Tramapar

TRAMAPAR, 37.5 mg + 325 mg, 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 for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What TRAMAPAR is and what it is used for
2. What you need to know 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 TRAMAPAR IS AND WHAT IT IS USED FOR

TRAMAPAR is a combination medicine containing two analgesics – tramadol and paracetamol – which together help relieve pain.
TRAMAPAR is intended for the treatment of moderate to severe pain when the doctor has determined that a combination of tramadol and paracetamol is necessary.
TRAMAPAR should be used only in adults and adolescents above 12 years of age.

2. IMPORTANT INFORMATION BEFORE USING TRAMAPAR

When not to use Tramapar

• If the patient is allergic (hypersensitive) to tramadol, paracetamol, or any of the other ingredients of Tramapar (listed in section 6).
• If the patient has previously experienced allergic reactions (e.g. skin rash, facial swelling, wheezing or breathing difficulties) after taking tramadol, paracetamol, or any of the other ingredients of Tramapar.
• In cases of acute alcohol intoxication, sedatives, analgesics, or other psychotropic medicines (medicines affecting mood and emotions).
• If the patient is currently 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 adequately controlled with medication.

When to exercise special caution when using Tramapar
Before starting Tramapar, discuss this with your doctor or pharmacist.
If any of the following symptoms occur during treatment with Tramapar, inform your 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 yellowing of the eyes or skin occurs. These may be signs of jaundice or bile duct disorders.
• If the patient has impaired kidney function.
• If the patient has serious breathing problems, such as asthma or severe lung disease.
• If the patient has epilepsy or has previously had seizures.
• If the patient has recently suffered a head injury, concussion, or severe headaches accompanied by vomiting.
• If the patient is dependent on any medicines, including painkillers such as morphine.
• If the patient is taking other painkillers containing buprenorphine, nalbuphine, or pentazocine.
• If the patient is due to undergo anesthesia. Inform the doctor or dentist about taking Tramapar.
• Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact a doctor, who will decide whether hormone replacement is necessary.

During treatment with Tramapar, contact your doctor immediately if:

• The patient suffers from depression and is taking antidepressants, as some of these may interact with tramadol (see “Tramapar with other medicines”).
• The patient has serious illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or is also taking flucloxacillin (an antibiotic). Cases of a serious condition called metabolic acidosis (a blood and fluid imbalance) have been reported in patients taking paracetamol regularly over a long period or taking paracetamol together with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties, including rapid deep breathing, drowsiness, nausea, and vomiting.

Inform your doctor if any of the above situations have affected the patient in the past or occur during treatment with Tramapar. The doctor will decide whether the patient can continue treatment with this medicine.
Sleep-related breathing disorders
Tramapar may cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels).
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 a doctor. The doctor may recommend reducing the dose.
Tolerance, dependence, and abuse
This medicine contains tramadol, an opioid medicine. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient’s body becomes accustomed to the medicine, known as tolerance). Repeated use of Tramapar may also lead to dependence, misuse, and abuse, which may result in life-threatening overdose. The risk of these adverse effects may increase with higher doses and longer duration of treatment.
Dependence or abuse may cause the patient to lose control over the amount or frequency of medicine intake.
The risk of dependence or abuse varies among individuals. Higher risk of dependence on Tramapar may occur in individuals in the following situations:

• The patient or a family member has ever misused 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, this may indicate dependence or abuse.

• Needing to take the medicine for longer than prescribed by the doctor.
• Needing to take a higher dose than prescribed.
• The patient uses the medicine for reasons other than those for which it was prescribed, e.g., “to calm down” or “to sleep better.”
• The patient has made multiple unsuccessful attempts to stop or control medicine use.
• After stopping the medicine, the patient feels unwell, and feels better after taking the medicine again (“withdrawal effects”). If the patient notices any of these symptoms, they should consult a doctor to discuss the best treatment approach, including when and how to stop taking the medicine safely (see section 3 “Stopping Tramapar”).

