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

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

The name of this medicine is Dihydrocodeine Tablets BP 30mg but within the leaflet it will be referred to as Dihydrocodeine Tablets. Dihydrocodeine belongs to a group of medicines called opioid analgesics (pain killers). Dihydrocodeine is used for the relief of moderate to severe pain such as 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.

It contains dihydrocodeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This 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, when it is appropriate to stop and 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 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. Do not take Dihydrocodeine Tablets if you:
• are allergic to dihydrocodeine tartrate or to any of the ingredients of this medicine (listed in section 6)
• have difficulty in breathing or any chronic lung disease
• are at risk of blocked intestines
• have a head injury or condition where there is increased pressure in the skull (may cause painful eyes, change in vision or headache behind the eyes)
• are addicted to alcohol
• are having a asthma attack

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Dihydrocodeine Tablets if you have:

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

• ever been addicted to opioids,

  alcohol, prescription medicines or illegal drugs

• 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
• are feeling unusually light-headed or faint
• inflammation of the pancreas (which causes severe pain in the abdomen and back)
• problems with your gall bladder or bile duct
• heart problem after long-term lung disease (cor pulmonale)
• a condition where your breathing stops for short periods whilst you are asleep, known as sleep apnoea.
• you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine.

Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.

Sleep-related breathing disorders

Dihydrocodeine Tablets can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.

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

Tolerance, dependence and addiction

This medicine contains dihydrocodeine which is an opioid medicine. It can cause dependence and/or addiction.

Repeated use of opioids can result in the drug being less effective (you become accustomed to it, known as tolerance). Repeated use of Dihydrocodeine Tablets can also lead to dependence, abuse and addiction, which may result in

life-threatening overdose. The risk of these side effects can increase with a higher dose and longer duration of use.

Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent on or addicted to Dihydrocodeine Tablets if:

• You or anyone in your family have ever abused or been dependent on alcohol, prescription medicines or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses. If you notice any of the following signs whilst taking Dihydrocodeine Tablets, it could be a sign that you have become dependent or addicted:
• You need to take the medicine for longer than advised by your doctor
• You need to take more than the recommended dose
• You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
• You are using the medicine for reasons other than prescribed, for instance, ‘to stay calm’ or ‘help you sleep’
• You have made repeated, unsuccessful attempts to quit or control the use of the medicine
• When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again (‘withdrawal effects’)

If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop taking Dihydrocodeine Tablets).

You may experience hormonal changes while taking these tablets. Your doctor may want to monitor these changes. Children and adolescents

Dihydrocodeine tablets are not

recommended for children under 12 years. Other medicines and Dihydrocodeine Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any that you can buy without a prescription.

This is particularly important if you are taking:

• medicines to treat allergies

  (antihistamines)

• used to treat sickness (cyclizine, metoclopramide or domperidone)

• to treat depression such as monoamine oxidase inhibitors (MAOIs e.g.

  moclobemide, linezolid) or tricyclic antidepressants (e.g. amitriptyline)

• cimetidine used to treat stomach ulcers
• mexiletine used to treat irregular heartbeat
• to aid sleep (hypnotics)
• to treat anxiety (anxiolytics)
• to treat mental illnesses (antipsychotic medicines e.g. chlorpromazine, haloperidol, sulpiride)
• medicines used in anaesthesia (important if you have recently or are about to receive treatment where an anaesthetic may be used)
• medicines used to treat HIV infections (e.g. ritonavir)

• gabapentin or pregabalin to treat epilepsy or pain due to nerve problems

  (neuropathic pain).

Concomitant use of Dihydrocodeine Tablets and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should be only considered when other treatment options are not possible. However if your doctor does prescribe Dihydrocodeine Tablets together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.

Dihydrocodeine Tablets with alcohol

Avoid drinking alcohol while you are taking this medicine as it may make you sleepy.

Pregnancy, breast-feeding and fertility

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. 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. Do not take Dihydrocodeine tablets while you are breast-feeding as dihydrocodeine passes into breast milk and will affect your baby. Driving and using machines

The medicine can affect your ability to drive and operate machinery as it may make you sleepy or dizzy, or may reduce your ability to think clearly, or may cause tingling or numbness in the hands or feet, a spinning sensation, muscle rigidity, visual disturbances, drowsiness, confusion or hallucinations.

• 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 and sodium

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

This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially `sodium-free´.

3. How to take Dihydrocodeine Tablets

Always take this medicine exactly as your doctor has told you.

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. Dihydrocodeine tablets should be used for the shortest duration necessary to relieve symptoms.

Dihydrocodeine tablets should be swallowed with water, and after food. Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Dihydrocodeine Tablets, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also, If you stop taking Dihydrocodeine Tablets.

The recommended dose is:

Adults and children over 12 years: One tablet (30mg) every 4 to 6 hours or as directed by your doctor.

Maximum dose in 24 hours is 180mg (6 tablets).

Elderly: The dose is usually reduced in elderly patients.

Use in children and adolescents For children under 12 years,

not recommended.

Dihydrocodeine Tablets should be used for the shortest duration necessary to relieve symptoms. If no effective pain relief is achieved while taking the medicine, you should seek the advice of a physician. If you take more Dihydrocodeine Tablets than you should

If you or anyone else takes too much of this medicine at the same time, or you think a child may have swallowed any, contact your doctor straight away or go to the nearest hospital casualty department or tell your doctor immediately. Take with you any remaining tablets and the package so that the medicine can be identified. Signs and symptoms of overdose that you might experience are dizziness or lightheaded, pin-point pupils, feeling or being sick, irregular heartbeat.

If you forget to take Dihydrocodeine Tablets

Take your dose as soon as you remember and then your next dose at the usual time. However, if it is almost time for your next dose, skip the missed dose and continue with your normal dosing schedule. Do not take a double dose to make up for a forgotten dose.

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.

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.

Stop taking Dihydrocodeine tablets and contact your doctor or go to a hospital immediately if you experience any of the following:

Uncommon (may affect up to 1 in 100 people):

• breathing more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect 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.

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

• signs of an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing

Other side effects include:

Common (may affect up to 1 in 10 people):

• constipation, feeling or being sick, abdominal pain, dry mouth
• drowsiness.

Uncommon (may affect up to 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
• 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).

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

• feeling elated
• extremely small pupils
• slow or fast heart rate, palpitations
• 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 section 2 ‘Pregnancy and breast-feeding’).
• problem affecting a valve in the intestines (sphincter of Oddi dysfunction).
• symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system (a problem affecting a valve in the intestines known as sphincter of Oddi dysfunction), e.g. severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever.

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 doctor
• 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.

If you notice any of these signs, it is important you talk to your doctor. 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 affects 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 this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.

Keep the tablets in the outer carton in order to protect from light and moisture. Store this medicine in a safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been intended for them.

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 substance (the ingredient that makes the tablets work) is dihydrocodeine tartrate. Each Dihydrocodeine Tablets BP 30mg contains 30mg of dihydrocodeine tartrate.
• The other ingredients are maize starch, lactose, sodium starch glycolate, stearic acid, and magnesium stearate. What Dihydrocodeine Tablets look like and contents of the pack

The tablets are white, round tablets engraved on one side with the company logo and A435 on the other side. This medicine is available in pack sizes of 28, 30, 42, 50, 56, 84, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

Marketing Authorisation Holder and Manufacturer

Crescent Pharma Ltd.,

Key House, Sarum Hill,

Basingstoke, RG21 8SR, UK.

This leaflet was last revised in February 2026.

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