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

Introduction

Package Leaflet: Information for the Patient

Tramadol/Paracetamol Teva 37.5 mg/325 mg

film-coated tablets EFG

tramadol hydrochloride/paracetamol

Read the entire package leaflet carefully before starting to take this medication because 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, contact your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

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

5 Storage of Tramadol/Paracetamol Teva 3

1. Package contents and additional information

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

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

This medication is used for the symptomatic treatment of moderate to severe pain, provided that your doctor considers the combination of tramadol and paracetamol necessary.

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

2. What you need to know before taking Tramadol/Paracetamol Teva

Do not take Tramadol/Paracetamol Teva

• if you are allergic to tramadol, paracetamol, or any of the other ingredients of this medication (listed in section 6);
• in case of acute alcohol intoxication, if you have taken any medication for the treatment of insomnia, potent analgesics, or other psychotropic medications (medications that can alter mood and emotions);
• if you are also taking monoamine oxidase inhibitors (MAOIs) (certain medications used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with Tramadol/Paracetamol Teva;
• if you have severe liver disease;
• if you have uncontrolled epilepsy.

Warnings and precautions

Consult your doctor before starting to take Tramadol/Paracetamol Teva.

• if you are taking other medications that contain paracetamol or tramadol;
• if 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;
• if you have kidney problems;
• if you have severe breathing difficulties, for example, asthma or severe lung problems;
• if you have epilepsy or have already experienced seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other medication used for pain relief, for example, morphine;
• if you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;
• if you are going to be anesthetized. Tell your doctor or dentist that you are using Tramadol/Paracetamol Teva.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol/Paracetamol Teva").

During treatment with Tramadol/Paracetamol Teva, inform your doctor immediately:

• If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Respiratory disorders related to sleep:

Tramadol/paracetamol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breathing, difficulties in maintaining sleep, or excessive drowsiness during the day. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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 medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

If any of the above points have occurred to you in the past or occur while you are taking tramadol/paracetamol, make sure your doctor knows. He/she may decide whether you should continue using this medication.

Talk to your doctor, pharmacist, or nurse if you experience any of the following symptoms while taking Tramadol/Paracetamol Teva: extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They 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.

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 present any of the symptoms linked to this serious syndrome (see section 4 "Possible side effects").

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of tramadol/paracetamol can also lead to dependence, abuse, and addiction, which could result in a potentially fatal 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 medication 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 [product name] may be greater 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 problems with your mood (depression, anxiety, or personality disorder) or have undergone psychiatric treatment for other mental illnesses.
• If you observe any of the following symptoms while using tramadol/paracetamol, it could be a sign of dependence or addiction:

• You need to use the medication for a longer period 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, 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 treatment option for you, when it is appropriate to stop the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol/Paracetamol Teva).

Children and adolescents

It is not recommended to use in children under 12 years of age.

Use in children with respiratory problems:

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

Using Tramadol/Paracetamol Teva with other medications

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

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

You must nottake Tramadol/Paracetamol Teva with monoamine oxidase inhibitors ("MAOIs") (see section "Do not take Tramadol/Paracetamol Teva").

It is not recommended to take Tramadol/Paracetamol Teva with the following:

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

Tell your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

The risk of side effects increases if you are taking:

• triptans (for migraine) or selective serotonin reuptake inhibitors (SSRIs) (for depression). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, or diarrhea, you should call your doctor.
• other pain relievers, such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), medications used to lower blood pressure, medications used to treat allergies. You may feel drowsy or faint. If this happens, tell your doctor.
• The concomitant use of tramadol/paracetamol and sedative medications, such as benzodiazepines or related medications, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Due to this, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes tramadol/paracetamol with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor. Talk to your doctor about all sedative medications you are taking, and follow your doctor's recommendations exactly. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.
• gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain)
• Medications that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol/Paracetamol Teva simultaneously. Your doctor will tell you if Tramadol/Paracetamol Teva is suitable for you.
• antidepressants. Tramadol/Paracetamol Teva may interact with these medications, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• warfarin or phenprocoumon (to prevent blood clots). The effectiveness of these medications may be altered, and bleeding may occur. You should inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Tramadol/Paracetamol Teva may be altered if you are also taking:

• metoclopramide, domperidone, or ondansetron (medicines for the treatment of nausea and vomiting),
• cholestyramine (a medicine that reduces cholesterol in the blood),

Your doctor will tell you which medications are safe to take with Tramadol/Paracetamol Teva.

Tramadol/Paracetamol Teva with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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

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

Breastfeeding

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

Based on human experience, it is suggested that tramadol does not affect female or male fertility. There are no data available on the influence of the combination of tramadol/paracetamol on fertility.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

Tramadol/Paracetamol Teva may cause drowsiness and may affect your ability to drive or use tools or machines safely.

Tramadol/Paracetamol Teva contains sodium

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

3. How to take Tramadol/Paracetamol Teva

Follow the instructions for administration of this medication indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from the use of tramadol/paracetamol, 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 Tramadol/Paracetamol Teva for the shortest possible time.

It is not recommended to use in children under 12 years of age.

The dose should be adjusted according to the intensity of the pain and your individual sensitivity to pain. In general, you should take the lowest dose that relieves the pain.

The recommended starting dose, unless your doctor prescribes otherwise, is 2 tablets for adults and adolescents over 12 years of age.

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

Do not take more than 8 film-coated Tramadol/Paracetamol Teva tablets per day.

Do not take Tramadol/Paracetamol Teva more frequently than indicated by your doctor.

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be delayed. If this happens to you, your doctor may recommend increasing the interval between doses.

Patients with severe kidney or liver disease (failure)/dialysis

Patients with severe kidney or liver failure should not take tramadol/paracetamol. If your failure is mild or moderate, your doctor may recommend increasing the interval between doses.

Method of administration:

The tablets are for oral administration.

Swallow the tablets whole with sufficient liquid; do not split or chew them.

If you think the effect of Tramadol/Paracetamol Teva is too strong (i.e., you feel very drowsy or have difficulty breathing) or too weak (i.e., you do not have adequate pain relief), tell your doctor.

If you take more Tramadol/Paracetamol Teva than you should

In such cases, consult your doctor or pharmacist immediately, even if you feel well. There is a risk that liver damage may occur, which may only become apparent later.

In case of overdose or accidental ingestion, call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Tramadol/Paracetamol Teva

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

If you interrupt treatment with Tramadol/Paracetamol Teva

Do 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 interrupt 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 about the use of this medication, 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.

If you experience any of the following, interrupt treatment and go to a doctor immediately. You should not take the medicine again.

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

• Skin rash, indicating an allergic reaction, with sudden swelling of the face and neck, breathing difficulties, or low blood pressure and fainting.

Other reported adverse effects include:

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 (hyperhidrosis),
• Headache, agitation,
• Confusion, sleep disorders, mood changes (anxiety, nervousness, feeling high).

Uncommon (may affect up to 1 in 100 people):

• Increased heart rate or blood pressure, heart rate or rhythm disorders,
• Tingling, 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,
• Breathing difficulties
• Difficulty swallowing, blood in the stool,

• Skin reactions (e.g., skin rashes, hives),
• Increased liver enzyme values,
• Presence of albumin in the urine, difficulty or pain when urinating,
• Chills, hot flashes, chest pain.

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

• Seizures, difficulty coordinating movements,
• Transient loss of consciousness (syncope),
• Drug dependence,
• Delirium,
• Blurred vision
• Pupillary constriction (miosis),
• Pupillary dilation (mydriasis),
• Transient loss of consciousness (syncope),
• Speech disorder.

Unknown (cannot be estimated from available data):

• Decreased blood sugar levels (hypoglycemia).
• Serotonin syndrome, which can manifest 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 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 Teva").

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 Tramadol/Paracetamol Teva, you should tell your doctor:

• Frequency not known (cannot be estimated from available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

• 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 existing asthma.
• Taking 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 blood plasma acidity.
• Taking tramadol/paracetamol with medications used to thin the blood (e.g., phenprocoumon, warfarin) may increase the risk of bleeding. Any unexpected or prolonged bleeding should be reported to your doctor immediately.
• In rare cases, skin rashes, indicating allergic reactions that can manifest as sudden swelling of the face and neck, shortness of breath, or low blood pressure and dizziness. If this happens, interrupt 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 instances, 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 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 Teva, consult your doctor.

Frequency not known: hiccups.

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

Very rare cases of severe skin reactions with paracetamol 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 Teva

Keep out of 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 carton and blister 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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

Composition of Tramadol/Paracetamol Teva

• 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 ingredients are: tablet core: kollicoat IR coating [macrogol polyvinyl alcohol copolymer], pregelatinized corn starch, microcrystalline cellulose, sodium glycolate starch (type A) from potato, hypromellose, magnesium stearate; film coating: opadry II beige 85F97409: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Appearance of the Product and Package Contents

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

Tramadol/Paracetamol Teva is available in cardboard boxes with blister packs of 2, 10, 15, 20, 30, 40, 60, 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

Teva Pharma S.L.U.

C/ Anabel Segura nº 11, Edificio Albatros B, 1ª planta

Alcobendas 28108 Madrid

Manufacturer

Teva Operations Poland Sp.z.o.o.

Mogilska 80, 31-546 Krakow

Poland

or:

PLIVA HRVATSKA D.O.O. (PLIVA CROATIA LTD)

Prilaz baruna Filipovica 25, 10000 Zagreb, Croatia

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

Belgium: Tramadol/Paracetamol Teva 37,5 mg/325 mg filmomhulde tabletten

Slovenia: Tramadol/Paracetamol Teva 37.5 mg/325 mg film-coated tablets

Spain: Tramadol/Paracetamol Teva 37,5 mg/325 mg comprimidos recubiertos con película EFG

France: TRAMADOL/PARACETAMOL TEVA

Netherlands: Tramadol HCl/Paracetamol 37,5/325 mg Teva

Poland: PADOLTEN 37.5 mg/325 mg film-coated tablets

United Kingdom (Northern Ireland): Tramadol hydrochloride/Paracetamol

Date of the Last Revision of this Prospectus:February 2025

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