Tramadol hydrochloride + paracetamol accord

Package leaflet: Information for the patient

Tramadol hydrochloride + Paracetamol Accord, 37.5 mg + 325 mg, effervescent tablets
Tramadoli hydrochloridum + Paracetamolum
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

2. Important information before taking Tramadol hydrochloride + Paracetamol Accord

3. How to take Tramadol hydrochloride + Paracetamol Accord

4. Possible side effects

5. How to store Tramadol hydrochloride + Paracetamol Accord

6. Contents of the pack and other information

7. What Tramadol hydrochloride + Paracetamol Accord is and what it is used for

Tramadol hydrochloride + Paracetamol Accord is a combination medicine containing two pain-relieving agents: tramadol hydrochloride and paracetamol, which work together to relieve pain.
Tramadol hydrochloride + Paracetamol Accord is indicated for the treatment of moderate to severe pain, when your doctor considers it necessary to use tramadol hydrochloride in combination with paracetamol.
Tramadol hydrochloride + Paracetamol Accord is intended for use in adults and adolescents aged 12 years and older.

2. Important information before taking Tramadol hydrochloride + Paracetamol Accord

Do not take Tramadol hydrochloride + Paracetamol Accord:

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• in cases of acute alcohol intoxication, sedatives, opioids, or other psychotropic medicines (used in the treatment of psychiatric disorders),
• when taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson’s disease), or within 14 days after stopping them,
• in severe hepatic impairment,
• in patients with treatment-resistant epilepsy.

Warnings and precautions
Before starting Tramadol hydrochloride + Paracetamol Accord, discuss with your doctor if:

• you have depression and are taking antidepressants, as some of them may interact with tramadol (see “Tramadol hydrochloride + Paracetamol Accord and other medicines”);
• you are taking other medicines containing paracetamol or tramadol hydrochloride;
• you have liver problems or liver disease, or if you notice yellowing of the eyes or skin. This may be due to jaundice or biliary tract disease;
• you have kidney problems;
• you have serious breathing difficulties, such as asthma or severe lung diseases;
• you have epilepsy or a history of seizures or convulsions;
• you have recently suffered a head injury, concussion, or severe headaches with associated vomiting;
• you are addicted to any medicines, including painkillers such as morphine;
• you are due to undergo anaesthesia. Inform your doctor or dentist that you are taking Tramadol hydrochloride + Paracetamol Accord.

If any of the above conditions applied to you in the past or occur during treatment with Tramadol hydrochloride + Paracetamol Accord, inform your doctor. Your doctor will decide whether treatment should continue.

Breathing problems during sleep
Tramadol hydrochloride + Paracetamol Accord contains an active substance belonging to the opioid group. Opioids may cause breathing problems during sleep, such as central sleep apnoea (shallow/intermittent breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). The risk of central sleep apnoea depends on the dose of the opioid. Your doctor may consider reducing the total opioid dose if you develop central sleep apnoea.
There is a small risk of developing serotonin syndrome when tramadol is taken alone or in combination with certain antidepressants.
If you experience any symptoms of this serious condition, seek immediate medical advice (see section 4 “Possible side effects”).

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may lead to different effects. In some individuals, pain relief may be insufficient, while in others, the risk of severe side effects may be higher. You should stop taking the medicine and contact your doctor immediately if you experience any of the following side effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Children and adolescents
Use in children with breathing disorders: tramadol is not recommended in children with breathing disorders, as tramadol toxicity symptoms may be more pronounced in them.
If you experience any of the following symptoms while taking Tramadol hydrochloride + Paracetamol Accord, inform your doctor, pharmacist, or nurse:
excessive tiredness, 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 your doctor, who will decide whether hormone replacement is necessary.

Tramadol hydrochloride + Paracetamol Accord and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Important: This medicine contains paracetamol and tramadol hydrochloride. Inform your doctor if you are taking other medicines containing paracetamol or tramadol hydrochloride to avoid exceeding the maximum daily doses.

Do not take Tramadol hydrochloride + Paracetamol Accord at the same time as monoamine oxidase inhibitors (MAOIs) (see section “When not to take Tramadol hydrochloride + Paracetamol Accord”).

Concomitant use of Tramadol hydrochloride + Paracetamol Accord is not recommended with:

• carbamazepine (commonly used as an antiepileptic and also for certain types of pain, such as severe facial pain known as trigeminal neuralgia);
• buprenorphine, nalbuphine, or pentazocine (opioid painkillers). The analgesic effect may be reduced.

Inform your doctor or pharmacist if you are taking:

• flucloxacillin (an antibiotic), due to the serious risk of a metabolic disorder with high anion gap metabolic acidosis, which requires urgent treatment and may occur particularly in patients with severe renal impairment, sepsis (a condition where bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and in patients taking maximum daily doses of paracetamol, especially if taking maximum daily doses of paracetamol for a prolonged period. Metabolic acidosis with high anion gap is a serious condition requiring urgent treatment.

