Israel - English - Ministry of Health
PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
(PREPARATIONS) - 1986
The medicine is dispensed
without a doctor’s prescription
Tsinun Classic Night
Each caplet contains:
Paracetamol 500 mg
Pseudoephedrine hydrochloride 25 mg
Chlorpheniramine maleate 2 mg
For the list of inactive ingredients in the
preparation, see section 6 – “Further
Read this leaflet carefully in its entirety
before using the medicine. This leaflet
contains concise information about the
medicine. If you have further questions,
refer to the doctor or pharmacist.
This medicine is dispensed without
need for a doctor’s prescription and
is intended for adults and children
from the age of 6 years and above.
Take the medicine properly. Consult
a pharmacist if you need further
Refer to the doctor if the fever persists
for more than 3 days or if the signs of
the ailment worsen or do not improve
after 5 days despite use of the medicine,
or in any case in which new symptoms
1. WHAT IS THE MEDICINE INTENDED
The medicine is intended for the relief
of common cold and nasal congestion,
accompanied by fever and pains – for
Paracetamol - analgesic and antipyretic.
Pseudoephedrine hydrochloride - relieves
Chlorpheniramine maleate - antihistamine.
2. BEFORE USING THE MEDICINE
Do not use this medicine:
Do not use the medicine when you
are pregnant or breastfeeding.
if you are sensitive (allergic) to
decongestants or to any of the other
ingredients of the medicine (see
if you have asthma.
if you are being concomitantly
treated with medicines from the
monoamine oxidase inhibitors group
(for depression) or within 14 days of
discontinuing treatment with them.
decongestants, beta blockers.
if you have severe heart disease or
severe hypertension, a severe liver
disease, impaired kidney function,
overactive thyroid gland, diabetes,
concomitantly with other paracetamol-
containing preparations (if you are
uncertain whether the medicine you
are taking contains paracetamol,
consult a doctor or pharmacist).
Special warnings regarding use of the
∙ If you have developed skin side
effects in the past as a result of taking
do not take preparations containing
paracetamol, so that severe skin
effects will not recur.
The preparation contains paracetamol
which may cause liver damage when:
∘ given at a dosage higher than
recommended or for a prolonged
∘ consuming alcoholic beverages
during the course of treatment.
taking additional medicines which
affect liver function.
∙ Do not use this medicine frequently
without consulting a doctor.
Do not take additional fever reducers
and pain relievers or cold medicines
pharmacist, to prevent paracetamol
overdose or poisoning.
∙ Do not take additional medicines
from the “Acamol family” and/or other
∙ Inform the doctor if you are due
to undergo laboratory tests, since
treatment with the medicine may
interfere with the results.
Avoid taking a high dosage (within the
recommended limit) of this medicine
∙ If you are sensitive to any food or
medicine, inform the doctor before
taking the medicine.
The preparation contains lactose and
may cause allergy in people sensitive
Before treatment with Acamol
Tsinun Classic Night, tell the doctor if
you are suffering, or have suffered in
the past, from:
∙ Disease or impaired function of the
heart and/or blood vessels
Problem with the eyes (e.g., glaucoma)
Impaired function of the kidney (e.g.,
a phaeochromocytoma-type tumor) or
urinary system (e.g., difficulty passing
Digestive system problem (e.g., ulcer)
If you are taking, or have recently
taken, other medicines, including
non-prescription medicines and food
supplements and vitamins, tell the
doctor or pharmacist. In particular inform
the doctor or pharmacist if you are taking
a medicine from the following groups or if
you have just finished treatment with the
central nervous system (e.g., appetite
Medicines to treat asthma (from the
Medicines which suppress the central
nervous system (e.g., sedatives,
hypnotics, medicines for Parkinson’s,
antihistamines that cause drowsiness],
surgical anesthetics and narcotic
Medicines to treat anxiety.
Anticoagulants, especially warfarin.
∙ Antidepressants (including MAO
inhibitors – see section 2, “Do not
use this medicine”, or tricyclic
Cough and cold medicines (e.g., other
medicines for nasal congestion -
see section 2, “Do not use this
Methyldopa or other antihypertensives
(e.g., beta blockers - see section 2, “Do
not use this medicine”, alpha blockers
or vasodilators) and heart medicines.
∙ Anticholinergics or medicines with
anticholinergic activity (e.g., abdominal
∙ Preparations that stimulate liver
enzyme activity (e.g., phenytoin [for
∙ Anticonvulsant medicines (to treat
a n t i -
inflammatories (in prolonged use).
∙ Metoclopramide or domperidone
(to treat nausea, vomiting and other
Probenecid (to treat gout).
Cholestyramine (to reduce excessive
Lopinavir (for viral infection).
∙ Medicines to treat migraines (ergot
Use of the medicine and food
The medicine can be taken without regard
Use of this medicine and alcohol
During the course of treatment with this
medicine do not consume alcohol due to
increased risk of liver damage.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do
not use this medicine.
Driving and use of machinery
Do not drive or operate dangerous
machinery while using the medicine,
as this medicine may impair alertness.
Children should be cautioned against
riding bicycles or playing near roads and
Use in children
This medicine is intended for adults and
children above the age of 6 years, see
Parents must inform the attending doctor
of any side effects as well as any other
medicine being given to the child.
