Skip to Content

REMEDEINE FORTE TABLETS

Active substance(s): DIHYDROCODEINE TARTRATE / PARACETAMOL DC (PVP)

View full screen / Print PDF » Download PDF ⇩
Transcript
If you forget to take &RG\GUDPRO 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 &RG\GUDPRO 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 medicine, ask
your doctor or pharmacist.

Page 15

67 x 60

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
All medicines can cause allergic reactions, although serious allergic
reactions are rare. Tell your doctor immediately if you get any sudden
wheeziness, difficulties in breathing, swelling of the eyelids, face or
lips, rash or itching especially those covering your whole body.
As with all strong painkillers, there is a risk you may become
addicted or reliant on these tablets.

Page 16

68 x 60

Taking a painkiller for headaches too often or for too long can make
your headaches worse.
Common side effects (Probably affecting more than 1 in 100 people
taking these tablets)
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 anti-vomiting medicine if it continues to be a problem.

Page 17

70 x 60

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.
The following side effects have also been commonly reported in
patients treated with these tablets:
• Headache.
• Rash or itchy skin.

Page 18

70 x 60

Uncommon side effects (Probably affecting fewer than 1 in 100
people taking these tablets)
• An unpleasant or uncomfortable mood.
• Hallucinations.
• Afeeling of dizziness or ‘spinning’.
• Difficulty in passing urine.
• Aneed 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.

Page 19

70 x 60

Rare side effects (Probably affecting fewer than 1 in 1,000 people
taking these tablets)
• Inflammation of the pancreas (which causes severe pain in the
abdomen and back).
• Abnormal cells in the blood (blood dyscrasias).
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: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information on
the safety of this medicine.
Page 20

70 x 60

5. How to store &RG\GUDPRO tablets
Keep this medicine out of the sight and reach of children.
Do not use any tablets after the expiry date which is stated on the
carton. EXP 08 2010 means that you should not take the tablets after
the last day of that month i.e.August 2010.
Do not store your tablets above 30ºC. Keep the bottle tightly closed
to protect the tablets from moisture.
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.

Page 21

71 x 60

What &RG\GUDPRO tablets contain
The active ingredients are paracetamol and dihydrocodeine tartrate.
Each&RG\GUDPRO PJtablet contains 500 mg of
paracetamol and 20mg of dihydrocodeine tartrate.
Each &RG\GUDPRO PJtablet contains 500mg of
paracetamol and 30 mg of dihydrocodeine tartrate.
The other ingredients are:

What &RG\GUDPRO tablets look like and the contents of the
pack
&RG\GUDPRO PJtablets are white and marked PD/20.
&RG\GUDPRO PJ tablets are white and marked PD/30.
In each bottle there are 56 or 112 tablets.

Marketing Authorisation Holder

This leaflet was last revised in $XJXVW 

Crescent Pharma Limited,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants, RG25 3ED
0DQXIDFWXUHU
Surepharm Services Ltd, Bretby,
Burton upon Trent, Staffs, DE15 OYZ, UK.

• Magnesium stearate
• Maize starch

CO-DYDRAMOL
30/500mg

This leaflet is available in large print,
Braille or as an audio CD. To request
a copy, please call Crescent Pharma
Limited on:

01256-772730

&RG\GUDPRO7DEOHWVVKRXOGEHWDNHQGXULQJRUDIWHUPHDOV

You will need to give details of the
product name: $PEZESBNPM tablets.
L3892
M0198TB

Page 22

71 x 60

Page 23

71 x 60

Page 24

71 x 60

Page 25

73 x 60

Page 26

73 x 60

Page 1

75 x 60

Package Leaflet:
Information for the user
&RG\GUDPROPJ
PJ7DEOHWV
Paracetamol and
Dihydrocodeine tartrate

Page 2

75 x 60

Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
• 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.

Page 3

73 x 60

In this leaflet:
 What &RG\GUDPRO tablets are and what they are used for
 Before you take &RG\GUDPRO tablets
 How to take &RG\GUDPRO tablets
 Possible side effects
 How to store &RG\GUDPRO tablets
 Further information

Page 4

73 x 60

1. What &RG\GUDPRO tablets are and ZKDW WKH\ DUH
used for
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 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.

Page 5

71 x 60

2. Before you take &RG\GUDPRO tablets
Do not take &RG\GUDPRO tablets if you:
• 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.

