Chloral

Main information

  • Trade name:
  • Chloral hydrate 143.3mg/5ml oral solution BP
  • Pharmaceutical form:
  • Oral solution (385023001)
  • Administration route:
  • Oral (26643006)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Chloral hydrate 143.3mg/5ml oral solution BP
    United Kingdom
  • Language:
  • English

Other information

Status

  • Source:
  • eMC
  • Last update:
  • 30-11-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

REGULATORY AUTHORITY

APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by

the appropriate market authority (if applicable, e.g.

MHRA, IMB, etc and that Amdipharm have license

approval to distribute this component for sale in the

relevent market.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

PAGE 1 OF 2

Received Date:

14/04/2014

CDL JOB No. :

59387

Required By :

16/04/2014

PRODUCT NAME:

Chloral Hydrate

143.3mg/5ml

Oral Solution x 150ml

PIP CODE:

GB 723-0170-APIL

COMPONENT:

Leaflet

SIZE:

250x148 mm

MARKET:

Great Britain

PRODUCT SITE:

SCALE:

100%

COLOURS:

Black

DATE:

15/04/2014

FONT SIZE:

8.5 pt

VERSION NO:

AMENDED BY:

PROJECT:

Marlborough

Pharmaceuticals

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloral Hydrate 143mg per 5ml Oral Solution

Please read both sides of this leaflet carefully before you start to take your medicine.

It will tell you what you need to know about Chloral Hydrate Oral Solution.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Remember this medicine is only for YOU. Never give it to anybody else, even if their symptoms are the

same as yours. If you are experiencing unpleasant side effects you should consult your doctor.

In this leaflet:

What Chloral Hydrate Oral Solution is and what it is used for

Before you take Chloral Hydrate Oral Solution

How to take Chloral Hydrate Oral Solution

Possible side effects

How to store Chloral Hydrate Oral Solution

Further information

1.

What Chloral Hydrate Oral Solution is and what it is used for

Chloral Hydrate Oral Solution contains Chloral Hydrate which is one of a group of medicines called

hypnotics (sleep inducing drugs). Chloral Hydrate Oral Solution is used for the short-term treatment of

severe insomnia (sleeping problems) which is interfering with normal daily life. Chloral Hydrate will

normally be given in addition to other non drug therapies e.g. counselling.

Chloral Hydrate is normally only used in children and adolescents under the supervision of a medical specialist.

2.

Before you take Chloral Hydrate Oral Solution

Do not take Chloral Hydrate Oral Solution if you or the patient:

have severe liver or kidney problems

have severe heart problems

suffer from porphyria (an inherited blood disorder)

are a child under 2 years of age

Speak to your doctor before taking Chloral Hydrate Oral Solution if you:

are allergic to chloral hydrate or any of the other ingredients in Chloral Hydrate Oral Solution

are suffering from stomach problems (gastritis).

Taking other medicines

Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

It is important to tell your doctor if you are taking any of the following:

medicines to thin your blood (such as Warfarin).

medicines for depression or nervous disorders.

medicines intended to reduce muscle spasms.

Taking Chloral Hydrate Oral Solution with food and drink

Alcohol can increase the sedative effect of chloral hydrate. Alcohol should therefore be avoided whilst

taking this medicine. Chloral Hydrate Oral Solution should be taken with water or milk.

Pregnancy and breast feeding

Chloral Hydrate Oral Solution should not be taken if you are pregnant or trying to become pregnant or you are breast

feeding.

Driving and using machines

Please note, your ability to drive or operate hazardous machinery may be impaired by drowsiness as a

result of taking Chloral Hydrate Oral Solution.

Important information about some of the ingredients of Chloral Hydrate Oral Solution

Chloral Hydrate Oral Solution contains the following:

Sunset Yellow FCF (E110) and Ponceau 4R (E124) which may cause allergic reactions.

Glycerol which may cause headache, stomach upset and diarrhoea.

Glucose liquid. If you have been told by your doctor that you have an intolerance to some sugars,

contact your doctor before taking this medicinal product.

Glucose may also be harmful to the teeth.

