Captor 75 mg/650 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Captor 75 mg/650 mg tablets

Tramadol hydrochloride/Paracetamol

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

• Keep this leaflet as 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, including any 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, whenever your doctor considers that the 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 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 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 that your eyes or skin turn 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 head trauma, severe headaches associated with vomiting;
• If you are dependent on any other pain-relief medicines, for example morphine;
• If you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• If you are going to be anaesthetized. 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 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 if you 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 breathing difficulties 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 apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices 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 in 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, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

There is a slight risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Seek immediate medical advice 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 make the medicine less effective (you become accustomed to it, known as tolerance). Repeated use of Captor 75 mg/650 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 75 mg/650 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 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 75 mg/650 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 to your doctor so they can advise you on the best treatment approach, 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:

Inform your doctor or pharmacist if you are taking:

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

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

Tell your doctor or pharmacist if you are using or have recently used any other medicines, 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.

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

Captor must not be used if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as intense facial pain attacks known as trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). 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 diarrhea, you should contact your doctor.

• Sedatives, sleeping medicines, other painkillers such as morphine and codeine (also when used for cough treatment), baclofen (a muscle relaxant), some 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 quit 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, increasing the 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 used to treat nausea and vomiting),
• Colestipol (a medicine that reduces cholesterol in the blood),
• 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:

You must not drink alcoholic beverages while taking this medicine.

Pregnancy, breastfeeding, and fertility:

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

Because Captor contains tramadol, 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 must 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 use machines during treatment with this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or use machines if you feel sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking it together with other medicines.

This medicine 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. The lowest possible dose that provides pain relief should normally 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 using Captor 75 mg/650 mg, when and for how long you should take it, when you should contact your doctor, and when you should discontinue treatment (see also section 2).

Unless otherwise prescribed by your doctor, the recommended starting dose for adults and adolescents over 12 years of age is 1 tablet.

If necessary, the dose may be increased as advised by your doctor. The shortest interval between doses must be at least 6 hours.

Do not take more than 4 tablets of Captor per day.

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

Your doctor may increase the dosing interval:

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

Use in children and adolescents:

The use of this medicine is not recommended in children under 12 years of age.

Elderly patients:

In elderly patients (over 75 years of age), elimination of tramadol may be slow. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/dialysis patients:

Treatment with Captor is not recommended in 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 swallowed whole or split in half with a glass of liquid, preferably water. The tablet's score line is intended to help split the tablet if you have difficulty swallowing it whole or if you need to take a half dose.

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 that may only become apparent later, as well as 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 your 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 undesirable effects occur after discontinuation of 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 discontinue treatment, 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 people:

• nausea
• dizziness, drowsiness

Common: may affect between 1 and 10 in every 100 people:

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

Uncommon: may affect between 1 and 10 in every 1,000 people:

• tachycardia, hypertension, disturbances in heart rhythm and rate
• difficulty or pain when urinating
• skin reactions (e.g., rashes, urticaria)
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears, involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or perceiving 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 every 10,000 people:

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

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

• decrease in blood sugar levels (hypoglycemia)
• a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2)
• hiccups
• serotonin syndrome, which may present 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 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 only or paracetamol only. 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 you experience any of these, stop treatment and consult your doctor immediately. You must 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 sensations 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 they are adverse effects 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 and can be fatal to individuals for whom it has not been prescribed.

This medicine does not require special storage conditions.

Do not use Captor after the expiry date stated on the container (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 at 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 75 mg of tramadol hydrochloride and 650 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 pack sizes:

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), Spain

Date of the most recent revision of this package 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 Medical Devices (AEMPS) http://www.aemps.gob.es/