Leaflet: information for the user

tramadol cinfa 50 mg hard capsules EFG

tramadol, hydrochloride

Read this leaflet carefully before you start to take 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Tramadol - the active ingredient in this medication - 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 cinfa is used in the treatment of moderate to severe pain.

Do not take tramadol cinfa

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).
• In case of acute intoxications caused by alcohol, sleeping pills, analgesics, or other psychotropic drugs (medicines that act on mood and emotions).
• If you are also taking MAO inhibitors (a certain type of medicine used to treat depression) or if you have taken them in the last 14 days before starting treatment with this medicine (see “Other medicines and tramadol cinfa”).
• If you have epilepsy and your seizures are not adequately controlled with treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tramadol cinfa:

• If you think you are dependent on other analgesics (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 increased intracranial pressure (for example, after a head injury or brain diseases).
• If you have difficulty breathing.
• If you are epileptic or have seizures, because the risk of seizures may increase.
• If you have any liver or kidney disease.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and tramadol cinfa”).

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 alone. Consult your 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 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.

Sudden 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).

Tolerance, dependence, and addiction

Be aware that this medicine may cause physical and psychological dependence. In patients with a tendency to abuse medicines or those with dependence on medicines, treatment with tramadol should only be carried out for short periods of time and under strict medical supervision.

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of tramadol cinfa can also cause dependence, abuse, and addiction, which could lead to 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 medicine 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 tramadol cinfa may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment by a psychiatrist for other mental health conditions.

If you observe any of the following symptoms while using tramadol cinfa, it could be a sign of dependence or addiction:

• You need to use the medicine for longer 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 and 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 course of treatment for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you interrupt treatment with tramadol cinfa).

Also inform your doctor if any of these problems occur during treatment with this medicine or if they have ever occurred.

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.

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, 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 medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, 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 may worsen in these children.

Other medicines and tramadol cinfa

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

It is recommended to avoid simultaneous treatment of tramadol with MAO inhibitors (a certain type of medicine used to treat depression).

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

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

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

The risk of adverse effects increases:

• If you are taking this medicine simultaneously with other analgesics 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. The concomitant use of tramadol with sedatives or sleep medications (such as benzodiazepines) increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, only consider concomitant use when other treatment options are not possible. However, if your doctor prescribes tramadol with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor about all sedatives you are taking and follow your doctor's dose recommendation strictly. It may be helpful to inform your friends and family about the signs and symptoms indicated above. Inform your doctor if you experience any of these symptoms.
• • If you are taking medicines that facilitate or may 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 tramadol is suitable for you.
  • If you are taking antidepressants, tramadol may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible side effects”).
  • If you are taking anticoagulant coumarins (medicines to thin the blood), such as warfarin, while taking tramadol. The effect of these medicines on blood coagulation may be affected, and bleeding may occur.
  • If you take medicines that can increase the accumulation of tramadol and, therefore, its adverse effects (such as, for example, ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin).
  • If you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will also explain to you what you can expect from the use of tramadol cinfa, 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 dose should be adjusted to the intensity of the pain and your individual sensitivity.

Normally, you should take the lowest dose possible that produces pain relief. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you otherwise.

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

Adults and adolescents over 12 years old

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

Use in children

This medication is not recommended for children under 12 years old.

Older patients

In older patients (over 75 years old), 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 and patients on dialysis

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

How and when to take tramadol cinfa?

The capsules are administered orally.

Swallow the capsules whole without dividing or chewing them and with sufficient liquid.

You can take this medication both with an empty stomach and with meals.

For how long should you take tramadol cinfa?

This medication 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 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 tramadol cinfa than you should

If you have taken an additional dose by mistake, generally you will not have any negative effects. Take the next dose as prescribed.

After taking very high doses of tramadol, you may experience pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that may lead to respiratory arrest. In this case, call a doctor immediately.

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

If you forget to take tramadol cinfa

If you forget to take the medication, it is likely that the pain will return. Do not take a double dose to compensate for the missed doses, simply continue taking tramadol as you have been doing until now.

If you interrupt treatment with tramadol cinfa

If you interrupt or discontinue treatment with this medication too soon, it is likely that the pain will return. If you want to discontinue treatment due to side effects, consult your doctor.

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, 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 discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

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

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 hives along with difficulty breathing.

The most common side 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

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

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

Rare: may affect up to 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 heart rate.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Seizures occur mainly after the use of high doses of tramadol or when another medicine that may induce them is taken simultaneously.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with tramadol. Their intensity and nature may vary (depending on the patient's personality and the duration of treatment). These may appear in the form of changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased and occasionally increased) and decreased cognitive and sensory perception (alterations of the senses and perception that may lead to errors in judgment).
• It may cause dependence on the medicine.
• When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking tramadol cinfa") may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).
• Slow breathing, shortness of breath (dyspnea).
• There have been reports of cases of worsening asthma, 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 urinating, decreased urine output (dysuria).

Very rare:may affect up to 1 in 10,000 people

• Increased liver enzymes.

Frequency not known: cannot be estimated from the available data

• Decreased blood sugar levels.
• Hypophagia.
• 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 tramadol cinfa").

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://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 and even be fatal to people to whom it has not been prescribed.

This medication does not require special conservation conditions.

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

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of tramadol cinfa

• The active ingredient is tramadol. Each capsule contains 50 mg of tramadol hydrochloride.
• The other components are:
• • Capule content: anhydrous calcium phosphate, magnesium stearate, anhydrous colloidal silica.
  • Durable gelatin capsule: gelatin, titanium dioxide (E-171), yellow iron oxide (E-172), and indigotin (E-132).

Appearance of the product and contents of the packaging

• Tramadol cinfa are hard capsules with a green opaque cap and a yellow opaque body, containing white odorless powder.
• Each package contains 20 or 60 capsules conditioned in aluminum/PVC blisters.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:August 2024

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/63440/P_63440.html

QR code to:https://cima.aemps.es/cima/dochtml/p/63440/P_63440.html