Laboratory Tests

If you are having blood tests for your thyroid, tell your doctor or nurse as chloral hydrate may interfere

with these tests.

3.

How to take Chloral Hydrate Oral Solution

Always take Chloral Hydrate Oral Solution exactly as your doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Chloral Hydrate Oral Solution should be taken as a single daily

dose usually 15-30 minutes before bedtime.

The usual doses are:

Adults and Children aged 12 years and over and the Elderly: 15-30ml. In the frail elderly or patients with

liver problems a smaller dose may be required. Not more than 70ml Chloral Hydrate Oral Solution

(equivalent to 2g of Chloral Hydrate) should be taken in any one day.

Children 2-11 years: The dose will be calculated by your doctor or pharmacist based on the weight of the

child. You should follow their instructions. Not more than 35ml of Chloral Hydrate Oral Solution

(equivalent to 1g of Chloral Hydrate) should be taken in any one day.

Children under 2 years Chloral Hydrate Oral Solution is not suitable for children under 2 years old.

If you are unsure about how to take your medicine, ask your doctor or pharmacist.

Chloral Hydrate Oral Solution is usually prescribed for the short term treatment of sleeping problems,

usually for less than 2 weeks. If you take Chloral Hydrate Oral Solution over a long period of time, you may

find that the medicine takes longer to work and does not last for as long. This is called “tolerance” to the

medicine. If you find you are becoming “tolerant” to Chloral Hydrate Oral Solution do not increase the

amount you take. Speak to your doctor.

If you take more Chloral Hydrate Oral Solution than you should

In the event of an accidental overdose, contact your nearest hospital casualty department or tell your

doctor immediately. It is advisable to have the medicine in its original packaging available for the doctor or

hospital. Signs of an overdose include, vomiting, breathing problems, abnormal heartbeat, abnormally low

body temperature, pin point pupils, low blood pressure or coma.

If you stop taking Chloral Hydrate Oral Solution

Suddenly stopping Chloral Hydrate Oral Solution may cause delirium (severe confusion). Contact your

doctor before you stop taking the medicine, he will advise you how to stop.

4.

Possible side effects

This medicine can cause side effects in some people.

Examples of side effects which may occur are:

Stomach irritation

Excitement

Wind

Headache

Allergic skin reactions

Lack of co-ordination (ataxia)

Confusion

Ketonuria (a condition in which ketone bodies are present in the urine) which

Gut swelling

can only be detected by tests arranged by your doctor.

If you are elderly you may be more susceptible to confusion and co-ordination problems which may lead

to falls and injury.

If you find that you are experiencing unpleasant side effects you should consult your doctor.

5.

How to store Chloral Hydrate Oral Solution

Store below 25°C. Store in the original packaging. Keep the bottle in the outer carton.

Keep out of the sight and reach of children.

The expiry date is printed on the carton and on the bottle label. Do not use your medicine after this date.

If your doctor decides to stop treatment, return any left over Oral Solution to your pharmacist. Medicines

should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of

medicines no longer required. These measures will help to protect the environment.

6.

Further information

What Chloral Hydrate Oral Solution contains

The active substance in Chloral Hydrate Oral Solution is chloral hydrate. Chloral Hydrate Oral Solution also

contains glycerol, glucose syrup, sodium benzoate, saccharin sodium, essence of passion fruit (containing

natural flavouring, artificial flavouring, propylene glycol (E1520)), purified water, ponceau 4R (E124) and

sunset yellow (E110).

What Chloral Hydrate Oral Solution looks like and contents of the pack

Chloral Hydrate Oral Solution is a clear, red syrup containing 143.3mg chloral hydrate per 5ml. A pack size

of 150ml is available.

Marketing Authorisation Holder

Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire SN8 1LW

Manufacturer

Dales Pharmaceuticals Ltd, Skipton BD23 2RW

The Product Licence number is PL23138/0016

For information in large print

tape,CD or Braille,

telephone 01672 514187

Date of preparation April 2014.

