Leaflet: information for the user

Captor 37.5 mg/325 mg tablets EFG

Tramadol hydrochloride/ Paracetamol

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

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms of the disease, as it may harm them.

- If you experience any side effects, inform your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What is Captor and what it is used for

2. What you need to know before taking Captor.

3. How to take Captor.

4. Possible side effects.

5. Storage of Captor.

6. Contents of the pack and additional information.

Captoris a combination of two analgesics, tramadol and paracetamol, that work together to relieve pain.

Captoris indicated for the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Captorshould only be used by adults and children over 12 years old.

Do not take Captor:

- If you are allergic to tramadol, paracetamol, or any of the other components of this medication (listed in section 6).

- In case of acute alcohol intoxication, if you are taking sleeping medications, powerful analgesics, or other psychotropic medications (medications that can alter mood and emotions).

- If you are taking monoamine oxidase inhibitors (certain medications 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 uncontrolled epilepsy.

Warnings and precautions:

- 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 bile duct problems;

- If you have kidney problems;

- If you have severe respiratory difficulties, for example asthma or severe lung problems;

- If you have epilepsy or have had seizures;

- If you have recently suffered a head trauma, intense headaches associated with vomiting;

- If you have dependence on any other medication used to relieve pain, for example morphine;

- If you are taking other pain medications that contain buprenorphine, nalbuphine, or pentazocine;

- If you are to be anesthetized. Inform your doctor or dentist that you are using Captor.

- Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicative of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

- If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Captor").

- During treatment with Captor, inform your doctor 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 if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty 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 levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, 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.

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 a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 "Possible adverse effects").

Tolerance, dependence, and addiction:

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become tolerant of it, known as tolerance). Repeated use of Captor 37.5 mg/325 mg may also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these adverse effects may increase with a higher dose and longer duration of use.

Dependence or addiction may make you feel like you no longer control the amount of medication you need to take or the frequency with which you need to take it.

The risk of becoming dependent or addicted to Captor 37.5 mg/325 mg 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 medications, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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

• You need to take the medication for a longer period than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medication for reasons other than those prescribed, for example, "to stay calm" or "to sleep".
• You have tried repeatedly and unsuccessfully to stop or control the use of the medication.
• When you stop taking the medication, 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 to determine the best course of 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 experience or have experienced any of these problems while taking Captor, inform your doctor. Your doctor will decide if you should continue taking this medication.

Children:

Use in children with respiratory problems: Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medications and Captor:

Inform your doctor or pharmacist if you are taking:

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

• Gabapentin or pregabalin for treating epilepsy or pain due to nerve problems (neuropathic pain).

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Captor is contraindicated in the following situations:

- Carbamazepine (a medication normally used to treat epilepsy or some types of pain, such as trigeminal neuralgia).

- Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.

The risk of adverse effects increases if you also use:

- Triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhea, you should contact your doctor.

- Sedatives, sleeping medications, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), some medications to lower blood pressure, antidepressants, or allergy medications. You may feel drowsy or dizzy. If this occurs, consult your doctor.

- Antidepressants, anesthetics, neuroleptics (medications that affect mood), or bupropion (a medication used to help 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 medication used to prevent blood clots). The effectiveness of these medications may be altered, with a risk of bleeding. You should inform your doctor immediately of any prolonged or unexpected bleeding.

- Medications that may cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Captor simultaneously with these medications. Your doctor will tell you if Captor is suitable for you.

- Antidepressants. Captor may interact with these medications and may cause a serotonin syndrome (see section 4 "Possible adverse effects").

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

- Metoclopramide, domperidone, and ondansetron (medications for nausea and vomiting),

- Cholestyramine (a medication that reduces cholesterol in the blood),

- Ketoconazole and erythromycin (medications used to treat infections).

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

Taking Captor with food, drinks, and alcohol:

You should not take alcoholic beverages while taking this medication.

Pregnancy, breastfeeding, and fertility:

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

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

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

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Driving and operating machinery:

Ask your doctor if you can drive or operate machinery during treatment with this medication. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Captor contains sodium

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

Follow exactly the administration instructions of this medication as indicated 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 smallest dose possible that produces pain relief should be used.

You should take Captor for the shortest time possible.

Before starting treatment and regularly during it, 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 something different, the recommended starting dose for adults and adolescents over 12 years old 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 medication is not recommended for children under 12 years old.

Older 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 insufficiency/patients on dialysis:

If you have a 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.

Administration form:

The tablets can be taken whole or split in half with the help of a liquid, preferably water. The groove on the tablet serves to split the tablet if it is difficult to swallow whole

If you estimate that the action of Captor is too strong (i.e., you feel very drowsy or have difficulty breathing) or weak (i.e., you do not have adequate pain relief), inform 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 of liver damage that will 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 medication and the amount taken.

If you forgot to take Captor:

If you forgot to take the tablets, it is possible that the pain will reappear. Do not take a double dose to compensate for the missed doses, simply continue taking the tablets as usual.

If you interrupt treatment with Captor:

Generally, there are no unwanted effects after interrupting treatment with Captor. However, in rare cases, patients who have been taking Captor for a while and have interrupted treatment abruptly may feel unwell (see section 4. "possible adverse effects"). If you have been taking Captor for some time, you should consult your doctor before interrupting treatment as your body may have become accustomed to it. Do not stop taking this medication 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 interrupt it, which can be done by gradually reducing the dose to reduce the probability of unnecessary adverse effects (withdrawal symptoms).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Captor can have side effects, although not everyone will experience them.

Very common:can affect more than 1 in 10 patients;

- nausea.

- dizziness, drowsiness.

Common:can affect between 1 and 10 in 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 "high" all the time).

Uncommon:can affect between 1 and 10 in 1,000 patients;

- tachycardia, hypertension, cardiac rhythm and frequency disorders.

- difficulty or pain urinating.

- skin reactions (e.g. rashes, urticaria).

- numbness, tingling, or pins and needles sensation in the extremities, ear noises, muscle spasms, involuntary muscle contractions.

- depression, nightmares, hallucinations (hearing, seeing, or perceiving something that is not real), memory loss.

- difficulty swallowing, blood in stool.

- chills, hot flashes, chest pain.

- difficulty breathing.

Rare:can affect between 1 and 10 in 10,000 patients;

- convulsions, difficulty with coordinated movements.

- addiction

- blurred vision.

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

• Decreased blood sugar level (hypoglycemia)
• A severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).
• Dehydration
• 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, rigidity, 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 side effects have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of those symptoms while taking Captor, 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.

- In rare cases, skin eruptions, indicating allergic reactions that can manifest as sudden swelling of the face and neck, shortness of breath, or a drop in blood pressure and dizziness.

If this happens, interrupt treatment and consult your doctor immediately. Do not take this medication again.

In rare cases, using a medication 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 stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and ear noises (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 cause nasal or gum bleeding.

The use of Captor with anticoagulants (e.g. femprocumona, warfarin) may increase the risk of bleeding. Inform your doctor immediately about any prolonged or unexpected bleeding.

Severe skin reactions have been rarely reported.

If you experience side effects, consult your doctor or pharmacist or nurse, even if it's about possible side effects that do not appear in this prospectus.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it's aboutpossibleside effects that do not appear in this prospectus.You can also report them directly throughthe Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of reach and sight of children.

Store this medication in a safe and protected place where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

This medication does not require special storage conditions.

Do not useCaptorafter the expiration date appearing on the packaging (after CAD). The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment..

Composition ofCaptor:

The active principles are hydrochloride of tramadol and paracetamol.

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

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

Appearance of the product and content of the packaging:

Captor is presented in the form of oral tablets for administration, in packaging of 20 and 60 tablets.

Holder of the marketing authorization:
Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028- Barcelona (Spain)

Responsible for manufacturing:
Ferrer Internacional, S.A.

Joan Buscallà, 1-9

Sant Cugat del Vallès (Barcelona)

Date of the last review of this leaflet: February 2025

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/