TRAMAPAR 37.5 mg/325 mg Tablets

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET: USER INFORMATION
2. TRAMAPAR, 37.5 mg + 325 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. WHAT IS TRAMAPAR AND WHAT IS IT USED FOR
4. IMPORTANT INFORMATION BEFORE TAKING TRAMAPAR
   1. Warnings and precautions
   2. When not to take Tramapar
   3. When to exercise special caution when taking Tramapar
   4. Respiratory depression during sleep
   5. Tolerance, dependence, and addiction
   6. Tramapar and other medicines
   7. Taking other medicines
   8. Taking Tramapar with food and drink
   9. Pregnancy and breastfeeding
   10. Driving and using machines
   11. Tramapar contains sodium
5. HOW TO TAKE TRAMAPAR
   1. Use in children
   2. Taking a higher dose of Tramapar than recommended
   3. Missing a dose of Tramapar
   4. Stopping Tramapar
6. POSSIBLE SIDE EFFECTS
   1. In case of the following symptoms, the patient should immediately consult their doctor:
   2. Reporting side effects
7. HOW TO STORE TRAMAPAR
8. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Tramapar contains
   2. What Tramapar looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of revision of the leaflet:

PATIENT INFORMATION LEAFLET: USER INFORMATION

TRAMAPAR, 37.5 mg + 325 mg, coated tablets

(Tramadol hydrochloride + Paracetamol)

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS TRAMAPAR AND WHAT IS IT USED FOR

Tramapar is a combination medicine containing two painkillers - tramadol and paracetamol, which together relieve pain.
Tramapar is intended for the treatment of moderate or severe pain, when the doctor decides that a combination of tramadol and paracetamol is necessary.
Tramapar should only be used in adults and adolescents over 12 years of age.

2. IMPORTANT INFORMATION BEFORE TAKING TRAMAPAR

Warnings and precautions

Before starting to take Tramapar, the patient should discuss it with their doctor if they have:
Depression and are taking antidepressants, as some of them may interact with tramadol (see "Tramapar and other medicines").
After taking tramadol in combination with certain antidepressants or tramadol alone, there is a small risk of developing a condition called serotonin syndrome. If the patient experiences any symptoms of this serious condition, they should immediately consult their doctor (see section 4 "Possible side effects").

When not to take Tramapar

• If the patient is allergic (hypersensitive) to the active substances (tramadol hydrochloride, paracetamol) or any of the other ingredients of Tramapar (see section 6 "Contents of the pack and other information").
• If the patient has had allergic reactions (e.g. skin rash, facial swelling, wheezing or difficulty breathing) after taking tramadol or paracetamol or any of the other ingredients of Tramapar.
• In case of acute alcohol poisoning, sleeping pills, painkillers or other psychotropic medicines (medicines that affect mood and emotions).
• If the patient is taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression or Parkinson's disease) or has taken them within 14 days before starting treatment with Tramapar.
• If the patient has severe liver disease.
• If the patient has epilepsy that is not well controlled with their medication.

When to exercise special caution when taking Tramapar

If the patient experiences any of the following symptoms while taking Tramapar, they should tell their doctor or pharmacist:

• If the patient is taking other medicines containing paracetamol or tramadol.
• If the patient has liver disorders or liver disease, or if they experience yellowing of the eyes or skin. These may be symptoms of jaundice or bile duct disorders.
• If the patient has impaired kidney function.
• If the patient has severe breathing difficulties, such as asthma or severe lung disease.
• If the patient has epilepsy or has had seizures.
• If the patient has recently had a head injury, concussion, or severe headaches accompanied by vomiting.
• If the patient is addicted to any medicines, including painkillers such as morphine.
• If the patient is taking other painkillers containing buprenorphine, nalbuphine, or pentazocine.
• If the patient is to undergo anesthesia. The patient should tell their doctor or dentist that they are taking Tramapar,
• Excessive tiredness, 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 consult their doctor, who will decide whether the patient needs hormone replacement therapy.

The patient should inform their doctor if any of the above situations have occurred in the past or occur while taking Tramapar. The doctor will decide whether the patient can continue taking the medicine.

