ZALDIAR

Israel - English - Ministry of Health

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Active ingredient:
PARACETAMOL; TRAMADOL HYDROCHLORIDE
Available from:
TEC-O-PHARM-LIBRA LTD
ATC code:
N02BE01
Pharmaceutical form:
FILM COATED TABLETS
Composition:
PARACETAMOL 325 MG; TRAMADOL HYDROCHLORIDE 37.5 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
GRUNENTHAL GMBH, GERMANY
Therapeutic group:
PARACETAMOL
Therapeutic area:
PARACETAMOL
Therapeutic indications:
Symptomatic treatment of moderate to severe pain.The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
Authorization number:
135 90 31296 00
Authorization date:
2012-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

26-05-2020

Patient package insert in accordance with the Pharmacists’ Regulations

(Preparations) – 1986

The medicine is dispensed according to a physician's prescription only

Name of preparation and form:

ZALDIAR

®

film-coated tablets

Active ingredients and quantity:

Tramadol Hydrochloride 37.5 mg

Paracetamol 325 mg

Inactive and allergic ingredients in the medicinal product – see section 6 and also

"Important information about some ingredients of the medicine" in section 2.

!

Read the entire leaflet carefully before using the medicine.

This leaflet contains concise information about the medicine. If you have any further

questions, refer to the physician or the pharmacist.

This medicine has been prescribed to treat your illness. Do not pass it on to others. It

may harm them, even if it seems like their disease is similar to yours.

1.

WHAT IS THE MEDICINE INTENDED FOR?

Zaldiar is a combination of two analgesics, tramadol and paracetamol, which work

together to relieve pain.

Zaldiar is intended for use only by adults and children over the age of 14.

Therapeutic group:

The preparation contains a combination of tramadol – a pain reliever from the

opioids group and paracetamol – a pain reliever and fever reducer from the anilide

group and is intended to treat moderate to severe pain.

2.

BEFORE USING THE MEDICINE:

Do not use the medicine if:

You are sensitive (allergic) to the active ingredients or to any of the additional

ingredients contained in the medicine (listed in section 6).

In cases of acute alcohol poisoning.

You are taking sleeping pills, pain relievers or medicines that affect mood and

emotions.

You are also taking medicines called monoamine oxidase inhibitors (MAOIs)

or have taken MAOIs in the last 14 days before treatment with Zaldiar. MAOIs

are used in the treatment of depression or Parkinson’s disease.

You have a severe liver disorder.

You have epilepsy that is not adequately controlled by your current medicine.

In children under the age of 14.

You are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility

section).

!

Special warnings regarding use of the medicine:

If you developed skin reactions in the past as a result of taking preparations

containing paracetamol, do not use preparations containing paracetamol, so that

severe skin reactions will not recur.

Before beginning Zaldiar treatment, inform your physician if:

You take medicines containing paracetamol or tramadol.

You have liver problems or disease, or your eyes and skin may turn yellow,

which may suggest jaundice.

You have kidney problems.

You have severe difficulties in breathing, for example asthma or severe lung

problems.

You have epilepsy or have already experienced fits or seizures.

You have recently suffered from a head injury, shock or severe headaches

associated with vomiting (being sick).

You are dependent on any medicine for example morphine.

You take other medicines to treat pain that contain buprenorphine,

nalbuphine or pentazocine.

You are going to have an anaesthetic (tell your physician or dentist that you

are taking Zaldiar).

If any of the above-mentioned points applied to you in the past or applies to you while

you are taking Zaldiar, please make sure your physician knows. He can then decide

whether you should continue to use this medicine.

Other Medicines and Zaldiar

If you are taking or have recently taken other medicines including non-

prescription medicines and food supplements, tell the physician or the

pharmacist.

Do not exceed the maximum daily doses of paracetamol or tramadol from this or

other medicines.

Do not take Zaldiar with MAOIs (see the section ‘Before using the medicine’).

Zaldiar is not recommended to be taken with the following:

carbamazepine (a medicine used to treat epilepsy or

some types of pain).

buprenorphine, nalbuphine or pentazocine (opioid-type

pain relievers).

The risk of side effects increases:

if you are taking triptans (used for migraine) or selective serotonin re-uptake

inhibitors (SSRIs, used for depression). Check with your physician if you

experience confusion, restlessness, fever, sweating, uncoordinated movement of

limbs or eyes, uncontrollable jerking of muscles or diarrhea.

if you are taking tranquilizers, sleeping pills, other pain relievers such as

morphine and codeine (also as cough medicine), baclofen (a muscle relaxant),

medicines used to lower blood pressure or medicines to treat allergies. Check

with your physician if you feel drowsy or feel faint.

if you are taking medicines which may cause convulsions (fits), such as certain

antidepressants or antipsychotics. The risk having a fit may increase if you take

Zaldiar at the same time. Your physician will tell you whether Zaldiar is suitable

for you.

if you are taking certain antidepressants. Zaldiar may interact with these

medicines and you may experience symptoms such as involuntary, rhythmic

contractions of muscles, including the muscles that control movement of the eye,

agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle

tension and body temperature above 38°C.

if you are taking warfarin or phenprocoumon (for blood thinning). The

effectiveness of such medicines may be altered and bleeding may occur (see

section 4).

The effectiveness of Zaldiar may be altered if you also take:

Metoclopramide, domperidone or ondansetron (medicines used to treat

nausea and vomiting/being sick).

Cholestyramine (medicine used to reduce cholesterol in the blood).

Your physician will advise you which medicines are safe to use with Zaldiar.

Zaldiar with food and alcohol:

Do not drink alcohol while you are taking Zaldiar, as you may feel drowsier.

Zaldiar may be taken with or without food.

Pregnancy, breastfeeding and fertility:

Do not take Zaldiar while you are pregnant or breastfeeding.

Check with your physician if you become pregnant during treatment with Zaldiar and

before taking any further tablets. Tramadol is excreted into breast milk. For this

reason, you should not take Zaldiar more than once during breastfeeding, or

alternatively, if you take Zaldiar more than once, you should stop breastfeeding.

Based on human experience, tramadol is suggested not to influence female or male

fertility. No data on the influence of the combination of tramadol and paracetamol on

fertility are available.

Ask your physician or pharmacist for advice before taking the medicine.

Driving and using machines:

If you feel drowsy while taking Zaldiar, do not drive, use tools or use machinery.

The medicine can affect your ability to drive as it may make you sleepy or dizzy.

Do not drive while taking this medicine until you know how it affects you.

Talk to your physician or pharmacist if you are not sure whether it is safe for you to

drive while taking this medicine.

Important information about some ingredients of the medicine:

Zaldiar contains lactose

If you have been told by your physician that you have an intolerance to some sugars,

contact your physician before taking this medicinal product.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use this medicine according to the physician’s instructions. You should check

with the physician or pharmacist if you are not sure.

