TIONER RETARD 150 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

TIONER RETARD 150 mg prolonged-release tablets

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:

1. What Tioner retard 150 mg is and what it is used for
2. What you need to know before you take Tioner retard 150 mg
3. How to take Tioner retard 150 mg
4. Possible side effects
5. Storage of Tioner retard 150 mg
6. Contents of the pack and other information

1. What is TIONER RETARD 150 MG and what is it used for

Tramadol - the active substance of Tioner retard 150 mg - 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.

Tioner retard 150 mg is indicated for the treatment of moderate to severe pain.

2. What you need to know before you take TIONER RETARD 150 MG

Do not take Tioner retard 150 mg

• 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, sleep-inducing drugs, analgesics or psychotropic drugs (drugs that act on mood and emotions).
• If you are taking MAO inhibitors (certain drugs used to treat depression) or if you have taken them in the last 14 days before starting treatment with Tioner retard 150 mg (see "Other medicines and Tioner retard 150 mg").
• 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 retard 150 mg

• If you think you are dependent on other analgesics (opioids).
• If you have disorders of consciousness (if you think you are going to faint).
• If you are in a state of shock (a sign of this state may be cold sweat).
• If you have increased pressure inside the skull (for example after a head injury or diseases that affect the brain).
• If you have difficulty breathing.
• If you are epileptic or have seizures, because the risk of these 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 retard 150 mg").

Respiratory disorders related to sleep

Tioner retard 150 mg 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). Among the symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive drowsiness during the day. 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).

Note that Tioner retard 150 mg may cause physical and psychological dependence. When Tioner retard 150 mg is used for a long period, its effect may decrease, so higher doses must be taken (development of tolerance).

In patients with a tendency to abuse medications or who have drug dependence, treatment with Tioner retard 150 mg should only be carried out for short periods and under strict medical supervision.

Also, inform your doctor if any of these problems occur during treatment with Tioner retard 150 mg or if they have ever happened to you.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They can 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.

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, sufficient pain relief may not be achieved, while others are more likely to suffer from 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.

There is a slight 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 present any of the symptoms related to this serious syndrome (see section 4 "Possible side effects").

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.

Use in athletes

This medicine contains tramadol, which can produce a positive result in doping tests.

Other medicines and Tioner retard 150 mg

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

Concomitant use of Tioner retard 150 mg and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can put your life at risk. Due to this, concomitant use should only be considered when no other treatment is possible.

However, if your doctor prescribes Tioner retard 150 mg along with sedative medicines, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's dose recommendation. It may be useful to inform friends or relatives so they are aware of the signs and symptoms indicated above. Consult your doctor if you experience any symptoms.

Simultaneous treatment with Tioner retard 150 mg and monoamine oxidase inhibitors (MAOIs) (certain medicines for the treatment of depression) should be avoided.

Both the analgesic effect of Tioner retard 150 mg and the duration of it may be reduced if you take medicines that contain:

• Carbamazepine (for epileptic seizures)
• Ondansetron (medicine to prevent nausea)

Your doctor will indicate if you should take Tioner retard 150 mg and at what dose.

The risk of side effects increases:

• If you are taking tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also when used for cough), and alcohol while taking Tioner retard 150 mg. It can cause more drowsiness or make you feel like you are going to faint. If this happens, consult your doctor.
• If you are taking medicines that can cause or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tioner retard 150 mg simultaneously with these medicines. Your doctor will tell you if Tioner retard 150 mg is suitable for you.
• If you are taking antidepressants, Tioner retard 150 mg 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 that prevent abnormal blood clotting), such as warfarin, along with Tioner retard 150 mg. The effect of these medicines on blood clotting may be affected, and it can lead to bleeding.
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain)

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the drug less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of Tioner retard 150 mg can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you should use or how often you should use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Tioner retard 150 mg 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 mood problems (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 retard 150 mg, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer time 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 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 Tioner retard 150 mg).

Taking Tioner retard 150 mg with food and alcohol

Do not consume alcohol during treatment with Tioner retard 150 mg, as its effect may be intensified. Food does not affect the effect of Tioner retard 150 mg.

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 little information on the safety of tramadol during human pregnancy. Therefore, you should not take Tioner retard 150 mg if you are pregnant.

Chronic use during pregnancy may lead to withdrawal syndrome in newborns.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you should not take Tioner retard 150 mg more than once during breastfeeding, or if you take Tioner retard 150 mg more than once, you should interrupt breastfeeding.

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 Tioner retard 150 mg. 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 drowsy, 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 administered concomitantly with other medicines.

Tioner retard 150 mg contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take TIONER RETARD 150 MG

Follow exactly the administration instructions of this medicine indicated 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 Tioner retard 150 mg, 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 must be adjusted to the intensity of the pain and your individual sensitivity. Normally, the smallest 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 indicated otherwise.

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

Adults and adolescents over 12 years

One Tioner retard 150 mg prolonged-release tablet twice a day (equivalent to 300 mg of tramadol hydrochloride per day), preferably in the morning and at night.

If necessary, your doctor may prescribe a different and more suitable dose of this medicine for you.

If necessary, the dose can be increased to 150 mg or 200 mg twice a day (equivalent to 300 mg - 400 mg of tramadol hydrochloride per day).

Use in children

Tioner retard 150 mg is not suitable for children under 12 years.

Elderly patients

In elderly patients (over 75 years), 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 impairment / patients on dialysis

If you have severe liver or kidney disease, treatment with Tioner retard 150 mg 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 retard 150 mg?

Tioner retard 150 mg prolonged-release tablets are administered orally.

Always swallow the Tioner retard 150 mg tablets whole, without dividing or chewing them, with sufficient liquid, preferably in the morning and at night. You can take the tablet with an empty stomach or with food.

For how long should you take Tioner retard 150 mg?

Tioner retard 150 mg 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 determine if you should continue treatment with Tioner retard 150 mg and at what dose.

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

If you take more Tioner retard 150 mg than you should

If you have taken more Tioner retard 150 mg than you should by mistake, it will generally not have negative effects. You should take the next dose as prescribed.

After taking very high doses, it can cause constricted pupils, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and difficulty breathing that can lead to respiratory arrest. In this case, call a doctor immediately!

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken.

It is recommended to bring the medicine leaflet to the healthcare professional.

If you forget to take Tioner retard 150 mg

If you forget to take the tablets, it is likely that the pain will return. Do not take a double dose to make up for the forgotten doses, simply continue treatment as indicated by your doctor.

If you stop treatment with Tioner retard 150 mg

If you stop or finish treatment with Tioner retard 150 mg too soon, it is likely that the pain will return. If you want to stop treatment due to undesirable 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 undesirable effects occur when finishing treatment with Tioner retard 150 mg. However, in rare cases, when some people who have been taking Tioner retard 150 mg for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or trembly. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, other unusual symptoms of the central nervous system have been seen, such as confusion, delirium, distorted perception of one's own personality (depersonalization), and altered perception of reality (derealization) and persecution delusions (paranoia). If you present any of these symptoms after stopping Tioner retard 150 mg, please consult your doctor.

If you have any other 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 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 Tioner retard 150 mg 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.
• Vomiting, dry mouth, constipation.
• 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 especially in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, 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, and numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that can cause epileptic seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may appear after treatment with Tioner retard 150 mg. Their intensity and nature may vary (according to the patient's personality and the duration of treatment). These problems can manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decrease, occasionally increase), and decreased cognitive and sensory perception (changes in senses and recognition, which can lead to errors in judgment).
• Drug dependence may occur.
• Blurred vision, contraction of the pupils (miosis), excessive dilation of the pupils (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• A worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. 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 can manifest 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before taking Tioner retard 150 mg").

If Tioner retard 150 mg is taken for a long period, drug dependence may appear, although the risk is very low.

When treatment is abruptly stopped, signs of drug withdrawal syndrome may appear (see "If you stop treatment with Tioner retard 150 mg").

Reporting of adverse effects:

If you experience any type of adverse effect, 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: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of TIONER RETARD 150 MG

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and protected place, where others cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

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 Tioner retard 150 mg prolonged-release tablets

• The active ingredient is tramadol hydrochloride. Each tablet contains 150 mg of tramadol hydrochloride.
• The other components are:

Core of the tablet: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, anhydrous colloidal silica.

Coating film: hypromellose 6 mPa·s, lactose monohydrate (see section 2 "Tioner retard 150 mg contains lactose"), macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), quinoline yellow lake (E 104), and red iron oxide (E 172).

Appearance of the product and package contents

Tioner retard 150 mg prolonged-release tablets are film-coated tablets of pale orange color, round and biconvex, marked with "T2" on one side and the manufacturer's logo ? on the other.

Tioner retard 150 mg tablets are contained in blister strips and packaged in boxes of 20 and 60 tablets.

Only some package 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 – D-52078 Aachen (Germany)

Date of the last revision of this prospectus: December 2024

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