DIHYDROCODEINE TABLETS BP 30 MG - patient leaflet, side effects, dosage

Patient leaflet - DIHYDROCODEINE TABLETS BP 30 MG

Dihydrocodeine 30mg tablets

This medicine is an opioid, which can cause addiction.You can get withdrawal symptoms if you stop taking it suddenly.

Read all ofthis 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 Dihydrocodeine tablets are and what they are used for
2

What you need to know before you take Dihydrocodeine tablets

| 3|How to take Dihydrocodeine tablets

Possible side effects

How to store Dihydrocodeine tablets

Contents of the pack and other information

1 What Dihydrocodeine tablets are and what they are used for

This medicine has been prescribed for you for relief of moderate to severe pain, such as: the pain of 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.
are allergic to dihydrocodeine or any of the other ingredients of this medicine (listed in section 6)
have difficulty breathing, or other chronic lung disease
have a head injury or a condition where there is increased pressure in the skull (may cause painful eyes, change in vision or headache behind the eyes)
are having an asthma attack
are alcohol dependant
are at risk of blocked intestines.

Warnings and precautions

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

have kidney or liver problems
have low blood pressure or are in shock

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have suffered with allergies
have an underactive thyroid gland
have an enlarged prostate gland and have difficulty urinating and are male
are weak due to illness
have adrenal gland insufficiency (symptoms include: low blood

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

have reduced lung capacity (e.g. asthma or other conditions causing breathing difficulties)
have a convulsive disorder (suffer from spasms/seizures)
have inflammation or blockage in the bowel (symptoms may include constipation, diarrhoea, abdominal pain/discomfort)
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.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your doctor should have explained howlong 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.

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, especially medicines:

treating allergies (antihistamines)
used to treat sickness (cyclizine, metoclopramide or domperidone)
to aid sleep (hypnotics)
treating anxiety (anxiolytics)
treating depression such as monoamine oxidase inhibitors (MAOIs e.g. moclobemide, linezolid) or tricyclic antidepressants (e.g. amitriptyline)
treating 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 are about to receive treatment where an anaesthetic may be used)
used to treat HIV infections (e.g. ritonavir).

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 lifethreatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor does prescribe Dihydrocodeine tablets together with sedative medicines

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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 doctors 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 and alcohol

Alcohol should be avoided whilst taking Dihydrocodeine tablets.

Pregnancy and breast-feeding

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

Dihydrocodeine tablets may reduce your ability to think clearly. 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 doctor 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

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

3 how to take dihydrocodeine tablets

Always take this medicine exactly as your doctor or pharmacist 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 swallowed with water, and after food.

The recommended dose is:

Adults and children over 12 years: One tablet (30mg) every 4 to 6 hours when necessary. Maximum dose in 24 hours is 180mg (6 tablets).
Children under 12 years: Not recommended.
Elderly: Dosage is usually reduced in the elderly.

If you take more Dihydrocodeine tablets than you should

If you (or someone else) swallow too many 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.

If you forget to take Dihydrocodeine 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 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 immediately or go to your nearest emergency department if you notice the below serious side effects:

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
hallucinations (seeing or hearing things that are not real), fainting.

Other side effects:

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

rash, itchy skin, irregular raised patches, sweating, flushed face
drowsiness, changes of mood, confusion, sexual dysfunction, feeling elated
‘spinning’ sensation, dizziness, headache, ‘pins and needles’ slow and shallow breathing, muscle rigidity
blurred or double vision, extremely small pupils
slow or fast heart rate, palpitations, low blood pressure
constipation, feeling or being sick, abdominal pain, dry mouth
biliary spasm (causing pain in the right side of your abdomen, particularly after eating a meal, which may spread towards your right shoulder)
pain and difficulty in passing urine and less frequent to do so
water retention (oedema)
dependence and addiction (see section “How do I know if I am addicted?”).

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.

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 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 tablets

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month.

Store below 25°C in a dry place, protected from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no J 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 30mg of dihydrocodeine tartrate.
The other ingredients are colloidal silica, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose (E460).

What Dihydrocodeine tablets look like and contents of the pack

Dihydrocodeine are white, uncoated tablets.

Pack sizes are 28, 30 and 100 tablets.

Marketing Authorisation Holder and Manufacturer

Accord, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in April 2021.