The dosage should be adjusted to the intensity of your pain and your individual pain

sensitivity. In general the lowest pain-relieving dose should be taken.

Take Zaldiar for as short a time as possible, and no longer than your physician has

told you.

The dosage and treatment will be determined only by the physician.

The usual dose is an initial dosage of up to 2 tablets. If required, further tablets may

be taken, as instructed by your physician. The shortest time between doses must be

at least 6 hours.

Do not take more than 8 tablets per day (300 mg tramadol, 2600 mg

paracetamol). Do not use Zaldiar more often than your physician has told you.

Older people:

In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this

applies to you, your physician may recommend prolonging the dosage interval.

Severe liver or kidney disease (insufficiency)/dialysis patients:

Patients with severe liver and/or kidney insufficiency should not take Zaldiar. If in

your case the insufficiency is mild or moderate, your physician may recommend

prolonging the dosage interval.

Do not exceed the recommended dose.

Method of administration:

The tablets are for oral use.

Swallow the whole tablet with sufficient liquid.

Do not chew, divide, or crush the tablets!

If you think that the effect of Zaldiar is too strong (you feel very drowsy or have

difficulty breathing) or too weak (you do not have enough pain relief), contact your

physician.

If you take more Zaldiar than you should

If you mistakenly took more Zaldiar than instructed, contact your physician or

pharmacist immediately, even if you feel well. This is because too much paracetamol

can cause delayed, serious liver damage.

In case of overdose, or if a child accidently swallowed the medicine, immediately

refer to the emergency room of a hospital, and bring the medicine package with you.

Do not induce vomiting without a physician’s specific instruction!

If you forget to take Zaldiar

If you forget to take Zaldiar, pain is likely to return.

Do not take a double dose to make up for forgotten individual doses; simply continue

taking the tablets as before.

If you stop taking Zaldiar

Generally, there will be no side effects when treatment with Zaldiar is stopped.

Rarely, people who have been using a medicine containing tramadol may become

dependent on it, making it hard to stop taking it. If you have been taking Zaldiar for

some time and want to stop, contact your physician because your body may have

become used to Zaldiar.

People may:

feel agitated, anxious, nervous or shaky

be over active

have difficulty sleeping

have stomach or bowel disorders.

Very few people may also get:

panic attacks

hallucinations, unusual perceptions such as itching, tingling and numbness

ringing in the ears.

If you experience any of these effects after stopping this medicine, please contact

your physician.

Other side effect information is listed in section 4.

Do not take medicines in the dark!

Check the label and dose each time you take the medicine. Wear glasses, if you

need them.

If you have any other questions regarding the use of the medicine, consult the

physician or the pharmacist.

4. SIDE EFFECTS

As with all medicines, this medicine may cause side effects in some users. Do not be

alarmed when reading the list of side effects. You may not experience any of them.

Some side effects could be serious. Contact your physician immediately if any

of the following occur:

rarely cases of skin rash, indicating an allergic reaction, may develop with

sudden swelling of the face and neck, difficulties breathing or drop of blood

pressure and fainting. If this happens to you, stop treatment. Do not take the

medicine again.

prolonged or unexpected bleeding, from the use of Zaldiar with medicines

used to thin the blood (e.g. warfarin, phenprocoumon).

Paracetamol may, in rare cases, cause severe skin diseases. The possible

signs are: skin redness, rashes, blisters, extensive dermal injury. Severe

dermal side effects may also appear even if you have previously taken

preparations that contain the active agent paracetamol without any problem.

Additional Side Effects:

Additionally, if any of the following side effects get serious, contact your physician or

pharmacist:

Very common: may affect more than 1 in 10 people

nausea

dizziness, drowsiness.

Common: may affect up to 1 in 10 people

vomiting (being sick), digestion problems (constipation, flatulence, diarrhoea),

stomach pain, dry mouth

itching, sweating (hyperhidrosis)

headache, shaking

confusional state, sleep disorders, mood changes (anxiety, nervousness,

feeling of high spirits).

Uncommon: may affect up to 1 in 100 people

increase in pulse or blood pressure, heart rate or heart rhythm disorders

tingling, numbness or feeling of pins and needles in the limbs, ringing in the

ears, involuntary muscle twitching

depression, nightmares, hallucinations (hearing, seeing or sensing things that

are not really there), memory lapses

difficulty breathing

difficulty swallowing, blood in the stools

skin reactions (for example rashes, hives)

increase in liver enzyme values

presence of albumin in urine, difficulties or pain on passing urine

shivering, hot flushes, pain in the chest.

Rare: may affect up to 1 in 1,000 people

fits, uncoordinated movements, transient loss of consciousness (syncope)

drug dependence

delirium

vision blurred, constriction of the pupil (miosis)

speech disorders

excessive dilation of the pupils (mydriasis).

Frequency unknown:

decrease in blood sugar level (hypoglycaemia).

In addition, the following side effects have been reported by people using medicines

that contain only tramadol or only paracetamol:

feeling faint when getting up from a lying or sitting position, slow heart rate,

fainting

changes in appetite

muscle weakness, slower or weaker breathing

mood changes, changes in activity, changes in perception

worsening of existing asthma

nose bleeds or bleeding gums, which may result from a low blood platelet

count

very rare cases of serious skin reactions have been reported with

paracetamol

rare cases of respiratory depression have been reported with tramadol.

If a side effect has appeared, if any of the side effects gets worse, or if you suffer

from any side effect that has not been mentioned in the leaflet, you should consult

the physician.

Side effects may be reported to the Ministry of Health by clicking on the link “Report

Side Effects of Drug Treatment” found on the Ministry of Health homepage

(www.health.gov.il) which refers you to the online form for reporting side effects, or

by entering the link:

https://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffe

ctMedic@moh.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

Prevent poisoning!

This medicine, like all medicines, must be stored in a closed place out of the sight

and reach of children and/or infants, to avoid poisoning. Do not induce vomiting

without a physician’s specific instruction.

Do not use this medicine after the expiry date (exp. date), which is printed on the box

and on the blister. The expiry date refers to the last day of the indicated month.

The medicine is to be stored at a temperature not higher than 30°C.

6. ADDITIONAL INFORMATION

In addition to the active ingredients, the medicine also contains:

Tablet core:

Powdered cellulose, Maize starch, Pregelatinized starch, Sodium starch glycolate,

Magnesium stearate.

Film-coating:

Hypromellose, Lactose monohydrate, Titanium dioxide, Macrogol 6000, Yellow iron

oxide, Propylene glycol, Talc.

Each tablet contains 1.878 mg Lactose monohydrate.

What the medicine looks like and contents of the pack:

Zaldiar tablets are pale yellow film-coated tablets, marked with the manufacturer’s

logo on one side and “T5” on the other. Zaldiar is packed in blister packs of 10

tablets.

Zaldiar comes in packages of 10 and 20 film-coated tablets.

Not all pack sizes may be marketed.

