Captor 37.5 mg/325 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Captor 37.5 mg/325 mg tablets EFG

Tramadol hydrochloride / Paracetamol

Read the entire 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, inform your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet.

Leaflet contents:

1. What Captor is 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. How to store Captor
6. Contents of the pack and other information

1. What Captor is and what it is used for

Captor is a combination of two analgesics, 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 the combination of tramadol and paracetamol is necessary.

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

2. What you need to know before taking Captor

Do not take Captor:

• If you are allergic to tramadol, paracetamol, or any of the other components of this medicine (listed in section 6).
• In cases of acute alcohol intoxication, if you are taking sleeping medications, strong painkillers, or other psychotropic medicines (medicines that may 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 within the last 14 days before starting 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 containing paracetamol or tramadol;
• If you have liver problems or liver disease, or if you notice your eyes or skin turning yellow. This may indicate jaundice or problems with your bile ducts;
• If you have kidney problems;
• If you have severe breathing difficulties, for example asthma or serious lung conditions;
• If you have epilepsy or have had seizures;
• If you have recently suffered a head injury, severe headaches associated with vomiting;
• If you are dependent on any other medicine used for pain relief, for example morphine;
• If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anaesthetized. 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 may be signs of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need 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, inform your doctor if:

You have serious illnesses such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Sleep-related breathing disorders:

Captor may cause sleep-related breathing disorders, such as sleep apnoea (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 breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. 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, which may affect individuals differently. In some people, sufficient pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, general malaise or vomiting, constipation, loss of appetite.

There is a low risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult a doctor immediately if you develop any 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 may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of Captor 37.5 mg/325 mg may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that 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 Captor 37.5 mg/325 mg if:

• You or a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood problems (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 longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than prescribed, for example, "to stay calm" 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 feel better when you take it again ("withdrawal effect").

If you notice any of these signs, speak with your doctor so they can advise you on the best course of treatment, including when it is appropriate to stop taking it and how to do so safely (see section 3, How to take Captor).

If you currently have or have previously had any of these problems while taking Captor, inform your doctor. They will decide whether you should continue taking this medicine.

Children

Use in children with breathing problems: The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may 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 abnormality (called metabolic acidosis) that requires urgent treatment (see section 2).

• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

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

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

Do not take Captor together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Captor”).

The use of Captor is contraindicated if you are being treated with:

• Carbamazepine (a medicine commonly used to treat epilepsy or certain types of pain, such as severe facial pain known 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 the treatment of migraine) or selective serotonin reuptake inhibitors (SSRIs) (for the treatment of depression). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle contractions, or diarrhoea, you should contact your doctor.

• Sedatives, sleeping medicines, other analgesics such as morphine and codeine (also when used for cough treatment), baclofen (muscle relaxant), certain medicines for lowering blood pressure, antidepressants, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.
• Antidepressants, anaesthetics, neuroleptics (medicines that affect mood), or bupropion (a medicine used to help stop smoking). The risk of seizures may increase. Your doctor will tell you whether Captor is suitable for you.
• Warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, posing a risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.
• Medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Captor simultaneously with these medicines. Your doctor will tell you whether Captor is suitable for you.
• Antidepressants. Captor may interact with these medicines and you may experience 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 treating nausea and vomiting),
• Colestyramine (a medicine that lowers blood cholesterol),
• Ketoconazole and erythromycin (medicines used to treat infections).

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

Taking Captor with food, drinks, and alcohol:

Do not drink alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility:

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

Because Captor contains tramadol, the use of this medicine during pregnancy is not recommended. If you become pregnant while being treated 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 must stop breastfeeding.

Driving and using machines:

Ask your doctor whether you can drive or operate machinery while being treated with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Captor contains sodium

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

3. How to take Captor

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest possible dose that provides pain relief should be used.

You should take Captor for the shortest possible time.

Before starting treatment and regularly during treatment, your doctor will explain what you can expect from using 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 taking 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, the dose may be increased as advised by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 tablets of Captor per day.

Do not take Captor more frequently than prescribed by your doctor.

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 of age), elimination of tramadol may be slower. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment / patients on dialysis

Captor is not recommended for patients with severe liver or kidney disease. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

Method of administration:

The tablets may be taken whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended to help divide the tablet if you have difficulty swallowing it whole.

If you feel that the effect of Captor is too strong (for example, if you feel very drowsy or have difficulty breathing) or too weak (for example, if you do not get 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, which may only become apparent later, and inflammation of the pancreas (pancreatitis).

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

If you forget to take Captor:

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking the tablets as usual.

If you stop taking Captor:

Generally, no adverse effects occur after stopping treatment with Captor. However, in rare cases, patients who have been taking Captor for some time and who stop treatment abruptly may feel unwell (see section 4, "Possible side effects"). If you have been taking Captor for a while, you should consult your doctor before stopping treatment, as your body may have become accustomed to it. Do not stop taking this medicine suddenly; speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Captor may have adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 patients:

• nausea
• dizziness, drowsiness

Common: may affect between 1 and 10 in 100 patients:

• vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth
• itching, increased sweating
• headache, restlessness
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a persistent feeling of being “on a high”)

Uncommon: may affect between 1 and 10 in 1,000 patients:

• tachycardia, hypertension, disturbances in heart rhythm and rate
• difficulty or pain when urinating
• skin reactions (e.g., rashes, urticaria)
• tingling sensation, numbness, or prickling sensation in the limbs, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or sensing something that does not actually exist), memory loss
• difficulty swallowing, blood in stools
• chills, hot flushes, chest pain
• difficulty breathing

Rare: may affect between 1 and 10 in 10,000 patients:

• seizures, difficulty performing coordinated movements
• addiction
• blurred vision

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

• Decrease in blood sugar levels (hypoglycaemia)
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who use paracetamol (see section 2).
• Hiccups
• Serotonin syndrome, which may present as changes in mental status (e.g., restlessness, hallucinations, coma), and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle 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 adverse effects have been reported in individuals taking medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Captor, you must inform your doctor:

• Dizziness upon standing up from a lying or sitting position, slow 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 indicating allergic reactions, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness.

If this happens, stop treatment and consult your doctor immediately. You should not take this medicine again.

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult for you to stop taking it.

Occasionally, people who have taken tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel restless, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances. Very few people may also experience 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 may reveal abnormalities, for example, low platelet count, which may result in nosebleeds or bleeding gums.

The use of Captor together with anticoagulants (e.g., fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

Very rare cases of serious skin reactions have been reported.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

This medicine does not require any special storage conditions.

Do not use Captor after the expiry date stated on the packaging (after EXP). The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Captor:

The active substances 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, colloidal anhydrous silica, sodium carboxymethyl starch (Type A) from potato, and pregelatinized corn starch.

Appearance of the product and contents of the pack:

Captor is presented as tablets for oral administration, in packs 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 most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/