for a few weeks. If after a few weeks you notice that the tablets are not working as well as when you first started treatment, you should speak to your doctor.
Sleep and Memory problems
Chlordiazepoxide Tablets may make you feel sleepy or forgetful. Chlordiazepoxide Tablets may also cause partial loss of memory (anterograde amnesia); this happens most often several hours after taking the product. Therefore to reduce the risk of these, you should take your medicine at bedtime and ensure that you will be able to have 7 to 8 hours of uninterrupted sleep.
Children and adolescents
Chlordiazepoxide Tablets are not to be used in anyone under 18 years of age.
Other medicines and Chlordiazepoxide Tablets
Some medicines can increase the sedative effects or other side effects of Chlordiazepoxide Tablets. Tell your doctor if you are taking, have recently taken or might take any other medicines, especially:
• drugs for mental disturbances *
disease).
If you go to a doctor, dentist or hospital for any reason, tell them you are taking Chlordiazepoxide film-coated Tablets.
such as chlorpromazine tranquillisers (to relieve anxiety), antidepressants (for depression) and medicines for sleep
medicines used to treat viral infections (e.g ritonavir) pain relieving medicines sedative antihistamines (for allergies) such as chlorphenamine barbiturates (for anxiety and difficulty sleeping) medicines for epilepsy (e.g. phenytoin and phenobarbital) medicines for high blood pressure (e.g. beta blockers, anticoagulants, cardiac glycosides, moxonidine) Theophylline; drug to make breathing easier
medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, omeprazole; medicines used to treat stomach problems e.g. cisapride, disulfiram and contraceptive agents
baclofen and tizanidine (muscle relaxants)
lofexidine (for opiate drug withdrawal)
nabilone (for nausea and vomiting after chemotherapy) anaesthetics (to remove sensation or cause unconsciousness for surgical procedures) sodium oxybate (to treat sudden muscular weakness in people who have a sleep disorder known as narcolepsy)
drugs known as dopaminergics (e.g. levodopa for Parkinson’s
Chlordiazepoxide Tablets with food, drink and alcohol
Take the medicine before or with your meals.
Do not take alcohol with this medicine. Alcohol is likely to increase the effects of chlordiazepoxide and this can be dangerous.
If you have a history of alcohol or drug abuse, you must tell your doctor before 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. Your doctor will then decide whether you should take this medicine.
Tell your doctor before taking Chlordiazepoxide Tablets if you are breast-feeding. Avoid use of Chlordiazepoxide if you are breast-feeding as this medicine passes into breast milk.
If your doctor has decided that you should receive this medicine during late pregnancy or during labour, your baby may have a low body temperature, floppiness, and breathing and feeding difficulties and may be at risk of developing withdrawal symptoms in the first few days.
Driving and using machines
Chlordiazepoxide Tablets can cause reduced alertness, drowsiness, blurred vision and dizziness, especially after a change in dose. If you are affected in this way, do not drive , use machines or take part in activities that may put you or others at risk.
Chlordiazepoxide Tablets contain the excipient lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Chlordiazepoxide film-coated Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You will be prescribed the lowest dose needed to control your symptoms. Long term use of Chlordiazepoxide Tablets is not recommended and treatment will be as short as possible. Take the medicine by mouth and only in the doses prescribed.
|
Anxiety: Adults: Starting dose 5 mg daily increased if needed up to 30mg per day. The maximum dose is 100 mg per day taken in divided doses throughout the day. |
Difficulty sleeping (insomnia) associated with anxiety: Adults\ 10 mg to 30 mg before going to sleep for a maximum of 4 weeks including a 2 week tapering off period. |
|
Muscle spasm: Adults: A total of 10 mg to 30 mg daily in separate doses. |
Relief of symptoms of acute alcohol withdrawal: Adults: 25 to 100 mg, repeated if needed in 2 to 4hrs after initial dose. |
If you are elderly or suffer from a lung, liver or kidney condition, or are generally unwell, your doctor will usually prescribe a lower dose.
