TRAMADOL RETARD VIATRIS 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Tramadol Retard Viatris 200 mg Prolonged-Release Tablets EFG

tramadol hydrochloride

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

Contents of the pack

1. What Tramadol Retard Viatris is and what it is used for
2. What you need to know before you take Tramadol Retard Viatris
3. How to take Tramadol Retard Viatris
4. Possible side effects
5. Storage of Tramadol Retard Viatris
6. Contents of the pack and other information

1. What Tramadol Retard Viatris is and what it is used for

Tramadol Retard Viatris contains the active substance tramadol hydrochloride. Tramadol hydrochloride is an opioid analgesic that acts on the central nervous system. It relieves pain by acting on specific neurons in the spinal cord and brain.

This medicine is used for the treatment of moderate to severe pain in adults and adolescents from 12 years of age.

2. What you need to know before you take Tramadol Retard Viatris

Do not take Tramadol Retard Viatris

• If you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a skin rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
• If you have taken too much alcohol or have taken too many sedatives, analgesics, opioids, or other psychotropic medicines (medicines that affect mood and emotions).
• If you are also taking MAOIs (monoamine oxidase inhibitors, used for the treatment of depression or Parkinson's disease) or have taken them in the 14 days before treatment with Tramadol Retard Viatris.
• If you have epilepsy and your seizures are not well controlled with treatment.
• As treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Tramadol Retard Viatris if:

• You have an increased pressure in the skull that causes symptoms such as headache and vomiting (possibly after a head injury or brain disease).
• You have loss of consciousness (for example, if you feel like you are going to faint).
• You are in a state of shock (one of the signs may be cold sweats).
• You have difficulty breathing.
• You have a tendency to epilepsy or seizures, as this may increase the risk of a seizure.
• 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 Tramadol Retard Viatris").

In such cases, please consult your doctor before starting to take this medicine.

Tramadol is transformed in the liver by an enzyme. Some people have a variant of this enzyme; this fact can affect people in different ways. In some people, they may not obtain sufficient pain relief, while others are more likely to suffer from serious side effects. If you detect any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, feeling unwell, constipation, loss of appetite.

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

Sleep-related breathing disorders

Tramadol may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen level in the blood). Among the symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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 Tramadol Retard Viatris 200 mg can also lead to dependence, abuse, and addiction, which could lead to a potentially fatal 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 on or addicted to Tramadol Retard Viatris 200 mg 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 a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Tramadol Retard Viatris 200 mg, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period 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 and 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 take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment option for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop treatment with Tramadol Retard Viatris 200 mg).

During treatment

Seizures have been reported in patients receiving tramadol at the recommended dose level. The risk may be greater when tramadol doses exceed the upper limit of the recommended daily dose (400 mg).

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may be indicators of adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

If you notice that your pain worsens after taking tramadol, do not take more without talking to your doctor. Talk to your doctor if your pain increases, if you feel more sensitive to pain, or if you have a new pain after taking tramadol.

Children and adolescents

Use in children with respiratory problems

Tramadol is not recommended for children with respiratory problems, as the symptoms of tramadol toxicity can be worse for these children.

Other medicines and Tramadol Retard Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, even if they are obtained without a prescription, herbal medicines, or any of the following:

• Do not take tramadol at the same time or in the 14 days after using MAOIs (for example, moclobemide or phenelzine for depression and selegiline for Parkinson's disease).

The analgesic effect of tramadol may be weakened or shortened if you also take other medicines that contain the following:

• Carbamazepine (used to treat epilepsy).
• Other opioids (for example, buprenorphine, nalbuphine, or pentazocine (analgesics).
• Ondansetron (to prevent nausea).

The risk of side effects increases if:

• You use sedatives, sleeping pills, other analgesics such as morphine and codeine (also as a cough medicine), and alcohol while taking this medicine. You may feel drowsy or feel like you are going to faint; if this happens, contact your doctor.
• You use gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• You use medicines that can cause seizures, such as certain antidepressants (for example, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants) or antipsychotics. The risk of seizures increases if you take tramadol at the same time as these medicines. Your doctor will confirm if tramadol is suitable for you.
• If you are taking certain antidepressants (for example, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or mirtazapine). Tramadol may interact with these medicines, and you may experience serotonin syndrome (see section 4 "Possible side effects").
• You use anticoagulant coumarins (blood-thinning medicines), such as warfarin, with this medicine. The effect of these medicines on blood clotting may be affected, and bleeding may occur.

Concomitant use of tramadol retard tablets and sedatives, such as benzodiazepines or other related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Due to this, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes tramadol retard tablets with sedatives, the doctor must limit the dose and duration of concomitant treatment.

