ÒȷȄ˜ ÒÈ·È„Â

Transcription

ÒȷȄ˜ ÒÈ·È„Â
23
±π∏∂†≠†Â¢Ó˘˙‰†®ÌÈ¯È˘Î˙©†ÌÈÁ˜Â¯‰†˙Â˜˙†ÈÙφÔίˆÏ†ÔÂÏÚ
‡Ù¯†Ì˘¯Ó·†˙·ÈÈÁ†Âʆ‰Ù¯˙
‰Ù¯˙·†ÈØ˘Ó˙˘˙†Ì¯Ë·†ÂÙÂÒ†„Ú†ÔÂÏÚ‰†˙‡†ÔÂÈÚ·†È؇¯˜
≤∞∞∑†¯·Ó·Â·†Â„È≠ÏÚ†¯˘Â‡Â†˜„·†ÂÎÂ˙†˙‡ȯ·‰†„¯˘Ó†È¢Ú†Ú·˜†‰Ê†ÔÂÏÚ†ËÓ¯ÂÙ
ÒȷȄ˜
ÒȷȄ˜
Ù¯ÈÒ
†˙ÂÒÂÓÎ
∫‰ÏÈÎÓ†®Ï¢Ó†¥Æ쩆˙ÈÙΆÏÎ
∫·Î¯‰
∫‰ÏÈÎÓ†‰ÒÂÓΆÏÎ
Codeine
10.0 mg
Phenyltoloxamine 3.3 mg
in a resin bound matrix
Codeine
30 mg
Phenyltoloxamine
10 mg
in a resin bound matrix
Ô¯˙†‚¢Ó†±Æμ∑†∫‰ÏÈÎÓ†ÔÎ≠ÂÓÎ
Ê¢φ‚¢Ó†±∂Æ¥∞†∫‰ÏÈÎÓ†ÔÎ≠ÂÓÎ
∫ÌÈÏÈÚÙ†È˙Ï·†ÌȯÓÂÁ
Polyethylene Glycol 10,000, Lactose†††††††††††††††††††††††††††††††††††††††††∫˙ÂÒÂÓΆÒȷȄ˜
Sorbitol Solution 70%, Apricot Flavour 4595, Gelcarin DG 3252,††††††††††∫Ù¯ÈÒ†ÒȷȄ˜
Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, Sodium Dihydrogen Phosphate,
Sodium Hydrogen Carbonate, Sodium Saccharin, Disodium Edetate, Ponceau 4R
ÆÏÂÚÈ˘†˙Ϙ‰Ï†‰‰˘ÂÓ†¯Â¯Á˘†ÏÚ·†¯È˘Î˙†∫˙ȇÂÙ¯†˙ÂÏÈÚÙ
ÆÏÂÚÈ˘‰†ÈÂÎȄφ˘Ó˘Ó‰†ÌÈˇÈÙ‡‰†˙ˆÂ·˜Ó†Codeine†∫˙ÈËÈÂÙ¯˙†‰ˆÂ·˜
ÆÌÈÈÓËÒȉÈË‡‰†˙ˆÂ·˜Ó†Phenyltoloxamine
ø¯È˘Î˙·†˘Ó˙˘‰Ï†Ôȇ†È˙Ó
Ɖ„Èω†Í˘Ó·†Â‡†ÍÂÓÒ†˘Ó˙˘‰Ï†Ôȇ†Æ‰˜ÈÈÓ†Íȉ†¯˘‡Î†‰Ù¯˙·†È˘Ó˙˘˙†Ï‡
˘Ó˙˘‰Ï†Ôȇ†Æ‰Ù¯˙‰†È·ÈίÓÓ†„Á‡Ï†˙Â˘È‚¯†Íφ‰Ú„Ȇ̇†˘Ó˙˘‰Ï†Ôȇ
‰ÓËÒ‡†Â‡†˙È¯Ά˙¯Ȉچ¨‰Ó˜‡ς†¨˙Ï„‚ÂÓ†˙ÈÂÓ¯Ú†˙ËÂÏ·Ó†ÌÈÏ·ÂÒ‰†ÌÈÏÂÁ·
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∫ÏÂÙÈˉ†˙ÏÁ˙‰†ÈÙφ‡Ù¯·†ıÚÂÂȉφÈÏ·Ó†‰Ù¯˙·†˘Ó˙˘‰Ï†Ôȇ
̇†ªÈÁÂÓ†Ú¯‡†Â‡†˙ÂÈ˙ÈÂÂÚ†˙ÂÏÁÓ†¨‰Â·‚†Ì„†ıÁÏÓ†˙ØÏ·Â҆‡†ÔÂȯ‰·†Íȉ†Ì‡
ÈÏΆ‡Ø†·Ï‰†¨‰ÓÈ˘‰†˙ίÚÓ†∫„˜Ù˙·†È˜ÈÏÓ†¯·Ú·†˙Ϸ҆‡†˙ØÏ·ÂÒ†Íȉ
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ȇÂÙ¯†·˜ÚÓ·†ÌÈ·ÈÈÁ†ÌÈ˘È˘˜†ÆÌȄȇÂÈÙ‡φ‰Ø¯ÂÎÓ†Íȉ†Ì‡†¨È˙Ï‚Ï‚†ÍÂ˙†ıÁÏ
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23
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LFL 007 02/08
ÆÔ¯˘‰†„‰†¨¥†˘¯Á‰†ßÁ¯†¨Ó¢Ú·†ËˆÎ†∫˜Â¢Ó
23
Codivis
Capsules
Codivis
Syrup
Composition:
Each capsule contains:
Each teaspoonful (4.5 ml) contains:
Codeine
30 mg
Codeine
10.0 mg
Phenyltoloxamine
10 mg
Phenyltoloxamine
3.3 mg
in a resin bound matrix
in a resin bound matrix
It also contains: Lactose 16.40 mg
It also contains: Sodium
1.57 mg
Inactive Ingredients:
Codivis capsules: Polyethylene Glycol 10,000, Lactose.
Codivis syrup: Sorbitol Solution 70%, Apricot Flavour 4595, Gelcarin DG 3252, Methyl
Hydroxybenzoate, Propyl Hydroxybenzoate, Sodium Dihydrogen Phosphate, Sodium
Hydrogen Carbonate, Sodium Saccharin, Disodium Edetate, Ponceau 4R.
Therapeutic Action: Controlled release product for the relief of cough.
Therapeutic Group: Codeine is an opiate used as cough suppressant.
Phenyltoloxamine is an antihistamine.
When should the product not be used?
Do not use this medicine when you are breast-feeding.
Do not use this medicine shortly before or during labour.
Do not use this medicine if you are hypersensitive to one of its ingredients.
Do not use this medicine in patients suffering from enlarged prostate gland, glaucoma,
chronic constipation or asthma and/or lung insufficiency.
Do not use in children below the age of four years.
This medicine should not be used without consulting your physician prior to
commencing treatment: If you are pregnant, or suffering from hypertension, convulsive
diseases or CVA; if you suffer or have suffered in the past from impaired function of the:
respiratory system, heart and/or blood vessels, liver, kidneys/urinary system, digestive
system (e.g. ulcer), disturbances of consciousness, intracranial pressure, if you are
addicted to opioids.
Elderly patients should be under medical supervision since they are more sensitive to
the side effects.
How will this medicine affect your every day life?
Use of this medicine may impair alertness and therefore caution should be exercised
when driving a car, operating dangerous machinery and in every activity demanding
alertness.
Children should be cautioned against riding a bicycle, playing near a road, etc.
Wines or alcoholic beverages must not be taken during treatment with this medicine.
Warnings: Naturally and rarely, in some people codeine undergoes metabolism more
rapidly than in most people. In these rare cases high levels of metabolites may accumulate
and can cause severe side effects, such as: excessive drowsiness, confusion and shallow
breathing. In such cases the patient should be referred immediately for medical care.
In most cases it is impossible to know in advance whether a patient belongs to this risk
group of people. Prolonged treatment may cause dependency! Use of this medicine
may cause blurred vision. Do not use this medicine frequently or for long periods of time
without consulting your doctor. If you are sensitive to any type of food or medicine,
consult your doctor prior to commencing treatment. Your doctor should be informed in
case you are about to undergo any kind of surgery (including dental).
