TRAMADOL 50 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Tramadol Vitabalans, 50 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Tramadol Vitabalans and what is it used for
4. Important information before taking Tramadol Vitabalans
   1. When not to take Tramadol Vitabalans
   2. Warnings and precautions
   3. Children and adolescents
   4. Tramadol Vitabalans and other medicines
   5. Tramadol Vitabalans with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Tramadol Vitabalans
   1. Adults and adolescents over 12 years of age
   2. Use in children under 12 years of age
   3. Elderly patients
   4. Patients with severe liver or kidney disorders (failure) and (or) patients on dialysis
   5. Taking a higher dose of Tramadol Vitabalans than recommended
   6. Missing a dose of Tramadol Vitabalans
   7. Stopping Tramadol Vitabalans
6. Possible side effects
   1. Reporting side effects
7. How to store Tramadol Vitabalans
8. Contents of the pack and other information
   1. What Tramadol Vitabalans contains
   2. What Tramadol Vitabalans looks like and what the pack contains
   3. Marketing authorization holder:
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Tramadol Vitabalans, 50 mg, tablets

Tramadol hydrochloride

You should carefully 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Tramadol hydrochloride, the active substance of Tramadol Vitabalans, is an opioid analgesic that acts on the central nervous system. It reduces pain by acting on specific nerve cells in the spinal cord and brain.
Tramadol Vitabalans is used to treat moderate to severe pain.

2. Important information before taking Tramadol Vitabalans

When not to take Tramadol Vitabalans

• as a substitute therapy for drug addiction,

Warnings and precautions

In the following cases, you should consult a doctor, pharmacist, or nurse before starting treatment with Tramadol Vitabalans:

In each of the above cases, you should consult a doctor before taking this medicine.
Seizures have occurred in patients taking the recommended dose. The risk increases in case of exceeding the maximum recommended daily dose (400 mg).
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, the risk of serious side effects is more likely. You should stop taking the medicine and contact a doctor immediately if you experience any of the following side effects: slowed breathing or shallow breathing, confusion, drowsiness, pupil constriction, nausea or vomiting, constipation, loss of appetite.
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of so-called serotonin syndrome. If the patient experiences any symptoms of this syndrome with a severe course, they should immediately consult a doctor (see section 4 "Possible side effects").
If such a problem occurs or has occurred in the past, you should consult a doctor.
If the patient experiences any of the following symptoms while taking Tramadol Vitabalans, they should tell their doctor, pharmacist, or nurse:

• Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that the patient has adrenal insufficiency (low cortisol levels). If such symptoms occur, the patient should contact a doctor, who will decide whether the patient needs hormone replacement.

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 Vitabalans 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 its administration.
The risk of dependence or addiction is different for different people. A higher risk of dependence on Tramadol Vitabalans may apply to people in the following situations:

• Necessity to take the medicine for a longer period than recommended by the doctor.
• Necessity to take a higher dose than recommended.
• The patient is taking the medicine for reasons other than those for which it was prescribed, for example, "to calm down" or "to sleep better"
• The patient has made 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 a 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 Vitabalans).

Breathing difficulties during sleep
Tramadol Vitabalans 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 maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, they should contact a doctor. The doctor may recommend reducing the dose.

Children and adolescents

Children under 12 years of age should not take this medicine, as its safety and efficacy have not been established in children.
Use in children with breathing difficulties
Tramadol is not recommended for children with breathing difficulties, as the symptoms of tramadol toxicity may be exacerbated in them.

Tramadol Vitabalans and other medicines

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 Vitabalans should not be taken if the patient is taking or has taken monoamine oxidase inhibitors (MAOIs) or MAO inhibitors within the last two weeks.
The analgesic effect of Tramadol Vitabalans may be weakened and/or shortened during concurrent use of medicines containing:

• carbamazepine (used in the treatment of epilepsy),
• ondansetron (an antiemetic). The doctor will determine whether the patient can take Tramadol Vitabalans and in what dose.

