DHC Continus prolonged release tablets 60mg, 90mg and 120 mg

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 or pharmacist.
• This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

Do not take DHC Continus tablets if you:

• are allergic to dihydrocodeine or any of the other ingredients of the tablets (listed in section 6);
• have severe breathing problems such as severe chronic obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• are having an asthma attack;
• have a severe heart problem after long-term lung disease (severe cor pulmonale);
• have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus);
• are addicted to alcohol;
• have an intolerance to some sugars;
• are under 12 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets if you:

• 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 DHC Continus 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 doctor who will discuss your treatment and may change your dose or switch you to an alternative pain reliever;
• are elderly;
• know you are suffering from a brain injury or tumour, or you have a head injury, severe headache or feel sick, as this may indicate that the pressure in your skull is increased. This is because the tablets may make these symptoms worse or hide the extent of any head injury;
• are feeling unusually light-headed or faint;
• have breathing problems such as chronic obstructive lung disease, bronchial asthma or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;
• have an under-active thyroid gland (hypothyroidism);
• have severe kidney problems;
• have liver problems;
• have constipation or obstructive bowel disorders;
• have inflammation of the pancreas (which causes severe pain in the abdomen and back);
• have problems with your gall bladder or bile duct;
• have an enlarged prostate gland, which causes difficulty in passing urine (in men);
• have a heart problem after long-term lung disease (cor pulmonale)
• have a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained how long you will be using 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 doctor 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 doctor 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.

You may experience hormonal changes while taking these capsules. Your doctor may want to monitor these changes.

Other medicines and DHC Continus tablets

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you take these tablets with some other medicines, the effect of these tablets or the other medicine may be changed.

Tell your doctor or pharmacist if you are taking:

• medicines to help you sleep (for example benzodiazepines, tranquillisers, hypnotics or sedatives);
• medicines to treat psychiatric or mental disorders (such as phenothiazines);
• medicines to treat depression;
• medicines to treat anxiety;
• a type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromine, phenelzine, isocarboxazid, moclobemide and linezolid), or you have taken this type of medicine in the last two weeks.

Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

However if your doctor does prescribe benzodiazepines or related drugs with opioids the dosage and duration of concomitant treatment should be limited by your doctor.

Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign or symptoms stated above. Contact your doctor when experiencing such symptoms.

DHC Continus tablets and alcohol

Drinking alcohol during your treatment with these tablets may make you sleepy. If you are affected you should avoid drinking alcohol.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking these tablets.

Pregnancy

Do not take DHC Continus tablets if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take DHC Continus tablets during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated, such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea.

Breast-feeding

Do not take DHC Continus tablets while you are breastfeeding as morphine passes into breast milk and will affect your baby.

Driving and using machines

These tablets may cause a number of side effects such as drowsiness, which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually most noticeable when you first start taking the tablets or when changing to a higher dose. If you are affected you should not drive or use 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 while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).
• This defence applies when:
  • 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 and in the information provided with the medicine.
• Please note that it is still an offence to drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

DHC Continus tablets contain lactose

These tablets contain lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

Adults and children over 12 years of age

The usual starting dose is 60 mg to 120 mg every 12 hours. If you are elderly your doctor may suggest a lower starting dose. Your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking these tablets, discuss this with your doctor.

Use in children

Children under 12 years of age should not take the tablets.

If you take more DHC Continus tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show the doctor.

If you forget to take DHC Continus tablets

If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking DHC Continus tablets

Do not suddenly stop taking this medicine. If you want to stop taking this medicine discuss this with your doctor 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.

How do I know if I am addicted?

If you notice any of the following signs whilst taking DHC Continus 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 doctor.

Taking a painkiller for headaches too often or for too long can make your headaches worse.

Common side effects (May affect more than 1 in 100 people)

• Constipation (your doctor can prescribe a laxative to overcome this problem).
• Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem).
• Drowsiness (this is most likely when you start taking your tablets or when your dose is increased, but it should wear off after a few days).
• Dry mouth, abdominal pain or discomfort.

Uncommon side effects (May affect fewer than 1 in 100 people)

• Withdrawal symptoms (see section ‘Drug Withdrawal’)
• Diarrhoea, a condition where the bowel does not work properly (paralytic ileus).
• Mood changes, unpleasant or uncomfortable mood.
• Headache, confusion, a feeling of unusual weakness, tiredness, generally feeling unwell.
• Hallucinations.
• Blurred vision.
• A feeling of dizziness or ‘spinning’, seizures, fits or convulsions.
• Tingling or numbness.
• Low blood pressure.
• Decreased sexual drive.
• Difficulty in passing urine.
• Flushing of the skin.
• Rash or itchy skin.
• Shortness of breath.
• Sweating.
• A need to take increasingly higher doses to obtain the same level of pain relief (tolerance).
• A worsening in liver function tests (seen in a blood test).

Side effects with unknown frequency (frequency cannot be estimated from the available date)

• Dependence and addiction (see section ‘How do I know if I am addicted?’)
• development of a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea;
• Withdrawal symptoms in babies born to mothers who have used DHC Continus tablets in pregnancy (see “Pregnancy and breastfeeding” in section 2).

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

What DHC Continus tablets contain

The active ingredient is dihydrocodeine tartrate. Each tablet contains 60 mg, 90 mg or 120 mg of dihydrocodeine tartrate.

The other ingredients are:

• Lactose
• Hydroxyethylcellulose
• Cetostearyl alcohol
• Magnesium stearate
• Talc

What DHC Continus tablets look like and the contents of the pack

The tablets are white, capsule shaped and marked DHC followed by the strength (e.g. 60, 90 etc.).

In each bottle there are 56 tablets.

Marketing Authorisation Holder and Manufacturer

The tablets are made by

for the marketing authorisation holder