Patient package insert according to Pharmacists’ • You are a child under the age of 12 years.

12 years. If you are taking, or have recently taken, other using this medicine because this medicine may Like any medicine, the use of Paramol Af & Shiul the medicine you may experience drug withdrawal
Regulations (Preparations) - 1986 • You are taking other preparations containing medicines, including non-prescription medicines impair alertness, you may feel drowsy, dizzy or have night care may cause side effects in some users. Do symptoms, which include: restlessness, difficulty
paracetamol (if you are not sure whether and nutritional supplements, tell the doctor or blurred vision. As for children, they should be warned not be alarmed when reading the list of side effects. sleeping, irritability, anxiety, palpitations, high blood
This medicine can be sold without a physician’s the medicine that you are taking contains pharmacist. Especially tell the doctor or pharmacist if about riding a bicycle or playing near roads etc. You may not suffer from any of them. pressure, nausea and vomiting, diarrhea, shaking,
prescription paracetamol, consult the doctor or pharmacist). you are taking a medicine from the following groups or sweating
Use in children Serious side effects:
PARAMOL® AF & SHIUL • You suffer from overactive thyroid gland.
• You suffer from increased pressure in the eye
if you have just finished treatment with the medicine:
• Anticholinergics (to treat cramps and spasms such
This medicine is intended for children over 12 years, Stop taking this medicine and refer to a doctor • Fatigue
• Dry mouth, loss of appetite, heartburn
NIGHT CARE, CAPLETS
see section 3. immediately with the occurrence of:
(glaucoma). as atropine) Parents must inform the attending doctor of any side • Acute allergic reactions such as rash and itching, • Nightmares, depression, low blood pressure, rash,
• You suffer from severe kidney disease. • Medicines from the Selective Serotonin Reuptake effects and any other medicine being given to the swelling of the face, lips, tongue, throat, which may sensitivity to light, nausea, increased viscosity of
Each caplet contains: Paracetamol 500mg, • You suffer from Phaeochromocytoma (a rare Inhibitors (SSRIs) group (for depression or anxiety) sputum (may cause cough or phlegm)
Pseudoephedrine hydrochloride 25mg, child. cause difficulty in breathing or swallowing, swelling
tumor in the adrenal gland which affects blood or if you have taken them within the last two weeks of the limbs • Ringing in the ears, blurred vision, inability to
Dextromethorphan hydrobromide 10mg and pressure and heart rate). (see in section 2, "Do not use the medicine if") Important information about some of the concentrate, malaise, muscle weakness, muscle
Chlorpheniramine maleate 2mg. ingredients of the medicine • Paracetamol may, in rare cases, cause acute
• You are taking medicines that stimulate or • Anticoagulants especially warfarin skin diseases whose signs can be: redness, rash, twitching, hyperactivity in children, blood disorders
Inactive ingredients and allergens in the medicine- suppress appetite or medicines for asthma • Antidepressants (including MAOIs, RIMAs – see This medicine contains less than 1 mmol sodium (23 such as: anemia.
in section 2, "Do not use the medicine if") or if you mg) per caplet, that is to say essentially "sodium- blisters, widespread skin damage. Acute skin
see section 6 "Additional information" and in section 2 (sympathomimetic medicines). side effects may occur even if you have taken • Low blood count, hepatitis (severe abdominal pain,
"Important information about some of the ingredients have taken them within the last two weeks free". nausea, vomiting, loss of appetite)
Special warnings regarding the use of the • Tricyclic antidepressants preparations containing the active ingredient
of the medicine". If a side effect occurs, if one of the side effects
medicine • Medicines for depression, psychiatric or emotional 3. How should you use the medicine? paracetamol in the past with no problem. If skin side
Read this entire leaflet carefully before using the Check with the doctor or pharmacist if you are not effects occur, stop treatment and refer to the doctor worsens or if you suffer from a side effect which
• If you have developed skin side effects in the conditions or Parkinson's disease or if you have is not mentioned in this leaflet, consult the doctor.