Registration Owner: Tec-O-Pharm Libra Ltd., POB 45054 Jerusalem.

Manufacturer: Grunenthal GmbH, Aachen, Germany.

Registration number of the medicine in the National Drug Registry of the Ministry of

Health:

1359031296.

This leaflet was checked and approved by the Ministry of Health on 06.2016 and

updated according to the guidelines of the Ministry of Health in 12.2017.

ZL-LFC-1217-04

Zaldiar

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Zaldiar

37.5 mg/325 mg, film coated-tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol.

Excipients: One film coated tablet contains 1.878 mg lactose monohydrate (= 1.784 mg lactose).

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Film-coated tablet

Pale yellow film-coated tablet, marked with the manufacturer‘s logo

on one side and ‘T5’ on the

other side.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Zaldiar tablets are indicated for the symptomatic treatment of moderate to severe pain.

The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered to

require a combination of tramadol and paracetamol (see also Section 5.1).

4.2

Posology and method of administration

Posology

The use of Zaldiar should be restricted to patients whose moderate to severe pain is considered

to require a combination of tramadol and paracetamol.

The dose should be individually adjusted according to intensity of pain and response of the patient.

The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets

(equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be

exceeded. The dosing interval should not be less than six hours.

Adults and Adolescents (14 years and older).

An initial dose of two tablets of Zaldiar is recommended Additional doses can be taken as needed,

not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day.

The dosing interval should not be less than six hours.

Zaldiar should under no circumstances be administered for longer than is strictly necessary (see

also section 4.4 - Special warnings and precautions for use). If repeated use or long term treatment

with Zaldiar is required as a result of the nature and severity of the illness, then careful, regular

monitoring should take place (with breaks in the treatment, where possible), to assess whether

continuation of the treatment is necessary.

Paediatric population

The effective and safe use of Zaldiar has not been established in children below the age of 14

years. Treatment is therefore not recommended in this population.

Older people

A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest

hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged.

Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.

Renal insufficiency/dialysis

In patients with renal insufficiency the elimination of tramadol is delayed. In these patients

prolongation of the dosage intervals should be carefully considered according to the patient's

requirements.

Hepatic impairment

In patients with hepatic impairment the elimination of tramadol is delayed. In these patients

prolongation of the dosage intervals should be carefully considered according to the patient’s

requirements (see section 4.4). Because of the presence of paracetamol Zaldiar should not be used

in patients with severe hepatic impairment (see Section 4.3).

Method of administration

Oral use

Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or

chewed.

4.3

Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or

psychotropic drugs,

Zaldiar should not be administered to patients who are receiving monoamine oxidase

inhibitors or within two weeks of their withdrawal (see 4.5. Interactions with other

medicinal products and other forms of interaction),

severe hepatic impairment,

epilepsy not controlled by treatment (see. 4.4. Special Warnings).

4.4.

Special warnings and precautions for use

Warnings:

In adults and adolescents 14 years and older. The maximum dose of 8 tablets of Zaldiar

should not be exceeded. In order to avoid inadvertent overdose, patients should be advised

not to exceed the recommended dose and not to use any other paracetamol (including over

the counter) or tramadol hydrochloride containing products concurrently without the advice

of a physician.

In severe renal insufficiency (creatinine clearance <10 ml/mm), Zaldiar is not

recommended.

In patients with severe hepatic impairment Zaldiar should not be used ( See Section 4.3). The

hazards of paracetamol overdose are greater in patients with non- cirrhotic alcoholic liver

disease. In moderate cases prolongation of dosage interval should be carefully considered.

In severe respiratory insufficiency, Zaldiar is not recommended.

Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid

agonist, tramadol cannot suppress morphine withdrawal symptoms.

Convulsions have been reported in tramadol-treated patients susceptible to seizures or taking

other medications that lower the seizure threshold, especially selective serotonin re-uptake

inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics or local

anaesthesia. Epileptic patients controlled by a treatment or patients susceptible to seizures

should be treated with Zaldiar only if there are compelling circumstances. Convulsions have

been reported in patients receiving tramadol at the recommended dose levels. The risk may be

increased when doses of tramadol exceed the recommended upper dose limit

Concomitant use of opioid agonists-antagonists (nalbuphine, buprenorphine, pentazocine) is not

recommended (see section 4.5).

Paracetamol has been associated with a risk of rare but serious skin reactions. These skin

reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and

acute generalized exanthematous pustulosis (AGEP), can be fatal.

Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur

with the use of drug products that contain paracetamol. These reactions can occur with first-time

use of paracetamol or at any time while it is being taken.

Anyone who develops a skin rash or reaction while using paracetamol should stop the drug and seek

medical attention right away. Anyone who has experienced a serious skin reaction with paracetamol

should not take the drug again and should contact their health care professional to discuss alternative

pain relievers/fever reducers.

Health care professionals should be aware of this rare risk and consider paracetamol along with

other drugs already known to have such an association, when assessing patients with potentially

drug induced skin reactions.

Sleep-related breathing disorders

Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-

related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who

present with CSA, consider decreasing the total opioid dosage.

Precautions for use

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs

Concomitant use of Tramadol hydrochloride/Paracetamol and sedative medicines such as

benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative drugs should be reserved for

patients for whom alternative treatment options are not possible. If a decision is made to prescribe

Tramadol hydrochloride/Paracetamol concomitantly with sedative medicines, the lowest effective dose

should be used, and the duration of the concomitant treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and

sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware

of these symptoms (see section 4.5).

Tolerance and physical and/or psychological dependence may develop, even at therapeutic doses. The

clinical need for analgesic treatment should be reviewed regularly (see 4.2). In opioid-dependent

patients and patients with a history of drug abuse or dependence, treatment should only be for short

period and under medical supervision. Zaldiar should be used with caution in patients with cranial

trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an

altered state of consciousness for unknown reasons, with problems affecting the respiratory center or

the respiratory function, or with an increased intracranial pressure.

Paracetamol in overdose may cause hepatic toxicity in some patients.

Symptoms of withdrawal reaction, similar to those occurring during opiate withdrawal, may occur

even at therapeutic doses and for short term treatment (see section 4.8). Withdrawal symptoms may

be avoided by taper it at the time of discontinuation especially after long treatment periods. Rarely,

cases of dependence and abuse have been reported (see section 4.8).

In one study, use of tramadol during general anaesthesia with enflurane and nitrous oxide was reported

to enhance intra-operative recall. Until further information is available, use of tramadol during light

planes of anaesthesia should be avoided.

Zaldiar tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the

Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-

free'.

4.5

Interactions with other medicinal products and other forms of interaction

Concomitant use is contraindicated with:

Non-selective MAO Inhibitors

Risk of serotonergic syndrome: diarrhoea, tachycardia, hyperhidrosis, trembling, confusional state,

even coma.

