TRAMAL Capsule, Solution for injection, Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Tramal (tramadol hydrochloride) immediate release capsules 50 mg. Tramal (tramadol hydrochloride) solution for injection 50 mg/mL, 100 mg/2mL. Tramal SR tablets (tramadol hydrochloride) sustained release ...
2. Qualitative and quantitative composition
Tramal 50 mg capsules are yellow-yellow capsules containing: 50 mg tramadol hydrochloride. Tramal 50 mg and 100 mg injections contain: tramadol hydrochloride 50 mg/mL. Tramal SR sustained release tablets ...
3. Pharmaceutical form
Tramal capsules are oblong, yellow/yellow, shiny hard gelatin capsules size 4. Tramal solution for injection is clear, colourless solution. Tramal SR 50mg sustained release tablets are pale yellow coloured, ...
4.1. Therapeutic indications
Relief of moderate to severe pain.
4.2. Posology and method of administration
Dose The dose of tramadol should be titrated to the severity of the pain and the clinical response of the individual patient. Tramadol is approved for use in adults, adolescents and children over the age ...
4.3. Contraindications
Tramadol is contraindicated in: individuals with known hypersensitivity to tramadol or any excipients listed in section 6.1 acute intoxication with alcohol, hypnotics, analgesics, opioids or psychotropic ...
4.4. Special warnings and precautions for use
Hazardous and harmful use Tramal contains the opioid tramadol hydrochloride and is a potential drug of abuse, misuse and addiction. Addiction can occur in patients appropriately prescribed Tramal at recommended ...
4.5. Interaction with other medicinal products and other forms of interaction
<b>Use with Central Nervous System (CNS) Depressants</b> - Tramadol should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, ...
4.6. Fertility, pregnancy and lactation
Post marketing surveillance does not suggest an adverse effect of tramadol on fertility. In rats tramadol dosages from 50 mg/kg/day upwards caused toxic effects. Published data suggest an adverse influence ...
4.7. Effects on ability to drive and use machines
Due to its sedative effect, patients should be advised to avoid driving or operating machinery whilst taking tramadol. Even when taken according to instructions, tramadol may cause effects such as somnolence ...
4.8. Undesirable effects
Adverse reactions that may occur after administration of tramadol resemble those known to occur with opioids. Adverse reactions were recorded in 13,802 patients from trials with different formulations ...
4.9. Overdose
Symptoms Symptoms of overdosage with tramadol are similar to those of other centrally acting analgesics (opioids) and include miosis, vomiting, cardiovascular collapse, consciousness disorders including ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> other opioids <b>ATC Code:</b> N02AX02 Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioid-like effects. It is not derived from ...
5.2. Pharmacokinetic properties
Tramadol is administered as a mixture of two stereoisomers; the following information refers to the combined concentration of both isomers. Tramadol has a linear pharmacokinetic profile within the therapeutic ...
5.3. Preclinical safety data
Carcinogenesis, mutagenesis and impairment of fertility Tramadol was not mutagenic in the following assays: Ames Salmonella microsomal activation test, CHO/HPRT mammalian cell assay, mouse lymphoma assay ...
6.1. List of excipients
<u>Tramal 50 mg capsules:</u> Excipients include: cellulose-microcrystalline, magnesium stearate, sodium starch glycollate, silica-colloidal anhydrous. Excipients in the capsule shell are: iron oxide yellow ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Tramal capsules have a shelf-life of 36 months when stored below 30°C. Tramal solution for injection and Tramal SR 100, 150 and 200 mg tablets have a shelf-life of 60 months when stored below 30°C. Tramal ...
6.4. Special precautions for storage
For storage conditions of the medicine, see section 6.3 Shelf-life.
6.5. Nature and contents of container
Tramal 50mg immediate release capsules-packs of 6, 10, 20, 30 and 50 capsules. Tramal 50, solution for injection-pack containing 5 ampoules of 1 mL each. Tramal 100, solution for injection-pack containing ...
6.6. Special precautions for disposal and other handling
<u>Tramal capsules:</u> If your doctor tells you to stop taking TRAMAL capsules or it passes its expiry date, ask your pharmacist what to do with any TRAMAL capsules that are left over. <u>Tramal solution ...
7. Marketing authorization holder
Seqirus (NZ) Ltd, PO Box 62 590, Greenlane, Auckland 1546, New Zealand, Telephone: 0800 502 757
9. Date of first authorization / renewal of the authorization
Tramal capsules 25/9/1997 Tramal solution for injection 25/9/1997 Tramal SR 50mg 2/11/2006 Tramal SR 100 mg 2/3/2000 Tramal SR 150mg 2/3/2000 Tramal SR 200 mg 2/3/2000
10. Date of revision of the text
23 February 2022
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