Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Dihydrocodeine 60 mg, prolonged-release tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Dihydrocodeine tartrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Dihydrocodeine tartrate
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

This medicine has been prescribed for you for the relief of severe pain over a period of 12 hours. It contains dihydrocodeine, which belongs to a class of medicines called opioids, which are 'pain relievers'. The medicine has been prescribed for 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 doctor should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. The tablets may be taken by adults and children aged 12 years and above. 2.

What you need to know before you take it

e Dihydrocodeine tablets

Do not take Dihydrocodeine tablets if you:

  • are allergic (hypersensitive) to dihydrocodeine or any of the other ingredients of the tablets (listed in section 6 of this leaflet);
  • 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 currently intoxicated from drinking alcohol;
  • have an intolerance to some sugars;
  • are under 12 years of age;

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•

have acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid induced ventilatory impairment (OIVI).

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 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 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 an obstructive bowel disorder; 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 tablets. Your doctor may want to monitor these changes.

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Other medicines and Dihydrocodeine 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. Taking Dihydrocodeine tablets at the same time as other medicines that slow down the central nervous system can cause slow or difficulty breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include: • • • • • •

other medicines used to treat pain known as opioids (such as codeine or morphine); medicines used to treat anxiety; medicines used to make you feel sleepy (such as benzodiazepines); medicines used to treat psychiatric or mental disorders (such as phenothiazines); medicines used to treat depression; a type of medicine used to treat depression known as monoamine oxidase inhibitors (MAOIs), such as tranylcypromine, phenelzine and isocarboxazid. You should not take Dihydrocodeine tablets if you are currently taking this type of medicine, or have taken this medicine in the last two weeks.

Because of this, your doctor will only prescribe Dihydrocodeine tablets where there are no other treatment options, and only in small doses for short periods of time. If you or your friends, family or caregivers notice that you are having difficulty breathing or that you have become very sleepy or lost consciousness you (or they) should inform your doctor immediately. Dihydrocodeine 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 Dihydrocodeine 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 Dihydrocodeine 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 Dihydrocodeine tablets while you are breastfeeding as dihydrocodeine 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 'Possible side effects' 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. • • •

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 commiting an offence if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and o It was not affecting your ability to drive safely.

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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 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. 3.

How to take it

Dihydrocodeine tablets

Always take these tablets exactly as your doctor has told you. The label on your medicine will tell you how many tablets to take and how often. Do not take for longer than directed by your doctor. Check with your doctor or pharmacist if you are not sure. Your doctor should have discussed with you how long the course of Dihydrocodeine 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. Swallow your tablets whole with a glass of water. Do not break, chew or crush them. Dihydrocodeine tablets are designed to work properly over 12 hours when swallowed whole. If a tablet is broken, crushed or chewed, the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose, which may be fatal. You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o'clock in the morning, you should take your next tablet at 8 o'clock in the evening. 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 Dihydrocodeine tablets than you should or if someone accidentally swallows your tablets Call your doctor or hospital immediately. 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 Dihydrocodeine 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 Dihydrocodeine 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. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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4.

Possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them. This medicine can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face, lips or throat, rash or itching especially those covering your whole body. The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 'Other medicines and Dihydrocodeine tablets'). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms. 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 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 (vertigo), seizures, fits or convulsions; tingling or numbness; low blood pressure; decreased sexual drive; difficulty or pain in passing urine; 5

• • • • • • •

swelling or puffiness of the skin, flushing of the skin; itching, redness or rash, or a raised itchy rash (hives); shortness of breath; increased sweating; a need to take increasingly higher doses to obtain the same level of pain relief (tolerance); abdominal pain or discomfort; a worsening in liver function tests (seen in a blood test).

Possible side effects

with unknown frequency (frequency cannot be estimated from the available data) • • •

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 Dihydrocodeine 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. 5.

How to store it

Dihydrocodeine tablets

Keep these tablets out of the sight and reach of children. Do not use the tablets after the expiry date, which is stated on the label after 'EXP'. The expiry date refers to the last day of that month. Do not store your tablets above 25°C. 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. 6.