Selective-A MAO Inhibitors

Extrapolation from non-selective MAO inhibitors

Risk of serotonergic syndrome: diarrhoea, tachycardia, hyperhidrosis, trembling, confusional

state, even coma.

Selective-B MAO Inhibitors

Central excitation symptoms evocative of a serotoninergic syndrome: diarrhoea, tachycardia,

hyperhidrosis, trembling, confusional state, even coma

.

In case of recent treatment with MAO inhibitors, a delay of two weeks should occur before treatment

with tramadol

Concomitant use is not recommended with:

Alcohol

Alcohol increases the sedative effect of opioid analgesics.

The effect on alertness can make driving of vehicles and the use of machines dangerous. Avoid intake

of alcoholic drinks and of medicinal products containing alcohol.

Carbamazepine and other enzyme inducers

Risk of reduced efficacy and shorter duration due to decreased plasma concentrations of tramadol.

Opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine)

Decrease of the analgesic effect by competitive blocking effect at the receptors, with the risk of

occurrence of withdrawal syndrome.

Concomitant use which needs to be taken into consideration:

Tramadol can induce convulsions and increase the potential for selective serotonin reuptake

inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic

antidepressants, antipsychotics and seizure threshold-lowering medicinal products (such as

bupropion, mirtazapine, tetrahydrocannabinol) to cause convulsions.

Concomitant therapeutic use of tramadol and serotonergic drugs such as selective serotonin

re-uptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), MAO

inhibitors (see section 4.3), tricyclic antidepressants and mirtazapine may cause serotonin

toxicity. Serotonin syndrome is likely when one of the following is observed:

Spontaneous clonus

Inducible or ocular clonus with agitation or diaphoresis ,

Tremor and hyperreflexia

Hypertonia and body temperature > 38 °C and inducible or ocular clonus.

Withdrawal of the serotonergic drugs usually brings about a rapid improvement. Treatment

depends on the type and severity of the symptoms.

Other opioid derivatives (including antitussive drugs and substitutive treatments),

benzodiazepines and barbiturates.

Increased risk of respiratory depression which can be fatal in cases of overdose.

Other central nervous system depressants, such as other opioid derivatives (including

antitussive drugs and substitutive treatments), barbiturates, benzodiazepines, other

anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics,

centrally-acting antihypertensive drugs, thalidomide and baclofen.

These drugs can cause increased central depression. The effect on alertness can make driving of

vehicles and the use of machines dangerous.

Sedating medicinal products such as benzodiazepines or related substances:

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs

increases the risk of sedation, respiratory depression, coma and death because of additive CNS

depressant effects. The dose and duration of the concomitant use should be limited (see section 4.4).

As medically appropriate, periodic evaluation of prothrombin time should be performed

when Zaldiar and warfarin like compounds are administered concurrently due to reports of

increased INR.

In a limited number of studies, the pre- or postoperative application of the antiemetic 5HT3

antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain.

4.6

Fertility, pregnancy and lactation

Pregnancy

Since Zaldiar is a fixed combination of active ingredients including tramadol, it should

not be used during pregnancy.

Data regarding paracetamol:

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used

in the recommended dosages.

Data regarding tramadol:

Tramadol should not be used during pregnancy as there is inadequate evidence available to

assess the safety of tramadol in pregnant women. Tramadol administered before or during birth

does not affect uterine contractility. In neonates it may induce changes in the respiratory rate

which are usually not clinically relevant. Long-term treatment during pregnancy may lead to

withdrawal symptoms in the newborn after birth, as a consequence of habituation.

Breast-feeding:

Since Zaldiar is a fixed combination of active ingredients including tramadol, it

should not be ingested during breast feeding.

Data regarding paracetamol:

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available

published data do not contraindicate breast feeding by women using single ingredient medicinal

products containing only paracetamol.

Data regarding tramadol:

Approximately 0.1% of the maternal dose of tramadol is excreted in breast milk. In the

immediate post-partum period, for maternal oral daily dosage up to 400 mg, this corresponds to a

mean amount of tramadol ingested by breast-fed infants of 3% of the maternal weightadjusted

dosage. For this reason tramadol should not be used during lactation or alternatively, breast-

feeding should be discontinued during treatment with tramadol. Discontinuation of breast-

feeding is generally not necessary following a single dose of tramadol.

Fertility

Post marketing surveillance does not suggest an effect of tramadol on fertility.

Animal studies did not show an effect of tramadol on fertility. No study on fertility was

accomplished with the combination of tramadol and paracetamol

4.7

Effects on ability to drive and use machines

Tramadol may cause drowsiness or dizziness, which may be enhanced by alcohol or other CNS

depressants. If affected, the patient should not drive or operate machinery.

4.8

Undesirable effects

The most commonly reported undesirable effects during the clinical trials performed with the

paracetamol/tramadol hydrochloride combination were nausea, dizziness and somnolence,

observed in more than 10 % of the patients.

The frequencies are defined as follows:

Very common:

≥1/10

Common:

≥1/100 to <1/10

Uncommon:

≥1/1000 to <1/100

Rare:

≥1/10 000 to <1/1000

Very rare:

<1/10 000

Unknown:

Frequency cannot be estimated from the available data

Within each frequency grouping, undesirable effects are presented in order of decreasing

seriousness.

Cardiac disorders:

Uncommon: palpitations, tachycardia, arrythmia.

Eye disorders:

Rare: vision blurred, miosis, mydriasis.

Ear and labyrinth disorders:

Uncommon: tinnitus.

Gastro-intestinal disorders:

Very common: nausea

Common: vomiting, constipation, dry mouth, diarrhea, abdominal pain, dyspepsia,

flatulence

Uncommon: dysphagia, melaena.

General disorders and administration site conditions:

Uncommon: chills, chest pain.

Investigations:

Uncommon: transaminases increased.

Metabolism and nutrition disorders:

Unknown: hypoglycaemia.

Nervous system disorders:

Very common: dizziness, somnolence

Common: headache, trembling

Uncommon: muscle contractions involuntary, paraesthesia, amnesia

Rare: ataxia, convulsions, syncope, speech disorders.

Psychiatric disorders:

Common: confusional state, mood altered, anxiety, nervousness, euphoric mood, sleep

disorders

Uncommon: depression, hallucinations, nightmares

Rare: delirium, drug dependence.

Post marketing surveillance

Very rare: abuse.

Renal and urinary disorders:

Uncommon: albuminuria, micturition disorders (dysuria and urinary retention).

Respiratory, thoracic and mediastinal disorders:

Uncommon: dyspnoea.

Skin and subcutaneous tissue disorders:

Common: hyperhidrosis, pruritus

Uncommon: dermal reactions (e.g. rash, urticaria).

Vascular disorders:

Uncommon: hypertension, hot flush.

Although not observed during clinical trials, the occurrence of the following undesirable

effects known to be related to the administration of tramadol or paracetamol cannot be

excluded:

Tramadol

Postural hypotension, bradycardia, collapse (tramadol).

Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect,

including elevation of prothrombin times.

Rare cases (10000 to < 1/1000) : allergic reactions with respiratory symptoms (e.g.

dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis

Rare cases (10000 to < 1/1000): changes in appetite, motor weakness, and respiratory

depression

Psychic side-effects may occur following administration of tramadol which vary

individually in intensity and nature (depending on personality and duration of

medication). These include changes in mood, (usually euphoric mood occasionally

dysphoria), changes in activity (usually suppression occasionally increase) and changes

in cognitive and sensorial capacity (e.g. decision behaviour perception disorders).

Worsening of asthma has been reported though a causal relationship has not been

established.

Symptoms of drug withdrawal syndrome, similar to those occurring during opiate

withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia,

hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that have very

rarely been seen if tramadol hydrochloride is discontinued abruptly include: panic

attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and unusual CNS

symptoms.

Paracetamol

Adverse effects of paracetamol are rare but hypersensitivity including skin rash may

occur. There have been reports of blood dyscrasias including thrombocytopenia and

agranulocytosis, but these were not necessarily causally related to paracetamol.

There have been several reports that suggest that paracetamol may produce

hypoprothrombinemia when administered with warfarin-like compounds. In other

studies, prothrombin time did not change.

Very rare cases of serious skin reactions have been reported.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

important. It allows continued monitoring of the benefit/risk balance of the medicinal

product. Any suspected adverse events should be reported to the Ministry of Health

according to the National Regulation by using an online form

https://sideeffects.health.gov.il

4.9

Overdose

Zaldiar

is a

fixed combination of active ingredients. In case of overdose, the symptoms

include the signs and symptoms of toxicity of tramadol or paracetamol

or of both these active

ingredients.

Symptoms of overdose from tramadol:

In principle, on intoxication with tramadol, symptoms similar to those of other centrally acting

analgesics (opioids) are to be expected. These include in particular, miosis, vomiting,

cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory

depression up to respiratory arrest.

Symptoms of overdose from paracetamol:

An overdose is of particular concern in young children. Symptoms of paracetamol overdosage

in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage

may become apparent 12 to 48 hours after ingestion.Abnormalities of glucose metabolism and

metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to

encephalophathy, coma and death. Acute renal failure with acute tubular necrosis may develop

even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been

reported.Liver damage is possible in adults who have taken 7.5-10 g or more of paracetamol. It

is considered that excess quantities of a toxic metabolite (usually adequately detoxified by

glutathione when normal doses of paracetamol are ingested), become irreversibly bound to

liver tissue.

Emergency treatment:

Transfer immediately to a specialised unit.

Maintain respiratory and circulatory functions

Prior to starting treatment, a blood sample should be taken as soon as possible after

overdose in order to measure the plasma concentration of paracetamol and tramadol and in

order to perform hepatic tests.

Perform hepatic tests at the start (of overdose) and repeat every 24 hours. An increase in

hepatic enzymes (ASAT, ALAT) is usually observed, which normalizes after one or two

weeks.

Empty the stomach by causing the patient to vomit (when the patient is conscious) by

irritation or gastric lavage.

Supportive measures such as maintaining the patency of the airway and maintaining

cardiovascular function should be instituted; naloxone should be used to reverse

respiratory depression; fits can be controlled with diazepam.

Tramadol

minimally eliminated from

the serum by haemodialysis

haemofiltration. Therefore treatment

of acute intoxication with

Zaldiar

with

haemodialysis

or haemofiltration alone

suitable for detoxification.

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of

significant early symptoms, patients should be referred to hospital urgently for immediate

medical attention and any adult or adolescent who had ingested around 7.5 g or more of

paracetamol in the preceding 4 hours or any child who has ingested

150 mg/kg of paracetamol

in the preceding 4 hours should undergo gastric lavage. Paracetamol concentrations in blood

should be measured later than 4 hours after overdose in order to be able to assess the risk of

developing liver damage (via the paracetamol overdose nomogram). Administration of oral

methionine or intravenous N-acetylcysteine (NAC) which may have a beneficial effect up to

at least 48 hours after the overdose, may be required. Administration of intravenous NAC is

most beneficial when initiated within 8 hours of overdose ingestion. However, NAC should

still be given if the time to presentation is greater than 8 hours after overdose and continued for

a full course of therapy. NAC treatment should be started immediately when massive

overdose is suspected. General supportive measures must be available.

Irrespective of the reported quantity of paracetamol ingested, the antidote for paracetamol,

NAC, should be administered orally or intravenously, as quickly as possible, if possible,

within 8 hours following the overdose.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Opioids in combination with non-opioid analgesics; tramadol and

paracetamol.

ATC code: N02A J 13X02

ANALGESICS

Tramadol is an opioid analgesic that acts on the central nervous system. Tramadol is a pure non

selective agonists of the µ,

, and

opioid receptors with a higher affinity for the µ receptors.

Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of

noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. Unlike

morphine, a broad range of analgesic doses of tramadol has no respiratory depressant effect.

Similarly, the gastro-intestinal motility is not modified. The cardiovascular effects are generally

slight. The potency of tramadol is considered to be one-tenth to one-sixth that of morphine.

The precise mechanism of the analgesic properties of paracetamol is unknown and may involve

central and peripheral effects.

Zaldiar is

positioned as

step II analgesic

pain ladder and

should

be utilised

accordingly by the physician.

5.2 Phamacokinetic properties

Tramadol is administered in racemic form and the [-] and [+] forms of tramadol and its metabolite

M1, are detected in the blood. Although tramadol is rapidly absorbed after administration, its

absorption is slower (and its half-life longer) than that of paracetamol.

After

single oral

administration of

tramadol/paracetamol

(37.5 mg/325 mg) tablet, peak

plasma concentrations of

64.3/55.5 ng/ml [(+)-tramadol/(-)-tramadol] and 4.2 µg/ml

(paracetamol) are reached

after 1.8

[(+)-tramadol/(-)-tramadol] and 0.9

(paracetamol)

respectively.

mean elimination half-lives

5.1/4.7 h [(+)-tramadol/(-)-tramadol]

and 2,5 h (paracetamol).

During pharmacokinetic studies

healthy volunteers

after single and repeated oral

administration of

Zaldiar,

no clinical

significant

change was

observed

kinetic parameters

of each active ingredient

compared

the parameters

active ingredients used alone.

Absorption:

Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean

absolute bioavailability of a single 100 mg dose is approximately 75 %. After repeated

administration, the bioavailability is increased and reaches approximately 90 %.

After administration of Zaldiar , the oral absorption of paracetamol is rapid and nearly complete

and takes place mainly in the small intestine. Peak plasma concentrations of paracetamol are

reached in one hour and are not modified by concomitant administration of tramadol.

The oral administration of Zaldiar with food has no significant effect on the peak plasma

concentration or extent of absorption of either tramadol or paracetamol so that Zaldiar can be

taken independently of meal times.

