TRAMADOL 50 mg /Ml Solution

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Tramadol Kalceks, 50 mg/ml, solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Tramadol Kalceks and what is it used for
4. Important information before using Tramadol Kalceks
   1. When not to use Tramadol Kalceks:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tramadol Kalceks and other medicines
   5. Using Tramadol Kalceks with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Tramadol Kalceks contains sodium
5. How to use Tramadol Kalceks
   1. Adults and adolescents over 12 years of age
   2. Elderly patients
   3. Patients with renal or hepatic impairment, dialysis patients
   4. Use in children and adolescents
   5. Method and duration of administration
   6. Using a higher dose of Tramadol Kalceks than recommended
   7. Missing a dose of Tramadol Kalceks
   8. Stopping Tramadol Kalceks
6. Possible side effects
   1. Reporting side effects
7. How to store Tramadol Kalceks
8. Contents of the packaging and other information
   1. What Tramadol Kalceks contains
   2. What Tramadol Kalceks looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
   5. Date of last revision of the leaflet: 06/2024

Leaflet accompanying the packaging: patient information

Tramadol Kalceks, 50 mg/ml, solution for injection/infusion

Tramadol hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tramadol Kalceks and what is it 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 packaging and other information

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

The active substance of Tramadol Kalceks, tramadol hydrochloride (hereinafter referred to as tramadol), belongs to the group of opioid analgesics acting on the central nervous system. It has an analgesic effect by acting on specialized nerve cells in the spinal cord and brain.
Tramadol Kalceks is used to relieve moderate to severe pain.

2. Important information before using Tramadol Kalceks

When not to use Tramadol Kalceks:

• in case of acute intoxication with alcohol, sleeping pills, painkillers or psychotropic drugs (affecting mood and emotions);
• in case of concomitant treatment with MAO inhibitors (antidepressant drugs) and for 14 days after their discontinuation (see "Tramadol Kalceks and other medicines");
• in patients with uncontrolled epilepsy;
• as a substitute in the treatment of opioid dependence.

Warnings and precautions

Before starting treatment with Tramadol Kalceks, discuss with your doctor or pharmacist:

• in case of impaired consciousness (if you feel faint);
• in case of shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (may occur after head injury or brain disease);
• in case of respiratory disorders;

Seizures have been observed in patients taking tramadol at the recommended dose.
The risk of seizures may increase when taking tramadol at a dose exceeding the maximum recommended daily dose (400 mg).
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 Kalceks can also lead to dependence, abuse, and addiction, which can cause life-threatening overdose.
The risk of these side effects may increase with 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 on Tramadol Kalceks is different for different people. A higher risk of dependence on Tramadol Kalceks may apply to people in the following situations:

If you experience any of the following symptoms while taking Tramadol Kalceks, it may indicate dependence or addiction.

• need to take the medicine for a longer period than recommended by the doctor;
• need to take a higher dose than recommended;
• taking the medicine for reasons other than those for which it was prescribed, such as "to calm down" or "to sleep better";
• repeated, unsuccessful attempts to stop or control the use of the medicine;
• after stopping the medicine, you feel unwell, and after taking it again, you feel better ("withdrawal symptoms"). If you experience any of these symptoms, you should consult your doctor to discuss the best treatment option for you, including deciding when to stop taking the medicine and how to do it safely (see section 3, "Stopping Tramadol Kalceks").

After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of so-called serotonin syndrome. If you experience any symptoms of this syndrome with a severe course, you should immediately consult your doctor (see section 4 "Possible side effects").
Respiratory disorders during sleep
Tramadol Kalceks may cause respiratory disorders 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 you or someone else observes these symptoms, you should contact your doctor. Your doctor may recommend reducing the dose.
In case of any of the above situations during treatment with Tramadol Kalceks, you should consult your doctor, even if these warnings refer to situations that have occurred in the past.
If you experience any of the following symptoms while taking Tramadol Kalceks, you should tell your doctor or pharmacist:
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
This may indicate that you have adrenal insufficiency (low cortisol levels). If such symptoms occur, you should contact your doctor, who will decide whether you need hormone replacement therapy.
Tramadol is metabolized in the liver by an enzyme. In some people, there is a certain variant 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 may be higher.
You should stop taking the medicine and immediately contact your doctor 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.