GB 723-0170-APIL

REGULATORY AUTHORITY

APPROVAL CONFIRMATION

Confirmation that this artwork has been approved by

the appropriate market authority (if applicable, e.g.

MHRA, IMB, etc and that Amdipharm have license

approval to distribute this component for sale in the

relevent market.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

PAGE 2 OF 2

Received Date:

14/04/2014

CDL JOB No. :

59387

Required By :

16/04/2014

PRODUCT NAME:

Chloral Hydrate

143.3mg/5ml

Oral Solution x 150ml

PIP CODE:

GB 723-0170-APIL

COMPONENT:

Leaflet

SIZE:

250x148 mm

MARKET:

Great Britain

PRODUCT SITE:

SCALE:

100%

COLOURS:

Black

DATE:

15/04/2014

FONT SIZE:

8.5 pt

VERSION NO:

AMENDED BY:

PROJECT:

Marlborough

Pharmaceuticals

PACKAGE LEAFLET: INFORMATION FOR THE USER

Chloral Hydrate 143mg per 5ml Oral Solution

Please read both sides of this leaflet carefully before you start to take your medicine.

It will tell you what you need to know about Chloral Hydrate Oral Solution.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Remember this medicine is only for YOU. Never give it to anybody else, even if their symptoms are the

same as yours. If you are experiencing unpleasant side effects you should consult your doctor.

In this leaflet:

What Chloral Hydrate Oral Solution is and what it is used for

Before you take Chloral Hydrate Oral Solution

How to take Chloral Hydrate Oral Solution

Possible side effects

How to store Chloral Hydrate Oral Solution

Further information

1.

What Chloral Hydrate Oral Solution is and what it is used for

Chloral Hydrate Oral Solution contains Chloral Hydrate which is one of a group of medicines called

hypnotics (sleep inducing drugs). Chloral Hydrate Oral Solution is used for the short-term treatment of

severe insomnia (sleeping problems) which is interfering with normal daily life. Chloral Hydrate will

normally be given in addition to other non drug therapies e.g. counselling.

Chloral Hydrate is normally only used in children and adolescents under the supervision of a medical specialist.

2.

Before you take Chloral Hydrate Oral Solution

Do not take Chloral Hydrate Oral Solution if you or the patient:

have severe liver or kidney problems

have severe heart problems

suffer from porphyria (an inherited blood disorder)

are a child under 2 years of age

Speak to your doctor before taking Chloral Hydrate Oral Solution if you:

are allergic to chloral hydrate or any of the other ingredients in Chloral Hydrate Oral Solution

are suffering from stomach problems (gastritis).

Taking other medicines

Please tell you doctor or pharmacist if you are taking or have recently taken any other medicines, including

medicines obtained without a prescription.

It is important to tell your doctor if you are taking any of the following:

medicines to thin your blood (such as Warfarin).

medicines for depression or nervous disorders.

medicines intended to reduce muscle spasms.

Taking Chloral Hydrate Oral Solution with food and drink

Alcohol can increase the sedative effect of chloral hydrate. Alcohol should therefore be avoided whilst

taking this medicine. Chloral Hydrate Oral Solution should be taken with water or milk.

Pregnancy and breast feeding

Chloral Hydrate Oral Solution should not be taken if you are pregnant or trying to become pregnant or you are breast

feeding.

Driving and using machines

Please note, your ability to drive or operate hazardous machinery may be impaired by drowsiness as a

result of taking Chloral Hydrate Oral Solution.

Important information about some of the ingredients of Chloral Hydrate Oral Solution

Chloral Hydrate Oral Solution contains the following:

Sunset Yellow FCF (E110) and Ponceau 4R (E124) which may cause allergic reactions.

Glycerol which may cause headache, stomach upset and diarrhoea.

Glucose liquid. If you have been told by your doctor that you have an intolerance to some sugars,

contact your doctor before taking this medicinal product.

Glucose may also be harmful to the teeth.

Laboratory Tests

If you are having blood tests for your thyroid, tell your doctor or nurse as chloral hydrate may interfere

with these tests.

3.

