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 to be able to read it again if needed.
• 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. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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. Important 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 poisoning with alcohol, hypnotics, analgesics, or other psychotropic medicines (used to treat mental 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 epilepsy resistant to treatment,
• in women who are pregnant or breastfeeding.

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

• if the patient is taking other medicines containing tramadol or paracetamol. Paracetamol overdose may cause life-threatening liver damage in some patients.
• if the patient has liver damage or liver disease, 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 respiratory disorders, e.g. asthma or other lung diseases.
• in 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.
• if the patient has recently suffered a 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 with other medicines”). There is a small risk of developing so-called serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol alone. 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, the patient should immediately inform the doctor if they have severe illnesses, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (abnormality in blood and body fluids) have been reported in patients who take paracetamol regularly for a prolonged period or who take paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.
If undergoing anesthesia, inform the doctor or dentist about the use of Zaldiar.
Zaldiar should not be used in the treatment of opioid dependence, as it does not alleviate withdrawal symptoms.
Tolerance, psychological and physical dependence may develop, especially after 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 sleep-related breathing disorders such as sleep apnoea (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 another person notices these symptoms, contact the 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.
This 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 people have a variant of this enzyme, which may lead to different effects. In some individuals, pain relief may be insufficient, while in others, severe adverse effects may be more likely.
Discontinue use and contact the doctor immediately if the patient experiences any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
If any of these conditions have occurred in the patient’s past or during treatment with Zaldiar, inform the doctor. The doctor will decide whether to continue treatment.

Zaldiar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Important: this medicine contains paracetamol and tramadol. Inform the doctor about the use of other medicines containing paracetamol or tramadol to prevent 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 medicines containing alcohol.

Inform the doctor or pharmacist if the patient is taking:

• flucloxacillin (an antibiotic), due to a serious abnormality in blood and body fluids (called metabolic acidosis), which requires urgent treatment (see section 2).

The risk of adverse effects increases if the patient is taking the following medicines during treatment with Zaldiar:

• certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, or mirtazapine. Zaldiar may interact with these medicines and cause serotonin syndrome (see section 4 “Possible side effects”).
• other analgesics such as morphine and codeine (used as a cough suppressant), baclofen (muscle relaxant), antihypertensive medicines, or antihistamines, as they may increase the risk of central nervous system depression. If drowsiness or impaired concentration occurs, report it to 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 when other treatment options are not possible. If the doctor prescribes Zaldiar together with sedatives, the treating physician should limit the dose and duration of concomitant treatment. Inform the doctor about all sedative medicines being taken and strictly follow the doctor’s 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.
• medicines that may cause 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 suitable for them.
• warfarin or phenprocoumon (used to “thin” the blood). 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 taken concomitantly with:

• metoclopramide, domperidone, or ondansetron (anti-nausea and anti-vomiting medicines),
• cholestyramine (a medicine used to reduce blood cholesterol levels),
• ketoconazole or erythromycin (anti-infective 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 in alcoholic beverages and certain medicines) may intensify this effect. Do not drink alcohol while taking Zaldiar.

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more pronounced in them.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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.
Do not use Zaldiar during pregnancy or breastfeeding.
Studies on the effect of the combination of tramadol and paracetamol on fertility have not been conducted.

Driving and operating machinery
Zaldiar may cause drowsiness, which may affect the ability to drive or operate machinery. Do not drive or operate machinery while taking this medicine.

Zaldiar contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

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

3. How to use Zaldiar

This medicine should always be used as directed by the physician. If in doubt, consult your
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 controls the 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 your doctor.
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, on 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 extending 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 them.
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.
Taking more than the recommended dose of Zaldiar
If you take more than the recommended dose, even if you feel well, seek immediate medical advice from your doctor or pharmacist. There is a risk of liver damage, the symptoms of which may appear later.
Missing a dose of Zaldiar
If you miss a dose, pain may return. Do not take a double dose to make up for the missed dose; instead, continue taking the medicine as prescribed.
Stopping the use of Zaldiar
Do not suddenly stop using this medicine without medical advice. If the patient wishes to discontinue treatment, this should be discussed with the doctor, especially if the medicine has been used long-term.
The doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the likelihood of adverse effects (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: occur in more than 1 in 10 patients

• nausea,
• dizziness, drowsiness.

Common: may occur in up to 1 in 10 patients

• vomiting, gastrointestinal disturbances (constipation, bloating, diarrhoea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, abnormal excitement).

Uncommon: may occur in up to 1 in 100 patients

• 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 (black tarry stools),
• chills, hot flushes, chest pain,
• difficulty breathing,
• increased liver enzyme levels.

Rare: may occur in up to 1 in 1000 patients

• seizures, difficulty maintaining coordinated movements,
• dependence, delirium,
• blurred vision, pinpoint pupils,
• speech disturbances,
• 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), and 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),
• serious condition causing blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

The following adverse reactions have been observed in patients after using tramadol alone or paracetamol alone. However, if any of these occur after taking Zaldiar, they should be reported to a doctor:

• Fainting upon standing from 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, skin rash indicating an allergic reaction occurred, which may manifest as sudden swelling of face and neck, difficulty breathing, drop in blood pressure, and fainting. If any of the above symptoms occur, treatment must be discontinued and immediate medical advice sought. Do not restart treatment.

• 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 of large blisters, peeling of large sheets of epidermis, weakness, fever and joint pain). Treatment must be discontinued and immediate medical advice sought. Do not restart treatment.

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 unpleasant symptoms after abrupt discontinuation. These may include agitation, restlessness, anxiety or tremor. Patients may become 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 in a patient after stopping Zaldiar, medical advice should be sought.

In exceptional cases, blood test results may show abnormalities: e.g. low platelet count, which may lead to 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, immediate medical advice must be sought.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform a 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 provide more information on the safety of the medicine.

5. How to store Zaldiar

Keep this medicine out of the 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 required.
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. Each coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• Other components of the medicine are:
  Tablet core: microcrystalline cellulose; maize starch; sodium carboxymethyl starch (type A); maize starch; magnesium stearate.
  Tablet 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 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 packed in blisters made of paper/PET/Aluminium-PVC within a cardboard box.
Zaldiar is available in cardboard boxes containing 10, 20, 30, 50 and 90 tablets (10 tablets per blister).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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 authorisation numbers in Spain, the country of export:
714014.6
714048.1
603029.5

Parallel import licence number: 91/25