Children and adolescents

Tramadol Kalceks should not be given to children under 1 year of age.
Use in children with respiratory disorders
Tramadol should not be used in children with respiratory disorders, as the symptoms of tramadol toxicity may be exacerbated in them.

Tramadol Kalceks and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take Tramadol Kalceks with MAO inhibitors and for 14 days after their discontinuation (see "When not to use Tramadol Kalceks").
The analgesic effect of Tramadol Kalceks may be weakened, and the duration of action may be shortened during concomitant use of medicines containing:

• carbamazepine (an antiepileptic drug);
• ondansetron (an antiemetic drug). You should consult your doctor about the use of Tramadol Kalceks and its dosage.

The risk of side effects increases:

• when Tramadol Kalceks is used concomitantly with sedatives, sleeping pills, other painkillers such as morphine and codeine (also used as a cough medicine), and alcohol. Drowsiness or impending fainting may occur. In such cases, you should consult your doctor;
• when taking anticoagulants such as warfarin concomitantly with Tramadol Kalceks, the anticoagulant effect of these medicines may be disrupted, and bleeding may occur.

Using Tramadol Kalceks with food, drink, and alcohol

Do not drink alcohol or take medicines containing alcohol while taking Tramadol Kalceks, as the effect of the medicine may be enhanced. Food does not affect the effect of Tramadol Kalceks.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
There is limited data on the safety of tramadol in pregnant women, so Tramadol Kalceks should not be used.
Long-term use of the medicine during pregnancy may lead to the occurrence of withdrawal symptoms in the newborn.
Tramadol should not be used during breastfeeding. Tramadol is excreted into breast milk. Therefore, during breastfeeding, do not take Tramadol Kalceks more than once, or if you have taken Tramadol Kalceks more than once, stop breastfeeding. Usually, it is not necessary to stop breastfeeding after a single dose of the medicine.
Observations after marketing authorization do not indicate that tramadol affects fertility in patients. Animal studies have not shown any effect of tramadol on fertility.

Driving and using machines

Tramadol Kalceks may cause drowsiness, dizziness, which may affect reaction time.
If you feel that your ability to react is impaired, do not drive or operate machinery.

Tramadol Kalceks contains sodium

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

3. How to use Tramadol Kalceks

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from Tramadol Kalceks, when and how long to take it, when to contact your doctor, and when to stop the medicine (see also section 2).
Your doctor will adjust the dose according to the severity of the pain and your individual response to treatment. This will be the smallest dose that effectively relieves the pain.
The total dose should not exceed 400 mg of tramadol per day (which corresponds to 8 ml of Tramadol Kalceks). Exceptionally, in clinically justified cases, your doctor may recommend a higher daily dose.
If your doctor does not recommend otherwise, the following dosing is usually used.

Adults and adolescents over 12 years of age

Depending on the severity of the pain, usually 50-100 mg of tramadol is used 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 the leaflet.

Elderly patients

In elderly patients (under 75 years) with no clinically significant liver or kidney impairment, dose adjustment is not necessary.
In elderly patients (over 75 years), the elimination of tramadol may be delayed. In these patients, your doctor may recommend prolonging the time interval between doses.

Patients with renal or hepatic impairment, dialysis patients

Do not take Tramadol Kalceks in case of severe hepatic and/or renal impairment. In case of mild or moderate impairment, your doctor may recommend prolonging the time interval between doses.

Use in children and adolescents

Children from 1 to 12 years of age
Usually, a single dose of 1-2 mg of tramadol per kilogram of body weight is used. The smallest effective dose of the medicine should be used.
Do not use a total daily dose greater than 8 mg of tramadol per kilogram of body weight, and in total, it should not exceed 400 mg of tramadol.
Detailed information for healthcare professionals on the use of this medicine in children is provided at the end of the leaflet.

