STEMETIL 5 мг Коированная таблетка
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Инструкция по применению STEMETIL
Содержание инструкции
STEMETIL 5 mg film-coated tablets, 10 mg suppositories
proclorperazine
PHARMACOTHERAPEUTIC CATEGORY
Antiemetic and anti-nausea.
THERAPEUTIC INDICATIONS
Treatment and prevention of vomiting and nausea of any kind.
CONTRAINDICATIONS
- hypersensitivity to proclorperazine or other phenothiazines and/or to any of the excipients;
- comatose states;
- depression of the CNS, particularly that induced by substances with a depressive action on the CNS (alcohol, barbiturates, narcotics, etc.);
- bone marrow depression;
- pheochromocytoma;
- severe impairment of hepatic and renal function;
- do not use under two years of age and in pediatric age;
- period before a surgical intervention;
- first trimester of pregnancy.
PRECAUTIONS FOR USE
Special attention is required when using in the elderly and in children as the risk of
extrapyramidal reactions is higher.
Stemetil, like other phenothiazines, must be used with caution in patients with hepatic or
renal insufficiency, heart disease, myasthenia gravis, severe respiratory diseases, prostatic hypertrophy, urinary
retention, intestinal obstruction and closed-angle glaucoma.
Caution is advised in patients with epilepsy as phenothiazines can lower the
convulsive threshold. Some caution is appropriate in patients with Parkinson's disease as
deterioration of the disease may occur.
As with other phenothiazines, caution is recommended in patients with leukopenia and/or neutropenia, in patients
taking drugs known to cause neutropenia, in patients with a history of
myelodepression or due to concomitant disease, radiotherapy or chemotherapy. Periodic monitoring of the blood count is appropriate, which should be requested promptly in case of unexplained infection
or fever.
Elderly patients are more prone to the adverse effects of phenothiazines due to the risk of orthostatic
hypotension. Periodic monitoring of blood pressure is recommended in patients over 65 years of age.
INTERACTIONS
Potential interactions involving proclorperazine:
The depressant effect on the CNS of phenothiazines can be potentiated by alcohol, use of anesthetics,
narcotics, sedatives, etc. Respiratory depression may occur. The anticholinergic action of
phenothiazines can be potentiated by other anticholinergics and cause constipation, urinary retention,
heat stroke, etc.
Decreased bioavailability: antacids, drugs for parkinsonism and lithium can interfere with
the absorption of antipsychotics.
There is an increased risk of ventricular arrhythmias with drugs that prolong the QT interval, including
antiarrhythmics, antidepressants and other antipsychotics.
There is an increased risk of agranulocytosis when phenothiazines are used together with drugs with
potential myelosuppressive effects, such as carbamazepine, sulfonamides or cytotoxics.
With lithium there is an increased risk of extrapyramidal effects and neurotoxicity.
Inform your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those without a prescription.
SPECIAL WARNINGS
Extrapyramidal symptoms (parkinsonian symptoms, dystonias and dyskinesias) depend in part on the dose,
duration and individual sensitivity. With discontinuation of the drug there is a remission of parkinsonian symptoms.
Phenothiazines can alter body temperature regulation, so caution is advised during very hot (risk of hyperthermia) or very cold (risk of hypothermia) seasons.
Neuroleptic Malignant Syndrome (NMS): is a potentially fatal condition associated with
treatment with proclorperazine or other neuroleptics used for antipsychotic purposes. Clinical manifestations
of NMS are: hyperpyrexia, muscle rigidity, dysfunction of the autonomic nervous system
(irregular pulse or blood pressure, sweating, tachycardia, arrhythmias), alterations in
state of consciousness that can progress to stupor and coma. In these cases, it is essential to
discontinue drug therapy.
Patients treated with phenothiazines should avoid excessive exposure to sunlight,
using, if necessary, special protective creams.
The antiemetic action of phenothiazines can mask the signs of overdose of other drugs or can
make the diagnosis of concomitant conditions difficult, especially of the gastrointestinal tract or the CNS, such as
intestinal obstruction, brain tumors or Reye's syndrome.
For this reason, these substances must be used with caution in association with chemotherapeutic drugs
with an anti-cancer action that can cause vomiting at toxic doses.
The drug can induce a depression of the cough center, thus increasing the risk of aspiration
of vomiting.
Prolonged doses over time determine an increase in serum prolactin levels with possible effects
on target organs.
As with other neuroleptics, cases of QT interval prolongation have been reported very rarely.
Caution should be exercised, especially during the initial phase of treatment in patients with predisposing factors
for ventricular arrhythmias such as significant heart disease, metabolic alterations such as
hypokalemia and hypomagnesemia, concomitant use of drugs that prolong the QT interval. Monitoring the electrolyte balance and ECG may be useful, particularly during the initial phase of
treatment.
Pregnancy and breastfeeding
Pregnancy: Do not administer in the first trimester of pregnancy. In the subsequent period the drug
can be used only when deemed essential and always under the direct control of the doctor. The use
of the drug as an antiemetic in pregnancy is not recommended.
It has been reported that the drug can prolong labor; therefore, avoid its administration until
the cervix has reached a dilation of 3-4 cm. The side effects on the fetus
include lethargy, paradoxical hyperactivity, tremor and a low Apgar score.
Ask your doctor or pharmacist for advice before taking any medicine.
Breastfeeding: since phenothiazines can be found in breast milk, breastfeeding should be discontinued
during treatment.
