Tramadol kalceks

Patient Information Leaflet

Tramadol Kalceks, 50 mg/ml, solution for injection/infusion
tramadoli hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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

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

The active substance in Tramadol Kalceks – tramadol hydrochloride (hereinafter referred to as tramadol) – belongs to a group of opioid pain-relieving medicines acting on the central nervous system. It relieves pain by acting on specialized nerve cells in the spinal cord and brain.
Tramadol Kalceks is used to treat moderate to severe pain.

2. Important information before using Tramadol Kalceks

When not to use Tramadol Kalceks:

• if the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute intoxication with alcohol, hypnotics, analgesics, or psychotropic drugs (affecting mood and emotions);
• during concomitant treatment with MAO inhibitors (antidepressant drugs) or within 14 days after their discontinuation (see "Tramadol Kalceks and other medicines");
• in patients with epilepsy that is not controlled by treatment;
• as a substitute in opioid dependence treatment.

Warnings and precautions
Before starting treatment with Tramadol Kalceks, discuss the following with your doctor or pharmacist:

• if the patient suspects dependence on painkillers (opioids);
• if the patient has increased sensitivity to opioids;
• in case of disturbances in consciousness (when the patient feels faint);
• during shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (which may occur after head injury or brain diseases);
• in case of respiratory disorders;
• if the patient has a tendency to seizures, as the risk of seizures may increase;
• if the patient has depression and is taking antidepressants, as some of them may interact with tramadol (see "Tramadol Kalceks and other medicines").

Seizures have been observed in patients taking tramadol at the recommended dose.
The risk of seizures may increase when tramadol is taken at doses exceeding the maximum recommended daily dose (400 mg).
Tolerance, dependence, and abuse
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 Kalceks may also lead to dependence, misuse, and abuse, 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 abuse may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of dependence or abuse varies among individuals. Higher risk of dependence on Tramadol Kalceks 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 ("abuse");
• 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 Kalceks, this may indicate dependence or abuse:

• need to take the medicine for a longer period 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 symptoms").
  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 Kalceks").

There is a small risk of 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").

Sleep-related breathing disorders
Tramadol Kalceks may cause sleep-related breathing disorders, 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 any of the above situations occur during treatment with Tramadol Kalceks, consult a doctor, even if these warnings relate to past conditions.
If the patient experiences any of the following symptoms while taking Tramadol Kalceks, inform the doctor or pharmacist:
Excessive fatigue, 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.
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 reactions are more likely.
Stop using the medicine and contact your doctor 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.

Children and adolescents
Tramadol Kalceks should not be given to children under 1 year of age.
Use in children with respiratory disorders
The use of tramadol in children with respiratory disorders is not recommended, as tramadol toxicity symptoms may be intensified in these patients.

Tramadol Kalceks and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Do not take Tramadol Kalceks together with MAO inhibitors or within 14 days after discontinuing them (see section "When not to use Tramadol Kalceks").
The analgesic effect of Tramadol Kalceks may be reduced, and its duration shortened, when taken concomitantly with medicines containing:

• carbamazepine (an antiepileptic medicine);
• ondansetron (an antiemetic medicine). Consult your doctor regarding the use and dosing of Tramadol Kalceks.

The risk of adverse effects increases:

• when Tramadol Kalceks is taken together with sedatives, hypnotics, other analgesics such as morphine and codeine (also used as antitussives), and alcohol. Drowsiness or faintness may occur. In such cases, consult your doctor;
• if the patient is taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain);
• if the patient is taking other medicines that may cause seizures, such as certain antidepressants. The risk of seizures may increase if the patient takes Tramadol Kalceks together with these medicines. The doctor should inform the patient whether Tramadol Kalceks is suitable for them;
• if the patient is taking certain antidepressants, Tramadol Kalceks may interact with them, potentially causing serotonin syndrome (see section 4, "Possible side effects");
• when anticoagulant coumarins (blood-thinning medicines), such as warfarin, are taken together with Tramadol Kalceks, the anticoagulant effect may be disrupted, leading to bleeding.

