Tioner Retard 200 mg prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

TIONER RETARD 200 mg prolonged-release tablets

Tramadol hydrochloride

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could 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 RETARD 200 mg is and what it is used for
2. What you need to know before taking TIONER RETARD 200 mg
3. How to take TIONER RETARD 200 mg
4. Possible side effects
5. How to store TIONER RETARD 200 mg
6. Contents of the pack and other information

1. What TIONER RETARD 200 MG is and what it is used for

Tramadol – the active substance in Tioner Retard 200 mg – 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 Retard 200 mg is indicated for the treatment of moderate to severe pain.

2. What you need to know before taking TIONER RETARD 200 MG

Do not take Tioner retard 200 mg

• If you are allergic to tramadol or any of the other components of this medicine (listed in section 6).
• In cases of acute intoxication caused by alcohol, sleep-inducing drugs, analgesics, or psychotropic medicines (medicines that affect mood and emotions).
• If you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression), or have taken them within the last 14 days before starting treatment with Tioner retard 200 mg (see "Other medicines and Tioner retard 200 mg").
• If you have epilepsy and your seizures are not adequately controlled by treatment.
• For the treatment of withdrawal syndrome.

Warnings and precautions

Consult your doctor before starting Tioner retard 200 mg

• If you think you are dependent on other analgesics (opioids).
• If you have disturbances in 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 difficulty breathing.
• 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 retard 200 mg").

Sleep-related breathing disorders

Tioner retard 200 mg may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels during sleep). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your 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 Tioner retard 200 mg may cause physical and psychological dependence. When Tioner retard 200 mg is used over a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to misuse medicines or who have medicine dependence, treatment with Tioner retard 200 mg should only be carried out over short periods and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with Tioner retard 200 mg or if you have ever experienced them.

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 in combination with certain antidepressants or with tramadol as monotherapy. Contact your doctor immediately if you experience any symptoms associated with this serious syndrome (see section 4, "Possible side effects").

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.

Use in athletes

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

Other medicines and Tioner retard 200 mg

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

Concomitant use of Tioner retard 200 mg and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment option is available.

However, if your doctor prescribes Tioner retard 200 mg together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience any symptoms.

Concomitant treatment with Tioner retard 200 mg and monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) must be avoided.

The analgesic effect of Tioner retard 200 mg and its duration may be reduced if you are taking medicines containing:

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

Your doctor will advise you whether you should take Tioner retard 200 mg and at what dose.

The risk of adverse 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 200 mg. This may cause increased drowsiness or a feeling of fainting. If this occurs, consult your doctor.
• If you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tioner retard 200 mg simultaneously with these medicines. Your doctor will advise whether Tioner retard 200 mg is suitable for you.
• If you are taking antidepressants, Tioner retard 200 mg may interact with these medicines and you may experience serotonin syndrome (see section 4, "Possible side effects").
• If you are taking coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, together with Tioner retard 200 mg. The effect of these medicines on blood clotting may be affected, potentially leading to bleeding.
• Gabapentin or pregabalin used to treat 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 cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tioner retard may also lead to dependence, abuse, and addiction, which could result in a 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 losing 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 retard may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a 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, they could be signs of dependence or addiction:

• You need to use the medicine for longer 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, e.g., "to stay calm" or "to help you sleep."
• You have made repeated but unsuccessful attempts to stop using the medicine or control its use.
• 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 interrupt treatment with Tioner retard).

Taking Tioner retard 200 mg with food and alcohol

Do not consume alcohol during treatment with Tioner retard 200 mg, as its effects may be intensified. Food does not affect the action of Tioner retard 200 mg.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is very limited information regarding the safety of tramadol during human pregnancy. Therefore, you should not take Tioner retard 200 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, Tioner retard should not be taken more than once during breastfeeding, or if you take Tioner retard more than once, you must stop breastfeeding.

Based on human experience, tramadol is not considered to affect fertility in men or women.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Tioner retard 200 mg. 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 a change in formulation, and/or when taken together with other medicines.

Tioner retard 200 mg contains lactose

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

3. How to take TIONER RETARD 200 MG

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

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Tioner Retard, 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

One Tioner Retard 200 mg prolonged-release tablet twice daily (equivalent to 400 mg of tramadol hydrochloride per day), preferably in the morning and at night.

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

If needed, the dose may be increased up to 150 mg or 200 mg twice daily (equivalent to 300 mg – 400 mg of tramadol hydrochloride per day).

Use in children

Tioner Retard 200 mg is not suitable for children under 12 years of age.

Elderly patients

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

Patients with hepatic or renal impairment / patients on dialysis

If you have severe liver or kidney disease, treatment with Tioner Retard 200 mg is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

How and when to take Tioner Retard 200 mg

Tioner Retard 200 mg prolonged-release tablets are taken orally.

The Tioner Retard 200 mg tablets must always be swallowed whole, not divided or chewed, with sufficient liquid, preferably in the morning and at night. You may take the tablet on an empty stomach or with food.

How long should you take Tioner Retard 200 mg?

Tioner Retard 200 mg should not be administered for longer than strictly necessary.

If long-term treatment is required, your doctor will monitor regularly and at short intervals (if necessary with treatment interruptions) whether treatment with Tioner Retard 200 mg should continue and at what dose.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Tioner Retard 200 mg than you should

If you have accidentally taken more Tioner Retard 200 mg than prescribed, you generally will not experience adverse effects. Take the next dose as prescribed.

After taking very high doses, 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 that 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 the Toxicology Information Service immediately at telephone number 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the medicine's package leaflet to the healthcare professional.

If you forget to take Tioner Retard 200 mg

If you forget to take the tablets, your pain may return. Do not take a double dose to make up for missed doses; simply continue treatment as directed by your doctor.

If you stop taking Tioner Retard 200 mg

If you stop or discontinue treatment with Tioner Retard 200 mg too early, your pain is likely to return. If you wish to stop treatment due to undesirable effects, consult your doctor.

Do not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking this 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 minimize the risk of experiencing unnecessary adverse effects (withdrawal symptoms).

Generally, no undesirable effects occur when stopping treatment with Tioner Retard 200 mg. However, in rare cases, some individuals who have been taking Tioner Retard 200 mg for some time may feel unwell when stopping abruptly. They may feel restless, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disturbances. Very few people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, or ringing in the ears (tinnitus). Very rarely, other uncommon central nervous system (CNS) symptoms have been observed, such as confusion, delirium, distorted perception of self (depersonalization), disturbances in perception of reality (derealization), and delusions of persecution (paranoia). If you experience any of these symptoms after stopping Tioner Retard 200 mg, please 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 will experience 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 retard 200 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 heartbeats and rapid heartbeat, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are standing up or performing physical exertion.
• Nausea with urge to vomit (nauseation), 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 (such as itching, tingling, and numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken concomitantly with other medicines that may provoke seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may occur after treatment with Tioner retard 200 mg. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (changes in senses and recognition, which may lead to impaired judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if tramadol 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 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 retard 200 mg").

If Tioner retard 200 mg is taken for a long period of time, drug dependence may occur, although the risk is very low.

When treatment is abruptly discontinued, signs of drug withdrawal syndrome may appear (see "If you stop taking Tioner retard 200 mg").

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 RETARD 200 MG

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to others. 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 after "EXP". The expiry date refers to the last day of the month indicated. This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Tioner retard 200 mg prolonged-release tablets

• The active substance is tramadol hydrochloride. Each tablet contains 200 mg of tramadol hydrochloride.
• The other components are:

Tablet core: microcrystalline cellulose, hypromellose 100,000 mPa·s, magnesium stearate, anhydrous colloidal silica.

Film coating: hypromellose 6 mPa·s, lactose monohydrate (see section 2 “Tioner retard 200 mg contains lactose”), macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), quinoline yellow lake (E 104), iron oxide red (E 172) and iron oxide brown (E 172).

Appearance of the product and contents of the container

Tioner retard 200 mg prolonged-release tablets are orange film-coated tablets with a slightly brownish hue, round and biconvex, marked with "T3" on one side and the manufacturer's logo ? on the other.

Tioner retard 200 mg tablets are contained in blister strips and packaged in boxes containing 20 and 60 tablets.

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 – D-52078 Aachen (Germany)

Date of latest revision of this leaflet: December 2024

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