Method and duration of administration

Tramadol Kalceks is administered by slow injection (1 ml per minute) into a vein, subcutaneously, e.g., into the elbow fold, into a muscle (usually into the buttock), or subcutaneously.
Tramadol Kalceks can also be diluted and administered by intravenous infusion.
Detailed information for healthcare professionals is provided at the end of the leaflet.
Do not use Tramadol Kalceks for longer than absolutely necessary. In case of need for long-term treatment, your doctor will regularly monitor your condition (interrupting the administration of the medicine for a while if necessary) to determine whether and at what dose the treatment with Tramadol Kalceks should be continued.
If you feel that the effect of Tramadol Kalceks is too strong or too weak, you should consult your doctor or pharmacist.

Using a higher dose of Tramadol Kalceks than recommended

Usually, accidental use of a higher dose than recommended does not have a negative effect on the patient. The next dose should be taken as recommended.
After taking a very high dose of the medicine, the following may occur: pinpoint pupils, vomiting, decreased blood pressure, rapid heartbeat, collapse, impaired consciousness up to coma, seizures, respiratory depression up to respiratory arrest.
In such cases, you should immediately contact your doctor!

Missing a dose of Tramadol Kalceks

If a dose of the medicine is not administered at the right time, you should expect the pain to return. Do not take a double dose to make up for the missed dose.
Return to the previous dosing schedule of Tramadol Kalceks.

Stopping Tramadol Kalceks

Do not stop taking this medicine abruptly without your doctor's advice. If you want to stop taking the medicine, you should discuss it with your doctor, especially if you have been taking it for a long time.
Your doctor will advise you when and how to stop taking the medicine; this may be a gradual reduction in dose to minimize the likelihood of side effects (withdrawal symptoms).
In case of sudden stop or premature discontinuation of Tramadol Kalceks, the pain is likely to return. If you want to stop the treatment due to side effects, you should inform your doctor or nurse.
Generally, after stopping Tramadol Kalceks, no serious withdrawal symptoms are observed. However, in rare cases, patients who have been taking Tramadol Kalceks for some time may feel unwell after sudden discontinuation of treatment. These patients may experience agitation, anxiety, nervousness, tremors. They may also experience: disorientation, excessive activity, sleep disorders, gastrointestinal disorders, gastrointestinal upset.
Some patients may experience: increased anxiety, panic attacks, hallucinations, abnormal perception of stimuli such as itching, tingling, numbness, and tinnitus. Other unusual central nervous system disorders, such as confusion, delusions, depersonalization, derealization, and paranoid delusions, have occurred very rarely.
If you experience any of the above symptoms after stopping this medicine, you should immediately consult your doctor or pharmacist.
If you have any further questions about the use of this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally, the frequency of side effects is classified as follows:
Very common(occurring in more than 1 in 10 patients):

• dizziness;
• nausea.

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

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

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

• heart and circulatory disorders (palpitations, rapid heartbeat, feeling of weakness, fainting or sudden cardiovascular collapse). Such side effects may occur during intravenous administration of tramadol and in patients after physical exertion;
• vomiting reflex, gastrointestinal upset (e.g., feeling of pressure in the stomach, bloating), diarrhea;
• skin reactions (e.g., itching, rash, hives).

Rare(occurring in less than 1 in 1000 patients)

• allergic reactions (e.g., breathing difficulties, bronchospasm, wheezing, swelling of the skin) and anaphylactic shock;
• slow heartbeat;
• high blood pressure;
• abnormal perception of stimuli (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 concomitant use of other medicines that may cause seizures;
• appetite disorders;
• hallucinations, disorientation, sleep disorders, delirium, anxiety, and nightmares;

After taking Tramadol Kalceks, psychiatric disorders may occur. Their severity may vary (depending on the patient's personality and treatment duration). They may include mood disorders (usually excitement, sometimes irritability), changes in activity (usually decreased, sometimes increased), and decreased sensory and cognitive perception (changes in feelings and recognition, which may lead to incorrect assessment of the situation). The medicine may cause dependence. In case of sudden discontinuation of treatment, withdrawal symptoms may occur (see "Stopping Tramadol Kalceks").

