Tramadol + paracetamol medreg

Package leaflet: Information for the patient

Tramadol + Paracetamol Medreg, 37.5 mg + 325 mg, film-coated tablets
Tramadoli hydrochloridum + Paracetamolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Tramadol + Paracetamol Medreg is and what it is 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 pack and other information

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

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

2. Important information before using Tramadol + Paracetamol Medreg

When not to use Tramadol + Paracetamol Medreg:

• if the patient is allergic to paracetamol, tramadol or any of the other ingredients of this medicine (listed in section 6)
• in case of acute intoxication with alcohol, sedatives, analgesics or drugs affecting mood and emotions
• if the patient is taking or has taken within the last 14 days medicines called monoamine oxidase inhibitors (MAOIs) before starting Tramadol + Paracetamol Medreg. MAOI medicines are used in the treatment of depression or Parkinson's disease.
• if the patient has severe liver disease
• if the patient has epilepsy which is not adequately controlled by current medication.

Warnings and precautions
Before starting to take Tramadol + Paracetamol Medreg, discuss this with your
doctor or pharmacist.

• if the patient is taking other medicines containing paracetamol or tramadol
• in patients with liver disease or alcoholic liver damage, or if yellowing of the eyes and skin occurs, which may indicate jaundice or biliary tract disease
• in patients with kidney disease
• in patients with breathing difficulties, e.g. asthma or lung problems
• in patients with epilepsy or who have experienced seizures or epileptic fits
• if the patient has depression and is taking antidepressant medicines, because some of them may interact with tramadol (see "Tramadol + Paracetamol Medreg and other medicines")
• if the patient has recently suffered a head injury, shock or severe headaches associated with vomiting
• in patients dependent on other medicines, e.g. morphine
• if the patient is taking other painkillers containing buprenorphine, nalbuphine or pentazocine
• if the patient is to undergo anaesthesia (medicines used in local or general anaesthesia, e.g. during surgery). Inform the doctor or dentist about taking Tramadol + Paracetamol Medreg.

If any of the above points apply to a patient who has previously or
currently takes Tramadol + Paracetamol Medreg, ensure that the doctor has been
informed. The doctor may then decide whether to continue treatment with this medicine.
Taking tramadol in combination with certain antidepressants or tramadol alone
carries a small risk of a condition called serotonin syndrome. If the patient develops
any symptoms of this serious condition, they should seek immediate medical advice
(see section 4 "Possible side effects").
Tolerance, dependence and addiction
This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may
cause the medicine to become less effective (the patient becomes accustomed to the medicine, known as
tolerance). Repeated use of Tramadol + Paracetamol Medreg may also lead to
development of dependence, abuse and addiction, which may result in life-threatening
overdose. The risk of these adverse effects may increase with dose and prolonged
duration of use.
Dependence may cause the patient to lose control over the dose or frequency of
medicine intake.
The risk of dependence varies among individuals. The risk of dependence on Tramadol + Paracetamol
Medreg may be higher if:

• The patient or a family member has ever abused or been dependent on alcohol, prescription medicines or illegal drugs ("addiction").
• The patient smokes tobacco.
• The patient has ever had mood disorders (depression, anxiety or personality disorders) or has been treated by a psychiatrist for other mental illnesses.

If any of the following symptoms occur while taking Tramadol + Paracetamol Medreg,
this may indicate dependence:

• The patient needs to take the medicine longer than prescribed by the doctor.
• The patient needs to take a higher dose than recommended.
• The patient uses the medicine for reasons other than prescribed, e.g. "to calm down" or "to help sleep".
• The patient has made repeated 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 any of these symptoms occur, talk to the doctor to discuss the best treatment
approach, including when and how to stop the medicine safely (see section 3 "Stopping Tramadol + Paracetamol Medreg").
Sleep-related breathing disorders
Tramadol + Paracetamol Medreg may cause sleep-related breathing disorders, such as
sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in 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, contact the doctor. The doctor may recommend reducing the dose.
If any of the following symptoms occur during treatment with Tramadol +
Paracetamol Medreg, inform the doctor, pharmacist or nurse:
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 metabolised in the liver by an enzyme. Some individuals have a genetic variation 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.
Stop taking the medicine and contact the doctor immediately if any of the following adverse effects occur:
slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, loss of appetite.
During treatment with Tramadol + Paracetamol Medreg, inform the doctor immediately:
If the patient has serious conditions, including severe kidney dysfunction or sepsis
(when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Cases of a serious condition called metabolic acidosis (a disturbance in blood and body fluids) have been reported in patients taking paracetamol regularly over a long period or taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.
Children and adolescents
This medicine is not intended for use in children under 12 years of age.
Use of tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be intensified in them.
Tramadol + Paracetamol Medreg and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
This medicine contains paracetamol and tramadol. Inform the doctor about taking other
medicines containing paracetamol or tramadol to avoid exceeding the maximum
daily dose.
Concomitant use of Tramadol + Paracetamol Medreg with monoamine oxidase inhibitors (MAOIs) is
contraindicated (see section "When not to use Tramadol + Paracetamol Medreg").
Inform the doctor or pharmacist if the patient is taking:

