Chlordiazepoxide 5mg Capsules
Athlone Laboratories Limited Module 1 Administrative
Chlordiazepoxide 5mg & 10mg Capsules 1.3.1 Summary of Product Characteristics, Labeling and Package Leaflet
1.3.1 SUMMARY OF PRODUCT CHARACTERISTICS, LABELING AND PACKAGE LEAFLET
1.3.2 PATIENT INFORMATION LEAFLET
PATIENT INFORMATION LEAFLET CHLORDIAZEPOXIDE 5mg AND 10mg CAPSULES
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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IN THIS LEAFLET | |
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1. |
What your medicine is and what it is used for |
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2. |
Before you take your medicine |
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3. |
How to take your medicine |
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4. |
Possible side effects |
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5. |
How to store your medicine |
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6. |
Further information |
1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
The name of your medicine is Chlordiazepoxide 5mg Capsules or Chlordiazepoxide 10mg Capsules.
Chlordiazepoxide is a member of a group of medicines called benzodiazepine anxiolytics. Your medicine can be used for the short-term relief (2-4 weeks treatment only) of:
■ muscle spasm
■ symptoms of alcohol withdrawal
■ anxiety causing distress or insomnia (difficulty sleeping)
■ anxiety occurring with mental health problems
2. BEFORE YOU TAKE YOUR MEDICINE
DO NOT take your medicine if you:
■ are allergic to chlordiazepoxide or any of the other ingredients in chlordiazepoxide capsules. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
■ have reduced blood flow to the lungs- symptoms may include coughing and shortness of breath
■ have any problems with your breathing
■ have anxiety disorders due to unreasonable thoughts and fears (obsessional states)
■ have an intolerance to sugar (galactose)
■ have sleep apnoea (stopping breathing while asleep)
■ have a severe liver disorder
■ have a muscle weakness disorder known as myasthenia gravis
■ suffer from depression that is not being treated.
Take special care with your medicine if you:
■ have recently suffered a bereavement or loss (your medicine may make it harder to come to terms with your loss)
■ suffer from psychiatric disorders such as schizophrenia, manic depression, delirium or senile dementia
■ have suffered long-term lung, kidney or liver problems (as you may need to take a lower dose)
■ have been taking this medication for a long period, as there is a risk of dependence
■ have a history of drug or alcohol abuse
Taking other medicines
Your medicine may interfere with other medicines that you are taking. Please tell your doctor
or pharmacist if you are taking, or have recently taken any other medicines even those not
prescribed.
Tell your doctor or pharmacist if you are taking any of the following medicines:
■ tranquillisers (e.g. diazepam)
■ sleeping tablets
■ drugs used to treat epilepsy (e.g. phenytoin, phenobarbitone)
■ anaesthetic drugs (drugs used to put you to sleep during an operation or surgery)
■ rifampicin, a drug used in the treatment of tuberculosis.
■ drugs known as dopaminergics, (e.g. levodopa, used to treat Parkinson’s disease)
■ pain killers (e.g. codeine, morphine) and anaesthetics.
■ anti-depressant drugs
■ cimetidine (used to treat acid indigestion & ulcers)
■ drugs to treat high blood pressure (e.g. furosemide)
■ sodium oxybate, used in patients with narcolepsy
Pregnancy and Breast- feeding
DO NOT take this medicine if you are pregnant (especially during the first and last trimester), or might become pregnant without consulting your doctor. Chlordiazepoxide may cause damage to the foetus.
DO NOT take this medicine if you are breast- feeding, as the drug may pass into breast milk. Always ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
This medicine may make you feel drowsy or affect your concentration. This may affect your ability to drive or operate machinery. If you are affected you should not drive or operate machinery.
Alcohol
You should avoid drinking any alcohol while you are taking chlordiazepoxide capsules, as you may feel drowsy.
Important information about some of the ingredients of your medicine
Chlordiazepoxide Capsules contain lactose monohydrate. 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 YOUR MEDICINE
This medicine is for short-term relief only and should not be used beyond 4 weeks. Always take your medicine exactly as your doctor has told you. The label on your medicine should also tell you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide the correct dosage for your condition.
Adults
■ Anxiety: The usual dose is 10mg three times daily and increased if necessary to 60mg-100mg daily in divided doses.
