Go Back to Top
Mundipharma

Pain Management:

TarginAct®
S6

TarginAct®

46/2.9/0645, 46/2.9/0646, 46/2.9/0647, 46/2.9/0648

Each TarginAct  5 mg/2,5 mg contains 5 mg oxycodone hydrochloride and 2,5 mg naloxone hydrochloride. Contains lactose 71,75 mg
Each TarginAct  10 mg/5 mg contains 10 mg oxycodone hydrochloride and 5,0 mg naloxone hydrochloride. Contains lactose 64,25 mg
Each TarginAct  20 mg/10 mg contains 20 mg oxycodone hydrochloride and 10,0 mg naloxone hydrochloride. Contains lactose 54,50 mg
Each TarginAct  40 mg/20 mg contains 40 mg oxycodone hydrochloride and 20,0 mg naloxone hydrochloride. Contains lactose 109 mg

Blister pack containing 28 film-coated tablets - 5 mg/2,5 mg, 10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg

Inactive Ingredients:

Tablet Core:

ethylcellulose, lactose monohydrate, magnesium stearate, stearyl alcohol, talc
5 mg/2,5 mg contains hydroxypropylcellulose
10 mg/5 mg; 20 mg/10 mg and 40 mg/20 mg contain povidone K30

Tablet Coat:

Polyvinylalcohol, macrogol, talc, titanium dioxide
5 mg/2,5 mg - contains Brilliant blue FCF aluminium lake
10 mg/5 mg - contains no additional colourant
20 mg/10 mg - contains iron oxide red
40 mg/20 mg - contains iron oxide yellow

TarginAct® – Important safety Information

Assessment and Monitoring

For the treatment of severe pain, which requires the use of a strong opioid analgesic and to reduce the risk of constipation.

An initial comprehensive assessment should be conducted using a bio psychosocial approach to identify a cause for the pain and the appropriateness of opioid therapy. If long-term treatment is anticipated given the nature and severity of illness, careful and regular assessment and monitoring is required to establish the clinical need for ongoing treatment with an opioid therapy.

Abuse/Addiction Risk

As with other opioids, tolerance and physical dependence tend to develop upon repeated administration of oxycodone. There is potential for abuse and for development of strong psychological dependence. TarginAct® should therefore be prescribed and handled with a high degree of caution appropriate to the use of a medicine with strong abuse potential. Like other opioids, TarginAct® can be diverted for non-medical use, into illicit channels of distribution. Oxycodone should be used with caution and under close supervision in patients with pain not due to malignancy who have a prior history of prescription medicine, alcohol or other substance abuse.

Withdrawal

Withdrawal symptoms may occur following abrupt discontinuation of all oxycodone therapy including TarginAct®. Therefore, patients on prolonged therapy should be withdrawn gradually from the product if it is no longer required for pain control. If abused parenterally or intranasally by individuals dependent on opioid agonists, such as heroin morphine or methadone, TarginAct® is expected to produce marked withdrawal symptoms due to the opioid receptor antagonist characteristics of naloxone, or to intensify already present withdrawal symptoms.

Discontinuation of treatment

Withdrawal symptoms may occur following abrupt discontinuation of all oxycodone therapy including TarginAct®. Therefore, patients on prolonged therapy should be gradually withdrawn from the product if it is no longer required for pain control.

Download package insert
SOVENOR® Patch
S6

SOVENOR® Patch

41/2.7/0589, 41/2.7/0590, 41/2.7/0591

Each SOVENOR® 5 Patch contains 5 mg buprenorphine in a medicine-containing matrix that releases a nominal 5 μg of buprenorphine per hour over 7 days
Each SOVENOR® 10 Patch contains 10 mg buprenorphine in a medicine-containing matrix that releases a nominal 10 μg of buprenorphine per hour over 7 days
Each SOVENOR® 20 Patch contains 20 mg buprenorphine in a medicine-containing matrix that releases a nominal 20 μg of buprenorphine per hour over 7 days

One transdermal patch packed into a heat sealed protective pouch composed of composite material, paper, LDPE film, aluminium and ethylene copolymer. Four individually sealed pouches are packed into an outer carton.