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

Do not take Tramadol + Paracetamol Medreg with monoamine oxidase inhibitors
(MAOIs) (see section "When not to use Tramadol + Paracetamol Medreg").
Concomitant use of Tramadol + Paracetamol Medreg with the following medicines is not recommended:

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

The risk of adverse effects is increased:

• if the patient is taking triptans (medicines used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs, medicines used to treat depression). Contact the doctor if confusion, agitation (especially motor restlessness), fever, excessive sweating, uncontrolled limb or eye movements, uncontrolled muscle contractions or diarrhoea occur.
• if the patient is taking sedatives, sleeping pills, other painkillers such as morphine and codeine (also used to treat cough), baclofen (a muscle relaxant), antihypertensives, antidepressants or antihistamines. Contact the doctor if drowsiness or fainting occurs.
• concomitant use of Tramadol + Paracetamol Medreg and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and may be life-threatening. Therefore, concomitant use should only be considered if other treatment options are not possible. If the doctor prescribes Tramadol + Paracetamol Medreg together with sedatives, the doctor should limit the dose and duration of combined treatment. Inform the doctor about all sedatives being taken and strictly follow the doctor's dosing instructions. It may be helpful to inform friends or family members to be aware of the above signs and symptoms. If such symptoms occur, contact the doctor.
• if the patient is taking gabapentin or pregabalin for epilepsy or nerve-related pain (neuropathic pain).
• if the patient is taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if the patient takes Tramadol + Paracetamol Medreg at the same time. The doctor will advise whether Tramadol + Paracetamol Medreg is suitable for the patient.
• if the patient is taking certain antidepressants. Tramadol + Paracetamol Medreg may interact with these medicines and cause serotonin syndrome (see section 4 "Possible side effects").
• if the patient is taking warfarin or phenprocoumon (medicines used to thin the blood). The effect of these medicines may change and bleeding may occur (see section 4).

The effect of Tramadol + Paracetamol Medreg may be altered if taken
concomitantly with the following medicines:

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

Tramadol + Paracetamol Medreg and alcohol
Do not drink alcohol while taking Tramadol + Paracetamol Medreg, as drowsiness may occur.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Since Tramadol + Paracetamol Medreg contains tramadol, it should not be taken during
pregnancy.
If pregnancy occurs during treatment with Tramadol + Paracetamol Medreg, discuss with the doctor before taking further tablets.
Breastfeeding
Tramadol passes into human milk. Therefore, while breastfeeding, this medicine should not be taken more than once, or if the patient takes it more than once, breastfeeding should be discontinued.
Fertility
Based on human experience, tramadol is not expected to affect fertility in women or men. There are no data on the effect of the combination of tramadol and paracetamol on fertility.
Driving and operating machinery
Tramadol + Paracetamol Medreg may affect the ability to drive and operate machinery. If dizziness or drowsiness occurs, do not drive or operate machinery.
Tramadol + Paracetamol Medreg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tramadol + Paracetamol Medreg

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 treatment, the doctor will discuss with the patient what to expect from using Tramadol + Paracetamol Medreg, when and for how long it should be taken, when to contact the doctor, and when it should be discontinued (see also section 2).
Dosage should be adjusted according to the intensity of pain and individual sensitivity to pain. Generally, the lowest effective dose that relieves pain should be used.
Tramadol + Paracetamol Medreg should be taken for as short a time as possible and not longer than prescribed by the doctor.

Adults and adolescents over 12 years of age
The recommended initial dose, unless otherwise directed by a physician, is 2 adult tablets for adults and adolescents over 12 years of age. If needed, further doses may be taken according to the doctor's instructions.
The minimum interval between doses must be at least 6 hours. Do not take more than 8 tablets per day.
Do not take this medicine more frequently than prescribed by a doctor.

Use in children
Use in children under 12 years of age is not recommended.

Elderly patients
In elderly patients (over 75 years of age), elimination of Tramadol + Paracetamol Medreg may be delayed. In such cases, the doctor may recommend extending the intervals between doses.

Patients with hepatic or renal impairment or patients undergoing dialysis
Patients with severe hepatic and/or renal impairment should not take Tramadol + Paracetamol Medreg. If the patient has mild or moderate hepatic and/or renal impairment, the doctor may recommend longer intervals between doses.

Method of administration
The tablets are intended for oral use.
Swallow the tablets whole with sufficient liquid. Do not break or chew the tablets.

If the patient feels that the effect of Tramadol + Paracetamol Medreg is too strong (experiencing excessive drowsiness or breathing difficulties) or too weak (inadequate pain relief), they should contact their doctor.

Taking a higher than recommended dose of Tramadol + Paracetamol Medreg
If an overdose of this medicine is taken, even if feeling well, contact a doctor immediately. This is because excessive amounts of paracetamol may cause delayed, serious liver damage.

Missing a dose of Tramadol + Paracetamol Medreg
If a patient forgets to take a tablet, pain may return.
Do not take a double dose to make up for a missed dose. If a dose is missed, take the next tablet at the usual time.

Stopping treatment with Tramadol + Paracetamol Medreg
Do not suddenly stop using this medicine unless directed by a doctor.
Generally, after discontinuing treatment with Tramadol + Paracetamol Medreg, no side effects are expected. However, if a patient wishes to stop taking the medicine, especially after long-term use, this should be discussed with the doctor.
The doctor will advise when and how to discontinue the medicine; this may involve gradually reducing the dose to minimize the likelihood of adverse effects (withdrawal symptoms) (see section 4 "Possible side effects").

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. If any of the following symptoms occur, contact your doctor immediately:

• Rare cases of skin rash indicating an allergic reaction, with sudden swelling of the face and neck, difficulty breathing, or drop in blood pressure and fainting. If this occurs, treatment must be discontinued. Do not take the medicine again.
• Prolonged or unexpected bleeding when Tramadol + Paracetamol Medreg is used together with anticoagulant medicines (e.g. warfarin, phenprocoumon).

Other possible adverse reactions include:
Very common (may affect more than 1 in 10 patients):

• Dizziness, drowsiness
• Nausea

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

• Confusion, sleep disorders, mood changes (anxiety, restlessness, feeling of well-being)
• Headache, tremor
• Vomiting, constipation, dry mouth, diarrhoea, abdominal pain, bloating
• Itching, sweating (excessive sweating), vomiting

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

• Depression, nightmares, hallucinations (hearing, seeing or sensing things that are not really there), memory impairment
• Numbness or tingling sensation in the limbs, involuntary muscle tremor
• Tinnitus (ringing in the ears)
• Increased heart rate or blood pressure, disturbances in heart function or heart rhythm
• Difficulty breathing
• Difficulty swallowing, blood in stool
• Skin reactions (e.g. rashes, urticaria)
• Presence of albumin in urine, difficulty or pain when urinating
• Chills, hot flushes, chest pain
• Increased liver enzyme levels

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

• Delirium, drug dependence
• Seizures, uncoordinated movements, transient loss of consciousness (fainting), speech disorders
• Blurred vision, pinpoint pupils (miosis), excessive dilation of the pupils (mydriasis)

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

• Misuse of the medicine

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

• Decreased blood sugar levels
• Hiccups
• Serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), as well as 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 + Paracetamol Medreg").
• A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Additionally, the following adverse reactions have been reported in patients 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 pre-existing asthma
• Nosebleeds or bleeding gums, which may be due to low platelet count
• Very rare cases of severe skin reactions have been reported after use of paracetamol
• Rare cases of respiratory depression have been reported during use of tramadol

Rarely, people who have taken a medicine containing tramadol may become dependent on it, making it difficult to stop taking it. In rare cases, people who have taken tramadol for some time may feel unwell after abruptly stopping treatment. They may feel agitated, restless, nervous, or shaky. They may be hyperactive, have trouble sleeping, and experience gastrointestinal or intestinal disturbances. Very few people may also experience panic attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and ringing in the ears (tinnitus). If any of these symptoms occur after stopping this medicine, talk to your doctor.

Reporting of adverse reactions
If any adverse reactions occur, including any 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, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Tramadol + Paracetamol Medreg

Keep the medicine out of the sight and reach of children.
The medicine should be stored in a safe place inaccessible to others. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
There are no special storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack 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 package and other information

What TramadoParacetamol Medreg contains

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

What Tramadol + Paracetamol Medreg looks like and contents of the pack
Tramadol + Paracetamol Medreg coated tablets are light yellow, capsule-shaped, biconvex coated tablets measuring approximately 15.5 mm x 6.4 mm, with the imprint "C8" on one side and smooth on the other.
The coated tablets are supplied in opaque PVC/aluminum blisters, packed 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 Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised 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