Patient leaflet - DYPRACET 20 MG / 500 MG TABLETS
2. What you need to know before you take DYPRACET Tablets
3. How to take DYPRACET Tablets
4. Possible side effects
5. How to store DYPRACET Tablets
6. Contents of the pack and other information
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1. What DYPRACET Tablets are and what they are used for
The name of this medicine is DYPRACET 20 mg/500 mg & DYPRACET 30 mg/500 mg Tablets.
This medicine has been prescribed for you to relieve severe pain over a period of 4 to 6 hours. It contains paracetamol and 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 doctor should have explained how long you will be taking it for, when it is appropriate to stop and how to do this safely.
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2. B
2. what you need to know before you take dypracet tablets
Do not take DYPRACET Tablets if you:
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– Are allergic to dihydrocodeine, paracetamol or any of the other ingredients of this medicine (listed in section 6)
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– Have breathing problems, such as breathing more slowly or weakly than expected, or obstructive airways disease
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– Are having an asthma attack
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– Children under 12 years of age should not take these tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking your DYPRACET Tablets if you suffer from any of the following:
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– Have asthma or any allergies
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– Have an under-active thyroid gland (hypothyroidism)
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– Have kidney or long-term liver problems
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– Have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is
because the tablets may make these symptoms worse or hide the extent of a head injury
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– Have prostate problems
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– Are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs
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– Have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking
alcohol or drugs
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– Feel you need to take more DYPRACET 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.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine.
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.
Other medicines and DYPRACET Tablets
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 some medicines together can be harmful.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
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– Any other medicines containing paracetamol (you should not take these tablets if you are already taking another medicine containing paracetamol)
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– Medicines to help you sleep (for example tranquillisers, hypnotics or sedatives)
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– Medicines to treat psychiatric or mental disorders
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– A type of medicine known as a monoamine oxidase inhibitor (examples include tranylcypromide, phenelzine, isocarboxazid, moclobamide and linezolid), or you have taken this type of medicine in the last two weeks
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– Medicines to treat depression or anxiety
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– Metoclopramide or domperidone to stop you feeling or being sick
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– Cholestyramine to treat high blood pressure or diarrhoea
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– Medicines such as warfarin to prevent your blood clotting or to help thin your blood. If you are unsure of the types of medicines you
are taking, ask your doctor or pharmacist.
Concomitant use of DYPRACET 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 DYPRACET 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.
DYPRACET Tablets with alcohol
Drinking alcohol during your treatment with these tablets may make you sleepy. If you are affected you should avoid drinking alcohol.
Pregnancy and breast feeding
Do not take DYPRACET 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 use DYPRACET Tablets during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Do not take DYPRACET Tablets while you are breastfeeding as dihydrocodeine tartrate passes into breast milk and will affect your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may feel sleepy when taking these tablets. If you are affected you should not drive or use machinery. 3. H
3. how to take dypracet tablets
Your doctor 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.
Two different strengths of tablets are available. Your doctor will decide which strength of tablet will suit you best.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
DYPRACET Tablets should be taken orally. The tablets should be swallowed whole with a glass of water.
Do not take these tablets if you are already taking another medicine containing paracetamol.
Adults:
The recommended starting dose for adults over 18 years of age is one or two tablets every 4 to 6 hours.
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.
Do not take more than eight tablets in 24 hours.
Adolescents 16–18 years:
The recommended starting dose for adolescents aged between 16 and 18 years is one or two tablets every 6 hours as needed.
Do not take more than eight tablets in 24 hours.
Children 12–15 years:
The recommended starting dose for children aged between 12 and 15 years is one tablet every 6 hours as needed.
Do not take more than four tablets in 24 hours.
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.
Elderly
If you are elderly your doctor may suggest a lower starting dose.
Children under 12 years of age:
This product should not be taken by children under 12 years of age.
If you take more DYPRACET Tablets than you should
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy and sick, and have abdominal pain. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. You should contact your doctor immediately even if you feel well as there is a risk of serious liver damage.
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 DYPRACET Tablets
If you miss a dose you should take it as soon as you remember and then carry on as before. Do not take a double dose to make up for a forgotten tablet.
If you stop taking DYPRACET 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 effect
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body as these may indicate an allergy to the product
Other side effects
Common side effects (may affect up to 1 in 10 people)
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– Most people will have constipation when they take these tablets. Your doctor can prescribe a laxative to overcome this problem
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– You may feel sick or vomit (be sick) when you take your tablets, this should normally wear off after a few days however your doctor
can prescribe an anti-vomiting medicine if it continues to be a problem
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– You may find that you feel more sleepy than normal when you start taking your tablets or when your dose is increased. This should wear off after a few days
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– Headache and a rash or itchy skin have also been commonly reported in patients treated with these tablets.
Uncommon side effects (may affect up to 1 in 100 people)
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– An unpleasant or uncomfortable mood
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– Hallucinations
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– A feeling of dizziness or ‘spinning’
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– Difficulty in passing urine
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– A need to take increasingly higher doses to obtain the same level of pain relief (tolerance)
Rare side effects (may affect up to 1 in 1,000 people)
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– Inflammation of the pancreas (which causes severe pain in the abdomen and back)
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– Abnormal cells in the blood (blood dyscrasias).
Unknown frequency side effects
Dependence and addiction (see section ‘How do I know if I am addicted?’).
Taking a painkiller for headaches too often or for too long can make your headaches worse.
Drug Withdrawal
When you stop taking DYPRACET 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 DYPRACET Tablets, it could be a sign that you have become addicted.
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– You need to take the medicine for longer than advised by your doctor
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– You feel you need to use more than the recommended dose
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– You are using the medicine for reasons other than prescribed
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– 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: ) 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 dypracet tablets
Keep this medicine out of the sight and reach of children.
There are no special storage instructions for DYPRACET Tablets.
Do not use this medicine after the expiry date which is stated on the carton, blister and pot container. The expiry date refers to the last day of that month.
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. Further Information
6. contents of the pack and other information
What DYPRACET Tablets contains
The active substances are paracetamol and dihydrocodeine tartrate.
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– Each Dypracet 20 mg/500 mg Tablet contains paracetamol 500 mg and dihydrocodeine tartrate 20 mg.
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– Each Dypracet 30 mg/500 mg Tablet contains paracetamol 500 mg and dihydrocodeine tartrate 30 mg.
What DYPRACET looks like and contents of the pack
DYPRACET 20 mg/500 mg Tablets are oblong, white tablets, 19 mm x 7 mm long with the marking ‘P500 D20’ on one side.
DYPRACET 30 mg/500 mg Tablets are oblong, white tablets, 19 mm x 7 mm long with the marking ‘P500 D30’ on one side.
DYPRACET 20 mg/500 mg Tablets are available in pots of 56 or 112 tablets and blisters of 56 or 112 tablets.
DYPRACET 30 mg/500 mg Tablets are available in pots of 56 tablets and blisters of 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex
HA1 4HF
United Kingdom
Manufacturer
Tiofarma B.V.
Benjamin Franklinstraat 7–9,
3261 LW Oud-Beijerland,
The Netherlands
This leaflet was last revised in March 2020