Contents of the pack and other information

What Dihydrocodeine 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 and talc. What Dihydrocodeine tablets look like and the contents of the pack The tablets are white, capsule shaped and marked DHC followed by the strength (60, 90 or 120). In each bottle there are 56 tablets. Marketing Authorisation Holder Ennogen IP Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK.

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Manufacturer 90mg and 120mg: Fidelio Healthcare Limburg GmbH, Mundipharma Strasse 2, D-65549 Limburg, Germany. 60mg , 90mg and 120mg: Ennogen Healthcare International Ltd, Unit G3, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK. This leaflet was last revised in September 2025.

ENV05

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Frequently asked questions about Dihydrocodeine 60 mg, prolonged-release tablets

How do I take Dihydrocodeine 60 mg, prolonged-release tablets?

Dihydrocodeine 60 mg, prolonged-release tablets comes as tablet containing 60mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Dihydrocodeine 60 mg, prolonged-release tablets?

The active substance in Dihydrocodeine 60 mg, prolonged-release tablets is dihydrocodeine tartrate.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Dihydrocodeine 60 mg, prolonged-release tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Dihydrocodeine 60 mg, prolonged-release tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Dihydrocodeine tartrate (5 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

For the relief of severe pain in cancer and other chronic conditions.

Dihydrocodeine 60mg tablets are indicated for use in adults and children over 12 years of age.

4.2. Posology and method of administration

Posology

Adults and children over 12 years:

One or two tablets 12-hourly.

Elderly:

Dosage should be reduced

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with dihydrocodeine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4).

Paediatric population

Children 12 years or under: Not recommended.

Method of administration

Oral.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; severe respiratory depression with hypoxia; severe chronic obstructive lung disease; severe cor pulmonale; severe bronchial asthma; paralytic ileus; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.4. Special warnings and precautions for use

Dihydrocodeine should be administered with caution to the elderly or patients with:

• a history of opioid abuse or dependence

• raised intracranial pressure, intracranial lesions or head injury

• reduced level of consciousness of uncertain origin

• biliary tract disorders

• prostatic hypertrophy

• pancreatitis

• impairment of hepatic function

• severe renal dysfunction

• constipation

• an obstructive bowel disorder

• respiratory depression with hypoxia

• chronic obstructive pulmonary disease

• cor pulmonale

• bronchial asthma

• hypothyroidism

• sleep apnoea

The primary risk of opioid excess is respiratory depression.

Opioids may cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use may increase the risk of CSA in a dose-dependent manner in some patients. Opioids may also cause worsening of pre-existing sleep apnoea (see section 4.8). In patients who present with CSA, consider decreasing the total opioid dosage.

Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.

Concomitant use of dihydrocodeine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe dihydrocodeine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also general dose recommendation in section 4.2).

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).

Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI).

Drug dependence, tolerance and potential for abuse

For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g., major depression).

Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.

A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.

Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced. Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.

Overuse and misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.

Patients should be closely monitored for signs of misuse, abuse or addiction.

The clinical need for analgesic treatment should be reviewed regularly.

Drug withdrawal syndrome

Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with dihydrocodeine.

Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months.

The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills myalgia, mydriasis and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.

If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.

Hyperalgesia

Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain. This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality. Symptoms of hyperalgesia may resolve with a reduction of opioid dose.

Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal.

Dihydrocodeine tablets must be swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed tablets may lead to a rapid release and absorption of a potentially fatal dose of dihydrocodeine and may result in overdose effects (see section 4.9).

Opioids, such as dihydrocodeine, may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decrease in plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

4.5. Interaction with other medicinal products and other forms of interaction

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Drugs which depress the CNS include, but are not limited to, other opioids, anxiolytics, hypnotics and sedatives (including benzodiazepines), antipsychotics, antidepressants, phenothiazines and alcohol.

Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors or within two weeks of such therapy.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of dihydrocodeine in pregnant women. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. Dihydrocodeine should only be used during pregnancy and labour if considered essential due to the risk of neonatal respiratory depression. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Administration during labour may depress respiration in the neonate and an antidote for the child should be readily available. Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression.

Breastfeeding

Administration to nursing women is not recommended as dihydrocodeine may be secreted in breast milk and may cause respiratory depression in the infant. It is advisable that dihydrocodeine only be administered to breast-feeding mothers if considered essential.