■ Sleeping disorders associated with anxiety: The usual dose is 10mg to 30mg before going to bed.
■ Relief of symptoms of withdrawal from alcohol: The usual dose is 25mg to 100mg repeated if necessary in 2 to 4 hours
■ Relaxation of muscle spasms: The usual dose is 10mg to 30mg daily in divided doses. Children
Chlordiazepoxide Capsules are NOT recommended for use in children.
Elderly
The elderly are particularly sensitive to the effects of this medicine and may experience confusion. The usual maximum dose for elderly patients is half the adult dose.
Overdose: If you take more of your medicine than you should
If you take too many capsules tell a doctor or contact your nearest hospital casualty department immediately. Take your medicine with you.
If you forget to take your medicine
If you forget to take a dose of your medicine at the correct time, take it as soon as you remember then carry on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking your medicine
Long term treatment with chlordiazepoxide, especially in high doses, may lead to dependence, with withdrawal symptoms after stopping treatment. Your doctor will advise you on this. Keep taking your medicine until your doctor tells you to stop. Withdrawal effects occur if the medicine is stopped suddenly. These may be:
■ difficulty sleeping
■ depression
■ nervousness
■ irritability
■ changes in behaviour
■ restlessness
■ tingling sensations
■ numbness
■ extreme anxiety
■ sweating
■ diarrhoea
■ confusion
■ fits (seizures and convulsions)
■ headaches and muscle pain
■ tension
■ sensitivity to light, noise and touch
■ hallucinations
■ changes in mood
The number of Chlordiazepoxide Capsules and how often you take them should always be reduced slowly before stopping them. Treatment should not be continued at the full dose beyond 4 weeks. Long term use is not recommended.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Chlordiazepoxide can cause side effects, although not everybody gets them.
Common side effects
■ drowsiness
■ sedation- symptoms include slurred speech, lack of co-ordination, tiredness or sometimes blackouts
■ ataxia- symptoms include unsteadiness and clumsiness
■ difficulty controlling movements
■ aggression, irritability, restlessness
■ inappropriate behaviour
■ dependence
■ muscle weakness
Rare side effects
■ dizziness
■ vertigo
■ skin rashes
■ changes in sex drive
■ difficulty passing urine
■ jaundice- yellowing of the eyes and skin
■ changes in salivation
■ incontinence
■ forgetfulness (amnesia)
■ hallucinations and nightmares
■ headache
■ problems with your eye sight
■ tummy upsets
■ excitement, confusion
■ depression
■ tremors and speech problems
■ numbed emotions
■ reduced alertness
■ blood disorders (e.g. blood dyscrasias symptoms include weakness, pale skin and bleeding problems)
■ lowering of blood pressure- symptoms include light-headedness, feeling dizzy or faint
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE YOUR MEDICINE
Do not take your medicine after the expiry date, which is stated on the carton or pot label. The expiry date refers to the last day of that month.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Store your capsules below 25oC.
Return any unused capsules to your pharmacist. Only keep them if your doctor tells you to. 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 protect the environment.
What your medicine contains
The capsules contain either 5mg or 10mg of the active substance chlordiazepoxide hydrochloride.
The other ingredients are lactose monohydrate, maize starch and magnesium stearate. The capsule shell contains the ingredients Erythrosine (E127) (5mg Capsules only), Iron oxide black (10mg Capsules only), Titanium dioxide, Indigo Carmine (E132), Quinoline Yellow (E104), Gelatin. The printing ink contains the ingredients: Shellac, Dehydrated alcohol, Isopropyl alcohol, Butyl alcohol, Propylene glycol, Strong Ammonia solution, Purified water, Potassium hydroxide and Titanium dioxide
What your medicine looks like and the contents of the pack
The 5mg capsules have a yellow body and turquoise cap and are marked “CDP 5” in white. The 10mg capsules have a green body and black cap and are marked “CDP 10” in white.
The capsules are available in pots containing of 28, 30, 56, 60, 100 and 500 capsules and blisters containing 28, 30 and 100 capsules, only on prescription from your doctor. Not all pack types or sizes may be marketed.
Marketing Authorisation Holder
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Company responsible for release of this medicine
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
PL 06453/0002 and PL 06453/0003
This leaflet was last revised August 2012
Confidential 6