Taking Tramadol Kalceks with food, drink, and alcohol
Do not drink alcohol or use medicines containing alcohol while taking Tramadol Kalceks, as the effect of the medicine may be intensified. Food does not affect the action of Tramadol Kalceks.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.
There is limited data on the safety of tramadol use in pregnant women; therefore, Tramadol Kalceks should not be used.
Long-term use during pregnancy may lead to withdrawal symptoms in the newborn.
Tramadol is not recommended during breastfeeding. Tramadol is excreted in breast milk. Therefore, during breastfeeding, Tramadol Kalceks should not be taken more than once, or if Tramadol Kalceks has been taken more than once, breastfeeding should be discontinued. Usually, interruption of breastfeeding is not required after a single dose of the medicine.

Post-marketing observations do not indicate that tramadol affects patient fertility. Animal studies have not shown any effect of tramadol on fertility.

Driving and operating machinery
Tramadol Kalceks may cause drowsiness and dizziness, which may affect reaction speed. If the patient feels that their ability to react is impaired, they should not drive or operate machinery.

Tramadol Kalceks contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per ml of solution, meaning the medicine is considered "sodium-free".

3. How to use Tramadol Kalceks

This medicine should always be used as directed by a physician. If in doubt, consult a doctor or pharmacist.
Before starting treatment and regularly during therapy, the doctor will discuss with the patient what effects to expect from using Tramadol Kalceks, when and for how long the medicine should be taken, when to contact the doctor, and when the medicine should be discontinued (see also section 2).
The doctor will adjust the dose according to the intensity of pain and the individual patient's response to treatment. The dose used will be the lowest effective dose that adequately relieves pain.
The total daily dose should not exceed 400 mg of tramadol (equivalent to 8 ml of Tramadol Kalceks). Exceptionally, in clinically justified cases, the doctor may prescribe a higher daily dose.
Unless otherwise directed by the physician, the following dosage regimens are generally recommended.

Adults and adolescents over 12 years of age
Depending on the severity of pain, the usual dose is 50–100 mg of tramadol every 4–6 hours. The maximum daily dose of 400 mg must not be exceeded.
Detailed information for healthcare professionals is provided at the end of this leaflet.

Elderly patients
In elderly patients (under 75 years of age) without clinically confirmed hepatic or renal impairment, dose adjustment is not usually necessary.
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. In these patients, the doctor may recommend prolonging the interval between doses.

Patients with renal impairment, on dialysis, or with hepatic impairment
Tramadol Kalceks should not be used in cases of severe hepatic and/or renal impairment. In cases of mild or moderate impairment, the doctor may recommend extending the time intervals between doses.

Use in children and adolescents
Children aged 1 to 12 years
The usual single dose is 1 to 2 mg of tramadol per kilogram of body weight. The lowest effective dose should be used.
The total daily dose should not exceed 8 mg of tramadol per kilogram of body weight, and in no case should the total daily dose exceed 400 mg of tramadol.
Detailed information for healthcare professionals on the use of this medicine in children is provided at the end of this leaflet.

Method and duration of administration
Tramadol Kalceks is administered by slow intravenous injection (1 ml per minute) into a peripheral vein, e.g. at the elbow crease, or by intramuscular (usually gluteal) or subcutaneous injection.
Tramadol Kalceks may also be diluted and administered as an intravenous infusion.
Detailed information for healthcare professionals is provided at the end of this leaflet.
Tramadol Kalceks should not be used for longer than absolutely necessary. If long-term treatment is required, the doctor will regularly monitor the patient's condition (possibly interrupting treatment temporarily, if needed) to determine whether and at what dose Tramadol Kalceks treatment should continue.

If the effect of Tramadol Kalceks seems too strong or too weak, consult a doctor or pharmacist.

Use of a higher than recommended dose of Tramadol Kalceks
Accidental use of a dose higher than recommended usually does not have adverse effects on the patient. The next dose should be taken as directed.
After administration of a very high dose, the following symptoms may occur: pinpoint pupil constriction, vomiting, drop in arterial blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
In such cases, seek immediate medical attention!

Missed dose of Tramadol Kalceks
If a dose is not administered at the scheduled time, expect a return of pain symptoms. Do not administer a double dose to make up for a missed dose.
Resume the usual dosing schedule of Tramadol Kalceks as previously prescribed.

