Leaflet: information for the user

Zaldiar 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/Paracetamol

Read this leaflet carefully before you start taking this medicine, because 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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Zaldiar is and what it is used for

2. What you need to know before you start taking Zaldiar

3. How to take Zaldiar

4. Possible side effects

5. Storage of Zaldiar

6. Contents of the pack and additional information

Zaldiar is a combination of two analgesics, tramadol and paracetamol, which act together to relieve pain.

Zaldiar is indicated for symptomatic treatment of moderate to intense pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Zaldiar should only be used by adults and adolescents over 12 years old.

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 any medication for the treatment of insomnia, potent analgesics (opioids), or psychotropic medications (medications that can alter mood and emotions) in case of acute alcohol intoxication;
• if you are also taking MAO inhibitors (certain medications used for the treatment of depression or Parkinson's disease) or if you have taken them in the last 14 days before treatment with Zaldiar;
• if you have severe liver disease;
• if you have uncontrolled epilepsy with your current treatment.

Warnings and precautions

Consult your doctor before starting to take Zaldiar, if

• you are taking other medications that contain paracetamol or tramadol;
• you have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe respiratory difficulties, for example asthma or severe lung problems;
• you are epileptic 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 had a head injury, shock or severe headaches associated with vomiting;
• you are dependent on any other medication used for pain relief, for example morphine;
• you are taking other medications for pain relief that contain buprenorphine, nalbuphine or pentazocine;
• you are going to be anaesthetized. Tell your doctor or dentist that you are taking Zaldiar.

Tolerance, dependence and addiction

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

Dependence or addiction can cause a feeling of lack of control over the amount of medication you should use or the frequency with which you should use it.

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

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medications or illegal drugs ("addiction").

- You are a smoker.

- You have had any problems with mood (depression, anxiety or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

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

– You need to use the medication for a longer time than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medication for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".

– You have made repeated and unsuccessful attempts to stop using the medication or control its use.

– You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

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

Sleep-related respiratory disorders

Zaldiar contains an active ingredient that belongs to the group of opioids. Opioids can cause sleep-related respiratory 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 dose of opioids if you experience central sleep apnea.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with 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 and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort or vomiting, constipation, loss of appetite.

If you experience or have experienced any of these problems while taking Zaldiar, please inform your doctor. He will decide whether you should continue taking this medication.

Children and adolescents

Use in children with respiratory problems:

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity can 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. They may be indicative of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Taking Zaldiar with other medicines

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

Important: This medicine contains paracetamol and tramadol. Inform your doctorif you are taking any other medication that contains paracetamol or tramadol, so as not to exceed the maximum daily dose.

Zaldiarshould not be takenwith monoamine oxidase inhibitors (MAOIs) (see section "Do not take Zaldiar").

Zaldiar should not be used if you are being treated with:

• carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as severe facial pain called trigeminal neuralgia).
• buprenorphine, nalbuphine or pentazocine (opioid analgesic). 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 disorder (metabolic acidosis with high anion gap) that must be treated urgently and that may occur particularly in cases of severe renal or hepatic failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if the maximum daily dose of paracetamol is used, especially if the maximum daily dose of paracetamol is used for a longer period. Metabolic acidosis with high anion gap is a serious disease that must have urgent treatment.

The risk of adverse effects increases if you are taking:

• triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions or diarrhea, you should call your doctor.
• other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, medications for allergy treatment.You may feel drowsy or dizzy. If this occurs, consult your doctor.

The concomitant use of Zaldiar and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribesyou this medicationwith sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendation strictly. 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.

• medications that can facilitate or cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Zaldiar simultaneously with these medications. Your doctor will tell you if Zaldiar is suitable for you.
• medications for depression treatment. Zaldiar may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• warfarin or phenprocoumon (medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of Zaldiar may be altered if you are also taking:

• metoclopramide, domperidone or ondansetron (medications for nausea and vomiting),
• colestiramine (medication that reduces cholesterol in the blood).

Your doctor will know which medications are safe to use with Zaldiar.

Taking Zaldiar with food and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Due to the fact that Zaldiar contains tramadol, it is not recommended to take this medication 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 should stop breastfeeding.

Based on human experience, it is not suggested that tramadol affects male and female fertility. There are no data available on the combination of tramadol and paracetamol in fertility.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during treatment with Zaldiar. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Zaldiar contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

You should take Zaldiar for the shortest time possible.

This medication is not recommended for use in children under 12 years old.

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

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

If necessary, you can increase the dose as recommended by your doctor. The shortest interval between doses should 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 indicated.

Older patients

In elderly patients (over 75 years old), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the dosing intervals.

Patients with liver or kidney disease/patients on dialysis

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

Administration form

Zaldiar is presented in the form of tablets for oral administration.

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

If you estimate 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 have 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, consult your doctor or pharmacist immediately, as there is a risk of severe liver damage that will only become apparent later.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20.

If you forget to take Zaldiar

If you forget to take a dose of Zaldiar, it is likely that the pain will recur. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Zaldiar

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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, diarrhea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling "high" all the time).

Uncommon: may affect 1 in 100 people;

• increased heart rate or increased blood pressure, heart rhythm and frequency disorders,
• sensation of tingling, numbness or pins and needles in the limbs, ear noises, involuntary muscle spasms,
• depression, nightmares, hallucinations (hearing, seeing or perceiving something that does not exist in reality), memory loss,
• difficulty breathing,
• difficulty swallowing, blood in the stool,
• skin reactions (e.g. rashes, urticarial hives),
• increased liver enzyme values,
• presence of albumin in the urine, difficulty or pain when urinating,
• chills, hot flashes, chest pain.

Rare: may affect 1 in 1,000 people;

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope),
• dependence on the medication,
• delirium,

• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive pupil dilation (mydriasis).

Frequency not known:

• decreased blood sugar levels (hypoglycemia),
• serotonin syndrome, which may manifest as changes in mental state (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, diarrhea) (see section 2 "What you need to know before starting to take Zaldiar").

The following adverse effects recognized have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking Zaldiar, please tell your doctor:

• Dizziness when getting up after lying down or sitting, low 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 paracetamol alone or when taken with the antibiotic flucloxacillin may induce an anomaly in the blood and fluids (metabolic acidosis with high anion gap) when there is an increase in plasma acidity.

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

• In rare cases, skin eruptions, 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, interrupt treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication like tramadol can make you dependent on it, making it difficult to stop taking it.

In rare instances, people who have been taking tramadol for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous or shaky. They may be hyperactive, have difficulty sleeping and experience gastrointestinal and intestinal disorders. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with Zaldiar, please consult your doctor.

Frequency not known: hiccups.

In exceptional cases, blood tests may reveal certain abnormalities, such as low platelet count, which may result in nasal or gum bleeding.

In very rare cases, severe skin reactions with paracetamol have been reported.

There have been reports of rare cases of respiratory depression 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Store this medication in a safe and protected place, inaccessible to other individuals. This medication may cause severe harm or even be fatal to individuals not prescribed it.

Do not use this medication after the expiration date appearing on the packaging after CAD. The expiration date is the last day of the month indicated. This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Zaldiar

• The active principles 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:

Core of the tablet: powdered cellulose, pregelatinized cornstarch, sodium starch glycolate (type A), cornstarch, magnesium stearate.

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

Appearance of the product and contents of the package

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 packaged in blisters.

They are presented in packs of 2, 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.

Only some pack sizes may be marketed.

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

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36 – 28027 Madrid, Spain

Responsible for manufacturing:

Grünenthal GmbH

Zieglerstrasse 6–D- 52078 Aachen, Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/