Respiratory depression during sleep

Tramapar may cause respiratory depression 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 the patient or another person observes these symptoms, they should consult their doctor. The doctor may prescribe a dose reduction.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can lead to decreased effectiveness of the medicine (the patient's body gets used to the medicine, which is called tolerance). Repeated use of Tramapar can also lead to dependence, abuse, and addiction, which can cause life-threatening overdose. The risk of these side effects may increase with the dose and duration of treatment.
Dependence or addiction can cause the patient to lose control over the amount of medicine they take or how often they take it.
The risk of dependence on Tramapar is different for different people. A higher risk of dependence on Tramapar may apply to people in the following situations:

• the patient or someone in their family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction");
• the patient is a 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 Tramapar, it may indicate dependence or addiction.

• Need to take the medicine for a longer period than prescribed by the doctor.
• Need to take a higher dose than prescribed.
• 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, the patient feels unwell, and after taking it again, they feel better ("withdrawal symptoms"). If the patient notices any of these symptoms, they should consult their doctor to discuss the best treatment option, including when to stop taking the medicine and how to do it safely (see section 3 "Stopping Tramapar").

Tramapar and other medicines

Taking 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.
Important:the medicine contains paracetamol and tramadol. The patient should tell their doctor if they are taking other medicines containing paracetamol or tramadol, to avoid exceeding the maximum daily doses.
Tramapar should not be taken at the same time as monoamine oxidase inhibitors (MAOIs) (see "When not to take Tramapar").
It is not recommended to take Tramapar with the following medicines:

• carbamazepine (a medicine used to treat epilepsy or certain types of pain, such as severe facial pain, called trigeminal neuralgia);
• buprenorphine, nalbuphine, or pentazocine (opioid painkillers). The pain-relieving effect may be weakened.

The risk of side effects increases when taking certain antidepressants, Tramapar may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
The effect of Tramapar may be altered if the patient is also taking:

• metoclopramide, domperidone, or ondansetron (used to treat nausea and vomiting);
• cholestyramine (a medicine that lowers cholesterol levels in the blood);
• ketokonazole or erythromycin (antibiotics).

The doctor will advise which medicines can be safely taken with Tramapar.

Taking Tramapar with food and drink

Tramapar may cause drowsiness. As alcohol can increase drowsiness, the patient should avoid drinking alcohol while taking Tramapar.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine is contraindicated during pregnancy. If pregnancy is detected during treatment with Tramapar, the patient should consult their doctor before taking further doses.
Breastfeeding
Small amounts of tramadol may pass into breast milk. Therefore, the patient should not take this medicine while breastfeeding.
Tramadol is excreted into human milk. For this reason, the patient should not take Tramapar more than once while breastfeeding, or if they take Tramapar more than once, they should stop breastfeeding.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Tramapar may cause drowsiness, which can affect the ability to drive or operate machines.
If the patient feels tired, they should not drive or operate machines.

Tramapar contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it can be considered "sodium-free".

3. HOW TO TAKE TRAMAPAR

Tramapar should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Before starting treatment and regularly during treatment, the doctor will discuss with the patient what to expect from taking Tramapar, when and for how long to take it, when to contact the doctor, and when to stop taking the medicine (see also section 2).
Dosage
Tramapar should be taken for as short a time as possible.
Unless the doctor has prescribed otherwise, the usual dose for adults and adolescents over 12 years of age is 2 tablets.
If necessary, the patient can take further doses according to the doctor's instructions. The minimum interval between doses must be at least 6 hours.
The patient should not take more than 8 Tramapar coated tablets per day.
The patient should not take Tramapar more frequently than prescribed by the doctor.
The doctor may increase the interval between doses in patients:

• over 75 years of age,
• with impaired kidney function or
• with impaired liver function.

Method of administration
The tablets should be taken orally.
The tablets should be swallowed whole, with a sufficient amount of liquid.
The patient should not divide or chew the tablets.
If the patient thinks that the effect of Tramapar is too strong (e.g. they feel increased drowsiness or have difficulty breathing) or too weak (i.e. they still feel pain), they should consult their doctor.

Use in children

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

Taking a higher dose of Tramapar than recommended

The patient should immediately consult their doctor or pharmacist, even if they feel well.
There is a risk of liver damage, which may become apparent later.