The risk of side effects increases:

Concurrent use of Tramadol Vitabalans and sedative drugs, such as benzodiazepines or similar drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, their concurrent use can only be considered if other treatment options are not available.
If the doctor prescribes Tramadol Vitabalans concurrently with sedative drugs, the doctor should also limit the dose and duration of concurrent treatment.
The patient should inform the doctor about all sedative drugs they are taking and strictly follow the doctor's dosage recommendations. It may be helpful to inform friends or relatives so that they are aware of the possibility of the above symptoms. In case of the above symptoms, the patient should contact a doctor.

Tramadol Vitabalans with food, drink, and alcohol

The patient should not consume alcohol while taking Tramadol Vitabalans, as alcohol may enhance the effect of Tramadol Vitabalans.
Food does not affect the action of Tramadol Vitabalans.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Information on the safety of tramadol during pregnancy is limited; therefore, tramadol should not be taken during pregnancy or breastfeeding.
Breastfeeding
Tramadol is excreted into breast milk. Therefore, during breastfeeding, Tramadol Vitabalans should not be taken more than once, or if Tramadol Vitabalans has been taken more than once, breastfeeding should be stopped.
Experience gathered during the use of the medicine in humans does not indicate an effect of tramadol on female and male fertility.

Driving and using machines

Tramadol Vitabalans may cause side effects such as drowsiness, dizziness, and vision disturbances. The patient should not drive a car or operate machines in such cases.

3. How to take Tramadol Vitabalans

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from Tramadol Vitabalans, 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 dosage should be adjusted based on the severity of the pain and the patient's individual sensitivity to pain.
The smallest dose that provides pain relief should be used.
The tablets can be taken with or without food.

Adults and adolescents over 12 years of age

The recommended dose is 1 to 2 tablets (corresponding to 50 mg or 100 mg). Depending on the type of pain, the effect lasts for about 4-8 hours. The dose should not exceed 8 tablets (a total of 400 mg) per day, unless the doctor recommends it.

Use in children under 12 years of age

Tramadol Vitabalans is not recommended for children under 12 years of age.

Elderly patients

In elderly patients (over 75 years of age), the elimination of tramadol may be delayed.
In such cases, the doctor may recommend prolonging the intervals between doses.

Patients with severe liver or kidney disorders (failure) and (or) patients on dialysis

Tramadol Vitabalans should not be taken by patients with severe liver failure and (or) kidney failure.
If the patient has mild or moderate liver or kidney failure, the doctor may recommend prolonging the intervals between doses.
Tramadol Vitabalans should not be taken for longer than necessary. If long-term use of a pain reliever is required, the doctor will regularly check whether continued use of Tramadol Vitabalans is justified and what dose the patient should take.
If the patient feels that the effect of Tramadol Vitabalans is too strong or too weak, they should consult a doctor or pharmacist.

Taking a higher dose of Tramadol Vitabalans than recommended

In case of taking a higher dose of Tramadol Vitabalans than recommended, the patient should immediately contact a doctor or go to the emergency department of the nearest hospital. Symptoms of overdose may include: vomiting, low blood pressure, rapid heart rate, collapse, fainting, and even coma, seizures, and breathing difficulties.

Missing a dose of Tramadol Vitabalans

The patient should not take a double dose to make up for a missed dose.

