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Chlordiazepoxide Capsules Bp 10mg

Document: leaflet MAH GENERIC_PL 20416-0038 change

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PATIENT INFORMATION LEAFLET

CHLORDIAZEPOXIDE Capsules 5mg & I Omg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist._

In this leaflet:

1.    What Chlordiazepoxide Capsules are and what they are used for

2.    Before you take Chlordiazepoxide Capsules

3.    How to take Chlordiazepoxide Capsules

4.    Possible side effects

5.    How to store Chlordiazepoxide Capsules

6.    Further information

1 .What Chlordiazepoxide Capsules are and what they are used for

The medicine belongs to the group of drugs known as benzodiazepines. These are used for depressing the central nervous system (CNS) (medicines that slow down the nervous system).

This medicine is used for the short term relief of severe anxiety, treatment of insomnia (trouble in sleeping), control of muscle spasms and symptomatic relief of acute alcohol withdrawal.

This medicine should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependent or of having problems when you stop taking it.

The risk of dependence (a need to keep taking the medicine) increases with dose and length of treatment period and is greater if you have ever had a history of alcohol or drug abuse, or in patients with personality disorders. Your doctor will monitor you whilst you are taking this medicine and will withdraw your treatment gradually.

2. Before you take Chlordiazepoxide Capsules Do not take these capsules if:

•    you are allergic to chlordiazepoxide, other benzodiazepines e.g. diazepam, or to any of the other ingredients in the capsules (see Section 6)

•    you have difficulty in breathing, any kind of lung disease e.g. asthma, or you suffer from sleep apnoea (sometimes stop breathing during sleep)

•    you are suffering from phobias (fears) or obsessions

•    you are suffering from chronic mental illness

•    you suffer from chronic muscular weakness

•    you have severe liver disease

•    you are pregnant or might become pregnant, or are breast feeding (see “Pregnancyand breastfeeding” section below).

Check with your doctor before taking these capsules if:

•    you have a history of alcohol or drug abuse or if you have a personality disorder

•    you have kidney or liver disease or breathing problems

•    you are elderly as you are more likely to experience side effects (see Section 4 Possible side effects)

•    you have recently suffered a bereavement as this medicine may prevent you from accepting the fact.

Taking other medicines

Check with your doctor or pharmacist before taking these capsules if you are taking other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:

•    medicines used for epilepsy e.g. phenobarbital and phenytoin

•    other medicines for helping you to sleep, or medicines for treating depression, mental illness or anxiety

•    pain killers e.g. codeine phosphate

•    anaesthetics - before you have any surgical or dental operations tell your doctor or dentist you are taking chlordiazepoxide

•    antihistamines (used to treat hay fever or other allergies) which cause drowsiness e.g. chlorphenamine

•    medicines that affect liver enzymes e.g. cimetidine and omeprazole (to treat stomach ulcers), disulfiram (to treat alcohol dependence), rifampicin (to treat bacterial infections) and contraceptive agents

•    medicines to treat high blood pressure e.g. methyldopa, moxonidine or beta blockers e.g. atenolol

•    anticoagulants e.g. warfarin

•    cardiac glycosides e.g. digoxin to treat heart problems

•    levodopa to treat Parkinson’s disease

•    sodium oxybate to treat narcolepsy

•    theophylline to treat asthma.

Other special warnings

This medicine should not be used alone to treat depression or anxiety associated with depression.

If you are elderly you should take extra care if you get up during the night because Chlordiazepoxide Capsules relax the muscles. This means there is a risk you may fall and consequently hip fractures may occur.

Alcohol:

Alcohol will increase the effects of this medicine and should therefore be strictly avoided during treatment.

Pregnancy and breast feeding:

Do not take chlordiazepoxide if you are pregnant, might become pregnant, or are breast feeding. If your doctor has decided that you should take this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, breathing or feeding difficulties.

