Captor Simplex 150 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

CAPTOR SIMPLEX 150 mg prolonged-release hard capsules

Tramadol hydrochloride

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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What CAPTOR SIMPLEX is and what it is used for
2. What you need to know before taking CAPTOR SIMPLEX
3. How to take CAPTOR SIMPLEX
4. Possible side effects
5. How to store CAPTOR SIMPLEX
6. Contents of the pack and other information

1. What Captor Simplex is and what it is used for

Tramadol hydrochloride—the active substance in Captor Simplex—belongs to a group of medicines known as opioid analgesics. Its analgesic effect is due to its action on specific nerve cells in the spinal cord and brain.

Captor Simplex is used for the treatment of moderate to severe pain.

2. What you need to know before taking Captor simplex

Do not take Captor simplex:

• If you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6).
• If you are intoxicated with alcohol or sedatives, such as sleeping pills, other analgesics, or psychotropic medicines (medicines that act on mood and emotions).
• If you are taking or have taken within the past two weeks certain medicines called "monoamine oxidase inhibitors" or MAO inhibitors (used to treat depression). The combination may lead to a serious, potentially fatal interaction.
• If you have epilepsy that is not controlled by your current medication. (see "Other medicines and Captor simplex").

Captor simplex is not an appropriate substitute for addiction treatment.

The use of Captor simplex 50 mg is not suitable for children weighing less than 25 kg.

Warnings and precautions

Talk to 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 feel you might faint)

• If you are in shock (a sign of this condition may be cold sweating)

• If you have epilepsy or seizures (epileptic fits) or have had them in the past, because tramadol could increase the risk of recurrence.

• 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 signs of adrenal insufficiency (low cortisol levels). If you have 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 simplex").

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of CAPTOR SIMPLEX may 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 higher doses and prolonged use.

Dependence or addiction may 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 higher if:

• You or any member of your family have abused alcohol or become dependent on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a 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 longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than 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 feel better once you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you interrupt treatment with CAPTOR SIMPLEX).

Sleep-related breathing disorders

Captor simplex may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness 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 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, 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 tramadol dose 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 disorders that may cause increased intracranial pressure.

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

There is a slight risk of developing serotonin syndrome after taking tramadol, either in combination with certain antidepressants or with tramadol alone. Contact a doctor immediately if you experience any symptoms associated with this serious syndrome (see section 4 "Possible side effects").

Children and adolescents

Use in children with respiratory problems:

The use of tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Captor simplex

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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

The analgesic effect of Captor simplex may be weakened and/or shortened if you are taking other medicines containing:

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

Your doctor will advise you whether you should take Captor simplex and at what dose.

The risk of adverse effects increases:

• If you are taking medicines that facilitate or may trigger seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Captor simplex simultaneously with these medicines. Your doctor will tell you whether Captor simplex is suitable for you.
• If you are taking medicines for the treatment of depression. Captor simplex may interact with these medicines, and you may experience 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, even when used for cough). You may feel excessively drowsy or feel like you might lose consciousness. If this occurs, consult your doctor.
  • If you take Captor simplex at the same time as alcohol. Tramadol may enhance the effect of alcohol and, therefore, you should be cautious if you plan to drink alcohol during treatment with Captor simplex.
  • If you take Captor simplex at the same time as medicines that inhibit blood clotting, such as warfarin. The dose of these medicines may need to be reduced, otherwise the risk of serious bleeding may increase.

Do not take Captor simplex at the same time as medicines known as "monoamine oxidase inhibitors" (used to treat depression) or if you have taken any of these medicines within the past two weeks.

The concomitant use of Captor simplex with sedatives such as benzodiazepines or medicines that increase the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendations. 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 action of Captor simplex.

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.

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, tramadol is not thought to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or use machines while being treated with Captor simplex. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machines if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, when switching to another treatment, and when taking it together 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 certain sugars, consult with him before taking this medicine.

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

3. How to take Captor simplex

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

Always follow exactly the instructions for administration of Captor simplex provided by your doctor. In case of 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 discontinue use (see also section 2).

