Tramadol aurobindo

Package leaflet: Information for the user

Tramadol Aurobindo, 50 mg, hard capsules
tramadol hydrochloride
Read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If any of the side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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 pack and other information

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

Tramadol hydrochloride – the active substance in Tramadol Aurobindo – is an analgesic 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 to severe pain.
If after several days of taking this medicine the patient does not feel better or feels worse, it is essential to discuss this with the doctor.

2. Important information before using Tramadol Aurobindo

When not to take Tramadol Aurobindo

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If the patient is under the influence of alcohol or sedative medicines, including sleeping pills, other painkillers, or antipsychotic medicines.
• If the patient is taking or has taken within the past two weeks medicines belonging to the group of monoamine oxidase inhibitors (MAO inhibitors) or the antibiotic linezolid. Combining these medicines may lead to serious and potentially life-threatening interactions.
• If the patient suffers from epilepsy that is not adequately controlled by current medication.
• As a substitute treatment after discontinuation of other medicines.

Warnings and precautions
Before starting to take Tramadol Aurobindo, consult a doctor,
pharmacist, or nurse:

• if the patient suffers from epilepsy or has ever had seizures in the past, as tramadol may increase the risk of further seizures,
• if the patient suffers from liver or kidney disease.
• If the patient has depression and is taking antidepressant medicines, because some of them may interact with tramadol (see "Tramadol Aurobindo and other medicines").
• There is a small risk of developing a condition called serotonin syndrome, which may occur when tramadol is taken together with certain antidepressants or tramadol alone. Immediate medical advice should be sought if any symptoms related to this serious condition occur (see section 4 "Possible side effects").

As with other painkillers of this type (i.e. opioid analgesics), tramadol should be used with caution and only under medical supervision in patients who are seriously ill, including those with respiratory disorders, extremely low blood pressure (in shock), impaired consciousness, following a severe head injury, or patients with brain disorders, as this medicine may increase intracranial pressure.
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient's body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramadol Aurobindo may also lead to dependence, misuse, and addiction, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of treatment.
Dependence or addiction may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of dependence or addiction varies among individuals. Higher risk of dependence on Tramadol Aurobindo may apply to individuals in the following situations:

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

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

• Needing to take the medicine for longer than recommended by the doctor.
• Needing to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those for which it was prescribed, e.g., "to calm down" or "to sleep better."
• The patient has made repeated, unsuccessful attempts to stop or control medicine use.
• After stopping the medicine, the patient feels unwell, and feels better after taking the medicine again ("withdrawal effects").

If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment approach, including when and how to safely discontinue the medicine (see section 3, "Discontinuing Tramadol Aurobindo").
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, severe adverse effects are more likely.
The medicine should be discontinued and medical advice sought immediately if the patient experiences any of the following adverse effects: slowed or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.
Breathing disorders during sleep
Tramadol Aurobindo may cause breathing disorders during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include breathing pauses during sleep, nocturnal awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, medical advice should be sought. The doctor may recommend reducing the dose.
If the patient experiences any of the following symptoms while taking Tramadol Aurobindo, inform the 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, contact the doctor, who will decide whether hormone replacement is necessary.
Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as symptoms of tramadol toxicity may be intensified in them.
Other medicines and Tramadol Aurobindo
Inform the doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Do not take Tramadol Aurobindo together with medicines belonging to the group of monoamine oxidase inhibitors (MAO inhibitors) or within two weeks after stopping such treatment. MAO inhibitors are medicines used to treat conditions such as depression.
The pain-relieving effect of Tramadol Aurobindo may be weakened and/or shortened if the patient is simultaneously taking medicines containing:

• carbamazepine (a medicine used to treat epilepsy),
• pentazocine, nalbuphine, or buprenorphine (analgesics),
• ondansetron (an antiemetic medicine).