If this medicine is taken regularly in pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines:

The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy or may cause memory loss, lack of concentration, poor muscle function or eyesight problems. If affected, do not drive or operate machinery. If you do not get enough sleep the likelihood of reduced alertness may be increased.

•    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.

Important information about an ingredient of Chlordiazepoxide Capsules:

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.    How to take Chlordiazepoxide Capsules

The capsules should be swallowed whole with a drink of water. The maximum length of treatment is 4 weeks. Your doctor will decide the dose that is best for you. The pharmacist’s label will also tell you how many capsules to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

This medicine can make you suffer memory loss several hours after taking it. Try to make sure you can have 7 to 8 hours of uninterrupted sleep each night whilst you are taking this medicine.

Adults:

Relief of anxiety: The usual dose is up to 30mg daily, with a maximum dose of up to 100mg daily in divided doses.

Insomnia: 10 - 30mg at bedtime.

Control of muscle spasm: 10 - 30mg daily in divided doses. Symptomatic relief of acute alcohol withdrawal: 25 - 100mg repeated if necessary in 2 - 4 hours.

Elderly and weak patients and patients with liver, kidney or breathing problems or with brain damage: The doses for all indications should not exceed half of those normally recommended for adults.

Children:

This medicine is not for use in children.

If you have taken too many capsules:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining capsules and the container so that the medicine can be identified.

If you miss a dose of this medicine:

Take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.

Tolerance:

After a few weeks of taking this medicine you may notice that it is not working as well as it did when you first started taking it.

If this happens speak to your doctor.

Stopping Chlordiazepoxide and withdrawal effects:

This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you stop taking the capsules suddenly you may experience the following withdrawal effects: headaches, muscle pain, extreme anxiety, restlessness, confusion, depression, nervousness, recurrence of sleep problems, irritability, sweating, and diarrhoea or the symptoms you are being treated for can come back worse than before. These effects may occur even after taking normal doses for short periods of time. In severe cases the following may occur: mood changes, numbness and tingling, sensitivity to light, noise and touch, hallucinations, convulsions and irrational behaviour.

4.    Possible side effects

Like all medicines chlordiazepoxide can cause side effects, although not everybody gets them.

The elderly are more susceptible to side effects and may experience confusion.

STOP TAKING the capsules and seek medical attention IMMEDIATELY if any of the following effects occur:

•    difficulty breathing, dizziness, swelling of the face, lips, tongue or throat (these may be signs of a serious allergic reaction)

•    yellowing of the skin or whites of the eyes (jaundice)

•    fever or chills, sore throat, frequent infections, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises (signs of a blood disorder).

Tell your doctor straight away if you notice any of the following effects:

•    thoughts of harming or killing yourself

•    changes in behaviour including restlessness, agitation, irritability, aggressive outbursts, excitement, confusion, delusion, rages, nightmares, hallucinations, depression.

Tell your doctor, pharmacist or nurse if you suffer from any of the side effects listed in the sections below:

Common (may affect up to 1 in 10 people):

•    drowsiness, sedation, dizziness, unsteadiness, poor muscle co-ordination. (These effects are usually dose related but may occur after a single dose and may last into the following day. They generally occur at the start of treatment and

usually disappear with repeated use of your medicine)

•    loss of balance, tiredness.

Rare (may affect up to 1 in 1,000 people):

•    headache, feeling of dizziness or spinning

•    eyesight problems including double vision

•    light-headedness, fainting (signs of low blood pressure)

•    stomach upsets

•    skin reactions e.g. rash

•    problems passing urine, incontinence

•    changes in the level of sexual desire, inability to develop or maintain an erection, menstrual disorder.

