Ebyndo

Package leaflet: Information for the patient

EBYNDO 37.5 mg/325 mg film-coated tablets, 75 mg/650 mg film-coated tablets

Tramadol hydrochloride and paracetamol
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EBYNDO is and what it is used for

EBYNDO is a combination of two analgesics, tramadol hydrochloride and paracetamol, which work together
to relieve pain.
EBYNDO is used for the treatment of moderate to severe pain when your doctor considers it necessary to use a combination of tramadol hydrochloride and paracetamol.
EBYNDO is indicated for use only in adults and adolescents over 12 years of age.

2. What you should know before taking EBYNDO

Do not take EBYNDO:
if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of
this medicine (listed in section 6). (Symptoms of an allergic reaction may include
skin redness, facial swelling, breathlessness or other breathing difficulties);
in acute alcohol intoxication;
if you are taking medicines for sleep, painkillers, or other medicines acting on mood and emotions;
if you are currently taking, or have taken within the last 14 days, medicines called monoamine oxidase inhibitors (MAOIs) before starting treatment with Ebyndo. MAOI medicines are used to treat depression or Parkinson’s disease;
if you have severe liver disease;
if you have epilepsy and your seizures are not adequately controlled by the medication you are currently using.

Warnings and precautions
Talk to your doctor or pharmacist before taking EBYNDO:

• if you are taking other medicines containing paracetamol or tramadol;
• if you have liver problems or liver disease, as you may develop yellowing of the skin or eyes, a sign of jaundice;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or serious lung conditions;
• if you have epilepsy or have previously had seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headache (cephalalgia) associated with vomiting (feeling unwell);
• if you have developed drug dependence (e.g., morphine);
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you think you might be given an anaesthetic (inform your doctor or dentist that you are taking EBYNDO). Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following side effects, you must stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.

Sleep-related breathing disorders
EBYNDO may cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
Inform your doctor or pharmacist if you experience any of the following symptoms while taking EBYNDO:
extreme tiredness, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This could indicate adrenal insufficiency (low cortisol levels).
If you have these symptoms, contact your doctor, who will decide whether you need to take a hormonal supplement.

Children and adolescents
Treatment is not recommended in children under 12 years of age.
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may be worse in these children.

Other medicines and EBYNDO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor will advise you which medicines can be taken with EBYNDO.
NOTE: this medicine contains paracetamol and tramadol. Inform your doctor if you are taking other medicines containing paracetamol and tramadol to avoid exceeding the maximum daily dosage of both active substances.
Do not take EBYNDO with monoamine oxidase inhibitors (MAOIs) (see section “Do not take EBYNDO”).
EBYNDO is not recommended with the following medicines, as their effect may be altered:
carbamazepine (a medicine used to treat epilepsy or certain types of pain, such as trigeminal neuralgia);
buprenorphine, nalbuphine, or pentazocine (opioid-type painkillers). The analgesic effect may be reduced.
The risk of side effects increases if you are taking:
triptans (used for migraine) or selective serotonin reuptake inhibitors (SSRIs) (for depression). If you experience confusion, restlessness, fever, sweating, uncoordinated limb or eye movements, uncontrollable muscle spasms, or diarrhoea, contact your doctor;
tranquillisers, sleeping medicines, other painkillers such as morphine and codeine (even when taken as a cough medicine), baclofen (a muscle relaxant), medicines to lower blood pressure, antidepressants, or medicines for treating allergies.
If you feel drowsy or dizzy. If this occurs, consult your doctor;
medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take EBYNDO at the same time.
Your doctor will advise whether EBYNDO is suitable for you;
antidepressants: EBYNDO may interact with these medicines and you may experience symptoms such as:
involuntary, rhythmic muscle contractions, including muscles controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C;
anaesthetics, neuroleptics (medicines acting on mental state), or bupropion (used in smoking cessation therapy). This may increase the risk of seizures. Your doctor will advise whether EBYNDO is suitable for you;
warfarin or phenprocoumon (to thin the blood). The effect of these medicines may be altered and bleeding may occur. Any prolonged or unexpected bleeding must be reported immediately to your doctor.
The effectiveness of EBYNDO may be altered if you are also taking the following medicines:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea, vomiting, or feeling unwell);
• cholestyramine (a medicine used to lower blood cholesterol);
• ketoconazole or erythromycin (medicines used to fight infections).

