PAZITAL 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pazital37.5 mg/325 mg film-coated tablets

Tramadol hydrochloride/Paracetamol

Read all of 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pazital and what is it used for
2. What you need to know before you take Pazital
3. How to take Pazital
4. Possible side effects
5. Storage of Pazital

1. Contents of the pack and further information

1. What is Pazital and what is it used for

Pazital is a combination of two pain relievers, 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 a 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 you take 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 any medicine for insomnia, potent analgesics (opioids), or psychotropic drugs in case of acute alcohol intoxication;
• if you are taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease) or have taken them in the last 14 days before treatment with Pazital;
• 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 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 a sign of jaundice or problems with your bile ducts;
• you have kidney problems;
• you have severe breathing 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 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 medicines for pain relief that contain buprenorphine, nalbuphine, or pentazocine;
• you are going to be anesthetized. Tell 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 can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Pazital can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

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

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

• You need to use the medicine for a longer period than indicated 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 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 using the medicine, 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 treatment option for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop taking Pazital).

Sleep-related breathing disorders

Pazital contains an active substance that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example, central sleep apnea (shallow breathing or pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level 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 a doctor immediately if you experience any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

Tramadol is transformed in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side 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 have had any of these problems in the past while taking Pazital, please inform your doctor. He will decide whether you should continue taking this medicine.

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Tell 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 to take hormonal supplements.

Taking Pazital with other medicines

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

Pazital must not be takenwith 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 normally used to treat epilepsy or certain types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesic). Pain relief may be reduced.

Tell your doctor or pharmacist if you are taking:

Flucloxacillin (an antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in case of severe renal or hepatic impairment, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are 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 requires urgent treatment.

The risk of side 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 the limbs or eyes, muscle contractions, or diarrhea, you should call your doctor.
• Other analgesics such as morphine and codeine (also when used for the treatment of cough), baclofen (muscle relaxant), some medicines to lower blood pressure, medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.

The concomitant use of Pazital and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine with sedative medicines, you should limit the dose and duration of concomitant treatment.

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

• Medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Pazital at the same time as these medicines. Your doctor will tell you if Pazital is suitable for you.
• Medicines for the treatment of depression. Pazital can interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• Warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and there is a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

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

• Metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• Colestyramine (a medicine that lowers cholesterol in the blood).

Your doctor will know which medicines are safe to use with Pazital.

Taking Pazital with food and alcohol

Pazital can make you feel drowsy. Alcohol can make you feel drowsy, so 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Breastfeeding

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

Based on human experience, tramadol is not expected to affect fertility in men and women. There are no data available on the combination of tramadol and paracetamol on fertility.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Pazital. It is important that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

Pazital contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Pazital

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of 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 possible time.

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

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces 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 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 Pazital tablets per day.

Do not take Pazital more frequently than indicated by your doctor.

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slow. If this is the case, 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 Pazital is not recommended. If you have moderate liver or kidney problems, your doctor may prolong the dosing intervals.

Method of administration

Pazital is available 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 think 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 have adequate pain relief), tell your doctor.

If you take more Pazital than you should

If you have taken more Pazital than you should, even if you feel well, consult your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone 91 562 04 20.

If you forget to take Pazital

If you forget to take a dose of Pazital, it is likely that the pain will return. Do not take a double dose to make up for forgotten doses; simply continue taking the tablets as usual.

If you stop taking Pazital

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you have any further questions on 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 all people suffer from them.

Very frequent: may affect more than 1 in 10 people;

• nausea,
• dizziness, drowsiness.

Frequent: 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 of being "high-spirited" all the time).

Infrequent: may affect 1 in 100 people;

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

Rare: may affect 1 in 1,000 people;

• seizures, difficulties in carrying out coordinated movements,
• dependence on the medicine,
• delirium,
• blurred vision, pupil constriction (miosis),
• speech disorders,
• excessive dilation of the pupils (mydriasis),
• temporary loss of consciousness (syncope).

Frequency not known:

• decrease in blood sugar levels (hypoglycemia),
• serotonin syndrome, which can manifest through 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Pazital").

The following recognized 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 should tell your doctor:

• Dizziness when standing up after lying down or sitting, low heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, changes in perception, worsening of asthma.
• Taking paracetamol alone or when taken with the antibiotic flucloxacillin may induce a blood and fluid anomaly (metabolic acidosis with high anion gap) when there is an increase in blood plasma acidity.

• In rare cases, skin rashes, indicating allergic reactions that can manifest through sudden swelling of the face and neck, shortness of breath, or a 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, using a medicine like tramadol can create dependence, making it difficult to stop taking it.

In rare cases, people who have been taking tramadol for some time may feel unwell if they suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly. They may be hyperactive, have difficulty sleeping, and have digestive and intestinal disorders. Very few people may also have panic attacks, hallucinations, unusual perceptions such as itching, tingling sensation, 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.

In exceptional cases, blood tests may reveal certain anomalies, such as low platelet count, which can result in nosebleeds or bleeding gums.

Taking Pazital 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 very rare cases, serious skin reactions have been reported with paracetamol.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Pazital Composition

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

Product Appearance and Package Contents

They are pale yellow tablets marked with the manufacturer's logo ? on one side and "T5" on the other. They are packaged in blisters and boxed in packs of 20 and 60 tablets.

Only some package 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 Last Revision of this Prospectus: December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/