Dihydrocodeine 30 mg tablets – patient leaflet, side effects, dosage

1. What Dihydrocodeine Tablets are and what they are used for

This medicine has been prescribed for you for the relief of moderate to severe pain.

It contains dihydrocodeine which belongs to a class of medicines called opioids, which are ‘pain relievers’.

This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly.Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

2. What you need to know before you take Dihydrocodeine Tablets

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

Do not take Dihydrocodeine Tablets if you:

• are allergic to dihydrocodeine, any other opioid analgesic or any of the other ingredients of this medicine (listed in section 6)
• have severe problems with breathing
• have increased pressure on the brain, have just had a head injury or if you are unconscious
• are suffering from acute alcoholism
• are at risk from a blocked intestine
• you have been told you have liver disease
• are suffering from severe diarrhoea
• are under 4 years of age

Warnings and precautions

Talk to your prescriber before taking this medicine if:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs. • feel you need to take more of Dihydrocodeine Tablets to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment. Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms. Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else.

Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death. Talk to your doctor before taking Dihydrocodeine Tablets if you:

• are taking or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression
• suffer from asthma (your doctor may decide to administer Dihydrocodeine Tablets if your asthma is controlled. However, you should not be given this medicine if you are having an acute asthma attack)
• suffer from bronchitis (an inflammation of the lining of the tubes in the lungs, resulting in coughing spells accompanied by thick phlegm and breathlessness) or emphysema (a lung condition which leaves you struggling for breath)

• suffer from cor-pulmonale ( a type of heart failure)

  • have liver problems
  • have kidney problems
  • have problems with your bile duct
  • suffer from an enlarged prostate gland (in men) or have difficulty passing urine

  • have an under-active thyroid or

    adrenal gland

  • have low blood pressure
  • are in a state of severe shock

  • have inflammatory bowel disease,

    such as Crohn’s disease or

    ulcerative colitis or a blockage in the

    bowel

  • suffer from convulsions (fits)
  • are elderly
  • are feeling weak and feeble

  • have ‘myasthenia gravis’ (tiredness

    and weakness of some muscles e.g.

    eyes, mouth and throat muscles)

If any of the above apply to you, speak

to your doctor, nurse or pharmacist

before you take Dihydrocodeine Tablets.

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

Other medicines and Dihydrocodeine Tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor if you are taking any of the following: • monoamine oxidase inhibitors (MAOIs) such as moclobemide or phenelzine used in the treatment of depression.You must also tell your doctor if you have stopped taking any of these or related medicines in the last two weeks • tricyclic antidepressants, which are used in the treatment of depression • tranquillising drugs or sleeping tablets such as diazepam, nitrazepam and temazepam

• medicines used to treat mental illnesses, including schizophrenia (e.g. chlorpromazine, haloperidol)
• medicines used for diarrhoea (e.g. loperamide, kaolin)
• medicines which are used as premedication before operations and after heart attacks such as atropine
• anaesthetics, particularly general anaesthetics (used in surgery to numb pain) • antihistamines such as benadryl (used to treat allergies e.g. hayfever) • sodium oxybate (used to treat narcolepsy)
• medicines used to treat nausea and vomiting, such as metoclopramide or domperidone
• mexiletine or quinidine, used to control heart rhythm
• cimetidine, used to treat stomach ulcers and indigestion

Dihydrocodeine Tablets with alcohol

You should not drink alcohol whilst you are taking Dihydrocodeine Tablets, as they will increase its effects.Alcohol may increase the sedative effects of dihydrocodeine and make you very sleepy.

Pregnancy and breast-feeding

Do not take Dihydrocodeine Tablets if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby. If you use Dihydrocodeine Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Do not take Dihydrocodeine Tablets while you are breastfeeding as dihydrocodeine passes into breast milk and will affect your baby. If you are given dihydrocodeine during labour there is a risk that you could be sick and have breathing difficulties, or the baby could have difficulty starting breathing.

Driving and using machines

You may feel drowsy and confused and you may develop blurred or double vision when you are taking Dihydrocodeine Tablets, so you should not drive or operate machinery.

This medicine can affect your ability to drive.

Do not drive whilst taking this medicine until you know how this medicine affects you.

It may be an offence to drive if your ability to drive safely is affected.There is further information for patients who are intending to drive in Great Britain – go to http://www.gov.uk/drug-driving-law

3. How to take Dihydrocodeine Tablets

The usual adult dose for Dihydrocodeine Tablets is one tablet every four to six hours.

The dose should be reduced in elderly patients.You may be given a reduced dose if you have kidney or liver problems.You may also be given a reduced dose if you suffer from any of the conditions listed above in the section headed ‘Speak to your doctor before you take Dihydrocodeine Tablets if you:’ For children from four to twelve years the usual dose is 0.5-1.0 mg per kg of body weight every four to six hours.

