Zaldiar

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Zaldiar, 37.5 mg + 325 mg, coated tablets
Tramadoli hydrochloridum + Paracetamolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Zaldiar is and what it is 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 pack and other information

1. What Zaldiar is and what it is used for

Zaldiar is a combination medicine containing two active substances with analgesic properties: tramadol hydrochloride and paracetamol.
Zaldiar is indicated for the symptomatic treatment of moderate to severe pain in patients for whom simultaneous administration of tramadol together with paracetamol is appropriate.
The medicine is intended for use in adults and adolescents aged 12 years and older.

2. Information before using Zaldiar

When not to use 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, hypnotics, analgesics, or other psychotropic medicines (used in the treatment of psychiatric disorders),
• during concomitant use of MAO inhibitors (certain medicines used to treat depression or Parkinson's disease) and within 14 days after their discontinuation,
• in severe hepatic insufficiency,
• in patients with treatment-resistant epilepsy,
• in women who are pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Zaldiar, discuss this with your doctor or pharmacist.

• when taking other medicines containing tramadol or paracetamol. Paracetamol overdose may cause life-threatening liver damage in some patients.
• in case of liver damage or liver disease, including alcoholic liver disease without cirrhosis, or yellowing of the eyes and skin. This may be due to jaundice or biliary tract disease.
• in case of kidney disease.
• in case of respiratory disorders, e.g., asthma or other lung diseases.
• in case of epilepsy or history of seizures, or when taking other medicines that lower the seizure threshold, particularly: selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, neuroleptics, centrally and locally acting analgesics.
• after recent head injury, shock, or severe headaches accompanied by vomiting.
• in case of dependence on any drugs, including analgesics such as morphine.
• when taking other analgesics containing buprenorphine, nalbuphine, or pentazocine.
• if the patient has depression and is taking antidepressants, because some of them may interact with tramadol (see "Zaldiar and other medicines"). There is a small risk of developing serotonin syndrome when tramadol is taken alone or in combination with certain antidepressants. If the patient experiences any symptoms of this serious condition, they should immediately consult a doctor (see section 4 "Possible side effects").

If undergoing anesthesia, inform the doctor or dentist about the use of Zaldiar.
Zaldiar must not be used in the treatment of opioid dependence, as it does not alleviate withdrawal symptoms.
Tolerance, psychological and physical dependence may develop, especially with long-term use.
Withdrawal symptoms similar to those seen after opioid discontinuation may occur even with therapeutic doses and short-term treatment.

Sleep-related breathing disorders
Zaldiar may cause breathing disorders during sleep, such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else notices these symptoms, contact a doctor. The doctor may consider reducing the dose.

If any of the following symptoms occur during treatment with Zaldiar, inform the doctor:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact the doctor, who will decide whether hormone replacement is necessary.

Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be inadequate, while in others, severe adverse reactions may be more likely.

Discontinue the medicine and contact a doctor immediately if any of the following adverse effects occur:
slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

If any of the above conditions have previously affected the patient or occur during treatment with Zaldiar, inform the doctor. The doctor will decide whether treatment should continue.

Zaldiar and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.

Important: this medicine contains paracetamol and tramadol. Inform your doctor about any other medicines containing paracetamol or tramadol to avoid overdose.

Concomitant use of Zaldiar with MAO inhibitors is contraindicated, as well as within 14 days after discontinuation of MAO inhibitors—see section "When not to use Zaldiar".

