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DYPRACET 30MG / 500MG TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL

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PATIENT INFORMATION LEAFLET
DYPRACET 20 mg/500 mg & DYPRACET 30 mg/500 mg TABLETS
(Dihydrocodeine Tartrate 20 mg or 30 mg & Paracetamol 500 mg)
Read all of this leaflet carefully because it contains important information for you.
1. Keep this leaflet.You may need to read it again.
2. If you have any further questions, ask your doctor or pharmacist.
3. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
4. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
• This medicine contains paracetamol.
• Do not take any other paracetamol containing products.
• Do not exceed the stated dose.
• Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver
damage.
In this leaflet:
1. What are DYPRACET Tablets and what are they used for?
2. Before you take DYPRACET Tablets
3. How to take DYPRACET Tablets
4. Possible side effects
5. Storing DYPRACET Tablets
6. Further information
1. What are DYPRACET Tablets and what are
they used for?
The name of this medicine is DYPRACET 20 mg/500 mg &
DYPRACET 30 mg/500 mg Tablets. These tablets have been
prescribed for you to relieve severe pain over a period of
4 to 6 hours. They contain the active ingredients
dihydrocodeine tartrate and paracetamol which belong to a
group of medicines called strong analgesics or ‘painkillers’.
The other ingredients are listed in section 6 of this leaflet.

2. B
 efore you take DYPRACET Tablets
Do not take DYPRACET Tablets if you are:
• Are allergic (hypersensitive) to dihydrocodeine,
paracetamol or any of the other ingredients of the tablets
(see section 6 ‘Further Information’);
• Have breathing problems, such as breathing more slowly
or weakly than expected, or obstructive airways disease;
• Are having an asthma attack.
Children under 12 years of age should not take these
tablets.
Special Precautions
Check with your doctor or pharmacist before taking your
medicine if you suffer from any of the following:
• Have asthma or any allergies;
• Have an under-active thyroid gland (hypothyroidism);
• Have kidney or long-term liver problems;
• 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;
• Have prostate problems;
• Are addicted to alcohol;
• Are or have ever been addicted to drugs.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken 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:
• Any other medicines containing paracetamol (you should
not take these tablets if you are already taking another
medicine containing paracetamol);

A1000246_2 V2 Dypracet PIL (Tio).indd 1

• Medicines to help you sleep (for example tranquillisers,
hypnotics or sedatives);
• Medicines to treat psychiatric or mental disorders;
• 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;
• Medicines to treat depression or anxiety;
• Metoclopramide or domperidone to stop you feeling or
being sick;
• Cholestyramine to treat high blood pressure or diarrhoea;
• 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.
Taking DYPRACET 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
If you are pregnant or breastfeeding do not take these
tablets until you have spoken to your doctor.
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
 ow to take DYPRACET Tablets
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.You should check with them if you
are not sure. DYPRACET should be taken orally. The tablets
should be swallowed whole with a glass of water.
Adults and children 12 years or over:
The usual starting dose for adults and children over 12 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.
Do not take these tablets if you are already taking another
medicine containing paracetamol.

15/05/2015 11:11

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:
You should not stop taking these tablets unless your doctor
tells you to. If you want to stop taking your tablets, discuss
this with your doctor first.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. P
 ossible side effects
Like all medicines, DYPRACET Tablets can have side effects,
although not everybody gets them.
To give you an idea of how many patients might get side
effects, they have been listed as very common, common,
uncommon, rare and very rare. These mean the following:
Very common

More than 1 in 10 people.

Common

up to 1 in 10 people.

Uncommon

up to 1 in 100 people.

Rare

up to 1 in 1,000 people.

Very rare

fewer than 1 in 10,000 people.

• Common:
> Most people will have constipation when they take
these tablets.Your doctor can prescribe a laxative to
overcome this problem.
> 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 antivomiting medicine if it continues to be a problem.
> 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.
> Headache and a rash or itchy skin have also been
commonly reported in patients treated with these
tablets.







