Tramadol aurovitas

Package leaflet: Information for the user

Tramadol Aurovitas, 50 mg, hard capsules
Tramadoli hydrochloridum
Please read the entire leaflet carefully before taking this 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 pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If any of the side effects worsens 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 Aurovitas is and what it is used for
2. What you need to know before taking Tramadol Aurovitas
3. How to take Tramadol Aurovitas
4. Possible side effects
5. How to store Tramadol Aurovitas
6. Contents of the pack and other information

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

Tramadol hydrochloride – the active substance in Tramadol Aurovitas – is an opioid analgesic acting on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Aurovitas is used to treat moderate to severe pain.

2. Important information before using Tramadol Aurovitas

When not to take Tramadol Aurovitas

• 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 from the group of monoamine oxidase inhibitors (MAO inhibitors), such as medicines used to treat depression or the antibiotic linezolid. Combining these medicines may lead to serious and potentially life-threatening interactions.
• If the patient has epilepsy that is not adequately controlled by currently used medicines.
• As a substitute treatment after discontinuation of other medicines.

Warnings and precautions
Before starting treatment with Tramadol Aurovitas, consult a doctor or pharmacist:

• if the patient has epilepsy or has ever had seizures in the past, as tramadol may increase the risk of further seizures;
• if the patient has liver or kidney disease;
• there is a small risk of developing so-called serotonin syndrome when tramadol is taken together with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should seek immediate medical advice (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, abnormally low blood pressure (patients in shock), impaired consciousness, following 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 Aurovitas may also lead to dependence, misuse and addiction, which may result in life-threatening overdose.
The risk of these adverse effects may increase with dose and longer 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 Aurovitas 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 during treatment with Tramadol Aurovitas, this may indicate dependence or addiction:

• Need to take the medicine for longer than recommended by the doctor.
• Need 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 use of the medicine.
• 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 stop taking the medicine safely (see section 3, Discontinuation of Tramadol Aurovitas).

Over time, the dose required to achieve the desired effect may increase. Tramadol should be used with caution and only for short periods in patients dependent on other opioid painkillers.
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 may be 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.

Sleep-related breathing disorders
Tramadol Aurovitas may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient notices such symptoms, they should contact their doctor. The doctor may consider reducing the dose.

If any of the following symptoms occur during treatment with Tramadol Aurovitas, consult a doctor or pharmacist:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate adrenal insufficiency (low cortisol levels). If the patient has such symptoms, they should contact their doctor, who will decide whether hormonal supplementation is needed.

Children and adolescents
Use in children with breathing disorders
Tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more pronounced in them.

Tramadol Aurovitas and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Do not take Tramadol Aurovitas together with medicines from the group of monoamine oxidase inhibitors (MAO inhibitors) (medicines used, for example, to treat depression), or within 2 weeks after the last dose of an MAO inhibitor.

The pain-relieving effect of Tramadol Aurovitas may be reduced and/or shortened if the patient is also taking medicines containing:

• carbamazepine (a medicine used to treat epilepsy),
• pentazocine, nalbuphine or buprenorphine (painkillers),
• ondansetron (an anti-nausea medicine).

The risk of adverse effects increases if Tramadol Aurovitas 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 Aurovitas is taken together with these medicines. The doctor will inform the patient whether Tramadol Aurovitas is appropriate in their case.

• Certain antidepressants. Tramadol Aurovitas may interact with these medicines, and the patient may develop symptoms of serotonin syndrome (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.

• Anticoagulant medicines, e.g. warfarin; dose reduction of these medicines may be necessary, otherwise the patient is 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 Aurovitas 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 possible.
If the doctor has prescribed Tramadol Aurovitas together with sedative medicines, the prescribing 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 dosing instructions. It may also be helpful to inform friends or relatives so they are aware of the above-mentioned symptoms. If such symptoms occur, contact the doctor.

Tramadol Aurovitas with food, drink and alcohol
During treatment with Tramadol Aurovitas, 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 become pregnant, 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 Aurovitas 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 Aurovitas should not be taken more than once, or if Tramadol Aurovitas has been taken more than once, breastfeeding should be discontinued.

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

Tramadol Aurovitas 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 Aurovitas

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult the doctor.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from using Tramadol Aurovitas, when and how long to take it, when to contact the 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 regardless of meals and must not be chewed.
Information on the doses usually used is provided below. Depending on the patient's individual 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 chosen.

Adults and adolescents aged 12 years and older
The usual dose is 50 mg or 100 mg (1 or 2 capsules) every 6–8 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 Aurovitas is not recommended for use in children under 12 years of age.

