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DIPIPANONE/CYCLIZINE 10 MG/30 MG TABLETS

Active substance(s): CYCLIZINE HYDROCHLORIDE / DIPIPANONE HYDROCHLORIDE

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This artwork is Not Technically Approved
and technical approval needs to be taken,
from the CMO, before Implementation.

Page 1
Package leaflet: Information for the patient
102447/LF/029/07

28033236

DiconalTM 10 mg + 30 mg Tablets
Dipipanone hydrochloride 10 mg and Cyclizine hydrochloride 30 mg

Read all of this 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.

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What is in this leaflet:
1. What Diconal 10 mg + 30 mg Tablets are and what they are used for
2. What you need to know before you take Diconal 10 mg + 30 mg Tablets
3. How to take Diconal 10 mg + 30 mg Tablets
4. Possible side effects
5. How to store Diconal 10 mg + 30 mg Tablets
6. Contents of the pack and other information
1. WHAT DICONAL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Diconal 10 mg + 30 mg Tablets (will be referred
to as Diconal Tablets throughout the leaflet). Diconal Tablets contain the active
ingredients dipipanone hydrochloride and cyclizine hydrochloride. Dipipanone
hydrochloride belongs to a group of medicines called opioid analgesics and is
used for pain relief. Cyclizine hydrochloride belongs to a group of medicines
called anti-emetics which reduce any nausea and vomiting that may occur.
Diconal Tablets are used to relieve moderate to severe pain and nausea in certain
medical or surgical situations.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DICONAL TABLETS
Do not take Diconal Tablets if you:
• are allergic to dipipanone hydrochloride, cyclizine hydrochloride or any of the
other ingredients in Diconal Tablets (allergic reactions include mild symptoms
such as itching and/or rash. More severe symptoms include swelling of the
face, lips, tongue and/or throat with difficulty in swallowing or breathing);
• have any lung disease (such as bronchitis), difficulty in breathing, or have
excessive phlegm;
• suffer from any obstructive airway disease;
• are having an asthma attack;
• suffer from heart failure as a result of chronic lung disease;
• are addicted to, or often drink large amounts of, alcohol;
• have recently suffered any head injury or have been told that you have raised
pressure around your brain;
• are taking, or have recently taken (within the last 14 days) a medicine from a
group of anti depressants called monoamine oxidase inhibitors (MAOIs);
• have a bowel disorder such as ulcerative colitis;
• are at risk of paralytic ileus (a condition where there is inactivity or paralysis
within the bowel which stops the passage of material within the intestine);
• suffer from abdominal pain/ spasm (spasms of the biliary tract and/or renal
tract). Do not take Diconal Tablets immediately after having abdominal
surgery (biliary tract surgery);
• are about to undergo surgery or have had surgery within the past 24
hours;
• have severe liver or kidney problems.
Warnings and precautions
Take special care with Diconal Tablets. Talk to your doctor or
pharmacist before taking Diconal Tablets if you:
• have previously been dependent on opioid painkillers or other
similar substances;
• are in a weakened or debilitated state;
• suffer from involuntary muscle movement (convulsive disorders);
• have suffered from alcohol withdrawal symptoms;
• have any problems with your thyroid, adrenal or pituitary glands;
• are a man with an enlarged prostate gland;
• are suffering from shock;
• have diabetes;
• suffer from an immune disorder characterised by muscle weakness
(myasthenia gravis);
• have low blood pressure due to loss of blood or fluids;

