Tioner 100 mg/ml oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

Tioner 100 mg/ml oral solution

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 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 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 starting Tioner

Do not take Tioner

• if you are allergic to tramadol or to 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 monoamine oxidase inhibitors (MAOIs) (a certain type of medicine used to treat depression) or have taken them within 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 by treatment;
• for the treatment of withdrawal syndrome;
• in children under 3 years of age.

Warnings and precautions

Talk to your doctor before starting to take Tioner:

• if you think you are dependent on other painkillers (opioids);
• if you have disturbances 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 (for example, after head injury or diseases affecting the brain);
• 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").

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 (your body gets used to it, known as pharmacological tolerance). Repeated use of Tioner 100 mg oral solution may also lead to dependence, abuse, and addiction, which could potentially result in a fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use.

Dependence or addiction may cause a feeling of lack of control over how much medicine you need to take or how often you need to take it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tioner 100 mg/mL oral solution may be higher if:

• You or a family member have abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

If you notice any of the following symptoms while using Tioner 100 mg/mL oral solution, it 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 those prescribed, e.g., "to feel calm" or "to help you sleep."
• You have made repeated 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 stop taking Tioner 100 mg/mL oral solution").

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 during sleep). Symptoms may include pauses in breathing during sleep, waking up at night 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 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 prolonged period, its effect may decrease, requiring higher doses (development of tolerance). In patients with a tendency to misuse medicines or those with a history of dependence, treatment with Tioner 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 this medicine 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 have these symptoms, contact your doctor, who will decide whether you need hormone supplements.

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 experience any of the following adverse effects, 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 alone. Contact a doctor immediately if you experience any symptoms related to this serious condition (see section 4, "Possible adverse effects").

Use in athletes

This medicine contains tramadol, which may result in a positive doping test.

Other medicines and Tioner

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

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

The effect and duration of pain relief provided by 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 simultaneously 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. The 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. For this reason, concomitant use should only be considered when no other treatment options are available.

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

Inform your doctor about all sedative medicines you are taking and follow your doctor's dosage recommendations strictly. 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 lower the seizure threshold or provoke seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tioner simultaneously 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 you may experience serotonin syndrome (see section 4, "Possible adverse 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 take medicines that may increase the accumulation of tramadol 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).

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 breathing problems:

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

In particular, the first administration of tramadol in children must be performed under strict medical supervision.

Monitor the child, especially during the first administration. If any warning signs occur (such as disturbances in consciousness, constricted pupils, vomiting, seizures, very slow breathing, etc.), call a doctor immediately or contact an emergency service (see section "If you take more Tioner than you should").

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 after birth.

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, there is no indication that tramadol affects fertility in men or 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 sleepy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after changing formulations, and/or when taking it together with other medicines.

Tioner contains sucrose, macrogol glycerol hydroxystearate, propylene glycol (E-1520), and sodium

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine. If Tioner is to be used chronically (e.g., for two weeks or more), it may cause tooth decay.

This medicine may cause stomach discomfort and diarrhea because it contains macrogol glycerol hydroxystearate.

This medicine contains 150 mg of propylene glycol (E-1520) in 1 mL of solution.

This medicine contains less than 1 mmol of sodium (23 mg) per 1 mL of solution; this is essentially "sodium-free".

3. How to take Tioner

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, please 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 100 mg/mL oral solution, 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 recommended dose is, unless your doctor has given you different instructions:

Adults and adolescents over 12 years of age

Normally, the initial dose is 4–8 pumps from the Tioner dosing pump (equivalent to 50–100 mg of tramadol hydrochloride). Depending on the pain, the effect of the medicine may last between 4–6 hours.

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 32 pumps from the Tioner dosing pump per day, equivalent to 400 mg of tramadol hydrochloride, i.e., 4 doses of 8 pumps within 24 hours, unless otherwise instructed by your doctor.

For dose adjustment in number of pumps, refer to the following equivalence table:

Equivalence table showing the number of pumps corresponding to the amount in mg of tramadol hydrochloride

Number of pumps	Tramadol hydrochloride content
1 pump	12.5 mg
2 pumps	25 mg
3 pumps	37.5 mg
4 pumps	50 mg
5 pumps	62.5 mg
6 pumps	75 mg
7 pumps	87.5 mg
8 pumps	100 mg

Children

For children over 3 years of age, the recommended dose is 1 mg of tramadol hydrochloride per kg of body weight.

Doses should not exceed 2 mg of tramadol hydrochloride per kg of body weight per administration.

As a general guide, the usual recommended and maximum doses per administration according to body weight are as follows:

Child's weight	Child's age (approximate)	Usual dose by child's weight and per administration (in actuations*)	Maximum dose by child's weight and per administration (in actuations*)
15 kg – 20 kg	3 – 5 years	1 actuation	2 actuations
20 kg – 25 kg	5 – 8 years	1 actuation	3 actuations
25 kg – 35 kg	8 – 11 years	2 actuations	4 actuations
35 kg – 37 kg	11 years	3 actuations	5 actuations
37 kg – 44 kg	11 – 13 years	3 actuations	6 actuations
44 kg – 45 kg	≥ 13 years	3 actuations	7 actuations

*always round the number of beats down to the next lower whole number.

The lowest effective dose that provides pain relief should be used. Daily doses must not exceed 8 mg of tramadol hydrochloride per kg of body weight or 400 mg of tramadol hydrochloride, whichever is lower.

Elderly patients

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

Patients with hepatic or renal impairment/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 recommend prolonging the dosing intervals.

How and when should you take Tioner?

It is administered orally.

The solution may be diluted in a sugared solution or with a small amount of liquid.

You may take the medicine 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 you at regular and frequent intervals (if necessary with treatment interruptions) to determine whether treatment with this medicine and which dose should be continued.

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

Information on handling Tioner 100 mg/ml oral solution, bottle with dosing pump

Note on use

Before using the dosing pump for the first time, actuate it several times until the oral solution appears (for technical reasons, this is necessary to fill the pump mechanism and ensure homogeneous release of the solution).

Place a container (spoon, cup, etc.) under the dispenser opening and press the pump. One complete stroke delivers an amount of oral solution equivalent to 5 drops, containing 12.5 mg of tramadol hydrochloride (for dosing instructions, see section 3. “ How to take Tioner”).

Note on the fill level of the container

Due to differences in the thickness of the glass walls and base of the bottles, the liquid level may vary by a few millimeters from one bottle to another (even though these are original Tioner bottles).

If you take more Tioner than you should

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

After taking very high doses of tramadol, pinpoint pupils, vomiting, low blood pressure, increased heart rate, collapse, reduced level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties which may lead to respiratory arrest can 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 at telephone number 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the package leaflet to the healthcare professional.

If you forget to take Tioner

If you forget to take the medicine, your pain is likely to 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 taking Tioner

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

You should not stop taking this medicine suddenly unless your doctor tells you to do so. If you want to stop taking the 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 unnecessary adverse effects (withdrawal symptoms).

Generally, adverse effects do not commonly occur when stopping treatment with tramadol. However, in rare cases, individuals 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, or noises 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 and rash together with difficulty breathing.

The most common adverse effects during treatment with Tioner 100 mg/ml oral solution are nausea and dizziness, occurring 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, rapid heartbeats, feeling of dizziness or collapse). 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), diarrhoea.
• 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, numbness), tremor, epileptic seizures, muscle jerks, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures occur mainly after use of high doses of tramadol or when taken concomitantly with another medicine that may trigger them.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological disturbances may occur following treatment with Tioner 100 mg/ml oral solution. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). These may present as changes in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and reduced cognitive and sensory perception (sensory and perceptual disturbances that may lead to impaired judgment).
• May lead to drug dependence. If Tioner 100 mg/ml oral solution is taken for prolonged periods, it may lead to dependence, although the risk is very low. When treatment is abruptly discontinued, withdrawal syndrome may occur (see section “If you stop taking Tioner 100 mg/ml oral solution”).
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• 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 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

• Increase in liver enzymes.

Frequency not known: frequency cannot be estimated from available data

• Decrease in blood sugar levels.
• Hiccups.
• Serotonin syndrome, which may manifest 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, diarrhoea) (see section 2 “What you need to know before taking Tioner”).

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 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 container and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

After opening the container, the solution must be used within a maximum of 12 months.

Keep the container tightly closed.

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

6. Contents of the pack and other information

Composition of Tioner 100 mg/ml oral solution

The active substance is tramadol hydrochloride.

1 ml of Tioner contains 100 mg of tramadol hydrochloride (1 pump actuation delivers an amount of oral solution containing 12.5 mg of tramadol hydrochloride).

The other components are: glycerol (E-422), potassium sorbate (E-202), macrogol glyceryl hydroxystearate, propylene glycol (E-1520), sodium cyclamate, sodium saccharin, sucrose (0.2 g/ml of solution), peppermint flavour, anise flavour, and purified water.

Appearance of the product and contents of the container

Clear, colourless to slightly yellowish, slightly viscous solution.

This medicine is packaged in brown glass bottles equipped with a dosing pump, containing 30 ml of oral solution.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent review of this leaflet: December 2024

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