Zaldiar Effervescent

Leaflet attached to the packaging: patient information

Zaldiar Effervescent, 37.5 mg + 325 mg, effervescent tablets

Tramadol hydrochloride + Paracetamol

You should carefully read the contents of the leaflet before using 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.
• If you have 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zaldiar Effervescent and what is it used for
• 2. Important information before using Zaldiar Effervescent
• 3. How to use 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 use of Zaldiar Effervescent is the symptomatic treatment of moderate to severe pain in patients for whom it is appropriate to use tramadol and paracetamol concomitantly.
The medicine is intended for use in adults and adolescents aged 12 and over.

2. Important information before using Zaldiar Effervescent

When not to use Zaldiar Effervescent:

• if the patient is hypersensitive to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6),
• in case of acute alcohol intoxication, sedatives, painkillers or other psychotropic drugs (used to treat mental disorders),
• in case of concomitant use of MAO inhibitors (certain drugs 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, the patient should discuss it with their doctor or pharmacist.

• in case of taking other medicines containing tramadol or paracetamol. Paracetamol overdose can cause life-threatening liver damage in some patients.
• in case of liver damage or disease, with alcoholic liver disease without cirrhosis, jaundice. 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 epilepsy and 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 drugs, 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").

During treatment with Zaldiar Effervescent, the patient should immediately inform their doctor if they experience severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins are present in the blood, leading to organ damage) or malnutrition, chronic alcoholism or if they are also taking flucloxacillin (an antibiotic). There have been reports of a serious disease called metabolic acidosis (a blood and fluid disorder) in patients who have taken paracetamol regularly for a long time or have taken paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
In case of anesthesia, the patient should inform their doctor or dentist about the use of Zaldiar Effervescent.
Zaldiar Effervescent should not be used to treat opioid dependence, as it does not alleviate their withdrawal symptoms.
Tolerance, psychological 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 therapeutic doses and short-term treatment.
Sleep apnea
Zaldiar Effervescent may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep 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 using 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.
Tramadol is converted in the liver by an enzyme. In some people, there is a certain variant 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 using the medicine and immediately contact a doctor if they experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
If any of these situations have occurred to the patient in the past or have occurred while using Zaldiar Effervescent, they should inform their doctor. The doctor will decide whether to continue using 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 use Zaldiar Effervescent".
Concomitant use of Zaldiar Effervescent with:

• carbamazepine (commonly used as an antiepileptic and also in certain types of pain, such as severe facial pain called trigeminal neuralgia) is not recommended.
• other opioid analgesics, such as buprenorphine, nalbuphine, 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), which requires emergency treatment (see section 2).

The risk of side effects increases if the patient is taking:

Zaldiar Effervescent and:

• certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and mirtazapine, as 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.

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

• metoclopramide, domperidone or ondansetron (antiemetic and antivomiting 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 used concomitantly with Zaldiar Effervescent.

Zaldiar Effervescent with food, drink, and alcohol

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

Children and adolescents

Use in children with respiratory disorders

Tramadol should not be used 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 a doctor or pharmacist before using 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 using this medicine.
The medicine contains a colorant - orange yellow (E 110), which may cause allergic reactions.
This medicine contains 7.8 mmol (or 179.4 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 use Zaldiar Effervescent

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult a 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 for pain relief.
Unless the doctor has otherwise directed, 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 directed by the 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
The patient should not take Zaldiar Effervescent in case of severe liver or kidney failure.
In case of mild or moderate failure, 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 a doctor.

Overdose of Zaldiar Effervescent

In case of taking a higher dose than recommended, even if the patient feels well, they should immediately consult a doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.

Missed dose of Zaldiar Effervescent

In case of missing a dose, the pain may return. The patient should not take a double dose to make up for the missed dose, but should continue using the medicine according to the established schedule.

Stopping treatment with Zaldiar Effervescent

The patient should not suddenly stop using this medicine without consulting a doctor. If the patient wants to stop using 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 using 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 using this medicine, the patient should consult a 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 disorders, mood changes (anxiety, nervousness, abnormal euphoria).

Uncommon: may occur in up to 1 in 100 patients

• increased heart rate or blood pressure, arrhythmias,
• difficulty urinating or pain,
• skin reactions (e.g., rash, hives),
• tingling, numbness or prickling sensation in the limbs, ringing in the ears, involuntary muscle twitching,
• depression, nightmares, hallucinations, 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 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).

The following side effects have been observed in patients taking only tramadol or only paracetamol. However, if they occur after using Zaldiar Effervescent, the patient should tell 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, mood changes, changes in activity, changes in cognitive function, worsening of asthma.
• •In rare cases, the following have been reported: skin rash indicating an allergic reaction, which may manifest as sudden swelling of the face and neck, difficulty breathing, low blood pressure, and fainting. If the above symptoms occur, the patient should stop using the medicine and immediately consult a doctor. The patient should not restart using the medicine.
• •During paracetamol use, 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 flakes, weakness, fever, and joint pain) have been reported. The patient should stop using the medicine and immediately consult a doctor. The patient should not restart using the medicine.

In rare cases, tramadol use may cause dependence and difficulties with withdrawal.
In rare cases, patients who have taken tramadol for some time may experience malaise after sudden discontinuation. They 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 ringing in the ears. If any of the above symptoms occur after discontinuing Zaldiar Effervescent, the patient should contact their doctor.
In exceptional cases, blood test results may show abnormalities, such as a low platelet count, which can lead to bleeding from the nose or gums.
Using 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 side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
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.
The patient should not use this medicine after the expiry date stated on the packaging (on the cardboard box, blister pack, or polypropylene tube). The expiry date refers to the last day of the month.
Effervescent tablets packaged in soft blisters:
Do not store above 25°C.
Effervescent tablets packaged in polypropylene tubes:
Do not store above 30°C.
After first opening: the patient should store it in the original packaging with the lid tightly closed.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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: anhydrous sodium citrate, anhydrous citric acid, povidone K 30, sodium bicarbonate, macrogol 6000, colloidal anhydrous silica, magnesium stearate, orange flavor, potassium acesulfame, 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:

• 1. Soft blister pack with aluminum foil and an outer layer of PET and an inner layer of PE, containing 2, 4, 6, or 10 effervescent tablets in a cardboard box. The single packaging contains: 2 effervescent tablets (1x2), 10 effervescent tablets (5x2), 20 effervescent tablets (5x4), 30 effervescent tablets (5x6), or 50 effervescent tablets (5x10).
• 2. Polypropylene tube with a desiccant and a polypropylene closure, containing 10 effervescent tablets in a cardboard box. The single packaging contains 10 effervescent tablets (1x10), 20 effervescent tablets (2x10), or 30 effervescent tablets (3x10).

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Phone: +48 22 737 79 20

Manufacturer:

• 1. Grünenthal GmbH Zieglerstrasse 6 52078 Aachen Germany
• 2. STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany

Date of last revision of the leaflet: 01/2025