DF 118 FORTE 40MG
Active substance(s): DIHYDROCODEINE TARTRATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
DF118 FORTE 40mg Tablet
Dihydrocodeine Tartrate
D02718
Read all of this leaflet carefully before you use
DF1 18 FORTE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or pharmacist.
• This medicine has been prescribed for you personally and
you must not pass it onto 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.
In this leaflet:
1. What DF1 18 FORTE is and what it is used for
2. Before you take DF118 FORTE
3. How to take DF118 FORTE
4. Possible side effects
5. Storing DF118 FORTE
6. Further information
1. What DF118 FORTE is and what it is used for
Dihydrocodeine is an alkaloid with powerful pain relieving
properties. This medicine is used for the relief of severe and longlasting pain.
2. Before you take DF118 FORTE
You should not take DF118 FORTE if:
• you are allergic (hypersensitive) to Dihydrocodeine or any
of the ingredients of this medicine (listed in section 6 and
‘Important information about some of the ingredients, column
2).
• you are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors (MAO|’s)
(see ‘Taking other medicines)
• you suffer from breathing difficulties, for example acute
asthma attacks
• you are suffering from severe headaches or have suffered a
head injury
• you suffer from alcoholism
• you suffer from heart problems after a lung disease
• you are suffering from stomach pains
• you are suffering from a problem that could cause paralysis of
the small intestine (paralytic ileus)
• you have a tumour of the adrenal gland known as
phaeochromocytoma
Take special care with DF118 FORTE
Tell your doctor if:
• you suffer from asthma
• you have an underactive thyroid gland
• you suffer from low blood pressure
• you have liver or kidney problems
• you suffer from a convulsive disorder (fits) such as epilepsy
• you have any prostate problems
• you have any breathing or lung problems or a productive
cough
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained without
prescription.
DF118 FORTE must not be used with drugs used to treat severe
depression, such as phenelzine or moclobemide, or if you are
within 2 weeks ofdiscontinuing them. These drugs are known as
Monoamine Oxidase Inhibitors (MAOl’s).
Other medicines which may interact with DF118 FORTE include:
• medicines for sleeping problems and anxiety, such as chloral,
diazepam, and barbiturates.
• CNS depressants (drugs that act on the brain to cause
drowsiness)
• ciprofloxacin, a drug used to prevent and treat bacterial
infections
• alcohol
Taking DF118 FORTE with food and drink
DF118 FORTE should be taken with or after food. You are advised
not to drink alcohol while being treated with Dihydrocodeine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or you are
breast-feeding, you should consult your doctor before taking
DF118 FORTE.
Driving and using machines
This medicine can affect your ability to drive and operate
machinery. Do not drive or operate machinery if you feel drowsy
or cannot think clearly.
This 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
Continued overleaf
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Important information about some of the ingredients
If you have been told by your doctor that you have an
intolerance to some sugars (lactose), contact your doctor before
taking this medicinal product.
3. How to take DF118 FORTE
Your doctor will decide on the dose and duration of your
therapy.
Always follow the instructions of your doctor and pharmacist.
This medicine is for oral use.
Adults and elderly: One or two tablets three times daily taken
with or after food up to a maximum of 6 tablets per day.
Children under 12 years: Not recommended.
If you forget to take DF118 FORTE
If you have missed a dose take it as soon as you remember unless
it is nearly time for your next dose. Then continue your normal
dose times. Do not take a double dose.
If you take more DF118 FORTE than you should
If you take too much of your medicine seek immediate medical
advice from your doctor or your nearest hospital. Symptoms
ofan overdose include sudden or unexpected difficulty in
breathing, pin-point pupils or a drop in blood pressure. In the
case of children they may suffer fits.
4. Possible side effects
Like all medicines, DF118 FORTE can cause side effects, although
not everybody gets them.
Repeated use of Dihydrocodeine can result in tolerance and
addiction.
If you experience any of the following side effects stop taking the
tablets and contact your doctor or go to the casualty/emergency
department of your nearest hospital immediately. These are
symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the face, lips,
tongue and/or throat
• swelling of the face, lips tongue and/or throat, which may
cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Other side effects that may occur include:
• hallucinations (seeing or hearing things that aren’t real)
• confusion
• changes in mood
• feeling of being unwell
• headaches
• dizziness or a feeling of spinning (vertigo)
• drowsiness
• sweating
• feeling faint when getting up from a seated position
• pin-point pupils
• fast, slow or irregular heartbeat
• facial flushing
• difficulty breathing
• constipation
• feeling sick (nausea)
• being sick (vomiting)
• dry mouth
• difficulty passing urine
• lower abdomen spasms
• an itchy rash or redness
• decrease in sex drive or ability to achieve and maintain an
erection
• lower body temperature
• serious allergic reaction (anaphylaxis)
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.
5. Storing DF118 FORTE
Keep all medicines out of the sight and reach of children.
Do not use DF118 FORTE after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Do not store above 25°C in a dry place. Protect from light.
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 DF118 FORTE contains:
Active ingredient: Dihydrocodeine Tartrate 40 mg per tablet
Other ingredients: lactose, maize starch, pregelatinised maize
starch and magnesium stearate.
What DF118 FORTE looks like and contents of the pack:
DF118 FORTE is a white, circular tablet supplied either in a plastic
container or in plastic blister packs. Each pack contains 10, 28, 56,
100 or 500 tablets.
Marketing Authorisation
Manufacturer:
Holder:
Dales Pharmaceuticals Ltd
Martindale Pharmaceuticals Ltd
Snaygill Industrial Estate
Bampton Road
Skipton
Romford Essex RM3 8UG, UK
North Yorkshire BD23 2RW
Product licence numbers: PL 0156/0093
Leaflet revised: January 2014
D02718
2718-D
100mm Measurement Verification Bar
By
DEVELOPMENT ARTWORK
Component Code: D02718
Paper size: x mm
Version Control Date
Version C
Version B
13/02/14 AC
10/02/14 AC
07/02/14 AC
Version A Created 17/01/14 HM
Version D
Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Limited
Amherst House, 22 London Road
Riverhead, Sevenoaks, Kent, TN13 2BT, UK
t: 01732 456 187
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk
100mm Measurement Verification Bar
DF118 FORTE 40mg Tablet
Dihydrocodeine Tartrate
D02718
Read all of this leaflet carefully before you use
DF1 18 FORTE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor
or pharmacist.
• This medicine has been prescribed for you personally and
you must not pass it onto 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.
In this leaflet:
1. What DF1 18 FORTE is and what it is used for
2. Before you take DF118 FORTE
3. How to take DF118 FORTE
4. Possible side effects
5. Storing DF118 FORTE
6. Further information
1. What DF118 FORTE is and what it is used for
Dihydrocodeine is an alkaloid with powerful pain relieving
properties. This medicine is used for the relief of severe and longlasting pain.
2. Before you take DF118 FORTE
You should not take DF118 FORTE if:
• you are allergic (hypersensitive) to Dihydrocodeine or any
of the ingredients of this medicine (listed in section 6 and
‘Important information about some of the ingredients, column
2).
• you are taking or have recently taken any drugs used to treat
depression known as Monoamine Oxidase Inhibitors (MAO|’s)
(see ‘Taking other medicines)
• you suffer from breathing difficulties, for example acute
asthma attacks
• you are suffering from severe headaches or have suffered a
head injury
• you suffer from alcoholism
• you suffer from heart problems after a lung disease
• you are suffering from stomach pains
• you are suffering from a problem that could cause paralysis of
the small intestine (paralytic ileus)
• you have a tumour of the adrenal gland known as
phaeochromocytoma
Take special care with DF118 FORTE
Tell your doctor if:
• you suffer from asthma
• you have an underactive thyroid gland
• you suffer from low blood pressure
• you have liver or kidney problems
• you suffer from a convulsive disorder (fits) such as epilepsy
• you have any prostate problems
• you have any breathing or lung problems or a productive
cough
Taking other medicines
Please tell your doctor if you are taking or have recently
taken any other medicines, including those obtained without
prescription.
DF118 FORTE must not be used with drugs used to treat severe
depression, such as phenelzine or moclobemide, or if you are
within 2 weeks ofdiscontinuing them. These drugs are known as
Monoamine Oxidase Inhibitors (MAOl’s).
Other medicines which may interact with DF118 FORTE include:
• medicines for sleeping problems and anxiety, such as chloral,
diazepam, and barbiturates.
