TRAMADOL TARBIS 200 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the pack

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

1. What is Tramadol Tarbis and what is it used for

Tramadol, the active substance in this medicine, 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 200 mg is indicated for the treatment of moderate to severe pain.

2. What you need to know before you take Tramadol Tarbis

Do not take Tramadol Tarbis:

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

If you are not sure if you should start taking this medicine, consult your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tramadol Tarbis

• If you think you are dependent on other analgesics (opioids). If you have disorders 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 have an increase in pressure inside the skull (for example, after a head injury or diseases that affect the brain).
• If you have difficulty breathing.
• If you are epileptic or have convulsive seizures, because 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 medicines 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 level in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to lack of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider a dose reduction.

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 alone. Consult a doctor immediately if you have any of the symptoms associated with 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 are more likely to suffer from serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, 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 dose of tramadol exceeds the maximum recommended daily dose (400 mg).

Note that Tramadol Tarbis 100 mg can cause physical and psychological dependence. When this medicine is used for a long period, its effect may decrease, so higher doses may be needed (development of tolerance).

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

Also, inform your doctor if you experience any of these problems during treatment with Tramadol Tarbis 100 mg or if you have experienced them before.

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. They can 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.

Children

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

Using Tramadol Tarbis with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In isolated cases, a "serotonin syndrome" has been observed in patients taking "Selective Serotonin Reuptake Inhibitors" (SSRIs: medicines for treating depression). If you have 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.

Concomitant treatment with Tramadol Tarbis and monoamine oxidase inhibitors (MAOIs), a type of medicine for treating depression, should be avoided.

The analgesic effect of Tramadol Tarbis, as well as its duration, may be reduced if you take medicines that contain:

• Carbamazepine (for epileptic seizures)
• Pentazocine, nalbuphine, or buprenorphine (analgesics);
• Ondansetron (a medicine to prevent nausea)

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

The risk of side effects increases,

-If you take medicines that have a depressant effect on the central nervous system at the same time as Tramadol Tarbis, as it can cause more sleepiness or fainting. If this happens, consult your doctor. These medicines are: tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also used for cough), and alcohol.

• If you are taking medicines that can cause or facilitate convulsive seizures, such as certain antidepressants or antipsychotics. The risk of convulsive seizures increases if you take Tramadol Tarbis at the same time as these medicines. Your doctor will tell you if Tramadol Tarbis is suitable for you.

• If you are taking medicines for the treatment of depression. Tramadol Tarbis can interact with these medicines, and you may experience a serotonin syndrome (see the section "Possible side effects").

• If you take coumarin anticoagulants (medicines that prevent abnormal blood clotting), such as warfarin, with Tramadol Tarbis. The effect of these medicines on blood clotting may be affected, and it may lead to bleeding.

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

Taking Tramadol Tarbis with food, drinks, and alcohol

Food does not affect the effects of tramadol.

You should avoid consuming alcohol during treatment with Tramadol Tarbis, as it can enhance the side effects of 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.

Pregnancy:

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

Breastfeeding:

Tramadol is excreted in breast milk. For this reason, you should not take Tramadol Tarbis more than once during breastfeeding, or if you take Tramadol Tarbis more than once, you should interrupt breastfeeding.

Driving and using machines

Ask your doctor if you can drive or use machines during treatment with Tramadol Tarbis. It is important 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 double vision, or have difficulty concentrating. Be especially careful at the start of treatment, after a dose increase, after a change in formulation, and/or when administering it in combination with other medicines.

3. How to take Tramadol Tarbis

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

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

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

Adults and adolescents over 12 years

One Tramadol Tarbis tablet (200 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 indicates otherwise.

Use in children

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

Elderly patients

In elderly patients (over 75 years), the elimination of tramadol may be slow. Therefore, your doctor may prolong the dosing intervals.

Patient with liver or kidney failure/patients on dialysis

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

How and when should you take Tramadol Tarbis?

Tramadol Tarbis is administered 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 require 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 think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Tramadol Tarbis than you should

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

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

In case of overdose or accidental ingestion, go to a medical center or call the Toxicology Information Service, phone (91) 562.04.20, indicating the medicine 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 make up for forgotten doses. Take the tablet as soon as you can, as soon as you realize you have forgotten it. Take the next dose 12 hours later.

If you stop taking Tramadol Tarbis

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

Do not stop taking this medicine 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 stop it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms).

Generally, no undesirable effects occur when finishing 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 trembly. They may feel hyperactive, have difficulty sleeping, or have gastrointestinal or intestinal disorders. Very few people may have panic attacks, hallucinations, unusual perceptions such as itching, tingling, or 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 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.

The following adverse effects have occurred, which have been classified using the following frequency definitions: Very common (≥1/10), Common (≥1/100 to <1>

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 circulation (strong and rapid heartbeats, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are incorporated or who make physical effort.
• Desire to vomit (retching), stomach problems (e.g., feeling of pressure in the stomach, bloating), diarrhea.
• Skin reactions (e.g., itching, rash).

Rare: may affect 1 in 1,000 people

• Allergic reactions (e.g., difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure) have occurred in very rare cases.
• Slow heartbeat.
• Increased blood pressure.
• Abnormal sensations (e.g., itching, tingling, and numbness), tremors, epileptic seizures, muscle twitches, uncoordinated movements, transient loss of consciousness (syncope), speech disorders.
• Epileptic seizures may occur mainly after taking high doses of tramadol or when taken simultaneously with other medicines that can cause epileptic 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 (according to the patient's personality and the duration of treatment). These problems can 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 can lead to errors in judgment).
• Drug dependence may occur.
• Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis).
• Slow breathing, shortness of breath (dyspnea).
• A worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If the recommended doses are exceeded or if it is taken concomitantly with other medicines that depress brain function, a decrease in respiratory frequency may occur.
• Muscle weakness.
• Difficulty or pain when urinating, less urine than normal (dysuria).

Very rare: may affect 1 in 10,000 people

• Increased liver enzymes.

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

• Decrease in blood sugar levels.
• Hiccup.
• Serotonin syndrome, which can manifest through 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 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 suddenly stopped, signs of drug withdrawal syndrome may appear (see "If you stop treatment with Tramadol Tarbis 100 mg").

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 www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tramadol Tarbis

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect it from light.

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 that 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 that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tramadol Tarbis

• The active ingredient is tramadol hydrochloride. Each prolonged-release tablet contains 200 mg of tramadol hydrochloride.
• The other components are: hypromellose, microcrystalline cellulose, povidone, anhydrous colloidal silica, vegetable magnesium stearate, macrogol 6,000, tartrazine (E-102), talc, 30% dispersion of polyacrylate.

Appearance of the Product and Package Contents

Tramadol Tarbis are prolonged-release tablets. They are presented in packages containing 20 or 60 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

G.L Pharma GmbH

Schlossplatz 1

A-8502 Lannach (Austria)

Date of the Last Revision of this Prospectus: August 2021.

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