Chlordiazepoxide Capsules Bp 5mg
Package Leaflet: Information for the User
Chlordiazepoxide Capsules BP 5mg or 10mg
Chlordiazepoxide Hydrochloride
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 Chlordiazepoxide Capsules are 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
Chlordiazepoxide belongs to a group of medicines known as benzodiazepines, which are tranquillisers (medicines that have a calming effect).
Chlordiazepoxide capsules are used for the short-term treatment of severe anxiety, which may occur alone or in association with sleeplessness (insomnia) or personality/behavioural disorders. Chlordiazepoxide capsules may also be used to treat muscle spasms, and to relieve symptoms of sudden alcohol withdrawal.
2. What you need to know before you take Chlordiazepoxide Capsules
Do not take Chlordiazepoxide if you:
• are allergic to Chlordiazepoxide or any of the the other ingredients of this medicine (listed in section 6)
• are allergic to any medicine known as a benzodiazepine (e.g. nitrazepam, diazepam, flurazepam, or temazepam)
• suffer from lung disease
• suffer from breathing difficulties while awake or asleep
• suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily)
• are suffering from a psychiatric illness or a personality disorder (severe mental problems)
• have a severe liver condition.
Chlordiazepoxide Capsules are not to be used in anyone under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Chlordiazepoxide Capsules if you:
• have a long term lung, liver or kidney disease
• suffer from depression or have recently suffered from the death of a close friend or relative
• are suffering or have suffered from a mental illness
• have abused alcohol or drugs
• are pregnant or breast feeding
• have a decrease in mental function as you should receive a lower dose.
Chlordiazepoxide Capsules relax the muscles, therefore old patients should take extra care when they get up at night as there is a risk of falls and consequently of injuries including hip fractures.
Other medicines and Chlordiazepoxide Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:
• Anti-depressants, sleeping tablets, neuroleptics, hypnotics, tranquillisers, or other such medicines which act on the brain and nerves
• Medicines used to relieve pain or anaesthetics
• Antihistamines (used for treating allergies) that cause drowsiness (e.g. chlorphenamine)
• Medicines for treating epilepsy (e.g., phenytoin and phenobarbital).
• Medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, omeprazole; medicines used to treat stomach problems, disulfiram and contraceptive agents)
• Medicines used to treat viral infections (e.g. ritonavir) as these medicines can potentiate the actions of benzodiazepines
• Drugs to treat high blood pressure (e.g. beta blockers, anticoagulants, cardiac glycosides, moxonidine)
• Drugs known as dopaminergics (e.g. levodopa, for Parkinson’s disease)
• Sodium oxybate; used in patients with narcolepsy
• Theophylline; drug to make breathing easier.
Chlordiazepoxide with food and alcohol
Take the medicine before or with your meals.
Do not drink alcohol for as long as you are taking Chlordiazepoxide Capsules. Alcohol will increase the effects of the capsules and this can be dangerous.
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.
Pregnancy
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. Also, your unborn baby may be at risk of developing dependency to this medicine and after birth may be at some risk of developing withdrawal symptoms.
Breast-feeding
Tell your doctor before taking Chlordiazepoxide Capsules if you are breastfeeding. Avoid use of Chlordiazepoxide if you are breast-feeding, as Chlordiazepoxide passes into breast-milk.
Driving and using machines
Chlordiazepoxide may make you feel sleepy or affect your concentration. Do not drive or use any tools or machines if you are affected in this way and do not drink alcohol, as this will make these effects worse.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive 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:
- The medicine 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.
Chlordiazepoxide Capsules contain Lactose
Chlordiazepoxide Capsules contain lactose. Therefore, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Chlordiazepoxide Capsules contain Tartrazine
This medicine also contains tartrazine (E102) which may cause allergic reactions.
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.
Your doctor will find the lowest dose to control your symptoms. The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.
Swallow the capsule(s) whole with a glass of water.
The recommended dose is:
|
For the treatment of: |
Usual dosage: |
|
Anxiety |
Up to 30 mg per day. The maximum dose is 100 mg per day, taken in divided doses throughout the day |
|
Sleeplessness (Insomnia) associated with anxiety |
10 to 30 mg before going to sleep |
|
Symptoms of sudden alcohol withdrawal |
25 to 100 mg. This can be repeated 2 to 4 hours after the initial dose, if necessary |
|
Muscle spasms |
10 to 30 mg per day, taken in divided doses throughout the day |
If you are old or suffer from a lung, liver or kidney condition, or are generally unwell, your doctor will usually prescribe a lower dose.
Chlordiazepoxide Capsules are not for use in children.
You will normally see an improvement in your symptoms after 10 to 15 days of taking Chlordiazepoxide regularly.
