Tramadol Aurobindo

Leaflet accompanying the packaging: information for the user

Tramadol Aurobindo, 50 mg, hard capsules

Tramadol hydrochloride

You should read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects get worse or if you notice any not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What Tramadol Aurobindo is and what it is used for
• 2. Important information before taking Tramadol Aurobindo
• 3. How to take Tramadol Aurobindo
• 4. Possible side effects
• 5. How to store Tramadol Aurobindo
• 6. Contents of the packaging and other information

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

Tramadol hydrochloride, the active substance of Tramadol Aurobindo, is a pain-relieving medicine belonging to the group of opioids acting on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain. Tramadol Aurobindo is used to treat moderate or severe pain. If, after a few days of treatment with this medicine, the patient does not feel better or feels worse, they should consult their doctor.

2. Important information before taking Tramadol Aurobindo

When not to take Tramadol Aurobindo

• If the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
• If the patient is under the influence of alcohol or sedatives, including sleeping pills, other pain-relieving medicines, or antipsychotic medicines.
• If the patient is taking or has taken within the last two weeks monoamine oxidase inhibitors (MAOIs), which are used to treat depression, or the antibiotic linezolid. The combination of these medicines may lead to serious and potentially life-threatening interactions.
• If the patient has epilepsy that is not adequately controlled by their current medication.
• As a substitute for other medicines after withdrawal.

Warnings and precautions

Before starting treatment with Tramadol Aurobindo, the patient should consult their doctor, pharmacist, or nurse:

• if they have epilepsy or have had seizures in the past, as tramadol may increase the risk of further seizures;
• if they have liver or kidney disease.
• If the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Tramadol Aurobindo and other medicines").
• There is a small risk of developing serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol alone. The patient should seek medical advice immediately if they experience any symptoms related to this serious syndrome (see section 4 "Possible side effects").

As with other pain-relieving medicines of this type (i.e., opioid pain-relieving medicines), tramadol should be used with caution and only under medical supervision in patients who are severely ill, including those with respiratory disorders, low blood pressure, impaired consciousness, head injuries, or brain disorders, as this medicine may cause increased intracranial pressure.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid. Repeated use of opioids can lead to reduced efficacy of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramadol Aurobindo may also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with dose and duration of treatment. Dependence or addiction can cause the patient to lose control over the amount of medicine taken or the frequency of taking it. The risk of dependence on Tramadol Aurobindo is different for different people. A higher risk of dependence on Tramadol Aurobindo may apply to people in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs, or illegal drugs ("addiction");
• the patient is a smoker;
• the patient has ever had mood problems (depression, anxiety, or personality disorders) or has been treated by a psychiatrist for other mental health problems.

If the patient notices any of the following symptoms while taking Tramadol Aurobindo, it may indicate dependence or addiction.

• Need to take the medicine for a longer period than prescribed by the doctor.
• Need to take a higher dose than prescribed.
• Taking the medicine for reasons other than those for which it was prescribed, such as "to calm down" or "to sleep better."
• Repeated, unsuccessful attempts to stop or control the use of the medicine.
• After stopping the medicine, the patient feels unwell, and after taking it again, they feel better ("withdrawal symptoms").

If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramadol Aurobindo). Tramadol is converted in the liver by an enzyme. In some people, there is a certain variation of this enzyme, which can have different effects. In some people, pain relief may not be sufficient, and in others, serious side effects are more likely to occur. The patient should stop taking the medicine and contact their doctor immediately if they experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite. Sleep apnea Tramadol Aurobindo may cause sleep apnea, such as pauses in breathing during sleep, and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to shortness of breath, difficulty staying asleep, or excessive daytime sleepiness. If the patient or someone else observes these symptoms, they should contact their doctor. The doctor may recommend reducing the dose.

If the patient experiences any of the following symptoms while taking Tramadol Aurobindo, they should tell their doctor or pharmacist: excessive tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact their doctor, who will decide whether hormone replacement therapy is necessary.

Children and adolescents

Use in children with respiratory disordersTramadol should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Other medicines and Tramadol Aurobindo

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tramadol Aurobindo should not be taken at the same time as monoamine oxidase inhibitors (MAOIs), which are used to treat depression, or within two weeks of taking an MAOI. The pain-relieving effect of Tramadol Aurobindo may be weakened and/or shortened if the patient is also taking medicines containing:

• carbamazepine (a medicine used to treat epilepsy),
• pentazocine, nalbuphine, or buprenorphine (pain-relieving medicines),
• ondansetron (an antiemetic medicine).

