TRAMADOL 37.5 mg/325 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Tramadol + Paracetamol Medreg, 37.5 mg + 325 mg, coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Tramadol + Paracetamol Medreg and what is it used for
4. Important information before taking Tramadol + Paracetamol Medreg
   1. When not to take Tramadol + Paracetamol Medreg:
   2. Warnings and precautions
   3. Children and adolescents
   4. Tramadol + Paracetamol Medreg and other medicines
   5. This medicine contains paracetamol and tramadol. The patient should inform their doctor about taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily dose.
   6. The effect of Tramadol + Paracetamol Medreg may change if it is taken with the following medicines:
   7. Tramadol + Paracetamol Medreg with alcohol
   8. Pregnancy, breastfeeding and fertility
   9. Driving and using machines
   10. Tramadol + Paracetamol Medreg contains sodium
5. How to take Tramadol + Paracetamol Medreg
   1. Adults and adolescents over 12 years
   2. Use in children
   3. Elderly patients
   4. Patients with liver or kidney failure or patients on dialysis
   5. Taking a higher dose of Tramadol + Paracetamol Medreg than recommended
   6. Missing a dose of Tramadol + Paracetamol Medreg
   7. Stopping Tramadol + Paracetamol Medreg
6. Possible side effects
   1. Reporting side effects
7. How to store Tramadol + Paracetamol Medreg
8. Contents of the packaging and other information
   1. What Tramadol + Paracetamol Medreg contains
   2. What Tramadol + Paracetamol Medreg looks like and contents of the pack
   3. Marketing authorization holder and manufacturer/importer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 01/2025

Leaflet attached to the packaging: patient information

Tramadol + Paracetamol Medreg, 37.5 mg + 325 mg, coated tablets

Tramadol hydrochloride+ Paracetamol

You should carefully read the contents of the leaflet before using 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.
• If you have 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 + Paracetamol Medreg and what is it used for
• 2. Important information before taking Tramadol + Paracetamol Medreg
• 3. How to take Tramadol + Paracetamol Medreg
• 4. Possible side effects
• 5. How to store Tramadol + Paracetamol Medreg
• 6. Contents of the packaging and other information

1. What is Tramadol + Paracetamol Medreg and what is it used for

Tramadol + Paracetamol Medreg is used to treat moderate to severe pain, when the doctor recommends a combination of tramadol and paracetamol.
Tramadol + Paracetamol Medreg is indicated for the treatment of pain in adults and adolescents over 12 years of age.

2. Important information before taking Tramadol + Paracetamol Medreg

When not to take Tramadol + Paracetamol Medreg:

Warnings and precautions

Before starting to take Tramadol + Paracetamol Medreg, the patient should discuss it with their doctor or pharmacist

• in patients with liver disease or alcoholic liver damage or who have developed yellowing of the eyes and skin, which may indicate jaundice or bile duct disease
• in patients with kidney disease
• in patients with breathing difficulties, such as asthma or lung problems
• in patients with epilepsy or who have had seizures or epileptic fits
• in patients addicted to other drugs, e.g. morphine

If any of the above points apply to the patient who is currently or has previously taken Tramadol + Paracetamol Medreg, they should make sure that their doctor is informed. The doctor will then decide whether to continue using this medicine.
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 their doctor (see section 4 "Possible side effects").
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to the medicine becoming less effective (the patient gets used to the medicine, which is called tolerance). Repeated use of Tramadol + Paracetamol Medreg can also lead to the development of dependence, abuse and addiction, which can result in life-threatening overdose. The risk of these side effects may increase with the dose and longer duration of use.
Dependence can make it difficult for the patient to control the dose of the medicine they take or how often they take it.
The risk of dependence is different for different people. The risk of dependence on Tramadol + Paracetamol Medreg may be higher if:

• The patient or someone in their family has ever abused or been dependent on alcohol, prescription drugs or illegal drugs ("addiction").
• The patient smokes.
• 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 experiences any of the following symptoms while taking Tramadol + Paracetamol Medreg, it may indicate dependence:

• The patient needs to take the medicine for longer than the doctor recommended.
• The patient needs to take a higher dose than recommended.
• The patient uses the medicine for reasons other than recommended, e.g. "to calm down" or "to help fall asleep".
• 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 feels better after taking it again ("withdrawal symptoms").

If the patient experiences any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when to stop the medicine and how to do it safely (see section 3 "Stopping Tramadol + Paracetamol Medreg").
Sleep apnea
Tramadol + Paracetamol Medreg may cause sleep apnea, 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 staying asleep or excessive daytime sleepiness. If the patient or someone else observes these symptoms, they should contact their doctor. The doctor may recommend reducing the dose.
If the patient experiences any of the following symptoms while taking Tramadol + Paracetamol Medreg, they should tell their doctor or 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 their doctor, who will decide whether the patient needs hormone replacement.

