Package Insert: Information for the Patient

CAPTOR SIMPLEX 200 mg Extended-Release Hard Capsules

Tramadol Hydrochloride

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert.You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, 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 any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey do not appear in this package insert. See section 4.

Tramadol hydrochloride —the active substance of Captor simplex— belongs to a group of medications known as opioid analgesics. Its analgesic action is due to the fact that it acts on specific nerve cells in the spinal cord and the brain.

Captor simplex is used for the treatment of moderate to intense pain

Do not take Captor Simplex:

• If you are allergic to tramadol or any of the other components of this medication (listed in section 6).
• If you are intoxicated by alcohol or sedatives, such as sleeping pills, other painkillers, or psychotropic medications.
• If you are taking or have taken in the past two weeks certain medications called "monoamine oxidase inhibitors" or MAO inhibitors (used to treat depression). The combination may lead to a severe, potentially fatal interaction.
• If you have uncontrolled epilepsy. (See "Other medications and Captor Simplex".)

Captor Simplex is not an appropriate substitute for the treatment of drug addiction.

The use of Captor Simplex 50 mg is not suitable for children with a weight of less than 25 kg.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Captor Simplex:

• If you think you have dependence on other painkillers (opioids)
• If you have consciousness disorders (if you think you are going to faint)
• If you are in shock (a sign of this state may be cold sweat)

• If you have epilepsy or seizures (epileptic crises) or have had them in the past, as tramadol may increase the risk of them recurring.
• If you have liver or kidney problems.
• If you experience extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have 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 Simplex".)

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 becomes accustomed to it, known as pharmacological tolerance). Repeated use of CAPTOR SIMPLEX can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medication to be used or the frequency with which it is used.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to [product name] may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illicit drugs ("addiction").

- You are a smoker.

- You have had any mental health problems (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using CAPTOR SIMPLEX, 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, such as "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 course of treatment for you, when it is appropriate to discontinue the medication, and how to do it safely (see section 3, if you interrupt treatment with CAPTOR SIMPLEX).

Respiratory disorders related to sleep

Captor Simplex 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 can affect each person differently. In some people, it may not be possible to achieve sufficient 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.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (400 mg).

As with all opioids, tramadol should be used with caution and only under medical supervision in severely ill patients, including those with respiratory difficulty, low blood pressure (shock), head trauma, or brain diseases that can cause increased intracranial pressure.

As with all opioids, tramadol can cause psychological and physical dependence or addiction in some people, especially with prolonged use. The dose required to achieve the desired effect may increase over time. In patients who are addicted to other opioid painkillers, tramadol should be used with caution and only for short periods.

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").

Children and adolescents

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 Simplex

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

- Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

The analgesic effect of Captor Simplex may be weakened and/or shortened if you are taking other medications that contain:

• Carbamazepine (used to treat epilepsy)
• Pentazocine, nalbuphine, or buprenorphine (painkillers)
• Ondansetron (used to interrupt nausea)

Your doctor will indicate if you should take Captor Simplex and at what dose.

The risk of adverse effects increases,

• If you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Captor Simplex simultaneously with these medications. Your doctor will tell you if Captor Simplex is suitable for you.
• If you are taking medications for depression. Captor Simplex may interact with these medications and may experiencea serotonin syndrome (see section 4 "Possible adverse effects").
• • If you take Captor Simplex at the same time as sedatives, such as tranquilizers or sleeping pills, and other painkillers (morphine, codeine, when used for cough). You may feel too drowsy or feel like you are going to pass out. If this happens, consult your doctor.
  • If you take Captor Simplex at the same time as alcohol. Tramadol may increase the effect of alcohol and, therefore, you should act with caution if you want to drink alcohol during treatment with Captor Simplex.
  • If you take Captor Simplex at the same time as medications that inhibit blood clotting, such as warfarin. You may need to reduce the dose of these medications, otherwise, you may increase the risk of severe bleeding.

Do not take Captor Simplex at the same time as the medications called "monoamine oxidase inhibitors" (used to treat depression) or if you have taken any in the past two weeks.

The concomitant use of Captor Simplex with sedatives such as benzodiazepines or medications that increase the risk of drowsiness, respiratory depression, coma, and may be potentially fatal. Therefore, it should only be considered when other treatment options are not possible.

However, if your doctor prescribes Captor Simplex with sedatives, you should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and strictly follow your doctor's recommended dose. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms.

Taking Captor Simplex with food and alcohol

Do not consume alcohol during treatment with Captor Simplex, as its effect may be intensified. Food does not affect the effect of Captor Simplex.

Pregnancy, breastfeeding, and fertility

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

Captor Simplex may affect the fetus. Therefore, it should not be taken during pregnancy.

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

Based on human experience, it is not suggested that tramadol affects male and female fertility.

Driving and operating machines

Ask your doctor if you can drive or operate machines during treatment with Captor Simplex. It is essential to observe how this medication affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the beginning of treatment, when changing to another treatment, and when administering it concomitantly with other medications.

Captor Simplex contains saccharose and benzoic acid

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 0.015 mg of benzoic acid per unit dose.

The dose should be adjusted to the intensity of the pain and individual sensitivity. Normally, the smallest dose possible that produces pain relief should be used.

Follow exactly the administration instructions for Captor simplex indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of CAPTOR SIMPLEX, when and for how long you should use it, when you should contact your doctor and when you should discontinue use (see also section 2).

Below are the usual doses.The dose may be increased or decreased gradually by your doctor depending on your response to treatment.

Adults and adolescents 12 years or older:

The usual dose is one 200 mg capsule taken twice a day, which is equivalent to 400 mg per day. Capsules should be taken in the morning and at night. Normally, do not take more than 400 mg per day.

Use in children:

The use of this medication is not suitable for children with a weight of less than 25 kg, which generally means it should not be administered to children under 12 years old. Other forms of this medication may be more suitable for use in children; ask your doctor, pharmacist, or nurse.

Elderly patients:

In elderly patients (over 75 years), 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 disease/patients on dialysis:

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

Administration form:

This medication is taken orally.

Capsules should be swallowed whole, with a glass of water.

Capsules can be taken with or without food. Do not crush, divide, or chew them.

For how long should you take Captor simplex?

This medication should not be administered for longer than strictly necessary.

If prolonged treatment is required, your doctor will monitor you at short and regular intervals (if necessary, with interruptions in treatment) to determine if you should continue treatment with this medication and at what dose.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Captor simplex than you should

If you have taken Captor simplex more than you should, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 915 620 420.You may experience various symptoms, including: pupil constriction, vomiting (dizziness), decreased blood pressure, tachycardia, hypotension, fainting, or even coma, seizures, and respiratory difficulties or shallow breathing.

.

If you forget to take Captor simplex, take it as soon as you remember and then continue taking it as before.Do not take a double dose to compensate for a missed dose.

If you interrupt treatment with Captor simplex, the pain may return.

Do not stop taking this medication suddenly, consult your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

If you have been taking this medication for a very long time and stop treatment suddenly, you may experience the following adverse effects: restlessness, anxiety, nervousness, tremors, or stomach pain.Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, numbness, and tingling, and "buzzing" in the ears (tinnitus). Very rarely, other unusual central nervous system symptoms, such as confusion, delirium, distorted perception of one's own personality (derealization), and altered perception of reality (despersonalization), and delusional persecution (paranoia), have been seen.If you experience any of these effects after stopping treatment with Captor simplex, consult your doctor.

If you have any other questions about the use of thismedication, ask your doctor, pharmacistor nurse.

Like all medicines, Captor simplex may cause side effects, although not everyone will experience them.

Captor simplex may occasionally cause allergic reactions, although severe allergic reactions (including anaphylaxis and angioedema) are rare.Inform your doctor immediately if you experience sudden wheezing or shortness of breath, difficulty breathing, swelling of the eyelids, face, or lips, skin rash or itching (especially if it affects your entire body).

The following side effects may occur:

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect fewer than 1 in 10,000 patients)

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

• Decreased blood glucose levels (hypoglycemia)
• Hyponatremia
• Serotonin syndrome, which may 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Captor simplex").

When treatment is suddenly discontinued, signs of drug withdrawal syndrome may appear (see "If you stop taking Captor simplex").

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse,even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano (www.notificaRAM.es).By reporting side effects, you can contribute to providing more information on the safety of this medicine

Keep this medication out of the sight and reach of children.

Conserve this medication in a safe and protected place, to which other people cannot access. This medication can cause serious harm or even be fatal to individuals who have not been prescribed it.

Do not use this medication after the expiration date that appears on the blister pack and the box. The expiration date is the last day of the month indicated.

Do not store at temperatures above 25°C

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Captor Simplex Composition

• The active ingredient is tramadol hydrochloride. Each capsule contains 200 mg of tramadol hydrochloride, which is equivalent to 175.64 mg of tramadol.
• The other components (excipients) are:

Sugar spheres (cornstarch and sucrose)

Macrogol 4000

30% polyacrylate dispersion (ethyl acrylate, methyl methacrylate, nonoxinol)

Simethicone emulsion (simethicone, triestearate depolyoxiethyleno-sorbitan, methylcellulose, polyethylene glycol stearate, glycerides, xanthan gum, benzoic acid, sorbic acid, sulfuric acid)

Hypromellose

Talc

Gelatin

Titanium dioxide (E 171)

Yellow iron oxide (E 172)

Product appearance and packaging contents

Yellow opaque head and white opaque body gelatin capsules containing white spherical microgranules (“microspheres”).

Boxes containing 20 and 60 prolonged-release hard capsules (prolonged-release capsules).

Marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Responsible for manufacturing:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 – Sant Cugat del Vallés (Barcelona)

Or

Ethypharm

Chemin de la Poudrière

F-76120 Grand-Quevilly (France)

Or

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Spain)

Or

Macarthys Laboratories Limited

Bampton road, Harold hill,

Romford, RM38UG

United Kingdom

This medicine is authorized in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: July 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/