TRADONAL RETARD 200 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Tradonal Retard 200 mg prolonged-release hard capsules

tramadol, hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Tradonal Retard and what is it used for
2. What you need to know before you take Tradonal Retard
3. How to take Tradonal Retard
4. Possible side effects
5. Storing Tradonal Retard

1. Package contents and further information

1. What is Tradonal Retard and what is it used for

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

Tradonal Retard is used to relieve moderate to severe pain (e.g., pain after an operation or after an injury).

2. What you need to know before you take Tradonal Retard

Do not take Tradonal Retard

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6), which have caused a skin rash, facial swelling, or difficulty breathing
• if you are taking, or have taken in the last two weeks, monoamine oxidase inhibitors (MAOIs) for depression (see section 2, "Other medicines and Tradonal Retard")
• if you have uncontrolled epilepsy
• if you have drunk enough alcohol to feel dizzy or 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 pain-relieving medicines that can reduce your breathing and reaction ability.

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 disorders
• 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 disorders
• if you are going 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 disorders related to sleep

This medicine may cause respiratory disorders 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 include pauses in breathing during sleep, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tell 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 need to take a hormonal supplement.

There is a small risk that this medicine may cause seizures (fits). This risk increases if you take higher doses 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 gets used to it, which is known as pharmacological tolerance). Repeated use of this medicine can also lead to dependence, abuse, and addiction, which could result in a potentially life-threatening 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 need to use or how often you need to 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 greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

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

• You need to use the medicine for longer 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, 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 start taking it again ("withdrawal symptoms").

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 treatment with Tradonal Retard).

Do not take this medicine to treat withdrawal symptoms in case of drug addiction.

There is a small risk that this medicine may cause a serotonin syndrome, which can occur after taking tramadol in combination with certain antidepressants or tramadol alone. Consult a doctor immediately if you experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

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 may be more likely to experience serious side effects. If you experience any of the following side effects, you must stop taking this medicine and consult your doctor immediately: shallow or slow breathing, confusion, drowsiness, constricted pupils, feeling dizzy, constipation, loss of appetite.

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

Children and adolescents

This medicine must not be used in children under 12 years of age.

Use in children with respiratory problems

The use of tramadol is not recommended in children with respiratory problems, as the symptoms of tramadol toxicity can worsen in these children.

Other medicines and Tradonal Retard

Tell your doctor or pharmacistif you are using, have recently used, or might use any other medicines, including those obtained 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:

• Carbamazepine (used to treat epilepsy)
• Buprenorphine, nalbuphine, or pentazocine (pain-relieving medicines)
• Ondansetron (prevents nausea)

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

The risk of side effects increases if you are taking medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tradonal Retard at the same time as these medicines. Your doctor will tell you whether it is suitable for you.

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

Medicines that act on the nervous system, such as hypnotics, sedatives, sleeping pills, and pain-relieving medicines, can make you feel more drowsy or weak if you use them with tramadol.

The risk of side 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 must tell your doctor if you are taking these medicines.

The concomitant use of tramadol with sedative medicines, such as benzodiazepines or related substances, increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma and could be potentially life-threatening. Due to this, concomitant use should only be considered when other options are not possible.

However, if your doctor prescribes Tradonal Retard with sedative medicines, the dose and duration of concomitant treatment will be limited by your doctor.

Tell your doctor about all sedative medicines you are taking, and take exactly the dose that your doctor recommends. It is helpful that you inform your friends or family to be alert to the appearance of the signs and symptoms explained above. Contact your doctor if you experience these symptoms.

Taking 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, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Contact your doctor if you become pregnant during treatment.

Pregnancy

Tradonal Retard must not be taken during pregnancy or 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 treatment.

Breastfeeding

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

Driving and using machines

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

Tradonal Retard contains sucrose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Tradonal Retard

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. 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 Tradonal 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 must be adjusted to the intensity of the pain and your individual sensitivity to pain. Normally, you should take the lowest dose that produces pain relief.

The modified-release capsules of Tradonal Retard are packaged in a child-resistant blister pack to ensure safety.

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

Pre-puncture the blister pack and then push the capsule to remove it from the blister pack, in order to avoid damaging the capsules.

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

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

Dose for adults and adolescents from 12 years

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

The maximum doseis normally 400 mg per day.

Use in children

This medicine must not be administered to children under 12 years of age.

Use in elderly patients

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

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

If you have severe liver or kidney disease, treatment with this medicineis not recommended. If you have moderate liver or kidney disorders, 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 by your doctor, inform your doctor or pharmacist immediately and, if necessary, contact your nearest hospital. Remember to take the package and any remaining medicine with you.

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

If you forget to take Tradonal Retard

Do not take a double doseto make up for forgotten doses.

If you stop treatment with Tradonal Retard

Do not stop treatment with this medicine suddenly, unless your doctor tells you to. If you want to stop taking this medicine, 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 side effects (withdrawal symptoms).

People who have been taking this medicinefor some time may feel unwell if they stop taking it suddenly. They may feel agitated, anxious, nervous, or shaky. They may be overactive, have difficulty sleeping, and have stomach or intestine problems. Consult your doctor if you experience any of these symptoms after stopping this medicine.

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 may cause adverse effects, although not all people suffer from them.

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

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

• Dizziness
• Vomiting and nausea (feeling 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)

• Accelerated heart rate, palpitations, sudden decrease in tension. 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
• Psychic effects including: mood changes, changes in behavior and activity, and perception, hallucinations, confusion, sleep disturbances, and nightmares
• Seizures
• Feeling of tingling and tremors
• Slowed heart rate, increased blood pressure
• Muscle weakness
• Difficulty or urinary retention
• Blurred vision

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

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

Frequency Not Known (cannot be estimated from the available data)

• Decrease in blood sugar levels
• Low sodium levels in the blood that can cause fatigue and confusion, muscle contractions, seizures, and coma
• Hiccup
• Serotonin syndrome, which can 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Tradonal retard").

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

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 is not listed 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. Storage of Tradonal Retard

• Do not store at a temperature above 25°C.
• Keep in the original packaging to protect the capsules from moisture.
• Keep this medicine out of the sight and reach of children.
• Keep 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 or EXP. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 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), colloidal anhydrous silica, ethylcellulose, gum, talc.

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

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

AppearanceofTradonal Retardand Package Contents

Hard prolonged-release capsules

Yellow capsules marked with T200SR.

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 blister strips, i.e., each package contains 10, 20, 30, 50, 60, or 100 capsules. Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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 under the following names:

Belgium Tradonal Retard 200 mg, prolonged-release capsules

Tradonal Retard 200 mg, capsules with prolonged release, hard

Tradonal Retard 200 mg, Hartkapseln, retardiert

Denmark Gemadol Retard

France Zamudol LP 200 mg, prolonged-release capsule

Germany Travex Retard 200 mg Hartkapseln, retardiert

Italy Tradonal SR 200 mg 30/60 capsule rigide rilascio prolungato

Luxembourg Tradonal Retard 200 mg, gélules à liberation prolongée

Tradonal Retard 200 mg, capsules met verlengde afgifte, hard

Tradonal Retard 200 mg, Hartkapseln, retardiert

Netherlands Tramadol HCl Retard Viatris 200 mg harde capsules met verlengde afgifte

Portugal Travex Cápsula dura de libertação prolongada

Spain Tradonal retard 200 mg cápsulas duras de liberación prolongada

United Kingdom Zamadol SR 200 mg prolonged-release hard capsule

Date of the last revision of this prospectus: May 2024

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