Pazital 37.5 mg/325 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pazital 37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/Paracetamol

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

• Keep this leaflet. 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 should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pazital is and what it is used for

2. What you need to know before taking Pazital

3. How to take Pazital

4. Possible adverse effects

5. How to store Pazital

6. Contents of the pack and other information

1. What Pazital is and what it is used for

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

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

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

2. What you need to know before taking Pazital

Do not take Pazital

• 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, or have taken within the last 14 days before starting Pazital, monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease);
• 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 Pazital 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 Pazital 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, for example morphine;
• you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• you are going to be anaesthetized. Inform your doctor or dentist that you are taking Pazital.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (your body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Pazital may also lead to dependence, abuse, and addiction, which could result in 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 loss 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 or addicted to Pazital may be higher if:

• You or any member of your family have abused or been dependent 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 Pazital, 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 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 interrupt treatment with Pazital).

During treatment with Pazital, 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 breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and being sick (vomiting).

Sleep-related breathing disorders

Pazital contains an active substance 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 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 slight risk of developing serotonin syndrome after taking tramadol, especially when taken 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 Pazital, 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 Pazital:

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 Pazital with other medicines

Important: This medicine contains paracetamol and tramadol. Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, so that you do not exceed the maximum daily dose.

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

The use of Pazital 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 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 (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) that requires urgent treatment (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 migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). 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 allergy treatment. You may feel drowsy or dizzy. If this occurs, consult your doctor.

Concomitant use of Pazital 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 of all sedative medicines you are taking and strictly follow your doctor’s dosing 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 Pazital simultaneously with these medicines. Your doctor will advise whether Pazital is suitable for you.
• medicines for the treatment of depression. Pazital may interact with these medicines and may cause 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 Pazital 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 Pazital.

Taking Pazital with food and alcohol

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

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

Breastfeeding

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

Based on human experience, tramadol is not thought to affect 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 if you can drive or operate machinery during treatment with Pazital. 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.

Pazital contains sodium

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

3. How to take Pazital

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, please 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 Pazital, 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 Pazital 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 possible 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, you may increase the dose as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 8 Pazital tablets per day.

Do not take Pazital 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 Pazital is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration

Pazital 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 Pazital 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 Pazital than you should

If you have taken more Pazital 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 Pazital

If you forget to take a dose of Pazital, 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 Pazital

You must not stop taking this medicine suddenly unless instructed by your doctor. 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 minimize the risk of 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 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, diarrhoea), stomach pain, dry mouth,
• itching, increased sweating (hyperhidrosis),
• headache, restlessness,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being “on a high” all the time).

Uncommon: may affect 1 in 100 people:

• increased pulse or increased blood pressure, disturbances in heart rhythm and heart rate,
• presence of albumin in urine, difficulty or pain when urinating,
• skin reactions (e.g. rashes, urticarial rash),
• tingling sensation, numbness or prickling sensation 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 swallowing, blood in the stools,
• increased liver enzyme levels,
• chills, hot flushes, chest pain,
• difficulty breathing.

Rare: may affect 1 in 1,000 people:

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

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 or only paracetamol. However, if you experience any of these symptoms while taking Pazital, 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.

• In rare cases, skin rashes, 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 must not take this medicine again.

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

In rare cases, people 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 digestive and intestinal disturbances. Very few people 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 Pazital, 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 Pazital”).

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

The use of Pazital 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 very rare cases, serious skin reactions have been reported with paracetamol.

A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2), occurring at an unknown frequency.

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 Pazital

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

Store this medicine in a safe and secure place, inaccessible to others. 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 requires no 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 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 Pazital

• 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 potato starch glycolate (type A), corn starch, magnesium stearate.

Coating film: OPADRY yellow YS-1-6382 G (hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172), polysorbate 80), carnauba wax.

Appearance of the product and contents of the pack

The tablets are pale yellow, marked with the manufacturer's logo ? on one side and "T5" on the other. They are presented in blister packs, and packaged in boxes containing 20 or 60 tablets.

Only certain pack sizes may be marketed.

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

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/