Uncommon:
> An unpleasant or uncomfortable mood.
> Hallucinations.
> A feeling of dizziness or ‘spinning’.
> Difficulty in passing urine.
> A need to take increasingly higher doses to obtain the
same level of pain relief (tolerance).
> Withdrawal symptoms such as agitation, anxiety, shaking
or sweating upon stopping taking the tablets.

Contact your doctor or pharmacist 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.
As with all strong painkillers, there is a risk you may become
addicted or reliant on these tablets.
Taking a painkiller for headaches too often or for too long
can make your headaches worse.
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: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

5. Storing DYPRACET Tablets
Keep all medicines out of the reach and sight of children.
There are no special storage instructions for DYPRACET
Tablets.
Do not use DYPRACET after the expiry date on the carton,
blister and pot container. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further Information
What DYPRACET Tablets contains:
The active ingredients are paracetamol and dihydrocodeine
tartrate.
Each Dypracet 20 mg/500 mg Tablet contains paracetamol
500 mg and dihydrocodeine tartrate 20 mg.
Each Dypracet 30 mg/500 mg Tablet contains paracetamol
500 mg and dihydrocodeine tartrate 30 mg.
The tablets also contain microcrystalline cellulose, povidone
K30, colloidal anhydrous silica and magnesium stearate.
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:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK
Manufacturer:
Tiofarma B.V.
Benjamin Franklinstraat 7-9, 3261 LW Oud-Beijerland,
The Netherlands
This leaflet was last approved in May 2015

For information in large print, on tape, on
CD or in Braille, phone +44 (0)1895 627 420.

• Rare:
> nflammation of the pancreas (which causes severe pain
in the abdomen and back).
> Abnormal cells in the blood (blood dyscrasias).
A1000246/2

A1000246_2 V2 Dypracet PIL (Tio).indd 2

15/05/2015 11:11

PATIENT INFORMATION LEAFLET
DYPRACET 20 mg/500 mg & DYPRACET 30 mg/500 mg TABLETS
(Dihydrocodeine Tartrate 20 mg or 30 mg & Paracetamol 500 mg)
Read all of this leaflet carefully because it contains important information for you.
1. Keep this leaflet.You may need to read it again.
2. If you have any further questions, ask your doctor or pharmacist.
3. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms
are the same as yours.
4. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
• This medicine contains paracetamol.
• Do not take any other paracetamol containing products.
• Do not exceed the stated dose.
• Immediate medical advice should be sought in the event of overdosage because of the risk of irreversible liver
damage.
In this leaflet:
1. What are DYPRACET Tablets and what are they used for?
2. Before you take DYPRACET Tablets
3. How to take DYPRACET Tablets
4. Possible side effects
5. Storing DYPRACET Tablets
6. Further information
1. What are DYPRACET Tablets and what are
they used for?
The name of this medicine is DYPRACET 20 mg/500 mg &
DYPRACET 30 mg/500 mg Tablets. These tablets have been
prescribed for you to relieve severe pain over a period of
4 to 6 hours. They contain the active ingredients
dihydrocodeine tartrate and paracetamol which belong to a
group of medicines called strong analgesics or ‘painkillers’.
The other ingredients are listed in section 6 of this leaflet.

2. B
 efore you take DYPRACET Tablets
Do not take DYPRACET Tablets if you are:
• Are allergic (hypersensitive) to dihydrocodeine,
paracetamol or any of the other ingredients of the tablets
(see section 6 ‘Further Information’);
• Have breathing problems, such as breathing more slowly
or weakly than expected, or obstructive airways disease;
• Are having an asthma attack.
Children under 12 years of age should not take these
tablets.
Special Precautions
Check with your doctor or pharmacist before taking your
medicine if you suffer from any of the following:
• Have asthma or any allergies;
• Have an under-active thyroid gland (hypothyroidism);
• Have kidney or long-term liver problems;
• 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;
• Have prostate problems;
• Are addicted to alcohol;
• Are or have ever been addicted to drugs.
If you are not sure if any of the above applies to you, talk to
your doctor or pharmacist before taking this medicine.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken 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:
• Any other medicines containing paracetamol (you should
not take these tablets if you are already taking another
medicine containing paracetamol);

