Prospect: information for the user

Tramadol Tarbis 100 mg prolonged-release tablets EFG

Tramadol hydrochloride

Tramadol, the active ingredient of this medication, is an analgesic belonging to the group of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.

Tramadol Tarbis 100 mg is indicated for the treatment of moderate to severe pain.

Do not take Tramadol Tarbis:

• If you are allergic to tramadol hydrochloride or any of the other components of this medication (listed in section 6).
• If you suffer from acute intoxication caused by alcohol,
• In cases of acute intoxication caused by alcohol, sleep-inducing medications, analgesics, or psychotropic drugs (medications that act on mood and emotions).
• If you have been treated with certain types of medications for depression (monoamine oxidase inhibitors or MAOIs) in the last two weeks or are taking them simultaneously, see the section "Taking other medications."
• If you have epilepsy and your seizures are not adequately controlled with treatment.
• As a treatment for withdrawal syndrome.

If you are unsure whether you should start taking this medication, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Tarbis

• If you think you have dependence on other opioids (analgesics). If you experience loss of consciousness (if you think you are going to faint).
• If you are in a state of shock (a sign of this state may be cold sweat).
• If you suffer from increased intracranial pressure (for example, after a head trauma or diseases affecting the brain).
• If you have difficulty breathing.
• If you are epileptic or have seizures, as the risk of these seizures may increase.
• If you have any liver or kidney disease.
• If you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medications and Tramadol Tarbis").

Respiratory disorders related to sleep

Tramadol Tarbis 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). Symptoms may include 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.

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 your doctor immediately if you experience any of the symptoms associated with this severe 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 may affect each person differently. In some people, it may be possible to achieve insufficient pain relief, while others may be more likely to experience severe side effects. If you notice any of the following side effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, somnolence, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase when the tramadol dose exceeds the recommended maximum daily dose (400 mg).

Be aware that Tramadol Tarbis 100 mg may cause physical and psychological dependence. When using this medication for a long period, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to abuse medications or who have medication dependence, treatment with Tramadol Tarbis 100 mg should only be carried out for short periods of time and under strict medical supervision.

Also inform your doctor if any of the following problems occur during treatment with Tramadol Tarbis 100 mg or if they have ever occurred:

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 experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements.

Children

Use in children with respiratory problems: Tramadol is not recommended for use in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Use of Tramadol Tarbis with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In isolated cases, a "serotonin syndrome" has been observed in patients taking "Selective Serotonin Reuptake Inhibitors" (SSRIs: medications for treating depression). If you experience symptoms such as: confusion, agitation, fever, sweating, vestibular disorders (ear disorders such as vertigo or dizziness), increased muscle reflexes, muscle cramps, and diarrhea, contact your doctor immediately.

Avoid simultaneous treatment of Tramadol Tarbis with monoamine oxidase inhibitors (MAOIs), a type of medication for treating depression.

The analgesic effect of Tramadol Tarbis and its duration may be reduced if you take medications containing:

- Carbamazepine (for epilepsy)

- Pentazocine, nalbuphine, or buprenorphine (analgesics);

- Ondansetron (medication to prevent nausea)

Your doctor will indicate if you should take Tramadol Tarbis and in what dose.

The risk of side effects increases:

- If you take medications that have a depressant effect on the nervous system simultaneously with Tramadol Tarbis, as it may cause more sleep or you may faint. If this occurs, consult your doctor. These medications are: tranquilizers, sleep-inducing medications, other analgesics such as morphine and codeine (also used for cough), and alcohol.

- If you are taking medications that facilitate or may cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol Tarbis simultaneously with these medications. Your doctor will tell you if Tramadol Tarbis is suitable for you.

- If you are taking medications for treating depression. Tramadol Tarbis may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").

- If you take anticoagulant medications (medications that prevent abnormal blood clotting), such as warfarin, with Tramadol Tarbis. The effect of these medications on blood clotting may be affected and may lead to bleeding.

Your doctor will indicate if you should take Tramadol Tarbis and in what dose.

Taking Tramadol Tarbis with food, drinks, and alcohol

Foods do not affect the effects of tramadol.

Avoid consuming alcohol during treatment with Tramadol Tarbis, as it may potentiate the side effects of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

There is very little information available on the safety of tramadol during human pregnancy. Therefore, do not take Tramadol Tarbis if you are pregnant.

Breastfeeding:

Tramadol is excreted in breast milk. Therefore, do not take Tramadol Tarbis more than once during breastfeeding, or if you take Tramadol Tarbis more than once, discontinue breastfeeding.

Driving and operating machinery

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

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

The dose should be adjusted according to the intensity of the pain and your individual sensitivity. Normally, the smallest dose possible that produces pain relief should be used. Do not take more than 400 mg of tramadol hydrochloride per day, unless your doctor has instructed you otherwise.

Unless your doctor has given you different instructions, the recommended dose is:

Adults and adolescents over 12 years old

One Tramadol Tarbis tablet (100 mg of tramadol) twice a day, preferably in the morning and at night.

The interval between one dose and another should not be less than 8 hours.

The total daily dose should not exceed 400 mg, unless your doctor instructs you otherwise.

Use in children

Tramadol Tarbis is not recommended for children under 12 years old, as there is not enough data on its safety and efficacy.

Elderly patients

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

Patients with liver or kidney insufficiency/patients on dialysis

If you have a severe liver or kidney disease, treatment with Tramadol Tarbis is not recommended. If you have moderate liver or kidney disease, your doctor may recommend prolonging the dosing intervals.

