TRAMADOL/PARACETAMOL SANDOZ 37.5 mg/325 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Sandoz 37.5 mg/325 mg Film-Coated Tablets EFG

Tramadol hydrochloride/paracetamol

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

• Keep this package 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Tramadol/Paracetamol Sandoz is and what it is used for
2. What you need to know before you take Tramadol/Paracetamol Sandoz
3. How to take Tramadol/Paracetamol Sandoz
4. Possible side effects

5 Storage of Tramadol/Paracetamol Sandoz

1. Package Contents and Additional Information

1. What Tramadol/Paracetamol Sandoz is and what it is used for

Tramadol/Paracetamol Sandoz is a combination of two pain relievers, tramadol and paracetamol, which work together to relieve pain.

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

Tramadol/Paracetamol should only be used in adults and adolescents over 12 years of age.

2. What you need to know before you take Tramadol/Paracetamol Sandoz

Do not take Tramadol/Paracetamol Sandoz:

• if you are allergic to tramadol, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• in case of acute alcohol intoxication, if you are taking sleeping pills, strong pain relievers, or other psychotropic medicines (medicines that can alter mood and emotions),
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with tramadol/paracetamol,
• 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 tramadol/paracetamol if you:

• are taking other medicines that contain paracetamol or tramadol,
• 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,
• have kidney problems,
• have severe breathing difficulties, for example, asthma or severe lung problems,
• have epilepsy or have already experienced seizures or convulsions,
• have recently suffered a head injury, shock, or severe headaches associated with vomiting,
• suffer from loss of consciousness of unknown origin (if you feel like you are going to faint),
• are dependent on any other medicine used for pain relief, for example, morphine,
• are taking other medicines for pain relief that contain buprenorphine, nalbuphine, or pentazocine,
• are going to be anesthetized. Inform your doctor or dentist that you are using tramadol/paracetamol,
• suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Tramadol/Paracetamol Sandoz"). 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 associated with this serious syndrome (see section 4 "Possible side effects").

Tolerance, Dependence, and Addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (you get used to it, which is known as tolerance). Repeated use of tramadol/paracetamol can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medicine you need to take or how often you need to take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or someone in your family has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever 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 signs while taking tramadol/paracetamol, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than those prescribed, for example, "to calm down" or "to sleep".
• You have repeatedly tried and failed to stop or control the use of the medicine.
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again ("withdrawal effect").

If you observe any of these signs, talk to your doctor so that they can indicate the best course of treatment for you, including when it is appropriate to stop taking it and how to do so safely (see section 3, "If you stop taking Tramadol/Paracetamol Sandoz").

If any of the above situations apply to you or have occurred to you in the past while taking tramadol/paracetamol, inform your doctor. They will decide if you should continue taking this medicine.

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, lack of appetite.

Tell your doctor or pharmacist if you experience any of the following symptoms while taking tramadol/paracetamol:

• Respiratory disorders related to sleep: tramadol/paracetamol may cause sleep-related respiratory disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. They may consider reducing the dose.
• Extreme fatigue, lack 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 if you need to take hormonal supplements.

Children and Adolescents

The use of tramadol/paracetamol is not recommended in children under 12 years of age because safety and efficacy have not been established in this age group.

Use in children with respiratory problems:

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

Other Medicines and Tramadol/Paracetamol Sandoz

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

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

Do not take tramadol/paracetamol if you are taking monoamine oxidase inhibitors ("MAOIs") (see section "Do not take Tramadol/Paracetamol Sandoz").

It is not recommended to take tramadol/paracetamol with the following medicines:

• carbamazepine (a medicine normally used to treat epilepsy or certain types of pain, such as intense facial pain called trigeminal neuralgia),
• buprenorphine, nalbuphine, or pentazocine (opioid pain relievers). Pain relief may be reduced.

The risk of side effects increases if you are also taking:

• triptans (for migraine) or selective serotonin reuptake inhibitors, "SSRIs" (for 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,
• sedative medicines such as benzodiazepines or related medicines (tranquilizers, sleeping pills). The concomitant use of tramadol/paracetamol and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. 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. Inform your doctor of all sedative medicines you are taking and strictly follow your doctor's dose recommendation. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.
• other pain relievers such as morphine or codeine (also used to treat cough), baclofen (muscle relaxant), medicines to lower blood pressure, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor,
• medicines that can cause seizures (attacks), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take tramadol/paracetamol at the same time. Your doctor will tell you if tramadol/paracetamol is suitable for you,
• certain antidepressants. Tramadol/paracetamol may interact with these medicines, and you may experience a serotonin syndrome (see the section 4 "Possible side effects").
• warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered, and bleeding may occur. You should inform your doctor immediately of any prolonged or unexpected bleeding,
• 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 that can occur particularly in cases of severe renal 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.
• gabapentin or pregabalin for the treatment of epilepsy or pain due to nerve problems (neuropathic pain).

The effectiveness of tramadol/paracetamol may be altered if you are also taking any of the following medicines:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine that reduces cholesterol in the blood).

Your doctor will tell you which medicines are safe to take with tramadol/paracetamol.

Using Tramadol/Paracetamol Sandoz with Alcohol

Tramadol/Paracetamol Sandoz may make you feel drowsy. Alcohol may make you feel drowsy, so it is recommended not to drink alcohol while taking Tramadol/Paracetamol Sandoz.

Pregnancy and Breastfeeding

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 this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant during treatment with Tramadol/Paracetamol Sandoz, consult your doctor before taking more tablets.