The tablets are not recommended for children under four years of age. Your doctor will decide the dose that is best for you.Always follow your doctor’s instructions completely.Also, follow any special instructions or warnings that appear on the label that the pharmacist has put on the package. If you do not understand or are in any doubt, ask your pharmacist.

Unless instructed differently, take your tablet(s) with a glass of water. If you have been given a blister pack, to obtain a tablet, press on the tablet from the blister (or bubble) pushing it through the foil. Do not remove the tablet from

the blister until you are ready to take it. Your prescriber should have discussed with you, how long the course of tablets will last.

They will arrange a plan for stopping treatment.This will outline how to gradually reduce the dose and stop taking the medicine.

If you forget to take

Dihydrocodeine Tablets

You should continue to take your medicine for as long as your doctor tells you to. If you forget a dose, take another as soon as you remember. If it is almost time for your next dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER double the next dose to make up for the one missed. Do not stop taking the medicine without telling your doctor first.

If you stop taking Dihydrocodeine Tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first.They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum.Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.Tell your doctor or nurse immediately if you experience the following serious side effect:

• A severe allergic reaction, (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing). If you suffer such a reaction, you should not be given any more dihydrocodeine. Your doctor will decide on the appropriate treatment for allergic reactions. Difficulty in breathing and physical and psychological dependence are possible serious side effects. It is possible that you could become dependent on dihydrocodeine.

Other side effects include:

• drowsiness
• feeling sick or being sick
• constipation
• sweating
• dizziness
• feeling faint on standing up
• small pupils (in the eye)
• blurred vision
• double vision or other changes in vision
• mental clouding or confusion
• mood changes such as depression and sadness
• feeling extremely happy for no particular reason
• imagining things (hallucinations)
• nightmares
• headache
• vertigo (a feeling of dizziness or being light-headed)
• facial flushing
• dry mouth
• difficulty breathing
• stomach cramps
• difficulty or pain in passing urine
• passing more or less urine than usual
• biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder) • increased pressure within your head (raised intracranial pressure) • hyperglycaemia (abnormally high levels of glucose in the blood) • pancreatitis (inflammation of the pancreas)
• feeling unwell
• feeling tired
• hypothermia (drop in body temperature below 35 °C)
• fever
• an enlarged spleen or swollen/enlarged lymph nodes
• anorexia (eating disorder)
• uncontrolled muscle movements
• restlessness
• muscle tension or stiffness
• palpitations (trembling, shaking, irregular heart beats)
• slower or faster pulse
• skin rash (hives)
• raised or itchy skin
• reduced sexual drive or impotence after long term use.

• dependence and addiction (see section “How do I know if I am addicted?”).

  Drug withdrawal

  When you stop taking Dihydrocodeine Tablets, you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating. How do I know if I am addicted?

  If you notice any of the following signs whilst taking Dihydrocodeine Tablets, it could be a sign that you have become addicted.

  • You need to take the medicine for longer than advised by your prescriber - You feel you need to use more than the recommended dose - You are using the medicine for reasons other than prescribed - When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again

If you notice any of these signs, it is important you talk to your prescriber. 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 national reporting systems listed below.

United Kingdom

Yellow Card Scheme

www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

Malta

ADR Reporting

www.medicinesauthority.gov.mt/adrportal

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

5. How to store Dihydrocodeine Tablets

Keep this medicine out of the sight and reach of children.

Do not use Dihydrocodeine Tablets if the tables show signs of discolouration. Do not use Dihydrocodeine Tablets after the expiry date which is stated on the carton.The expiry date refers to the last day of that month.

REMEMBER this medicine is for YOU only. Never give it to anyone else. It may harm them, even if the symptoms are the same as yours. Unless your doctor tells you to, do not keep tablets that you no longer need. Give them back to the pharmacist. Do not throw away any medicines via wastewater or household waste.Ask your pharmacist how throw away medicines you no longer use.These measures will help to protect the environment.

6. Contents of the pack and other information

What Dihydrocodeine Tablets contain

Dihydrocodeine Tablets contain the active ingredient Dihydrocodeine Tartrate. The tablets are available in one strength of 30mg.

Other ingredients are lactose, maize starch, magnesium stearate and povidone. What Dihydrocodeine Tablets looks like and contents of the pack

Dihydrocodeine Tablets are white, circular tablets with DHC 30 and a breakline on one face and CP on the reverse

Dihydrocodeine Tablets are available in packs of 28, 30 or 100 tablets. Not all strengths and pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder in UK: Wockhardt UK Ltd,Ash Road North, Wrexham, LL13 9UF, UK

Marketing Authorisation Holder in Malta: Pinewood Laboratories Ltd., Ballymacarbry, Clonmel, Co.Tipperary, Ireland.

Manufacturer: CP Pharmaceuticals Ltd,Ash Road North,Wrexham, LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People. For patients in Malta, please call + 44 1978 661261.

This leaflet was last revised in 04/2020.

11002071