CHLORDIAZEPOXIDE 5 MG CAPSULES - patient leaflet, side effects, dosage

WHAT YOU NEED TO KNOW BEFORE

2 YOU TAKE CHLORDIAZEPOXIDE . CAPSULES

DO NOT take your medicine if you:

• are allergic to chlordiazepoxide or any of the other ingredients in chlordiazepoxide capsules (listed in section 6), or to any medicine known as a benzodiazepine (e.g. nitrazepam, diazepam, flurazepam, or temazepam). 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 a long-term mental condition causing hallucinations and delusions etc.
• 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
• suffer from spinal or cerebral ataxia

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Chlordiazepoxide capsules if you:

• are elderly, have suffered long-term lung, kidney or liver problems (as you may need to take a lower dose)
• have recently suffered a bereavement or loss (your medicine may make it harder to come to terms with your loss) should not be used as a primary treatment or alone
• suffer from psychiatric disorders such as schizophrenia, manic depression, delirium or senile dementia
• have a decrease in mental functions you should receive a lower dose
• have a history of drug or alcohol abuse

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 injuries, including hip fractures.

Children and Adolescents

Chlordiazepoxide is not recommended for use in children (under 18 years of age).

Taking other medicines

Your medicine may interfere with other medicines that you are taking.Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

• anti-depressants, tranquillisers (e.g. diazepam), sleeping tablets, neuroleptics, hypnotics and other such medicines which act on the brain and nerves
• drugs used to treat epilepsy (e.g. phenytoin, phenobarbitone) or barbiturates or combinations including them
• anaesthetic drugs (drugs used to put you to sleep during an operation or surgery)
• drugs known as dopaminergics, (e.g. levodopa, used to treat Parkinson's di­sease)
• baclofen (muscle relaxant), cisparide (prevent constipation), nabilone (anti-sickness)
• pain killers (e.g. codeine, morphine) and anaesthetics.
• drugs to treat high blood pressure (antihypertensives) e.g. ACE inhibitors, alpha blockers, angiotensin-II receptor antagonists, calcium channel blockers, adrenergic neurone blockers and moxonidine.
• drugs used to open blood vessels (vasodilators) e.g. nitrates, hydralazine, minoxidil and sodium nitroprusside.
• drugs used to treat heart conditions (cardiac drugs) e.g. digoxin.
• drugs used to thin the blood (anticoagulants) e.g. warfarin
• drugs that increase the loss of salt and water from the body (diuretics) e.g. furosemide.
• sodium oxybate, used in patients with narcolepsy
• theophylline used to make breathing easier
• antihistamines (used for treating allergies) that cause drowsiness (e.g chlorphenamine)

Concomitant use of Chlordiazepoxide and opioids increase the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor does prescribe Chlordiazepoxide with opioids the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all opioid medicines you are taking, and follow your doctor's dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Pregnancy, breast-feeding and fertility

DO NOT take this medicine if you are pregnant (especially during the first and last trimester), or might become pregnant without consulting your doctor. If your doctor has decided you should receive this medicine during late pregnancy or labour, your baby might have a low body temperature, floppiness and breathing and feeding difficulties. Also your unborn baby might be at risk of developing dependency to this medicine and may be at risk of developing withdrawal symptoms after birth.

DO NOT take this medicine if you are breastfeeding, as the drug may pass into breast milk. Always ask your doctor, nurse or pharmacist for advice before taking any medicine.

Driving and using machines

This medicine may make you feel drowsy or affect your concentration. Patients should be advised that sedation, amnesia (forgetfulness), impaired concentration, dizziness, blurred vision and impaired muscular function may occur and that, if affected, you should not drive or operate machinery or take part in other activities where this would put themselves or others at risk. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased.

You may be committing an offence, if any of the below applies:

• 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
• you have taken it according to the instructions given by the prescriber and in the information provided with the medicine
• 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 with alcohol

You should avoid drinking any alcohol while you are taking chlordiazepoxide capsules, as you may feel drowsy. Alcohol may intensify any impairment, and should therefore be avoided during treatment.