Codivis capsules contain lactose and may cause an allergic reaction in patients who
are sensitive to lactose.
Drug Interactions: If you are taking another medicine, or if you have just finished
treatment with another medicine, you must consult your doctor to avoid risks or inefficacy
arising from drug interactions, especially with drugs from the following groups: aspirin
and drugs containing other salicylates, drugs which affect the central nervous system
(such as tranquillizers, hypnotics, anti-parkinson medicines, antiepileptics), analgesics,
antipyretics, narcotic drugs, tricyclic antidepressants and MAO inhibitors, drugs for cough
and cold, anti-allergics (additional antihistamines).
Side Effects: In addition to the desired effects of the drug, some side effects may appear
during treatment with this drug, such as: dryness of the mouth and constipation.
These side effects usually disappear soon after the system adapts to the medicine, but
if they continue or are bothersome, refer to your doctor.
Side Effects which demand special attention: Nausea and vomiting, drowsiness,
tiredness, disturbances in the digestive system, difficulty in urination, headache, euphoria,
tinnitus, shortness of breath, decrease in blood pressure, confusion, restlessness,
irregular heartbeats, disturbances in vision, itching and reddening of the skin, slow
breathing (rare): discontinue treatment and contact your doctor. Take the medicine a
few hours before retiring, since difficulties in sleeping may occur.
If you notice side effects not mentioned in this leaflet or if there has been any change
in your general health, consult your doctor immediately.
Side Effects and Drug Interactions in Children and Infants:
Parents should inform the doctor of any side effects and about any other medicine being
administered to the child! See side effects and drug interactions listed above.
Dosage according to the doctor's instructions only.
Do not exceed the recommended dosage.
Recommended Dosage - unless otherwise specified by the doctor:
Capsules: Adults and children above 12 years of age: one capsule in the morning and
in the evening.
Syrup:
Children 4–6 years of age: 4.5 ml in the morning and in the evening.
Children 6–12 years of age: 9 ml (4.5 x 2) in the morning and in the evening.
Adults and children above 12 years of age: 13.5 ml (4.5 x 3) in the morning and
in the evening.
It is recommended to drink after taking this medicine.
This medicine is not intended for children below the age of four years.
If there is no improvement in your condition after 7 days, refer to the attending physician.
This medicine should be taken at fixed periods as determined by your doctor. If you
forget to take this medicine at its fixed time, take a dose as soon as you remember;
under no circumstances, however, should two doses be taken together!
Instructions for Use: This medicine should be taken with a meal.
The syrup should be well shaken before use and taken with the measuring cup supplied
with the package.
The capsule should be swallowed whole with a small quantity of water.
Avoid Poisoning! This medicine and any other medicine must be kept in a closed place
out of the reach of children and/or infants to avoid poisoning. If you took an overdose,
or by mistake a child swallowed this medicine, go to the emergency room of the hospital
immediately and take the package of medicine with you.
Do not induce vomiting unless clearly indicated by the doctor!
This medicine has been indicated for the treatment of your disease; in another patient,
it may cause harm. Do not give this medicine to relatives, neighbours or acquaintances.
Medicines should not be taken in the dark! Check the label and the dose every time you
take the medicine. Wear glasses if you need them.
Storage: In a cool dry place. Even if stored according to their recommended conditions,
medicines have a limited life. Pay attention to the expiry date of the product! If in doubt,
you must consult your dispensing pharmacist.
Different medicines should not be stored in the same container.
Registration number of the medicine:
Capsules: 1324623488, Syrup: 1324722196
Manufacturer: CTS Chemical Industries Ltd., Kiryat-Malachi.
LFL 007 02/08
Distributor: CTS Ltd., 4 Haharash St., Hod Hasharon.
23
PATIENT LEAFLET AS PER THE PHARMACISTS’ REGULATIONS (PRODUCTS) - 1986
Prescription only medicine
Read the entire leaflet carefully before commencing treatment
The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in November 2007