MEPTID Film-coated tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Meptid 200 mg Film-Coated Tablets.

2. Qualitative and quantitative composition

Each tablet contains 200 mg of meptazinol (as hydrochloride). Excipient with known effect: Each tablet contains 2.15 mg of sunset yellow FCF (E110). For the full list of excipients, see section ...

3. Pharmaceutical form

Film-coated tablet. Oval, biconvex, orange, film-coated tablets. The tablets are engraved MPL 023 on one side.

4.1. Therapeutic indications

Meptid tablets are indicated for the short term treatment of moderate 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 meptazinol in order to minimise the risk of addiction and drug withdrawal ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with the following conditions:acute alcoholism and where there is a risk of paralytic ileus raised intracranial ...

4.4. Special warnings and precautions for use

Clinical studies have indicated absence of clinically significant respiratory depression but caution should be exercised in patients whose respiratory system is already compromised. Patients with moderate ...

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

The following undesirable effects could occur as a result of possible interaction with meptazinol hydrochloride. Antidepressants: CNS excitation or depression manifesting as hypertension or hypotension ...

4.6. Pregnancy and lactation

Pregnancy Reproductive studies in animal have shown no evidence of teratogenic effect. No experience is available in human beings. Meptazinol should not be used during pregnancy, unless considered essential ...

4.7. Effects on ability to drive and use machines

Since dizziness and occasionally drowsiness have been reported, patients should be cautioned against driving or operating machinery until it is established that they do not become dizzy or drowsy whilst ...

4.8. Undesirable effects

System Organ Class Very Common (≥1/10) Uncommon (≥1/1,000 to ≤1/100) Unknown (frequency cannot be estimated from the available data) Psychiatric disorders     Drug dependence (see section ...

4.9. Overdose

Meptid tablets are subject to hepatic first pass metabolism which prevents systemic concentration of the drug reaching levels achieved by parenteral administration. Recommended treatment includes gastric ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Opioids, Other Opioids ATC Code: N02AX Meptid (meptazinol) is a centrally acting analgesic belonging to the hexahydroazepine series, which has demonstrated mixed ...

5.2. Pharmacokinetic properties

After oral administration, meptazinol is rapidly absorbed and peak plasma levels are reached within 90 minutes. The plasma elimination half-life is variable (1.4-4 hours). The peak analgesic effect is ...

5.3. Preclinical safety data

Standard toxicity tests revealed no unexpected findings of clinical significance.

6.1. List of excipients

Tablet Core: Microcrystalline cellulose Polacrilin potassium (as Amberlite IRP 88) Magnesium stearate Tablet Coating: Hypromellose (E464) Macrogol 400 Sunset yellow FCF (E110) Titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Cartons containing PVC blister packs of 6, 28, 56, 100 or 112 tablets. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Almirall S.A., Ronda General Mitre, 151, 08022 Barcelona, Spain

8. Marketing authorization number(s)

UK-PL 16973/0017

9. Date of first authorization / renewal of the authorization

17 December 1992/11 October 2005

10. Date of revision of the text

01 October 2020

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