Zaldiar

Leaflet accompanying the packaging: patient information

Zaldiar, 37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride + Paracetamol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 those 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 and what is it used for
• 2. Important information before taking Zaldiar
• 3. How to take Zaldiar
• 4. Possible side effects
• 5. How to store Zaldiar
• 6. Contents of the packaging and other information

1. What is Zaldiar and what is it used for

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

2. Important information before taking Zaldiar

When not to take Zaldiar:

• 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),
• when using MAO inhibitors (certain medicines used to treat depression or Parkinson's disease) and for 14 days after their withdrawal,
• 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, 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, yellowing of the eyes and skin. 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 painkillers.
• in case of a recent head injury, shock, or severe headaches with accompanying 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 and other medicines"). After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should immediately consult their doctor (see section 4 "Possible side effects").

During treatment with Zaldiar, 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. The symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
In case of anesthesia, the patient should inform their doctor or dentist about taking Zaldiar.
Zaldiar 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 taking therapeutic doses and during short-term treatment.
Respiratory disorders during sleep
Zaldiar may cause respiratory disorders during sleep, 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 notices these symptoms, they should contact their doctor. The doctor may consider reducing the dose.
If the patient experiences any of the following symptoms while taking Zaldiar, 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 their 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 taking the medicine and immediately contact their 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 taking Zaldiar, they should inform their doctor. The doctor will decide whether to continue treatment with the medicine.

Zaldiar 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 overdosing on these medicines.

Contraindicatedis the simultaneous use of Zaldiar with MAO inhibitors and for 14 days after their withdrawal, see "When not to take Zaldiar".
It is not recommended to use Zaldiar simultaneously with:

• carbamazepine (commonly used as an antiepileptic and also in certain types of pain, such as severe facial pain called trigeminal neuralgia).
• other opioid painkillers, such as buprenorphine, nalbuphine, pentazocine, as the 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 a serious blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

The risk of side effects increases if the patient takes:

• certain antidepressants, selective serotonin reuptake inhibitors, tricyclic antidepressants, and mirtazapine, as Zaldiar 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 occurs, the patient should report it to their doctor. The simultaneous use of Zaldiar and sedatives, such as benzodiazepines or derivatives, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, the simultaneous use of these medicines should only be considered

when other treatment options are not possible. If the doctor has prescribed Zaldiar with sedatives, the doctor should limit the dose and duration of simultaneous 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 and to contact a doctor if they occur.

• medicines that may cause seizures, such as antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Zaldiar with these medicines. The doctor should inform the patient whether Zaldiar is suitable for them.
• warfarin or phenprocoumon (for "thinning" the blood). The effect of these medicines may change, and bleeding may occur. Any prolonged or unexpected bleeding requires immediate consultation with a doctor. The prothrombin time should be checked periodically.

The effectiveness of Zaldiar may change when taken simultaneously with:

• metoclopramide, domperidone, or ondansetron (anti-nausea and vomiting 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.

Zaldiar with food, drink, and alcohol

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

Children and adolescents

Use in children with respiratory disorders

Tramadol 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 more than once, or if they have taken Zaldiar more than once, they should stop breastfeeding.
Zaldiar 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 may cause drowsiness, which can affect the ability to drive vehicles and operate machines. The patient should not drive vehicles or operate machines while taking this medicine.
This medicinal product contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicinal product is considered "sodium-free".

3. How to take Zaldiar

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 should be taken 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 is 2 tablets for adults and adolescents over 12 years of age.
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 tablets per day.

The patient should not take Zaldiar 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 should not be taken in case of severe liver or kidney failure.
In case of mild or moderate failure, the doctor may recommend prolonging the time intervals between doses.

Method of administration

The tablets should be taken orally.
The tablets should be taken whole, with a liquid. They should not be divided or crushed.
If the patient feels that the effect of Zaldiar 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 than recommended

In case of taking a higher dose of Zaldiar 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

If a dose of Zaldiar is missed, 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

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).
If the patient has any further doubts about taking this medicine, they 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, pathological euphoria).

Uncommon: may occur in up to 1 in 100 patients

• increased heart rate or blood pressure, heart rhythm disorders,
• 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, 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,
• brief loss of consciousness (fainting).

Unknown: frequency cannot be estimated from the available data

• decrease in 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, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, and lack of coordination and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Zaldiar"),

In rare cases, the use of tramadol may cause dependence and difficulties with withdrawal.
In rare cases, in patients taking tramadol for some time, after sudden withdrawal, a feeling of malaise may occur. Symptoms may include: 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 like itching, tingling, numbness, or ringing in the ears. If any of the above symptoms occur in the patient after stopping Zaldiar, they should contact their doctor.
In exceptional cases, blood test results may show abnormalities, such as a low platelet count, which may result in bleeding from the nose or gums.
Taking Zaldiar 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 their doctor.
Reporting side effects
If side effects occur, including those not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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 (edge of the carton and blister). The expiry date refers to the last day of the month.
No special storage precautions are required.
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 contains

• The active substances of Zaldiar are tramadol hydrochloride and paracetamol. One coated tablet contains 37.5 mg of tramadol and 325 mg of paracetamol.
• The other ingredients of the medicine are: Tablet core: Microcrystalline cellulose, pregelatinized starch, sodium carboxymethylcellulose, cornstarch, magnesium stearate. Tablet coating: Opadry Light Yellow YS-1-6382-G (hypromellose 2910 3cP, hypromellose 2910 6cP, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80), carnauba wax.

What Zaldiar looks like and contents of the pack

Zaldiar coated tablets are light yellow with a logo of the manufacturer  on one side and T5 on the other side and are packaged in child-resistant blisters (PVC/PVDC/Aluminum/PVC).
Zaldiar is available in cartons of 2, 10, 20, 30, 50, and 90 tablets (2 or 10 tablets per blister).

Marketing authorization holder:

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information about 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