TRAMADOL CODRAMOL 50 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tramadol Codramol 50 mg Hard Capsules EFG

Tramadol hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

1. What is Tramadol Codramol and what is it used for

Tramadol, the active substance in this medicine, is an analgesic belonging to the group of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol Codramol is used for the treatment of moderate to severe pain in adults and adolescents from 12 years of age.

2. What you need to know before you take Tramadol Codramol

Do not take Tramadol Codramol

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).

• In case of acute intoxication caused by alcohol, sleeping pills, pain relievers, or other psychotropic drugs (drugs that act on mood and emotions).

• If you are taking monoamine oxidase inhibitors (a certain type of medication used to treat depression) or if you have taken them in the last 14 days before treatment with this medicine (see "Taking Tramadol Codramol with other medicines");

• for the treatment of withdrawal syndrome;

Warnings and precautions

Consult your doctor before starting to take Tramadol Codramol:

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 serious syndrome (see section 4 "Possible side effects").

Respiratory disorders related to sleep

Tramadol Codramol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). 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 a dose reduction.

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).

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 Tramadol Codramol can also lead to dependence, abuse, and addiction, which can result in potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use.

Dependence or addiction can cause a 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 Tramadol Codramol 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 Tramadol Codramol, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period than prescribed 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 start taking 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 Tramadol Codramol).

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.

Also, inform your doctor if you experience any of these problems during treatment with this medicine or if you have had them before.

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, 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, 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.

Children and adolescents

Use in children with respiratory problems:

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

In particular, in children, the first administration of tramadol should be done under strict medical supervision.

Monitor the child, especially during the first administration. In case of warning signs (such as altered consciousness, constricted pupils, vomiting, seizures, very slow breathing...), call a doctor immediately or consult an emergency service (see section "If you take more Tramadol Codramol than you should").

Other medicines and Tramadol Codramol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Concomitant treatment with tramadol and monoamine oxidase inhibitors (a certain type of medication used to treat depression) should be avoided.

The effect and duration of pain relief produced by this medicine may be reduced if you take medicines that contain:

• Carbamazepine (for epilepsy);
• Ondansetron (to prevent nausea)

Your doctor will tell you if you should take this medicine and in what dose.

The risk of side effects increases:

• If you are taking this medicine simultaneously with other pain relievers such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsy or dizzy. If this happens, consult your doctor.
• Concomitant use of tramadol with sedatives or medicines for the treatment of insomnia (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when no other treatment options are possible.

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

Tell your doctor about all sedative medicines you are taking and strictly follow your doctor's dosage recommendation. 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;

• If you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take tramadol simultaneously with these medicines. Your doctor will tell you if this medicine is suitable for you.
• If you are taking antidepressant medicines, Tramadol Codramol may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").

Taking Tramadol Codramol with food and alcohol:

Do not consume alcohol during treatment with this medicine, as its effect may be intensified. Food does not affect the effect of Tramadol Codramol.

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.

Pregnancy:

There is very little information available on the safety of tramadol in pregnant women. Therefore, you should not take this medicine if you are pregnant.

Chronic treatment during pregnancy can cause withdrawal syndrome in newborns.

Breastfeeding:

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding, or if you take Tramadol Codramol more than once, you should interrupt breastfeeding.

Fertility:

Based on human experience, it is not suggested that tramadol affects fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with this medicine.

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 sleepy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it concomitantly with other medicines.

3. How to take Tramadol Codramol

Follow exactly the administration instructions of this medicine given 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 the use of Tramadol Codramol, 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 dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you to do so.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and children over 12 years:

Normally, the initial dose is 1 or 2 capsules (equivalent to 50 or 100 mg of tramadol hydrochloride). Depending on the pain, the effect can last between 4 to 6 hours.

Use in children and adolescents:

This medicine is not recommended for children under 12 years of age.

Elderly patients:

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

Patient with liver or kidney problems/patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may prolong the dosing intervals.

This medicine should not be administered for longer than strictly necessary. If you require prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary with interruptions in treatment) to see if you should continue treatment with this medicine and at what dose.

Method of administration:

The capsules are taken orally. Take the capsule whole with a little water.

You can take the capsules with or without food.

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

If you take more Tramadol Codramol than you should

If you have taken an extra dose by mistake, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses of tramadol, contraction of the pupil, vomiting, decrease in blood pressure, increase in heart rate, collapse, decrease in the level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing that can lead to respiratory arrest may occur. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tramadol Codramol

Do not take a double dose to make up for forgotten doses, but continue taking the capsules as usual.

If you stop treatment with Tramadol Codramol

If you stop or finish treatment with this medicine too early, it is likely that the pain will return. If you want to stop treatment due to side effects, consult your doctor.

Do not stop taking this medicine suddenly unless your doctor tells you to. If you want to stop taking your medicine, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform 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).

Generally, no side effects are experienced when treatment with tramadol is stopped. However, in rare cases, people who have been taking this medicine for some time may feel unwell if they stop treatment abruptly. They may feel agitated, anxious, nervous, or trembly. They may be overactive, have difficulty sleeping, or have digestion and bowel problems. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, unusual symptoms of the central nervous system have been detected, such as confusion, delirium, change in perception of personality (depersonalization), and change in perception of reality (derealization) and persecution delusions (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

You should consult your doctor immediately if you experience symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat and/or difficulty swallowing and rash along with difficulty breathing.

The most frequent adverse effects during treatment with tramadol are nausea and dizziness, which occur in more than 1 in 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

Common: may affect 1 in 10 people

• Headache, numbness.
• Fatigue.
• Constipation, dry mouth, vomiting.
• Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

• Effects on the heart and blood circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), gastrointestinal discomfort (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Dermatological reactions (e.g., itching, skin rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness

(syncope), speech disorders.

• Epileptic seizures occur mainly after taking high doses of tramadol or when taken simultaneously with another medicine that may induce them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological alterations may appear after treatment with tramadol. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These may appear in the form of mood changes (usually euphoria, occasionally irritability), changes in activity (usually decrease and occasionally increase), and decreased cognitive and sensory perception (alterations of the senses and perception that can lead to errors of judgment).
• It may cause dependence on the medicine. When treatment is interrupted abruptly, withdrawal syndrome may appear (see "If you stop treatment with Tramadol Codramol").
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• Cases of worsening asthma have been reported, however, it has not been established whether they were caused by tramadol. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from the available data

• Decrease in blood sugar levels.
• Hypo
  • Serotonin syndrome, which may manifest 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 Tramadol Codramol").

Reporting of adverse effects:

If you experience any of the adverse effects, consult your doctor or pharmacist, 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 Tramadol Codramol

Keep this medicine out of sight and reach of children.

Keep this medicine in a safe and protected place, to which other people cannot access. This medicine can cause serious harm and even be fatal to people to whom it has not been prescribed.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 Tramadol Codramol

The active ingredient is tramadol hydrochloride. Each hard capsule contains 50 mg of tramadol hydrochloride.

The other components (excipients) are: calcium hydrogen phosphate, magnesium stearate, and anhydrous colloidal silica. The gelatin capsule is composed of: gelatin and titanium dioxide (E171).

Appearance of the Product and Package Contents

Tramadol Codramol is presented in the form of hard capsules. The capsules are hard, oblong, with a white body and cap.

Each package contains 20 or 60 hard capsules.

Marketing Authorization Holder:

Farmalider S.A:

C/ La Granja, 1

28108 Alcobendas

Madrid, Spain

Manufacturer:

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 – Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus: April 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).