TRAMADOL 50 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Tramadol Aurovitas, 50 mg, hard capsules
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Contents of the leaflet:
3. What Tramadol Aurovitas is and what it is used for
4. Important information before taking Tramadol Aurovitas
   1. When not to take Tramadol Aurovitas
   2. Warnings and precautions
   3. Tolerance, dependence, and addiction
   4. Breathing difficulties during sleep
   5. Children and adolescents
   6. Tramadol Aurovitas and other medicines
   7. Tramadol Aurovitas with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Tramadol Aurovitas contains sodium
5. How to take Tramadol Aurovitas
   1. Taking a higher dose of Tramadol Aurovitas than recommended
   2. Missing a dose of Tramadol Aurovitas
   3. Stopping Tramadol Aurovitas
6. Possible side effects
   1. Reporting suspected side effects
7. How to store Tramadol Aurovitas
8. Contents of the pack and other information
   1. What Tramadol Aurovitas contains
   2. What Tramadol Aurovitas looks like and contents of the pack
   3. Marketing authorization holder:
   4. Manufacturer/Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 06/2024

Leaflet accompanying the packaging: information for the user

Tramadol Aurovitas, 50 mg, hard capsules

Tramadol hydrochloride

You should read the contents of the leaflet 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.

Contents of the leaflet:

• 1. What Tramadol Aurovitas is and what it is used for
• 2. Important information 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 of Tramadol Aurovitas, 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 Aurovitas is used to treat moderate or severe pain.

2. Important information before taking Tramadol Aurovitas

When not to take Tramadol Aurovitas

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

Warnings and precautions

Before starting to take Tramadol Aurovitas, you should consult a doctor or pharmacist:

• if you have epilepsy or have had seizures in the past, as tramadol may increase the risk of further seizures,
• if you have liver or kidney disease,
• after taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If you experience any symptoms of this serious condition, you should seek medical advice immediately (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 breathing difficulties, low blood pressure, impaired consciousness, head injuries, or brain disorders, as the 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 a decrease in the medicine's effectiveness (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramadol Aurovitas can also lead to dependence, abuse, and addiction, which can cause life-threatening overdose.
The risk of these side effects may increase with the 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 administration.
The risk of dependence on Tramadol Aurovitas is different for different people. A higher risk of dependence on Tramadol Aurovitas may apply to people in the following situations:

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

If you notice any of the following symptoms while taking Tramadol Aurovitas, 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"
• repeatedly trying to stop or control the use of the medicine but failing to do so
• feeling unwell after stopping the medicine and feeling better after taking it again ("withdrawal symptoms").

If you notice any of these symptoms, you should consult a doctor to discuss the best treatment option for you, including when to stop taking the medicine and how to do it safely (see section 3, Stopping Tramadol Aurovitas).
Over time, the dose required to achieve the desired effect may increase. In patients dependent on other opioid pain-relieving medicines, tramadol should be used with caution and only for short periods.
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, while in others, the risk of serious side effects may be higher.
You should stop taking the medicine and contact a doctor immediately if you experience any of the following side effects: slow breathing or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea, or vomiting, constipation, loss of appetite.

Breathing difficulties during sleep

Tramadol Aurovitas may cause breathing difficulties during sleep, such as sleep apnea (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 you experience such symptoms, you should consult a doctor. The doctor may consider reducing the dose.
If you experience any of the following symptoms while taking Tramadol Aurovitas, you should 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 you experience such symptoms, you should consult a doctor, who will decide whether you need hormonal supplementation.

Children and adolescents

Use in children with breathing difficulties
Tramadol should not be used in children with breathing difficulties, as the symptoms of tramadol toxicity may be more severe in them.

Tramadol Aurovitas and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should not take Tramadol Aurovitas at the same time as monoamine oxidase inhibitors (MAOIs), which are medicines used to treat depression, or within two weeks of stopping MAOIs.
The pain-relieving effect of Tramadol Aurovitas may be reduced and/or shortened if you are 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 Aurovitas is taken at the same time as:

• medicines that can cause seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if Tramadol Aurovitas is taken at the same time as these medicines. The doctor will inform you whether Tramadol Aurovitas is suitable for you.
• certain antidepressants. Tramadol Aurovitas may interact with these medicines, and you may experience symptoms of serotonin syndrome (see section 4, Possible side effects).
• medicines with a sedative effect, such as antipsychotics, sleeping pills, antidepressants, and other pain-relieving medicines (morphine, codeine), as you may feel excessively drowsy or experience impending fainting.
• blood thinners, such as warfarin; the dose of these medicines may need to be reduced, as you may be at risk of serious bleeding.

Tramadol Aurovitas and sedatives, such as benzodiazepines or similar medicines, should only be taken at the same time if other treatment options are not possible.
If your doctor has prescribed Tramadol Aurovitas at the same time as sedatives, the doctor should limit the dose and duration of concurrent treatment.
You should inform your doctor about all sedatives you are taking and follow the doctor's instructions for dosing. It may also be helpful to inform friends or family members to be aware of the above symptoms. If you experience such symptoms, you should consult a doctor.