Discontinuation of Tramadol Kalceks
Do not abruptly stop using this medicine without medical advice. If a patient wishes to discontinue treatment, this should be discussed with the doctor, especially if the medicine has been used long-term.
The doctor will advise when and how to stop treatment; this may involve gradually reducing the dose to minimize the likelihood of withdrawal symptoms.
If treatment with Tramadol Kalceks is suddenly stopped or prematurely discontinued, pain symptoms are likely to return. If a patient wishes to discontinue treatment due to adverse effects, they should inform the doctor or nurse.
Generally, no serious withdrawal symptoms are observed after discontinuation of Tramadol Kalceks. However, in rare cases, patients who have used Tramadol Kalceks for some time may feel unwell after abrupt discontinuation. These patients may experience restlessness, anxiety, nervousness, and tremors. Other possible symptoms include: disorientation, excessive activity, sleep disturbances, gastrointestinal discomfort, and gastrointestinal disorders.
In some patients, pronounced anxiety, panic attacks, hallucinations, and abnormal sensory perceptions such as itching, tingling, numbness, and tinnitus may occur. Other rare central nervous system disturbances such as confusion, delusions, altered perception of self (depersonalization), altered perception of reality (derealization), and persecutory delusions (paranoia) have been reported very rarely.
If any of the above symptoms occur after discontinuation of this medicine, consult a doctor or pharmacist immediately.
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 everybody will experience them.
The frequency of adverse effects is generally classified as follows:

Very common (occurs in more than 1 in 10 patients):

• dizziness;
• nausea.

Common (occurs in less than 1 in 10 patients):

• headache, drowsiness;
• constipation, dry mouth, vomiting;
• excessive sweating;
• fatigue.

Uncommon (occurs in less than 1 in 100 patients):

• cardiovascular disorders (palpitations, rapid heartbeat, feeling of weakness, fainting or acute circulatory collapse). Such adverse effects may occur during intravenous administration of tramadol formulations and in patients after physical exertion;
• vomiting reflex, gastrointestinal discomfort (e.g. feeling of pressure in the stomach, bloating), diarrhoea;
• skin reactions (e.g. itching, rash, urticaria).

Rare (occurs in less than 1 in 1,000 patients):

• allergic reactions (e.g. breathing difficulties, bronchospasm, wheezing, skin swelling) and shock (sudden circulatory failure);
• slow heartbeat;
• high blood pressure;
• abnormal sensation (e.g. itching, tingling, numbness), tremors, seizures, muscle spasms, uncoordinated movements, fainting, speech disorders; seizures occur mainly after administration of high doses of tramadol and when used concomitantly with other medicines that may provoke seizures;
• loss of appetite;
• hallucinations, disorientation, sleep disturbances, delirium, restlessness and nightmares;
• psychiatric disorders may occur after administration of Tramadol Kalceks. Their severity may vary (depending on the patient's personality and duration of treatment). These may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased) and reduced sensory and cognitive perception (changes in sensation and recognition which may lead to misjudgement of situations). The medicine may cause dependence. Withdrawal symptoms may occur if treatment is stopped abruptly (see “Discontinuation of treatment with Tramadol Kalceks”);
• constricted pupils (miosis), excessive pupil dilation (mydriasis), blurred vision;
• slow breathing, “shortness of breath” (dyspnoea);
• worsening of bronchial asthma has been reported during tramadol treatment, although a causal relationship has not been established;

When higher than recommended doses are taken and tramadol is used concomitantly with other medicines affecting brain activity, respiratory depression may occur;

• muscle weakness;
• urinary disorders (difficulty or pain during urination, reduced urine volume, urinary retention).

Very rare (occurs in less than 1 in 10,000 patients):

• increased liver enzyme activity.

Unknown (frequency cannot be estimated from available data):

• low blood sugar levels;
• hiccups;
• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma) and other symptoms such as fever, increased heart rate, 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 Kalceks”).

