Package leaflet: Information for the patient Dihydrocodeine 30mg tablets This medicine is an opioid, which can cause • have suffered with allergies addiction. You can get withdrawal symptoms if you • have an underactive thyroid gland stop taking it suddenly. • have an enlarged prostate gland and have difficulty urinating and are male Read all of this leaflet carefully before you start • are weak due to illness taking this medicine because it contains important • have adrenal gland insufficiency (symptoms include: low blood information for you. pressure, low blood sugar, muscle weakness, nausea, vomiting, dizziness, skin discolouration, weight loss) • Keep this leaflet. You may need to read it again. • have reduced lung capacity (e.g. asthma or other conditions causing • If you have any further questions, ask your doctor or breathing difficulties) pharmacist. • have a convulsive disorder (suffer from spasms/seizures) • This medicine has been prescribed for you only. Do • have inflammation or blockage in the bowel (symptoms may include not pass it on to others. It may harm them, even if constipation, diarrhoea, abdominal pain/discomfort) their signs of illness are the same as yours. • are or have ever been addicted to opioids, alcohol, prescription • If you get any side effects, talk to your doctor or medicines or illegal drugs • have previously suffered from withdrawal symptoms such as pharmacist. This includes any possible side effects not agitation, anxiety, shaking or sweating, when you have stopped taking listed in this leaflet. See section 4. alcohol or drugs • feel you need to take more Dihydrocodeine tablets to get the same What is in this leaflet level of pain relief, this may mean you are becoming tolerant to the 1 What Dihydrocodeine tablets are and what 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 they are used for switch you to an alternative pain reliever. 2 What you need to know before you take Taking this medicine regularly, particularly for a long time, can lead to Dihydrocodeine tablets addiction. Your doctor should have explained how long you will be taking 3 How to take Dihydrocodeine tablets it for, when it is appropriate to stop and how to do this safely. 4 Possible side effects Rarely, increasing the dose of this medicine can make you more sensitive 5 How to store Dihydrocodeine tablets to pain. If this happens, you need to speak to your doctor about your treatment. 6 Contents of the pack and other information Addiction can cause withdrawal symptoms when you stop taking this 1 What Dihydrocodeine tablets are and what they are medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), used for increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, This medicine has been prescribed for you for relief of moderate to severe shaking, shivering or sweating. Your doctor will discuss with you how to pain, such as: the pain of sciatica (nerve pain of the leg/back), joint and gradually reduce your dose before stopping the medicine. It is important bone pain (osteoarthritis, rheumatoid arthritis and arthritis of the spine), that you do not stop taking the medicine suddenly as you will be more nerve pain, pain following blood vessel disease, cancer or after operations. likely to experience withdrawal symptoms. It contains dihydrocodeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for Opioids should only be used by those they are prescribed for. Do not you and should not be given to anyone else. Opioids can cause addiction give your medicine to anyone else. Taking higher doses or more frequent and you may get withdrawal symptoms if you stop taking it suddenly. doses of opioid, may increase the risk of addiction. Overuse and misuse Your doctor should have explained how long you will be taking it for, can lead to overdose and/or death. when it is appropriate to stop and how to do this safely. Children and adolescents Dihydrocodeine tablets are not recommended for children under 12 2 What you need to know before you take years. Dihydrocodeine tablets • Do not take for longer than directed by your prescriber Other medicines and Dihydrocodeine tablets • Taking dihydrocodeine regularly for a long time can lead to addiction, Tell your doctor or pharmacist if you are taking, have recently taken or which might cause you to feel restless and irritable when you stop the might take any other medicines, especially medicines: tablets. • treating allergies (antihistamines) • Taking a painkiller for headaches too often or for too long can make • used to treat sickness (cyclizine, metoclopramide or domperidone) them worse. • to aid sleep (hypnotics) • treating anxiety (anxiolytics) Do not take Dihydrocodeine tablets if you: • treating depression such as monoamine oxidase inhibitors (MAOIs e.g. • are allergic to dihydrocodeine or any of the other ingredients of this moclobemide, linezolid) or tricyclic antidepressants (e.g. amitriptyline) medicine (listed in section 6) • treating mental illness (antipsychotic medicines e.g. chlorpromazine, • have difficulty breathing, or other chronic lung disease haloperidol, sulpiride) • have a head injury or a condition where there is increased pressure • such as mexiletine (used to control heart rhythm) in the skull (may cause painful eyes, change in vision or headache • such as cimetidine (to treat stomach ulcers) behind the eyes) • used in anaesthesia (important if you have recently or are about to • are having an asthma attack receive treatment where an anaesthetic may be used) • are alcohol dependant • used to treat HIV infections (e.g. ritonavir). • are at risk of blocked intestines. Concomitant use of Dihydrocodeine tablets and sedative medicines such Warnings and precautions as benzodiazepines or related drugs increases the risk of drowsiness, Talk to your doctor or pharmacist before taking Dihydrocodeine tablets difficulties in breathing (respiratory depression), coma and may be life- if you: threatening. Because of this, concomitant use should only be considered • have kidney or liver problems when other treatment options are not possible. However, if your doctor • have low blood pressure or are in shock does prescribe Dihydrocodeine tablets together with sedative medicines Continued top of next column Continued over page 148x210 Leaflet Reel Fed Profile (BST) Dihydrocodeine Tablets 30mg x 28, 30, 100 (UK) Dihydrocodeine 30mg Tablets PIL - UK JDE No.: 50999094 approved for print/date Item number: BBBB0939 Colours Non Printing Colours Dimensions: 148x210 (Reel Fed) 1. Black 1. Profile Originator: T. Hull Dimensions: 148x210 Component: Leaflet for Blisters Origination Date: 16.03.2021 Min Body Text Size: 7pt 2. 2. Revision Date: 23/03/2021 Supplier: Accord Barnstaple 3. 3. Pharmacode: 4553 Revised By: C.Grant 4. 5. Proof Round n/a Date Sent: 08/03/21 Technical Date sent: 6. 03 Approval Date received: Technologist: T. Hull [email protected] Technically Approved Cartons and label leaflets only (labels only when specified) German GTIN 14 (incorporating PZN): * Please note that only Artwork Studio is permitted to make changes to the above artwork. Version 7 No changes are permitted by any 3rd party other than added notes and mark ups for required changes. 12.02.2020 the dose and duration of concomitant treatment should be limited by your 4 Possible side effects doctor. Tell your doctor about all sedative medicines you are taking and follow Like all medicines, this medicine can cause side effects, although not everybody your doctor’s dose recommendation closely. It could be helpful to inform friends gets them. Please tell your doctor or pharmacist if you notice any of the or relatives to be aware of the signs and symptoms stated above. Contact your following effects or any effects not listed. doctor when experiencing such symptoms. Stop taking Dihydrocodeine tablets and contact your doctor immediately Dihydrocodeine tablets and alcohol or go to your nearest emergency department if you notice the below Alcohol should be avoided whilst taking Dihydrocodeine tablets. serious side effects: Pregnancy and breast-feeding Not known (frequency cannot be estimated from the available data): If you are pregnant or breast-feeding, think you may be pregnant, or are • signs of an allergic reaction such as itchy skin rash, swelling of the face, lips, planning to have a baby, ask your doctor or pharmacist for advice before taking tongue or throat, or difficulty breathing or swallowing this medicine. • hallucinations (seeing or hearing things that are not real), fainting. Do not take Dihydrocodeine tablets if you are pregnant or think you might Other side effects: be pregnant unless you have discussed this with your doctor and the benefits Not known (frequency cannot be estimated from the available data): of treatment are considered to outweigh the potential harm to the baby. If • rash, itchy skin, irregular raised patches, sweating, flushed face you take Dihydrocodeine tablets during pregnancy, your baby may become • drowsiness, changes of mood, confusion, sexual dysfunction, feeling elated dependent and experience withdrawal symptoms after the birth which may • ‘spinning’ sensation, dizziness, headache, ‘pins and needles’, slow and shallow need to be treated. Do not take Dihydrocodeine tablets while you are breathing, muscle rigidity breast-feeding as dihydrocodeine passes into breast milk and will affect your • blurred or double vision, extremely small pupils baby. • slow or fast heart rate, palpitations, low blood pressure Driving and using machines • constipation, feeling or being sick, abdominal pain, dry mouth Dihydrocodeine tablets may reduce your ability to think clearly. Effects such • biliary spasm (causing pain in the right side of your abdomen, particularly as ‘pins and needles’, dizziness, spinning sensations, muscle rigidity, visual after eating a meal, which may spread towards your right shoulder) disturbances, drowsiness, confusion, fainting or hallucinations may occur.