• pinpoint pupils, dilated pupils, blurred vision;
• slow breathing, "short breath" (shortness of breath);
• worsening of asthma during treatment with tramadol, although a causal relationship between these facts has not been established;

In case of taking higher doses than recommended and concomitant use of other medicines affecting brain activity, respiratory depression may occur;

• muscle weakness;
• urination disorders (difficulty or pain when urinating, decreased urine output, urinary retention).

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

• increased liver enzyme activity.

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

• low blood sugar;
• hiccups;
• serotonin syndrome, whose symptoms may include changes in mental state (e.g., excitement, hallucinations, coma), as well as other symptoms such as fever, rapid heartbeat, unstable blood pressure, involuntary muscle contractions, muscle stiffness, and lack of coordination and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "Important information before using Tramadol Kalceks").

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your 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
PL-02 222 Warsaw
Phone: +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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tramadol Kalceks

Do not freeze. Do not store in the refrigerator.
Store the medicine out of sight and reach of children.
This 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 ampoule after EXP.
The expiry date refers to the last day of the month stated.
After opening the ampoule, the medicine should be used as soon as possible.
Physical and chemical stability has been established for 48 hours at 25 °C with the addition of 0.9% sodium chloride and 5% glucose solutions.
From a microbiological point of view, the opened/diluted medicine should be used immediately, unless the method of opening/dilution precludes the risk of microbiological contamination.
If the medicine is not used immediately, the user is responsible for the further storage period and conditions.
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 packaging and other information

What Tramadol Kalceks contains

• The active substance of Tramadol Kalceks is tramadol hydrochloride. 1 ml of the solution for injection contains 50 mg of tramadol hydrochloride. One ampoule (1 ml) of the solution for injection contains 50 mg of tramadol hydrochloride. One ampoule (2 ml) of the solution for injection 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

Clear, colorless solution, free from visible particles.
1 ml or 2 ml ampoule made of colorless type I glass with a break line or break point where it can be easily opened.
5 ampoules in a PVC blister pack or 10 ampoules (in two blister packs of 5 ampoules each) in a cardboard box.
100 ampoules (20 blister packs of 5 ampoules each) in a cardboard box (hospital packaging). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Phone: +371 67083320
e-mail: [email protected]

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

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

Date of last revision of the leaflet: 06/2024

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Information intended for healthcare professionals only.
Instructions for handling Tramadol Kalceks ampoules
Ampoules with a break line are filled with Tramadol Kalceks. On the ampoule, there is a break line or break point where it can be easily opened:

• 1) turn the ampoule so that the break point is facing upwards
• 2) break the ampoule.

Further information on use
For single use only.
Tramadol can be diluted with a 0.9% sodium chloride solution or 5% glucose solution.
Method of administration
Intravenously (the solution should be administered slowly, 1 ml (50 mg of tramadol hydrochloride) per minute), intramuscularly, or subcutaneously.
Tramadol Kalceks can be diluted with an appropriate infusion solution (e.g., 0.9% sodium chloride solution or 5% glucose solution) for intravenous administration.
How to use Tramadol Kalceks in children from 1 to 12 years of age (see also section 3).
Tramadol Kalceks should not be used in children under 1 year of age.
In children under 12 years of age, a single dose of tramadol is 1-2 mg/kg of body weight.
Generally, the smallest effective analgesic dose should be chosen.
Do not use a total daily dose greater than 8 mg of tramadol per kilogram of body weight, and in total, it should not exceed 400 mg of tramadol.
Calculating the injected volume

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

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