Reporting of adverse effects
If any adverse effects occur, including any symptoms not listed in this leaflet,
you should inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Tramadol Kalceks

Do not freeze. Do not store in the refrigerator.
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 and vial after: EXP.
The expiry date refers to the last day of the stated month.
After opening the vial, the medicine should be used as soon as possible.
Physical and chemical stability has been demonstrated for 48 hours at 25 °C when diluted with 0.9% sodium chloride or 5% glucose solutions.
From a microbiological standpoint, the opened/diluted medicine should be used immediately, unless the method of opening/dilution excludes the risk of microbiological contamination.
If the medicine is not used immediately, the user is responsible for subsequent storage periods and conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tramadol Kalceks contains

• The active substance in Tramadol Kalceks is tramadol hydrochloride. 1 ml of injection solution contains 50 mg of tramadol hydrochloride. One ampoule (1 ml) of injection solution contains 50 mg of tramadol hydrochloride. One ampoule (2 ml) of injection solution contains 100 mg of tramadol hydrochloride.
• The other ingredients are: sodium acetate trihydrate, water for injections.

What Tramadol Kalceks looks like and contents of the pack
A clear, colourless solution free from visible solid particles.
1 ml or 2 ml ampoule made of colourless type I glass with a break ring or OPC point.
5 ampoules in a PVC holder or 10 ampoules (in two holders of 5 ampoules each) in a cardboard box.
100 ampoules (20 holders containing 5 ampoules each) in a cardboard box (hospital pack).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: + 371 67083320
e-mail: [email protected]

This medicinal product is authorised in the following names in the European Economic Area countries and in the United Kingdom (Northern Ireland):
Latvia: Tramadol Kalceks 50 mg/ml šķīdums injekcijām/infūzijām
Lithuania: Tramadol Kalceks 50 mg/ml injekcinis ar infuzinis tirpalas
Austria: Tramadol Kalceks 50 mg/ml Injektions-/Infusionslӧsung
Hungary: Tramadol Kalceks 50 mg/ml oldatos injekció/infúzió
Czech Republic: Tramadol Kalceks
Poland: Tramadol Kalceks
United Kingdom (Northern Ireland):
Tramadol 50 mg/ml solution for injection/infusion
Romania: Tramadol Kalceks 50 mg/ml soluție injectabilă/perfuzabilă

Information intended exclusively for healthcare professionals.

Instructions for handling Tramadol Kalceks ampoules
The scored ampoules are filled with Tramadol Kalceks. On the ampoule there is a break line or mark indicating the opening point where it can be easily opened:

1. Rotate the ampoule so that the opening point is facing upwards
2. Snap open the ampoule.

Further usage information
For single use only.
Tramadol may be diluted with 0.9% sodium chloride solution or 5% glucose solution.

Route of administration
Intravenous (the solution should be administered slowly at a rate of 1 ml (50 mg of tramadol hydrochloride) per minute), intramuscular, or subcutaneous.
Tramadol Kalceks can be diluted with an appropriate infusion solution (e.g., 0.9% sodium chloride or 5% glucose) for intravenous administration.

How to administer Tramadol Kalceks in children aged 1 to 12 years (see also section 3).
Use of Tramadol Kalceks is not recommended in children under 1 year of age.
In children aged up to 12 years, the single dose of tramadol is 1 to 2 mg/kg body weight.
Generally, the lowest effective analgesic dose should be selected.
The total daily dose should not exceed 8 mg of tramadol per kilogram body weight, and in total should not exceed 400 mg of active substance.

Calculation of injection volume

1. Calculate the required total dose of tramadol hydrochloride (mg) – multiply body weight (kg) by dose (mg/kg).
2. Calculate the volume of diluted solution to be injected (ml) – divide the total dose (mg) by the desired concentration (mg/ml, see table below).

Table: Dilution of the medicinal product Tramadol Kalceks, 50 mg/ml, injection solution.

According to calculations, dilute the contents of the Tramadol Kalceks vial by adding an appropriate solvent, mix, and use the calculated volume of the diluted solution.
Discard any remaining solution.
Incompatibility of Tramadol Kalceks
Tramadol Kalceks 50 mg/ml injection/infusion solution should not be mixed with injection solutions containing diclofenac, indomethacin, phenylbutazone, diazepam, midazolam, flunitrazepam, and glyceryl trinitrate.