Chlordiazepoxide 5mg Capsules
Package Leaflet: Information for the User
Chlordiazepoxide 5mg & 10mg Capsules
Read all of this leaflet carefully before you start 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 Capsules and what they are used for
2. What you need to know before you take Chlordiazepoxide Capsules
3. How to take Chlordiazepoxide Capsules
4. Possible side effects
5. How to store Chlordiazepoxide Capsules
6. Contents of the pack and other information
|1. What Chlordiazepoxide Capsules are and what they are used for|
The active ingredient (which makes the capsules work) is chlordiazepoxide hydrochloride. It belongs to a group of drugs known as benzodiazepines and has tranquillising (sedating/calming) properties. Chlordiazepoxide Capsules are used for the short-term relief (2 — 4 weeks) 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 Capsules
Do not take Chlordiazepoxide Capsules if you:
have a condition called sleep apnoea where you have difficulty breathing while asleep are pregnant or breast-feeding unless it is under the guidance of your doctor (see Pregnancy and breast-feeding below) are suffering from a psychiatric illness or personality disorder (severe mental problems)
have had any unusual or allergic reactions to chlordiazepoxide, other benzodiazepine medicines or to any of the other ingredients in the capsules (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
Warnings and precuations
Talk to your doctor or pharmacist before taking Chlordiazepoxide Capsules if you:
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)
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.
Chlordiazepoxide Capsules 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 higher 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 Capsules’.
Tolerance
Some of the sedating effects of Chlordiazepoxide may wear off after a few weeks of treatment. If after a few weeks you notice that the capsules are not working as well as when you first started treatment, you should speak to your doctor.
Sleep and Memory problems
Chlordiazepoxide Capsules may make you feel sleepy or forgetful. Chlordiazepoxide Capsules 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 Capsules are not to be used in anyone under 18 years of age.
Other medicines and Chlordiazepoxide Capsules
Some medicines can increase the sedative effects or other side effects of chlordiazepoxide. Tell your doctor if you are taking, have recently taken or might take any other medicines, especially:
disease)
If you go to a doctor, dentist or hospital for any reason, tell them you are taking Chlordiazepoxide Capsules.
antipsychotic drugs (for mental health problems such as chlorpromazine)
tranquillisers (for anxiety or sleep problems)
antidepressants (to treat low mood such as Prozac) hypnotics (medicines for sleep such as opioids) medicines used to treat viral infections (e.g ritonavir) analgesics (for pain relief such as codeine/morphine) sedative antihistamines (for allergies such as chlorphenamine) barbiturates (to treat sleep problems or epilepsy) disulfiram (used to treat alcoholism)
Theophylline; drug to make breathing easier drugs known as dopaminergics (e.g. levodopa for Parkinson’s
medicines for epilepsy (eg phenytoin and phenobarbital) medicines for high blood pressure (e.g. beta blockers, anticoagulants, cardiac glycosides, moxonidine) 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 (used for operations such as lidocaine) sodium oxybate (to treat sudden muscular weakness in people who have a sleep disorder known as narcolepsy).
Chlordiazepoxide Capsules 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 before taking this medicine. Your doctor will then decide whether you should take this medicine.
Tell your doctor before taking Chlordiazepoxide Capsules 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 can cause reduced alertness, drowsiness, dizziness and blurred vision. If you are affected, do not drive use machines or take part in activities that may put you or others at risk.
Chlordiazepoxide Capsules 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 Capsules
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 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 5mg daily increased if needed up to 30mg per day. The maximum dose is 100mg per day taken in divided throughout the day. |
Difficulty sleeping (insomnia) associated with anxiety: Adults': 10mg to 30mg 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-30mg daily in separate doses. |
Relief of symptoms of acute alcohol withdrawal: Adults': 25mg to 100 mg, repeated if needed in 2 to 4 hrs 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 Capsules than you should
If you accidentally take more capsules 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 capsules with you in the container or packaging, so that they can be identified.
If you forget to take Chlordiazepoxide Capsules
If you miss a dose, skip the missed dose and then take the next one when it is due. Do not take two doses to make up for a forgotten dose.
If you stop taking Chlordiazepoxide Capsules
Withdrawal symptoms can occur after you stop treatment, including: headache, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability, sleep disturbances and mood changes. In severe cases, the following symptoms may occur: a feeling of unreality or of being separated from the body, numbness and tingling of the extremities, high sensitivity to light, noise and touch, hallucinations (seeing or hearing things that are not there) or epileptic fits. Withdrawal symptoms will be worse in patients who have been dependent on alcohol or other narcotic drugs in the past. Therefore there will be a tapering off period, during which the dose will be gradually decreased. Do not stop taking Chlordiazepoxide Capsules without talking to your doctor. Treatment will not normally last more than 4 weeks. This is because Chlordiazepoxide Capsules 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.
Common
• light-headedness, drowsiness,
sedation (sleep like state), dizziness, shaky movements and unsteadiness (ataxia), loss of balance and walking difficulties, poor muscle coordination, confusional states, speech disorder.
Rare
Tell your doctor or pharmacist if you develop any of the following side effects:
The following side effects have also been reported (Frequency unknown):
• forgetfulness, memory loss, dependence, restlessness, agitation, irritability, aggressive outbursts, delusion (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, suicide ideation)
shaking (tremor), stiffness and slow movement.
• headache, dizziness, vertigo (spinning sensation), blurred vision, double vision, low blood pressure
• stomach upsets, muscle weakness, skin rashes
• emotional disturbances, changes in the level of sexual desire, impotence, menstrual disorders, incontinence and difficulty passing urine.
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 Capsules
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 capsules to the pharmacist for safe disposal. Do not use after the expiry date stated on the 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 Capsules contain
The active substance (which makes the medicine work) is chlordiazepoxide hydrochloride. Each capsule contains 5mg or 10mg chlordiazepoxide hydrochloride. The capsules also contain lactose monohydrate, maize starch, sodium starch glycollate (type A), magnesium stearate, quinoline yellow (E104), titanium dioxide (E171) and gelatin.
What Chlordiazepoxide Capsules look like and contents of pack
The 5mg capsules are yellow and black and also contain erythrosine (E127) and black iron oxide (E172). The 10mg capsules are green and white and also contain indigotine (E132). The capsules are available in containers and blister packs of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 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