The risk of adverse effects is higher:

• if you are taking triptans (medicines used to treat migraine) or selective serotonin reuptake inhibitors (SSRIs) (used to treat depression). If you experience confusion, agitation, fever, sweating, uncoordinated limb or eye movements, involuntary muscle contractions, or diarrhoea, contact your doctor.
• if you are taking other painkillers such as morphine and codeine (also in cough medicines), baclofen (a muscle relaxant), blood pressure-lowering medicines, or antihistamines. Contact your doctor if you experience drowsiness or fainting. Concurrent use of Tramadol hydrochloride + Paracetamol Accord with sedatives such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible. If your doctor prescribes Tramadol hydrochloride + Paracetamol Accord together with sedatives, your doctor should limit the dose and duration of combined treatment. Inform your doctor about all sedatives you are taking and strictly follow dosing instructions. It may be helpful to inform family or friends so they are aware of the possibility of the above-mentioned symptoms. If such symptoms occur, contact your doctor.
• if you are taking medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of seizures may increase if you take Tramadol hydrochloride + Paracetamol Accord together with these medicines. Your doctor should advise you whether Tramadol hydrochloride + Paracetamol Accord is suitable for you.
• if you are taking certain antidepressants, Tramadol hydrochloride + Paracetamol Accord may interact with them and cause serotonin syndrome (see section 4 “Possible side effects”).
• if you are taking warfarin or phenprocoumon (blood-thinning medicines). The effectiveness of these medicines may change, leading to bleeding. Any prolonged or unexpected bleeding requires immediate medical attention.

The effectiveness of Tramadol hydrochloride + Paracetamol Accord may be altered when taken concomitantly with:

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

Your doctor will decide which medicines can be safely taken together with Tramadol hydrochloride + Paracetamol Accord.

Tramadol hydrochloride + Paracetamol Accord, food, drink, and alcohol
Tramadol hydrochloride + Paracetamol Accord may cause drowsiness. Alcohol increases drowsiness; therefore, it is best not to drink alcohol while taking Tramadol hydrochloride + Paracetamol Accord.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Because Tramadol hydrochloride + Paracetamol Accord contains tramadol hydrochloride, it should not be used during pregnancy or breastfeeding. If you become pregnant while taking Tramadol hydrochloride + Paracetamol Accord, consult your doctor before taking further tablets.

Breastfeeding
Tramadol passes into breast milk. Therefore, Tramadol hydrochloride + Paracetamol Accord should not be taken more than once during breastfeeding, or, if you need to take Tramadol hydrochloride + Paracetamol Accord more than once, an alternative is to stop breastfeeding.

Based on human use of tramadol, it is suggested that tramadol does not affect fertility in men or women. There are no available data on the effect of combined tramadol and paracetamol treatment on fertility.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Tramadol hydrochloride + Paracetamol Accord may cause drowsiness, which may affect your ability to drive or operate tools and machinery safely.

Tramadol hydrochloride + Paracetamol Accord contains sodium
This medicine contains 10.06 mmol (or 231.49 mg) of sodium (the main component of table salt) in each effervescent tablet. This corresponds to 11.57% of the maximum recommended daily sodium intake in the diet of adults. Inform your doctor or pharmacist if you need to take 2 or more tablets daily for a prolonged period, especially if you are on a low-salt (low-sodium) diet.

Tramadol hydrochloride + Paracetamol Accord contains sugar and soya lecithin
Tramadol hydrochloride + Paracetamol Accord contains a sugar called sucrose. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Tramadol hydrochloride + Paracetamol Accord contains soya lecithin. Patients allergic to peanuts or soya should not take this medicine.

3. How to use Tramadol hydrochloride + Paracetamol Accord

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Tramadol hydrochloride + Paracetamol Accord should be used for the shortest possible duration.
Use in children under 12 years of age is not recommended.
The dose should be adjusted according to the intensity of pain and the individual patient's response to treatment.
In general, the lowest effective dose that controls pain should be used.
Unless otherwise directed by your doctor, the recommended dose of Tramadol hydrochloride + Paracetamol Accord is
2 effervescent tablets for adults and adolescents over 12 years of age.
If needed, your doctor may recommend taking additional doses. The minimum interval between doses
must be at least 6 hours.
Do not use more than 8 effervescent tablets of Tramadol hydrochloride + Paracetamol Accord per day.
Do not take Tramadol hydrochloride + Paracetamol Accord more frequently than prescribed by your doctor.

Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol from the body may be delayed.
In these patients, your doctor may recommend extending the interval between doses.

Patients with renal impairment, on dialysis, or with hepatic impairment
Tramadol hydrochloride + Paracetamol Accord should not be taken in cases of severe hepatic and/or renal impairment.
In cases of mild or moderate impairment, your doctor may recommend extending the interval between doses.

Method of administration
Effervescent tablets should be taken orally.
Effervescent tablets should be dissolved in a glass of water.
If you feel that the effect of Tramadol hydrochloride + Paracetamol Accord is too strong (e.g., drowsiness or breathing difficulties)
or too weak (pain not adequately relieved), consult your doctor.

Taking more than the recommended dose of Tramadol hydrochloride + Paracetamol Accord
In such cases, even if you feel well, seek immediate advice from your doctor or pharmacist.
There is a risk of liver damage, the symptoms of which may appear later.

