CAPTOR 37.5 mg/325 mg TABLETS

Introduction

Package Leaflet: Information for the User

Captor 37.5 mg/325 mg Tablets EFG

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Captor and what is it used for
2. What you need to know before you take Captor
3. How to take Captor
4. Possible side effects
5. Storage of Captor
6. Contents of the pack and further information

1. What is Captor and what is it used for

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

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

Captor should only be used by adults and children over 12 years of age.

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

Do not take Captor:

• 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, potent pain relievers, or other psychotropic medicines (medicines that can alter mood and emotions).
• If you are taking 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 Captor.
• If you have severe liver disease.
• If you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions:

• If you are taking other medicines 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 a sign 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 had seizures;
• If you have recently had a head injury, severe headaches associated with vomiting;
• If you have dependence on any other medicine used for pain relief, for example, morphine;
• If you are taking other pain relievers that contain buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anesthetized. Tell your doctor or dentist that you are using Captor.
• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These can 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.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Captor").
• During treatment with Captor, tell your doctor if:

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 have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious 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 with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Respiratory disorders related to sleep:

Captor may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep or excessive sleepiness during the day. If you or someone else notices 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 should 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.

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 monotherapy. Consult your doctor immediately if you present any of the symptoms related to 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 Captor 37.5 mg/325 mg 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 a higher dose and longer use.

Dependence or addiction can make you feel like you no longer control the amount of medicine you need to take or the frequency with which you should 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 Captor 37.5 mg/325 mg 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 a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Captor 37.5 mg/325 mg, it could be a sign that you have become dependent or addicted:

• You need to take the medicine for a longer time than your doctor advised.
• 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 to stop or control the use of the medicine without success.
• 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 treatment for you, including when it is appropriate to stop taking it and how to do it safely (see section 3, "How to take Captor").

If you have had any of these problems in the past while taking Captor, inform your doctor. They will decide if you should continue taking this medicine.

Children

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 Captor:

Tell your doctor or pharmacist if you are taking:

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

• Gabapentin or pregabalin to treat epilepsy or nerve pain (neuropathic pain).

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those bought without a prescription.

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

Do not take Captor with monoamine oxidase inhibitors (MAOIs) (see section "Do not take Captor").

It is contraindicated to use Captor if you are being treated with:

• 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 also use:

-Triptans (for the treatment of migraines) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, uncontrolled muscle contractions, or diarrhea, you should call your doctor.

• Sedatives, sleeping pills, other pain relievers such as morphine and codeine (also when used to treat cough), baclofen (muscle relaxant), some medicines to lower blood pressure, antidepressants, or medicines for the treatment of allergies. You may feel drowsy or dizzy. If this happens, consult your doctor.
• Antidepressants, anesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used as an aid to quit smoking). The risk of having a seizure may increase. Your doctor will tell you if Captor is suitable for you.
• 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.
• Medicines that can cause or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Captor at the same time as these medicines. Your doctor will tell you if Captor is suitable for you.
• Antidepressants. Captor may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

The effectiveness of Captor may be altered if you also use:

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

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

Taking Captor with food, drinks, and alcohol:

You should not drink alcoholic beverages if you are taking this medicine.

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 Captor contains tramadol, it is not recommended to use this medicine during pregnancy. If you become pregnant during treatment with Captor, consult your doctor before taking the next tablet.

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

Driving and using machines:

Ask your doctor if you can drive or use machines during treatment with this medicine. 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 administering it in combination with other medicines.

Captor contains sodium

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

3. How to take Captor

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

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.

You should take Captor for the shortest time possible.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from the use of Captor 37.5 mg/325 mg, when and for how long you should take it, when you should contact your doctor, and when you should stop it (see also section 2).

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 Captor tablets per day.

Do not take Captor more frequently than your doctor has indicated.

Your doctor may increase the interval between doses:

• If you are over 75 years old.
• If you have kidney problems.
• If you have liver problems.

Use in children and adolescents:

This medicine is not recommended for use in children under 12 years of age.

Elderly patients:

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

Patients with liver or kidney failure/patients on dialysis

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

Method of administration:

The tablets can be taken whole or broken in half with the help of a glass of liquid, preferably water. The score line on the tablet is to break the tablet in half if you find it difficult to swallow whole.

If you think the effect of Captor 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 Captor than you should:

You should consult your doctor or pharmacist, even if you feel well. There is a risk that liver damage may occur, which may only become apparent later, and pancreatitis (inflammation of the pancreas).

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Captor:

If you forget to take the tablets, it is possible 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 stop taking Captor:

Generally, no unwanted effects appear after stopping treatment with Captor. However, in rare cases, patients who have been taking Captor for a while and have stopped treatment abruptly may feel unwell (see section 4 "Possible side effects"). If you have been taking Captor for some time, you should consult your doctor before stopping treatment, as your body may have become accustomed to it. Do not stop taking this medicine suddenly; 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Captor can have adverse effects, although not all people suffer from them.

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

• nausea.
• dizziness, drowsiness.

Frequent: may affect between 1 and 10 out of 100 patients;

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

Infrequent: may affect between 1 and 10 out of 1,000 patients;

• tachycardia, hypertension, cardiac rhythm and frequency disorders.
• difficulty or pain when urinating.
• skin reactions (e.g., rashes, hives).
• tingling sensation, numbness, or feeling of pins and needles in the limbs, ringing in the ears, muscle spasms, involuntary muscle contractions.
• depression, nightmares, hallucinations (hearing, seeing, or perceiving something that does not exist in reality), memory loss.
• difficulty swallowing, blood in stools.
• chills, hot flashes, chest pain.
• difficulty breathing.

Rare: may affect between 1 and 10 out of 10,000 patients;

• seizures, difficulties in carrying out coordinated movements.
• addiction
• blurred vision.

Frequency not known(cannot be estimated from the available data):

• Decrease in blood sugar levels (hypoglycemia)
• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).
• Hiccup
• 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 Captor").

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

• Feeling of dizziness when standing up after being 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.
• In rare cases, skin rashes, which are indicative of 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, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping treatment with Captor, please consult your doctor.

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

Using Captor with anticoagulants (e.g., femprocumon, 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.

If you experience adverse effects, consult your doctor or pharmacist or nurse, even if they are adverse effects that do not appear in this prospectus.

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 Captor

Keep out of the reach and sight 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 to people who have not been prescribed it.

This medicine does not require special storage conditions.

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

Do not use this medicine if you observe visible signs of deterioration.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at 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

Composition ofCaptor:

The active ingredients are tramadol hydrochloride and paracetamol.

One tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

The other components are: Povidone, magnesium stearate, anhydrous colloidal silica, sodium carboxymethylcellulose (Type A) of potato and pregelatinized corn starch.

Appearance of the Product and Package Contents:

Captor is presented in the form of oral tablets, in packages of 20 and 60 tablets.

Marketing Authorization Holder:Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Manufacturer:Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

Date of the Last Revision of this Prospectus:February 2025

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/