TEMGESIC Sublingual tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Temgesic 200 microgram Sublingual Tablets. Temgesic 400 microgram Sublingual Tablets.

2. Qualitative and quantitative composition

Temgesic 200 microgram Sublingual Tablets Buprenorphine hydrochloride 216 µg/tablet, equivalent to 200 µg buprenorphine base. Excipient(s) with known effect: lactose. For the full list of excipients, ...

3. Pharmaceutical form

Sublingual tablet. Temgesic 200 microgram Sublingual Tablets: White to creamy white, circular, biconvex tablets, embossed on one side with L. Temgesic 400 microgram Sublingual Tablets: White ...

4.1. Therapeutic indications

As a strong analgesic for the relief of moderate to severe pain.

4.2. Posology and method of administration

Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with buprenorphine in order to minimise the risk of addiction and drug ...

4.3. Contraindications

Hypersensitivity to the active substance or to other opiates or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Temgesic occasionally causes significant respiratory depression and, as with other strong centrally acting analgesics, care should be taken when treating patients with impaired respiratory function or ...

4.5. Interaction with other medicinal products and other forms of interaction

Temgesic should be used cautiously when co-administered with serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake ...

4.6. Pregnancy and lactation

Pregnancy Temgesic is not recommended for use during pregnancy. Regular use during pregnancy may cause drug dependence in the foetus, leading to withdrawal symptoms in the neonate. If opioid use is required ...

4.7. Effects on ability to drive and use machines

If you feel drowsy after taking these tablets do not use machines. This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine is in the list of ...

4.8. Undesirable effects

Nausea, vomiting, dizziness, sweating and drowsiness have been reported and may be more frequent in ambulant patients. Hallucinations and other psychotomimetic effects have occurred although more rarely ...

4.9. Overdose

Patients should be informed of the signs and symptoms of overdose and to ensure that family and friends are also aware of these signs and to seek immediate medical help if they occur. The expected symptoms ...

5.1. Pharmacodynamic properties

Buprenorphine is a µ (mu) opioid partial agonist and k (kappa) antagonist. It is a strong analgesic of the partial agonist (mixed agonist/antagonist) class.

5.2. Pharmacokinetic properties

Absorption When taken orally, buprenorphine undergoes first-pass hepatic metabolism with N-dealkylation and glucuroconjungation in the small intestine. The use of this medication by oral route is therefore ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Lactose Mannitol Maize starch Povidone k30 Citric acid anhydrous Magnesium stearate Sodium citrate Purified water Alcohol (96%)

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years – Nylon/aluminium/uPVC blister strip. 3 years – HDPE bottle.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package- Nylon/aluminium/uPVC blister strip Do not store above 30°C – HDPE bottle.

6.5. Nature and contents of container

Nylon/aluminium/uPVC blister strips of 10 tablets each, packed in cartons of 50 tablets. HDPE bottle consisting of 50 tablets.

6.6. Special precautions for disposal and other handling

To be dissolved under the tongue and not to be chewed or swallowed.

7. Marketing authorization holder

Indivior UK Limited, The Chapleo Building, Henry Boot Way, Priory Park, Hull, HU4 7DY, United Kingdom

8. Marketing authorization number(s)

Temgesic 200 microgram Sublingual Tablets: PL 36699/0004 Temgesic 400 microgram Sublingual Tablets: PL 36699/0005

9. Date of first authorization / renewal of the authorization

11/11/1980 / 17/05/2002

10. Date of revision of the text

24/11/2020

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