Tramadol is converted 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, it is more likely to experience severe side effects.
The patient should stop taking the medicine and immediately contact their doctor if they experience any of the following side effects: slowed breathing or shallow breathing, feeling confused, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
While taking Tramadol + Paracetamol Medreg, the patient should immediately inform their doctor:

Metabolic acidosis (a blood and fluid disorder) has been reported in patients who take paracetamol regularly for a long time or take paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.

Children and adolescents

This medicine is not intended for use in children under 12 years of age.
Tramadol is not recommended for use in children with breathing difficulties, as the symptoms of tramadol toxicity may be exacerbated in them.

Tramadol + Paracetamol Medreg 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.

This medicine contains paracetamol and tramadol. The patient should inform their doctor about taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily dose.

Taking Tramadol + Paracetamol Medreg with monoamine oxidase inhibitors (MAOIs) iscontraindicated(see "When not to take Tramadol + Paracetamol Medreg").
The patient should inform their doctor or pharmacist if they are taking:

• flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis), which requires emergency treatment (see section 2).

The patient should not take Tramadol + Paracetamol Medreg with monoamine oxidase inhibitors (MAOIs) (see "When not to take Tramadol + Paracetamol Medreg").
It is not recommended to take Tramadol + Paracetamol Medreg at the same time as the following medicines:

• carbamazepine (a medicine used to treat epilepsy or certain types of pain),
• buprenorphine, nalbuphine or pentazocine (opioid painkillers).

The risk of side effects is increased:

• concomitant use of Tramadol + Paracetamol Medreg and sedatives, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if the doctor has prescribed Tramadol + Paracetamol Medreg with sedatives, the doctor should limit the dose and duration of concomitant treatment. The patient should inform their doctor about all sedatives they are taking and strictly follow the doctor's dosage instructions. It may be helpful to inform friends or relatives to be aware of the above signs and symptoms. If such symptoms occur, the patient should contact their doctor.

The effect of Tramadol + Paracetamol Medreg may change if it is taken with the following medicines:

• metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting),
• cholestyramine (a medicine used to lower cholesterol levels in the blood).

Tramadol + Paracetamol Medreg with alcohol

The patient should not drink alcohol while taking Tramadol + Paracetamol Medreg, as it may cause drowsiness.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Because Tramadol + Paracetamol Medreg contains tramadol, it should not be taken during pregnancy.
If the patient becomes pregnant while taking Tramadol + Paracetamol Medreg, they should discuss it with their doctor before taking any more tablets.
Breastfeeding
Tramadol passes into breast milk. For this reason, the patient should not take this medicine more than once while breastfeeding, or if they take it more than once, they should stop breastfeeding.
Fertility
Based on human experience, it is suggested that tramadol does not affect female or male fertility. There is no data on the effect of the combination of tramadol and paracetamol on fertility.

Driving and using machines

Tramadol + Paracetamol Medreg may affect the patient's ability to drive and use machines. If the patient experiences dizziness or drowsiness, they should not drive or operate machinery.

Tramadol + Paracetamol Medreg contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Tramadol + Paracetamol Medreg

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what they can expect from Tramadol + Paracetamol Medreg, when and for how long they should take it, when they should contact their doctor and when they should stop taking it (see also section 2).

• 2).

The dose should be adjusted according to the severity of the pain and individual sensitivity to pain. In general, the lowest dose that relieves the pain should be used.
Tramadol + Paracetamol Medreg should be taken for as short a time as possible and not longer than recommended by the doctor.

Adults and adolescents over 12 years

The recommended initial dose, unless the doctor recommends otherwise, is 2 tablets for adults and adolescents over 12 years. If necessary, the patient can take additional doses as directed by the doctor.
The minimum interval between doses must be at least 6 hours. The patient should not take more than 8 tablets per day.
The patient should not take this medicine more often than recommended by the doctor.

Use in children

Tramadol + Paracetamol Medreg is not recommended for use in children under 12 years of age.

Elderly patients

In elderly patients (over 75 years), the elimination of Tramadol + Paracetamol Medreg may be delayed. In this case, the doctor may recommend prolonging the intervals between doses.

Patients with liver or kidney failure or patients on dialysis

Patients with severe liver or kidney failure should not take Tramadol + Paracetamol Medreg. If the patient has mild or moderate liver or kidney failure, the doctor may recommend prolonging the intervals between doses.
Method of administration
The tablets are for oral use.
The tablets should be swallowed whole, with a sufficient amount of liquid. The tablets should not be broken or chewed.
If the patient feels that the effect of Tramadol + Paracetamol Medreg is too strong (they feel very drowsy or have difficulty breathing) or too weak (the patient does not experience sufficient pain relief), they should contact their doctor.

Taking a higher dose of Tramadol + Paracetamol Medreg than recommended

If the patient takes too much of this medicine, even if they feel well, they should immediately talk to their doctor. This is because too much paracetamol can cause delayed, serious liver damage.

