ZYDOL Soluble tablet (2021)

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Περιεχόμενα

1. Name of the medicinal product

ZYDOL 50mg Soluble Tablets.

2. Qualitative and quantitative composition

Each ZYDOL soluble tablet contains 50 mg tramadol hydrochloride. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

White to near white, round, flat tablets with bevelled edges, characteristic peppermint odour, engraved with T4 on one side, manufacturers logo on the other.

4.1. Therapeutic indications

Treatment 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 tramadol in order to minimise the risk of addiction and drug withdrawal ...

4.3. Contraindications

ZYDOL is contraindicated in hypersensitivity to the active substance or any of the excipients listed in section 6.1, in acute intoxication with alcohol, hypnotics, analgesics, opioids, or other psychotropic ...

4.4. Special warnings and precautions for use

Tramadol may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre ...

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

ZYDOL should not be combined with MAO inhibitors (see section 4.3). In patients treated with MAO inhibitors in the 14 days prior to the use of the opioid pethidine, life-threatening interactions on the ...

4.6. Fertility, pregnancy and lactation

Pregnancy Animal studies with tramadol revealed at very high doses effects on organ development, ossification and neonatal mortality. Tramadol crosses the placenta. There is inadequate evidence available ...

4.7. Effects on ability to drive and use machines

Even when taken according to instructions, tramadol may cause effects such as somnolence and dizziness and therefore may impair the reactions of drivers and machine operators. This applies particularly ...

4.8. Undesirable effects

The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10% of patients. The frequencies are defined as follows: Very common ≥1/10, Common ≥1/100, <1/10, Uncommon ...

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. Symptoms In principle, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: other opioids ATC code: N02AX02 Tramadol is a centrally acting opioid analgesic. It is a non-selective pure agonist at µ, δ and κ opioid receptors with a higher ...

5.2. Pharmacokinetic properties

More than 90% of ZYDOL is absorbed after oral administration. The mean absolute bioavailability is approximately 70%, irrespective of the concomitant intake of food. The difference between absorbed and ...

5.3. Preclinical safety data

On repeated oral and parenteral administration of tramadol for 6 26 weeks in rats and dogs and oral administration for 12 months in dogs haematological, clinico-chemical and histological investigations ...

6.1. List of excipients

ZYDOL soluble tablets contain: Microcrystalline cellulose Maize starch Saccharin sodium Aniseed flavour Peppermint flavour Colloidal anhydrous silica Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Aluminium/Polypropylene foil blisters. Pack sizes of 10, 20 or 100 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

The tablets are formulated to be dissolved in water prior to administration, producing a slightly peppermint/aniseed flavoured oral solution. Any unused product or waste material should be disposed of ...

7. Marketing authorization holder

Grünenthal Ltd., 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, England, HP14 3FE, UK

8. Marketing authorization number(s)

PL 21727/0006

9. Date of first authorization / renewal of the authorization

14 February 2002

10. Date of revision of the text

21/09/2021

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