Inactive Ingredients:

Levulinic acid, oleyl oleate, polyacrylate (dry solids), polyethylene terephthalate (PET) and povidone (PVP)

Sovenor® – Important safety Information

Assessment and Monitoring

For chronic treatment of moderate to severe pain where treatment with Sovenor® Patch is necessary, careful and regular monitoring should be carried out.  

Abuse/Addiction Risk

Controlled human and animal studies indicate that buprenorphine has a lower dependence liability than pure agonist analgesics. In humans limited euphorigenic effects have been observed with buprenorphine. This may result in some abuse of the product and caution should be exercised when prescribing to patients known to have, or suspected of having, a history of product abuse or alcohol abuse or serious mental illness.

Withdrawal

As with all opioids, chronic use of buprenorphine can result in the development of physical dependence withdrawal (abstinence syndrome), when it occurs, it is generally mild, begins after 2 days and may last up to 2 weeks.

Discontinuation of treatment

After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Sovenor® Patch is to be followed by other opioids.

Download package insert
OxyContin® Prolonged Release Tablet
S6

OxyContin® Prolonged Release Tablet

41/2.9/1098, 41/2.9/1099, 41/2.9/1100, 41/2.9/1101, 41/2.9/1102

Each OxyContin® 5mg Prolonged Release Tablet contains 5 mg oxycodone hydrochloride
Each OxyContin® 10 mg Prolonged Release Tablet contains 10 mg oxycodone hydrochloride
Each OxyContin® 20 mg Prolonged Release Tablet contains 20 mg oxycodone hydrochloride
Each OxyContin® 40 mg Prolonged Release Tablet contains 40 mg oxycodone hydrochloride
Each OxyContin® 80 mg Prolonged Release Tablet contains 80 mg oxycodone hydrochloride

Blister pack containing 28 film-coated tablets - 5 mg, 10 mg, 20 mg, 40 mg, 80 mg

Inactive Ingredients:

Tablet Core:

ammoniomethacrylate co-polymer, lactose monohydrate, magnesium stearate, povidone, stearyl alcohol, talc, triacetin

Tablet Coat:

hypromellose, macrogol, talc, titanium dioxide
5 mg - contains Brilliant blue FCF aluminium lake
10 mg - contains hydroxypropylcellulose and no additional colourant
20 mg - contains polysorbate and iron oxide red
40 mg - contains polysorbate and iron oxide yellow
80 mg - contains hydroxypropylcellulose, iron oxide yellow and indigo carmine

OxyContin® Prolonged Release Tablets – Important safety Information

Assessment and monitoring

For appropriate patients who suffer with moderate to severe cancer pain or severe pain requiring the use of a strong opioid. An initial comprehensive assessment should be conducted using a bio psychosocial approach to identify a cause for the pain and the appropriateness of opioid therapy – and to identify psychosocial factors that may exacerbate pain or magnify overall distress.

Abuse/Addiction Risk

As with other opioids, tolerance and physical dependence tent to develop upon repeated administration of oxycodone. There is potential for abuse of the product and for development of strong psychological dependence. OxyContin® Tablets should therefore be prescribed and handled with high degree of caution appropriate to the use of a product with strong abuse potential, especially in patients with pain not due to malignancy who have a prior history of substance abuse.

Withdrawal

Withdrawal symptoms may occur following abrupt discontinuation of all oxycodone therapy or upon administration of an opioid antagonist. Therefore, patients on prolonged therapy should be gradually withdrawn from the product if it is no longer required for pain control.

Discontinuation of treatment

Patients on prolonged therapy should be withdrawn gradually from the product if it is no longer required for pain control.

