Tramundin

Leaflet attached to the packaging: patient information

Tramundin,100 mg, prolonged-release tablets
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 or pharmacist if you have any further doubts.
• 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 as yours.
• If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Tramundin and what is it used for

Tramundin contains the active substance tramadol hydrochloride, which is a pain reliever belonging to the opioid group. The pain-relieving effect is related to the effect on specific nerve cells in the spinal cord and brain.
Tramundin is used to treat moderate to severe pain.

2. Important information before taking Tramundin

When not to take Tramundin

Other medicines and Tramundin);

Warnings and precautions

Before starting to take Tramundin, you should discuss it with your doctor if:

• you have breathing problems (respiratory center and respiratory function disorders);
• you have sleep apnea;
• you have depression and are taking antidepressants, as some of them may interact with tramadol (see "Tramundin and other medicines").
• you are taking other medicines that affect the central nervous system and/or consume alcohol;
• you have tolerance to the medicine, are physically dependent on opioids and show signs of withdrawal syndrome;
• you are psychologically dependent on medicines, psychotropic substances and/or alcohol;
• you have a head injury;
• you have increased intracranial pressure (possible after a head injury or brain disease);
• you have had a shock;
• you have consciousness disorders of unknown cause;
• you have a tendency to seizures or convulsions;
• you have liver or kidney function disorders;
• you have severe liver or kidney function disorders, the medicinal product should not be used;
• you have constipation;
• you are more sensitive to opioids.

Respiratory depression
The primary risk of opioid overdose is respiratory depression.
Opioids can cause breathing disorders during sleep, including central sleep apnea (CSA, English central sleep apnoea) and hypoxia during sleep. In some patients, the use of opioids may increase the risk of CSA in a dose-dependent manner. Opioids can also exacerbate existing sleep apnea (see section 4. The doctor may then consider
reducing the total daily dose of opioids.
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing so-called serotonin syndrome. If the patient experiences
any symptoms of this severe syndrome, they should immediately consult a doctor
(see section 4 "Possible side effects").
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, you should contact your doctor, who will decide whether the patient needs hormone replacement.
Long-term use of Tramundin may lead to the development of tolerance to tramadol
(requiring increasingly higher doses of the medicine to control the pain). The medicine may cause psychological and physical dependence. After sudden cessation of treatment, withdrawal syndrome may occur. If the doctor decides that treatment with Tramundin is no longer necessary,
they will recommend a gradual reduction in dose to prevent the occurrence of withdrawal symptoms.
Tramundin may cause dependence and may be abused. In patients with a tendency to abuse medicines or dependence on medicines and/or alcohol, treatment with Tramundin should be short-term and under close medical supervision.
You should also inform your doctor if any of the above problems occurred while taking Tramundin or concerned the patient in the past.

Children

Tramundin is not intended for use in children under 12 years of age.

Elderly patients

In elderly patients, the time intervals between doses may be extended ( see also
section How to take Tramundin).

Tramundin and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
The pain-relieving effect of Tramundin may be reduced, and the duration of action may be shortened,

The risk of side effects is higher,
Tramundin should not be used at the same time as MAO inhibitors (drugs used, among others, in the treatment of depression). When MAO inhibitors were used within the last 14 days before taking another opioid (pethidine), life-threatening disorders of the central nervous system and respiratory and circulatory systems were observed. It cannot be ruled out that such interactions with MAO inhibitors may occur during the use of Tramundin. See section "When not to take Tramundin".

Other possible interactions

limited. Symptoms similar to those that occur when tramadol is suddenly stopped may occur.

Risk associated with concurrent use of sedatives, such as benzodiazepines or derivatives:
Concurrent use of Tramundin and sedatives, such as benzodiazepines or derivatives, may lead to excessive sedation, respiratory depression, coma or death. Therefore, combined treatment with such sedatives will be used by the doctor only in patients for whom no alternative treatment methods are available.
If Tramundin is used together with sedatives, the doctor should limit the dose of the medicine and the period of concurrent use.
You should be carefully monitored for symptoms related to respiratory depression and excessive sedation. It may be helpful to inform a relative or close friend of the patient about the possibility of the above-mentioned symptoms. If these symptoms occur, you should consult a doctor.
It should be remembered that the above information also applies to medicines taken recently.