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

Patients with severe liver or kidney disease (severe impairment), and dialysis patients
Patients with severe hepatic and/or renal impairment should not take Tramadol Aurovitas. In patients with mild or moderate hepatic and/or renal impairment, the doctor may recommend administering individual doses at longer intervals.

If you take more Tramadol Aurovitas than you should
If you take more capsules than recommended, contact your doctor immediately or go to the nearest hospital emergency department. The patient may experience various symptoms, including: vomiting, drop in blood pressure, rapid heartbeat, collapse, fainting, even coma, seizures, and breathing difficulties.

If you forget to take Tramadol Aurovitas
If you miss a dose of Tramadol Aurovitas, 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 Aurovitas
If the patient stops taking Tramadol Aurovitas, pain symptoms may return.
Do not suddenly stop taking this medicine without medical advice. If the patient wishes to stop 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 the medicine; this may involve gradually reducing the dose to minimize the likelihood of withdrawal symptoms.
If the patient wishes to discontinue this medicine due to unpleasant side effects, they should discuss this with their doctor. If the patient has taken this medicine 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 Aurovitas, the patient should discuss this with their doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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, shortness of breath, 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 case of seizures.
The following are adverse effects that may occur in patients.

Very common (affects more than 1 in 10 patients):
Nausea; dizziness.

Common (affects up to 1 in 10 patients):
Headache, somnolence; fatigue, vomiting, constipation, dry mouth; increased sweating.

Uncommon (affects up to 1 in 100 patients):
Irregular and rapid heartbeat, increased heart rate, decreased blood pressure (especially after assuming an upright position) which may lead to collapse (manifested by fainting). Diarrhoea, retching, gastrointestinal irritation (feeling of pressure in the abdomen, bloating); skin reactions (e.g. itching, rash, sudden reddening of the skin).

Rare (affects up to 1 in 1000 patients):
Slow heartbeat, increased blood pressure; changes in appetite, speech disorders, tingling and numbness sensations; tremor, breathing difficulties, seizures resembling epilepsy, uncoordinated movements, muscle twitching, fainting; blurred vision; difficulty in urination and urinary retention. Reduced muscle strength. Generalized allergic reactions (e.g. anaphylaxis or angioedema – see above). Hallucinations, disorientation, anxiety symptoms, sleep disturbances and nightmares, mood changes (elevated or depressed mood), changes in activity (general slowing down, although sometimes increased activity), as well as reduced consciousness and decision-making ability, which may lead to impaired judgment.

Unknown (frequency cannot be estimated from available data):
Increased liver enzyme levels. Cases of asthma exacerbation have been reported, although it has not been established whether this was caused by tramadol. Low blood sugar levels. Hiccups. Serotonin syndrome, which may present with mental status changes (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, tachycardia, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 Important information before taking Tramadol Aurovitas).

During treatment with Tramadol Aurovitas, dependence on or misuse of this medicine may develop. After discontinuation of the medicine, withdrawal symptoms may occur, such as psychomotor agitation, anxiety symptoms, restlessness, insomnia, involuntary movements (hyperkinesia), tremor, and gastrointestinal symptoms. After discontinuation of tramadol, other symptoms have also been observed very rarely, such as panic attacks, severe anxiety symptoms, hallucinations, tingling and numbness sensations, as well as hearing various sounds, such as ringing or buzzing without external cause (this symptom is known as tinnitus).

Reporting suspected adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration 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, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Tramadol Aurovitas

Keep the medicine out of the sight and reach of children.
This medicine must 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 and blister after 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 Aurovitas contains
The active substance is tramadol hydrochloride. One hard capsule contains 50 mg of tramadol hydrochloride.
The other ingredients are:
Capsule contents: microcrystalline cellulose, colloidal anhydrous silica, sodium carboxymethyl starch (type A), magnesium stearate.
Capsule body: gelatin, purified water, sodium lauryl sulfate, yellow iron oxide (E 172), titanium dioxide (E 171).
Capsule cap: gelatin, purified water, sodium lauryl sulfate, indigo carmine (E 132), yellow iron oxide (E 172), titanium dioxide (E 171).
Printing ink: shellac, black iron oxide (E 172).

What Tramadol Aurovitas looks like and contents of the pack
Hard capsules.
Size 4 hard gelatin capsules containing white to creamy powder, composed of a green cap printed in black ink with the mark "T" and a yellow body printed in black ink with the mark "02".
Tramadol Aurovitas is available in blister packs.
Pack sizes: 20, 30 or 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
email: [email protected]

Manufacturer/Importer:
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:
Czech Republic: Tramadol Aurovitas 50 mg tvrdé tobolky
Poland: Tramadol Aurovitas
Portugal: Tramadol Aurovitas
Spain: Tramadol Aurovitas 50 mg cápsulas duras EFG