Stopping Tramadol Vitabalans

Stopping Tramadol Vitabalans will cause the return of pain symptoms. The patient should consult a doctor before stopping Tramadol Vitabalans due to possible side effects.
The patient should not suddenly stop taking this medicine without the doctor's recommendation. If the patient wants to stop taking the medicine, they should discuss it with their doctor, 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).
Usually, stopping treatment does not cause withdrawal symptoms. Rarely, in patients who have taken this medicine for a long time, stopping it abruptly may cause symptoms such as anxiety, fear, nervousness, or uncertainty. Sleep disturbances, excessive activity, or gastrointestinal disorders are also possible. In very rare cases, panic attacks, hallucinations, unexplained itching, numbness, or tinnitus may occur. Very rarely, symptoms related to the central nervous system, such as disorientation, delusions, personality changes (depersonalization), disorders of perception of reality (derealization), and paranoia, have been observed. If the patient experiences any side effects after stopping Tramadol Vitabalans, they should consult a doctor.
In case of any further doubts about the use of this medicine, the patient should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Tramadol Vitabalans can cause side effects, although not everybody gets them.
The patient should contact a doctor immediatelyif they experience any of the following symptoms:
allergic reaction: itching, rash, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, narrowing of the airways, worsening of asthma, if present, shock or collapse,
slowed breathing - usually when taking large doses of tramadol or during concurrent use of other medicines that slow down breathing.
The following side effects may occur:
Very common(may affect more than 1 in 10 people):

• nausea, dizziness.

Common(may affect up to 1 in 10 people):

• headache, drowsiness,
• vomiting, constipation, dry mouth,
• increased sweating,
• fatigue.

Uncommon(may affect up to 1 in 100 people):

• irregular, rapid heartbeat or pulse, rapid heart rate, low blood pressure (especially when standing up), which can lead to collapse,
• diarrhea, vomiting reflex, stomach and intestinal irritation (feeling of pressure in the stomach, bloating),
• skin disorders (e.g., itching, rash, sudden reddening of the skin).

Rare(may affect up to 1 in 1,000 people):

• slow heart rate, high blood pressure,
• changes in appetite, tingling sensation on the skin, speech disorders,
• tremors, breathing difficulties, seizures, lack of coordination, muscle spasms, fainting, blurred vision, difficulty urinating and urinary retention, muscle weakness,
• generalized allergic reactions (e.g., anaphylactic reaction and angioedema, see above), hallucinations, disorientation, anxiety, sleep disturbances and nightmares, mood changes (mood swings), changes in activity (slowing down of activity or sometimes its increase) and decreased attention and decision-making ability, which can lead to incorrect assessment of the situation,
• pupil dilation (mydriasis), pupil constriction (miosis), blurred vision,
• shortness of breath, respiratory arrest.

Very rare(may affect up to 1 in 10,000 people):

• increased liver enzyme activity.

Unknown(frequency cannot be estimated from the available data):

• low blood sugar (hypoglycemia),
• hiccups,
• serotonin syndrome, whose symptoms may include changes in mental state (e.g., agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heart rate, 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 Vitabalans").

More information on possible symptoms can be found in the section "Stopping Tramadol Vitabalans".

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Tramadol Vitabalans

There are no special requirements for storage conditions.
The medicine should be stored out of sight and reach of children.
This medicine should be stored in a closed and secure place, to which other people do not have access. It can cause serious harm and be fatal for people it has not been prescribed for.
The medicine should not be taken after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Vitabalans contains

• The active substance of Tramadol Vitabalans is tramadol hydrochloride. Each tablet contains 50 mg of tramadol hydrochloride.
• The other ingredients are: microcrystalline cellulose, magnesium stearate, and sodium carboxymethyl cellulose (type A).

What Tramadol Vitabalans looks like and what the pack contains

Appearance of Tramadol Vitabalans tablets:
white, round, convex tablets with a dividing line on one side. Diameter 9 mm.
The tablet can be divided into two equal parts.
Package size:
10, 15, 20, 25, 30, 40, 50, 60, 100, 150, 200, 250, and 300 tablets in blisters.
Not all package sizes may be marketed.

Marketing authorization holder:

Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Phone: +358 (3) 615600
Fax: +358 (3) 6183130

Manufacturer:

Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
FINLAND

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

Tramadol Vitabalans (Czech Republic, Denmark, Estonia, Finland, Hungary, Lithuania, Latvia, Norway, Poland, Sweden, Slovenia, Slovakia)
Date of last revision of the leaflet:26.9.2024