Tramundin with food, drinks and alcohol

You should not drink alcohol while being treated with Tramundin, as it increases the risk of side effects.

Pregnancy

Before taking any medicine, you should consult a doctor or pharmacist.
Tramundin should not be used during pregnancy.

Breast-feeding

Tramadol is excreted into breast milk. Therefore, during breast-feeding, you should not take Tramundin more than once, or if you have taken Tramundin more than once, you should stop breast-feeding.

Driving and using machines

Tramundin may cause drowsiness and vision disturbances (blurred vision) and thus affect the ability to react to stimuli. This applies in particular to the beginning of treatment, switching of medicines and interactions with other substances that affect the central nervous system (drugs that affect mood, mental state and psyche) and in particular in the case of interaction with alcohol. If you feel that your ability to react is impaired, you should not drive vehicles or operate electrical or mechanical equipment and work without proper protection.

Important information about some ingredients of Tramundin

The medicine contains lactose.
One tablet contains 68 mg of lactose.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Tramundin

This medicine should always be taken according to the doctor's instructions. If you are unsure, you should consult a doctor or pharmacist.
The dose prescribed by the doctor is adjusted to the severity of the pain and the individual sensitivity of the patient.

Unless the doctor has prescribed otherwise, the usual dosing is as follows:

Adults and adolescents over 12 years of age: 100 mg (1 tablet) of Tramundin every 12 hours.
Do not take more than 400 mg (4 tablets) in 24 hours.
Maintain a 12-hour interval between doses.
Do not change the dosage of the medicine determined by the doctor without prior consultation with the doctor.
Tramadol should not be taken for longer than necessary. If the nature and severity of the disease require long-term treatment with Tramundin, the doctor will carefully and regularly monitor the patient's condition (including the use of necessary breaks in treatment, if necessary), in order to determine whether there is a need for further treatment.
Prolonged-release tablets should be swallowed whole, without chewing and crushing, with a sufficient amount of liquid, regardless of meals.
Tablets can be divided into two along the break line if the doctor so instructs.

Elderly patients

The doctor will determine the appropriate dose based on the patient's health. In patients over 75 years of age, the doctor may recommend extending the time between doses if necessary.
The maximum daily dose for people over 75 years of age is 300 mg in divided doses.

Patients with liver or kidney impairment, patients on dialysis and patients with chronic pain:

Tramundin should not be used in case of severe liver or kidney impairment.
In cases of liver or kidney impairment and in patients with chronic pain, it is recommended to consider extending the intervals between doses.
If you feel that the effect of Tramundin is too strong or too weak, you should consult a doctor.

Taking a higher dose of Tramundin than recommended

If you have taken a double dose by mistake, it will not cause any negative effects under normal circumstances. If the pain recurs, you should take Tramundin according to the previous schedule.
Taking much higher doses may lead to: pupil constriction, vomiting, decreased blood pressure, cardiovascular collapse, disorders of consciousness up to coma (deep loss of consciousness), seizures, respiratory failure up to respiratory arrest, which can lead to death.
If there is a suspicion of overdose or symptoms of overdose occur, you should immediately contact a doctor or pharmacist.

Missing a dose of Tramundin

If you forget to take Tramundin, the pain may recur again.
Do not take a double dose to make up for the missed dose, continue taking the medicine according to the previous schedule.

