Zaldiar Tablets Uses, Dosage, Side Effects, Precautions & Warnings

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zaldiar tablets english Generic drug of the therapeutic class: Analgesics
active principles: Tramadol , Paracetamol
laboratory: Grunenthal

Is Zaldiar the same as tramadol? and Important to know

• ZALDIAR is a combination of 2 analgesics, tramadol and paracetamol, which work together to relieve your pain.
• ZALDIAR is indicated for the treatment of moderate to severe pain when your doctor thinks that a combination of tramadol and paracetamol is needed.
• ZALDIAR is reserved for adults and adolescents from 12 years old.

What is Zaldiar tablets  37 5mg/325mg used for and indication?

Symptomatic treatment of moderate to severe pain.
The use of Zaldiar should be limited to patients with moderate to severe pain requiring treatment with a combination of paracetamol and tramadol ( see Pharmacodynamics ).

zaldiar tablets dosage

RESERVED FOR ADULTS and ADOLESCENT (from 12 years old)

Use of ZALDIAR should be limited to patients with moderate to severe pain requiring treatment with paracetamol and tramadol.

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

The recommended starting dose is 2 tablets of ZALDIAR. Additional doses may be administered as needed, without exceeding 8 tablets per day (300 mg tramadol and 2600 mg paracetamol).

The catches must be spaced at least 6 hours apart.

ZALDIAR should under no circumstances be administered longer than is strictly necessary (see Warnings and Precautions ). If the nature or severity of the disease requires repeated treatment or prolonged treatment, careful and regular monitoring should be carried out (with treatment breaks if possible) to check whether continuation of treatment is necessary.

zaldiar tablets dosage

children:

• The safety and efficacy of ZALDIAR have not been established in children under 12 years of age. Treatment is not recommended in this population.

Elderly

• The usual dosage may be used although a 17% increase in the elimination half-life of tramadol has been observed in healthy subjects over 75 years of age after oral administration.
•  In patients over 75 years of age, a minimum interval of 6 hours between dosages is recommended because of the presence of tramadol.

Renal failure:

• Due to the presence of tramadol, the use of ZALDIAR is not recommended in cases of severe renal impairment (creatinine clearance <10 ml / min).
• In patients with moderate renal impairment (creatinine clearance between 10 and 30 ml / min), the interval between doses should be 12 hours. Since tramadol is eliminated very slowly by hemodialysis or haemofiltration, post-dialysis is not usually necessary to maintain analgesia.

Hepatic insufficiency:

• ZALDIAR should not be used in patients with severe hepatic impairment . In patients with moderate hepatic impairment, an increase in the interval between doses should be carefully considered (see Warnings and Precautions ).

Administration mode:

Oral way.

The tablets should be swallowed as is, with a sufficient amount of liquid. They should not be split or chewed.

Contraindications

• Tramadol hypersensitivity
• Paracetamol hypersensitivity
• Acute poisoning with CNS depressants
• Severe hepatic impairment
• Uncontrolled epilepsy
• Child under 6
• Pregnancy

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

 Acute intoxication with alcohol, hypnotics, central analgesics, opioids or psychotropic drugs.

Zaldiar should not be administered to patients who are simultaneously treated or have been treated in the previous 2 weeks MAOI (see Interactions with other drugs and other forms of interaction).

Severe hepatic impairment.

 Epilepsy not controlled by treatment (see Warnings and Precautions).

How it works Zaldiar Tablets?

Pharmacotherapeutic group: Tramadol in combination , ATC code: N02AX52

ANALGESIC

• Tramadol is an opioid analgesic of central action. Tramadol is a nonselective agonist for the μ, δ and κ morphine receptors, with a higher affinity for μ receptors. In addition, the other mechanisms contributing to the analgesic effects of the product are inhibition of neuronal norepinephrine reuptake and increased serotonin release. Tramadol has an antitussive effect. Unlike morphine, a wide range of analgesic doses of tramadol have no respiratory depressant effect. Gastrointestinal motility is not changed either.
• The effects on the cardiovascular system are generally weak.
• The power of tramadol would be 1/10 to 1/6 of that of morphine.
• The exact mechanism of action of the analgesic properties of paracetamol remains to be established; it could involve central and peripheral actions.
• ZALDIAR is a level II analgesic in the WHO scale and should be considered as such by the prescriber.

zaldiar tablets side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 patients;

but first Does Zaldiar make you sleepy?

• · Nausea,
• · Feeling dizzy, drowsy.

Frequent: may affect up to 1 in 10 patients

• · Vomiting, difficult digestion (constipation, bloating, diarrhea), abdominal pain, dry mouth,
• · Itching, sweating (hyperhidrosis),
• · Headaches, tremors,
• · Confusional state, sleep disturbances, mood changes (anxiety, nervousness, euphoria).

Uncommon: may affect up to 1 in 100 patients

• · Increased blood pressure, heart rhythm disorders,
• · Tingling, numbness, tingling sensation in the limbs, tinnitus, involuntary muscle contractions,
• · Depression, nightmares, hallucinations (perception of things that do not exist in reality), amnesia,
• · Breathing difficulty.
• · Difficulty swallowing, blood in the stool,
• · Skin reactions (rashes, urticaria for example),
• · Increase in liver enzymes.
• · Albumin in urine, difficulty or pain when you urinate,
• · Chills, hot flashes, chest pains

Rare: may concern up toto 1 patient in 1000;

• · Convulsions, difficulty coordinating movements, transient loss of consciousness (syncope)
• · Drug dependence,
• · Delirium,
• · Blurred vision, narrowing of the pupil (myosis),
• · Speech disorders,
• · Excessive dilation of the pupil (mydriasis).

Frequency unknown: Frequency can not be estimated from the available data :

· Decreased blood sugar level (hypoglycemia)

The following side effects have been reported in people taking medicines containing only hydrochloride detramadol or paracetamol. Contact your doctor if you experience any of these effects while taking ZALDIAR:

• · Feeling weak when you get up after lying down or sitting down, heart rate decrease, appetite change, muscle weakness, slowed or weakened breathing, mood changes, activity changes, changes in mood perception, aggravation of existing asthma.
• · Using ZALDIAR with a treatment that thins the blood (eg coumarin derivatives, warfarin) may increase the risk of bleeding. You should immediately report to your doctor any prolonged or unexpected bleeding.
• · In rare cases, a rash, a sign of an allergic reaction, may develop with sudden swelling of the face and neck, difficulty breathing or decreased blood pressure and fainting. If you are concerned, stop your treatment and consult your doctor immediately. You must not continue taking this treatment.

In rare cases, taking a drug containing tramadol hydrochloride can cause dependence and make it difficult to stop treatment.

Some people have also had panic attacks, hallucinations, unusual sensations such as itching, tingling or numbness, and a ringing of ears. If you experience this type of symptoms after stopping, contact your doctor.

Exceptionally, blood tests may have revealed abnormalities, such as an abnormally low platelet count, which can cause bleeding from the nose or gums.

Very rare cases of serious skin reactions have been reported with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

Zaldiar Tablets Interactions :

Associations contraindicated

Non-selective MAOIs

Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.

 MAOI selective A

By extrapolation from non-selective MAOIs

Risk of serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion or coma.

Selective MAOI B

• Manifestations of central excitement evoking serotonin syndrome: diarrhea, tachycardia, sweating, tremors, confusion, even coma.
• In case of recent treatment by the MAOIs, observe a delay of 2 weeks before starting treatment with tramadol.

Associations advised against

Alcohol

• Alcohol enhancement of the sedative effect of opioid analgesics.
• Altered alertness can make driving dangerous and the use of machinery dangerous.
• Avoid taking alcoholic drinks and drugs containing alcohol.

Carbamazepine and other enzyme inducers

• Risk of decreased efficacy and duration of action due to decreased plasma concentrations of tramadol.
• Morphine agonist-antagonists (buprenorphine, nalbuphine, pentazocine).
• Decrease of the analgesic effect by competitive blocking of the receptors, with the risk of appearance of a withdrawal syndrome.

Associations to consider

Isolated cases of serotonin syndrome with a chronological link to therapeutic doses of tramadol have been reported in association with other serotoninergic drugs such as selective serotonin reuptake inhibitors (SSRIs) and triptans. Signs of serotonin syndrome may include:

Confusion, agitation, fever, sweat, ataxia, hyperreflexia, myoclonus and diarrhea.

Other morphine derivatives (including antitussives and substitution treatments), benzodiazepines, barbiturates.

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

Other central nervous system depressants, such as other morphine derivatives (including antitussive drugs and substitution treatments), barbiturates, benzodiazepines, other anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, central antihypertensives, thalidomide, baclofen.

These medications may increase the central depression. Altered alertness can make driving dangerous and the use of machinery dangerous.

Depending on the clinical needs, an evaluation of the prothrombin level should be carried out periodically in case of co-administration of ZALDIAR with warfarin-type derivatives, with lengthening of the INR reported.

 Other drugs known to inhibit CYP3A4,

Such as ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and probably also the metabolism of the O-demethylated active metabolite. The clinical significance of this interaction has not been studied.

Drugs that lower the epileptogenic threshold, such as bupropion, antidepressants, serotonin reuptake inhibitors, tricyclic antidepressants and neuroleptics.

Concomitant use of tramadol with these drugs may increase the risk of seizures. The rate of absorption of paracetamol can be increased by metoclopramide or domperidone and the absorption rate decreased by cholestyramine.

In a limited number of studies, pre- or post-operative use of the anti-emetic 5HT3 receptor antagonist (ondansetron) necessitated an increase in tramadol doses in patients treated for postoperative pain.

Warnings and Precautions :

Special warnings

• For adults and adolescents from 12 years. The maximum dose of 8 tablets of ZALDIAR should not be exceeded. To avoid the risk of accidental overdose, patients should be advised not to exceed the recommended dose and not to use other medicines containing paracetamol (including over-the-counter medications) or tramadol without the doctor’s advice.
• ZALDIAR is not recommended in patients with severe renal impairment (creatinine clearance <10 ml / min).
• ZALDIAR should not be administered in patients with severe hepatic impairment . The risks associated with paracetamol overdose are higher in patients with non-cirrhotic alcoholic liver injury. In patients with moderate hepatic impairment, careful consideration should be given to lengthening the dosing interval.
• ZALDIAR is not recommended in cases of severe respiratory failure.
• Tramadol is not suitable for substitution treatment in patients with opioid dependence. Indeed, although opioid antagonist, tramadol hydrochloride can not correct the withdrawal symptoms of opioids .

Seizures have been reported mainly in predisposed patients treated with tramadol and / or treated with drugs that may lower the seizure threshold, particularly selective serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, central analgesics or local anesthetics. Treatment-experienced epileptic patients or patients who may experience seizures should be treated with ZALDIAR only when absolutely necessary. Seizures have been reported in patients receiving tramadol hydrochloride at the recommended doses. The risk may be increased when doses of tramadol hydrochloride exceed the maximum recommended dose.

Concomitant administration of agonist-antagonist morphines (nalbuphine, buprenorphine, pentazocine) is not recommended .

Precautions for use

• Habituation and physical and / or mental dependence can develop, even at therapeutic doses. The clinical need for analgesic treatment should be reassessed on a regular basis. In patients with opioid dependence and in patients with a history of abuse or dependence, treatment should be short-term and under strict medical supervision.
• ZALDIAR should be used with caution in opioid-dependent patients, in patients with head trauma, in patients prone to seizures, in patients with bile duct dysfunction, in a state of shock, with an alteration of the original consciousness. unknown, central or peripheral disorders of the respiratory function or an increase in intracranial pressure.
• Overdosage with paracetamol may cause liver toxicity in some patients.
• Withdrawal symptoms similar to those seen during opioid withdrawal may occur even at therapeutic doses and for short-term treatment. Withdrawal symptoms can be avoided by gradually decreasing the doses at the end of treatment, especially after long periods of administration. Rare cases of dependence and abuse have been reported  .
• In one study, the use of tramadol during a general anesthesia with enflurane and nitrous oxide promoted intraoperative memory. In the meantime, new data is needed to prevent tramadol use during shallow anesthesia.
• ZALDIAR contains lactose. Patients should not take this medicine for hereditary history such as galactosemia, lactase deficiency or glucose-galactose malabsorption.

Drive and use machines:

Tramadol may cause drowsiness or dizziness, which may be exacerbated by alcohol or other central nervous system depressants. In the event of these symptoms, the patient must not drive or use machines.

Zaldiar and PREGNANCY / BREAST FEEDING / FERTILITY:

zaldiar when pregnant

• Since Zaldiar is a fixed combination of tramadol-based active ingredients, this medicine should not be used during pregnancy.

Data on paracetamol:

• The results of the epidemiological studies have not revealed the deleterious effect of paracetamol used at the recommended doses.

Tramadol data:

• Tramadol should not be used during pregnancy as there are no data of sufficient relevance to evaluate the safety of tramadol in pregnant women.
• Administered before or during delivery, tramadol does not affect uterine contractility. In neonates, it can induce changes in respiratory rate usually not clinically significant. Prolonged use during pregnancy may result in withdrawal syndrome in the newborn.

Breastfeeding

• Since Zaldiar is a fixed combination of active ingredients containing tramadol, this medicine should not be administered during breastfeeding.

Data on paracetamol:

• Paracetamol is excreted in breast milk in non-clinically significant amounts. To date, published data do not contraindicate breastfeeding in women using drugs containing only paracetamol.

Tramadol data:

• Tramadol and its metabolites are found in low amounts in breast milk. During breastfeeding, approximately 0.1% of the dose administered to the mother could be ingested by the newborn. Tramadol should not be administered during breastfeeding.

What should I do if I miss a dose?

If you forget to take the tablets, the pain may reappear. Do not double the dose you forgot to take. Continue your treatment as before.

What happens if I overdose from Zaldiar ?

See your doctor or pharmacist immediately, even if you feel well. There may be a risk of liver injury whose symptoms will appear later.

What is  Forms and Composition?

FORMS and PRESENTATIONS

37.5 mg / 325 mg film-coated tablet (light yellow):   Box of 20, in blister packs.

Hospital model: Box of 60.

COMPOSITION

	p cp
Tramadol (DCI) hydrochloride	37.5 mg
Paracetamol (INN)	325 mg

Excipients: Core: pulverized cellulose, pregelatinized starch, sodium carboxymethyl starch (type A), corn starch, magnesium stearate. Film coating :hypromellose, lactose monohydrate, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), propylene glycol, talc.

Lactose content: 1.784 mg / cp (as monohydrate: 1.878 mg / cp).

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.

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