Page 6

71 x 60

Take special care with &RG\GUDPRO tablets
Before treatment with these tablets tell your doctor or pharmacist if
you:

• have prostate problems;
• are addicted to alcohol;
• are or have ever been addicted to drugs.






Taking other medicines
Tell your doctor or pharmacist if you are taking:
• any other medicines containing paracetamol (you should not take
these tablets if you are already taking another medicine containing
paracetamol);
• medicines to help you sleep (for example tranquillisers, hypnotics
or sedatives);
• medicines to treat psychiatric or mental disorders;

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;

Page 7

71 x 60

Page 8

71 x 60

• a type of medicine known as a monoamine oxidase inhibitor
(examples include tranylcypromide, phenelzine, isocarboxazid,
moclobemide 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;
• colestyramine to treat high blood pressure or diarrhoea;
• medicines such as warfarin to prevent your blood clotting or to
help thin your blood.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription. If you take these tablets with some other
Page 9

70 x 60

medicines, the effect of these tablets or the other medicine may be
changed.
Other special warnings:
• 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 taking the tablets.
• Taking a painkiller for headaches too often or for too long can
make them worse.
Taking &RG\GUDPRO with alcohol
Drinking alcohol during your treatment with these tablets may make
you sleepy. If you are affected you should avoid drinking alcohol.
Page 10

70 x 60

Pregnancy and breastfeeding
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. This medicine can affect your
ability to drive. Do not drive whilst taking this medicine until you
know how this medicine affects you. It may be an offence to
drive if your ability to drive safely is affected. There is further
information for patients who are intending to drive in Great
Britain - go to https://www.gov.uk/drug-driving-law.
Page 11

70 x 60

3. How to take &RG\GUDPRO tablets
Two different strengths of tablets are available. Your doctor will
decide which strength of tablet will suit you best.
Always take these tablets exactly as your doctor has told you. The
label on your medicine will tell you how many tablets to take and
how often. Do not take for longer than directed by your doctor. You
should check with your doctor or pharmacist if you are not sure.
Swallow your tablets whole with a glass of water.

Page 12

70 x 60

The usual starting dose for adults and children over 12 years of age
is one or two tablets every 4 to 6 hours. If you are elderly your doctor
may suggest a lower starting dose.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.

Page 13

68 x 60

If you take more &RG\GUDPRO tablets than youshould or if
someone accidentally swallows your tablets
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. Talk to
a doctor at once if you take too much of this medicine even if you
feel well. This is because too much paracetamol can cause delayed,
serious liver damage. When seeking medical attention make sure that
you take this leaflet and any remaining tablets with you to show the
doctor.

Page 14

67 x 60

CO-DYDRAMOL
30/500mg

CO-DYDRAMOL
30/500mg

Job No.: 301284 Date:
12th August 2015
PROOF 3 100%

5 017123 121210

&RG\GUDPRO7DEOHWVVKRXOGEHWDNHQGXULQJRUDIWHUPHDOV

Colour Reference:

L3892
M0198TB

24

Base Page

Base Label:

60mm x 111mm

Leaflet Page 1:

60mm x 75mm

Label Code L3892

Right Hand Opening

■ ■ ■ ■ ■

Overall Leaflet Size:

199

280

339

286

Black

Page Widths:

75



&RG\GUDPRO7DEOHWVVKRXOGEHWDNHQGXULQJRUDIWHUPHDOV

60 x 920
73

73

71

71

71

71

70

70

70

70

68

67

L3892
M0198TB

75 x 60

12

Page 1

75 x 60

CO-DYDRAMOL
30/500mg

CO-DYDRAMOL
30/500mg

Job No.: 301284 Date:
12th August 2015
PROOF 3 100%

5 017123 121210

&RG\GUDPRO7DEOHWVVKRXOGEHWDNHQGXULQJRUDIWHUPHDOV

Colour Reference:

L3892
M0198TB

24

Base Page

Base Label:

60mm x 111mm

Leaflet Page 1:

60mm x 75mm

Label Code L3892

Right Hand Opening

■ ■ ■ ■ ■

Overall Leaflet Size:

199

280

339

286

Black

Page Widths:

75



&RG\GUDPRO7DEOHWVVKRXOGEHWDNHQGXULQJRUDIWHUPHDOV

60 x 920
73

73

71

71

71

71

70

70

70

70

68

67

L3892
M0198TB

75 x 60

12

Page 1

75 x 60

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.

Hide