Chlordiazepoxide contains lactose

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 CHLORDIAZEPOXIDE

. CAPSULES

Always take this medicine exactly as your doctor, nurse or pharmacist has told you. The label on your medicine should also tell you, check with your doctor, nurse or pharmacist if you are not sure. This medicine is for short-term relief only and should not be used beyond 4 weeks. The dose that your doctor prescribes will depend on the nature of your illness, your reaction to the medicine, your age, and bodyweight. Do not change the prescribed dose yourself. If you think that the effect of your medicine is too weak or too strong, talk to your doctor.

Your doctor will decide the correct dosage for your condition.

Swallow the capsule(s) whole with a glass of water.

Adults

• Anxiety: The usual dose is 30mg per day taken in divided doses throughout the day. Your doctor may prescribe up to a maximum of 100mg per day in divided doses, depending on the severity of your symptoms.
• Sleeping disorders (insomnia) 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 2 to 4 hours after the initial dose, if necessary.
• Relaxation of muscle spasms: The usual dose is 10mg to 30mg daily in divided doses throughout the day.

Children

Chlordiazepoxide Capsules are NOT recommended for use in children (under 18 years of age).

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.

If you take more of your medicine than you should

If you or someone else takes too many capsules tell a doctor, nurse or pharmacist 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 may occur if the medicine is stopped suddenly. This is less likely if your dose is gradually reduced towards the end of your treatment. Withdrawal symptoms may include:

• difficulty sleeping
• depression
• nervousness
• irritability
• restlessness
• extreme anxiety
• sweating
• diarrhoea
• confusion
• headaches and muscle pain

In severe cases the following symptoms may occur:

• changes in mood and behaviour or the way you are feeling
• tingling sensations and numbness of the extremities
• over-sensitivity to light, noise and touch
• feeling of unreality or being separated from the body
• hallucinations
• fits (seizures and convulsions)
• if you are woken up soon after taking the medicine your memory may be temporarily affected.

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.

If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.

4. possible side effects

Like all medicines, Chlordiazepoxide can cause side effects, although not everybody gets them. Stop taking Chlordiazepoxide Capsules and see a doctor or go to a hospital straight away 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 (suicidal ideation), yellowing of the skin and eyes (jaundice).

Changes in behaviour may occur rarely. These changes may include aggression, 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, nurse or pharmacist if you develop any of the following side effects:

Common side effects may affect up to 1 in 10 people

• drowsiness and light-headedness the next day
• sedation and dizziness – symptoms include slurred speech, lack of co-ordination, tiredness (fatigue) or sometimes blackouts
• ataxia – symptoms include unsteadiness and clumsiness
• difficulty controlling movements
• balance disorder
• confusional states

Rare side effects may affect up to 1 in 10,000 people

• vertigo
• skin rashes/reactions
• changes in sex drive
• difficulty passing urine
• incontinence
• impotence
• reduced alertness
• headache
• problems with your eye sight including double vision
• stomach upsets
• emotional disturbances
• menstrual disorder
• blood disorders
• lowering of blood pressure (hypotension) -symptoms include light-headedness, feeling dizzy or faint.

The following side effects have also been reported (Frequency unknown):

• decreased/depressed level of consciousness
• respiratory depression
• forgetfulness, memory loss
• aggressive outbursts, inappropriate behaviour
• restlessness, agitation, delusion, irritability, nightmares, depression, increased liver enzymes, changes in the way you walk and muscle weakness
• paradoxical reactions (e.g. saliva altered, anxiety, sleep disorders, insomnia, suicide attempt, suicidal ideation)
• hypersensitivity (physical sensitivity to particular substances or conditions)
• tremors, stiffness and slow movement
• hallucinations, if you are woken up soon after taking this medicine your memory may be partially affected.
• increased appetite
• dependence

What Chlordiazepoxide 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 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 February 2022.

Dimensions: 148mm x 500mm