Tradonal Retard 200 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tradonal Retard 200 mg prolonged-release hard capsules

tramadol hydrochloride

Read the entire 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 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, talk to your doctor or pharmacist, even if they are not effects listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Tradonal Retard

3. How to take Tradonal Retard

4. Possible adverse effects

5. How to store Tradonal Retard

6. Contents of the pack and other information

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

Tradonal retard belongs to a group of medicines called analgesics, commonly known as pain-relieving medicines. The active substance, tramadol hydrochloride, blocks pain signals sent to the brain and also acts on your brain to prevent you from feeling pain. This means that the medicine does not stop the pain from occurring, but rather reduces the sensation of pain.

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

2. What you need to know before taking Tradonal retard

Do not take Tradonal retard

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6), which have caused you a skin rash, facial swelling, or difficulty breathing
• if you are taking, or have taken within the last two weeks, monoamine oxidase inhibitors (MAOIs) for depression (see section 2, “Other medicines and Tradonal retard”)
• if you have epilepsy that is not controlled by treatment
• if you have consumed enough alcohol to feel dizzy or intoxicated
• 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 painkillers, which may reduce your ability to breathe or 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 disorders
• if you have recently had a head injury or have a headache so severe that it makes you feel unwell
• if you have had seizures (fits) or suffer from epilepsy
• if you have asthma or respiratory disorders
• if you are undergoing any type of surgery requiring general anesthesia
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tradonal retard”).

Sleep-related breathing disorders

This medicine may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices 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 adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

There is a rare possibility that this medicine may cause seizures (fits). This risk increases if doses above the maximum daily dose are taken, 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 may make the medicine less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of this medicine 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 cause a feeling of lack of control over the amount of 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 this medicine may be greater if:

• You or any member of your family have abused alcohol or been dependent 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 received psychiatric treatment for other mental illnesses.

If you notice 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 prescribed 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 stay 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 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 Tradonal retard).

You should not take this medicine to treat withdrawal symptoms in cases of drug addiction.

There is a slight risk that you may experience serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol as monotherapy. Consult a doctor immediately if you experience any symptoms related to 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, 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, you must stop taking this medicine and consult your doctor immediately: shallow or slow breathing, confusion, drowsiness, constricted pupils, dizziness, constipation, or 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 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 symptoms of tramadol toxicity may worsen in these children.

Other medicines and Tradonal retard

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

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

The pain relief provided by tramadol may be weakened or shortened if you are also taking medicines containing:

• Carbamazepine (used to treat epilepsy)
• Buprenorphine, nalbuphine, or pentazocine (used for pain relief)
• Ondansetron (used 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 medicines that may facilitate or 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 advise you 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 you may experience serotonin syndrome (see section 4, “Possible side effects”).

Medicines that act on the central nervous system, such as hypnotics, tranquilizers, sleeping tablets, and painkillers, may make you feel more drowsy or weak if taken together with tramadol.

The risk of adverse effects increases if you are taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).

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

You must inform 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 fatal. For this reason, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor of all sedative medicines you are taking and take exactly the dose recommended by your doctor. It may be helpful for you to inform your friends or family members to be alert for the signs and symptoms described 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Contact your doctor if you become pregnant during your 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 during pregnancy. Contact your doctor if you become pregnant during your treatment.

Breastfeeding

Tramadol is excreted in breast milk. For this reason, you must not take Tradonal retard more than once during breastfeeding; alternatively, 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 increased by alcohol, antihistamines, and other CNS depressants. If patients are affected, they should be warned not to drive or operate machinery.

Tradonal retard contains sucrose

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 Tradonal retard

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

Before starting treatment and regularly during treatment, your doctor will also explain to you what to 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 should be adjusted according to the intensity of pain and your individual sensitivity to pain. Normally, the lowest dose that provides pain relief should be taken.

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

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

Puncture the foil first, then push the capsule through the blister to remove it, 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 may open them. You should open them very carefully by pulling and twisting simultaneously over a spoon, so that the granules remain in the spoon. Do not chew them. Swallow the granules with water.

Dosage for adults and adolescents aged 12 years and older

The usual initial dose is 50–100 mg twice daily, in the morning and at night. Your doctor may increase this dose to 150–200 mg twice daily, depending on the intensity of pain and your needs. The medicine should normally be taken every 12 hours, at the same time in the morning and at night.

The maximum dose is normally 400 mg per day.

Use in children

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

Use in elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slow. If this occurs, your doctor may recommend increasing the dosing interval.

Use in patients with hepatic or renal impairment/dialysis patients

If you have severe liver and/or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may extend the dosing intervals.

If you take more Tradonal retard than you should

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

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

If you forget to take Tradonal retard

Do not take a double dose to make up for missed doses.

If you stop taking Tradonal retard

Do not stop treatment with this medicine suddenly, unless your doctor tells you to. If you wish 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 involve gradually reducing the dose, to reduce the risk of adverse effects (withdrawal symptoms).

People who have been taking this medicine for some time may feel unwell if they stop taking it suddenly. They may feel agitated, anxious, nervous, or shaky. They may become hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances. 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 can cause adverse effects, although not everyone will experience them.

The most serious adverse effects that may occur include allergic reaction (difficulty breathing, wheezing, and swelling of the face or throat), anaphylactic reaction (an extreme allergic reaction causing difficulty breathing, changes in heart rate, weakness, collapse, or unconsciousness due to a drop in blood pressure), or seizures (fits). If you experience any of these symptoms, you must 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)

• Increased heart rate, palpitations, sudden drop in blood pressure. These effects may occur especially with intravenous administration and in physically stressed patients
• Itching, skin rash
• Retching, bloating or fullness sensation

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

• Changes in appetite
• Psychic effects including: mood, activity behavior and perception changes, hallucinations, confusion, sleep disturbances, and nightmares
• Seizures
• Tingling sensation and tremor
• Slow 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 (sensation of dizziness or "spinning")
• Asthma and breathing difficulties
• Increased liver enzymes

Frequency not known (cannot be estimated from available data)

• Decreased blood sugar levels
• Low sodium levels in blood, which may cause tiredness and confusion, muscle spasms, seizures, and coma
• 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 Tradonal retard").

Withdrawal symptoms include: agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremor, 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 not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es**. By reporting adverse effects, you can help provide more information on the safety of this medicine.**

5. Storage of Tradonal retard

• Do not store 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.
• 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 CAD or EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Tradonal retard

The active substance is tramadol hydrochloride.

Each capsule contains 200 mg of tramadol hydrochloride.

The other components (excipients) of the capsule contents are: sugar spheres (sucrose and maize starch), anhydrous colloidal silica, ethylcellulose, gum, talc.

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

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

Appearance of Tradonal retard and contents of the pack

Prolonged-release hard capsules.

Yellow capsules marked with T200SR.

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

All capsules are packed in PVC/PVDC-aluminium blisters of 10 capsules. Each pack contains 1, 2, 3, 5, 6 or 10 blisters, i.e. each pack contains 10, 20, 30, 50, 60 or 100 capsules. Only certain pack 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

For more information about this medicine, contact 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 European Economic Area Member States under the following names:

Belgium Tradonal Retard 200 mg, gélules à libération prolongée
Tradonal Retard 200 mg, capsules met verlengde afgifte, hard
Tradonal Retard 200 mg, Hartkapseln, retardiert

Denmark Gemadol Retard

France Zamudol LP 200 mg, gélule à libération prolongée

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 most recent revision of this leaflet: May 2024

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