• CNS depressants (drugs that act on the brain to cause
drowsiness)
• ciprofloxacin, a drug used to prevent and treat bacterial
infections
• alcohol
Taking DF118 FORTE with food and drink
DF118 FORTE should be taken with or after food. You are advised
not to drink alcohol while being treated with Dihydrocodeine.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or you are
breast-feeding, you should consult your doctor before taking
DF118 FORTE.
Driving and using machines
This medicine can affect your ability to drive and operate
machinery. Do not drive or operate machinery if you feel drowsy
or cannot think clearly.
This 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
Continued overleaf
Talk to your doctor or pharmacist if you are not sure whether it is
safe for you to drive while taking this medicine.
Important information about some of the ingredients
If you have been told by your doctor that you have an
intolerance to some sugars (lactose), contact your doctor before
taking this medicinal product.
3. How to take DF118 FORTE
Your doctor will decide on the dose and duration of your
therapy.
Always follow the instructions of your doctor and pharmacist.
This medicine is for oral use.
Adults and elderly: One or two tablets three times daily taken
with or after food up to a maximum of 6 tablets per day.
Children under 12 years: Not recommended.
If you forget to take DF118 FORTE
If you have missed a dose take it as soon as you remember unless
it is nearly time for your next dose. Then continue your normal
dose times. Do not take a double dose.
If you take more DF118 FORTE than you should
If you take too much of your medicine seek immediate medical
advice from your doctor or your nearest hospital. Symptoms
ofan overdose include sudden or unexpected difficulty in
breathing, pin-point pupils or a drop in blood pressure. In the
case of children they may suffer fits.
4. Possible side effects
Like all medicines, DF118 FORTE can cause side effects, although
not everybody gets them.
Repeated use of Dihydrocodeine can result in tolerance and
addiction.
If you experience any of the following side effects stop taking the
tablets and contact your doctor or go to the casualty/emergency
department of your nearest hospital immediately. These are
symptoms of an allergic reaction.
• difficulty in breathing with or without swelling of the face, lips,
tongue and/or throat
• swelling of the face, lips tongue and/or throat, which may
cause difficulty in swallowing
• severe itching of the skin (with raised lumps).
Other side effects that may occur include:
• hallucinations (seeing or hearing things that aren’t real)
• confusion
• changes in mood
• feeling of being unwell
• headaches
• dizziness or a feeling of spinning (vertigo)
• drowsiness
• sweating
• feeling faint when getting up from a seated position
• pin-point pupils
• fast, slow or irregular heartbeat
• facial flushing
• difficulty breathing
• constipation
• feeling sick (nausea)
• being sick (vomiting)
• dry mouth
• difficulty passing urine
• lower abdomen spasms
• an itchy rash or redness
• decrease in sex drive or ability to achieve and maintain an
erection
• lower body temperature
• serious allergic reaction (anaphylaxis)
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.
5. Storing DF118 FORTE
Keep all medicines out of the sight and reach of children.
Do not use DF118 FORTE after the expiry date which is stated on
the carton. The expiry date refers to the last day of that month.
Do not store above 25°C in a dry place. Protect from light.
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 DF118 FORTE contains:
Active ingredient: Dihydrocodeine Tartrate 40 mg per tablet
Other ingredients: lactose, maize starch, pregelatinised maize
starch and magnesium stearate.
What DF118 FORTE looks like and contents of the pack:
DF118 FORTE is a white, circular tablet supplied either in a plastic
container or in plastic blister packs. Each pack contains 10, 28, 56,
100 or 500 tablets.
Marketing Authorisation
Manufacturer:
Holder:
Dales Pharmaceuticals Ltd
Martindale Pharmaceuticals Ltd
Snaygill Industrial Estate
Bampton Road
Skipton
Romford Essex RM3 8UG, UK
North Yorkshire BD23 2RW
Product licence numbers: PL 0156/0093
Leaflet revised: January 2014
D02718
2718-D
100mm Measurement Verification Bar
By
DEVELOPMENT ARTWORK
Component Code: D02718
Paper size: x mm
Version Control Date
Version C
Version B
13/02/14 AC
10/02/14 AC
07/02/14 AC
Version A Created 17/01/14 HM
Version D
Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Limited
Amherst House, 22 London Road
Riverhead, Sevenoaks, Kent, TN13 2BT, UK
t: 01732 456 187
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk
100mm Measurement Verification Bar
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
