Patient Information Leaflet

Tramadol Retard Viatris 100 mg prolonged-release tablets EFG

tramadol hydrochloride

Read 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 questions, ask your doctor, pharmacist or nurse.

-This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking 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 additional information

Tramadol

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

This medicationis used for the treatment of moderate to severe pain in adults and in adolescents 12 years of age and older.

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 can cause skin rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.

-If you have consumed too much alcohol or taken too many sedatives, analgesics, opioids, or other psychotropic medications (medicines that affect mood and emotions).

-If you are also taking IMAO (monoamine oxidase inhibitors, used to treat depression or Parkinson's disease) or have taken them in the 14 days prior to treatment with Tramadol Retard Viatris.

-If you have epilepsy and your seizures are not well controlled with treatment.

-As a treatment for withdrawal syndrome.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Retard Viatris if:

-You have increased intracranial pressure 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 concussion (one of the signs may be cold sweats).

-You have difficulty breathing.

-You have a tendency to epilepsy or seizures, as it 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”).

Please consult your doctor before starting to take this medicine.

Tramadol is metabolized in the liver by an enzyme. Some people have a variant of this enzyme; this may affect people in different ways. In some people, it may not provide sufficient pain relief, while others may be more likely to experience severe adverse effects. If you detect any of the following adverse effects, 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 can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult a doctor immediately if you experience any of the symptoms associated with this severe syndrome (see section 4 “Possible adverse effects”).

Respiratory disorders related to sleep

Tramadol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood).Among the symptoms may be pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (the body becomes accustomed to it, known as pharmacological tolerance). Repeated use of Tramadol Retard Viatris 100 mg may 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 may cause a feeling of lack of control over the amount of medication to be used or the frequency with which it is used.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Tramadol Retard Viatris 100 mg may be higher if:

- You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs (“addiction”).

- You are a smoker.

- You have had any problems with mood (depression, anxiety, or personality disorder) or have followed treatment with a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using Tramadol Retard Viatris 100 mg, it may be a sign of dependence or addiction:

– You need to use the medication for a longer time than indicated by your doctor.

– You need to use a higher dose than recommended.

– You are using the medication 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 medication or control its use.

– You feel unwell when you stop using the medication, and you feel better once you take it again (“withdrawal symptoms”).

If you notice any of these signs, consult your doctor to determine the best treatment for you, when it is appropriate to stop taking the medication, and how to do it safely (see section 3, if you interrupt treatment with Tramadol Retard Viatris 100 mg).

During treatment

Seizures have been reported in patients receiving tramadol at the recommended dose level. The risk may be higher 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 hormone 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 may be worse for these children.

Other medicines and Tramadol Retard Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Although they may be over-the-counter medications, herbal medications, or any of the following:

• Do not take tramadol at the same time or in the 14 days after using IMAO (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 medications 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 adverse effects increases if:

• You use tranquilizers, sedatives, other analgesics such as morphine and codeine (also for cough), and alcohol while taking this medication. You may experience drowsiness or feel like you are going to faint; if this occurs, contact your doctor.
• You use gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).
• You use medications that facilitate or may 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 simultaneously with these medications. 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 medications and may experience serotonin syndrome (see section 4 “Possible adverse effects”).
• You use anticoagulant coumarins (blood-thinning medications), such as warfarin, with this medication. The effect of these medications on blood clotting may be affected, and bleeding may occur.

The concomitant use of tramadol retard tablets and sedatives, such as benzodiazepines or other related medications, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, 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 should limit the dose and duration of concomitant treatment.

Inform your doctor of all sedatives you are taking, and follow your doctor's dose recommendation carefully. It may be helpful to inform your friends or family members to be aware of the previously described signs and symptoms. Contact your doctor if you experience these symptoms.

Tramadol Retard Viatris with food, drinks, and alcohol

Do not drink alcohol during treatment with tramadol, as its effects may intensify. Food has no influence on the effect of tramadol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine. There is very little information on the safety of tramadol in human pregnancy. Therefore, do not take tramadol if you are pregnant. Prolonged use during pregnancy may cause withdrawal symptoms in newborns.

Tramadol is excreted in breast milk. Therefore, do 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 operating machines

Ask your doctor if you can drive or operate machines during treatment with tramadol. It is essential to observe how this medicine affects you before driving or operating machines. Do not drive or operate machines if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Tramadol Retard Viatris contains lactose

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

Dosage

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

Your doctor will also explain to you what you can expect from the use of this medication, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (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 capable of relieving pain.

Unless your doctor's prescription is otherwise, the recommended dose is as follows:

Use in adults and those 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 it is not enough to mitigate 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.

Your doctor will prescribe a different and more suitable dose of the medication if necessary.

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

Use in children:

Tramadol should not be administered to children under 12 years.

Older adults:

In elderly patients (over 75 years), 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 disease / 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.

Administration form

Always swallow the tablets whole with a glass of water, preferably in the morning and at night. Do not break, chew, or crush them. You can take the tablets with an empty stomach or with food.

