Tramadol Tarbis 200 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tramadol Tarbis 200 mg prolonged-release tablets EFG

Tramadol hydrochloride

Read the entire 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Tramadol, the active substance in this medicine, is an analgesic belonging to the opioid group 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 taking Tramadol Tarbis

Do not take Tramadol Tarbis:

• If you are allergic to tramadol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have acute intoxication due to alcohol,
• In cases of acute intoxication caused by alcohol, hypnotic drugs, analgesics, or psychotropic medicines (medicines that affect mood and emotions).
• If you have been treated in the last two weeks or are currently taking certain types of antidepressant medicines (monoamine oxidase inhibitors or MAOIs); see section “Other medicines and Tramadol Tarbis”.
• If you have epilepsy and your seizures are not adequately controlled by treatment.
• As treatment for withdrawal syndrome.

If you are unsure whether 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 feel you might faint).
• If you are in shock (a sign of this condition may be cold sweat).
• If you have increased pressure inside the skull (for example, after a head injury or brain diseases).
• If you have difficulty breathing.
• If you have epilepsy or suffer from seizures, as the risk of seizures may increase.
• If 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 Tarbis”).

Sleep-related breathing disorders

Tramadol Tarbis may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). 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 notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

There is a slight risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Seek immediate medical advice if you experience any symptoms associated with 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 notice any of the following adverse effects, 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 tramadol dose exceeds the maximum recommended daily dose (400 mg).

Please note that Tramadol Tarbis 100 mg may cause physical and psychological dependence. When this medicine is used for long periods, its effect may decrease, requiring higher doses (development of tolerance).

In patients with a tendency to drug abuse or who are dependent on drugs, treatment with Tramadol Tarbis 100 mg should only be carried out for short periods 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 you have ever experienced them:

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

Children

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.

Taking Tramadol Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

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

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

Your doctor will advise you whether and at what dose you should take Tramadol Tarbis.

The risk of adverse effects increases:

• If you take medicines that have a depressant effect on the central nervous system simultaneously with Tramadol Tarbis, as this may cause increased drowsiness or fainting. If this occurs, consult your doctor. These medicines include: tranquilizers, sleep-inducing drugs, other analgesics such as morphine and codeine (also used for cough), and alcohol.

• If you are taking medicines that may facilitate or trigger seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Tramadol Tarbis simultaneously with these medicines. Your doctor will advise you whether Tramadol Tarbis is suitable for you.

• If you are taking medicines for depression. Tramadol Tarbis may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).

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

Your doctor will advise you whether and at what dose you should take Tramadol Tarbis.

Taking Tramadol Tarbis with food, drinks, and alcohol

Food does not influence the effects of tramadol.

You should avoid consuming alcohol during treatment with Tramadol Tarbis, as it may 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 limited 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 stop breastfeeding.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Tramadol Tarbis. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred or double vision, or have difficulty concentrating. Exercise particular caution at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taking it concomitantly with other medicines.

3. How to take Tramadol Tarbis

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

The dose should be adjusted according to the intensity of pain and your individual sensitivity. The lowest possible dose that provides pain relief should normally 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 of age

One tablet of Tramadol Tarbis (200 mg of tramadol) twice daily, preferably in the morning and at night.

The interval between doses should not be less than 8 hours.

The total daily dose must not exceed 400 mg unless otherwise directed by your doctor.

Use in children

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

Elderly patients

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

Patients with hepatic or renal impairment/dialysis patients

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 extend the dosing intervals.

How and when should you take Tramadol Tarbis?

Tramadol Tarbis is administered orally.

The tablets should be taken whole, without crushing or chewing, with sufficient liquid, preferably in the morning and at night. The tablets may be taken with or without food.

How long should you take Tramadol Tarbis?

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

If you feel that the effect of this medicine 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, you will generally not experience negative effects.

Poisoning due to very high doses of Tramadol Tarbis may cause pupil constriction, vomiting, decreased blood pressure, increased pulse rate, collapse, decreased level of consciousness up to coma (deep unconsciousness), epileptic seizures, and breathing difficulties that may lead to respiratory arrest. In such a case, seek immediate medical help.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service at telephone (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, your pain is likely to return.

Do not take a double dose to make up for missed doses. Take the tablet as soon as you remember. Take the next dose 12 hours after the previous one.

If you stop taking Tramadol Tarbis

If you stop or discontinue treatment with Tramadol Tarbis too early, your pain is likely to reappear. If you wish to discontinue treatment due to undesirable effects, consult your doctor.

You should not stop taking this medicine suddenly; speak with your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to reduce the likelihood of experiencing unnecessary adverse effects (withdrawal symptoms).

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

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 experiences them.

The following adverse effects have occurred, classified according to 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), Frequency not known (cannot be estimated from the available data).

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, feeling of dizziness or collapse). These adverse effects may occur especially in patients who are standing up or performing physical exertion.
• Nausea (retching), stomach problems (e.g. feeling of pressure in the stomach, bloating), diarrhoea.
• 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 (such as itching, tingling, and numbness), tremor, seizures, muscle jerks, 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 medicines that can provoke seizures.
• Changes in appetite.
• Hallucinations, confusion, sleep disturbances, delirium, anxiety, and nightmares.
• Psychological problems may occur after treatment with Tramadol Tarbis 100 mg. Their severity and nature may vary (depending on the patient's personality and duration of treatment). These problems may manifest as changes 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 impaired judgment).
• Drug dependence may occur.
• Blurred vision, constriction of the pupils (miosis), excessive dilation of the pupils (mydriasis).
• Slow breathing, shortness of breath (dyspnoea).
• Worsening of asthma has been reported; however, a causal relationship with tramadol has not been established. If recommended doses are exceeded or if tramadol is taken concomitantly with other medicines that depress brain function, respiratory rate may decrease.
• 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 cannot be estimated from the available data

• Decreased blood sugar levels.
• 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, diarrhoea) (see section 2, "What you need to know before taking Tramadol Tarbis").

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

When treatment is abruptly discontinued, 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 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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tramadol Tarbis

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

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container following “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 containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tramadol Tarbis

• The active substance is tramadol hydrochloride. Each prolonged-release tablet contains 200 mg of tramadol hydrochloride.
• The other components are: hypromellose, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate (vegetable origin), macrogol 6000, tartrazine (E-102), talc, 30% polyacrylate dispersion.

Appearance of the medicine and contents of the pack

Tramadol Tarbis are prolonged-release tablets. It is available in packs containing 20 or 60 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: August 2021.

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