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DIHYDROCODEINE INJECTION BP 50 MG / ML - patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - DIHYDROCODEINE INJECTION BP 50 MG / ML

Dihydrocodeine Injection BP 50mg/ml

Di hydrococI

Read all of this leaflet carefully before you are given Dihydrocodeine injection.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, please askyour doctor or nurse
  • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

In this leaflet:

  • 1. What Dihydrocodeine Injection is and what it is used for

  • 2. Before Dihydrocodeine Injection is given

  • 3. How Dihydrocodeine Injection is given

  • 4. Possible side effects

  • 5. Storing Dihydrocodeine Injection

  • 5. Further information

1. what dihydrocodeine injection is and what it is used for

Dihydrocodeine belongs to a group of medicines known as analgesics which are used to relieve pain. Dihydrocodeine is used for the relief of severe pain.

2. Before Dihydrocodeine Injection is given

You should not be given Dihydrocodeine Injection if you:

  • are allergic (hypersensitive) to dihydrocodeine or any of the other ingredients listed in section 6
  • suffer from breathing difficulties, or you are having an asthma attack
  • have difficulty opening your bowel
  • have a tumour of the adrenal gland known as phaeochromocytoma

Dihydrocodeine Injection should not be given to children under4years of age.

fake special care with Dihydrocodeine Injection, fell your doctor if you:

  • suffer from asthma
  • have an underactive thyroid gland
  • suffer from low blood pressure
  • suffer from seizures (fits) e.g. epilepsy
  • have been diagnosed as suffering from an enlarged prostate gland
  • have any breathing or lung problems
  • are suffering from severe headaches or have suffered a head injury
  • have liver or kidney problems

If any of the above applies to you or your child, please consult your doctor.

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Taking other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without prescription

Medicines that may interact with Dihydrocodeine Injection include:

  • anxiolytics or hypnotics (these are medicines that reduce anxiety or cause sleepiness) e.g. diazepam and chlordiazepoxide.
  • Dihydrocodeine injection should not be administered to patients receiving severe depression treatment known as Monoamine Oxidase Inhibitors (MAOIs), such as phenelzine or moclobemide or within two weeks of their withdrawal.

Taking Dihydrocodeine Injection with food and drink:

You areadvised notto drinkalcohol while being treated with Dihydrocodeine Injection.

Pregnancy and breast-feeding:

Dihydrocodeine injection should not be used if you are pregnant or try to become pregnant unless it is prescribed by your doctor.

Dihydrocodeine is likely to cross the placenta and be present in breast milkand it may cause breathing problems in new born babies.

Effects on the ability to drive and use machines:

Dihydrocodeine Injection may cause drowsiness. If you are affected in this way, however slightly, you should not drive or operate machinery.

This 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 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 foryou to drive while taking this medicine.

Important information about some of the ingredients:

This medicine contains sodium metabisulfite which may cause allergic (hypersensitive) type reactions in some people and can lead to breathing difficulties or collapse. People with a history of asthma or allergies are most likely to experience these problems.

  • 3. How Dihydrocodeine Injection is given

Your doctor or nurse will give you Dihydrocodeine njection either into a muscle or deep beneath the surface of the skin.

Under some circumstances your doctor may prescribe a dose higher than those stated here.

Adults

Up to 50mg.

Elderly or ill patients

It is recommended that a reduced dose be used.

Children (over 4 years)

0.5–1 mg per kg of body weight every 4 to 6 hours.

Children (under 4 years)

Not recommended.

If you are given too much Dihydrocodeine Injection

As this medicine will be given to you whilstyou are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.

4. possible side effects

_ike all medicines, Dihydrocodeine Injection can cause side effects, although not everybody gets them:

Repeated use of dihydrocodeine can result in tolerance and addiction.

If you experience any of the following side effects you should tell your doctor immediately. These are symptoms of an allergic reaction.

  • difficulty in breathing with or without swelling of the face, lips, tongue and/or throat
  • swelling of the face, lips tongue and/or throat, which may cause difficulty in swallowing
  • severe itching of the skin (with raised lumps).

Other possible side effects include:

  • constipation
  • nausea (feeling sick)
  • vomiting (being sick)
  • headaches
  • dizziness or a feeling of spinning (vertigo)
  • drowsiness
  • difficulty breathing
  • difficulty in passing urine
  • feeling of anxiety, depression and/or restlessness (dysphoria)
  • dry mouth
  • sweating
  • pin-point pupils
  • facial flushing
  • feeling faint when getting up from a seated position
  • hallucinations (seeing or hearing things that aren't real)
  • feeling of being unwell
  • mood changes
  • itching or skin rashes

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

  • 5. Storing Dihydrocodeine Injection

Keep out of the reach and sight of children.

This product has an expiry date on the ampoule and carton label. The expiry date refers to the last day of that month. The doctor or nurse will check that the product has not passed this date.

Store protected from light.

  • 6. Further Information

What Dihydrocodeine Injection looks like and the contents of the pack:

The injection is supplied in glass ampoules each containing 1 ml. The ampoules are supplied in packs of 5 or lOampoules.

Product Licence Holder and Manufacturer:

Martindale Pharmaceuticals Ltd

Bampton Road

Romford, Essex, RM3 8UG, UK

Product licence number: PL 00156/0091

Dihydrocodeine injection BP 50mg in 1 ml

Leaflet last revised: July 2014

Martindale Ikjk Pharmaceuticals fVi

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom

D0281 4 ____________:

Headings 11 on 11 pt

2814-C


100mm Measurement Verification Bar


Body text 9 on lOpt

MARTINDALE PHARMA

DEVELOPMENT ARTWORK

Component Code: D02814

Paper size: 170 × 296mm

Version Control

Date

By

Version A Created

26/03/14

AC

Version B

15/04/14

AC

Version C

17/07/14

HM

Version D

Version E

Version F

Version G

Version H

Version I

Version J

Version K

Version L

Version M

Version N

Grand Fromage Creative Ltd Amherst House, 22 London Road Sevenoaks, Kent TN13 2BT t :+44 (0)1732 456 1­87 e :

Sources: Original (products.mhra.gov.uk)