Tioner 50 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tioner 50 mg 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, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Tioner is and what it is used for

Tramadol, the active substance in this medicine, is an analgesic belonging to the opioid group 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 to treat moderate to severe pain.

2. What you need to know before taking Tioner

Do not take Tioner

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in cases of acute intoxication due to alcohol, sleeping medicines, painkillers, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are currently taking or have taken within the last 14 days monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression) (see “Taking Tioner with other medicines”);
• if you have epilepsy and your seizures are not adequately controlled by treatment;
• for the treatment of withdrawal syndrome.

Warnings and precautions

Talk to your doctor before taking Tioner

• if you think you are dependent on other painkillers (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 increased intracranial pressure (e.g. after head injury or brain diseases);
• if you have breathing difficulties;
• if you have epilepsy or suffer from seizures, as the risk of seizures may increase;
• if you have liver or kidney disease;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tioner”).

Sleep-related breathing disorders

Tioner 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 breathing pauses 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.

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).

Please note that this medicine may cause physical and psychological dependence. When used over a long period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to drug abuse or those with drug dependence, treatment with Tioner should only be carried out for short periods and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with this medicine or if you have experienced them previously.

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 experience these symptoms, contact your doctor, who will decide whether you need hormonal supplementation.

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.

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

Use in athletes

This medicine contains tramadol, which may lead to a positive result in doping control tests.

Other medicines and Tioner

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

Concomitant treatment with MAO inhibitors (a certain type of medicine used to treat depression) should be avoided.

The effect and duration of pain relief from Tioner may be reduced if you take medicines containing:

• Carbamazepine (for epileptic seizures);
• Ondansetron (to prevent nausea).

Your doctor will advise you whether you should take this medicine and at what dose.

The risk of adverse effects increases

• if you are taking this medicine together with sedatives, sleeping medicines, other painkillers 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 Tioner with sedatives or medicines for insomnia (such as benzodiazepines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes tramadol together with sedative medicines, your dose and duration of concomitant treatment should be limited.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing 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;

• if you are taking medicines that may trigger or lower the seizure threshold, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tioner concomitantly with these medicines. Your doctor will advise you whether Tioner is suitable for you;
• if you are taking antidepressants. Tioner may interact with these medicines and may cause serotonin syndrome (see section 4 “Possible side effects”);
• if you are taking coumarin anticoagulants (blood-thinning medicines) such as warfarin while taking Tioner. The effect of these medicines on blood clotting may be affected, leading to bleeding;
• if you are taking medicines that may increase tramadol accumulation and thus its adverse effects (e.g., ritonavir, quinidine, paroxetine, fluoxetine, sertraline, amitriptyline, isoniazid, ketoconazole, and erythromycin);
• Gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may result in reduced effectiveness (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tioner 50 mg hard capsules may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may lead to a feeling of loss of control over the amount of medicine used or how often it is used.

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

• You or any family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”);
• You are a smoker;
• You have ever had mood disorders (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 Tioner 50 mg hard capsules, this could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor;
• You need to take a higher dose than recommended;
• You are using the medicine for reasons other than prescribed, e.g., “to feel calm” or “to help you sleep”;
• You have made repeated unsuccessful attempts to stop or control your use of the medicine;
• You feel unwell when you stop taking 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 approach for you, when it is appropriate to stop the medicine, and how to do so safely (see section 3, if you stop taking Tioner 50 mg hard capsules).

Taking Tioner with food and alcohol

Do not consume alcohol during treatment with this medicine, as its effects may be intensified. Food does not affect the action of Tioner.

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.

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.

There is very limited 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 may cause withdrawal syndrome in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take this medicine more than once during breastfeeding; or, if you take Tioner more than once, you must stop breastfeeding.

Based on human experience, tramadol is not expected to affect fertility in men and women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while taking this medicine. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulation, and/or when taken together with other medicines.

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

3. How to take Tioner

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using Tioner 50 mg hard capsules, 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 according to the intensity of pain and your individual sensitivity. The lowest possible dose that provides pain relief should normally 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 of age

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.

Children

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

Elderly patients

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

Patients with hepatic or renal insufficiency / patients on dialysis

If you suffer from 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.

How and when should you take Tioner?

Tioner capsules are administered orally.

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

You may take the capsules either on an empty stomach or with food.

For how long should you take Tioner?

This medicine should not be administered for longer than strictly necessary. If prolonged treatment is required, your doctor will monitor at short, regular intervals (if necessary with treatment interruptions) 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 Tioner than you should

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

After taking very high doses of tramadol, symptoms such as pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest may occur. In such a case, call a doctor immediately!

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to take Tioner

If you forget to take the medicine, your pain may return. Do not take a double dose to make up for missed doses; simply continue taking Tioner as you have been doing.

If you stop treatment with Tioner

If you interrupt or stop treatment with this medicine too early, your pain is likely to return. If you wish to discontinue treatment due to adverse effects, consult your doctor.

You should not stop taking this medicine suddenly unless your doctor tells you to. If you wish to stop taking your medicine, 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 reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not usually occur when stopping treatment with tramadol. However, in rare cases, people who have been taking this medicine for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience digestive and intestinal transit problems. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been reported, such as confusion, delirium, changes in personality perception (depersonalization), changes in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping treatment with this medicine, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

You must 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, rash, and difficulty breathing.

The most common adverse effects during treatment with Tioner 50 mg hard capsules are nausea and dizziness, which occur in more than 1 in every 10 people.

Very common: may affect more than 1 in 10 people

• Dizziness.
• Nausea.

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, rapid heartbeat, dizziness or fainting). These adverse effects may occur particularly in patients who are standing up or engaging in physical exertion.
• Feeling the urge to vomit (nausea), gastrointestinal discomfort (e.g. sensation of pressure in the stomach, bloating), diarrhea.
• Skin 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 heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g. itching, tingling, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after using high doses of tramadol or when taken simultaneously with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur after treatment with Tioner 50 mg hard capsules. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (alterations in senses and perception that may lead to impaired judgment).
• This medicine may lead to dependence. If Tioner hard capsules are taken for prolonged periods, dependence may occur, although the risk is very low. If treatment is abruptly discontinued, withdrawal syndrome may occur (see section “If you stop taking Tioner 50 mg hard capsules”).
• 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 recommended doses are exceeded or if the medicine is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

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

• Increased liver enzymes.

Frequency not known: frequency cannot be estimated from available data

• Decreased blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may present 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 Tioner”).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tioner

Keep this medicine out of the 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 packaging and on the blister after EXP. 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 drains or household waste. Dispose of unused medicines and their packaging at a SIGRE Point in your pharmacy. If you have any doubts, 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 Tioner 50 mg hard capsules

The active substance is tramadol hydrochloride.

Each capsule contains 50 mg of tramadol hydrochloride.

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

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

Appearance of the product and contents of the pack

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

Tioner 50 mg hard capsules are packed in blisters and available in pack sizes of 20 and 60 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

Grünenthal GmbH

Zieglerstrasse 6 --52078 Aachen (Germany)

Date of the most recent revision of this summary: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/