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

Driving and Using Machines

Tramadol/Paracetamol Sandoz may make you feel drowsy, and this can affect your ability to drive or use tools and machines safely.

Tramadol/Paracetamol Sandoz Contains Sodium

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

3. How to Take Tramadol/Paracetamol Sandoz

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

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

You should take tramadol/paracetamol for the shortest possible time.

The dose should be adjusted according to the intensity of the pain and the individual patient's sensitivity. Generally, the smallest effective dose that produces analgesia should be selected.

Use in Adults and Adolescents (from 12 years)

Unless your doctor prescribes otherwise, the recommended starting dose is 2 tablets.

If necessary, you can take more doses, as recommended by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 8 Tramadol/Paracetamol Sandoz tablets per day.

Do not take tramadol/paracetamol more frequently than prescribed by your doctor.

If you think the effect of tramadol/paracetamol 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.

Elderly Patients

In elderly patients (over 75 years), the excretion of tramadol may be delayed. If this happens to you, your doctor may recommend a prolonged dose interval.

Severe Liver or Kidney Disease (Insufficiency)/Patients on Dialysis

Patients with severe hepatic and/or renal insufficiency should not take tramadol/paracetamol. If your insufficiency is mild to moderate, your doctor may recommend a prolonged dose interval.

Method of administration:

The tablets are for oral use.

Swallow the tablets whole with sufficient liquid. Do not break or chew them.

If you take more Tramadol/Paracetamol Sandoz than you should

Consult your doctor or pharmacist immediately, even if you feel well, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tramadol/Paracetamol Sandoz

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

If you stop taking Tramadol/Paracetamol Sandoz

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 tell you when and how to stop taking it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms) (see section 4 "Possible side effects").

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.

Some adverse effects can be serious. Contact your doctor immediately if you experience any of the following:

• rare cases of skin rash, indicating an allergic reaction, swelling of the face, tongue, or throat, difficulty breathing, or decrease in blood pressure and fainting. If this happens, discontinue treatment. Do not take this medicine again,
• prolonged or unexpected bleeding, due to the use of tramadol/paracetamol with medicines used to thin the blood (e.g., warfarin, phenprocoumon).

Additionally, if any of the following adverse effects worsen, contact your doctor or pharmacist:

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

• nausea,
• dizziness, drowsiness.

Common:may affect up to 1 in 10 people

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth,
• itching, sweating,
• headache, agitation,
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling of being in high spirits).

Uncommon:may affect up to 1 in 100 people

• increase in pulse or blood pressure, heart rate or rhythm disorders,
• difficulty or pain when urinating,
• skin reactions (e.g., skin rashes, hives),
• tingling, numbness, or tingling 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,
• chills, hot flashes, chest pain,
• difficulty breathing,
• increase in liver enzymes (transaminases), loss of certain proteins in the urine (albumin).

Rare:may affect up to 1 in 1,000 people

• seizures, difficulty coordinating movements,
• addiction, delirium,
• blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis),
• speech disorders,
• transient loss of consciousness (syncope).

Frequency Not Known:cannot be estimated from the available data

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

In addition, the following recognized adverse effects have been reported by people who have taken medicines that contained only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should inform your doctor:

• feeling of 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 (generally decreasing, occasionally increasing), changes in perception,
• worsening of existing asthma,
• nasal bleeding or gum bleeding, which can result from a low platelet count,
• severe reduction in the number of white blood cells, making it more likely that infections have possible signs of fever and sore throat (agranulocytosis).

Using a medicine like tramadol can create dependence, making it difficult to stop taking it. People who have been taking tramadol for some time may feel unwell when they suddenly stop treatment. They may feel agitated, anxious, nervous, or trembly. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal disorders. Very few people may also have 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 tramadol/paracetamol, consult your doctor.

The use of tramadol/paracetamol along with anticoagulants (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

Very rare cases of severe skin reactions have been reported.

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 Tramadol/Paracetamol Sandoz

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

Store this medicine in a safe and protected place, where other people cannot access it. It can cause serious harm and be fatal for people who have not been prescribed it.

Do not use this medicine after the expiration date that appears on the cardboard box, blister pack, or container after CAD. The expiration date is the last day of the month indicated.

After the first opening of the container, this medicine can be administered for 50 days if stored between 15°C - 30°C.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the drains or into the trash. Deposit the containers 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 containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol/Paracetamol Sandoz

• 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 are:

Tablet core: macrogol polyvinyl alcohol copolymer, pregelatinized corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) potato, hypromellose, magnesium stearate.

Coating film: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of the Product and Package Contents

Tramadol/Paracetamol Sandoz film-coated tablets are peach-colored, capsule-shaped, engraved with T37.5 on one side and A325 on the other side.

Tramadol/Paracetamol Sandoz is available in cardboard boxes with blister packs of 2, 10, 15, 20, 30, 40, 60, 80, and 90 tablets, and bottles with 10 and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Teva Pharma, S.L.U.

C/ C, n 4 Polígono Industrial Malpica (Zaragoza) – 50016

Spain

or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana

Slovenia

or

Pliva Hrvatska D.O.O.

Prilaz Baruna Filipovica 25 (ZAGREB) – 10000

Croatia

This medicine is authorized in the Member States under the following names:

Czech Republic: Tutus 37,5 mg/325 mg

Portugal: Tramadol + Paracetamol Sandoz

Date of the Last Revision of this Prospectus:April 2025

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