Effects on the ability to drive and operate machinery
Since phenothiazines induce sedation and drowsiness, during the use of Stemetil patients
should avoid driving vehicles and operating machinery.
If you have an intolerance to certain sugars, contact your doctor before taking
this medicine.
DOSAGE, ADMINISTRATION AND DURATION OF TREATMENT
Oral use:
Adults:
For the treatment of an acute attack of vomiting and nausea, the recommended dose is one tablet three
times a day at regular intervals.
For the prevention of vomiting and nausea the recommended dose is 1-2 tablets.
Elderly:
Reduced doses are recommended in patients over 65 years of age.
Children:
use reduced doses.
Rectal use:
Adults:
The recommended dose is 2 suppositories per day, one in the morning and one in the evening.
In some cases, such as intractable vomiting, 1 or 2 suppositories can be administered initially and then the treatment continued orally.
Elderly:use reduced doses .
Children:the use of Stemetil suppositories is not recommended in children.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.
OVERDOSE
The most common symptoms of overdose are of an extrapyramidal type, generally accompanied by
restlessness, agitation, hypotension and CNS depression.
Treatment is symptomatic and supportive of vital functions. It is important to proceed as soon as possible with
gastric lavage; particular attention must be paid to keeping breathing active.
In case of accidental ingestion of an excessive dose of the medicine, immediately notify
the doctor or go to the nearest hospital.
UNDESIRABLE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone will
experience them.
The frequency of the adverse reactions described below has been used the following convention: very
common (>10%); common (≥1%, <10%); uncommon (≥ 0.1%, <1%); rare (≥0.01%, <0.1%); very rare
(<0.01%).
The most frequent adverse reactions affect the central nervous system.
Nervous system disorders
Especially at the beginning of therapy, sedation and drowsiness are very common but usually disappear with
appropriate dose reduction. Also manifested with varying frequency: restlessness,
insomnia, euphoria, psychomotor agitation and depression.
Convulsions are also possible.
Extrapyramidal reactions are common during therapy with phenothiazines, although their frequency and
intensity have been correlated with dosage and duration of treatment.
They include: dyskinesia, akathisia, parkinsonian symptoms and tardive dyskinesia.
Gastrointestinal disorders
Due to the anticholinergic activity of phenothiazines, dry mouth, constipation, and rarely paralytic ileus can occur.
Blood and lymphatic system disorders
Effects on the blood count are rare but serious. They include leukopenia, agranulocytosis,
thrombocytopenia, purpura and hemolytic anemia.
Skin and annex disorders
Hypersensitivity reactions (general or from contact) and photosensitivity are possible, mostly
represented by erythema, urticaria, eczema, exfoliative dermatitis, systemic lupus erythematosus-like reactions.
Hypersensitivity reactions
Cholestatic jaundice, laryngeal edema, laryngo- and bronchospasm, anaphylactic-type reactions. In such cases the
therapy must be immediately suspended.
Endocrine system disorders
The effects of the product on the endocrine system are possible but related to dosage and duration of
therapy. The most frequent are: galactorrhea and menstrual disorders in women, gynecomastia and decreased libido
in men.
Metabolism disorders
Hyperglycemia and glycosuria.
Cardiac disorders
Cases of QT interval prolongation and arrhythmias have been reported very rarely
Vascular disorders
Peripheral edema.
Urinary system disorders
Urinary retention.
General disorders
Visual disturbances.
Hyperpyrexia, not otherwise explained, may be due to intolerance to the product and requires
suspension of therapy.
Neuroleptic Malignant Syndrome (hyperthermia, muscle rigidity, dysfunction of the autonomic nervous system
and fluctuations in level of consciousness) is a very rare but serious event that requires immediate
suspension of treatment.
If any of these side effects worsen, or if you notice any side effect
EXPIRY DATE AND STORAGE
Film-coated tablets: store protected from light, at a temperature not exceeding 25°
C.
Suppositories :if the suppositories appear softened, immerse the container, before opening it, in
cold water.
Expiry date: see the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.
Warning: do not use the product after the expiry date indicated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN
COMPOSITION
Stemetil 5 mg film-coated tablets
Each tablet contains:
Active ingredient:proclorperazine maleate 8.25 mg equivalent to proclorperazine 5 mg.
Excipients:lactose, povidone, magnesium stearate, corn starch zein, castor oil.
Stemetil 10 mg suppositories
Each suppository contains: Active ingredient:proclorperazine 10 mg
Excipients:solid semi-synthetic glycerides
PHARMACEUTICAL FORM AND CONTENT
Pack of 20 film-coated tablets
Pack of 5 suppositories
MARKETING AUTHORISATION HOLDER
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
MANUFACTURER AND FINAL CONTROLLER
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia
Determination of November 2007
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- Страна регистрации
- Форма выпускаCoated tablet, 5 MG
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги STEMETILФорма выпуска: Hard capsule, 125 MG + 80 MGДействующее вещество: АпрепитантПроизводитель: TEVA B.V.Отпускается по рецептуФорма выпуска: Hard capsule, 80 MGДействующее вещество: АпрепитантПроизводитель: SINTESY PHARMA S.R.L.Отпускается по рецептуФорма выпуска: Hard capsule, 80 MGДействующее вещество: АпрепитантПроизводитель: MERCK SHARP & DOHME B.V.Отпускается по рецепту
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