If you take more Chlordiazepoxide Tablets than you should
If you accidentally take more tablets than prescribed, you may have difficulty walking and speaking, and you must contact your doctor or nearest hospital casualty department at once. Take any remaining tablets with you, so that they can be identified.
If you forget to take Chlordiazepoxide Tablets
If you miss a dose, skip the missed dose and take the next one when it is due. Do not take a double dose to make up for a forgotten dose.
If you stop taking Chlordiazepoxide Tablets
If you stop treatment suddenly, withdrawal symptoms can occur. These include headache, muscle pain, extreme anxiety, tension, difficulty sleeping, restlessness, confusion, irritability and in severe cases mental disturbances, numbness and tingling of the hands and feet, extreme sensitivity to light, noise and touch or fits. To avoid this there will be a tapering off period, during which the dose will be gradually decreased. Do not stop taking Chlordiazepoxide Tablets without talking to your doctor. Treatment will not normally last more than 4 weeks. This is because Chlordiazepoxide Tablets may become less effective if you take them for more than four weeks. If you think your medicine is no longer working you should consult your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Chlordiazepoxide can cause side effects. Do not be alarmed by this list of adverse side effects. Most people take Chlordiazepoxide without any problems. Tell your doctor at once if you notice any of the following effects:
A severe allergic reaction (anaphylaxis) or serious allergic reaction which causes swelling of your face or throat (angioedema), difficulty breathing, thoughts of selfharm, yellowing of the eyes and skin (jaundice), abnormality in the blood (blood dyscrasias) with symptoms such as weakness, pale skin, bleeding problems, sore throat and frequent infections.
Changes in behaviour may occur rarely. These changes may include aggression, excitement, confusion and depression.
If these behavioural symptoms occur, you must inform your doctor. He/she may want you to stop taking this medicine.
Tell your doctor or pharmacist if you develop any of the following side effects:
• Common: light-headedness, drowsiness, sleepiness, sedation and dizziness, unsteadiness, loss of balance and walking difficulties, poor muscle coordination, confusional states, speech disorder.
• Rare: headache, dizziness, muscle weakness, vertigo (spinning sensation), low blood pressure, stomach upsets, skin rashes, blurred vision, double vision, emotional disturbances, changes in the level of sexual desire, impotence, menstrual disorders, incontinence and difficulty passing urine.
• The following side effects have also been reported (Frequency unknown): forgetfulness, memory loss, dependence, restlessness, agitation, irritability, aggressive outbursts, delusions (being suspicious or believing things that are not true), nightmares, hallucinations (seeing or hearing things that are not there), changes in salivation, increased liver enzymes, changes in the way you walk and muscle weakness, paradoxical reactions (e.g. anxiety, sleep disorders, insomnia, suicide attempt, suicidal ideation), tremor, stiffness and slow movement.
If you are woken up soon after taking the medicine your memory may be temporarily affected.
If you are an elderly patient, you may be more susceptible to side effects and may suffer from confusion. If this happens, tell your doctor and he/she may decide to change your dose.
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
5. How to store Chlordiazepoxide Tablets
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Keep blister in the outer carton. If your doctor tells you to stop the treatment, return any unused tablets to the pharmacist for safe disposal. Do not use after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month. 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 Chlordiazepoxide Tablets contain
The active substance (which makes the medicine work) is chlordiazepoxide hydrochloride. Each tablet contains 5mg or 10mg of
chlordiazepoxide hydrochloride. The other ingredients are: magnesium stearate, lactose monohydrate, pregelatinised maize starch, hydroxypropylmethylcellulose, ethylcellulose, diethyl phthalate, Brilliant Blue (E133), Indigo Carmine (E132).
What Chlordiazepoxide Tablets look like and contents of the pack
The tablets are round, green, film-coated tablets. Available in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500, 1000.
Not all pack sizes may be marketed.
Marketing authorisation holder
Dr. Reddy’s Laboratories (UK) Ltd.,
6 Riverview Road, Beverley, HU17 0LD, UK.
Date leaflet revised April 2015