Missing a dose of Tramapar

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

Stopping Tramapar

Usually, no withdrawal symptoms are experienced when stopping Tramapar. However, in rare cases, people taking tramadol for a long time may feel unwell after suddenly stopping treatment (see section 4 "Possible side effects").
If the patient has been taking Tramapar for a long time, before stopping treatment, they should consult their doctor, as they may have become dependent on the medicine.
In case of any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tramapar can cause side effects, although not everybody gets them.

In case of the following symptoms, the patient should immediately consult their doctor:

• skin rash indicating an allergic reaction with sudden swelling of the face and neck, difficulty breathing, or low blood pressure and fainting;
• prolonged or unexpected bleeding caused by taking Tramapar with medicines that reduce blood clotting (e.g. coumarin, warfarin); the risk of bleeding may increase.

The following side effects have been reported with the following frequencies, defined as follows:
Very common:
occur in more than 1 in 10 patients,
Common:
occur in 1 to 10 in 100 patients,
Uncommon: occur in 1 to 10 in 1000 patients,
Rare:
occur in 1 to 10 in 10,000 patients,
Very rare: occur in less than 1 in 10,000 patients,
Frequency not known: frequency cannot be estimated from the available data.
Very common:

• nausea,
• dizziness, drowsiness.

Common:

• vomiting,
• gastrointestinal disorders (constipation, bloating, diarrhea),
• stomach pain,
• dry mouth,
• itching,
• sweating,
• headache,
• tremors,
• confusion,
• sleep disorders,
• mood changes (anxiety, nervousness, euphoria).

Uncommon:

• rapid heartbeat or increased blood pressure,
• heart rhythm disorders,
• difficult or painful urination,
• skin changes (e.g. rashes, hives),
• tingling, numbness, or prickling of limbs,
• ringing in the ears,
• muscle cramps,
• depression,
• nightmares,
• hallucinations (hearing, seeing, or feeling things that are not there),
• temporary memory problems,
• difficulty swallowing,
• blood in the stool,
• chills,
• flushing,
• chest pain,
• breathing difficulties.

Rare:

• seizures,
• difficulty coordinating movements,
• dependence,
• blurred vision.

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

• hiccups,
• serotonin syndrome, the symptoms of which may include changes in mental state (e.g. agitation, hallucinations, coma), as well as other symptoms, such as fever, rapid heartbeat, 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 Tramapar").

Others:
The following side effects have been reported by people taking medicines containing only tramadol or only paracetamol. If the patient experiences any of these symptoms while taking Tramapar, they should tell their doctor:

• feeling of fainting when changing position from lying or sitting to standing,
• slow heartbeat,
• fainting,
• changes in appetite,
• muscle weakness,
• slower or shallower breathing,
• mood changes,
• changes in activity,
• changes in perception,
• worsening of asthma.

In rare cases, taking medicines like tramadol can lead to dependence on the medicine, making it difficult to stop taking it.
People who have been taking tramadol for a long time may sometimes feel unwell after suddenly stopping treatment.
They may feel anxious, nervous, or agitated. They may be overactive, have difficulty sleeping, and experience stomach or gastrointestinal disorders. In rare cases, patients may experience panic attacks, hallucinations, unusual feelings such as itching, tingling, and numbness, and ringing in the ears. If the patient experiences any of these symptoms after stopping Tramapar, they should consult their doctor.
In exceptional cases, blood test results may be abnormal, e.g. indicating a low platelet count, which can cause bleeding from the nose or gums.

Reporting side effects

If the patient experiences any side effects, including any 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
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.
If any of the side effects get worse or if the patient experiences any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

5. HOW TO STORE TRAMAPAR

The medicine should be kept out of the reach and sight of children.
This medicine should be stored in a closed and secure place, to which other people do not have access. It can cause serious harm and be fatal to people it has not been prescribed for.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Tramapar contains

• The active substances of Tramapar are tramadol hydrochloride and paracetamol. One coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients are: cellulose, powder, maize starch, sodium starch glycolate (type A), maize starch, magnesium stearate. Coating: Opadry Yellow YS-1-6382G [hypromellose, titanium dioxide (E 171), macrogol 400, yellow iron oxide (E 172), polysorbate 80], carnauba wax.

What Tramapar looks like and contents of the pack

Tramapar is a light yellow, oblong, coated tablet.
The pack contains 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

Date of revision of the leaflet: