Zaldiar effervescent

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Zaldiar Effervescent (Zaldiar), 37.5 mg + 325 mg, effervescent tablets
Tramadoli hydrochloridum + Paracetamolum
Zaldiar Effervescent and Zaldiar are different trade names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, 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 others, 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 of the leaflet

1. What Zaldiar Effervescent is and what it is used for
2. Important information before taking Zaldiar Effervescent
3. How to take Zaldiar Effervescent
4. Possible side effects
5. How to store Zaldiar Effervescent
6. Contents of the pack and other information

1. What Zaldiar Effervescent is and what it is used for

Zaldiar Effervescent is a combination medicine containing two active substances with analgesic properties: tramadoli hydrochloridum and paracetamolum.
Zaldiar Effervescent is indicated for the symptomatic treatment of moderate to severe pain in patients for whom combined therapy with tramadol and paracetamol is appropriate.
This medicine is intended for use in adults and adolescents aged 12 years and older.

2. Important information before using Zaldiar Effervescent

When not to use Zaldiar Effervescent:

• 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, sedatives, 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 Effervescent, discuss this with your doctor or
pharmacist.
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• when taking other medicines containing tramadol or paracetamol. Paracetamol overdose may cause potentially life-threatening liver damage in some patients.
• in case of liver damage or liver disease, alcoholic liver disease without cirrhosis, 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. in 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, tricyclic antidepressants, neuroleptics, centrally and locally acting analgesics.
• if recent head injury, shock, or severe headaches with accompanying vomiting have occurred.
• in case of addiction to any medicines, including analgesics such as morphine.
• when taking other analgesics containing buprenorphine, nalbuphine, or pentazocine.
• if the patient suffers from depression and is taking antidepressants, because some of them may interact with tramadol (see "Zaldiar Effervescent and other medicines"). There is a small risk of developing so-called serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should seek immediate medical advice (see section 4 "Possible side effects"). During treatment with Zaldiar Effervescent, the doctor should be informed immediately if the patient has 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 Effervescent.
Zaldiar Effervescent 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 prolonged use.
Withdrawal symptoms similar to those seen after opioid discontinuation may occur even with therapeutic doses and during short-term treatment.

Sleep-related breathing disorders
Zaldiar Effervescent may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, contact the doctor. The doctor may consider reducing the dose.
If any of the following symptoms occur during treatment with Zaldiar Effervescent, 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.
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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 insufficient, while in others, severe adverse effects are more likely.
Discontinue the medicine and contact the 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 these situations have previously affected the patient or occur during treatment with Zaldiar Effervescent, inform the doctor. The doctor will decide whether treatment should continue.

Zaldiar Effervescent and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Important: this medicine contains paracetamol and tramadol. Inform your doctor about the use of
other medicines containing paracetamol or tramadol to prevent overdose of these
medicines.
Concomitant use of Zaldiar Effervescent with MAO inhibitors is contraindicated,
as well as within 14 days after discontinuation of MAO inhibitors, see section "When not to use Zaldiar Effervescent".
Concomitant use of Zaldiar Effervescent is not recommended with:

• carbamazepine (commonly used as an antiepileptic and also in certain types of pain, such as severe facial pain attacks 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 blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

The risk of adverse effects increases if the patient, during treatment with
Zaldiar Effervescent, takes:

• certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and mirtazapine; Zaldiar Effervescent may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• other analgesics such as morphine and codeine (as a cough suppressant), baclofen (muscle relaxant), antihypertensive medicines, 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 Effervescent and 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 no other treatment options are available. If the doctor prescribes Zaldiar Effervescent together with sedatives, the prescribing doctor should limit the dose and duration of concomitant treatment. Inform the doctor about all sedative medicines being taken and strictly follow the doctor's dosage 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. In case of such symptoms, contact the doctor.

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• medicines that may cause seizures, such as antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Zaldiar Effervescent together with these medicines. The doctor should inform the patient whether Zaldiar Effervescent is suitable for them.
• warfarin or phenprocoumon (for "thinning" 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 Effervescent may change 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
Effervescent.

Zaldiar Effervescent with food, drink, and alcohol
Zaldiar Effervescent may cause drowsiness. Alcohol (including in alcoholic beverages and certain medicines) may intensify drowsiness. Do not drink alcohol during treatment with Zaldiar Effervescent.

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 them.

Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans 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 Effervescent should not be taken more than once, or if Zaldiar Effervescent has been taken more than once, breastfeeding should be discontinued.
Do not use Zaldiar Effervescent during pregnancy and breastfeeding.
Studies on the effect of the combination of tramadol and paracetamol on fertility have not been conducted.

