Tramadol vitabalans

Patient Information Leaflet

Tramadol Vitabalans, 50 mg, tablets
Tramadoli hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Tramadol Vitabalans is and what it is used for
2. What you need to know 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 Tramadol Vitabalans is and what it is used for

Tramadol hydrochloride – the active substance in 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 using Tramadol Vitabalans

When not to use Tramadol Vitabalans

• if the patient is allergic to tramadol hydrochloride or 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 and sedatives,
• if the patient is currently taking or has taken within the last two weeks medicines called monoamine oxidase inhibitors or MAO inhibitors (used, for example, in the treatment of depression), or the antibiotic linezolid,
• if the patient has epilepsy which is not currently being appropriately treated,
• as a substitute therapy for drug addiction,
• if the patient has severe renal or hepatic insufficiency.

Warnings and precautions
In the following cases, consult a doctor, pharmacist or nurse before starting treatment with Tramadol Vitabalans:

• if the patient suspects dependence on other opioid painkillers. Tramadol should be used with caution in patients dependent on other opioid painkillers, and only for a short period,
• if the patient has reduced consciousness (a feeling similar to fainting),
• if the patient is in shock (one of the symptoms may be cold sweats),
• if the patient has increased intracranial pressure (which may be caused by a severe head injury or brain diseases),
• if the patient has breathing difficulties,
• if the patient suffers from epilepsy or has had seizures in the past, as tramadol may increase the risk of seizures,
• if the patient has impaired kidney or liver function,
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Tramadol Vitabalans and other medicines").

In each of the above cases, consult a doctor before taking this medicine.
Seizures have occurred in patients taking the recommended dose. The risk increases if the maximum recommended daily dose (400 mg) is exceeded.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a variant 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. Discontinue the medicine and contact a doctor immediately if any of the following adverse effects occur: slowed or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, or loss of appetite.
There is a small risk of a condition called serotonin syndrome when tramadol is taken in combination with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, medical advice should be sought immediately (see section 4 "Possible side effects").
If any of these problems have occurred or occurred in the past, consult a doctor.
If any of the following symptoms occur during treatment with Tramadol Vitabalans, inform the doctor, pharmacist or nurse:

• Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact a doctor who will decide whether hormone replacement is necessary.

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 Vitabalans 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 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 Vitabalans 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 disorders (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 Vitabalans, 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 multiple unsuccessful attempts to stop or control medicine use,
• After stopping the medicine, the patient feels unwell, and feels better after taking it again ("withdrawal effects"). If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment approach, including when and how to safely discontinue the medicine (see section 3, "Discontinuing Tramadol Vitabalans").

Breathing problems during sleep
Tramadol Vitabalans may cause breathing problems during sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If the patient or another person observes these symptoms, contact a doctor. The doctor may recommend reducing the dose.

Children and adolescents
Children under 12 years of age should not use this medicine, as the efficacy and safety of this product have not been established in children.
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.

Tramadol Vitabalans and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not use Tramadol Vitabalans if the patient is currently taking or has taken within the last two weeks medicines called monoamine oxidase inhibitors or MAO inhibitors (used, for example, in the treatment of depression).
The pain-relieving effect of Tramadol Vitabalans may be weakened and/or shortened when taken simultaneously with medicines containing:

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

The risk of adverse effects increases:

• if Tramadol Vitabalans is taken simultaneously with sedatives, sleeping pills, other painkillers such as morphine or codeine (even if it is an ingredient in a cough medicine), and alcohol. Excessive drowsiness or a feeling of fainting may occur,
• if the patient takes medicines that may cause seizures, such as certain antidepressants or antipsychotics. Concurrent use of Tramadol Vitabalans may increase the risk of seizures. The doctor will determine whether Tramadol Vitabalans use is appropriate,
• if the patient takes certain antidepressants. Tramadol Vitabalans may interact with these medicines, potentially causing serotonin syndrome (see section 4 "Possible side effects"),
• if the patient takes Tramadol Vitabalans simultaneously with blood-thinning medicines such as warfarin. Increased risk of bleeding may occur,
• if the patient takes gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain).

Concurrent use of Tramadol Vitabalans and sedative medicines, such as benzodiazepines or similar medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should only be considered when no other treatment options are available.
If a doctor prescribes Tramadol Vitabalans together with sedative medicines, the doctor should also limit the dose and duration of concurrent treatment.
Inform the doctor about all sedative medicines the patient is taking and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members so they are aware of the possible signs and symptoms mentioned above. If any of the above symptoms occur, contact a doctor.

Tramadol Vitabalans with food, drink and alcohol
Do not consume alcohol while taking Tramadol Vitabalans, as alcohol may intensify the effect of Tramadol Vitabalans.
Food does not affect the action of Tramadol Vitabalans.

Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Information on the safety of tramadol use during pregnancy is limited; therefore, tramadol should not be used during pregnancy or breastfeeding.
Breastfeeding
Tramadol is excreted in 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 discontinued.
Experience from use in humans does not show an effect of tramadol on fertility in women and men.

Driving and operating machinery
Tramadol Vitabalans may cause adverse effects such as drowsiness, dizziness and visual disturbances. In such cases, do not drive or operate machinery.