Tell your doctor about all sedatives you are taking, and follow your doctor's dosage recommendation carefully. It may be helpful to inform your friends or family so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Taking Tramadol Retard Viatris with food, drinks, and alcohol

Do not drink alcohol during treatment with tramadol, as its effects may be intensified. Food does not affect the effect of tramadol.

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 little information on the safety of tramadol in human pregnancy. Therefore, you should not take tramadol if you are pregnant. Prolonged use during pregnancy may cause withdrawal symptoms in newborns.

Tramadol is excreted in breast milk. For this reason, you should not take tramadol tablets more than once during breastfeeding or, as an alternative, if you take it more than once, you should interrupt breastfeeding.

Based on human experience, tramadol hydrochloride does not affect fertility in men and women.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with tramadol. It is essential that before driving or using machines, you observe how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administered concomitantly with other medicines.

Tramadol Retard Viatris contains lactose

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

3. How to take Tramadol Retard Viatris

Dose

Follow the instructions for administration of this medicine exactly as indicated by your doctor. 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 using this medicine, 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 administration interval should be adjusted according to the intensity of the pain and your specific sensitivity to pain. In general, you should take the lowest possible dose that can relieve the pain.

Unless your doctor prescribes otherwise, the recommended dose is as follows:

Use in adults and children over 12 years:

Tramadol Retard Viatris 100 mg tablets: one tablet (100 mg of tramadol hydrochloride) twice a day, preferably in the morning and at night.

If this is not sufficient to alleviate the pain, it can be increased as follows:

Tramadol Retard Viatris 150 mg tablets: one tablet (150 mg of tramadol hydrochloride) twice a day, preferably in the morning and at night.

or:

Tramadol Retard Viatris 200 mg tablets: one tablet (200 mg of tramadol hydrochloride) twice a day, preferably in the morning and at night.

In case of need, your doctor will prescribe a different and more suitable dose of the medicine for you.

Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor tells you to do so.

Use in children:

Tramadol should not be administered to children under 12 years of age.

Elderly patients:

In elderly patients (over 75 years of age), the elimination of tramadol may be slow. If this is your case, your doctor may recommend prolonging the administration interval.

Severe liver and/or kidney impairment / patients on dialysis:

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

Method of administration

Always swallow the tablets whole with a glass of water, preferably in the morning and at night. Do not divide, chew, or crush them. You can take the tablets with or without food.

Duration of treatment

Your doctor will indicate the duration of treatment with tramadol, which will depend on the cause of the pain. You should not take tramadol for longer than strictly necessary. If you need longer treatment, your doctor will review you at regular, short intervals to determine if you should continue taking tramadol and at what dose. If necessary, you can take breaks in treatment. If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Tramadol Retard Viatris than you should

If you (or someone else) take more tramadol than you should, contact your doctor or go to the emergency department of the nearest hospital immediately.

You may feel sick, notice small pupils (constriction), feel dizzy due to a drop in blood pressure, lose consciousness, fall into a coma, experience seizures (convulsions), or have difficulty breathing that can be severe.

If you accidentally take too many tablets, contact your doctor or pharmacist immediately, call the Toxicology Information Service (Tel. 91 562 04 20) indicating the medicine and the amount taken, or go to the emergency department of the nearest hospital.

If you forget to take Tramadol Retard Viatris

If you forget to take your tablets, you may experience pain again. Take your dose as soon as you remember, unless it is almost time for your next dose. Do nottake a double dose to make up for forgotten doses.

If you stop treatment with Tramadol Retard Viatris

You should not stop taking this medicine suddenly, unless your doctor tells you to do so. If you want to stop taking the medicine, you must first talk to your doctor, especially if you have been taking it for a long time. Your doctor will inform you about the time and the way to stop taking it, which may consist of gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

If you stop or finish treatment with this medicine too early, you may experience pain again. If you want to finish treatment despite the unpleasant effects, tell your doctor.

Generally, there will be no after-effects once treatment with tramadol is finished. However, in rare cases, some people who have taken tramadol for some time may feel unwell if they stop taking it abruptly. They may feel agitated, anxious, nervous, or trembly. They may also feel confused, be overactive, have difficulty sleeping, and experience gastrointestinal disorders.

In isolated cases, you may experience confusion, panic attacks, persecutory mania (paranoia), hallucinations, alterations in the perception of reality (derealization), or a feeling of loss of identity (depersonalization). You may experience unusual perceptions such as itching, tingling, and ringing in the ears (tinnitus).

If you experience any of these problems after stopping treatment with tramadol, consult your doctor.

If you have any other 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 all people suffer from them.

