Chlordiazepoxide 5mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
CHLORDIAZEPOXIDE 5 mg & 10 mg 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 Chlordiazepoxide is and what it is 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 is and what is used for
Chlordiazepoxide belongs to a group of medicines called benzodiazepines (medicines that have a calming effect). It can be used in the short-term (2-4 weeks only) treatment of:
In adults:
• severe anxiety, occurring alone or in association with difficulty in sleeping (insomnia) stress or a loss of control with reality (psychosis).
• muscle spasms.
• the symptoms of sudden alcohol withdrawal.
You must talk to a doctor if you do not feel better or if you feel worse.
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 other ingredients of this medicine (listed in section 6) or to other benzodiazepines (e. g. nitrazepam, diazepam, flurazepam, or temazepam).
• If you have severe liver, lung or breathing problems.
• If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily).
• If you suffer from breathing problems whilst asleep (sleep apnoea).
• If you suffer from depression, mental health problems, irrational fears (phobias) or obsessions.
• If you have spinal or cerebral ataxia (loss of control of bodily movements).
Warnings and Precautions
Talk to your doctor or pharmacist before taking chlordiazepoxide:
• If you have a history of alcohol or drug abuse.
• If you suffer from a personality disorder.
• If you have recently suffered a loss or bereavement
• If you have a long-term liver, kidney or lung disease.
• If you are pregnant or breast feeding..
• If you have 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 at night as there is a risk of falls and consequently of injuries including hip fractures.
Children and adolescents
Chlordiazepoxide capsules are not to be used in anyone under 18 years of age.
Medicines such as Chlordiazepoxide may lead to:
• Addiction. You may become dependent on these capsules. Any risk is more likely with high doses, prolonged treatment or if you have a history of alcohol or drug abuse.
• Tolerance. Chlordiazepoxide capsules may become less effective after a few weeks. If you think that the capsules are not working as well as they did, you should consult your doctor.
• Withdrawal. You may experience withdrawal effects if your treatment is stopped suddenly. Withdrawal symptoms can occur with Chlordiazepoxide capsules even when normal doses are given for short periods of time, (see section 3; ‘If you suddenly stop taking Chlordiazepoxide’).
• Memory problems. Chlordiazepoxide capsules may cause partial loss of memory (anterograde amnesia). Therefore, to reduce the risk of these you will be able to have 7 to 8 hours of uninterrupted sleep.
Other medicines and Chlordiazepoxide
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Chlordiazepoxide capsules work:
• Medicines to treat depression such as Fluvoxamine or Mirtazapine.
• Medicines to treat mental health problems such as Olanzapine or Prochlorperazine
• Tranquilisers (may increase effects of relaxing muscles -higher risk of falling in elderly patients).
• Medicines to calm you down or to help you sleep.
• Sodium oxybate to reduce daytime sleepiness or sudden loss of muscle strength.
• Disulfiram or Lofexidine for drug dependence.
• Strong pain killers or general anaesthetics.
• Nabilone to treat sickness caused by chemotherapy.
• Medicines to treat epilepsy such as Phenytoin or barbiturates.
• Levodopa to treat Parkinson’s disease.
• Drugs to treat high blood pressure (e.g. beta blockers, anticoagulants, cardiac glycosides,moxonidine). Medicines to treat high blood pressure or chest pain such as Propranolol, Atenolol (beta-blockers), Amlodipine,
Felodipine (calcium-channel blockers), Glyceryl trinitrate, Isosorbide mononitrate (nitrates).
• Medicines to increase urine production such as Diuretics.
• Muscle relaxants such as Baclofen or Tizanidine.
• Medicines that affect the liver (e.g. the antibiotic rifampicin and cimetidine, omeprazole, macrolide antibiotics (erythromycin); medicines used to treat stomach problems and contraceptive agents). Medicines used to treat viral infections (e.g. ritonavir) as these medicines can potentiate the actions of benzodiazepines.
• Cimetidine to treat ulcers.
• Antihistamines for allergies (chlorphenamine).
• Theophylline; drug to make breathing easier.
Chlordiazepoxide with food, drink and alcohol
Take the medicine before or with your meals.
Alcohol may increase the sedative effects of Chlordiazepoxide and make you feel very sleepy. Do not drink alcohol whilst taking Chlordiazepoxide.
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including benzodiazepines. Do not drink grapefruit juice whilst taking Chlordiazepoxide.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Avoid use of chlordiazepoxide if you are breast-feeding, as chlordiazepoxide passes into breast-milk.
If your doctor has decided that you should receive this medicine late in your pregnancy or during labour your baby might have a low body temperature, floppiness, and breathing and feeding difficulties.
If you take this medicine regularly during late pregnancy, your baby may become dependent on Chlordiazepoxide and may develop withdrawal symptoms after birth.
Make sure you follow your doctor’s advice.
Driving and using machines
Chlordiazepoxide Capsules may cause side effects such as drowsiness, tiredness, dizziness, confusion, poor muscle co-ordination and problems with your eyesight. This may affect your ability to drive and operate machinery. Do not drive or operate machinery if you experience any of these side effects Do not drive or operate machinery 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:
- Chlordiazepoxide 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.
There is further information for patients who are intending to drive in Great Britain - go to https://www.gov.uk/drug-driving-law
Chlordiazepoxide Contains
Chlordiazepoxide 5 mg and 10 mg capsules contain lactose (a type of sugar). If you know you have an intolerance to some sugars contact your doctor before taking this medicine.