3. How to use Tramadol Vitabalans

This medicine should always be taken exactly as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to
expect from using Tramadol Vitabalans, when and for how long it should be taken, when to contact the
doctor, and when the medicine should be discontinued (see also section 2).
The dosage should be adjusted according to the intensity of pain and the individual patient's sensitivity to
pain.
Usually, the lowest effective dose providing pain relief should be used.
Tablets may be taken with or without food.

Adults and adolescents aged 12 years and older
The usual recommended dose is 1 to 2 tablets (corresponding to 50 mg or 100 mg). Depending on the
type of pain, the effect lasts approximately 4–8 hours. The daily dose should not exceed 8 tablets (400 mg
in total), unless otherwise directed by a doctor.

Use in children under 12 years of age
Tramadol Vitabalans 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 such cases, the doctor
may recommend extending the intervals between doses.

Patients with severe liver or kidney function disorders (impairment) and (or) dialysis patients
Tramadol Vitabalans should not be used in patients with severe liver and (or) kidney impairment.
If mild or moderate liver and (or) kidney impairment is present, the doctor may recommend extending the
intervals between doses.

Tramadol Vitabalans should not be used for longer than necessary. If long-term pain treatment is required,
the doctor will regularly monitor whether continued use of Tramadol Vitabalans is still indicated 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
their doctor or pharmacist.

Taking more than the recommended dose of Tramadol Vitabalans
If more tablets of Tramadol Vitabalans than recommended have been taken, contact a doctor immediately
or go to the emergency department of the nearest hospital. Symptoms of overdose may include: vomiting,
low blood pressure, rapid heartbeat, collapse, fainting, even coma, seizures, and breathing difficulties.

Missing a dose of Tramadol Vitabalans
Do not take a double dose to make up for a missed dose.

Stopping the use of Tramadol Vitabalans
Discontinuing Tramadol Vitabalans will result in the return of pain symptoms. Consult your doctor before
stopping Tramadol Vitabalans due to possible adverse effects.
Do not suddenly stop taking this medicine without medical advice. If the patient wishes to discontinue the
medicine, this should be discussed with the doctor, especially if the medicine has been taken long-term.
The doctor will advise when and how to stop the medicine; this may involve gradually reducing the dose
to reduce the likelihood of adverse effects (withdrawal symptoms).
Usually, stopping treatment does not cause withdrawal symptoms. Rarely, in patients who have taken this
medicine for a long time, the following symptoms may occur after abrupt discontinuation: restlessness,
anxiety, nervousness, or a sense of unease. Sleep disturbances, excessive activity, or gastrointestinal
disturbances may also occur. In very rare cases, panic attacks, hallucinations, unexplained itching,
numbness, or tinnitus may occur. Very rarely, central nervous system-related symptoms have been
observed, such as disorientation, delusions, personality changes (depersonalization), disturbances in
perception of reality (derealization), and paranoia. If any adverse symptoms occur after stopping
Tramadol Vitabalans, consult a 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, Tramadol Vitabalans may cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if any of the following symptoms occur:
allergic reaction: itching, rash, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing, narrowing of the airways, worsening of bronchial asthma if present, shock or collapse,
slowed breathing – usually when taking high doses of tramadol or when used concomitantly with other medicines that slow breathing.

The following adverse reactions 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,
• excessive sweating,
• fatigue.

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

• irregular, rapid heartbeat or palpitations, fast heart rate, low blood pressure (especially upon standing), which may lead to collapse,
• diarrhoea, 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, skin tingling, speech disturbances,
• tremor, breathing difficulties, seizures resembling epileptic fits, lack of motor coordination, muscle spasms, fainting, blurred vision, difficulty in passing urine 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 or occasionally increased activity), as well as reduced attention and decision-making ability, which may lead to incorrect assessment of situations,
• dilated pupils (mydriasis), constricted pupils (miosis), blurred vision,
• shortness of breath, respiratory arrest.

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

• increased activity of liver enzymes.

Unknown (frequency cannot be estimated from available data):

• low blood sugar level (hypoglycaemia),
• hiccups,
• serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms such as fever, rapid pulse, 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 Vitabalans).

More information about possible symptoms can be found in the section "Stopping Tramadol Vitabalans".
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Tramadol Vitabalans

No special requirements for storage conditions.
The medicine should be stored in a place out of sight and reach of children.
This medicine should be kept in a closed and secure place, inaccessible to others. It may cause serious harm or be fatal to people to whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the stated month.
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 packaging and other information

What Tramadol Vitabalans contains

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

What Tramadol Vitabalans looks like and contents of the pack
Appearance of Tramadol Vitabalans tablets:
white, round, convex tablets with a score line on one side. Diameter 9 mm.
The tablet can be divided into two equal parts.
Pack sizes:
10, 15, 20, 25, 30, 40, 50, 60, 100, 150, 200, 250 and 300 tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Vitabalans Oy
Varastokatu 8
13500 Hämeenlinna
FINLAND
Tel.: +358 (3) 615600
Fax: +358 (3) 6183130
Manufacturer:
Vitabalans Oy
Varastokatu 7-9
13500 Hämeenlinna
FINLAND
This medicinal product is authorised 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)