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• suffer from pancreatitis (which can cause severe pain in the abdomen or
back);
• suffer from an obstructive disease affecting the stomach and intestines;
• suffer from an inflammatory bowel disorder;
• have a disease affecting the series of passageways that carry bile into the
intestines;
• have difficulty breathing (impaired respiratory function);
• have difficulty passing urine (urinary retention);
• have severe heart failure;
• have been told you have a rare condition called porphyria (a blood disease);
• suffer from an eye disease caused by a rise of pressure within the eye
(glaucoma);
• have a tumour of the adrenal gland (phaeochromocytoma).
If any of these apply to you, or if you are not sure, tell your doctor before
taking Diconal Tablets.
Other medicines and Diconal Tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription. This is
especially important if you are taking:
• medicines for problems such as depression, anxiety or psychosis, or are
taking a sedative (usually to treat insomnia);
• gabapentin (to treat epilepsy or nerve pain);
• medicines used to relieve high blood pressure;
• muscle relaxants;
• pethidine (used in the treatment of pain);
• mexiletine (used in the treatment of heart rhythm disorders);
• metoclopramide (used in the treatment of nausea and vomiting);
• monoamine oxidase inhibitors (see section ‘Do not take…’);
• cimetidine (used in the treatment of heartburn and ulcers);
• any medicines which belong to a group of medicines called anticholinergic
medicines. This may be for Parkinson’s disease, asthma etc. Check with your
doctor if you are not sure;
• aminoglycoside antibiotics, such as gentamicin (used in the treatment of
infections);
• a medicine called dexamphetamine (used to treat narcolepsy or attention
deficit disorder);
• diuretics (used to promote urine production);
• hydroxyzine (used to relieve anxiety caused by some mental disorders);
• propranolol (used in the treatment of high blood pressure or anxiety);
• St John’s Wort (a herbal medication used in the treatment of depression);
• ritonavir (used in the treatment of HIV and AIDS).
Diconal Tablets may also interfere with some laboratory tests performed by your
doctor.
Taking Diconal Tablets with food and drink
Do not drink alcohol while taking Diconal Tablets, as the tablets can increase the
effects of alcohol.
Pregnancy and breast-feeding
If you are pregnant or thinking of becoming pregnant, please talk to you doctor
before taking Diconal Tablets. You should not breast-feed whilst you are taking
Diconal Tablets.
Driving and using machines
Diconal Tablets may make you feel dizzy or drowsy. If they affect you in
this way, do not drive or operate any machinery.
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
prescriber 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.

Version No.:
Revision No.:
Revision Date:
Product Description:

102419/LF/029/07

Revised by:

1
14-Jun-2017
Diconal Tablets 50’s
Leaflet
102419
UK
Cenexi
AMCo.CRF.355.2015
PR 6565
ADD

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:

148 x 210 mm
28033236
28033236
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Non-Print Colours:

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Min. Font Size:

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PAGE 1 OF 2

This artwork is Not Technically Approved
and technical approval needs to be taken,
from the CMO, before Implementation.

Page 1

28033236

Diconal Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking these tablets.
3. HOW TO TAKE DICONAL 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.
The recommended dosage for adults is one tablet taken every 6 hours.
Swallow your tablets whole with water.
Your doctor may change your dose depending on your response and how severe
your pain is.
Do not exceed the recommended dose.
Treatment with Diconal should not be withdrawn suddenly, particularly if the
medicine has been used by the patient for a long time. The use of the drug
should be gradually withdrawn to avoid unnecessary side effects.
Use in children
Diconal Tablets are rarely used in children. No guidelines can be given on the
recommended dose for children.
Older people
Diconal Tablets may cause confusion in this age group. Careful monitoring is
advised.
If you take more Diconal Tablets than you should
Symptoms of overdose include difficulty breathing, slower or faster heartbeat,
pin point pupils, low blood pressure, drowsiness, dry mouth, nose and throat,
blurred vision, difficulty passing urine, dizziness, lack of balance and
coordination, weakness, excitability, disorientation, impaired judgment,
hallucinations, muscle spasms, involuntary movements, fits, and high
temperature. If you take more Diconal Tablets than you should, contact your
doctor or nearest hospital emergency department immediately. Take the
container and any remaining tablets with you.
If you forget to take Diconal Tablets
If you forget to take a dose, just take the next dose at the usual time, DO NOT
take a double dose.
If you stop taking Diconal Tablets
If you stop taking Diconal Tablets suddenly you may experience withdrawal
symptoms.
Withdrawal symptoms include: yawning, dilated pupils, tears, a runny nose,
sneezing, muscle tremors, weakness, sweating, anxiety, irritability, disturbed
sleep or inability to sleep, restlessness, decreased appetite, weight loss, feeling
or being sick, diarrhoea, dehydration, an increase in white blood cells, bone
pain, stomach pain and cramps, "goose pimples", increased heart rate, breathing
rate, blood pressure and temperature.
4. POSSIBLE SIDE EFFECTS
Like all medicines Diconal Tablets can cause side effects, although not
everybody gets them.
If you notice:
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness.
tell your doctor immediately. These may be signs of an allergic reaction.
Tell your doctor as soon as possible, if you experience the following:
• feeling very tired, experience unexpected bruising or bleeding, or more
infections (e.g. colds and sore throats) than usual please tell your doctor as
soon as possible, your doctor may decide to conduct tests on your
blood periodically as a result of these symptoms;
• inflammation of the pancreas which causes severe pain in the
abdomen and back;
• decreased consciousness;
• experiencing a loss of contact with reality;
• fits;
• loss of coordination or unusual body movements, particularly of the
hands, arms or legs;
• fatigue, nausea, loss of appetite, or yellow skin or eyes could be due
to inflammation of the liver (hepatitis);
• abdominal pain/spasm could be due to condition known as biliary
pain/spasm.
The side effects of Diconal Tablets may include:
• a dry mouth, nose or throat;
• sweating;
• feeling of weakness;
• generally feeling unwell;
• feeling cold;