If you experience any of the following adverse effects, contact your doctor or go to an emergency service immediately:

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

• Allergic reactions, for example, difficulty breathing, wheezing, or skin swelling.
• Swelling of the face, tongue, and/or throat, and/or difficulty swallowing or rashes along with difficulty breathing.
• Sudden circulatory collapse/shock.
• Seizures (convulsions).

Other adverse effects:

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

• Dizziness.
• Nausea.

Common(may affect up to 1 in 10 people):

• Headache, drowsiness.
• Vomiting, constipation, and dry mouth.
• Fatigue.
• Sweating.

Uncommon(may affect up to 1 in 100 people):

• Effects on the heart and blood circulation (strong heartbeat, tachycardia, feeling of fainting or syncope). These adverse effects may occur especially in patients in an upright position or under physical stress.
• Feeling of vomiting (retching), stomach problems (e.g., feeling of pressure in the stomach or bloating), diarrhea.
• Skin reactions (e.g., itching or skin rash).

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

• Weak heartbeat and increased blood pressure.
• Slow breathing and difficulty breathing (dyspnea).
• Changes in appetite, abnormal sensations (e.g., itching, tingling, and numbness), and tremors.
• Muscle contractions, muscle weakness, and movement coordination disorders.
• Fainting (syncope).
• Speech disorders.

• Blurred vision, small (constricted) pupil, dilated pupils.
• Difficulty or pain when urinating, decreased urine output.
• Hallucinations (seeing, feeling, or hearing things that are not real), confusion, sleep disorders, anxiety, mood changes, and attention disorders (delirium) and nightmares.

Psychological problems may appear after treatment with tramadol, whose intensity and nature will be variable (depending on the patient's personality and the duration of treatment). These problems may manifest as mood changes (mostly excitement, sometimes irritation), changes in the degree of activity (reduction, although sometimes increased activity), reduced consciousness, and decreased ability to make decisions, which can cause errors in judgment. It can cause dependence.

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

• Feeling of dizziness or spinning (balance problems (vertigo))
• A noticeable redness appears on the face and often on other parts of the skin (flushing)
• Increased liver enzyme values.

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

• Low blood sugar levels (hypoglycemia).
• Low sodium levels in the blood that can cause fatigue and confusion, muscle spasms, convulsions, and coma (hyponatremia).

• Worsening of asthma, although it has not been determined if they are caused by tramadol hydrochloride.
• Hiccup.
• Serotonin syndrome, which can manifest through 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 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 Tramadol Retard Viatris").

If the recommended doses are exceeded, or if other central nervous system depressant medicines are taken simultaneously, it is possible that breathing will slow down.

When treatment is interrupted or stopped abruptly, it may cause withdrawal symptoms (see the section "If you stop taking Tramadol Retard Viatris").

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 does not appear 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. Conservation of Tramadol Retard Viatris

Keep this medicine out of sight and reach of children.

Store this medicine in a safe and protected place, where other people cannot access it. This medicine can cause serious harm and even be fatal to people who have not been prescribed it.

No special storage conditions are required.

Do not use this medicine if you notice that the tablet has changed color or shows any other sign of deterioration, and talk to your pharmacist; they will tell you what to do.

Do not use this medicine after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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 of Tramadol Retard Viatris

• The active ingredient is tramadol (in the form of hydrochloride). Each prolonged-release tablet contains 200 mg of the active ingredient.
• The other ingredients are microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate.
• The tablet coating contains the following excipients: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, titanium dioxide, red iron oxide, and yellow quinoline lacquer.

Appearance of Tramadol Retard Viatris and Package Contents

Film-coated tablets, orange-brown in color, and capsule-shaped, marked with "M" on one side and "TM3" on the other.

It is packaged in:

• Blister packs and supplied in cardboard boxes containing 10, 20, 28, 30, 50, 56, 60, 90, and 100 prolonged-release tablets, and single-dose perforated blister packs in cardboard boxes containing 20 and 60 prolonged-release tablets.
• HDPE bottles with child-resistant polypropylene closures containing 100 prolonged-release tablets.
• HDPE bottles with screw caps made of polypropylene containing 500 and 1,000 prolonged-release tablets (dispensing packaging).

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1

H-2900, Komárom

Hungary

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Denmark Dolatramyl

Slovakia Tramadol Mylan 200 mg prolonged-release tablets

Spain Tramadol Retard Viatris 200 mg prolonged-release tablets EFG

Finland Dolatramyl

Norway Dolatramyl

Netherlands Tramadol HCI Retard Mylan 200 mg

Portugal Tramadol Mylan

United Kingdom Maneo 200 mg Prolonged-release tablets

Czech Republic Tramadol Mylan 200 mg prolonged-release tablets

Sweden Dolatramyl

Date of the Last Revision of this Prospectus:August 2024

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