The risk of adverse effects increases if Tramadol Aurobindo is taken simultaneously with the following medicines:

• Medicines that may cause seizures, e.g., certain antidepressants or antipsychotics. The risk of seizures increases when Tramadol Aurobindo is taken together with these medicines. The doctor will inform the patient whether Tramadol Aurobindo is appropriate in their case.
• Certain antidepressants. Tramadol Aurobindo may interact with these medicines and may cause serotonin syndrome in the patient (see section 4 "Possible side effects").
• Sedative medicines, e.g., antipsychotics, sleeping pills, antidepressants, and other painkillers (morphine, codeine), as the patient may experience excessive drowsiness or near-fainting.
• Anticoagulants, e.g., warfarin; a dose reduction of these medicines may be necessary, otherwise the patient may be at increased risk of potentially serious bleeding.
• Gabapentin or pregabalin used in the treatment of epilepsy or nerve-related pain (neuropathic pain).

Concomitant use of Tramadol Aurobindo and sedative medicines such as benzodiazepines or similar medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other treatment options are available.
If the doctor prescribes Tramadol Aurobindo together with sedative medicines, the treating doctor should limit the dose and duration of concomitant treatment.
Inform the doctor about all sedative medicines being taken and strictly follow the doctor's dosage instructions. It may also be helpful to inform friends or family members so they are aware of the above-mentioned symptoms. If such symptoms occur, contact the doctor.
Tramadol Aurobindo with food, drink, and alcohol
During treatment with Tramadol Aurobindo, the patient should not drink alcohol, as its effects may be intensified.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
There is very limited information on the safety of tramadol use during pregnancy. Therefore, Tramadol Aurobindo should not be used during pregnancy. If the patient becomes pregnant, she should inform her doctor as soon as possible.
Breastfeeding
Tramadol is excreted in 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 discontinued.
Experience with tramadol use in humans does not indicate that tramadol affects fertility in women or men.
Driving and operating machinery
Tramadol Aurobindo may cause adverse 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, meaning it is essentially sodium-free.

3. How to take Tramadol Aurobindo

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from taking Tramadol Aurobindo, when and for how long to take it, when to contact your doctor, and when to discontinue the medicine (see also section 2).
The capsules should be swallowed whole with a glass of water.
These capsules may be taken independently of meals and must not be chewed.
Information on the doses usually used is provided below. Depending on the patient's response, the doctor may gradually increase or decrease the dose of this medicine.
The dosage of this medicine should be adjusted according to the intensity of pain and the individual sensitivity of the patient. Generally, the lowest effective analgesic dose should be used.

Adults and adolescents (aged 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 pain. Generally, the total daily dose should not exceed 400 mg (8 capsules).

Children under 12 years of age
Tramadol Aurobindo is not recommended for use in children under 12 years of age.

Elderly patients
In elderly patients (over 75 years of age), tramadol elimination may be delayed. In these patients, the doctor may recommend administering doses at longer intervals.

Patients with severe liver or kidney disease (severe impairment) and patients undergoing dialysis
Tramadol Aurobindo should not be used in patients with severe liver and/or kidney impairment. In patients with mild or moderate liver and/or kidney impairment, the doctor may recommend administering doses at longer intervals.

Taking more Tramadol Aurobindo than recommended
If more capsules are taken than recommended, contact a doctor immediately or go to the nearest hospital emergency department. The patient may experience a range of symptoms, including: vomiting, drop in blood pressure, rapid heartbeat, collapse, fainting, even coma, seizures, and breathing difficulties.

Missing a dose of Tramadol Aurobindo
If a dose of Tramadol Aurobindo is missed, take it as soon as possible, then continue taking the medicine as before.
Do not take a double dose to make up for a missed dose.

