Zaldiar 37.5 mg/325 mg effervescent tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zaldiar 37.5 mg/325 mg effervescent tablets

Tramadol hydrochloride/Paracetamol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet Contents

1. What Zaldiar is and what it is used for
2. What you need to know 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 of two analgesics, tramadol hydrochloride and paracetamol, which work together to relieve pain.

This medicine is used to treat moderate to severe pain when your doctor considers that the combination of tramadol hydrochloride and paracetamol is necessary.

This medicine should only be used by adults and adolescents over 12 years of age.

2. What you need to know before taking Zaldiar

Do not take Zaldiar

• if you are allergic to tramadol hydrochloride, paracetamol, orange-yellow dye (E110), or any of the other ingredients of this medicine (listed in section 6);
• if you have taken any medicines for insomnia, analgesics, or psychotropic medicines (medicines that may alter mood and emotions) in cases of acute alcohol intoxication;
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease), or if you have taken them within the last 14 days before starting treatment with this medicine;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Consult your doctor before starting to take Zaldiar if

• you are taking other medicines containing paracetamol or tramadol hydrochloride;
• you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe breathing difficulties, for example asthma or serious lung conditions;
• you have epilepsy or have experienced seizures or convulsions;
• you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Taking Zaldiar with other medicines”);
• you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• you are dependent on any other medicine used for pain relief, such as morphine;
• you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• you are due to undergo anesthesia. Inform your doctor or dentist that you are taking this medicine.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Zaldiar may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of losing control over the amount of medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Zaldiar may be higher if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Zaldiar, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor.
• You need to take a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop taking the medicine, and feel better once you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop taking Zaldiar).

During treatment with Zaldiar, inform your doctor immediately if:

you have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders

This medicine contains an active ingredient belonging to the opioid group. Opioids may cause sleep-related breathing disorders; for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).

The risk of experiencing central sleep apnea depends on the opioid dose. Your doctor may consider reducing the total opioid dose if you experience central sleep apnea.

There is a small risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, loss of appetite.

If you develop or have previously experienced any of these problems while taking this medicine, please inform your doctor. He or she will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with respiratory problems:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Inform your doctor if you experience any of the following symptoms while taking this medicine:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide whether you need hormonal supplements.

Taking Zaldiar with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Important: This medicine contains paracetamol and tramadol hydrochloride. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol hydrochloride, so that you do not exceed the maximum daily dose.

This medicine must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Zaldiar”).

The use of this medicine is not recommended if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

Inform your doctor or pharmacist if you are taking:

flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disturbances (called metabolic acidosis) that must be treated urgently (see section 2). Metabolic acidosis with a high anion gap is a serious condition requiring urgent treatment.

The risk of adverse effects increases if you are taking:

• triptans (for the treatment of migraine) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of limbs or eyes, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.
• other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of this medicine with sedative medicines such as benzodiazepines or other sedatives, or medicines that affect respiratory activity (e.g., opioids), increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, the dose and duration of concomitant treatment should be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

• medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take this medicine simultaneously with these medicines. Your doctor will advise you whether this medicine is suitable for you.
• medicines for the treatment of depression. This medicine may interact with these medicines, and you may experience serotonin syndrome (see section 4 “Possible side effects”).
• warfarin or fenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).
• medicines used to treat allergies, dizziness, or nausea (antihistamines or antiemetics).
• medicines for treating psychiatric disorders (antipsychotics or neuroleptics).
• muscle relaxants.
• medicines for treating Parkinson’s disease.

The effectiveness of this medicine may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medicines for treating nausea and vomiting),
• colestyramine (a medicine that lowers blood cholesterol).

Your doctor will know which medicines are safe to use together with this medicine.

Taking Zaldiar with food and alcohol

This medicine may make you feel drowsy. Alcohol may increase drowsiness; therefore, it is recommended not to drink alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because this medicine contains tramadol hydrochloride, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while taking this medicine, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take this medicine more than once during breastfeeding, or if you take this medicine more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men and women. There are no data available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with this medicine. It is important that you observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Zaldiar contains orange-yellow dye (E110), sodium, and sulfite

This medicine may cause allergic reactions because it contains orange-yellow dye (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains 179.3 mg of sodium (a main component of table/cooking salt) in each effervescent tablet. This corresponds to 9.0% of the maximum recommended daily dietary intake of sodium for an adult. Consult your doctor or pharmacist if you need 2 or more effervescent tablets daily over a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

The orange flavoring in this medicine contains small amounts of sulfite, which rarely may cause severe hypersensitivity reactions and bronchospasm.

3. How to take Zaldiar

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Zaldiar, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

You should take this medicine for the shortest time possible.

Use of this medicine is not recommended in children under 12 years of age.

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 2 effervescent tablets.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 effervescent tablets a day.

Do not take this medicine more frequently than prescribed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

The effervescent tablets are taken orally.

The effervescent tablets should be dissolved in a glass of water before taking.

If you feel the effect of this medicine is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not get adequate pain relief), inform your doctor.

If you take more Zaldiar than you should

If you have taken more of this medicine than you should, even if you feel well, contact your doctor or pharmacist immediately.

After taking very high doses, symptoms such as pupil constriction, vomiting, low blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest and death may occur. In such a case, call a doctor immediately!

An overdose of paracetamol may cause nausea and vomiting. There is a risk of serious liver damage, which may only become apparent later. Severe cases may lead to liver failure, brain problems, coma, or death.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Zaldiar

If you forget to take a dose of this medicine, your pain may return. Do not take a double dose to make up for the missed dose; simply continue taking the effervescent tablets as usual.

If you stop taking Zaldiar

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking this medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• nausea,
• dizziness, drowsiness.

Common: may affect 1 in 10 people:

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – feeling "high-spirited" all the time).

Uncommon: may affect 1 in 100 people:

• increased pulse or increased blood pressure, disturbances in heart rhythm and heart rate,
• tingling sensation, numbness or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or sensing something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stools,
• skin reactions (e.g. rashes, urticaria),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flushes, chest pain.

Rare: may affect 1 in 1,000 people:

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• drug dependence,
• delirium,
• blurred vision, constriction of the pupil (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decrease in blood sugar levels (hypoglycaemia).

The following recognised adverse effects have been reported by people who have taken medicines containing only tramadol hydrochloride or only paracetamol. However, if you experience any of these symptoms while taking this medicine, you must tell your doctor:

• Dizziness when standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, changes in mood, changes in activity, changes in perception, worsening of asthma.

• The use of this medicine together with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes may occur, indicating allergic reactions that may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens to you, stop treatment and consult your doctor immediately. You should not take this medicine again.

In rare cases, taking a medicine such as tramadol hydrochloride may lead to dependence, making it difficult for you to stop taking it.

Occasionally, people who have been taking tramadol hydrochloride for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with this medicine, please consult your doctor.

Frequency not known: hiccups.

Serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "What you need to know before taking Zaldiar").

In exceptional cases, blood tests may reveal certain abnormalities, for example low platelet count, which may result in nosebleeds or bleeding gums.

Very rarely, serious skin reactions have been reported with paracetamol.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) has been reported in patients with severe illness using paracetamol (see section 2), with unknown frequency.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Zaldiar

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the carton and on the aluminium strip after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zaldiar

• The active substances are tramadol hydrochloride and paracetamol.

Each effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

Anhydrous monosodium citrate, anhydrous citric acid, Povidone K30, sodium hydrogen carbonate, Macrogol 6000, colloidal anhydrous silica, magnesium stearate, orange flavour (containing maltodextrin from maize, modified starch (E1450), natural and artificial flavours, sulphite), acesulfame potassium, sodium saccharin, orange-yellow colour (E110).

What Zaldiar looks like and contents of the pack

White to slightly pinkish tablets with coloured specks. The tablets are packed in coated aluminium blisters.

Available in packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 effervescent tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 –28027 Madrid, Spain

Manufacturer

Grünenthal GmbH

Zieglerstrasse 6–D- 52078 Aachen, Germany

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Slovenia Zaldiar® 37.5 mg/325 mg šumece tablete

Spain Zaldiar® 37.5 mg/325 mg effervescent tablets

France Ixprim® 37.5mg/325mg, comprimé effervescentZaldiar® 37.5mg/325mg, comprimé effervescent

Hungary Zaldiar® 37.5 mg/325 mg, pezsgotabletta

Ireland Ixprim® effervescent 37.5 mg/325 mg, effervescent tablet

Portugal Zaldiar® EFE 37.5mg/325 mg effervescent tablets

United Kingdom (Northern Ireland) Tramacet® 37.5 mg/325 mg effervescent tablet

Date of the most recent revision of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/