DHC Continus 120mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dihydrocodeine tartrate

Available from:

Ennogen Healthcare International Ltd

ATC code:

N02AA08

INN (International Name):

Dihydrocodeine tartrate

Dosage:

120mg

Pharmaceutical form:

Modified-release tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070200; GTIN: 5012854026339

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_DHC_
_®_
_ CONTINUS_
_®_
_ _60 MG, 90 MG AND 120 MG PROLONGED-RELEASE TABLETS
Dihydrocodeine tartrate
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 phamacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What _DHC CONTINUS _tablets are and what they are used for
2.
What you need to know before you take _DHC CONTINUS _tablets
3.
How to take _DHC CONTINUS _tablets
4.
Possible side effects
5.
How to store _DHC CONTINUS _tablets
6.
Contents of the pack and other information
1.
WHAT _DHC CONTINUS _TABLETS ARE AND WHAT THEY ARE USED FOR
These tablets have been prescribed for you to relieve severe pain over
a period of 12 hours. They contain the
active ingredient dihydrocodeine which belongs to a group of medicines
called strong analgesics or
‘painkillers’.
The tablets may be taken by adults and children aged 12 years and
above.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE_ DHC CONTINUS _TABLETS
DO NOT TAKE _DHC CONTINUS _TABLETS IF YOU:

are allergic to dihydrocodeine or any of the other ingredients of the_
_tablets (listed in section 6);

have severe breathing problems such as severe chronic obstructive lung
disease, severe bronchial asthma
or severe respiratory depression. Your doctor will have told you if
you have these conditions.
Symptoms may include breathlessness, coughing or breathing more slowly
or weakly than expected;

are having an asthma attack;

have a severe heart problem after long-term lung disease (severe cor
pulmonale);

have a condition where the small bowel (part of yo

Summary of Product characteristics

OBJECT 1
DHC CONTINUS PROLONGED RELEASE TABLETS 60MG
Summary of Product Characteristics Updated 10-Apr-2018 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
DHC
®
CONTINUS
®
60mg, 90mg and 120mg prolonged release tablets.
2. Qualitative and quantitative composition
Dihydrocodeine Tartrate 60 mg, 90 mg and 120 mg.
Excipient with known effect:
Lactose anhydrous 58.4 mg, 40.5 mg, 54 mg.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablet.
White capsule-shaped tablet, 60 mg tablets are marked DHC 60, 90 mg
tablets are marked DHC 90 and
120 mg tablets are marked DHC 120.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain in cancer and other chronic conditions.
DHC CONTINUS tablets are indicated for use in adults and children over
12 years of age.
4.2 Posology and method of administration
Posology
60 mg:
Adults and children over 12 years: One or two tablets 12-hourly.
90 mg and 120 mg:
Adults: The usual dose is one tablet 12-hourly.
Elderly: Dosage should be reduced.
Paediatric population
Children 12 years or under: Not recommended.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1; severe respiratory
depression with hypoxia; severe chronic obstructive lung disease;
severe cor pulmonale; severe bronchial
asthma; paralytic ileus; acute alcoholism. As dihydrocodeine may cause
the release of histamine, it should
not be given during an asthma attack.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase deficiency or glucose-
galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
Dihydrocodeine should be administered with caution to the elderly or
patients with:
• a history of opioid abuse or dependence
• raised intracranial pressure or head injury
• biliary tract disorders
• prostatic hypertrophy
• pancreatitis
• impairment of hepatic function
• severe