Download package insert
OxyNorm® Capsules
S6

OxyNorm® Capsules

41/2.9/1103, 41/2.9/1104, 41/2.9/1105

Each OxyNorm® 5 mg Capsule contains 5 mg oxycodone hydrochloride
Each OxyNorm® 10 mg Capsule contains 10 mg oxycodone hydrochloride
Each OxyNorm® 20 mg Capsule contains 20 mg oxycodone hydrochloride

Blister pack containing 28 film-coated capsules - 5 mg, 10mg, 20mg

Inactive Ingredients:

Capsule: Gelatine, indigo carmine, iron oxide, magnesium stearate, microcrystalline cellulose, sodium laurylsulphate, Sunset Yellow, and titanium dioxide. The capsules are sugar free

OxyNorm® – Important safety Information

Assessment and monitoring

For appropriate patients who suffer with moderate to severe cancer pain or severe pain requiring the use of a strong opioid. Opioids should be used as part of a comprehensive treatment program involving other medications and treatment modalities. A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s addiction and substance abuse history.

Abuse/Addiction Risk

Oxycodone has an abuse profile similar to other strong opioids. Oxycodone may be sought and abused by people with latent or manifest addiction disorders. There is potential for development of psychological dependence (addiction) to opioid analgesics, including oxycodone. OxyNorm® Capsules and/or Injections should be used with particular care in patients with a history of alcohol and drug abuse.

Withdrawal

The patient may develop tolerance to OxyNorm® with chronic use and require progressively higher doses to maintain pain control. Prolonged use of OxyNorm® may lead to physical dependence and a withdrawal syndrome may occur upon abrupt cessation of therapy.

Discontinuation of treatment

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Download package insert
MST Continus® Tablets
S6

MST Continus® Tablets

R/2.9/294, R/2.9/295, S/2.9/278, S/2.9/279,

Each MST Continus® 10 mg tablet contains morphine sulphate 10 mg in a controlled release matrix. Contains sugar: Lactose 90 mg
Each MST Continus® 30 mg tablet contains morphine sulphate 30 mg in a controlled release matrix. Contains sugar: Lactose 70 mg
Each MST Continus® 60 mg tablet contains morphine sulphate 60 mg in a controlled release matrix. Contains sugar: Lactose 40 mg
Each MST Continus® 100 mg tablet contains morphine sulphate 100 mg in a controlled release matrix. Sugar free

Blister pack containing 60 film-coated tablets - 10 mg, 30 mg, 60 mg, 100 mg

Inactive Ingredients:

Tablet Core:

cetostearyl alcohol, hydroxyethylcellulose, magnesium stearate, purified talc, purified water

Tablet Coat:

10 mg - Opadry tan and purified water. Opadry tan contains permitted colourants
30 mg - Opadry violet and purified water. Opadry violet contains permitted colourants
60 mg - Opadry orange and purified water. Opadry orange contains permitted colourants
100 mg - Opadry and purified water. Opadry contains permitted colourants

Download package insert
Img E0014
S6

OxyNorm® Injection

46/2.9/0718, 46/2.9/0719

Each OxyNorm® 10 mg Injection contains 10 mg/1 ml of oxycodone hydrochloride equivalent to 9 mg/1 ml oxycodone.

Each OxyNorm® 20 mg Injection contains 20 mg/2 ml of oxycodone hydrochloride equivalent to 18 mg/2 ml oxycodone.

OxyNorm® 10 mg Injection: 1 ml Type 1 Ph.Eur clear glass ampoules with white break ring and yellow identification ring in cardboard boxes of 5 ampoules per box.

OxyNorm® 20 mg Injection: 2 ml Type 1 Ph.Eur clear glass ampoules with white break ring and red identification ring in cardboard boxes of 5 ampoules per box.

Clear glass ampoules with white break ring and yellow identification ring in cardboard boxes of 5 ampoules per box. 

Inactive Ingredients:

Citric acid monohydrate, sodium citrate, sodium chloride and water for injections.

Download package insert