There is a small risk of developing serotonin syndrome after taking tramadol in combination with certain antidepressants or tramadol alone. If the patient experiences any symptoms of this serious condition, they should seek immediate medical advice (see section 4 “Possible side effects”).

Tramapar with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Important: This medicine contains paracetamol and tramadol. Inform your doctor if the patient is taking other medicines containing paracetamol or tramadol to avoid exceeding the maximum daily doses.
Tramapar must not be taken simultaneously with monoamine oxidase inhibitors (MAOIs) (see section “When not to use Tramapar”).
The use of Tramapar is not recommended with the following medicines:

• Carbamazepine (a medicine used to treat epilepsy or certain types of pain, such as severe facial pain known as trigeminal neuralgia);
• Buprenorphine, nalbuphine, or pentazocine (opioid painkillers). Pain relief may be reduced.

The risk of adverse effects increases when Tramapar is taken together with the following medicines:

• Triptans (used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs) (used to treat depression). If confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle spasms, or diarrhea occur, contact a doctor.
• Sedatives, hypnotics, other painkillers such as morphine and codeine (including in cough medicines), baclofen (a muscle relaxant), blood pressure-lowering medicines, antidepressants, or medicines used to treat allergies. Drowsiness or weakness may occur. Inform the doctor if these symptoms occur.
• Antidepressants, anesthetics, neuroleptics (medicines affecting mental state), or bupropion (a medicine to help quit smoking). The risk of seizures may increase. The doctor will decide whether Tramapar can be used.
• Warfarin or phenprocoumon (medicines that reduce blood clotting). The effect of these medicines may change, leading to bleeding. Any episodes of prolonged or unexpected bleeding should be reported to the doctor immediately.
• Gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain).

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 blood cholesterol levels);
• Ketoconazole or erythromycin (antibiotics).

Paracetamol with other medicines
Inform your doctor or pharmacist if the patient is taking:

• Flucloxacillin (an antibiotic) due to a serious blood and fluid imbalance (called metabolic acidosis), which requires urgent treatment (see section 2).

Your doctor will advise which medicines can be safely taken together with Tramapar.
Tramapar with food, drink, and alcohol
Tramapar may cause drowsiness. Since alcohol may increase drowsiness, alcohol should be avoided during treatment with Tramapar.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Tramadol is excreted in breast milk. Therefore, Tramapar should not be taken more than once during breastfeeding. If the patient takes Tramapar more than once, an alternative is to stop breastfeeding.
Small amounts of tramadol may pass into breast milk. Therefore, this medicine should not be used during breastfeeding.
Studies on the effects of the combination of tramadol and paracetamol on fertility have not been conducted.
Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
Tramapar may cause drowsiness, which may affect the ability to drive or operate machinery.
If the patient feels tired, they should not drive or operate machinery.
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 USE TRAMAPAR

Tramapar should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from using Tramapar, when and for how long to take it, when to contact your doctor, and when to discontinue the medicine (see also section 2).

Dosage
Tramapar should be used for the shortest possible duration.
Unless otherwise advised by your doctor, the usual dose for adults and adolescents over 12 years of age is 2 tablets.
If needed, further doses may be taken according to your doctor’s instructions. The minimum interval between doses must be at least 6 hours.
Do not take more than 8 coated Tramapar tablets per day.
Do not take Tramapar more frequently than prescribed by your doctor.

Your doctor may increase the interval between doses in patients:

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

Tramapar should not be taken in cases of severe kidney failure. Tramadol is eliminated very slowly during hemodialysis or hemofiltration; therefore, administration of the medicine after dialysis to maintain analgesia is usually not necessary.

Method of administration
The tablets should be taken orally.
Swallow the tablets whole with an adequate amount of liquid.
Do not divide or chew the tablets.

If you feel that the effect of Tramapar is too strong (e.g. you experience increased drowsiness or have breathing difficulties) or too weak (i.e. you still feel pain), contact your doctor.

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

Overdose of Tramapar
Seek immediate medical advice from a doctor or go to a hospital emergency department, even if you feel well. There is a risk of liver damage, which may manifest later.