Distribution:

Tramadol has a high tissue affinity (V

=203

40 l). It has a plasma protein binding of about

20%.

Paracetamol appears to be widely distributed throughout most body tissues except fat. Its

apparent volume of distribution is about 0.9 l/kg. A relative small portion (~20%) of paracetamol

is bound to plasma proteins.

Metabolism:

Tramadol is extensively metabolized after oral administration. About 30 % of the dose is excreted

in urine as unchanged drug, whereas 60% of the dose is excreted as metabolites.

Tramadol is metabolised through O-demethylation (catalysed by the enzyme CYP2D6) to the

metabolite M1, and through N-demethylation (catalysed by CYP3A) to the metabolite M2. M1 is

further metabolised through N-demethylation and by conjugation with glucuronic acid. The plasma

elimination half-life of M1 is 7 hours. The metabolite M1 has analgesic properties and is more potent

than the parent drug. The plasma concentrations of M1 are several-fold lower than those of tramadol

and the contribution to the clinical effect is unlikely to change on multiple dosing.

Paracetamol is principally metabolized in the liver through two major hepatic routes:

glucuronidation and sulphation. The latter route can be rapidly saturated at doses above the

therapeutic doses. A small fraction (less than 4%) is metabolized by cytochrome P 450 to an

active intermediate (the N-acetyl benzoquinoneimine) which, under normal conditions of use, is

rapidly detoxified by reduced glutathione and excreted in urine after conjugation to cysteine and

mercapturic acid. However, during massive overdose, the quantity of this metabolite is increased.

Elimination:

Tramadol and its metabolites are eliminated mainly by the kidneys. The half-life of paracetamol is

approximately 2 to 3 hours in adults. It is shorter in children and slightly longer in the newborn

and in cirrhotic patients. Paracetamol is mainly eliminated by dose-dependent formation of

glucuro- and sulpho-conjugate derivatives. Less than 9 % of paracetamol is excreted unchanged

in urine. In renal insufficiency, the half-life of both compounds is prolonged.

5.3 Preclinical safety data

No preclinical study has been performed with the fixed combination (tramadol and paracetamol)

to evaluate its carcinogenic or mutagenic effects or its effects on fertility.

No teratogenic effect that can be attributed to the medicine has been observed in the progeny of

rats treated orally with the combination tramadol/paracetamol.

The combination tramadol/paracetamol has proven to be embryotoxic and foetotoxic in the rat at

materno-toxic dose (50/434 mg/kg tramadol/paracetamol), i.e., 8.3 times the maximum therapeutic

dose in man. No teratogenic effect has been observed at this dose. The toxicity to the embryo and

the foetus results in a decreased foetal weight and an increase in supernumerary ribs. Lower doses,

causing less severe materno-toxic effect (10/87 and 25/217 mg/kg tramadol/paracetamol) did not

result in toxic effects in the embryo or the foetus.

Results of standard mutagenicity tests did not reveal a potential genotoxic risk for tramadol in

man.

Results of carcinogenicity tests do not suggest a potential risk of tramadol for man.

Animal studies with tramadol revealed, at very high doses, effects on organ development,

ossification and neonatal mortality, associated with maternotoxicity. Fertility reproductive

performance and development of offspring were unaffected. Tramadol crosses the placenta. Male

and female fertility was not affected.

Extensive investigations showed no evidence of a relevant genotoxic risk of paracetamol at

therapeutic (i.e. non-toxic) doses.

Long-term studies in rats and mice yielded no evidence of relevant tumorigenic effects at

nonhepatotoxic dosages of paracetamol.

Animal studies and extensive human experience to date yield no evidence of reproductive

toxicity.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core:

powdered cellulose, maize starch, pregelatinised starch, sodium starch glycolate,

magnesium stearate

Film-coating: hypromellose, lactose monohydrate,titanium dioxide, macrogol 6000, yellow

iron oxide, propylene glycol, talc.

6.2

Incompatibilities

Not applicable.

6.3

Shelf-life

The expiry date of the product is indicated on the packaging materials

6.4

Special precautions for storage

Do not store above 30ºC

6.5

Nature and contents of container

Zaldiar tablets are packed in.paper/PET/aluminium-PVC blisters.

Box of 10 or 20 tablets

Not all packaging sizes may be marketed.

6.6

Special precautions for disposal and other handlings

No special requirements.

7.

MARKETING AUTHORISATION HOLDER

TEC-O-PHARM-LIBRA LTD

POB 45054, JERUSALEM 91450

8.

MANUFACTURER:

Grünenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany

9.

MARKETING AUTHORISATION NUMBER(S)

135-90-31296

ZL-LFP-0320-05

The content of this leaflet was approved by the Ministry of Health in October 2013 and and

updated according to the guidelines of the Ministry of Health in March 2020

ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה :ךיראת

30/09/2013

םושירה רפסמו תילגנאב רישכת םש

1359031296

Zaldiar

,

:םושירה לעב םש מ"עב הרביל-םראפ-וא-קט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט שמתשהל ןיא יתמ רישכתב .טסקט תנזהל ןאכ ץחל .טסקט תנזהל ןאכ ץחל שמתשהל ןיא ילבמ הפורתב ינפל אפורב ץעוויהל לופיטה תלחתה תלחממ ת/לבוס ךנה םייעמ וא תוילכ ,דבכ

אפורל חוודל ךילע ךנה םא וז הפורת לטונ ךנהש וא חותינ רובעל דמוע .המדרה דבכ תלחממ לבוס ךנה

םא וא וא ךלש םייניעה עבצש תנחבה רבד ,םיבוהצל וכפה ךלש רועה היעב וא תבהצ לע עיבצהל לוכיה הרמה יכרדב .הילכ תייעבמ לבוס ךנה םא וא חותינ רובעל דמוע ךנה וא אפורל ךכ לע רפס המדרה םייניש אפור

תורהזא

יאוול תועפות רבעב תחתיפ םא תליטנמ האצותכ תוירוע לומאטצרפ םיליכמה םירישכת םיליכמה םירישכת לוטיל ןיא בוש ומרגי אלש ידכ ,לומאטצרפ תורומח תוירוע תועפות

