CAPTOR SIMPLEX 150 mg PROLONGED-RELEASE HARD CAPSULES

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

Do not take Captor simplex:

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).
• If you are intoxicated by alcohol or sedatives, such as sleeping pills, other analgesics, or psychotropic drugs (drugs that act on mood and emotions).
• If you are taking or have taken in the last two weeks certain medicines called "monoamine oxidase inhibitors" or MAO inhibitors (used to treat depression). The combination can lead to a serious, potentially fatal interaction.
• If you have uncontrolled epilepsy. (See "Other medicines and Captor simplex").

Captor simplex is not a suitable substitute for treatment of drug addiction.

The use of Captor simplex 50 mg is not suitable for children with a weight below 25 kg.

Warnings and precautions

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

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

• If you have epilepsy or convulsions (epileptic seizures) or have had them in the past, because tramadol may increase the risk of having them again.
• If you have liver or kidney problems.
• If you have 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 hormonal supplements.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Captor simplex").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of CAPTOR SIMPLEX can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

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

• You or any member of your family have abused alcohol or experienced dependence on it, prescription drugs, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using CAPTOR SIMPLEX, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated, unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, 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 treatment option for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop 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, nighttime awakenings due to lack of breath, 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 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, 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.

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

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

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

There is a slight risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Children and adolescents

Use in children with respiratory problems:

Tramadol is not recommended for use in children with respiratory problems, as symptoms of tramadol toxicity can worsen in these children.

Other medicines and Captor simplex

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

• 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 medicines that contain:

• Carbamazepine (used to treat epilepsy)
• Pentazocine, nalbuphine, or buprenorphine (analgesics)
• Ondansetron (used to stop nausea).

Your doctor will tell you if you should take Captor simplex and at what dose.

The risk of side effects increases,

• If you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Captor simplex at the same time as these medicines. Your doctor will tell you if Captor simplex is suitable for you.
• If you are taking medicines for depression. Captor simplex may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• • If you take Captor simplex at the same time as sedatives, such as tranquilizers or sleeping pills, and other analgesics (morphine, codeine, also when used for cough). You may feel too drowsy or feel like you are going to lose consciousness. 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 medicines that inhibit blood coagulation, such as warfarin. You may need to reduce the dose of these medicines; otherwise, you may increase the risk of severe bleeding.

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

Concomitant use of Captor simplex with sedatives such as benzodiazepines or medicines that increase the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Captor simplex with sedative medicines, they will limit the dose and duration of concomitant treatment.

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendation strictly. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Tell 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Tramadol is excreted in breast milk. For this reason, you should 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 influences fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Captor simplex. 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, when changing treatment, and when taking it in combination with other medicines.

Captor simplex contains sucrose and benzoic acid

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take Captor simplex

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

Follow your doctor's instructions for taking Captor simplex exactly. If you are in doubt, consult your doctor or pharmacist again.

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

The following are the usual doses. Your doctor may gradually increase or decrease the dose depending on your response to treatment.

Adults and adolescents 12 years and older:

The usual dose is one 150 mg capsule taken twice a day, which is equivalent to 300 mg per day. The capsules should be taken in the morning and at night. You should not take more than 400 mg per day.

Use in children:

The use of this medicine is not suitable for children with a weight below 25 kg, which generally means that it should not be administered to children under 12 years. Other forms of this medicine 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 the case, your doctor may recommend prolonging the dosing intervals.

Patient with hepatic or renal impairment/patients on dialysis:

If you have 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.

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Method of administration:

This medicine is taken orally.

The capsules should be swallowed whole with a glass of water.

The capsules can be taken with or without food. THEY SHOULD NOT BE CHEWED, DIVIDED, OR CRUSHED.

How long to take Captor simplex

This medicine should not be taken for longer than strictly necessary.

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

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Captor simplex than you should

If you have taken more Captor simplex than you should, consult your doctor or pharmacist immediately or contact the Toxicology Information Service, telephone 915 620 420. You may experience various symptoms, including: constricted pupils, vomiting (dizziness), low blood pressure, rapid heart rate, fainting, or even coma, seizures, and breathing difficulties or shallow breathing.

If you forget to take Captor simplex, take it as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.

If you stop treatment with Captor simplex, the pain may come back.

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

If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, Captor simplex can have adverse effects, although not all people suffer from 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 wheezing or sudden whistling when breathing, difficulty breathing, swelling of the eyelids, face, or lips, skin rash, or itching (especially if it affects the whole body).

The following adverse effects may occur:

Very frequent: may affect more than 1 in 10 patients

Frequent: may affect up to 1 in 10 patients

Infrequent: may affect up to 1 in 100 patients

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

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

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

• Decrease in blood glucose level (hypoglycemia)
• Hypo
• Serotonin syndrome, which can manifest through 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 simplex").

When treatment is suddenly stopped, signs of drug withdrawal syndrome may appear (see "If you interrupt treatment with Captor simplex")

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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 (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Captor simplex

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

Store this medicine in a safe and protected place, where other people cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medicine 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

Medicines should not be thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 of Captor simplex

• The active ingredient is tramadol hydrochloride. Each capsule contains 150 mg of tramadol hydrochloride, equivalent to 131.73 mg of tramadol.
• The other components (excipients) are:

Sugar spheres (cornstarch and sucrose)

Macrogol 4000

Polyacrylate dispersion at 30% (ethyl acrylate, methyl methacrylate, nonoxinol)

Simethicone emulsion (simethicone, polyoxyethylene stearate, methylcellulose, polyethylene glycol stearate, glycerides, xanthan gum, benzoic acid, sorbic acid, and sulfuric acid)

Hypromellose

Talc

Gelatin

Titanium dioxide (E 171)

Yellow iron oxide (E 172)

Appearance of the Product and Package Contents

Yellow opaque gelatin capsules containing white spherical microgranules ("microspheres").

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

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 – Sant Cugat del Vallés (Barcelona)

O

Ethypharm

Chemin de la Poudrière

F-76120 Grand-Quevilly (France)

O

Toll Manufacturing Services, S.L.

Aragoneses, 2

28108 Alcobendas (Spain)

O

Macarthys Laboratories Limited

Bampton road, Harold hill,

Romford, RM3 8UG

United Kingdom

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

Date of the last revision of this prospectus: July 2024

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/