Treatment will not normally be continued for more than 4 weeks. This is because Chlordiazepoxide may become less effective if you take them for more than four weeks. If you think that your medicine is no longer working, you should consult your doctor.
Also, you may become dependent on the capsules if you use them at high doses and for long periods. Therefore, Chlordiazepoxide Capsules are not suitable for long-term use and after a few weeks it is worth trying to get by without these capsules. This will help to prevent you becoming used to Chlordiazepoxide and reduce the risk of dependence.
Do not stop taking Chlordiazepoxide Capsules without discussing with your doctor (refer to “If you stop taking Chlordiazepoxide Capsules” below).
If you take more Chlordiazepoxide Capsules than you should
If you take too many capsules or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away. The symptoms of overdose include drowsiness, mental confusion and feeling of tiredness, in more serious cases, symptoms may include unsteadiness when walking, low muscle strength, low blood pressure, shallow breathing, rarely coma and very rarely death.
If you forget to take Chlordiazepoxide Capsules
Do not take a double dose to make up for a forgotten dose. Instead you should simply continue with the next dose when it is due.
If you stop taking Chlordiazepoxide Capsules
Your doctor will advise you when to stop taking the capsules. Do not stop taking Chlordiazepoxide Capsules abruptly. You may experience withdrawal effects if your treatment is stopped suddenly. This is less likely if your dose is gradually reduced towards the end of your treatment.
Withdrawal symptoms may include:
• a recurrence of sleep problems
• depression
• nervousness
• irritability
• sweating
• extreme anxiety
• diarrhoea
• confusion
• restlessness
• incontinence
• headaches
• muscle pain.
In severe cases the following symptoms may occur:
• changes in behaviour or the way you are feeling
• numbness and tingling of the extremities
• over-sensitivity to light, noise and touch
• hallucinations
• fits.
If you are woken up soon after taking the medicine your memory may be temporarily affected.
If you have taken benzodiazepines for a long time, the reduction in your dosage will be over a longer period of time than would normally be required when you stop taking this medicine.You may need additional help. Your doctor will be able to discuss this 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.
It is very important that you immediately seek medical advice if you develop any of the following symptoms:
A severe allergic (anaphylaxis) or serious allergic reaction which causes swelling of your face or throat (angioedema), difficulty breathing, thoughts of self-harm, 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: may affect up to 1 in 10 people
• drowsiness and lightheadedness the next day
• tiredness
• sedation and dizziness
• loss of balance
• unsteadiness and clumsiness
• poor muscle co-ordination
• confusional states.
• Speech disorder
Rare: may affect up to 1 in 1,000 people
• headache
• vertigo
• low blood pressure
• stomach upsets
• skin rashes
• problems with your eyesight
• emotional disturbances
• double vision
• changes in the level of sexual desire
• inability to pass urine
• incontinence
• impotence
• menstrual disorder.
Not known: frequency cannot be estimated from the available data
• forgetfulness, memory loss, hallucinations, dependence, depression, restlessness,
agitation, irritability, aggression, delusion, nightmares, 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 old patient, you may be more susceptible to side effects and may be at risk of fall which may lead to fracture or 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 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.
5. How to store Chlordiazepoxide Capsules
Keep out of the reach and sight of children. Keep container tightly closed.
Do not store above 25°C. Do not use Chlordiazepoxide after the expiry date that is stated on the outer packaging. 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.
6. Contents of the pack and other information
What Chlordiazepoxide contains:
• The active ingredient is 5mg or 10mg of Chlordiazepoxide Hydrochloride.
• Chlordiazepoxide Capsules BP 5mg also contain lactose, maize starch, magnesium stearate (E572), erythrosine (E127), quinoline yellow (E104), titanium dioxide (E171), indigotine (E132) and gelatin.
• Chlordiazepoxide Capsules BP 10 mg also contain lactose, maize starch, magnesium stearate (E572), tartrazine (E102), titanium dioxide (E171), iron oxides (E172), patent blue V (E131) and gelatin.
What Chlordiazepoxide looks like and contents of the pack:
The 5mg capsules are yellow/green hard gelatin capsule, overprinted with Rima 5 or RCDP 5.
The 10mg capsules are green/black size 4 hard gelatin capsule, overprinted with Rima 10 or RCDP 10.
Both the capsules are available in containers of 14, 15, 21, 28, 42, 56, 70, 84, 100, 500 and 1000 and in blister packs of 14, 15, 21, 28, 42, 56, 70 and 84 capsules. The 5mg capsules are also available in containers of 250 capsules.
*Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Focus Farma B.V.
Lagedijk 1-3
1541 KA Koog aan de Zaan The Netherlands
Manufacturer:
Ranbaxy Ireland Ltd.
Spafield
Cashel
Co-Tipperary Republic of Ireland
This leaflet was last revised in: November 2015
PL 25821/0003-0004