Other side effects include:

•    memory loss (see section 3 How to take Chlordiazepoxide Capsules), dependence on chlordiazepoxide, reduced alertness, emotional disturbances, paradoxical drug reaction (e.g. anxiety, sleep disorders, insomnia, suicide attempt or thoughts of suicide)

•    difficulty speaking, changes in the way you walk, shaking, involuntary muscle movements, muscle weakness

•    increased blood bilirubin or alkaline phosphatase levels, increased liver enzymes (detected in laboratory tests)

•    changes in salivation.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Chlordiazepoxide Capsules

Keep the capsules in the pack provided and protect from heat, light and moisture.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

Do not take the capsules if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6.    Further information Ingredients:

Chlordiazepoxide Capsules are available in two strengths and contain either 5mg or 10mg of chlordiazepoxide hydrochloride as the active ingredient. Other ingredients are: lactose and magnesium stearate. The 5mg capsule shell is composed of erythrosine (E127), yellow iron oxide (E172), titanium dioxide (E171), quinoline yellow (E104), indigo carmine (E132) and gelatin. The 10mg capsule shell is composed of red and black iron oxides (E172), indigo carmine (E132), titanium dioxide (E171), quinoline yellow (E104) and gelatin.

What the medicine looks like:

Chlordiazepoxide Capsules 5mg are orange and dark green, marked with the logo RL and CDZ5. Chlordiazepoxide Capsules 10mg are dark green and chocolate brown, marked with the logo RL and CDZ10. This medicine is available in pack sizes of 28, 56, 84, 100, 112 or 500 capsules (not all pack sizes may be marketed).

Who makes this medicine and holds the product licence:

Crescent Pharma Limited, Units 3 &4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED.

Date leaflet revised: March 2014 If you would like this leaflet in a different format please contact the licence holder at the above address.

P0400T Q2270


PATIENT INFORMATION LEAFLET

CHLORDIAZEPOXIDE Capsules

5mg & lOmg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist._

In this leaflet:

1.    What Chlordiazepoxide Capsules are and what they are used for

2.    Before you take Chlordiazepoxide Capsules

3.    How to take Chlordiazepoxide Capsules

4.    Possible side effects

5.    How to store Chlordiazepoxide Capsules

6.    Further information

1 .What Chlordiazepoxide Capsules are and what they are used for

The medicine belongs to the group of drugs known as benzodiazepines. These are used for depressing the central nervous system (CNS) (medicines that slow down the nervous system).

This medicine is used for the short term relief of severe anxiety, treatment of insomnia (trouble in sleeping), control of muscle spasms and symptomatic relief of acute alcohol withdrawal. This medicine should be used for as short a time as possible and should not be used for more than four weeks. If used for too long without a break, there is a risk of becoming dependent or of having problems when you stop taking it.

The risk of dependence (a need to keep taking the medicine) increases with dose and length of treatment period and is greater if you have ever had a history of alcohol or drug abuse, or in patients with personality disorders. Your doctor will monitor you whilst you are taking this medicine and will withdraw your treatment gradually.

2. Before you take Chlordiazepoxide Capsules Do not take these capsules if:

•    you are allergic to chlordiazepoxide, other benzodiazepines e.g. diazepam, or to any of the other ingredients in the capsules (see Section 6)

•    you have difficulty in breathing, any kind of lung disease e.g. asthma, or you suffer from sleep apnoea (sometimes stop breathing during sleep)

•    you are suffering from phobias (fears) or obsessions

•    you are suffering from chronic mental illness

•    you suffer from chronic muscular weakness

•    you have severe liver disease

•    you are pregnant or might become pregnant, or are breast feeding (see “Pregnancyand breastfeeding” section below).

Check with your doctor before taking these capsules if:

•    you have a history of alcohol or drug abuse or if you have a personality disorder

•    you have kidney or liver disease or breathing problems

•    you are elderly as you are more likely to experience side effects (see Section 4 Possible side effects)

•    you have recently suffered a bereavement as this medicine may prevent you from accepting the fact.

