Leaflet: information for the user

Tioner50 mg hard capsules

Tramadol, hydrochloride

Read this leaflet carefully before you start taking this medicine, as 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, and you must 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.

1.What isTionerand what it is used for

2.What you need to know before starting to takeTioner

3.How to takeTioner

4.Possible side effects

5.Storage ofTioner

6.Contents of the pack and additional information

Tramadol, the active ingredient ofthis medication,is a pain reliever 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.

Tioner is used in the treatment of moderate to severe pain.

Do not takeTioner

• 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 medicines (medicines that act on the 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 “Taking Tioner with other medicines”);
• 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 before starting to take Tioner

• if you think you have dependence 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 can be cold sweat);
• if you have increased intracranial pressure (for example after a head trauma 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 Tioner”).

Respiratory disorders related to sleep

Tioner 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). Among the 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.

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).

Be aware thatthis medicinemay cause physical and psychological dependence. When this medicine is used for a prolonged period, its effect may decrease, requiring the use of higher doses (development of tolerance). In patients with a tendency to abuse medicines or those with dependence on medicines, treatment withTionershould only be carried out for short periods of time and under strict medical supervision.

Also inform your doctor if any of the following 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. They 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 may 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.

There is a weak risk that you may experience a serotonin syndrome that may appear after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult a doctor immediately if you experience any of the symptoms linked to this severe syndrome (see section 4 “Possible adverse effects”).

Other medicines and Tioner

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 Tioner with MAO inhibitors (a certain type of medicine used to treat depression).

The effect and duration of pain relief produced by Tioner 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 adverse effects increases,

• if you are taking this medicine simultaneously with tranquilizers, sleeping pills, other analgesics such as morphine and codeine (even when used to treat cough) and alcohol. In these cases, you may feel drowsiness or dizziness. If this happens, consult your doctor. The concomitant use of Tioner with sedatives or sleep disorder medicines (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 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;

• if you are takingmedicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tioner simultaneously with these medicines. Your doctor will tell you if Tioner is suitable for you;
• if you are taking antidepressants. Tioner may interact with these medicines and you may experience a serotonin syndrome (see section 4 “Possible adverse effects”);
• if you are taking anticoagulant coumarins (medicines to thin the blood) such as warfarin, while taking Tioner. The effect of these medicines on blood coagulation may be affected and may causebleeding;
• if you are taking medicines that may increase the accumulation of tramadol and, therefore, its adverse effects (such as ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole and erythromycin).
• Gabapentin or pregabalin to treat epilepsy or pain due to nervous system problems (neuropathic pain).

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, which is known as pharmacological tolerance). Repeated use of Tioner 50 mg hard capsules may 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 may cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tioner 50 mg hard capsules may be higher if:

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

If you notice any of the following symptoms while using Tioner 50 mg hard capsules, 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 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 effects”).

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop taking the medicine and how to do it safely (see section 3, if you interrupt treatment with Tioner 50 mg hard capsules).

Taking Tioner with food and alcohol

Do not consume alcohol during treatment withthis medicine, as its effect may be intensified. Food does not affect the effect ofTioner.

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.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

There is very little information available on the safety of tramadol in pregnant women. Therefore, do not takethis medicineif you are pregnant.

Long-term treatment during pregnancy may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. Therefore, do not take this medicine more than once during breastfeeding, or if you take Tioner more than once, 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 use machines during treatment with this medicine. It is essential to observe how this medicine affects you before driving or using machines. 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, after increasing the dose, after changing the formulation and/or when taking it with other medicines.

This medicine contains less than 1 mmol of sodium (23 mg) per 50 mg of tramadol hydrochloride; it is essentially “sodium-free”.

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

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Tioner 50 mg hard capsules, 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, 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 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).

The effect may last between 4-6 hours depending on the pain.

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 insufficiency/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 Tioner?

Tioner capsules are administered orally.

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

You can take the capsules either with an empty stomach or with meals.

For how long should you take Tioner?

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 Tioner 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, contraction of the pupil, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), 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, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the medication package insert to the healthcare professional.

If you forgot to take Tioner

If you forgot 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 Tioner as you have been doing until now.

If you interrupt treatment with Tioner

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 adverse effects occur when treatment with tramadol is discontinued. However, in rare cases, people who have been taking this medication for some time may feel unwell if they discontinue treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may find themselves hyperactive, have difficulty sleeping, or experience digestive 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 discontinuing 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 medicinecan 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 Tioner 50 mg hard capsules 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 heartbeats and rapid heartbeats, sensation of dizziness or collapse). These side effects may occur particularly in patients who are taking part in physical activity or who are exerting themselves physically.
• 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 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 taking high doses of tramadol or when another medicine that may induce them is taken at the same time.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological changes may occur after treatment with Tioner 50 mg hard capsules. 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 of judgment).
• This may lead to dependence on the medicine. If Tioner hard capsules are taken for prolonged periods, it may produce dependence, although the risk is very low. When treatment is stopped abruptly, withdrawal syndrome (see "If you stop taking Tioner 50 mg hard capsules") may occur.
• Blurred vision, constriction of the pupils (miosis), excessive dilation of the pupils (mydriasis).
• 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 other medicines that depress the brain function are taken at the same time, 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

• Decreased blood sugar levels.
• Hypophagia.
• Serotonin syndrome, which may manifest itself 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tioner").

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.

Store this medication in a safe and protected place, inaccessible to others. This medication may cause severe harm or even be fatal to individuals who have not been prescribed it.

Do not usethis medicationafter the expiration date appearing on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25 °C.

Medications should not be disposed of through drains or trash.Deposit the 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tioner 50 mg hard capsules

The active ingredient is tramadol hydrochloride.

Each capsule contains 50 mg of tramadol hydrochloride.

The other components are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, anhydrous colloidal silica.

Capsule coating: gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Appearance of the product and contents of the packaging

Pale green/yellow capsules, shiny, oblong, and with the manufacturer's logo printed.

Tioner 50 mg hard capsules are packaged in blisters and supplied in containers of20 and 60 capsules.

Only some container sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible manufacturer:

Grünenthal GmbH

Zieglerstrasse 6 --52078 Aachen (Germany)

Last review date of this leaflet: April 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/