Missing a dose of Tramadol + Paracetamol Medreg

If the patient forgets to take a tablet, the pain will likely return.
The patient should not take a double dose to make up for the missed dose. If the patient misses a dose, they should take the next tablet at the usual time.

Stopping Tramadol + Paracetamol Medreg

The patient should not suddenly stop taking this medicine unless their doctor recommends it.
Generally, after stopping treatment with Tramadol + Paracetamol Medreg, there will be no side effects. 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) (see section 4 "Possible side effects").
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Tramadol + Paracetamol Medreg can cause side effects, although not everybody gets them.
Some side effects can be serious. If the patient experiences any of the following symptoms, they should immediately contact their doctor:

• rare cases of skin rash, indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing or low blood pressure and fainting. If this happens, the patient should stop taking the medicine and not take it again.
• prolonged or unexpected bleeding due to the use of Tramadol + Paracetamol Medreg with blood-thinning medicines (e.g. warfarin, phenprocoumon).

Other possible side effects include:
Very common(may affect more than 1 in 10 people):

• dizziness, drowsiness
• nausea.

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

• confusion, sleep disturbances, mood changes (anxiety, nervousness, feeling of well-being)
• headache, tremor
• vomiting, constipation, dry mouth, diarrhea, abdominal pain, bloating
• itching, sweating (excessive sweating) vomiting.

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

• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not really there), memory lapses
• numbness or tingling in the limbs, involuntary muscle tremors
• ringing in the ears
• increased heart rate or blood pressure, heart rhythm disorders
• breathing difficulties
• difficulty swallowing, blood in the stool
• skin reactions (e.g. rashes, hives)
• presence of albumin in the urine, difficulty or pain when urinating
• chills, hot flashes, chest pain
• increased liver enzyme values.

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

• delirium, drug dependence
• seizures, uncoordinated movements, transient loss of consciousness (fainting), speech disorders
• blurred vision, pinpoint pupils, excessive pupil dilation (pupil dilation).

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

• drug abuse.

Frequency not known(frequency cannot be estimated from the available data):

• decreased blood sugar levels
• hiccups
• serotonin syndrome, whose symptoms may include changes in mental status (e.g. agitation, hallucinations, coma) and 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 + Paracetamol Medreg").
• a serious condition that can cause the blood to become more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

In addition, the following side effects have been reported in people taking medicines containing only tramadol or only paracetamol:

• feeling faint when standing up from a lying or sitting position, slow heartbeat, fainting
• changes in appetite
• muscle weakness, slower or weaker breathing
• mood changes, changes in activity, changes in perception
• worsening of existing asthma
• nosebleeds or bleeding gums, which may be due to a low platelet count
• very rare cases of severe skin reactions have been reported after taking paracetamol
• rare cases of respiratory depression have been reported when taking tramadol.

Rarely, people who have taken a medicine containing tramadol may become dependent on it, making it difficult for them to stop taking it. In rare cases, people who have taken tramadol for some time may feel unwell after suddenly stopping treatment. They may feel agitated, restless, nervous or jittery. They may be overactive, have sleep problems and gastrointestinal disorders. Very few people also experience panic attacks, hallucinations, unusual sensations, such as itching, tingling and numbness, and ringing in the ears (tinnitus). If the patient experiences any of these symptoms after stopping this medicine, they should talk to their doctor.

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, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Tramadol + Paracetamol Medreg

The medicine should be stored out of sight and reach of children.
The medicine should be stored in a safe place, to which other people do not have access. It can cause serious harm and be fatal to people for whom it has not been prescribed.
There are no special precautions for storing the medicine.
The patient should not take this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
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 packaging and other information

What Tramadol + Paracetamol Medreg contains

• The active substances of the medicine are tramadol hydrochloride and paracetamol. Each coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• Other ingredients are: Tablet core: maize starch, corn starch, cellulose powder, carmellose sodium (type A), corn starch, magnesium stearate. Coating: Opadry yellow 15B32209 (hypromellose 2910/3cp, hypromellose 2910/6cp, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80).

What Tramadol + Paracetamol Medreg looks like and contents of the pack

Tramadol + Paracetamol Medreg coated tablets are yellow, capsule-shaped, biconvex coated tablets with dimensions of approximately 15.5 mm x 6.4 mm, with the inscription "C8" on one side and smooth on the other.
The coated tablets are supplied in non-transparent blisters of PVC/Aluminum, in a cardboard box.
Pack sizes: 10, 20, 30, 40, 50, 60, 90 and 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

Medreg s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

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

Poland:
Tramadol + Paracetamol Medreg
Czech Republic:
Tramadol/Paracetamol Medreg
Romania:
Tramadol/Paracetamol Gemax Pharma 37.5 mg/325 mg film-coated tablets
Slovakia:
Tramadol/Paracetamol Medreg

Date of last revision of the leaflet: 01/2025