Zaldiar

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Zaldiar, 37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride + Paracetamol

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.
• 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 as yours.
• 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 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 that contains 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 in combination with paracetamol.
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),
• in the 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, you should discuss it with your doctor or pharmacist.

• in case of taking other medicines containing tramadol or paracetamol. Overdose of paracetamol 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 analgesics.
• 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 a doctor (see section 4 "Possible side effects").

During treatment with Zaldiar, you should immediately inform your doctor if you have severe diseases, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition, chronic alcoholism, or if you 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 take paracetamol regularly for a long time or take 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, you should inform your 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 stopping opioids, may occur even after taking therapeutic doses and during short-term treatment.
Sleep apnea
Zaldiar may cause sleep apnea, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low oxygen level in the blood). The 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 notices 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, 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.
You should stop taking the medicine and immediately contact a doctor if you 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 applied to the patient in the past or occurred during the use of Zaldiar, they should inform their doctor. The doctor will decide whether to continue taking the medicine.

Zaldiar and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Important: this medicine contains paracetamol and tramadol. You should tell your doctor about taking other medicines containing paracetamol or tramadol to avoid overdosing on these medicines.

Concomitant useof Zaldiar with MAO inhibitors and for 14 days after their discontinuation is contraindicated(see "When not to take Zaldiar").
Concomitant use of Zaldiar 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 the analgesic effect may be weakened.
• alcohol, including medicines containing alcohol.

You should inform your doctor or pharmacist if you 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 takes:

Zaldiar concomitantly with:

• certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), 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, it should be reported to the doctor. Concomitant use of Zaldiar and sedatives, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can 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 with sedatives, the doctor should limit the dose and duration of concomitant treatment. You should inform the doctor about all sedatives taken and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives to be aware of the possibility of these subjective and objective symptoms. In case of such symptoms, you should contact a doctor.
• 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.

The effectiveness of Zaldiar 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 taken concomitantly with Zaldiar.

Zaldiar with food, drink, and alcohol

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

Children and adolescents

Use in children with respiratory disorders

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Tramadol is excreted into breast milk. Therefore, during breastfeeding, you should not take Zaldiar more than once, or if you have taken Zaldiar more than once, you 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 may affect your ability to drive and use machines. You should not drive or use machines while taking this medicine.

Zaldiar contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Zaldiar contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it 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, you should consult a doctor or pharmacist.
Zaldiar 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.
You should take the smallest effective dose to relieve pain.
Unless the doctor recommends otherwise, the recommended dose of Zaldiar is 2 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 tablets per day.

You should not take Zaldiar more frequently than recommended 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 renal or hepatic impairment, dialysis patients
You should not take Zaldiar in case of severe hepatic or renal impairment.
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.
The tablets should be taken whole, with a liquid. They should not be divided or crushed.
If you feel that the effect of Zaldiar is too strong (drowsiness or breathing difficulties occur) or too weak (the pain does not subside significantly), you should consult a doctor.

Overdose of Zaldiar

In case of taking a higher dose than recommended, even if you feel well, you 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

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

Stopping treatment with Zaldiar

You should not suddenly stop taking this medicine without the doctor's recommendation. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you 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, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zaldiar 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 feeling of well-being).

Uncommon: may occur in up to 1 in 100 patients

• increased heart rate or blood pressure, disorders of 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,
• dependence, hallucinations,
• blurred vision, pinpoint pupils,
• speech disorders,
• dilated pupils,
• short-term 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, the symptoms of which 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, lack of coordination, and (or) gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Zaldiar"),
• a serious condition that can make the blood more acidic (metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

The following side effects have been observed in patients taking only tramadol or only paracetamol. However, if they occur after taking Zaldiar, you should tell your 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 these symptoms occur, you should stop taking the medicine and immediately consult a doctor. You should not restart taking the medicine.

In rare cases, during the use of 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 flakes, weakness, fever, and joint pain) have been reported. You should stop taking the medicine and immediately consult a doctor. You should not restart taking the medicine.

In rare cases, the use of tramadol may cause dependence and difficulties in stopping the medicine.
In rare cases, in patients who have been taking tramadol for some time, after sudden discontinuation, a feeling of malaise may occur. The following symptoms may occur: 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 these symptoms occur after stopping Zaldiar, you should contact a 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 with medicines used to thin the blood (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. In case of any prolonged or unexpected bleeding, you should immediately consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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, you can help gather more information on the safety of the medicine.

5. How to store Zaldiar

The medicine should be stored out of sight and reach of children.
You should 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 hydrochloride and 325 mg of paracetamol.
• The other ingredients of the medicine are: Tablet core: cellulose, powder; corn starch; sodium carboxymethylcellulose (type A); corn starch; magnesium stearate.

Coating: hypromellose, titanium dioxide (E 171), macrogol 6000, yellow iron oxide (E 172), propylene glycol (E 1520), lactose monohydrate, talc.

What Zaldiar looks like and what the packaging contains

Zaldiar coated tablets are pale yellow in color with the manufacturer's logo embossed on one side and T5 on the other side and are packaged in paper/PET/Aluminum-PVC blisters in a carton box.
Zaldiar is available in carton boxes of 10, 20, 30, 50, and 90 tablets (10 tablets per blister).
For more detailed information, you should contact the marketing authorization holder or 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:Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged by:Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Spain, the country of export: 714014.6

• 714048.1
• 603029.5

Parallel import authorization number: 91/25

Date of leaflet approval:07.03.2025
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