Package leaflet: Information for the patient

Warning! Keep the 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 brand names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with 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

What Zaldiar Effervescent is and what it is used for
Important information before taking Zaldiar Effervescent
How to take Zaldiar Effervescent
Possible side effects
How to store Zaldiar Effervescent
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 ingredients with analgesic properties: tramadoli hydrochloridum and paracetamolum.
Zaldiar Effervescent is indicated for the symptomatic treatment of moderate to severe pain in patients for whom simultaneous administration of tramadol 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 Effervescent

When not to use Zaldiar Effervescent:

if the patient is allergic to tramadol hydrochloride, paracetamol, or any of the other components of this medicine (listed in section 6),
in case of acute intoxication with alcohol, sedatives, painkillers, 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 liver failure,
in patients with treatment-resistant epilepsy,
in pregnant and breastfeeding women.

Warnings and precautions
Before starting treatment with Zaldiar Effervescent, 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, 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 addiction to any drugs, 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”). When tramadol is taken together with certain antidepressants or tramadol alone, there is a small risk of developing serotonin syndrome. If any symptoms of this serious condition occur, the patient should seek immediate medical advice (see section 4 “Possible side effects”).

During treatment with Zaldiar Effervescent, inform the doctor immediately if the patient develops serious conditions, including severe kidney dysfunction, sepsis (when bacteria and their toxins circulate in the blood causing 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 over a long 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 relieve withdrawal symptoms.
Tolerance, and psychological and physical dependence on the medicine may develop, especially after prolonged 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 Effervescent may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person 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.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects. In some individuals, 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: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
If any of the above situations have occurred in the past or during treatment with Zaldiar Effervescent, inform the doctor. The doctor will decide whether treatment should continue.
Zaldiar Effervescent and other medicines
Tell 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 any other medicines containing paracetamol or tramadol to avoid overdose.
Concomitant use of Zaldiar Effervescent with MAO inhibitors is contraindicated, as well as within 14 days after their discontinuation—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 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.

Inform your doctor or pharmacist if the patient is taking:

flucloxacillin (an antibiotic), due to the risk of a serious blood and fluid disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

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

certain antidepressants, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and mirtazapine. Zaldiar Effervescent may interact with these and cause serotonin syndrome (see section 4 “Possible side effects”).
other analgesics such as morphine and codeine (used as a cough suppressant), baclofen (a muscle relaxant), antihypertensive or antihistamine medicines, as they may increase the risk of central nervous system depression. If drowsiness or difficulty concentrating occurs, inform the doctor. Concomitant use of Zaldiar Effervescent with sedatives such as benzodiazepines or related derivatives 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 dosing instructions. It may be helpful to inform family members or friends so they are aware of the possible occurrence of the above subjective and objective symptoms. If such symptoms occur, contact the doctor.
medicines that may provoke 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 (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 Effervescent may be altered when used concomitantly with:

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

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 (also present in alcoholic beverages and certain medicines) intensifies drowsiness. Do not drink alcohol while taking Zaldiar Effervescent.
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 her 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 more than one dose has been taken, 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 while taking this medicine.
This medicine contains a dye – sunset yellow (E 110), which may cause allergic reactions.
This medicine contains 7.8 mmol (or 179.3 mg) of sodium per dose.
Talk to your doctor or pharmacist if the patient needs to take 2 or more effervescent tablets daily over a prolonged period. This is particularly important when on a low-sodium diet.
One tablet contains 2.9 mg of potassium.

3. How to use Zaldiar Effervescent

This medicine should always be used as prescribed by your 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. The lowest effective dose that controls pain should be used.
Unless otherwise directed by your doctor, the recommended dose of Zaldiar Effervescent is 2 effervescent tablets for adults and children aged 12 years and older.
If needed, your doctor may recommend taking additional doses. Do not take subsequent doses more frequently than every 6 hours.
Do not use more than 8 effervescent tablets per day.
Do not take Zaldiar Effervescent more often 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, your doctor may recommend extending the interval between doses.
Patients with renal impairment, those 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, your doctor may recommend extending the intervals between doses.
Method of administration
The tablets should be taken orally.
Dissolve one effervescent tablet in a glass of water.
If you feel the effect of Zaldiar Effervescent is too strong (e.g. drowsiness or breathing difficulties) or too weak (pain not adequately relieved), 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 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 Effervescent
If you miss a dose, pain may return. Do not take a double dose to make up for a missed dose; continue taking the medicine as prescribed.
Stopping Zaldiar Effervescent
Do not stop using this medicine abruptly without consulting your doctor. If you wish to discontinue treatment, discuss this with your doctor, especially if the medicine has been used long-term.
Your doctor will advise when and how to stop the medicine, which may involve gradually reducing the dose to minimize the risk of withdrawal symptoms.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common: occurs in more than 1 in 10 patients

nausea,
dizziness, drowsiness.

Common: may occur in up to 1 in 10 patients

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

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 the 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 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),
a serious condition that may cause the blood to become more acidic (so-called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

The following adverse effects 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 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, skin rash indicating an allergic reaction may occur, which may present as sudden swelling of the face and neck, difficulty breathing, low blood pressure, and fainting. If any of these symptoms occur, treatment should 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 center, bursting large blisters, peeling of large sheets of skin, weakness, fever and joint pain). Treatment should be stopped 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, patients who have taken tramadol for some time may experience withdrawal symptoms after abrupt discontinuation. These may include restlessness, anxiety, nervousness 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 these symptoms occur after stopping Zaldiar Effervescent, consult your 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, immediate medical advice should be sought.

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

5. How to store Zaldiar Effervescent

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging (on the cardboard box,
soft blister, or polypropylene tube). The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What Zaldiar Effervescent contains

The active substances in this medicine are tramadol hydrochloride and paracetamol. One effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
Other ingredients are sodium citrate, citric acid, povidone K 30, sodium hydrogen carbonate, macrogol 6000, colloidal anhydrous silica, magnesium stearate, orange flavour, potassium acesulfame, sodium saccharin, sunset yellow (E 110).

What Zaldiar Effervescent looks like and contents of the pack
Round, flat tablet with bevelled edges, mottled, 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, in a cardboard box.
The unit pack contains: 10 effervescent tablets (2x4 + 2), 20 effervescent tablets (5x4), 28 effervescent tablets (7x4), 30 effervescent tablets (7x4 + 2), 32 effervescent tablets (8x4), 48 effervescent tablets (12x4), 50 effervescent tablets (12x4 + 2).
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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
ul. Działkowa 56 ul. Forteczna 35-37 ul. Tymiankowa 24/28
02-234 Warsaw 87-100 Toruń 95-054 Ksawerów
Spanish marketing authorisation number (country of export): 662457.9
Parallel import authorisation number: 219/25