Driving and operating machinery
Zaldiar Effervescent may cause drowsiness, which may affect the ability to drive and operate machinery. Do not drive or operate machinery during treatment with this medicine.

This medicine contains a colouring agent - Sunset Yellow (E 110), which may cause allergic reactions.
This medicine contains 7.8 mmol (or 179.4 mg) of sodium per dose.
Talk to your doctor or pharmacist if the patient needs to take 2 or more effervescent tablets daily for a prolonged period. This is particularly important if on a low-sodium diet.
One tablet contains 2.9 mg of potassium.
This medicine contains sulphites (ingredient of the orange flavour) – This medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Zaldiar Effervescent

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This medicine should always be used exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
Zaldiar Effervescent 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 doctor, the recommended dose of Zaldiar Effervescent is 2 effervescent tablets for
adults and children aged 12 years and older.
If needed, the doctor may recommend taking additional doses. Do not take further doses more frequently than every 6 hours.
Do not exceed 8 effervescent tablets per day.
Do not take Zaldiar Effervescent more frequently than prescribed by the doctor.
Elderly patients
In patients over 75 years of age, elimination of tramadol from the body may be delayed. In these
patients, the doctor may recommend extending the interval between doses.
Patients with renal impairment, on dialysis, or with hepatic impairment
Do not take Zaldiar Effervescent in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, the doctor may recommend extending the intervals
between doses.
Method of administration
The tablets should be taken orally.
An effervescent tablet should be dissolved in a glass of water.
If you feel that the effect of Zaldiar Effervescent is too strong (e.g. drowsiness or breathing difficulties) or too weak (pain not significantly subsiding), consult your doctor.
Taking more than the recommended dose of Zaldiar Effervescent
If you take more than the recommended dose, 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.
Missing a dose of Zaldiar Effervescent
If you miss a dose, 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 Effervescent
Do not suddenly stop taking this medicine without medical advice. If the patient wishes to discontinue the medicine, this should be discussed with the doctor, especially if the medicine has been taken 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 withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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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, digestive disorders (constipation, bloating, diarrhoea), stomach pain, dry mouth,
• itching, excessive sweating,
• headache, tremors,
• 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 urinating 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 really there), memory lapses,
• difficulty swallowing, blood in stool (tarry stools),
• chills, hot flushes, chest pain,
• breathing difficulties,
• 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 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 literature, although a causal relationship with tramadol has not been established),
• serotonin syndrome, which may present with changes in mental status (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 Effervescent),
• serious condition causing the 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 Effervescent, you should inform your doctor:

• Fainting upon standing up 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.

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• In rare cases: skin rash indicating an allergic reaction, which may present as sudden swelling of the face and neck, difficulty breathing, low blood pressure, and fainting. If any of the above symptoms occur, treatment must be discontinued immediately and medical advice sought without delay. 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, rupturing of large blisters, peeling off large sheets of epidermis, weakness, fever and joint pain). Treatment must be discontinued immediately and medical advice sought without delay. Do not restart treatment.

In rare cases, use of tramadol may lead to dependence and difficulty discontinuing the medicine.
In rare cases, in patients who have been taking tramadol for some time, abrupt discontinuation may result in feeling unwell. Symptoms may include: agitation, anxiety, nervousness or tremors. Patients may become hyperactive, have trouble sleeping and experience 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 Effervescent, contact a doctor.

In exceptional cases, blood test results may show abnormalities: e.g. low platelet count, which may lead to nosebleeds or bleeding gums.
Use of Zaldiar Effervescent 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, seek medical advice 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 also be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse reactions, additional information on the safety of this medicine can be collected.

5. How to store Zaldiar Effervescent

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 Effervescent contains

• The active substances in this medicinal product are tramadol hydrochloride and paracetamol. One effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

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• Other components of the medicine are: sodium citrate, citric acid, povidone K 30, sodium hydrogen carbonate, macrogol 6000, colloidal anhydrous silica, magnesium stearate, orange flavour (maltodextrin (maize), modified starch (E 1450), natural and artificial flavours, sulphites), potassium acesulfame, sodium saccharin, sunset yellow (E 110).

What Zaldiar Effervescent looks like and contents of the pack
Round, flat tablet with bevelled edges, marbled, white to light pink in colour.
The tablets are packed in soft blisters made of aluminium foil with an outer layer of PET and an inner layer of PE, placed in a cardboard box.
The unit pack contains: 20 effervescent tablets (5x4), 28 effervescent tablets (7x4), 32 effervescent tablets (8x4), or 48 effervescent tablets (12x4).
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Spain, country of export: 662457.9
Parallel import authorisation number: 22/24
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