medicine. This leaflet contains concise information past as a result of taking preparations containing sure about the dosage and the manner of treatment immediately
about the medicine. If you have any further questions, taken them within the last two weeks (see in section
paracetamol, do not take preparations containing 2, "Do not use the medicine if") with the medicine. • Stomach upset Reporting side effects
ask the doctor or pharmacist. paracetamol, so that severe skin effects will not Unless otherwise instructed by the doctor, the • Dizziness, drowsiness, confusion Side effects can be reported to the Ministry of Health
This medicine is administered without a doctor’s • Moclobemide – antidepressant
recur. • Other antihistamines, including those in cough usual recommended dosage is: • Hallucinations (rare) (hearing or seeing things that by clicking the link
prescription and is intended for adults and children • The preparation contains paracetamol, which may Adults and children over 12 years: do not exist, irrational thoughts and feelings) "‫ "דיווח על תופעות לוואי עקב טיפול תרופתי‬found on the
over 12 years. and cold medicines (e.g. other medicines for nasal
cause liver damage when: congestion, see in section 2, "Do not use the 1-2 caplets before bedtime. • Problem passing urine, especially in men with a homepage of the Ministry of Health website
Take this medicine according to the instructions in o Given at a dosage higher than recommended or medicine if") that make you sleepy Patients over 60 years: consult the doctor before prostate problem (www.health.gov.il) directing to the online form for
section 3 "How should you use the medicine?" in this for a prolonged period. • Antihypertensives (to treat high blood pressure) using this medicine, as they may be sensitive to • Signs of changes in the blood system such as: reporting side effects or via the link:
leaflet. Consult the pharmacist if you need additional o Alcoholic beverages are consumed during the such as: guanethidine, methyldopa, adrenergic preparations of this kind. unexplained tiredness, bleeding, anemia, bruises, https://sideeffects.health.gov.il
information. course of treatment. neuron blockers, debrisoquine, bretylium and Upon concomitant use of Paramol Af & Shiul day development of infections more easily
Refer to a doctor if the fever persists for more than o Other medicines which affect liver function are betanidine or other antihypertensives (e.g., care do not exceed a total daily dosage of 8 caplets • Irregular heartbeat, chest tightness 5. How to store the medicine?
3 days or if the symptoms worsen or do not improve taken. beta-blockers – see in section 2, "Do not use the (upon concomitant use of Paramol Af & Shiul day • Sudden severe headache, nausea, vomiting, • Avoid poisoning! This medicine and any other
after 5 days despite use of the medicine or in any • Do not use this medicine frequently without medicine if") care, replace a dose of Paramol Af & Shiul day care confusion, fits, visual disturbances medicine must be stored in a closed place out of the
case in which new symptoms occur. consulting a doctor. • Preparations which stimulate liver enzyme activity with a dose of Paramol Af & Shiul night care and do • Sudden and severe abdominal pain or rectal reach and sight of children and/or infants to avoid
• Do not take other antipyretics and analgesics or cold (e.g., barbiturates) not take it as a supplement to the maximum dosage bleeding due to inflammation of the colon as a result poisoning. Do not induce vomiting unless explicitly
1. What is the medicine intended for? recommended above for Paramol Af & Shiul night of insufficient blood supply instructed to do so by the doctor.
The medicine is intended for the symptomatic relief medicines without consulting a doctor or pharmacist • Antiepileptics – phenytoin, carbamazepine
to prevent paracetamol overdose or poisoning. • Metoclopramide or domperidone (for treatment of care). • Reduced blood flow to the heart which can cause • Do not use the medicine after the expiry date (‫תאריך‬
of cold, cough and nasal congestion accompanied by nausea, vomiting and other digestive problems) angina (discomfort or pain in the chest, neck, back, ‫ )תפוגה‬stated on the package. The expiry date refers
fever and pain, for treatment at night. • You must inform the doctor if you are about to Do not exceed the recommended dose.
undergo laboratory tests, since the treatment with • Chloramphenicol or rifampicin (antibiotic) shoulders, arms) to the last day of that month.
Therapeutic group: • Probenecid (for treatment of gout) Refer to a doctor if the fever persists for more • Stroke (weakness of the face, arms or legs or • Storage conditions: Store below 25°C.
this medicine may affect the test results. than 3 days or if the symptoms worsen or do not
Paracetamol – analgesic and antipyretic. • Do not take other medicines from the Paramol • Cholestyramine (to reduce excessive blood fats) speech problems) • Do not throw away any medicines via wastewater
Pseudoephedrine – relieves nasal congestion. • Non-steroidal anti-inflammatory drugs improve after 5 days despite use of the medicine, • A sudden onset of fever, reddening of the skin, or or household waste. Ask the pharmacist how to
family and/or other paracetamol containing or in any case in which new symptoms occur.
Dextromethorphan – cough suppressant. preparations. • Medicines for anxiety and sleeping pills many small pustules (possible symptoms of Acute throw away medicines you no longer use. These
Chlorpheniramine – antihistamine. • Avoid taking a high dosage (within the • Oral contraceptives Method of administration: Generalised Exanthematous Pustulosis - AGEP) measures will help protect the environment.