3. How to take Chlordiazepoxide Capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Swallow the capsules whole. When taking this medicine try to make sure you sleep well for 7-8 hours per night.
You will be prescribed the lowest effective dose for the shortest time necessary to treat your symptoms. This will reduce the risk of addiction. The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age and bodyweight.
If you think that the effect of your medicine is too weak or too strong, talk to your doctor.
Dosage
Adults:
Anxiety: The recommended dose is up to 30 mg a day in divided doses. This can be increased to a maximum of 100 mg a day in divided doses.
Insomnia in association with anxiety: The recommended dose is 10-30 mg before going to sleep.
Muscle spasms: The recommended dose is 10-30 mg a day in divided doses.
Alcohol withdrawal symptoms: The recommended dose is 25-100 mg, which may be repeated after two to four hours if necessary.
If you are elderly/debilitated/organic brain damage or suffer from a lung, liver or kidney condition, or are generally unwell, your doctor will usually prescribe a lower dose.
If you have kidney or mild liver problems you may also be given a lower dose, this should not be more than half the usual adult dose.
Use in Children and adolescents:
Chlordiazepoxide are not to be used in anyone under 18 years of age.
Swallow the capsule(s) whole with a glass of water.
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 Capsules 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” below.)
If you take more Chlordiazepoxide than you should
Contact your doctor or go to a hospital immediately. Show them the package or container. Symptoms of an overdose may include drowsiness, confusion, tiredness, breathing problems, difficulty in controlling movements, low blood pressure or falling into a coma.
If you forget to take Chlordiazepoxide
Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Chlordiazepoxide
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 headache, sweating, diarrhoea, Confusion, Restlessness, Headaches, muscle pain, tension, extreme anxiety, mood changes, sleep disturbances, depression or irritability, Nervousness and occasionally hallucinations,
In severe cases the following symptoms may occur:
fits, unusual behaviour, numbness and tingling of the hands
and feet or sensitivity to light, noise or touch.
If you are woken up soon after taking 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:
Rare (may affect up to 1 in 1,000 people) abnormality in the blood (blood dyscrasias) with symptoms such as weakness, pale skin, bleeding problems, sore throat and frequent infections.
Very rare (may affect up to 1 in 10,000 people)
A severe allergic (anaphylaxis) or serious allergic reaction which causes swelling of your face or throat (angioedema), difficulty breathing, thoughts of self-harm.
Not know: frequency cannot be estimated from the available data
Yellowing of the eyes and skin (jaundice),
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.
If you get any of the following side effects, STOP TAKING this medicine and see your doctor at once:
Common (may affect up to 1 in 10 people)
• feeling sleepy, light-headed
• tiredness
• sedation and dizziness
• loss of balance
• confusional states
• unsteadiness
• clumsiness and loss of muscle co-ordination.
• Speech disorder
You could notice the above common side effects even after a single dose and they may continue for more than 24 hours. If you are elderly you are more likely to suffer from side effects, especially confusion.
Rare (may affect up to 1 in 1,000 people)
• headache
• dizziness or a feeling of spinning (vertigo)
• reduced alertness and tiredness
• low blood pressure
• stomach upsets
• skin rashes
• muscle weakness
• problems with your vision
• changes in sex drive
• difficulty passing urine
• numbed emotions
• incontinence
• 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.
• Increased appetite
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 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 this medicine out of the sight and reach of children.
Do not use the capsules after the expiry date which is stated on the package or container. The expiry date refers to the last day, month and year.
Store below 25°C and away from light. Store in the original package or container and keep the container tightly closed.
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 to protect the environment.
6. Contents of the pack and other information
What Chlordiazepoxide contains
The active ingredient in Chlordiazepoxide 5 mg and 10 mg capsules is chlordiazepoxide hydrochloride.
The other ingredients are lactose, maize starch, sodium starch glycollate, magnesium stearate, quinoline yellow (E104), titanium dioxide (E171) and gelatin. The 5 mg capsules also contain erythrosine (E127) and black iron oxide (E172) and the 10 mg capsules also contain indigotine (E132).
What Chlordiazepoxide looks like and contents of the pack
Chlordiazepoxide 5 mg capsules are yellow and black with the marking MP1 in white.
Chlordiazepoxide 10 mg capsules are white and green with the marking MP2 in black.
The capsules come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Genethics Europe Limited,
41 - 43 Klimentos, Klimentos Tower, Nicosia 1061, Cyprus Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road, London SW5 9JQ
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 08/2016
GE0001-0002/0/PIL/GE2
|
Chlordiazepoxide Product: 5 & 10 mg Capsules MA Holder: Genethics Europe |
Printing Colours: | Black |
Non-Printing Colours: Profile |
Genethics EUROPE Final Preparation Date For Submission: 18/08/2016 |
|
PL No.: 42976/0001 & 0002 |
Packing Site Technical Approval: 00/00/0000 Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000 | ||
|
Pack Size: All Pack |
Dimensions: 148 X 297 mm | ||
|
Livery: Genethics Europe |
Created By: DTawde/SDodle | ||
|
Manufacturer: -Market: UK Component: Leaflet |
Artwork Code: GE0001-0002/O/PIL/GE2 |
Print Proof Approval: 00/00/0000 | |
|
Bar Code: - | |||
|
Font Type: Arial Narrow Font Size: 7.8 pt | |||