Stopping Tramadol Aurobindo
If the patient stops taking Tramadol Aurobindo, pain symptoms may return. Do not stop taking this medicine suddenly without medical advice. If the patient wishes to discontinue treatment, this should be discussed with the doctor, especially if the medicine has been taken 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 likelihood of experiencing adverse effects (withdrawal symptoms).
If the patient wishes to discontinue the medicine due to unpleasant side effects, they should discuss this with their doctor. If the medicine has been taken for a very long time, sudden discontinuation may lead to the following adverse effects: psychomotor agitation, anxiety symptoms, nervousness, tremor, and gastrointestinal disturbances. If any of the above-mentioned adverse effects occur after stopping Tramadol Aurobindo, the patient should discuss this with their doctor.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Tramadol may in rare cases cause allergic reactions, although severe allergic reactions (including anaphylaxis and angioedema) occur rarely. If a patient suddenly develops
wheezing, breathlessness, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body), the patient should immediately contact a doctor or emergency
services. The same applies in the event of seizures.
The frequency of individual adverse reactions is presented according to the following convention:
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Frequency not known: frequency cannot be estimated from the available data.

Listed below are adverse reactions that may occur in patients.
Very common: Nausea; dizziness.
Common: Headache, somnolence; vomiting, constipation, dry mouth; increased sweating.
Uncommon: Irregular and rapid heartbeat (palpitations), tachycardia, decreased blood pressure (especially upon standing) – these symptoms may lead to fainting. Such adverse reactions may occur particularly with intravenous administration of tramadol pharmaceutical forms and in patients after physical exertion.
Diarrhoea, gag reflex, gastrointestinal irritation (feeling of pressure in the abdominal cavity, bloating); skin reactions (e.g. itching, rash, sudden reddening of the skin).
Rare: Bradycardia, increased blood pressure; somnolence, changes in appetite, tingling and numbness; tremor, breathing difficulties, seizures resembling epilepsy, uncoordinated movements, muscle twitching, fainting; blurred vision, pupillary constriction (miosis), excessive pupillary dilation (mydriasis); difficulty in passing urine and urinary retention. Muscle weakness. Generalised allergic reactions (e.g. anaphylaxis or angioedema – see below). Hallucinations, disorientation, anxiety symptoms, sleep disturbances and nightmares, mood changes (elevated or depressed mood), changes in activity (general slowing, although sometimes increased activity), as well as reduced consciousness and decision-making ability, which may lead to impaired judgment.
Frequency not known: Increased liver enzyme levels. Cases of worsening asthma have been reported, although it has not been established whether this was caused by tramadol.
Speech disorders, low blood sugar concentration, hiccups, Serotonin syndrome, which may manifest as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle spasms, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Tramadol Aurobindo").

During treatment with Tramadol Aurobindo, dependence on or abuse of this medicine may develop. After discontinuation of the medicine, withdrawal symptoms may occur, such as psychomotor agitation, anxiety symptoms, restlessness, insomnia, uncontrolled muscle activation (hyperkinesia), tremor and gastrointestinal symptoms. Very rarely, other symptoms have also been observed after discontinuation of tramadol, such as panic attacks, intensified anxiety symptoms, hallucinations, tingling and numbness, as well as hearing various sounds, e.g. ringing or buzzing without external cause (this symptom is known as tinnitus).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to:
Department for Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
e-mail: [email protected]
Reporting adverse reactions enables further collection of information on the safety of the medicine.

5. How to store Tramadol Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine should be stored in a closed and secure place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton or bottle following "EXP". The expiry date refers to the last day of the specified month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tramadol Aurobindo contains
The active substance is tramadol hydrochloride. One hard capsule contains 50 mg of tramadol hydrochloride.
Other ingredients are:
Capsule contents: Microcrystalline cellulose, colloidal anhydrous silica, sodium carboxymethyl starch (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).
Printing ink: Shellac and black iron oxide (E 172).

What Tramadol Aurobindo looks like and contents of the pack
Hard, green and yellow gelatin capsules, size 4, containing a white to creamy powder, with a green cap printed in black ink with the letter "T" and a yellow body printed in black ink with the number "02".
Blister packs made of PVC/PVDC/Aluminium: 10, 20, 30, 50, 60, 90, 100 and 500 capsules.
HDPE bottles with PP closure: 30, 200 and 500 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Malta: Tramadol Aurobindo 50 mg capsules, hard
Netherlands: Tramadol HCl Aurobindo 50 mg, capsules, hard
Poland: Tramadol Aurobindo