recommended limit) of this medicine when fasting. • Medicines for the treatment of migraines (Ergot Swallow the caplet with water. The caplet can be which may occur during the first two days of
2. Before using the medicine: alkaloids) halved. There is no information regarding chewing or treatment with this medicine 6. Additional information
• If you are sensitive to any food or medicine, you In addition to the active ingredients, the medicine
Do not use the medicine if: must inform the doctor before taking this medicine. • Cardiac glycosides (medicines used to treat heart crushing the caplet. • Sudden loss of vision
rhythm disorders or heart failure such as digoxin) • Liver problems including jaundice (yellowing of the also contains:
• Taking this medicine regularly for a long period of If you have accidentally taken a higher dosage Povidone, croscarmellose sodium, hypromellose,
• You are pregnant or breastfeeding. time can lead to addiction. Take this medicine as • Medicines to treat heart problems such as If you have taken an overdose or if a child has skin and eyes)
• You are hypersensitive (allergic) to the active quinidine and amiodarone • Lack of coordination magnesium stearate, titanium dioxide (E171),
described in this leaflet. accidentally swallowed the medicine, proceed macrogol, erythrosine aluminum lake (E127), silica
ingredients (paracetamol, pseudoephedrine, • Oxytocin (medicine to help contractions during immediately to a doctor or a hospital emergency • Confusion among the elderly
dextromethorphan, chlorpheniramine), to other Before the treatment with Paramol Af & Shiul childbirth) room and bring the package of the medicine with you. Additional side effects:
colloidal anhydrous, indigo carmine aluminum lake
antihistamine or any other decongestants, or night care, tell the doctor if you suffer or have • Terbinafine for the treatment of fungal infections Even if you feel well, immediate treatment is essential, Very common side effects (effects that occur in
(E132), quinoline yellow aluminum lake (E104),
to any of the other ingredients this medicine suffered in the past from: • Cinacalcet for the treatment of secondary due to the risk of developing severe liver damage. more than 1 in 10 users):
brilliant blue FCF aluminum lake (E133), carnauba
contains (see section 6). • Disease or impaired function of the heart and/or hyperparathyroidism (overactive parathyroid gland) wax
blood vessels (such as: coronary artery disease – Side effects could be: nausea and vomiting, diarrhea, • Headache
• You are taking or have taken in the last 14 • Methadone for the treatment of severe pain loss of appetite, abdominal pain, flatulence, increased What the medicine looks like and what the
days, medicines from the Monoamine Oxidase blocked arteries or veins) If you are taking Paramol Af & Shiul night care Common side effects (effects that occur in 1-10 out package contains:
sweating, pain or tenderness in the upper abdomen. of 100 users):
Inhibitors (MAOIs) group (for depression) or • Disease or impairment in the respiratory system, with antidepressants or antipsychotics, you may
They may not reflect the severity of the liver A pink caplet with a score line on both sides.
Reversible Inhibitors of Monoamine Oxidase such as: asthma, bronchitis, persistent cough, experience mental status changes (such as: • Difficulty sleeping, nervousness, dizziness Approved package sizes: 10, 20, 50 caplets. Not all
cough accompanied by fever, rash or persistent agitation, hallucinations, coma) and other symptoms damage. Muscle contractions, agitation, confusion, • Dry mouth or nausea
(RIMAs). somnolence, impaired alertness (consciousness), package sizes may be marketed.
• You are taking or have taken in the last two headache or any other lung problem such as: body temperature above 38°C, increased Side effects with unknown frequency (effects for Revised in October 2022 according to MOH
• Liver disease or impaired liver function heart rate, unstable blood pressure, exaggeration of rapid and involuntary eye movements, heart problems which a frequency has not yet been determined):
weeks, medicines from the Selective Serotonin (rapid heart rate), coordination problems, severe guidelines.
Reuptake Inhibitors (SSRIs) group (for • Impaired kidney function reflexes, muscular rigidity, lack of coordination and/
mental disorder with hallucinations, hyperexcitability.
• Anxiety, restlessness, irritability, feeling jittery or Drug registration number at the national drug
depression or anxiety). • Difficulty passing urine or enlarged prostate (causes or gastrointestinal symptoms (nausea, vomiting, feelings of extreme happiness registry of the Ministry of Health:
• You are taking or have taken in the last frequent urination) diarrhea). If you forgot to take this medicine, take the next • Sleep disturbances 127-90-30770-00
two weeks other medicines for depression, • Impaired thyroid function Use of the medicine and food dose when needed, provided that the last dose was • A fast or irregular heartbeat or an increased
Manufacturer and registration holder:
psychiatric or emotional conditions or medicines • Impaired prostate function The medicine should be taken after a meal. taken at least 4 hours before taking the current dose. awareness of the heartbeat (palpitations)
Dexcel Ltd., 1 Dexcel St., Or Akiva 3060000, Israel
for Parkinson's disease. • You are or have ever been addicted to opioids, Do not take a double dose. • Drowsiness
alcohol, prescription medicines or illegal drugs Use of the medicine and alcohol consumption • High blood pressure
• You are taking other decongestants, additional During treatment with this medicine, do not consume Do not take medicines in the dark! Check the label
cough and cold medicines. • You have recently suffered from withdrawal and the dose each time you take a medicine. Wear • Abdominal pain, diarrhea, vomiting
symptoms such as: agitation, anxiety, sweating or alcohol due to the increased risk of liver damage. • Pain when passing urine
• You are taking medicines for the treatment of glasses if you need them.
heart problems from the beta-blockers group. shaking, when you have stopped taking alcohol or Pregnancy and breastfeeding If you have further questions on the use of this • Tingling or numbness of the hands or feet
• You suffer from heart disease or high blood drugs. Do not use this medicine if you are pregnant or medicine, consult the doctor or pharmacist. • Tremor
pressure. • Epilepsy breastfeeding. • Reduced blood flow to the optic nerve (Ischaemic
• You have diabetes. • Jaundice Driving and using machines 4. Side effects optic neuropathy)
Drug interactions Do not drive or operate dangerous machinery while • Dependence and addiction - when you stop taking