DF 118 Forte 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dihydrocodeine tartrate

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

N02AA08

INN (International Name):

Dihydrocodeine tartrate

Dosage:

40mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5014124798045

Patient Information leaflet

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 long-
lasting 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 intera

Summary of Product characteristics

OBJECT 1
DF118 FORTE 40MG (DIHYDROCODEINE TARTRATE
TABLETS)
Summary of Product Characteristics Updated 26-Sep-2014 | Martindale
Pharma
1. Name of the medicinal product
DF118 FORTE 40mg
2. Qualitative and quantitative composition
Dihydrocodeine Tartrate BP 40mg
3. Pharmaceutical form
White circular biconvex tablets engraved DF118 on one side and Forte
on the other.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe and chronic pain
4.2 Posology and method of administration
ROUTE OF ADMINISTRATION
Oral
DF118 tablets should be administered with or after food.
ADULTS AND ELDERLY
One or two tablets three times daily. The maximum daily dose is 240mg.
CHILDREN UNDER 12 YEARS
Not recommended.
4.3 Contraindications
• Hypersensitivity to any of the products ingredients.
• Acute respiratory depression or Chronic Obstructive Airways
Disease.
• Asthma attack.
• Acute alcoholism.
• Biliary colic.
• Head injuries or increased intracranial pressure.
• Heart failure secondary to lung disease.
• Concurrent use with Monoamine Oxidase Inhibitors (including
moclobemide), or within two weeks of
their withdrawal.
• Risk of paralytic ileus.
• Phaeochromocytoma.
4.4 Special warnings and precautions for use
As dihydrocodeine may cause the release of histamine it should be
given with caution to asthmatics.
Repeated use can cause tolerance and dependence. Caution in use should
be exercised and a reduction in
dose may be advisable in the elderly and in the following cases.
• Hypotension.
• Hypothyroidism.
• Depressed respiratory reserve.
• Prostatic hypertrophy.
• Hepatic or renal impairment or chronic hepatic disease.
• Convulsive disorders.
4.5 Interaction with other medicinal products and other forms of
interaction
ALCOHOL: Enhanced sedative and hypertensive effects.
ANTIDEPRESSANTS: The use of dihydrocodeine should be avoided or used
with caution in patients receiving
monoamine oxidase inhibitors (including moclobemide), or within two
weeks of their withdrawal.
ANXIOLYTICS, HYPNOT