Package Insert: Information for the User

Tradonal Retard 200 mg Extended-Release Hard Capsules

tramadol hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Tradonal retard belongs to a group of medications called analgesics, commonly known as pain-relieving medications. The active substance, tramadol hydrochloride, interrupts the pain messages sent to the brain and also acts on the brain to prevent the sensation of pain from being felt. This means that the medication does not prevent the pain from occurring, but rather you will not be able to feel the pain as much.

Tradonal retard is used to relieve moderate to severe pain (for example, pain after surgery, or after an injury).

Do not take Tradonal retard

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6), which have caused a skin rash, swelling of the face, or difficulty breathing
• if you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs) to treat your depression (see section 2, “Other medicines and Tradonal retard”)
• if you have uncontrolled epilepsy
• if you have drunk enough alcohol to feel dizzy or have drunk
• if you have taken more than the prescribed dose of your sleeping pills, antipsychotics, antidepressants (antipsychotics and antidepressants are medicines that affect behavior and emotions), or other analgesics, which may reduce your ability to breathe and react.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tradonal retard:

• if you have had an allergic reaction to any medicine similar to morphine

• if you have been taking this medicine or any other medicine containing tramadol for a long time
• if you have severe liver or kidney problems
• if you have recently had a head injury or have a severe headache that makes you feel unwell
• if you have had seizures (fits) or suffer from epilepsy
• if you have asthma or respiratory problems
• if you are about to undergo surgery that requires general anesthesia
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tradonal retard”).

Respiratory problems related to sleep

This medicine may cause respiratory problems related to sleep such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). These symptoms may be, pauses in breathing during sleep, nocturnal awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Inform your doctor if you experience any of the following symptoms while taking Tradonal retard:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you should take a hormone supplement.

There is a rare possibility that this medicine may cause seizures (fits). This risk increases if you take doses higher than the maximum daily dose and if you are also taking antidepressants or antipsychotics.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of this medicine can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you should use or the frequency with which you should use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to this medicine may be higher if:

If you observe any of the following symptoms while using this medicine, it could be a sign of dependence or addiction:

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

You should not take this medicine to treat withdrawal symptoms in the case of addiction to medicines.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult your doctor immediately if you experience any of the symptoms associated with this serious syndrome (see section 4 “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you experience any of the following adverse effects, stop taking this medicine and consult your doctor immediately: shallow or slow breathing, confusion, drowsiness, constricted pupils, feeling of dizziness, constipation, loss of appetite.

In rare cases, increasing the dose of this medicine may make you more sensitive to pain. If this occurs, talk to your doctor about your treatment.

Children and adolescents

This medicine should not be used in children under 12 years old.

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tradonal retard

Inform your doctor or pharmacistifyou are taking, have taken recently, or may need to take any other medicine, including those purchased without a prescription.

Do not take Tradonal retard at the same time, or during the 14 days after taking medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson's disease).

The pain relief produced by tramadol may be weakened or shortened if you also take medicines that contain:

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

The risk of adverse effects increases if you are taking medicines that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tradonal retard simultaneously with these medicines. Your doctor will indicate whether it is suitable for you.

The risk of adverse effects increases if you are taking antidepressants. Tradonal retard may interact with these medicines and may experience a serotonin syndrome(see section 4 “Possible side effects”).

Medicines that act on the nervous system, such as hypnotics, tranquilizers, sleeping pills, and analgesics, may make you feel more sleepy or weak if you use them with tramadol.

The risk of adverse effects increases if you are taking gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

Anticoagulants to thin your blood, such as warfarin. The effectiveness of these medicines may be altered if taken with tramadol.

You should inform your doctor if you are taking these medicines.

The concomitant use of tramadol with sedatives, such as benzodiazepines or related substances, increases the risk of somnolence, respiratory difficulties (respiratory depression), and coma and may be potentially fatal. Therefore, concomitant use should only be considered when other options are not possible.

However, if your doctor prescribes Tradonal retard along with sedatives, the dose and duration of concomitant treatment will be limited by your doctor.

Inform your doctor of all sedatives you are taking and take exactly the dose your doctor recommends. It is helpful to inform your friends or family members to be aware of the appearance of the signs and symptoms explained above. Contact your doctor if you experience these symptoms.

Tradonal retard with food, drinks, and alcohol

This medicine should be taken with a little water, with or without food. Avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medicine. Contact your doctor if you become pregnant during your treatment.

Pregnancy

Tradonal retard should not be taken during pregnancy or during breastfeeding. This is because it is not yet known how safe it is to take this medicine when pregnant. Contact your doctor if you become pregnant during your treatment.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Tradonal retard more than once during breastfeeding, or if you take this medicine more than once, you should stop breastfeeding.

Driving and operating machinery

Tradonal retard may cause drowsiness, and this effect may be potentiated by alcohol, antihistamines, and other central nervous system depressants. If patients are affected, they should be advised not to drive or operate machinery.

Tradonal retard contains saccharose

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

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

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Tradonal retard, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity to pain. Normally, the lowest dose that produces pain relief should be taken.

The modified-release capsules of Tradonal retard are packaged in a child-resistant laminate to ensure safety.

The child-resistant laminate is more resistant, making it more difficult to push the capsules through it.

Perforate the laminate beforehand and then push the capsule to remove it from the blister, in order to avoid damaging the capsules.

Swallow the capsules whole, without chewing, with a little water.

If you have difficulty swallowing the capsules, you can open them. You must open them carefully, pulling and turning at the same time, over a spoon, so that the granules remain on the spoon. Do not chew them. Swallow the granules with water.

Dosage for adults and adolescents 12 years and older

The usual initial dose is 50-100 mg twice a day, in the morning and at night. Your doctor may increase this dose to 150-200 mg twice a day, according to the intensity of the pain and your needs. Normally, you should take the medication every 12 hours, at the same time in the morning and at night.