Tramadol Aurovitas with food, drink, and alcohol

During treatment with Tramadol Aurovitas, you should not drink alcohol, as its effects may be enhanced.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
There is very little information on the safety of tramadol during pregnancy. Therefore, Tramadol Aurovitas should not be used during pregnancy. If you become pregnant, you should inform your doctor as soon as possible.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, you should not take Tramadol Aurovitas more than once during breastfeeding, or you should stop breastfeeding if you have taken more than one dose of Tramadol Aurovitas.

Driving and using machines

Tramadol Aurovitas may cause side effects such as drowsiness and dizziness. If you experience these symptoms, you should not drive or operate any machines.

Tramadol Aurovitas 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 Aurovitas

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult a doctor.
Before starting treatment and regularly during treatment, the doctor will discuss with you what to expect from Tramadol Aurovitas, when and for how long to take it, when to contact the doctor, and when to stop taking 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.
Information on the usual doses is given below. Depending on the patient's response, the doctor may gradually increase or decrease the dose of the medicine.
The dose of the medicine should be adjusted according to the severity of the pain and the patient's individual sensitivity. Generally, the lowest effective pain-relieving dose should be chosen.
Adults and adolescents over 12 years
The usual dose is 50 mg or 100 mg (1 or 2 capsules) every 6-8 hours, depending on the severity of the pain. The total daily dose should not exceed 400 mg (8 capsules).
Children under 12 years
Tramadol Aurovitas should not be used in children under 12 years.
Elderly patients
In elderly patients (over 75 years), the elimination of tramadol may be delayed. In these patients, the doctor may recommend administering individual doses at longer intervals.

Taking a higher dose of Tramadol Aurovitas than recommended

If you have taken more capsules than recommended, you should contact a doctor or go to the nearest hospital emergency department immediately. You may experience a range of symptoms, including vomiting, low blood pressure, rapid heartbeat, collapse, fainting, and even coma, seizures, and breathing difficulties.

Missing a dose of Tramadol Aurovitas

If you miss a dose of Tramadol Aurovitas, you should take it as soon as possible, and then continue taking the medicine as before.
You should not take a double dose to make up for a missed dose.

Stopping Tramadol Aurovitas

If you stop taking Tramadol Aurovitas, your pain may return.
You should not stop taking the medicine suddenly without consulting a doctor, especially if you have been taking it for a long time.
The doctor will advise you 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 you want to stop taking the medicine due to unpleasant side effects, you should discuss this with your doctor. If you have been taking the medicine for a very long time, you may experience side effects such as restlessness, anxiety, nervousness, insomnia, involuntary movements (hyperkinesia), tremors, and gastrointestinal symptoms after stopping the medicine.
If you experience any of the above side effects after stopping Tramadol Aurovitas, you should discuss this with your doctor.
If you have any further questions about the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol Aurovitas 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 you experience sudden wheezing, shortness of breath, swelling of the eyelids, face, or lips, rash, or itching (especially all over the body), you should contact a doctor or emergency services immediately. The same applies if you experience seizures.
The following side effects may occur:

Very common(affects more than 1 in 10 people):
Nausea; dizziness.
Common(affects up to 1 in 10 people):
Headache, drowsiness; fatigue, vomiting, constipation, dry mouth; increased sweating.
Uncommon(affects up to 1 in 100 people):
Irregular and rapid heartbeat, palpitations, accelerated heartbeat, low blood pressure (especially when standing up) that can lead to fainting. Diarrhea, 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 1,000 people):
Slow heartbeat, increased blood pressure; changes in appetite, speech disorders, tingling and numbness; tremors, breathing difficulties, seizures, uncoordinated movements, muscle twitching, fainting; blurred vision; difficulty urinating and urinary retention. Muscle weakness. Generalized allergic reactions (e.g., anaphylaxis or angioedema – see above). Hallucinations (delusions), 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.
Unknown(frequency cannot be estimated from the available data):
Increased liver enzyme levels. Cases of worsening asthma have been reported, although it is not clear whether this was caused by tramadol. Low blood sugar levels. Hiccup. Serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination, and gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2, Important information before taking Tramadol Aurovitas).
During treatment with Tramadol Aurovitas, dependence or abuse of the medicine may develop. After stopping the medicine, withdrawal symptoms may occur, such as restlessness, anxiety, nervousness, insomnia, involuntary movements (hyperkinesia), tremors, and gastrointestinal symptoms. After stopping tramadol, very rare symptoms such as panic attacks, increased anxiety, hallucinations (delusions), tingling and numbness, and ringing in the ears (tinnitus) have also been observed.

Reporting suspected side effects

If you experience any side effects, including those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tramadol Aurovitas

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a closed and secure place, inaccessible to others. It can cause serious harm and be fatal to people 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 that month.
Store in a temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tramadol Aurovitas contains

The active substance of Tramadol Aurovitas is tramadol hydrochloride. One hard capsule contains 50 mg of tramadol hydrochloride.
The other ingredients are:
capsule contents:
microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose (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).
ink:
shellac, black iron oxide (E 172).

What Tramadol Aurovitas looks like and contents of the pack

Hard capsules.
The hard gelatin capsules, size 4, contain 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".
Tramadol Aurovitas is available in blisters.
Package sizes: 20, 30, or 60 capsules.
Not all package sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

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:

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

Date of last revision of the leaflet: 06/2024