DHC Continus prolonged release tablets 90mg

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 phamacist. 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 elderly;
• have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the tablets may make these symptoms worse or hide the extent of a head injury;
• 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);
• are or have ever been addicted to alcohol or drugs or have a known opioid dependence;
• need to take increasingly higher doses of the tablets to gain the same level of pain relief (tolerance).

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 depresssion;
• 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 and 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.

Newborn babies may suffer withdrawal effects (such as high-pitched cry, jitteriness, fits, poor feeding and diarrhoea) if their mothers have taken dihydrocodeine for a long time during pregnancy.

If you are breastfeeding, do not take these tablets until you have spoken to your doctor.

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

You should not suddenly stop taking these tablets unless your doctor tells you to. If you want to stop taking your tablets, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, shaking or sweating may occur if you suddenly stop taking these tablets.

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