Theusual maximum doseis 400 mg per day.

Use in children

This medication should not be administered to children under 12 years old.

Use in elderly patients

In elderly patients (over 75 years old), the elimination of tramadol may be slow. If this happens, your doctor may recommend increasing the interval between doses.

Use in patients with liver or kidney disease/patients on dialysis

If you have any severe liver or kidney disease, treatment with this medication is not recommended. If you have moderate liver or kidney disease, your doctor may prolong the dosing intervals.

If you take more Tradonal retard than you should

If you have accidentally taken more capsules than the dose indicated, inform your doctor or pharmacist immediately and, if necessary, contact your nearest hospital. Remember to bring the packaging and any remaining medication with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, or go immediately to a hospital.

If you forget to take Tradonal retard

Do not take a double doseto compensate for the missed doses.

If you interrupt treatment with Tradonal retard

Do not stop treatment with this medication suddenly, unless your doctor tells you to. If you want to stop taking this medication, consult your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop treatment, which may be done by gradually reducing the dose, to reduce the risk of adverse effects (withdrawal symptoms).

People who have been taking this medication for some time may feel unwell if they stop taking it suddenly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and have gastrointestinal or intestinal disorders. Consult your doctor if you experience any of these symptoms after stopping this medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The most serious side effects that may occur include an allergic reaction (difficulty breathing, wheezing, and swelling of the face or throat), anaphylactic reaction (extreme allergic reaction causing difficulty breathing, changes in heart rate, weakness, collapse, or loss of consciousness due to a drop in blood pressure) or seizures (attacks). If you have any of these symptoms, stop taking this medicine immediately and seek medical advice.

Very common (may affect more than 1 in 10 people)

• Dizziness
• Vomiting and nausea (feeling or being sick)

Common (may affect up to 1 in 10 people)

• Headache
• Drowsiness (fatigue)
• Constipation, dry mouth
• Sweating

Uncommon (may affect up to 1 in 100 people)

• Acceleration of heart rate, palpitations, sudden drop in blood pressure. These effects may occur especially with intravenous administration and in physically stressed patients
• Itching, skin rash
• Belching, feeling bloated or full

Rare (may affect up to 1 in 1,000 people)

• Changes in appetite
• Psychological effects that include: changes in mood, behavior, activity, and perception, hallucinations, confusion, sleep disturbances, and nightmares
• Convulsive crises
• Feeling of tingling and trembling
• Slowing of pulse, increase in blood pressure
• Muscle weakness
• Difficulty or retention of urine
• Blurred vision

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

• Flush
• Dizziness (feeling of dizziness or "spinning")
• Asthma and breathing difficulties
• Elevation of liver enzymes

Frequency not known (cannot be estimated from available data)

• Decrease in blood sugar level
• Low levels of sodium in the blood that may cause fatigue and confusion, muscle contractions, seizures, and coma
• Hiccups
• Serotonin syndrome, which may manifest as changes in mental state (e.g., agitation, hallucinations, coma), and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before starting Tradonal retard").

Withdrawal symptomsinclude: agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremors, and gastrointestinal problems (see section 3 "How to take Tradonal retard")..

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Do not store at a temperature above 25°C.
• Store in the original packaging to protect the capsules from moisture.
• Keep this medication out of the sight and reach of children.
• Store this medication in a safe and secure location, inaccessible to others. This medication may cause severe harm or even be fatal to individuals who have not been prescribed it.
• Do not use this medication after the expiration date appearing on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE drop-off point at your pharmacy. If unsure, ask your pharmacist how to properly dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofTradonal retard

The active ingredient is tramadol hydrochloride.

Each capsule contains 200 mg of tramadol hydrochloride.

The other components (excipients) of the capsule content are:sugar spheres (sucrose and cornstarch),anhydrous colloidal silica,cellulose,gum,talc.

The capsule contains:gelatin,titanium dioxide (E 171),yellow iron oxide (E 172),indigotin(E 132).

The printing ink contains: gum, iron oxide black (E 172), propylene glycol, ammonium hydroxide.

AppearanceofTradonal retardand contents of the package

Hard prolonged-release capsules

Yellow capsules marked withT200SR.

This medicine is in the form of hard prolonged-release capsules. The capsules release the active ingredient over a period of time.

All capsules are packaged in PVC/PVDC-aluminum blisters of 10 capsules. Each package contains 1, 2, 3, 5, 6 or 10 strips of blisters, i.e., each package contains 10, 20, 30, 50, 60 or 100 capsules. Only some package sizes may be marketed.

Holder of the Marketing Authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Temmler Pharma GmbH

Temmlerstrasse, 2

35039 –Marburg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area with the following names::

BelgiumTradonal Retard 200 mg, prolonged-release gelatin capsules

Tradonal Retard 200 mg, hard capsules with prolonged release

Tradonal Retard200mg, hard capsules, prolonged-release

DenmarkGemadol Retard

FranceZamudol LP200mg, prolonged-release gelatin capsule

GermanyTravex Retard200mg hard capsules, prolonged-release

ItalyTradonal SR200mg 30/60 hard prolonged-release capsules

LuxembourgTradonal Retard200mg, prolonged-release gelatin capsules

Tradonal Retard 200 mg, hard capsules with prolonged release

Tradonal Retard 200 mg, hard capsules, prolonged-release

NetherlandsTramadolHCl Retard Viatris200mg hard capsules with prolonged release

PortugalTravex Hard prolonged-release capsule

SpainTradonal retard200mg hard prolonged-release capsules

United KingdomZamadol SR200mg prolonged-release hard capsule

Date of the last review of this leaflet: May 2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)