The risk of side effects increases if Tramadol Aurobindo is taken at the same time as the following medicines:

• Medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if Tramadol Aurobindo is taken at the same time as these medicines. The doctor will inform the patient whether Tramadol Aurobindo is suitable for them.
• Certain antidepressants. Tramadol Aurobindo may interact with these medicines, and the patient may experience serotonin syndrome (see section 4 "Possible side effects").
• Sedative medicines, such as antipsychotics, sleeping pills, antidepressants, and other pain-relieving medicines, as the patient may experience excessive drowsiness or impending fainting.
• Anticoagulant medicines, such as warfarin; the dose of these medicines may need to be reduced, as the patient may be at risk of potentially serious bleeding.
• Gabapentin or pregabalin for the treatment of epilepsy or neuropathic pain.

Taking Tramadol Aurobindo at the same time as sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concurrent use should only be considered if other treatment options are not possible. If the doctor has prescribed Tramadol Aurobindo at the same time as sedative medicines, the doctor should limit the dose and duration of concurrent treatment. The patient should inform their doctor about all sedative medicines they are taking and strictly follow the doctor's dosage instructions. It may also be helpful to inform friends or relatives to be aware of the above symptoms. If such symptoms occur, the patient should contact their doctor.

Tramadol Aurobindo with food, drink, and alcohol

During treatment with Tramadol Aurobindo, the patient should not drink alcohol, as its effects may be enhanced.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. PregnancyThere is very little information on the safety of tramadol during pregnancy. Therefore, Tramadol Aurobindo should not be used during pregnancy. If the patient becomes pregnant, they should inform their doctor as soon as possible. BreastfeedingTramadol is excreted into breast milk. Therefore, during breastfeeding, Tramadol Aurobindo should not be taken more than once, or if Tramadol Aurobindo has been taken more than once, breastfeeding should be stopped. Experience with tramadol in humans does not indicate that it affects fertility in men and women.

Driving and using machines

Tramadol Aurobindo may cause side effects such as drowsiness and dizziness. If these symptoms occur, the patient should not drive or operate any machinery.

Tramadol Aurobindo contains sodium

This medicine contains no more than 1 mmol of sodium (23 mg) per capsule, which means it is essentially sodium-free.

3. How to take Tramadol Aurobindo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramadol Aurobindo, when and for how long to take it, when to contact the doctor, and when to stop the medicine (see also section 2). The capsules should be swallowed whole, with a glass of water. The capsules can be taken with or without food and should not be chewed. The usual doses are listed below. Depending on the patient's response, the doctor may gradually increase or decrease the dose. The dosage should be adjusted according to the severity of the pain and the patient's individual sensitivity. Generally, the lowest effective dose should be chosen. Adults and adolescents (12 years and older)The usual dose is 50 mg (1 capsule) or 100 mg (2 capsules) every 4-6 hours, depending on the severity of the pain. The total daily dose should not exceed 400 mg (8 capsules). Children under 12 yearsTramadol Aurobindo should not be used in children under 12 years. Elderly patientsIn elderly patients (over 75 years), tramadol may be eliminated more slowly. In these patients, the doctor may recommend longer intervals between doses. Patients with severe liver or kidney disease and patients on dialysisPatients with severe liver or kidney disease should not take Tramadol Aurobindo. In patients with mild or moderate liver or kidney disease, the doctor may recommend longer intervals between doses.

Taking a higher dose of Tramadol Aurobindo than prescribed

In case of overdose, the patient should contact their doctor or go to the nearest hospital emergency department immediately. The patient may experience symptoms such as vomiting, low blood pressure, rapid heart rate, collapse, fainting, and even coma, seizures, and breathing difficulties.

Missing a dose of Tramadol Aurobindo

If the patient misses a dose of Tramadol Aurobindo, they should take it as soon as possible and then continue with the original treatment schedule. The patient should not take a double dose to make up for the missed dose.