Missed dose of Tramapar
If you miss a dose, pain may return. Do not take a double dose to make up for a missed dose. Take the next tablet at the usual time.

Stopping Tramapar
Usually, no withdrawal effects are experienced when stopping Tramapar. However, in rare cases, individuals who have taken tramadol for a prolonged period may feel unwell after abruptly stopping treatment (see section 4 "Possible side effects").
If you have been taking Tramapar for a long time, consult your doctor before stopping treatment, as physical dependence may have developed.

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 experiences them.
If any of the following symptoms occur, contact your doctor immediately:

• 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 concomitant use of Tramapar with medicines that reduce blood clotting (e.g. coumarin, warfarin); the risk of bleeding may increase.

Very common (may occur in more than 1 in 10 patients):

• nausea,
• dizziness, drowsiness.

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

• vomiting,
• gastrointestinal disturbances (constipation, bloating, diarrhoea),
• stomach pain,
• dry mouth,
• itching,
• sweating,
• headache,
• tremor,
• confusion,
• sleep disturbances,
• mood changes (anxiety, nervousness, euphoria).

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

• increased heart rate or elevated blood pressure,
• disturbances in heart function or rhythm,
• difficulty or pain when urinating,
• skin reactions (e.g. rashes, hives),
• tingling, numbness or pins and needles in the 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 stool,
• chills,
• hot flushes,
• chest pain,
• difficulty breathing.

Rare (may occur in up to 1 in 1000 patients):

• seizures,
• difficulty with coordination,
• dependence, delirium,
• blurred vision, pupil constriction,
• excessive pupil dilation.

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

• drop in blood sugar levels (hypoglycaemia),
• hiccups,
• serotonin syndrome, which may present with changes in mental state (e.g. agitation, hallucinations, coma) and other symptoms such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 "Important information before taking Tramapar"),
• serious condition causing the blood to become more acidic (so-called metabolic acidosis) in patients with severe illness taking paracetamol (see section 2).

Others:
The following adverse reactions have been reported by individuals using medicines containing tramadol only or paracetamol only. If any of these symptoms occur while taking Tramapar, inform your doctor:

• feeling faint when changing position from lying down or sitting to standing,
• slowed heart rate,
• fainting,
• changes in appetite,
• muscle weakness,
• slower or shallower breathing,
• mood changes,
• changes in activity,
• perceptual disturbances,
• worsening of asthma.

In rare cases, use of medicines such as tramadol may lead to drug dependence, making discontinuation difficult.
Patients who have used tramadol long-term may sometimes feel unwell after abruptly stopping treatment.
They may experience agitation, anxiety, nervousness or tremor. They may become hyperactive, have difficulty falling asleep, and experience gastrointestinal or digestive disturbances. In a few patients, anxiety attacks, hallucinations, unusual sensations such as itching, tingling and numbness, and ringing in the ears may occur. If any of these symptoms are experienced after stopping Tramapar, consult your doctor.
In exceptional cases, blood test results may be abnormal, e.g. indicating a low platelet count, which may cause nosebleeds or bleeding gums.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 authorisation holder.

5. HOW TO STORE TRAMAPAR

Keep this medicine out of the sight and reach of children.
This medicine should be stored in a closed and secure place inaccessible to others. It may cause serious harm and be fatal to individuals for whom it has not been prescribed.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Tramapar contains

• The active substances in this medicinal product are: tramadol hydrochloride and paracetamol.

One film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• Other ingredients are: microcrystalline cellulose, pregelatinized starch, sodium carboxymethyl starch (type A), maize starch, magnesium stearate.
  Coating: Opadry Yellow YS-1-6382G [hypromellose, titanium dioxide (E 171), polyethylene glycol 400, iron oxide yellow (E 172), polysorbate 80], carnauba wax.

What Tramapar looks like and contents of the pack
Tramapar is a film-coated tablet, light yellow in colour and oblong in shape.
Pack sizes contain 10, 20, 30, 40, 50, 60, 70, 80, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]