Taking other medicines

Check with your doctor or pharmacist before taking these capsules if you are taking other medicines, including any that you can buy without a prescription. This is particularly important if you are taking:

•    medicines used for epilepsy e.g. phenobarbital and phenytoin

•    other medicines for helping you to sleep, or medicines for treating depression, mental illness or anxiety

•    pain killers e.g. codeine phosphate

•    anaesthetics - before you have any surgical or dental operations tell your doctor or dentist you are taking chlordiazepoxide

•    antihistamines (used to treat hay fever or other allergies) which cause drowsiness e.g. chlorphenamine

•    medicines that affect liver enzymes e.g. cimetidine and omeprazole (to treat stomach ulcers), disulfiram (to treat alcohol dependence), rifampicin (to treat bacterial infections) and contraceptive agents

•    medicines to treat high blood pressure e.g. methyldopa, moxonidine or beta blockers e.g. atenolol

•    anticoagulants e.g. warfarin

•    cardiac glycosides e.g. digoxin to treat heart problems

•    levodopa to treat Parkinson’s disease

•    sodium oxybate to treat narcolepsy

•    theophylline to treat asthma.

Other special warnings

This medicine should not be used alone to treat depression or anxiety associated with depression.

If you are elderly you should take extra care if you get up during the night because Chlordiazepoxide Capsules relax the muscles. This means there is a risk you may fall and consequently hip fractures may occur.

Alcohol:

Alcohol will increase the effects of this medicine and should therefore be strictly avoided during treatment.

Pregnancy and breast feeding:

Do not take chlordiazepoxide if you are pregnant, might become pregnant, or are breast feeding. If your doctor has decided that you should take this medicine during late pregnancy or during labour, your baby might have a low body temperature, floppiness, breathing or feeding difficulties.

If this medicine is taken regularly in pregnancy, your baby may develop withdrawal symptoms.

Driving and using machines:

The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy or may cause memory loss, lack of concentration, poor muscle function or eyesight problems. If affected, do not drive or operate machinery. If you do not get enough sleep the likelihood of reduced alertness may be increased.

•    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.

Important information about an ingredient of Chlordiazepoxide Capsules:

Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

P0400T


3.    How to take ChlordiazepoxideCapsules

The capsules shouldbeswallowedwholewitha drinkofw^atcsr. The maximum length of treatment is 4 weeks. Your doctor will decide the dosethat is best foryou.Thepharmacist’slabel will also tell you how many capsules to take and how often. If you iboutandthing,dskyeurdoctoiorpharmacist. This medicine canmakeyossufhdr memotyloda saveral housr after taking it.crk fa mokesuseyou canhove7No8 l^^urhi of uninterruptedsleepkach usrU^^riH^U yio urkf^l'^u^!e^his medicine.

Adults:

Relief of anx/a/fThe usualkuoelu ufko een^^adi^^,o^hh u maximum doae of uplolOOm0 dGtymdMdedaoses. Insomnia: 10 - 30mg oe Hiatime.

jsale saasmW 0 - 30mg daily individad doses. '.relieHofacute alcoholwithdrawal:25 -WQmg repeated if necessary in 2 - 4hesrs.

I wuakyaeientsunopdeiegts wrthlivar, kidney or breathing problems or with brain damage: The doses for alliah iodrionsshouie nolmxcoed hakoftOose normally recommen dedfocaee|tk.

Children:

This medicine isout foruselndSlldren.

If you have Oaken toomany

Contact your doctorohraightaway or go to the nearest hospital casualty department. Take with you any remaining capsules Oner oo ingitOemadieineuanbeiguaiilied.

If you miss a doseof thismedioiner

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next dose, skip the missed dose and continue with the regular dosing schedu lelDONOTDOUBUdTnEDOSES.

Tolerance:

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If this happens sproktoyouednetor.

Stopping Chlordiazepoxide and withdrawal effects:

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following withdrawal cffscfo:headnches,mascle pain, extreme anxiety, restleconessc aonhfsioe.depressicn. nervousness, recurrence oc sleep eroOlemk, ifritabiiity, seeufingl aoT theo

rorseidgn l^sigr^u.Thi^!

after taking normeidlses lor shortpaelods of time. In severe cases the following may occurimoodchauges,numanesu ag, tingling, sensitihiOeoNghend^ andtouch.hallucinanions, convulsions an.^ertiana.te iic^s.tLid

4.    Possible sideeffecis

Like all medicines chlo cd0^zesexk^^i^rrh c^nseoic^uyeoe^^. although not everoUoayeeNsfaem.

The elderly are more susceptible to side effects and may experience confusion.

STOP TAKING tOesacaules ank seet medicalatteation IMMEDIATELYrasyoftherollowing offacfa occusi

•    difficulty breafhleg,dizolncss,swollmokffheUuceliips, tongue or Ofxoat (ttesemcy be esnsof aserious uNergreaction)

•    yellowing of the skin or whites of the eyes (jaundice)

•    fever or chillc.sorohhroat, ho^skntmfeeriono, u|unukiayouk mouth orthdrl0 amaruol tiredness of wakkness, snussal

>runsxplained tsruiiesS sign tor^1^^^iigfiptiw^^h younoOiso eay on hax foltow^

effects:

•    thoughts oS Oarmirigo s eillinggo srsaif

•    changes in behaviour including restlessness, agitation, irritability, aoorescivco uebursds.excitcmeno, confusion, delusion, rahdh, nightmares, hafscihatios^depressioni

Tell your doctsr,ehamtecist ornurseif yousuffdNfrom anyoi the side effecth l.steUinrhosactiunsbslow:

Common (may affect up to 1 in 10 people):

•    drowsiness, ostbtias,diesiness, unsteadiness, poor muscle co-ordinatioo. tThieisre eSeetsereuhuxlloYzoerelated but may occur aflter nirngla dosesndmayladtifZotZzfollowing day. They generall0 u>ccurnn thesnartoftnsufmdu t and uoudllysisouohoewithreeeaUua uueof y(Nsrun edicrno)

•    h:)sssfbalancs,tiredneah.

Reee imsy bttuef ep to1 inr.hhTpsopieT

•    hhadacte, feefPoofTizeinhssorupinsiag

•    eyesight problems including double vision

s Iight-Seauedsess,iainrikgrsigns o^ow bloaUdrepsdre) e sfomask spsats t ssin reaction, e.g.rash e problem, pasoo, ^^ine,iseokdnf^ncnc

•    eaangeslnthu ^^^^ouf sexual desire, inability to develop or muintam akereet.oUimenstrual disorder.

CttirousiUd effsaromdude:

•    mumofn losstseeseetiau3i-iawtotaku ehlordiazepoxide Oupsutenk depemtenou an chlord|anauoxide, reduced

ai artnf-s, eomTioo-IWieTdrbnaved a odraSeoioi reaction (e.g. anxiety, sleep disorders, insomnia, suicide attempt or thouehtsefkuicida)

•    uiffeP1tyapoukinh,osnnaesintsewayaonwalk, shaking, meduntary muscle movements, muscle weakness

Dj ncreasnT blood u i lirobin •rulSalinepnesphutaseieveIs, mereesed \iver    ( ^tictedmtatoratory tests)

•    changes in salivation.

Deporting sf sidhofSncts

e souget aoy s|desffects,talstooootducfor|PhofmaeiuNer n urse1 .Tate edudes scuuossikleside utfectsnorliothgi•ti^is leifSt. la uonnslnerei

Oara Qcheme atldwcev■mhra■qsa■ntdaellawuhreiSyrehortino siSeeffectn ycaseohslakfoaikemore inforromtioaok the safumco Chls m^<di(fin^.

5. Howto store Chlordiazepoxide Capsules

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Do not take the capsules if the expiry date on the pack has

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tti eoi louour pharmasidt foruafu hisoesel.

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onjjnesiurs steurath.r

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COfe1 r, quinolineyollew(E1g4) ano ue|alin.

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If you would like this leaflet in a different format pleasecontabthde lic2nceholder at the above ah^mn^^.

SO46988_Q2270_P2.indd 2 03/05/2016 16:09