Stopping Tramadol Aurobindo

If the patient stops taking Tramadol Aurobindo, their pain may return. The patient should not stop taking this medicine suddenly without their doctor's advice, especially if they have been taking it for a long time. The doctor will advise when and how to stop taking the medicine; this may involve gradually reducing the dose to minimize the risk of side effects (withdrawal symptoms). If the patient wants to stop taking the medicine due to unpleasant side effects, they should discuss this with their doctor. If the patient has been taking the medicine for a very long time, they may experience side effects such as restlessness, anxiety, nervousness, tremors, and gastrointestinal disturbances after stopping the medicine. If the patient experiences any of these side effects after stopping Tramadol Aurobindo, they should consult their doctor. In case of any further doubts about the use of this medicine, the patient should consult their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tramadol Aurobindo can cause side effects, although not everybody gets them. Tramadol may rarely cause allergic reactions, although severe allergic reactions (including anaphylaxis and angioedema) are rare. If the patient experiences sudden wheezing, shortness of breath, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body), they should contact their doctor or emergency services immediately. The same applies if the patient experiences seizures.The frequency of side effects is presented according to the following convention:

Very common:

may affect up to 1 in 10 people

Common:

may affect up to 1 in 100 people

Uncommon:

may affect up to 1 in 1,000 people

Rare:

may affect up to 1 in 10,000 people

Frequency not known:

frequency cannot be estimated from the available data. The following side effects may occur:

Very common:Nausea; dizziness. Common:Headache, drowsiness; vomiting, constipation, dry mouth; increased sweating. Uncommon:Irregular and rapid heartbeat, rapid heartbeat, low blood pressure (especially when standing up) - these side effects may lead to fainting. Such side effects are more likely to occur during intravenous administration of tramadol and in patients who have exerted themselves physically. Diarrhea, retching, gastrointestinal irritation (feeling of pressure in the abdomen, bloating); skin reactions (e.g., itching, rash, flushing). Rare:Slow heartbeat, high blood pressure; drowsiness, changes in appetite, feeling of tingling and numbness; tremors, breathing difficulties, seizures, uncoordinated movements, muscle twitching, fainting; blurred vision, pinpoint pupils, excessive pupil dilation. Weakness. Generalized allergic reactions (e.g., anaphylaxis or angioedema - see below). Hallucinations, disorientation, anxiety, sleep disturbances and nightmares, mood changes (elevated or lowered mood), changes in activity (general slowing down, although sometimes increased activity), as well as decreased consciousness and decision-making ability, which can lead to errors in judgment. Frequency not known:Increased liver enzyme levels. There have been reports of worsening asthma, although it is not clear whether this was caused by tramadol. Speech disorders, low blood sugar, hiccups, serotonin syndrome, which may manifest as changes in mental state (e.g., agitation, hallucinations, coma) and other effects, such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before taking Tramadol Aurobindo"). During treatment with Tramadol Aurobindo, dependence or abuse of this medicine may develop. After stopping the medicine, withdrawal symptoms may occur, such as restlessness, anxiety, nervousness, insomnia, uncontrolled muscle activation (hyperkinesia), tremors, and gastrointestinal disturbances. After stopping tramadol, very rare symptoms such as panic attacks, increased anxiety, hallucinations, tingling, and numbness, as well as hearing sounds (e.g., ringing or buzzing) without an external cause (a symptom known as tinnitus), have also been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: [email protected]. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Tramadol Aurobindo

The medicine should be stored out of sight and reach of children. This medicine should be stored in a closed and secure place, inaccessible to others. It can cause serious harm and be fatal to people it has not been prescribed for. Do not use this medicine after the expiry date stated on the carton or bottle after EXP. The expiry date refers to the last day of that month. Store in a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Tramadol Aurobindo contains

The active substance of Tramadol Aurobindo is tramadol hydrochloride. One hard capsule contains 50 mg of tramadol hydrochloride. The other ingredients are: Capsule content: Microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose (type A), magnesium stearate. Capsule shell - Cap: Gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), indigo carmine (E 132), and titanium dioxide (E 171). Capsule shell - Body: Gelatin, sodium lauryl sulfate, yellow iron oxide (E 172), and titanium dioxide (E 171). Ink: Shellac and black iron oxide (E 172).

What Tramadol Aurobindo looks like and contents of the pack

Hard gelatin capsules, size 4, containing a white to cream-colored powder, consisting of a green cap with a black ink print "T" and a yellow body with a black ink print "02". Blister packs of PVC/PVDC/Aluminum: 10, 20, 30, 50, 60, 90, 100, and 500 capsules. HDPE bottles with PP caps: 30, 200, and 500 capsules. Not all pack sizes may be marketed.

Marketing authorization holder

Aurobindo Pharma (Malta) Limited, Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

Manufacturer

APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta

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

Malta: Tramadol Aurobindo 50 mg capsules, hard Netherlands: Tramadol HCl Aurobindo 50 mg, capsules, hard Poland: Tramadol Aurobindo

Date of last revision of the leaflet: 10/2024