ןיב תובוגת תויתפורת

inhibitors

SSRI

לופיטל , לוכי םירידנ םירקמב ,)ןואכידב לטונ ךנה םא םינטפירט - וא )הנרגימל(

selective

"ןינוטורסה םורדניס" םרגיהל םייונישב אטבתהל לוכיה תונבצע :ןוגכ( ישפנה בצמב ,)תמדרת ,תויזה ,רתי :ןוגכ( תימונוטוא תוביצי-יא יתלב םד ץחל ,ריהמ בל בצק םייוקיל ,)הימרתרפיה ,ביצי :ןוגכ( םירלוקסומ-וריונ רסוח ,היסקלפ-רפיה םינימסת וא/ו )היצנידרואוק :ןוגכ( לוכיעה תכרעמ לש )רידנ( )לושלש ,האקה ,הליחב לע תועיפשמה תופורת תיזכרמה םיבצעה תכרעמ וא שוטשטל םרגל תויושע ולא תופורת .ןופליע תשוחת ,העגרהל תופורת תוללוכ ,ןוסניקרפב לופיטל ,הנישל דגנ ,היספליפאב לופיטל םימידרמ םירמוח ,תויגרלא םיבאכ יככשמו חותינל דגנ םיפוריסב םג( םייטוקרנ .לוהוכלאו )לועיש םד תשירק דגנ תופורת לש העפשהב הדירי ןכתת תוחקלנ ןהו הדימב ראידלאז :תואבה תופורתה םע דחי לופיטל( ןיפזאמברק - .)היספליפא יפקתהב םידיאויפוא םיבאכ יככשמ - :ומכ( םימייוסמ

nalbuphine,

buprenorphine,

pentazocine

לופיטל( ןורטסנדנוא -

serotonin re-uptake inhibitors

SSRI

םא .)ןואכידב לופיטל , ,רתי תונבצע ,לובלב שיגרמ ךנה ,םוח תועזה היצנידרואוק רסוח , תוינוצר אל םירירש תועונתו – לושלש וא םייניעב וא םייפגב .אפורל הנפ ,העגרהל תופורת לטונ ךנה םא - ןוגכ םיבאכ יככשמ וא ,הנישל דגנ םיפוריסב םג( ןיאדוקו ןיפרומ ,)לועיש תייפרהל הפורת( ןפולקב ץחל תדרוהל תופורת ,)םירירש ,םד .תויגרלא דגנ תופורת ינונשי שיגרתו ןכתי ולא םירקמב ןופלע תשוחת וא הלא םירקמב . .אפורל רפס תומיוסמ תופורת לטונ ךנה םא הווחתו ןכתי .ןואכד דגנ םירירש יצוויכ לש םימוטפמיס ,ןיעה ירירש ללוכ ,םיינוצר אל ,דער ,רתי תעזה, תונבצע סונוט ,םימזגומ םיסקלפר לעמ םוחו הובג םירירש

38°C

לטונ ךנה םא - דגנ תופורת םד תשירק לש תויביטקפאה . ונכתיו תונתשהל הלוכי תופורתה תידימ אפורל חוודל שי .םימומיד ךשוממ םומיד לש הרקמ לכ לע יופצ אל וא

לש העפשהב יוניש ןכתת דחי תוחקלנ ןהו הדימב ראידלאז :תואבה תופורתה םע ןודירפמוד וא דימארפולקוטמ תוליחב דגנ( ןורטסנדנוא )תואקהו לופיטל( ןימאריטסלוכ םדב לורטסלוכ רתיב

:הקנהו ןוירה .)תוליחבב הנמ תליטנב ,תאז םע דחי ךרדב ןיא ראידלאז לש תדדוב תא קיספהל ךרוצ ללכ .הקנהה ןיצימורתיראו לוזנוקוטק )םימוהיזב לופיטל(

)הלטוב וז הלקה( יאוול תועפות )החירפ( תוירוע תובוגת ,הליל יטויס תורידנ םיתיעל יביטינגוק דוקפתב הדירי תויועטל םורגל הלולעה ,ןובאיתב יוניש ,טופישב ,היצנידרואוק תוערפה ץחלב הילע ,היאר תוערפה ,םירירש תיווע ,יטיא קפוד ,םד ,דוריג( תוליגר אל תושוחת תבחרה )המודכו ץוצקע םינושיא

החירפ המגודל תוירוע תובוגת (תויחופלשו "ףיעס האר תורהזא שומישב תועגונה תודחוימ הפורתב

,)"

םיפקתה :תורידנ םיתיעל תוערפה ,םייטפליפא ,תורכמתה ,היצנידרואוק שוטשט היאר

רובידב תוערפה

תבחרה .הפוקניס ,םינושיא תוצווכתה וא שמתשת דציכ ?הפורתב

----

קרפל ראידלאז לוטיל שי ,ןורקעב .שרדנה רתויב רצקה ןמזה

ןונימה תא לוטיל שי יללכ ןפואב תעינמל ירשפאה רתויב ךומנה .באכ הרומח דבכ הלחמ

הקיפס יא(

לש הרקמב ראידלאז לוטיל ןיא תקיפס יא

דבכ

םא

לבוס ךנה תינוניב וא הלק דבכ תקיפס יאמ

ץילמהל יושע אפורה לע

תכראה חוורמ

.ןונימה תוילכ תלחמ

הקיפס יא(

ילוח הזילאיד

ץילמהל יושע אפורה לע תכראה

חוורמ

.ןונימה תעפשהש בשוח התא םא ךנה( ידמ הקזח איה ראידלאזה יישק ךל שי וא שטשוטמ שיגרמ ךוכיש( ידמ השלח וא )המישנ םע רשק רוצ ,)קפסמ וניא באכה ךלש אפורה

ראידלאז רתוי תלטנ םא אפורל תונפל שי ,תויחנההמ התא םא םג ,תידיימ חקורל וא ןוכיס םייקו תויה ,בוט שיגרמ עיפוהל לוכיש דבכל קזנ לש רתוי רחואמ

,תורידנ יאוול תועפות אפורל הנפ הבוגת חתפמ ךנה םא תאטבתמ .תיגרלא ,ןושלה ,םינפה תוחפנתהב החירפ ,העילבב ישוק ,עולה םלהו המישנב ישוק ,רועב .)קוש( יטקליפנא )החירפ( תוירוע תובוגת )תופסונ יאוול תועפות ףיעסב(

תובוגת קרפב קר תוסחייתה שי .תויתפורת ןיב ,תיגרלא הבוגת חתפמ ךניה םא םינפה תוחפנתהב תאטבתמה ראווצהו ישוק ,עולה ,ןושלה

ישוק ,רועב החירפ ,העילבב ,המישנב הדירי

םד ץחלב ןופליעו .)קוש( יטקליפנא םלהו , םירקמב םורגל לוכי לומטצרפ רוע תולחמ תעפוהל ,םירידנ םילוכי םהלש םינמיסהש תופירח ,תויחופלש ,החירפ ,םדוא :תויהל תועפות .תבחרנ תירוע העיגפ תולולע תופירח תוירוע יאוול תלטנ רבעב םא םג עיפוהל ביכרמה תא םיליכמה םירישכת .היעב אלל לומטצרפ ליעפה יאוול תועפות תועיפומ םא לופיטה קיספהל שי ,תוירוע ידיימ ןפואב אפורל תונפלו

םיאבה םירכומה יאוולה תועפות וחווד

ידי לע

םישמתשמה םישנא תופורתב

תוליכמה לודמרט קר קר וא

לומאטצרפ

םא

םתא םיווח

הלאמ דחא

תליטנ תעב ראידלאז ךכ לע חוודל שי , :אפורל

בצממ המיקב ןופלע תשוחת בל בצק ,הבישי וא הביכש יטיא ,תויופלעתה , ייוניש ןובאית ,םירירש תשלוח , המישנ רתוי תיטיא

וא

השלח ,רתוי

חור בצמ ייוניש םייוניש , תוליעפב םייוניש , ,הסיפתב המתסא לש הרמחה

.תמייק םירידנ םירקמב

רועב החירפ

לע העיבצמש תיגרלא הבוגת ףיעס האר(

תונפל שי" , דימ .)"םא ,אפורל םיגירח םירקמב ת ןכתי הריפס לש הכומנ

םד תויסט

אטבתתש ףאהמ םימומידב

וא

םייכינח .תוממדמ דחי ראידלאזב שומיש םדה לולידל תופורת םע לוכי שי .םימומידל ןוכיסה תא לידגהל םומיד לכ לע חוודל

וא ךשוממ יופצ יתלב

ידימ ןפואב אפורל

םע יאוול תועפות לופיטה תקספה לופיט תקספהל ,יללכ ןפואב .יאוול תועפות הנייהת אל םיטעמ םילפוטמ לצא ,םלוא תפוקת ךשמב ולפוטש דאמ וקיספהשו ,הכורא ןמז הפורתה תליטנ תא תימואתפ יאוול תועפות עיפוהל תויושע ,הדרח ,טקש יא :ןוגכ תומיוסמ וא םדריהל ישוק ,תונבצע םירקמב .םייעמו הביק תויעב ,הקינאפ יפקתה ונכתי םירידנ תוליגר אל תושוחתו ,תויזה םיינזואב שער ,ץוצקע ומכ ( תוגירח תועפות .)המודכו ,לובלב ומכ םיבצעה תכרעמב .רתויב תורידנ ןניה היונראפו תועפותמ תחא העיפומ םא תקספה רחאל הלאה יאוולה םע ץעייתהל אנ – לופיטה .ךלש אפורה אל לופיט תקספהל ,יללכ ןפואב ,םלוא .יאוול תועפות הנייהת דאמ םיטעמ םילפוטמ לצא ןמז תפוקת ךשמב ולפוטש תא תימואתפ וקיספהשו ,הכורא עיפוהל תולולע הפורתה תליטנ האר( תומיוסמ יאוול תועפות ףיעס

םא .)"יאוול תועפות" ךנה תכשוממ הפוקתל ראידלאז לטונ ץעייתהל אנ ,קיספהל ךנוצרבו ךפוגו ןכתיו תויה ךלש אפורה םע הפורתל לגרתה

ףיעס ךותמ

4

:)יאוול תועפות( ולטנש םישנא םירידנ םירקמב לודמרט םילולע ןמז ךרואל שוחל ערב

םה םא

לופיטה תא וקיספי .תוימואתפב

ונכתי ולא םירקמב ,תונבצע ,הדרח לש תושוחת תיביטקארפיה ,דער

םיישק הנישב

הביקב תוערפה

וא םייעמ

םישנא דואמ טעמ

ולבס ,הקינאפ יפקתהמ

,תויזה תושוחת

ץוצקעו דרג ו לומינ , שער םיינזואב

.)ןוטניט שוחתו הדימב ולא תועפות

תקספה רחאל ראידלאזב לופיטה אנא , הנפ ךלש אפורל

אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה :ךיראת

30/09/2013

:םושירה רפסמו תילגנאב רישכת םש

1359031296

Zaldiar

,

:םושירה לעב םש הרביל םראפ-וא-קט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט

Indication

Contraindication

Posology, dosage

and administration

The dose should be individually

adjusted according to intensity of pain

and response of the patient.

Elderly patients

The usual dosages may be used

although it should be noted that in

volunteers aged over 75 years the

elimination half life of tramadol was

increased by 17% following oral

administration. In patients over 75

years old, it is recommended that

the minimum interval between doses

should be not less than 6 hours, due

to the presence of tramadol

The dose should be individually adjusted

according to intensity of pain and response

of the patient. The lowest effective dose for

analgesia should generally be selected.

Elderly patients

A dose adjustment is not usually

necessary in patients up to 75 years

without clinically manifest hepatic or renal

insufficiency. In elderly patients over 75

years elimination may be prolonged.

Therefore, if necessary the dosage interval

is to be extended according to the patient's

requirements.

Special Warnings and

Special Precautions

for Use

Interaction with Other

Medicaments and

Other Forms of

Interaction

In isolated cases there have been

reports of Serotonin Syndrome in a

temporal connection with the

therapeutic use of tramadol in

combination with other

serotoninergic medicines such as

selective serotonin re-uptake

inhibitors )SSRIs( and triptans.

Signs of Serotonin Syndrome may

be for example, confusion, agitation,

fever, sweating, ataxia,

hyperreflexia, myoclonus and

diarrhoea.

Concomitant therapeutic use of

tramadol and serotoninergic drugs

such as selective serotonin re-uptake

inhibitors )SSRIs(, serotonin-

norephnepherine reuptake inhibitors

)SNRIs(, MAO inhibitors )see section

4.3(, tricyclic antidepressants and

mirtazapine may cause serotonin

toxicty. Serotonin Syndrome is likely

when one of the following is observed:

Spontaneous clonus, Inducible or

ocular clonus with, agitation, or

diaphoresis, Tremor and

hyperreflexia,Hypertonia and body

temperature > 38°C and inducible or

oclurar clonus .Withdrawal of the

serotonergic drugs usually brings

about a rapid improvement.

Treatment depends on type and

severity of symptoms

Medicinal products reducing

the seizure threshold, such as

bupropion, serotonin reuptake

inhibitor antidepressants,

tricyclic antidepressants and

neuroleptics. Concomitant use

of tramadol with these drugs

can increase the risk of

convulsions.

Tramadol can induce convulsions and

increase the potential for selective

serotonin reuptake inhibitors )SSRIs(,

serotonin-norepinephrine reuptake

inhibitors )SNRIs(, tricyclic antidepressants

antipsychotics and other seizure

threashold-lowering medicinal products

)such as bupropion, mirtazapine,

tetrahydrocannabinol( to cause

convulsions.

Fertility, pregnancy

and Lactation

Long-term treatment during pregnancy may

lead to withdrawal symptoms in the newborn

after birth, as a consequence of habituation

Adverse events

Central and peripheral nervous system

disorders:

Rare )≥ 1/10000 to < 1/1000(: ataxia,

convulsions

Vision disorders

:

Rare )<0.1 %(: blurred vision

Central and peripheral nervous system

disorders:

Rare )≥ 1/10000 to < 1/1000(: ataxia,

convulsions, speech disorder, syncope.

Eye disorders:

Rare )≥ 1/10000 to < 1/1000(: vision blurred

, miosis, mydriasis

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