Missed dose of Tramadol hydrochloride + Paracetamol Accord
If you miss a dose, pain may return. Do not take a double dose to make up for the missed dose, but continue taking the medicine as prescribed.

Stopping Tramadol hydrochloride + Paracetamol Accord
Do not suddenly stop using this medicine unless otherwise instructed by your doctor.
If you wish to discontinue the medicine, discuss this with your doctor, especially if it has been taken long-term.
Your doctor will advise you when and how to stop the medicine; this may involve gradually reducing the dose to reduce the likelihood of withdrawal symptoms.

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

4. Possible adverse effects

Like all medicines, Tramadol hydrochloride + Paracetamol Accord may cause adverse effects, although not everyone experiences them.

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, excessive sweating,
• headache, tremor,
• confusion, sleep disturbances, mood changes (anxiety, nervousness, abnormal state of euphoria).

Uncommon: may occur in up to 1 in 100 patients

• increased heart rate or blood pressure, disturbances in heart rate or rhythm,
• tingling, numbness or prickling sensation in the limbs, ringing in the ears, involuntary muscle twitching,
• depression, nightmares, hallucinations (hearing, seeing or feeling things that are not real), memory lapses,
• breathing difficulties,
• difficulty swallowing, blood in stool,
• skin reactions (e.g. rash, urticaria),
• increased liver enzyme levels,
• presence of albumin in urine, difficulty or pain when passing urine,
• chills, hot flushes, chest pain.

Rare: may occur in up to 1 in 1000 patients

• seizures, difficulty maintaining coordinated movements, brief loss of consciousness (fainting),
• drug dependence,
• delirium,
• blurred vision, constricted pupils,
• speech disorders,
• excessive dilation of the pupils.

Unknown frequency: frequency cannot be estimated from available data

• decrease in blood sugar levels (hypoglycaemia).

The following adverse effects have been observed in patients taking medicines containing only tramadol hydrochloride or only paracetamol. However, if any of these occur after taking Tramadol hydrochloride + Paracetamol Accord, inform your doctor:

• Fainting upon standing from a lying or sitting position, bradycardia (slow heart rate), collapse (fainting), changes in appetite, muscle weakness, slower or shallower breathing, mood changes, changes in activity, changes in cognitive abilities, worsening of asthma.
• Use of Tramadol hydrochloride + Paracetamol Accord together with anticoagulant medicines (e.g. phenprocoumon, warfarin) may increase the risk of bleeding. In case of any prolonged or unexpected bleeding, consult your doctor immediately.
• In rare cases, a skin rash indicating an allergic reaction may occur, which may present as sudden swelling of the face and neck, difficulty breathing, low blood pressure, and fainting. If any of the above symptoms occur, stop taking the medicine immediately and consult your doctor without delay. Do not restart the medicine.

In rare cases, use of tramadol hydrochloride may lead to dependence and difficulty discontinuing the medicine.
In rare cases, patients who have been taking tramadol hydrochloride for some time may experience withdrawal symptoms after abrupt discontinuation. These may include restlessness, anxiety, nervousness, or tremors. Patients may become hyperactive, have trouble sleeping, and experience gastrointestinal disturbances.
A very small number of patients may experience panic attacks, hallucinations, or unusual sensations such as itching, tingling, numbness, or ringing in the ears. If any of the above symptoms occur after stopping Tramadol hydrochloride + Paracetamol Accord, contact your doctor.
Frequency unknown:

• hiccups,
• serotonin syndrome, which may present with changes in mental state (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 hydrochloride + Paracetamol Accord").

In exceptional cases, blood tests may show abnormalities, such as low platelet count, which may result in nosebleeds or bleeding gums.
Very rarely, severe skin reactions associated with paracetamol intake have been reported.
Respiratory depression associated with tramadol intake has been reported rarely.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorisation holder.

5. How to store Tramadol hydrochloride + Paracetamol Accord

Do not store above 25°C.
Keep in the original packaging to protect from moisture.
Store the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box or soft blister pack.
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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tramadol hydrochloride + Paracetamol Accord contains

• The active substances are tramadol hydrochloride and paracetamol. Each effervescent tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
• The other ingredients are: anhydrous citric acid (E 330), monosodium citrate (E 331), sodium hydrogen carbonate (E 500), anhydrous sodium carbonate (E 500), povidone K 25 (E 1201), sodium saccharin (E 954), acesulfame potassium (E 950), polyethylene glycol 6000 (E 1521), orange flavour (containing maize maltodextrin, sugar, soya lecithin (E 322), silicon dioxide (E 551), natural flavouring substances).

What Tramadol hydrochloride + Paracetamol Accord looks like and contents of the pack
Tramadol hydrochloride + Paracetamol Accord is a white or almost white, marbled, round, flat
with bevelled edges, smooth on both sides effervescent tablet with an orange odour.
The tablets are available in soft blisters containing 10, 20, 30, 50, 60 or 100 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa Street 7
02-677 Warsaw
Tel: + 48 22 577 28 00
Manufacturer
Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice
Laboratori Fundació Dau
C/C, 12-14. Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA3000
Malta