Stopping treatment with Tramundin

If you stop taking Tramundin suddenly or prematurely, it may lead to the recurrence of pain.
If you want to stop treatment due to unacceptable side effects, you should consult a doctor. The doctor will discuss the measures with you and determine whether other medicines may be suitable for treatment.
Do not stop taking this medicine suddenly without the doctor's recommendation. 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.
The doctor will advise when and how to stop taking the medicine; this may be a gradual reduction in dose to reduce the likelihood of side effects (withdrawal symptoms).
Generally, stopping treatment with Tramundin does not have any consequences that occur later.
In some patients who have been taking Tramundin for a long time, late effects such as restlessness, anxiety, nervousness, insomnia, muscle tremors, and gastrointestinal symptoms may occur.
Additionally, in very rare cases, panic attacks, hallucinations, paresthesia, tinnitus, or other symptoms have been observed after stopping treatment.
If any of these side effects occur after stopping treatment with Tramundin, you should consult a doctor.
In case of doubts related to the use of the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramundin can cause side effects, although not everybody gets them.
In the assessment of side effects, the following frequency is taken into account:
Common (occurs in 1 to 10 out of 100 patients): dizziness, drowsiness, nausea, vomiting, constipation, dry mouth, excessive sweating, feeling of fatigue
Uncommon (occurs in 1 to 10 out of 1,000 patients): allergic reactions, hypersensitivity reactions, anaphylactic shock, palpitations, tachycardia, hypotension, disorders of circulatory system function (orthostatic hypotension and fainting), cognitive disorders, seizures, headaches, psychomotor agitation, sensory disturbances, vision disturbances, emotional instability, confusion, decreased activity, drug dependence, euphoric states, hallucinations, shortness of breath, bronchospasm, wheezing, respiratory depression, vomiting reflex, stomach and intestine irritation (feeling of pressure in the stomach, bloating), diarrhea, itching, rash, urticaria, angioedema, urinary disorders, urinary retention, withdrawal reactions, similar to those observed after opioid withdrawal, including: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremors, gastrointestinal symptoms, increased liver enzyme activity.
Rare (occurs in 1 to 10 out of 10,000 patients): difficulty urinating, changes in appetite, abnormal sensations (paresthesia), tremors, involuntary muscle contractions, coordination disorders, fainting, sleep disorders, anxiety, nightmares, blurred vision, muscle weakness.
Very rare (occurs less frequently than 1 in 10,000 patients): bradycardia (slow heart rate), hypertension.
Frequency not known (cannot be estimated from the available data): pupil dilation, hiccups, decreased blood sugar levels (hypoglycemia), sleep apnea syndrome, serotonin syndrome, whose symptoms may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms, such as fever, accelerated 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 Tramundin").
Taking such medicines as tramadol may lead to dependence on the medicine, which makes it difficult to stop taking the medicine when further treatment is no longer necessary. In rare situations, people who have been taking tramadol for a long time may feel unwell after suddenly stopping treatment, this is called the withdrawal effect of the medicine. They may feel agitated, anxious, nervous or shaky, have difficulty sleeping and complain of gastrointestinal or digestive disorders. In very few people, panic attacks, hallucinations, unusual sensations, such as itching, tingling and numbness, and tinnitus may occur. If any of these symptoms occur after stopping treatment with Tramundin, you should consult a doctor.
It has been reported that asthma worsened during treatment with tramadol, but the relationship with the use of the medicine has not been explained.
Concurrent use of Tramundin with blood-thinning medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. Any case of prolonged or unexpected bleeding should be reported to the doctor immediately.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist or nurse. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Tramundin

Medicine should be stored out of sight and reach of children.
Store in a temperature below 25 ° C.
Do not use the medicine after the expiry date stated on the packaging after the words "Expiry date". The expiry date refers to the last day of the month.
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 Tramundin contains

The active substance of the medicine is tramadol hydrochloride.
One prolonged-release tablet contains 100 mg of tramadol hydrochloride.
Other ingredients of the medicine are:

• Core: cetostearyl alcohol, ethylcellulose dispersion (Surlease E-7-19030) [ethylcellulose 20 mPa*s, dibutyl sebacate, oleic acid, anhydrous colloidal silica], talc, magnesium stearate.
• tablet core coating: Opadry II OY-L-28900 [hypromellose 15 mPa*s, lactose monohydrate, polyethylene glycol 4000, titanium dioxide (E171)].
• Coating: Opadry II OY-L-28900 [hypromellose 15 mPa*s, lactose monohydrate, polyethylene glycol 4000, titanium dioxide (E171)].

What Tramundin looks like and contents of the pack

White, elongated, coated tablets with a break line on one side.
10 and 30 coated tablets in blisters of 10, in a cardboard box

Marketing authorization holder and manufacturer

Marketing authorization holder:
Mundipharma A/S,
Frydenlundsvej 30,
2950 Vedbæk,
Denmark
Manufacturer:
Fidelio Healthcare Limburg GmbH,
Mundipharma Strasse 2,
D-65549 Limburg,
Germany
In order to obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder: Mundipharma Polska Sp. z o.o.,
ul. J. Kochanowskiego 45A, 01-864 Warsaw, tel. 22 866 87 12, fax 22 866 87 13.

Date of last revision of the leaflet: