STEMETIL Tablet (2020)

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Περιεχόμενα

1. Name of the medicinal product

Stemetil 5 mg tablets.

2. Qualitative and quantitative composition

The active component of the Stemetil tablets is prochlorperazine maleate BP 5 mg. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Tablet. Off-white to pale cream coloured circular tablets for oral use. The tablets are marked on one face STEMETIL around a centrally impressed 5, reverse face plain.

4.1. Therapeutic indications

Vertigo due to Menieres Syndrome, labyrinthis and other causes, and for nausea and vomiting from whatever cause including that associated with migraine. It may also be used for schizophrenia (particularly ...

4.2. Posology and method of administration

Posology Adults Indication Dosage Prevention of nausea and vomiting 5–10 mg b.d. or t.d.s. Treatment of nausea and vomiting 20 mg stat, followed if necessary by 10 mg two hours later. Vertigo and Meniere ...

4.3. Contraindications

Known hypersensitivity to prochlorperazine or to any of the other ingredients listed in section 6.1.

4.4. Special warnings and precautions for use

Stemetil should be avoided in patients with liver or renal dysfunction, Parkinsons disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy. It should be avoided ...

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

Adrenaline must not be used in patients overdosed with Stemetil (see section 4.9). The CNS depressant actions of neuroleptic agents may be intensified (additively) by alcohol, barbiturates and other sedatives. ...

4.6. Pregnancy and lactation

Pregnancy Animal studies are insufficient with respect to reproductive toxicity. However, potential harmful effect in animals cannot be ruled out. There is inadequate evidence of safety in pregnancy. Data ...

4.7. Effects on ability to drive and use machines

Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.

4.8. Undesirable effects

Generally, adverse reactions occur at a low frequency; the most common reported adverse reactions are nervous system disorders. Immune system disorders: Type I hypersensitivity reactions such as ...

4.9. Overdose

Symptoms of phenothiazine overdose include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extrapyramidal dyskinesias may occur. ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antipsychotics ATC code: N05AB04 Stemetil is a potent phenothiazine neuroleptic.

5.2. Pharmacokinetic properties

There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

Lactose Maize starch Aerosil (E551) Magnesium stearate

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store in original packaging in order to protect from light.

6.5. Nature and contents of container

Stemetil tablets 5mg are available in “securitainers” or HDPE bottles in packs of 25, 250 and 1000 tablets and PVDC coated UPVC/aluminium foil blisters containing 28 or 84 tablets. Not all pack sizes may ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

8. Marketing authorization number(s)

PL 04425/0593

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 2 October 2006

10. Date of revision of the text

03/01/2020

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