A1000252_2 V2 Dypracet PIL (SP).indd 1

• Medicines to help you sleep (for example tranquillisers,
hypnotics or sedatives);
• Medicines to treat psychiatric or mental disorders;
• 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;
• Medicines to treat depression or anxiety;
• Metoclopramide or domperidone to stop you feeling or
being sick;
• Cholestyramine to treat high blood pressure or diarrhoea;
• 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.
Taking DYPRACET 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
If you are pregnant or breastfeeding do not take these
tablets until you have spoken to your doctor.
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
 ow to take DYPRACET Tablets
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.You should check with them if you
are not sure. DYPRACET should be taken orally. The tablets
should be swallowed whole with a glass of water.
Adults and children 12 years or over:
The usual starting dose for adults and children over 12 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.
Do not take these tablets if you are already taking another
medicine containing paracetamol.

15/05/2015 11:10

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:
You should not stop taking these tablets unless your doctor
tells you to. If you want to stop taking your tablets, discuss
this with your doctor first.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. P
 ossible side effects
Like all medicines, DYPRACET Tablets can have side effects,
although not everybody gets them.
To give you an idea of how many patients might get side
effects, they have been listed as very common, common,
uncommon, rare and very rare. These mean the following:
Very common

More than 1 in 10 people.

Common

up to 1 in 10 people.

Uncommon

up to 1 in 100 people.

Rare

up to 1 in 1,000 people.

Very rare

fewer than 1 in 10,000 people.

• Common:
> Most people will have constipation when they take
these tablets.Your doctor can prescribe a laxative to
overcome this problem.
> 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 antivomiting medicine if it continues to be a problem.
> 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.
> Headache and a rash or itchy skin have also been
commonly reported in patients treated with these
tablets.







Uncommon:
> An unpleasant or uncomfortable mood.
> Hallucinations.
> A feeling of dizziness or ‘spinning’.
> Difficulty in passing urine.
> A need to take increasingly higher doses to obtain the
same level of pain relief (tolerance).
> Withdrawal symptoms such as agitation, anxiety, shaking
or sweating upon stopping taking the tablets.

Contact your doctor or pharmacist 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.
As with all strong painkillers, there is a risk you may become
addicted or reliant on these tablets.
Taking a painkiller for headaches too often or for too long
can make your headaches worse.
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: www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide more
information on the safety of this medicine.

5. Storing DYPRACET Tablets
Keep all medicines out of the reach and sight of children.
There are no special storage instructions for DYPRACET
Tablets.
Do not use DYPRACET after the expiry date on the carton,
blister and pot container. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. Further Information
What DYPRACET Tablets contains:
The active ingredients are paracetamol and dihydrocodeine
tartrate.
Each Dypracet 20 mg/500 mg Tablet contains paracetamol
500 mg and dihydrocodeine tartrate 20 mg.
Each Dypracet 30 mg/500 mg Tablet contains paracetamol
500 mg and dihydrocodeine tartrate 30 mg.
The tablets also contain microcrystalline cellulose, povidone
K30, colloidal anhydrous silica and magnesium stearate.
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:
Auden Mckenzie (Pharma Division) Ltd.
Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, UK
Manufacturer:
Surepharm Services Limited
Unit 2H, Bretby Business Park, Ashby Road East, A50 Bretby,
Burton Upon Trent, Staffordshire, DE15 0YZ, UK
This leaflet was last approved in May 2015

For information in large print, on tape, on
CD or in Braille, phone +44 (0)1895 627 420.

• Rare:
> Inflammation of the pancreas (which causes severe pain
in the abdomen and back).
> Abnormal cells in the blood (blood dyscrasias).
A1000252/2

A1000252_2 V2 Dypracet PIL (SP).indd 2

15/05/2015 11:10

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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