How and when to take Tramadol Tarbis:

Tramadol Tarbis should be taken orally.

The tablets should be taken without crushing or chewing, with sufficient liquid, preferably in the morning and at night. The tablets can be taken during meals or outside of meals.

For how long should you take Tramadol Tarbis?

Tramadol Tarbis should not be administered for longer than strictly necessary. If you need a prolonged treatment, your doctor will monitor you at short and regular intervals (if necessary, with interruptions in treatment) to see if you should continue treatment with Tramadol Tarbis and at what dose.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Tramadol Tarbis than you should

If you have taken more Tramadol Tarbis than you should, generally you will not have any negative effects.

Overdose of high doses of Tramadol Tarbis may cause pupil constriction, vomiting, decreased blood pressure, increased heart rate, collapse, decreased level of consciousness to coma (deep unconsciousness), seizures, and difficulty breathing that can lead to respiratory arrest. In this case, inform your doctor immediately.

In case of overdose or accidental ingestion, go immediately to a medical center or call theService ofInformationToxicology, phone (91) 562.04.20, indicating the medication and the amount ingested.

If you forget to take Tramadol Tarbis

If you forget to take Tramadol Tarbis, it is likely that the pain will return.

Do not take a double dose to compensate for the missed doses. Take the tablet as soon as you remember that you have forgotten it. Take the next dose 12 hours later.

If you interrupt treatment with Tramadol Tarbis

If you interrupt or discontinue treatment with Tramadol Tarbis too soon, it is likely that the pain will return. If you want to interrupt treatment due to undesirable effects, consult your doctor.

You should not stop taking this medication suddenly, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to interrupt it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary adverse effects (withdrawal symptoms).

Generally, there are no undesirable effects when discontinuing treatment with Tramadol Tarbis. However, in rare cases, when some people who have been taking Tramadol Tarbis for some time stop taking it suddenly, they may feel unwell. They may feel agitated, anxious, nervous, or shaky. They may feel hyperactive, have difficulty sleeping, or experience gastrointestinal or intestinal disorders. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ringing in the ears (tinnitus). If you experience any of these symptoms after stopping Tramadol Tarbis, please consult your doctor.

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 following side effects have been reported, which have been classified using the following frequency definitions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (≤1/10,000).

Very common: may affect more than 1 in 10 people

•Dizziness.

•Nausea.

Common: may affect 1 in 10 people

•Headache, numbness.

•Fatigue.

•Vomiting, dry mouth, constipation.

•Sweating (hyperhidrosis).

Uncommon: may affect 1 in 100 people

•Effects on the heart and blood circulation (strong heartbeats and rapid heartbeats, sensation of dizziness or collapse). These side effects may occur especially in patients who are lying down or who are physically exerting themselves.

•Desire to vomit (retching), stomach problems (for example, feeling of pressure in the stomach, bloating), diarrhea.

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

Rare: may affect 1 in 1,000 people

•Allergic reactions (for example, difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.

•Slow heart rate.

•Increased blood pressure.

•Abnormal sensations (such as itching, tingling, and numbness), tremors, seizures, muscle cramps, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.

•Seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medications that can cause seizures.

•Changes in appetite.

•Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.

•Psychological problems may appear after treatment with Tramadol Tarbis 100 mg. Their intensity and nature may vary (in accordance with the patient's personality and the duration of treatment). These problems may manifest as a change in mood (usually euphoria, occasionally irritability), changes in activity (usually decreased, occasionally increased), and decreased cognitive and sensory perception (changes in senses and recognition, which may lead to judgment errors).

•May cause drug dependence.

•Blurred vision, pupil constriction (miosis), excessive pupil dilation (midriasis).

•Slow breathing, shortness of breath (dyspnea).

•Worsening of asthma has been reported, although no causal relationship with tramadol has been established. If the recommended doses are exceeded or if taken concomitantly with other medications that depress cerebral function, a decrease in respiratory frequency may occur.

•Muscle weakness.

•Difficulty or pain urinating, decreased urine output (dysuria).

Very rare: may affect 1 in 10,000 people

•Increased liver enzymes.

Frequency not known: frequency that cannot be estimated from available data

•Decreased blood sugar level.

•Hypotension.

•Serotonin syndrome, which may manifest as changes in mental state (for example, 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 (for example, nausea, vomiting, diarrhea) (see section 2 "what you need to know before taking Tramadol Tarbis").

If Tramadol Tarbis 100 mg is taken for a long period, drug dependence may appear, although the risk is very low.

When treatment is stopped abruptly, signs of drug withdrawal syndrome (see "If you stop taking Tramadol Tarbis 100 mg") may appear.

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 Pharmacovigilance of Medicinal Products for Human Use 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 in the original packaging to protect it from light.

Do not use this medicationafter 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 pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tramadol Tarbis

- The active ingredient is tramadol hydrochloride. Each prolonged-release tablet contains 100 mg of tramadol hydrochloride.

- The other components are: hypromellose, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, macrogol 6,000, titanium dioxide (E-171), talc, and a 30% dispersion of polyacrylate.

Appearance of the product and content of the packaging

Tramadol Tarbisare prolonged-release tablets. They are presented in packaging containing 20 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing:

G.L Pharma GmbH

Schlossplatz 1

A-8502 Lannach (Austria)

Last review date of this leaflet: August 2021.

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