4.7. Effects on ability to drive and use machines

Dihydrocodeine may cause drowsiness and, if affected, patients should not drive or operate machinery.

This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:

▪ The medicine is likely to affect your ability to drive.

▪ Do not drive until you know how the medicine 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

4.8. Undesirable effects

The adverse experiences listed below are classified by body system according to their incidence (common or uncommon). Common adverse drug experiences have an incidence of ≥ 1% and uncommon adverse drug experiences have an incidence of < 1%.

Undesirable Effects

Common (≥ 1%)

Uncommon (< 1%)

Not known (frequency cannot be estimated from the available data)

Immune system disorders

Angioedema

Psychiatric disorders

Confusional state

Hallucination

Mood altered

Dysphoria

Drug dependence (see section 4.4)

Nervous system disorders

Somnolence

Convulsions

Dizziness

Headache

Paraesthesia

Sedation

Sleep apnoea syndrome

Eye disorders

Blurred vision

Ear and labyrinth disorders

Vertigo

Vascular disorders

Hypotension

Flushing

Respiratory, thoracic and mediastinal disorders

Dyspnoea

Respiratory depression

Gastrointestinal disorders

Abdominal pain

Constipation

Dry mouth

Nausea

Vomiting

Diarrhoea

Paralytic ileus

Hepatobiliary disorders

Biliary colic

Hepatic enzymes increased

Skin and subcutaneous tissue disorders

Hyperhidrosis

Pruritus

Rash

Urticaria

Renal and urinary disorders

Urinary retention

Uretic spasm

Reproductive system and breast disorders

Decreased libido

General disorders and administration site conditions

Asthenia

Fatigue

Malaise

Drug withdrawal syndrome

Drug tolerance

Drug withdrawal syndrome neonatal

Prolonged use of a painkiller for headaches can make them worse.

Paediatric population

Neonatal respiratory depression and withdrawal symptoms may occur in the newborn of mothers undergoing treatment with dihydrocodeine (see section 4.6).

Reporting of adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.

4.9. Overdose

Acute overdosage with dihydrocodeine can be manifested by somnolence progressing to stupor or coma, miotic pupils, rhabdomyolysis, non-cardiac pulmonary oedema, bradycardia, hypotension and respiratory depression or apnoea, which may in severe cases result in a fatal outcome.

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur.

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation.

In the case of massive overdosage, administer naloxone intravenously (0.4 to 2 mg for an adult and 0.01 mg/kg body weight for children) if the patient is in a coma or respiratory depression is present. Repeat the dose at 2 minute intervals if there is no response, or by an infusion. An infusion of 60% of the initial dose per hour is a useful starting point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a substitute for frequent review of the patient's clinical state. Intramuscular naloxone is an alternative in the event that IV access is not possible.

As the duration of action of naloxone is relatively short, the patient must be carefully monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive antagonist and large doses (4 mg) may be required in seriously poisoned patients. For less severe overdosage, administer naloxone 0.2 mg intravenously followed by increments of 0.1 mg every 2 minutes if required.

Naloxone should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to dihydrocodeine overdosage. Naloxone should be administered cautiously to persons who are known, or suspected, to be physically dependent on dihydrocodeine. In such cases, an abrupt or complete reversal of opioid effects may precipitate pain and an acute withdrawal syndrome.

Additional/other considerations:

• Consider activated charcoal (50 g for adults, 10-15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged release preparations but there is no evidence to support this.

Dihydrocodeine tablets will continue to release and add to the dihydrocodeine load for up to 12 hours after administration and the management of overdosage should be modified accordingly. Gastric contents may therefore need to be emptied, as this can be useful in removing unabsorbed drug, particularly when a prolonged release formulation has been taken.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • DHC CONTINUS 60 mg prescriptionDIHYDROCODEINUM · taken by mouth
  • DHC CONTINUS 90 mg prescriptionDIHYDROCODEINUM · taken by mouth
  • DHC CONTINUS 120 mg prescriptionDIHYDROCODEINUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • DHC EnnogenDihydrocodeini tartras · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Dihydrocodeine 60 mg, prolonged-release tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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