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headaches;
facial flushing;
dizziness, light-headedness or vertigo;
low blood pressure/fainting, coma;
high blood presssure;
increased blood pressure within the head;
swelling of the ankles, feet or fingers;
increase in heart rate;
slow or irregular heart beat;
palpitations;
nervousness or restlessness, agitation, confusion and mood changes;
uncomfortable mood or feeling of happiness;
seeing or hearing things that are not really there (hallucinations);
ringing in the ears;
breathing difficulties such as wheezing;
a decreased cough reflex;
itching or nettle rash;
sensitivity to light;
abdominal pain;
constriction of the pupils (small pupils);
blurred vision;
visual disturbances;
feeling sick and being sick;
constipation;
acid reflux;
diarrhoea;
loss of appetite;
indigestion;
taste disturbances;
difficulty or pain in passing water;
difficulty in sleeping;
tiredness or drowsiness;
muscle twitches, spasms or tremors;
a tingling/burning sensation of the skin;
jaundice (yellowing of the skin and whites of the eyes);
blood tests which show changes in the way the liver is working;
difficulty in speaking;
changes in blood counts which may:
- make infections more likely, or
- make the skin pale and cause weakness or breathlessness, or
- increase the risk of bleeding or bruising;
• decreased sex drive;
• erectile dysfunction (in men);
• absence of menstrual periods (in women).
Some people may become tolerant of, or addicted to, this medicine when
treatment continues for a long time.
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. HOW TO STORE DICONAL TABLETS
Keep this medicine out of the sight and reach of children.
Do not use Diconal Tablets after the expiry date shown on the foil or carton. The
expiry date refers to the last day of that month. Store in a dry, safe place
below 25°C. Store in the original package in order to protect from light.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Diconal Tablets contain
The active substances are dipipanone hydrochloride 10 mg and
cyclizine hydrochloride 30 mg. The other ingredients are lactose,
starches, erythrosine (E127), gelatin and magnesium stearate.
What Diconal Tablets look like and contents of the pack
Diconal Tablets are deep pink in colour, scored, coded F3A and are
supplied in blister packs containing 50 tablets.
Marketing Authorisation Holder and Manufacturer responsible for
release:
Amdipharm UK Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was last revised in June 2017.
Amdipharm is licensed to use the trademark.
102419/LF/029/07

28033236

Version No.:
Revision No.:
Revision Date:
Product Description:

102419/LF/029/07

Revised by:

1
14-Jun-2017
Diconal Tablets 50’s
Leaflet
102419
UK
Cenexi
AMCo.CRF.355.2015
PR 6565
ADD

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref.:
Print Colours:

148 x 210 mm
28033236
28033236
N/A
Black

Non-Print Colours:

Cutter

Min. Font Size:

8 pt

Component:
Product Code:
Country:
Vendor Name:
CRF(s):

PAGE 2 OF 2

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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