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ספסמלגין SPASMALGIN (ATROPINE SULFATE, CODEINE PHOSPHATE, PAPAVERINE HYDROCHLORIDE, PARACETAMOL)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

טבליה : TABLETS

Adverse reactions : תופעות לוואי

4.8 Undesirable effects
As with any medicine, use of this medicine may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them.
The medicine should be stooped as soon as possible in case of dizziness, blurred vision, accelerated heart rate, appearance of jaundice, abnormal liver activity, hypersensitivity (rash or skin irritation, shortness of breath or difficulty breathing), increased drowsiness, eye pain.
In the elderly-
Confusion and restlessness, difficulty in passing urine, eosinophilia (rare).
Additional side effects:
Dry mouth, constipation, nausea/vomiting, drowsiness, headache, digestive system disturbances, increased seating.
Paracetamol & Codeine:
The most common side effects are: nausea, vomiting, constipation, dry mouth, sweating, skin rashes and other allergic reactions.
There have been reports of: blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.
Paracetamol: very rare cases of serious skin reactions have been reported.
Regular prolonged use of codeine is known to lead to addiction and symptoms of restlessness and irritability may result when treatment is then stopped.
Prolonged use of a painkiller for headaches can make them worse.


Atropine:
Some of the central effects of atropine seen at toxic doses may also occur at therapeutic doses.
Immune system disorders, Hypersensitivity.
In rare cases a fever may develop.
Psychiatric disorders, Confusional states (particularly in the elderly).
Nervous system disorders, Occasionally giddiness and staggering may occur.
Eye disorders, Dilation of the pupils with loss of accommodation and photophobia.
Increased intraocular pressure.
In rare cases, angle-closure glaucoma may develop.
Cardiac disorders, Transient bradycardia, followed by tachycardia, palpitations and arrhythmias.
Respiratory, thoracic and mediastinal disorders Bronchial secretions may be reduced, with formation of mucous plugs.
Gastrointestinal disorders, Dry mouth with difficulty in swallowing, thirst.
Occasionally nausea and vomiting may occur.
A reduction in the tone and mobility of the gastro-intestinal tract may lead to constipation.
Increased gastric reflux may result in retrosternal pain.
Skin and subcutaneous tissue disorders Flushing and dryness of the skin. Rashes.
Renal and urinary disorders, Urinary urgency, difficulty or retention.



Papaverine:

Common Adverse Effects

Nausea, abdominal distress, anorexia, constipation, malaise, drowsiness, vertigo, sweating, headache, diarr hea, rash, flushing of the face, increased heart rate, increased depth of respirations, slight increase in BP, sedation.


Reporting side effects
Side effects can be reported to the Ministry of Health by clicking on the link Report Side Effe ts of Drug Treat e t fou d o the Mi istry of Health homepage (www.health.gov.il) that directs you to the online form for reporting side effects, or by entering the link: https://sideeffects.health.gov.il 


שימוש לפי פנקס קופ''ח כללית 1994 לא צוין
תאריך הכללה מקורי בסל 01/03/2002
הגבלות תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת

בעל רישום

SAM-ON LTD

רישום

036 36 22208 00

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0 ₪

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