Treatment duration

Your doctor will indicate the duration of treatment with tramadol, which will depend on the cause of the pain. Do not take tramadol for longer than strictly necessary. If you need a longer treatment, your doctor will perform regular and short-term reviews 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 medication 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) take more tramadol than you should, contact your doctor or go to the nearest hospital emergency department 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 Toxicological Information Service (Tel. 91 562 04 20) indicating the medication and the amount ingested, or go to the nearest hospital emergency department.

If you forget to take Tramadol Retard Viatris

If you forget to take your tablets, it is possible that the pain will return. Take your dose as soon as you remember, unless it is almost time for your next dose.Do nottake a double dose to compensate for the missed doses.

If you interrupt treatment with Tramadol Retard Viatris

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

If you interrupt or end treatment with this medication too soon, it is possible that the pain will return. If you want to end treatment despite the unpleasant effects, inform your doctor.

Generally, there will be no aftereffects once treatment with tramadol is completed. However, in rare cases, some people who have taken tramadol for some time may feel unwell if they stop taking it suddenly. You may feel agitated, anxious, nervous, or shaky. You may also feel confused, be hyperactive, 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 (dissociation). 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 medication, ask your doctor or pharmacist.

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

If you experience any of the following side effects, contact your doctor or seek immediate medical attention:

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 hives along with difficulty breathing.

•Sudden circulatory collapse.

•Seizures.

Other side 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 heartbeats, tachycardia, feeling of fainting, or syncope). These side effects may occur especially in patients in an upright position or under physical stress.

•Wanting to vomit (retching), stomach problems (for example, feeling of pressure in the stomach or swelling), diarrhea.

•Skin reactions (for example, itching or skin rash).

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

•Weak heartbeats and increased blood pressure.

•Slow breathing and difficulty breathing (dyspnea).

•Alterations in appetite, abnormal sensations (for example, itching, tingling, and numbness) and tremors.

•Muscle contractions, muscle weakness, and movement discoordination.

•Fainting (syncope).

• Speech disorders.

•Blurred vision, small (constricted) pupil, dilated pupils.

•Difficulty or pain urinating, decreased amount of urine.

•Illusions (seeing, feeling, or hearing things that are not real), confusion, sleep disorders, anxiety, mood changes, and attention (delirium) and nightmares.

It is possible that 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 (mainly excitement, sometimes irritability), alterations in the level of activity (reduction, although sometimes increased activity), reduction in consciousness, and decreased ability to make decisions, which may cause errors in judgment. It may cause dependence.

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

•Sensation of dizziness or spinning (balance problems (vertigo))

•Notable redness on the face and, often, on other parts of the skin (flushing)

•Increased levels of liver enzymes.

Unknown frequency(cannot be estimated from available data):

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

•Worsening of asthma, although it has not been determined if they are caused by tramadol hydrochloride.

•Hypophagia.

•Serotonin syndrome, which may manifest as changes in mental state (for example, agitation, illusions, 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 (for example, nausea, vomiting, diarrhea) (see section 2 “What you need to know before starting to take Tramadol Retard Viatris”).

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

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

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.

Keep this medication out of the sight and reach of children.

Store this medication in a safe and protected place, to which other people cannot access. This medication may cause serious harm or even be fatal to individuals who have not been prescribed it.

No special storage conditions are required.

Do not use this medication if you observe that the tablet shows any change in color or other signs of deterioration and speak with your pharmacist; they will tell you what to do.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Tramadol Retard Viatris

-The active ingredient is tramadol (in the form of hydrochloride). Each prolonged-release tablet contains 100 mg of the active ingredient.

-The other components are microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate.

-The coating of the tablet contains the following excipients: hypromellose, lactose monohydrate, talc, macrogol, propylene glycol, and titanium dioxide.

Appearance of Tramadol Retard Viatris and contents of the package

Polymer-coated tablets, white or off-white in color, round, marked with "M" on one face and "TM1" on the other.

It is presented in:

-Blister packs and supplied in cardboard boxes containing 10, 20, 28, 30, 50, 56, 60, 90, and 100 prolonged-release tablets and perforated single-dose blister packs in cardboard boxes containing 20 and 60 prolonged-release tablets.

-HDPE bottles with polypropylene child-resistant closures containing 100 prolonged-release tablets.

-HDPE bottles with polypropylene screw-top closures containing 500 and 1,000 prolonged-release tablets (dispensing pack).

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

DenmarkDolatramyl

SlovakiaTramadol Mylan 100 mg tablets with prolonged release

SpainTramadol Retard Viatris 100 mg prolonged-release tablets EFG

FinlandDolatramyl

NorwayDolatramyl

NetherlandsTramadol HCI Retard Mylan 100 mg

PortugalTramadol Mylan

United KingdomManeo 100 mg Prolonged-release tablets

Czech RepublicTramadol Mylan 100 mg tablets with prolonged release

SwedenDolatramyl

Last review date of this leaflet:August 2024

Further detailed information on this medicinal product is availableon the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/