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

1. WHAT DIHYDROCODEINE 30MG TABLETS ARE AND WHAT THEY ARE USED FOR

This medicine has been prescribed for you for analgesia (pain relief). It contains dihydrocodeine tartrate 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 30MG TABLETS

! Do not take for longer than directed by your prescriber ! Taking dihydrocodeine (DHC) 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 30mg Tablets if:

! You are allergic to dihydrocodeine, codeine or any of the

other ingredients of this medicine (listed in section 6) ! You have breathing difficulties or other chronic lung

disease

! You are at risk of blocked intestines (paralytic ileus) ! You are alcohol dependant

! You have a head injury or a condition where there is

increased pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes) ! You are having an asthma attack.

Warnings and precautions

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.

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

Talk to your doctor, pharmacist or nurse before taking Dihydrocodeine 30mg Tablets:

! If you have kidney or liver problems

! If you have low blood pressure or are in shock ! If you have suffered with allergies

! If you have an underactive thyroid gland

! If you have an enlarged prostate gland and have great

difficulty urinating and are male

! If you are weak due to illness

! If you have adrenal gland insufficiency (symptoms include

low blood pressure, low blood sugar, muscle weakness, nausea, vomiting, dizziness, skin discolouration, weight loss)

! If you have reduced lung capacity (e.g. asthma or other

conditions causing breathing difficulties)

! If you have a convulsive disorder (suffer from

spasms/seizures)

! If you have inflammation or blockage in the bowel

(symptoms may include constipation, diarrhoea, abdominal pain/discomfort).

Talk to your prescriber before taking this medicine 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 30mg 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.

! Are elderly

! Are feeling unusually light-headed or faint

! Have inflammation of the pancreas (which causes severe

pain in the abdomen and back)

! Have problems with your gall bladder or bile duct ! 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.

Children and adolescents

For children under 12 years, a more suitable dosage form is recommended.

Other medicines and Dihydrocodeine 30mg Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular medicines:

! Used in treating allergies (antihistamines)

! Used to treat sickness (cyclizine, metoclopramide or

domperidone)

! To aid sleep (hypnotics)

! To treat anxiety (anxiolytics)

! Used to treat depression such as monoamine oxidase

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

! Used to treat mental illness (antipsychotic medicines e.g.

chlorpromazine, haloperidol, sulpiride)

! Such as mexiletine (used to control heart rhythm) ! Such as cimetidine (to treat stomach ulcers) ! Used in anaesthesia (important if you have recently or

about to receive treatment where an anaesthetic may be used)

! Used to treat HIV infections (e.g. ritonavir).

Concomitant use of Dihydrocodeine 30mg 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 only be considered when other treatment options are not possible. However, if your doctor does prescribe Dihydrocodeine 30mg Tablets together with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

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 30mg Tablets with alcohol

Drinking alcohol during your treatment with these tablets may make you sleepy. Alcohol should be avoided whilst taking Dihydrocodeine Tablets.

Pregnancy and breast-feeding

Do not take Dihydrocodeine 30mg 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 30mg 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 30mg Tablets while you are breast-feeding as dihydrocodeine passes into breast milk and will affect your baby.

Driving and using machines

Using Dihydrocodeine 30mg Tablets may affect your ability to drive or operate machinery. Effects such as 'pins and needles', dizziness, spinning sensations, muscle rigidity, visual disturbances, drowsiness, confusion, fainting or hallucinations may occur.

Do not drive or operate machinery if affected.

The 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 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 30mg Tablets contain lactose

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

3. HOW TO TAKE DIHYDROCODEINE 30MG TABLETS

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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Dihydrocodeine 30mg Tablets should be swallowed with water after a meal.

Adults and children over 12 years of age

Recommended dose: one tablet (30mg) every 4 to 6 hours

when necessary. Maximum dose in 24 hours is 180mg

(6 tablets).

Children under 12 years of age

Not recommended.

Elderly

Dosage is usually reduced in the elderly.

If you take more Dihydrocodeine 30mg Tablets than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include; very small pupils, feeling or being sick, feeling dizzy or lightheaded, irregular heartbeat.

It is important that you take your tablets as stated on the pharmacist's label or as advised by your doctor. You should use only as much as your doctor recommends.

If you forget to take Dihydrocodeine 30mg Tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Dihydrocodeine 30mg 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.

Stop taking Dihydrocodeine 30mg Tablets and contact your doctor immediately or go to your nearest emergency department if you notice the below serious side effects: 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:

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 30mg Tablets in pregnancy (see section 2 'Pregnancy and breast-feeding').

Drug Withdrawal

When you stop taking Dihydrocodeine 30mg 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 30mg 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 Yellow Card Scheme at: or search for

www.mhra.gov.uk/yellowcard 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 DIHYDROCODEINE 30MG 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 label or side of the box. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light.

Do not use this medicine if you notice any visible signs of deterioration.

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 30mg Tablets contain

The active substance is dihydrocodeine tartrate. Each tablet contains 30mg of dihydrocodeine tartrate.

The other ingredients are: maize starch, polyvinylpyrrolidone, lactose (see section 2), sodium starch glycollate, magnesium stearate and colloidal silicon dioxide.

What Dihydrocodeine 30mg Tablets looks like and contents of the pack

The tablets are round, white coloured tablets with a flat bevel-edge, with 30 on one side and plain on the other side.

The tablets are available in securitainers with pack sizes: 25, 50, 100, 250, 500, 1000.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Ennogen IP Ltd

Unit G4, Riverside Industrial Estate,

Riverside Way, Dartford, DA1 5BS, UK.

Manufacturer

Clonmel Healthcare Limited

Waterford Road, Clonmel, Co Tipperary

Republic of Ireland

This leaflet was last revised in January 2026.

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