How to take Chloral Hydrate Oral Solution

Always take Chloral Hydrate Oral Solution exactly as your doctor has told you. You should check with your

doctor or pharmacist if you are not sure. Chloral Hydrate Oral Solution should be taken as a single daily

dose usually 15-30 minutes before bedtime.

The usual doses are:

Adults and Children aged 12 years and over and the Elderly: 15-30ml. In the frail elderly or patients with

liver problems a smaller dose may be required. Not more than 70ml Chloral Hydrate Oral Solution

(equivalent to 2g of Chloral Hydrate) should be taken in any one day.

Children 2-11 years: The dose will be calculated by your doctor or pharmacist based on the weight of the

child. You should follow their instructions. Not more than 35ml of Chloral Hydrate Oral Solution

(equivalent to 1g of Chloral Hydrate) should be taken in any one day.

Children under 2 years Chloral Hydrate Oral Solution is not suitable for children under 2 years old.

If you are unsure about how to take your medicine, ask your doctor or pharmacist.

Chloral Hydrate Oral Solution is usually prescribed for the short term treatment of sleeping problems,

usually for less than 2 weeks. If you take Chloral Hydrate Oral Solution over a long period of time, you may

find that the medicine takes longer to work and does not last for as long. This is called “tolerance” to the

medicine. If you find you are becoming “tolerant” to Chloral Hydrate Oral Solution do not increase the

amount you take. Speak to your doctor.

If you take more Chloral Hydrate Oral Solution than you should

In the event of an accidental overdose, contact your nearest hospital casualty department or tell your

doctor immediately. It is advisable to have the medicine in its original packaging available for the doctor or

hospital. Signs of an overdose include, vomiting, breathing problems, abnormal heartbeat, abnormally low

body temperature, pin point pupils, low blood pressure or coma.

If you stop taking Chloral Hydrate Oral Solution

Suddenly stopping Chloral Hydrate Oral Solution may cause delirium (severe confusion). Contact your

doctor before you stop taking the medicine, he will advise you how to stop.

4.

Possible side effects

This medicine can cause side effects in some people.

Examples of side effects which may occur are:

Stomach irritation

Excitement

Wind

Headache

Allergic skin reactions

Lack of co-ordination (ataxia)

Confusion

Ketonuria (a condition in which ketone bodies are present in the urine) which

Gut swelling

can only be detected by tests arranged by your doctor.

If you are elderly you may be more susceptible to confusion and co-ordination problems which may lead

to falls and injury.

If you find that you are experiencing unpleasant side effects you should consult your doctor.

5.

How to store Chloral Hydrate Oral Solution

Store below 25°C. Store in the original packaging. Keep the bottle in the outer carton.

Keep out of the sight and reach of children.

The expiry date is printed on the carton and on the bottle label. Do not use your medicine after this date.

If your doctor decides to stop treatment, return any left over Oral Solution to your pharmacist. Medicines

should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of

medicines no longer required. These measures will help to protect the environment.

6.

Further information

What Chloral Hydrate Oral Solution contains

The active substance in Chloral Hydrate Oral Solution is chloral hydrate. Chloral Hydrate Oral Solution also

contains glycerol, glucose syrup, sodium benzoate, saccharin sodium, essence of passion fruit (containing

natural flavouring, artificial flavouring, propylene glycol (E1520)), purified water, ponceau 4R (E124) and

sunset yellow (E110).

What Chloral Hydrate Oral Solution looks like and contents of the pack

Chloral Hydrate Oral Solution is a clear, red syrup containing 143.3mg chloral hydrate per 5ml. A pack size

of 150ml is available.

Marketing Authorisation Holder

Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire SN8 1LW

Manufacturer

Dales Pharmaceuticals Ltd, Skipton BD23 2RW

The Product Licence number is PL23138/0016

For information in large print

tape,CD or Braille,

telephone 01672 514187

Date of preparation April 2014.

F1029

GB 723-0170-APIL

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EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

Europe -DG Health and Food Safety

12-6-2018

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Celgene Europe B.V.)

EU/3/10/794 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3803 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/069/10/T/03

Europe -DG Health and Food Safety