Concomitant use of Zaldiar is not recommended with:

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

The risk of adverse effects increases if the patient uses the following during treatment with Zaldiar:

• certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, or mirtazapine. Zaldiar may interact with these and cause serotonin syndrome (see section 4 "Possible side effects").
• other analgesics such as morphine and codeine (as a cough suppressant), baclofen (muscle relaxant), antihypertensives, and antihistamines, as they may increase the risk of central nervous system depression. If drowsiness or impaired concentration occurs, inform the doctor. Concomitant use of Zaldiar with sedatives such as benzodiazepines or related substances increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered if no other treatment options are available. If your doctor prescribes Zaldiar together with sedatives, the prescribing doctor should limit the dose and duration of combined treatment. Inform the doctor about all sedatives being taken and strictly follow dosing instructions. It may be helpful to inform family members or friends so they are aware of the possibility of the above-mentioned subjective and objective symptoms. If such symptoms occur, contact the doctor immediately.
• medicines that may provoke seizures, such as antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Zaldiar together with these medicines. The doctor should inform the patient whether Zaldiar is appropriate for them.
• warfarin or phenprocoumon (for "blood thinning"). The effect of these medicines may change, leading to bleeding. Any prolonged or unexpected bleeding requires immediate medical consultation. Prothrombin time should be monitored periodically.

The effectiveness of Zaldiar may be altered when used concomitantly with:

• metoclopramide, domperidone, or ondansetron (anti-nausea and antiemetic medicines),
• cholestyramine (a medicine used to reduce blood cholesterol levels),
• ketoconazole or erythromycin (antimicrobial medicines).

The doctor will decide which medicines can be safely used together with Zaldiar.

Zaldiar with food, drink, and alcohol
Zaldiar may cause drowsiness. Alcohol (including that contained in alcoholic beverages and certain medicines) may intensify drowsiness. Do not drink alcohol while taking Zaldiar.

Children and adolescents

Use in children with respiratory disorders
Tramadol is not recommended in children with respiratory disorders, as tramadol toxicity symptoms may be more pronounced in this group.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Tramadol is excreted in breast milk. Therefore, during breastfeeding, Zaldiar should not be taken more than once, or if Zaldiar has been taken more than once, breastfeeding should be discontinued.
Zaldiar must 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 operating machinery
Zaldiar may cause drowsiness, which may impair the ability to drive or operate machinery. Do not drive or operate machinery while taking this medicine.

Zaldiar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Zaldiar

This medicine should always be used as directed by the physician. If in doubt, consult a doctor or pharmacist.
Zaldiar should be used for the shortest duration possible.
Do not use this medicine in children under 12 years of age.
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment.
Use the lowest effective dose that adequately relieves pain.
Unless otherwise directed by the physician, the recommended dose of Zaldiar is 2 tablets for adults and adolescents aged 12 years and older.
If needed, the physician may recommend taking additional doses. Do not take subsequent doses more frequently than every 6 hours.
Do not take more than 8 tablets per day.
Do not take Zaldiar more frequently than prescribed by the physician.

Elderly patients
In patients over 75 years of age, elimination of tramadol from the body may be delayed. In these patients, the physician may recommend extending the interval between doses.

Patients with renal impairment, undergoing dialysis, or with hepatic impairment
Do not take Zaldiar in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the physician may recommend prolonging the time intervals between doses.

Method of administration
The tablets should be taken orally.
Tablets should be swallowed whole with liquid. Do not divide or chew the tablets.
If you feel that the effect of Zaldiar is too strong (e.g. drowsiness or breathing difficulties) or too weak (pain does not subside significantly), consult your doctor.

Overdose of Zaldiar
If an overdose of Zaldiar is taken, even if you feel well, seek immediate medical advice from a doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.

Missed dose of Zaldiar
If a dose is missed, pain may return. Do not take a double dose to make up for the missed dose; continue taking the medicine according to the prescribed schedule.

Stopping Zaldiar
Do not abruptly discontinue use of this medicine without medical advice. If a patient wishes to stop taking the medicine, this should be discussed with the physician, especially if the medicine has been taken long-term.
The physician will advise when and how to stop treatment; this may involve gradually reducing the dose to minimize the likelihood of withdrawal symptoms.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common: may occur in more than 1 in 10 people

• nausea,
• dizziness, drowsiness.

Common: may occur in up to 1 in 10 people

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

Uncommon: may occur in up to 1 in 100 people

• increased heart rate or blood pressure, disturbances in heart rate or rhythm,
• difficulty in passing urine or pain,
• skin reactions (e.g. rash, urticaria),
• tingling, numbness or pins and needles sensation in limbs, tinnitus, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not there), memory lapses,
• difficulty swallowing, blood in stool (tarry stools),
• chills, hot flushes, chest pain,
• difficulty breathing,
• increased liver enzyme values.

Rare: may occur in up to 1 in 1000 people

• seizures, difficulty maintaining coordinated movements,
• dependence, delirium,
• blurred vision, pinpoint pupils,
• speech disorders,
• excessive dilation of pupils,
• brief loss of consciousness (fainting).

Unknown frequency: cannot be estimated from available data

• decrease in blood sugar levels,
• hiccups,
• central sleep apnoea syndrome (cases of SIADH (syndrome of inappropriate antidiuretic hormone secretion) and hyponatraemia (low sodium levels in blood) have been reported in the literature, although a causal relationship with tramadol has not been established).
• serotonin syndrome, which may present with mental status changes (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, tachycardia, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 Important information before taking Zaldiar).

The following adverse reactions have been observed in patients using tramadol or paracetamol alone. However, if any of these occur after taking Zaldiar, inform your doctor:

• Fainting upon standing 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 levels, changes in cognitive abilities, worsening of asthma.
• In rare cases: skin rash indicating an allergic reaction, which may present with sudden swelling of the face and neck, difficulty breathing, low blood pressure and fainting. If any of these symptoms occur, stop taking the medicine immediately and consult a doctor without delay. Do not restart the medicine.
• During use of paracetamol, very rare cases of severe skin reactions have been reported (rash with blisters all over the body, erosions in the mouth, eyes, genital organs and on the skin, red spots on the trunk, often with blisters in the centre, bursting large blisters, peeling of large sheets of epidermis, weakness, fever and joint pain). Discontinue the medicine immediately and consult a doctor without delay. Do not restart the medicine.

In rare cases, use of tramadol may lead to dependence and difficulty discontinuing the medicine.
In rare cases, patients who have taken tramadol for some time may experience malaise after abrupt discontinuation. Symptoms may include: agitation, restlessness, anxiety or tremors. Patients may be hyperactive, have sleep problems and gastrointestinal disturbances.
A very small number of patients may experience panic attacks, hallucinations, or unusual sensations such as itching, tingling, numbness, or tinnitus. If any of the above symptoms occur after stopping Zaldiar, contact your doctor.
In exceptional cases, blood test results may show abnormalities: e.g. low platelet count, which may result in nosebleeds or bleeding gums.
Use of the medicinal product Zaldiar together 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, consult a doctor immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Zaldiar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (edge of the cardboard box and blister). The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zaldiar contains

• The active substances in this medicine are tramadol hydrochloride and paracetamol. One coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• Other components of the medicine are:
  Tablet core: microcrystalline cellulose; pregelatinized starch; sodium carboxymethyl starch (type A); maize starch; magnesium stearate.
  Tablet coating: Opadry Light Yellow YS-1-6382-G (hypromellose 2910 3cP, hypromellose 2910 6cP, titanium dioxide (E 171), polyethylene glycol 400, iron oxide yellow (E 172), polysorbate 80), carnauba wax.

What Zaldiar looks like and contents of the pack

Zaldiar coated tablets are pale yellow in colour, marked with the manufacturer's logo on one side and "T5" on the other side, and are packed in blisters made of Paper/PET/Aluminium/PVC.
Zaldiar is available in cardboard boxes containing 10, 20 or 30 tablets (10 tablets per blister).
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in the Czech Republic, 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
Authorisation number in the Czech Republic, country of export: 65/237/02-C
Authorisation number for parallel import: 385/17