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

Adults and adolescents aged 12 years and older:

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

Use in children:

This medicine is not suitable for children weighing less than 25 kg, which generally means it should not be given to children under 12 years of age. Other formulations of this medicine may be more appropriate for use in children; please consult your doctor, pharmacist, or nurse.

Elderly patients:

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

Patients with hepatic or renal impairment/patients on dialysis:

Treatment with Captor simplex is not recommended if you have severe liver or kidney disease. If you have moderate liver or kidney impairment, your doctor may extend the dosing intervals.

Method of administration:

This medicine is taken orally.

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

The capsules may be taken with or without food. They must NOT be chewed, split, or crushed.

How long should you take Captor simplex?

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

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

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

If you take more Captor simplex than you should

If you have taken more Captor simplex than you should, contact your doctor or pharmacist or the Toxicology Information Service immediately at telephone number 915 620 420. You may experience various symptoms, including pupil constriction,

vomiting (nausea), low blood pressure, tachycardia, dizziness, fainting, or even coma, epileptic 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 missed dose.

If you stop taking Captor simplex, your pain may return.

You should 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 minimize the risk of unnecessary adverse effects (withdrawal symptoms).

If you have been taking this medicine for a very long time and stop treatment abruptly, you may experience the following adverse effects: restlessness, anxiety, nervousness, tremors, or stomach pain. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual central nervous system (CNS) symptoms have been reported, such as confusion, delirium, distorted perception of self (depersonalization), disturbances in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these effects after stopping treatment with Captor simplex, consult your doctor.

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

4. Possible adverse effects

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

Captor simplex may occasionally cause allergic reactions, although serious allergic reactions (including anaphylaxis and angioedema) are rare. Inform your doctor immediately if you suddenly develop noisy or wheezing 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 common: may affect more than 1 in 10 people

Nausea

Dizziness

Frequent: may affect up to 1 in 10 patients

Headache Vomiting Constipation Fatigue (tiredness)

Somnolence Dry mouth Sweating (hyperhidrosis)

Uncommon: may affect up to 1 in 100 patients

Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are standing up or performing physical exertion)

Nausea Stomach problems (e.g., feeling of pressure in the stomach, bloating, diarrhea) Skin reactions (e.g., itching, rash, sudden onset of skin redness)

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

Slow heartbeats Increased blood pressure Appetite disturbances Abnormal skin sensations (e.g., itching, tingling, numbness), tremor, seizures, muscle contractions, uncoordinated movements, transient loss of consciousness (syncope), speech disorders Slow breathing, shortness of breath (dyspnea) Seizures ("fits") have occurred: mainly with high doses of tramadol or when tramadol was taken simultaneously with other medicines that may trigger seizures Psychological problems may occur after treatment with Captor simplex. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (often euphoria, occasionally irritability), changes in activity (slowing down, but sometimes increased activity), and reduced sensory and cognitive perception (being less aware and less able to make decisions, which may lead to impaired judgment)

Hallucinations, confusion, sleep difficulties, delirium, anxiety, and nightmares Blurred vision, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis) Muscle weakness Difficulty or pain during urination, reduced urine output (dysuria) Drug dependence may occur Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, a decrease in respiratory rate may occur. Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.

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

Increase in liver enzyme levels

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

• Decreased blood glucose levels (hypoglycemia)
• Hiccups
• Serotonin syndrome, which may present with 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 simplex").

When treatment is abruptly discontinued, drug withdrawal syndrome symptoms may occur (see "If you stop taking Captor simplex").

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines (www.notificaRAM.es). By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Captor simplex

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the blister pack and the outer carton. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, 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 simplex

• The active substance 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 (corn starch and sucrose)

Macrogol 4000

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

Simethicone emulsion (simethicone, polyoxethylene sorbitan tristearate, 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 contents of the container

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

Pack sizes of 20 and 60 prolonged-release hard capsules (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 Vallès (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, RM3 8UG

United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany	Tramadol Ethypharm
Ireland	By-Madol SR
Portugal	Gelotralib
United Kingdom	Maxitram SR

Date of the most recent review of this leaflet: July 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/