Zaldiar 37.5 mg/325 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Zaldiar 37.5 mg/325 mg film-coated 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects 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 adverse 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 and paracetamol, which work together to relieve pain.

Zaldiar is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that the combination of tramadol and paracetamol is necessary.

Zaldiar 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, or any of the other ingredients of this medicine (listed in section 6);
• if you have taken medicines for insomnia, strong painkillers (opioids), 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 have taken them within the last 14 days before starting treatment with Zaldiar;
• 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 taking Zaldiar if

• you are taking other medicines containing paracetamol or tramadol;
• 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 had 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 going to be anaesthetised. Tell your doctor or dentist that you are taking Zaldiar.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become 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 lack of 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 any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever 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 use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, “to stay 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 using 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 for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with 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 have 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and being sick (vomiting).

Sleep-related breathing disorders

Zaldiar contains an active substance belonging to the group of opioids. 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 oxygen levels in the blood).

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

There is a low risk that you may develop a serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol 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 Zaldiar, please inform your doctor. He or she will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with breathing problems:

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

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

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 hormone 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. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

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

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

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

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that must be treated urgently (see section 2). Metabolic acidosis with 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 painkillers 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.

Concomitant use of Zaldiar and 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, your doctor will limit the dose and duration of concomitant treatment.

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 Zaldiar simultaneously with these medicines. Your doctor will advise you whether Zaldiar is suitable for you.
• medicines for the treatment of depression. Zaldiar 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, posing a 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 Zaldiar 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 with Zaldiar.

Taking Zaldiar with food and alcohol

Zaldiar may make you feel drowsy. Alcohol may also make you feel drowsy, so it is recommended not to drink alcohol while taking Zaldiar.

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

Breastfeeding

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

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

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Zaldiar. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines 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 lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him or her before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free.”

3. How to take Zaldiar

Follow exactly the instructions for administering this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you 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 Zaldiar for the shortest possible time.

This medicine is not recommended for use 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 tablets.

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

Do not take more than 8 Zaldiar tablets per day.

Do not take Zaldiar more frequently than your doctor has instructed.

Elderly patients

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

Patients with hepatic or renal impairment/patients on dialysis

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

Method of administration

Zaldiar is available as tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel that the effect of Zaldiar 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 Zaldiar 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 pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may progress 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 91 562 04 20.

If you forget to take Zaldiar

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

If you stop taking Zaldiar

Do not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking the 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 reduce the likelihood 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 can 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 – a feeling of being constantly "in high spirits").

Uncommon: may affect 1 in 100 people:

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate,
• tingling, 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 levels,
• 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, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis).

Frequency not known:

• decrease in blood sugar levels (hypoglycaemia).

The following adverse effects have been reported in individuals taking medicines containing tramadol only or paracetamol only. However, if you experience any of these symptoms while taking Zaldiar, you must inform your doctor:

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

• The use of Zaldiar together with anticoagulants (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. You should 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 a drop in blood pressure and dizziness. If this happens, stop treatment and consult your doctor immediately. You must not take this medicine again.

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

Rarely, individuals who have been taking tramadol 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 rarely, individuals may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Zaldiar, please consult your doctor.

Frequency not known: hiccups.

Serotonin syndrome, which may present as 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 make the blood more acidic (called metabolic acidosis) has been reported in patients with severe illness taking paracetamol (see section 2), frequency not known.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects:

If you experience any adverse effect, talk to 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 packaging after EXP. The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Zaldiar

• The active substances are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are:

Tablet core: powdered cellulose, pregelatinized corn starch, sodium starch glycolate (type A), corn starch, magnesium stearate.

Coating film: hypromellose, monohydrate lactose, titanium dioxide (E171), macrogol 6000, yellow iron oxide (E172), propylene glycol (E1520), talc.

Appearance of the product and contents of the pack

Zaldiar film-coated tablets are pale yellow tablets marked with the manufacturer's logo ? on one side and "T5" on the other.

Zaldiar film-coated tablets are packed in blisters.

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

Only certain pack sizes may be commercially available.

Zaldiar film-coated tablets are also available in packs of 2x1, 10x1, 20x1, 30x1, 40x1, 50x1, 60x1, 70x1, 80x1, 90x1 or 100x1 tablets in single-dose pre-cut blisters.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Grünenthal Pharma, S.A.
Doctor Zamenhof, 36 – 28027 Madrid, Spain

Manufacturer:

Grünenthal GmbH
Zieglerstrasse 6 – D-52078 Aachen, Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany	Zaldiar 37.5 mg/325 mg Film tablets
Austria	Zaldiar 37.5 mg/325 mg Film tablets
Belgium	Zaldiar 37.5 mg/325 mg, film-coated tablets / filmomhulde tabletten
	Pontalsic 37.5 mg/325 mg, film-coated tablets / filmomhulde tabletten
Slovenia	Zaldiar 37.5 mg/325 mg filmsko obložene tablete
Spain	Zaldiar 37.5 mg/325 mg film-coated tablets
	Pontalsic 37.5 mg/325 mg film-coated tablets
France	Zaldiar 37.5 mg/325 mg, film-coated tablet
	Ixprim 37.5 mg/325 mg, film-coated tablet
Greece	ZALDIAR
Netherlands	Zaldiar 37.5 mg/325 mg, filmomhulde tabletten
Hungary	Zaldiar 37.5 mg/325 mg filmtabletta
Ireland	Ixprim 37.5 mg/325 mg, film-coated tablets
Luxembourg	Zaldiar 37.5 mg/325 mg, comprimés pelliculés
Portugal	Zaldiar 37.5 mg/325 mg film-coated tablets
United Kingdom	Tramacet 37.5 mg/325 mg, film-coated tablets

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/