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The product code for this leaflet is: PL 00142/0223

 

Dihydrocodeine Tablets 30mg

Company Details

Actavis UK Ltd


Whiddon ValleyBarnstapleDevonEX32 8NS
Telephone:
Fax:
Medical Information Direct Line:
Medical Information e-mail:medinfo@actavis.co.uk
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PATIENT INFORMATION LEAFLET

Dihydrocodeine 30mg tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist or nurse.
  • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1 What Dihydrocodeine tablets are and what they are used for
2 What you need to know before you take Dihydrocodeine tablets
3 How to take Dihydrocodeine tablets
4 Possible side effects
5 How to store Dihydrocodeine tablets
6 Contents of the pack and other information

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1 What Dihydrocodeine tablets are and what they are used for

Dihydrocodeine tablets belong to a group of medicines called analgesics.

They are used for the relief of moderate to severe pain including the pain of sciatica (nerve pain of the leg/back), joint and bone pain (osteoarthritis, rheumatoid arthritis and arthritis of the spine), nerve pain, pain following blood vessel disease, cancer or after operations.

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2 What you need to know before you take Dihydrocodeine tablets

Do not take Dihydrocodeine tablets:

  • if you are allergic (hypersensitive) to dihydrocodeine or any of the ingredients in the tablet (see section 6)
  • if you have difficulty breathing, or other chronic lung disease
  • if you have a head injury or a condition where there is increased pressure in the skull (may cause painful eyes, change in vision or headache behind the eyes)
  • if you are having an asthma attack
  • if you are alcohol dependant
  • if you are at risk of blocked intestines

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Dihydrocodeine tablets:

  • if you have kidney or liver problems
  • if you have low blood pressure or are in shock
  • if you have suffered with allergies
  • if you have an underactive thyroid gland.
  • if you have an enlarged prostate gland and have difficulty urinating and are male
  • if you are weak due to illness
  • if you have adrenal gland insufficiency (symptoms include-low blood pressure, low blood sugar, muscle weakness, nausea, vomiting, dizziness, skin discolouration, weight loss)
  • if you have reduced lung capacity (e.g. asthma or other conditions causing breathing difficulties)
  • if you have a convulsive disorder (suffer from spasms/seizures)
  • if you have inflammation or blockage in the bowel (symptoms may include constipation, diarrhoea, abdominal pain/discomfort)
  • if you have a history of drug abuse.

Other important warnings:

  • do not take for longer than directed by your prescriber
  • taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets
  • taking a painkiller for headaches too often or for too long can make them worse.

Children and adolescents

For children under 12 years, a more suitable dosage form is recommended.

Other medicines and Dihydrocodeine tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Especially medicines:

  • treating allergies (antihistamines)
  • used to treat sickness (cyclizine, metoclopramide or domperidone)
  • to aid sleep (hypnotics)
  • treating anxiety (anxiolytics)
  • treating depression such as monoamine oxidase inhibitors (MAOIs e.g. moclobemide, linezolid) or tricyclic antidepressants (e.g. amitriptyline)
  • treating mental illnesses e.g. chlorpromazine, haloperidol
  • such as mexiletine used to control heart rhythm
  • such as cimetidine (to treat stomach ulcers)
  • used in anaesthesia (important if you have recently or are about to receive treatment where an anaesthetic may be used)

Dihydrocodeine tablets and alcohol

Alcohol should be avoided whilst taking Dihydrocodeine tablets.

Pregnancy, breast-feeding and fertility

Do not take Dihydrocodeine tablets during late pregnancy or whilst breast-feeding, unless advised by your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Dihydrocodeine tablets may reduce your ability to think clearly. Effects such as ‘pins and needles’, dizziness, spinning sensations, muscle rigidity, visual disturbances, drowsiness, confusion or hallucinations may occur. Do not drive or operate machinery if affected.

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 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.

Dihydrocodeine tablets contain lactose.

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

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3 How to take Dihydrocodeine tablets

Always take Dihydrocodeine tablets exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not drink alcohol whilst taking Dihydrocodeine tablets. Swallow the tablets with water, with or after food.

Take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

The recommended dose is:

  • Adults: 1 tablet every four to six hours or as directed by your doctor.
  • Children under 12 years: Not recommended
  • Elderly: Dosage is usually reduced in the elderly

If you take more Dihydrocodeine tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include; very small pupils, feeling or being sick, feeling dizzy or lightheaded, irregular heartbeat.

If you forget to take Dihydrocodeine tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dihydrocodeine tablets

Talk to your doctor before you stop taking the tablets and follow their advice.

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

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4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Contact your doctor at once if signs of an allergic reaction occur such as itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

  • Gastrointestinal system – constipation, feeling or being sick, abdominal pain, dry mouth
  • Nervous system – ‘spinning’ sensation, dizziness, headache, ‘pins and needles’, slow and shallow breathing, muscle rigidity.
  • Skin – rash, itchy skin, irregular raised patches, sweating, flushed face
  • Eyes – blurred or double vision, extremely small pupils
  • Psychiatric effects – drowsiness, changes of mood, confusion, sexual dysfunction, hallucinations (seeing or hearing things that are not real), excitation
  • Heart – slow or fast heart rate, palpitations, low blood pressure
  • Liver and biliary system – biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder)
  • Urinary system – pain and difficulty in passing urine and less frequent to do so
  • Other – water retention (oedema)

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.

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5 How to store Dihydrocodeine tablets

Keep out of the sight and reach of children.

Store below 25°C in a dry place, protected from light

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6 Contents of the pack and other information

What Dihydrocodeine tablets contain

  • The active substance (the ingredient that makes the tablets work) is 30mg of dihydrocodeine tartrate.
  • The other ingredients are colloidal silica, lactose, magnesium stearate, maize starch, microcrystalline cellulose (E460)

What Dihydrocodeine tablets look like and contents of the pack

Dihydrocodeine are white, uncoated tablets.

Pack sizes are 28, 30 and 100 tablets.

Marketing Authorisation Holder and Manufacturer

Actavis
Barnstaple
EX32 8NS
UK
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This leaflet was last revised in June 2016

Actavis
Barnstaple
EX32 8NS
UK

50902766 AAAJ1028


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