3. HOW SHOULD YOU USE THE
Check with the doctor or pharmacist if
you are uncertain.
The usual dosage, unless instructed
otherwise by the doctor:
Adults and children above 12 years of
age: 1-2 caplets at bedtime.
Children ages 10-12 years: 1 caplet at
Children ages 6-9 years:
Patients above the age of 60 years:
consult the doctor before using this
medicine, as they may be sensitive to
preparations of this kind.
Upon concomitant use of Acamol
Classic Day, exchange a dose of Acamol
Tsinun Classic Day with a dose of Acamol
Tsinun Classic Night, and do not take it
as a supplement to the recommended
dosage of Acamol
Tsinun Classic Night.
Do not exceed the recommended
Refer to the doctor if the fever persists
for more than 3 days or if the signs of the
ailment worsen or do not improve after
5 days despite use of the medicine, or in
any case in which new symptoms occur.
Directions for use
Do not chew or crush! The caplet can be
halved on the score line.
Swallow the caplet with a small amount
If you took an overdose or if a child
accidentally swallowed the medicine,
immediately refer to a doctor or to a
hospital emergency room and bring
the package of the medicine with you.
Do not induce vomiting without explicit
instruction from the doctor! Even if you
feel well, immediate treatment is essential,
due to the risk of developing severe
Side effects can be nausea and vomiting,
diarrhea, loss of appetite, abdominal
pains, flatulence, increased sweating,
pain or tenderness in the upper abdomen
and they may not reflect the severity of
the liver damage.
Do not take medicines in the dark! Check
the label and the dose each time you
take medicine. Wear glasses if you need
If you have further questions regarding
use of the medicine, consult a doctor or
4. SIDE EFFECTS
As with any medicine, use of this medicine
may cause side effects. Do not be alarmed
when reading the list of side effects. You
may not suffer from any of them.
Severe side effects
Stop treatment and refer to the doctor
∙ If severe allergic reactions occur,
such as rash and itching, swelling of
the face, lips, tongue, throat and/or
limbs, which may cause breathing or
swallowing difficulties (rare)
∙ Paracetamol may, in rare cases,
cause the appearance of severe
skin diseases, whose signs can be:
redness, rash, blisters, widespread
skin damage. Severe skin side effects
may occur even if you have taken
preparations containing the active
ingredient paracetamol in the past
without any problem. If skin side
effects occur, stop treatment and refer
to the doctor immediately.
∙ Difficulty passing urine in men,
especially when there is a prostate
Tightness in the chest
Change in heart rate
∙ Liver problems, including jaundice
(yellowing of the skin and eyes)
If signs of changes in the blood system
occur, such as: anemia, bleeding,
bruises, development of inflammations
more easily, unexplained tiredness
∙ Severe pancreatitis (as a result of
Lack of coordination
Confusion among the elderly
Additional side effects:
Dizziness, sleepiness, tiredness
Lack of appetite, heartburn, nausea,
vomiting, diarrhea, abdominal pain,
Dry mouth - it is recommended to use
saliva substitutes; in particular, be sure
to maintain dental hygiene, in view
of the fact that caries may be more
Low blood pressure, palpitations
Increased bronchial secretion (which
may cause cough or phlegm)
∙ Muscle weakness, transient muscle
Ringing in the ears
General unwell feeling
Difficulty passing urine
Blurred vision, sensitivity to light
∙ Lack of concentration, headache,
∙ Nightmares, nervousness or lack of
Hyperactivity in some children.
If a side effect occurs, if any of the side
effects worsen, or if you are suffering
from a side effect not mentioned in the
leaflet, consult the doctor.
5. HOW SHOULD THE MEDICINE BE
Avoid poisoning! This medicine and
any other medicine must be kept in a
safe place out of the reach of children
and/or infants to avoid poisoning. Do
not induce vomiting without explicit
instruction from the doctor.
∙ Do not use the medicine after the
expiry date (Exp. Date) that appears
on the package. The expiry date refers
to the last day of that month.
Store in a dry place, below 25°C.
Do not discard medicines in the waste
water or waste bin. Ask the pharmacist
how to dispose of medicines that are
not in use. These measures will help
protect the environment.
6. FURTHER INFORMATION
In addition to the active ingredients,
the medicine also contains:
Microcrystalline cellulose, povidone,
sodium starch glycolate (from potato),
lactose monohydrate, hypromellose,
stearic acid, titanium dioxide, magnesium
stearate, silicon dioxide, polyethylene
glycol, iron oxide yellow, iron oxide red,
iron oxide black.
Each caplet contains:
0.25-0.38 mg sodium
6.48 mg lactose.
What the medicine looks like and the
contents of the package:
Yellow, capsule-shaped, film-coated
biconvex tablet. One side has a score
line and the other side is plain.
The package contains 14 caplets.
Manufacturer and license holder:
Teva Pharmaceutical Industries Ltd.,
P.O.B. 3190, Petah-Tikva.
This leaflet was checked and approved
by the Ministry of Health in December
Registration number of the medicine
in the National Drug Registry of the
Ministry of Health: