Zaldiar Effervescent

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Zaldiar Effervescent (Zaldiar), 37.5 mg + 325 mg, effervescent tablets

Tramadol hydrochloride + Paracetamol
Zaldiar Effervescent and Zaldiar are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Zaldiar Effervescent and what is it used for
• 2. Important information before taking Zaldiar Effervescent
• 3. How to take Zaldiar Effervescent
• 4. Possible side effects
• 5. How to store Zaldiar Effervescent
• 6. Contents of the packaging and other information

1. What is Zaldiar Effervescent and what is it used for

Zaldiar Effervescent is a combination medicine that contains two active substances with analgesic effects: tramadol hydrochloride and paracetamol.
The indication for the use of Zaldiar Effervescent is the symptomatic treatment of moderate to severe pain in patients for whom it is appropriate to use tramadol in combination with paracetamol.
The medicine is intended for use in adults and adolescents aged 12 and over.

2. Important information before taking Zaldiar Effervescent

When not to take Zaldiar Effervescent:

• if the patient is allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• in case of acute alcohol intoxication, sleeping pills, painkillers, or other psychotropic medicines (used to treat mental disorders),
• in case of concurrent use of MAO inhibitors (certain medicines used to treat depression or Parkinson's disease) and for 14 days after their discontinuation,
• in severe liver failure,
• in patients with epilepsy that is resistant to treatment,
• in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Zaldiar Effervescent, you should discuss it with your doctor or pharmacist.

• in case of taking other medicines containing tramadol or paracetamol. Overdose of paracetamol can cause liver damage in some patients.
• in case of liver damage or disease, with alcoholic liver disease without cirrhosis, jaundice, and skin discoloration. This may be due to jaundice or bile duct disease.
• in case of kidney disease.
• in case of respiratory disorders, such as asthma or other lung diseases.
• in case of a history of seizures or taking other medicines that lower the seizure threshold, especially: selective serotonin reuptake inhibitors, tricyclic antidepressants, neuroleptics, centrally and locally acting analgesics.
• in case of a recent head injury, shock, or severe headaches with vomiting.
• in case of dependence on any medicines, including painkillers, such as morphine.
• in case of taking other painkillers containing buprenorphine, nalbuphine, or pentazocine.
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Zaldiar Effervescent and other medicines". After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of serotonin syndrome. If the patient experiences any symptoms of this serious syndrome, they should immediately consult a doctor (see section 4 "Possible side effects").

In case of anesthesia, you should inform your doctor or dentist about taking Zaldiar Effervescent.
Zaldiar Effervescent should not be used to treat opioid dependence, as it does not alleviate their withdrawal symptoms.
Tolerance, psychological dependence, and physical dependence on the medicine may develop, especially after long-term use.
Withdrawal symptoms similar to those after opioid withdrawal may occur even after taking therapeutic doses and in case of short-term treatment.
Sleep apnea
Zaldiar Effervescent may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact a doctor. The doctor may consider reducing the dose.
If the patient experiences any of the following symptoms while taking Zaldiar Effervescent, they should tell their doctor:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact a doctor, who will decide whether the patient needs hormone replacement therapy.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, the risk of serious side effects may be higher.
The patient should stop taking the medicine and immediately contact a doctor if they experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.
If any of these situations applied to the patient in the past or occurred while taking Zaldiar Effervescent, they should inform their doctor. The doctor will decide whether to continue taking the medicine.

Zaldiar Effervescent and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Important: this medicine contains paracetamol and tramadol. The patient should tell their doctor about taking other medicines containing paracetamol or tramadol to avoid overdose of these medicines.

Concomitant useof Zaldiar Effervescent with MAO inhibitors and for 14 days after their discontinuation is contraindicated, see "When not to take Zaldiar Effervescent".
Concomitant use of Zaldiar Effervescent with:

• carbamazepine (commonly used as an antiepileptic and also for certain types of pain, such as severe facial pain called trigeminal neuralgia) is not recommended.
• other opioid painkillers, such as buprenorphine, nalbuphine, or pentazocine, as their analgesic effect may be weakened.
• alcohol, including medicines containing alcohol.

The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (metabolic acidosis with a large anion gap), which requires urgent treatment and may occur especially in patients with severe kidney disorders, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol.

The risk of side effects increases if the patient takes:

the following medicines during treatment with Zaldiar Effervescent:

• certain antidepressants, selective serotonin reuptake inhibitors, tricyclic antidepressants, and mirtazapine. Zaldiar Effervescent may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• other painkillers, such as morphine and codeine (as a cough suppressant), baclofen (a muscle relaxant), blood pressure-lowering medicines, and antihistamines, as they may increase the risk of central nervous system depression. If drowsiness or decreased attention occur, the patient should inform their doctor. Concomitant use of Zaldiar Effervescent and sedatives, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use of these medicines should only be considered when other treatment options are not possible. If the doctor prescribes Zaldiar Effervescent together with sedatives, the doctor should limit the dose and duration of concomitant treatment. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of the above-mentioned symptoms. In case of their occurrence, the patient should contact a doctor.

The patient should tell their doctor or pharmacist if they are taking:

• warfarin or phenprocoumon (for "blood thinning"). The effect of these medicines may change, and bleeding may occur. Any prolonged or unexpected bleeding requires immediate consultation with a doctor. The patient should periodically have their prothrombin time checked.

The efficacy of Zaldiar Effervescent may be affected by concomitant use of:

• metoclopramide, domperidone, or ondansetron (anti-emetic and anti-nausea medicines),
• cholestyramine (a medicine used to lower cholesterol levels in the blood),
• ketoconazole or erythromycin (antibiotics).

The doctor will decide which medicines can be safely taken with Zaldiar Effervescent.

Zaldiar Effervescent with food, drink, and alcohol

Zaldiar Effervescent may cause drowsiness. Alcohol (including alcoholic beverages and some medicines) enhances the feeling of drowsiness. The patient should not drink alcohol while taking Zaldiar Effervescent.

Children and adolescents

Use in children with respiratory disorders

Zaldiar Effervescent is not recommended for use in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Tramadol is excreted into breast milk. Therefore, during breastfeeding, the patient should not take Zaldiar Effervescent more than once, or if they have taken Zaldiar Effervescent more than once, they should stop breastfeeding.
Zaldiar Effervescent should not be used during pregnancy and breastfeeding.
No studies have been conducted on the effect of the combination of tramadol and paracetamol on fertility.

Driving and using machines

Zaldiar Effervescent may cause drowsiness, which may affect the ability to drive and use machines. The patient should not drive or use machines while taking this medicine.
The medicine contains a colorant - orange yellow (E 110), which may cause allergic reactions.
This medicine contains 7.8 mmol (or 179.3 mg) of sodiumper dose.
The patient should talk to their doctor or pharmacist if they need to take 2 or more effervescent tablets per day for a long time. This is especially important for a low-sodium diet.
One tablet contains 2.9 mg of potassium.

3. How to take Zaldiar Effervescent

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Zaldiar Effervescent should be used for the shortest possible time.
The medicine should not be used in children under 12 years of age.
The dose should be adjusted according to the severity of the pain and the individual patient's response to treatment.
The patient should take the smallest effective dose to relieve pain.
Unless the doctor has recommended otherwise, the recommended dose of Zaldiar Effervescent is 2 effervescent tablets for adults and adolescents aged 12 and over.
If necessary, the doctor may recommend taking additional doses. Additional doses should not be taken more frequently than every 6 hours.

Do not take more than 8 effervescent tablets per day.

The patient should not take Zaldiar Effervescent more frequently than recommended by their doctor.
Elderly patients
In patients over 75 years of age, the elimination of tramadol from the body may be delayed. In these patients, the doctor may recommend prolonging the time interval between doses.
Patients with kidney or liver failure, or those undergoing dialysis
Zaldiar Effervescent should not be taken in case of severe liver or kidney failure.
In case of mild or moderate impairment, the doctor may recommend prolonging the time interval between doses.

Method of administration

The tablets should be taken orally.
An effervescent tablet should be dissolved in a glass of water.
If the patient feels that the effect of Zaldiar Effervescent is too strong (drowsiness or breathing difficulties) or too weak (pain does not subside significantly), they should consult their doctor.

Taking a higher dose of Zaldiar Effervescent than recommended

In case of taking a higher dose of the medicine than recommended, even if the patient feels well, they should immediately consult their doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.
Missing a dose of Zaldiar EffervescentIf the patient misses a dose, the pain may return. The patient should not take a double dose to make up for the missed dose but should continue taking the medicine according to the established schedule.

Stopping treatment with Zaldiar Effervescent

The patient should not suddenly stop taking this medicine without their doctor's recommendation. If the patient wants to stop taking the medicine, they should discuss it with their doctor, especially if they have been taking it for a long time.
The doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms).
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: occur in more than 1 in 10 patients

• nausea,
• dizziness, drowsiness.

Common: may occur in up to 1 in 10 patients

• vomiting, digestive disorders (constipation, bloating, diarrhea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremors,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, abnormal euphoria).

Uncommon: may occur in up to 1 in 100 patients

• increased heart rate or blood pressure, disturbances in heart rate or rhythm,
• difficulty urinating or pain,
• skin reactions (e.g., rash, hives),
• tingling, numbness, or a feeling of pins and needles in the limbs, ringing in the ears, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing, or feeling things that are not there), memory lapses,
• difficulty swallowing, blood in the stool (black stools),
• chills, hot flashes, chest pain,
• breathing difficulties,
• increased liver enzyme values.

Rare: may occur in up to 1 in 1000 patients

• seizures, difficulty coordinating movements,
• addiction, delirium,
• blurred vision, pinpoint pupils,
• speech disorders,
• dilated pupils,
• short-term loss of consciousness (fainting).

Unknown: frequency cannot be estimated from the available data

• decreased blood sugar levels,
• hiccups,
• central sleep apnea syndrome (cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatremia (low sodium levels in the blood) have been reported in the literature, although a causal relationship with tramadol has not been established).
• serotonin syndrome, the symptoms of which may include changes in mental status (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Zaldiar Effervescent").

The following side effects have been observed in patients taking only tramadol or only paracetamol. However, if they occur after taking Zaldiar Effervescent, the patient should inform their doctor:

• Fainting when standing up from a lying or sitting position, bradycardia (slow heart rate), collapse (fainting), changes in appetite, muscle weakness, slower or shallower breathing, changes in mood, changes in activity, changes in cognitive function, worsening of asthma.
• In rare cases, the following have occurred: skin rash indicating an allergic reaction, which may manifest as sudden swelling of the face and neck, difficulty breathing, decreased blood pressure, and fainting. If the above symptoms occur, the patient should stop taking the medicine and immediately consult a doctor. The patient should not restart taking the medicine.
• During treatment with paracetamol, very rare cases of severe skin reactions (rash with blisters all over the body, ulcers in the mouth, eyes, genitals, and skin, red spots on the torso, often with blisters in the center, large blisters bursting, peeling of large skin patches, weakness, fever, and joint pain) have been reported. The patient should stop taking the medicine and immediately consult a doctor. The patient should not restart taking the medicine.

In rare cases, taking tramadol may lead to addiction and difficulties in stopping the medicine.
In rare cases, after taking tramadol for some time, sudden discontinuation may cause a feeling of malaise. The patient may experience agitation, anxiety, nervousness, or tremors. Patients may be overactive, have sleep problems, and gastrointestinal disorders.
A very small number of patients may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or a feeling of pins and needles. If any of the above symptoms occur in the patient after stopping Zaldiar Effervescent, they should contact their doctor.
In exceptional cases, blood test results may show abnormalities, such as a low platelet count, which may lead to nosebleeds or bleeding gums.
Taking Zaldiar Effervescent with medicines used to thin the blood (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. In case of any prolonged or unexpected bleeding, the patient should immediately consult a doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zaldiar Effervescent

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zaldiar Effervescent contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. One effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients of the medicine are: sodium citrate, citric acid, povidone K 30, sodium bicarbonate, macrogol 6000, colloidal silica anhydrous, magnesium stearate, orange flavor (maltodextrin (corn), modified starch (E 1450), natural and artificial flavors), acesulfame potassium, sodium saccharin, orange yellow (E 110).

What Zaldiar Effervescent looks like and what the packaging contains

The tablet is round, flat with beveled edges, marbled, white to light pink in color.
The tablets are packaged in soft foil blisters with a PET outer layer and a PE inner layer, in a cardboard box.
The single-packaging contains: 20 effervescent tablets (5x4), 28 effervescent tablets (7x4), 32 effervescent tablets (8x4), or 48 effervescent tablets (12x4).
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Grünenthal Pharma, S.A., Doctor Zamenhof, 36, 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH, Zieglerstrasse 6, D-52078 Aachen, Germany

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Spain, the country of export:662457.9

Parallel import authorization number: 321/24

Date of leaflet approval: 07.08.2024

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