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

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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 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 (some 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 and 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. 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, jaundice, or liver and bile duct disease. This may be due to jaundice or liver and 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 epilepsy or seizures, or when 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.
• when 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").

In case of anesthesia, the patient should inform their doctor or dentist about the use of 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.
Sleep apnea
Zaldiar 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 staying asleep, 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. Some people have 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 applied to the patient in the past or occurred during treatment with 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 the use of other medicines containing paracetamol or tramadol to avoid overdose of these medicines.

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

• carbamazepine (commonly used as an antiepileptic and also for certain types of pain, such as severe facial pain called trigeminal neuralgia).
• other opioid painkillers, such as buprenorphine, nalbuphine, or pentazocine, as their analgesic effect may be weakened.
• alcohol, including medicines containing alcohol.

The risk of adverse reactions increases if the patient is taking:

Zaldiar and:

• 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, the patient should inform 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 together with sedatives, the doctor should limit the dose and duration of concurrent 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 these subjective and objective symptoms. In case of such symptoms, the patient should contact their doctor.
• medicines that may cause seizures, such as antidepressants or antipsychotics. The risk of seizures may increase if the patient is taking 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 be affected by the simultaneous use of:

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

The doctor will decide which medicines can be safely used 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

Zaldiar should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be more severe 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 and use machines. The patient should not drive or use machines while taking this medicine.

Zaldiar contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine 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 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 patient's individual response to treatment.
The patient should take the smallest effective dose to relieve pain.
If the doctor has not recommended 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.

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 renal or hepatic impairment, or those undergoing dialysis
Zaldiar should not be taken 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 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

In case of missing a dose of Zaldiar, 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 Zaldiar 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, 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 disturbances, 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, 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 (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,
• transient 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 level 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").

The following side effects have been observed in patients taking only tramadol or only paracetamol. However, if they occur after taking Zaldiar, 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, mood changes, changes in activity, changes in cognitive abilities, 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 patient experiences any of these symptoms, they should stop taking the medicine and immediately consult their 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 middle, large blisters bursting, shedding of large skin patches, weakness, fever, and joint pain) have been reported. The patient should stop taking the medicine and immediately consult their doctor. The patient should not restart taking the medicine.

In rare cases, the use of tramadol may lead to dependence and difficulties in stopping the medicine.
In rare cases, patients taking tramadol for some time may experience malaise after sudden discontinuation. They may experience: restlessness, 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 these 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 can lead to bleeding from the nose or 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, the patient should immediately consult their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the 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 of the 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

The medicine should be stored out of sight and reach of children.
Zaldiar should not be used after the expiry date stated on the packaging (edge of the carton and blister). The expiry date refers to the last day of the specified month.
There are no special precautions for storage.
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 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; cornstarch; sodium carboxymethylcellulose (type A); 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 what the packaging contains

Zaldiar coated tablets are pale yellow with the manufacturer's logo engraved on one side and T5 on the other side and are packaged in paper/PET/aluminum/PVC blisters.
Zaldiar is available in cartons of 10, 20, and 30 tablets (10 tablets per blister).
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany
STADA Arzneimittel AG, Stadastraße 2-18, 61118 Bad Vilbel, 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 the Czech Republic, the country of export: 65/237/02-C

Parallel import authorization number: 385/17

Date of leaflet approval:10.11.2022
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