Concomitant use of EBYNDO and sedative medicines, 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 no other treatment options are possible.
However, if your doctor prescribes EBYNDO together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.
Inform your doctor about all sedative medicines you are taking and carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or relatives so they are aware of the signs and symptoms listed above. Contact your doctor if these symptoms occur.
Your doctor will advise you which medicines can be taken with EBYNDO.

EBYNDO and alcohol
Do not drink alcohol during treatment with EBYNDO, as you may experience drowsiness.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take EBYNDO during pregnancy.
Consult your doctor if you discover you are pregnant while being treated with EBYNDO and before taking further tablets.

Breastfeeding
Tramadol is excreted in breast milk. Therefore, you should not take EBYNDO more than once during breastfeeding, or alternatively, if you take EBYNDO more than once, you must stop breastfeeding.

Fertility
Based on data collected from human studies, tramadol does not affect fertility in men and women. There are no available data on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines
If you feel drowsy while taking EBYNDO, do not drive or operate tools or machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per ml, i.e., essentially “sodium-free”.

3. How to take EBYNDO

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The duration of treatment with EBYNDO should be as short as possible. The dosage should be adjusted
according to the intensity of pain and your individual sensitivity to pain. In general, the lowest effective dose
capable of relieving pain should be taken.
Use in children under 12 years of age should be avoided.
Use in children and adolescents over 12 years of age
The recommended starting dose for children and adolescents over 12 years of age is 2 film-coated tablets (or 1 tablet for the higher dosage strength), unless otherwise prescribed by the doctor. Additional doses may be taken as prescribed by the doctor, if necessary.
The minimum interval between doses must be at least 6 hours.
Do not take more than 8 tablets per day (or 4 for the higher dosage strength).
Your doctor may recommend increasing the interval between doses if:

• you are over 75 years of age;
• you have kidney problems;
• you have liver problems.

Elderly patients
In elderly patients (over 75 years of age), elimination of tramadol may be delayed. If this applies to you, your
doctor may advise you to increase the interval between doses.
Patients with severe hepatic or renal insufficiency / patients undergoing dialysis
Patients with severe hepatic and/or renal insufficiency must not take EBYNDO. In cases of mild or moderate
insufficiency, your doctor may recommend increasing the interval between doses.
The film-coated tablets should be swallowed with a sufficient amount of liquid. They must not be chewed.
The film-coated tablets in the 75 mg/650 mg strength may be divided into two equal doses.
If you feel that the effect of EBYNDO is too strong (e.g. you experience excessive drowsiness or difficulty breathing) or
too weak (pain is not sufficiently relieved), contact your doctor.
Do not take EBYNDO for longer than necessary.
If you take more EBYNDO than you should
If you have taken an excessive dose of this medicine, contact a doctor immediately, even if you feel well, as there is a risk of delayed severe liver damage.
If you forget to take EBYNDO
If you forget to take your tablets, your pain may return. Do not double the dose to make up for the missed dose; simply continue taking the tablets as previously directed.
If you stop taking EBYNDO
Generally, no withdrawal effects occur when stopping treatment with EBYNDO.
Rarely, individuals taking a medicine containing tramadol may develop dependence and experience difficulty discontinuing the medicine. Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to stop taking the medicine, discuss this with your doctor first, especially if you have been taking it for a long time. Your doctor will advise you on when and how to stop, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).
If you experience any of these symptoms after stopping treatment with EBYNDO, consult your doctor. Further information on adverse effects is listed in section 4.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

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

• nausea;
• dizziness, drowsiness.

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

• vomiting (feeling of nausea), digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth;
• itching, sweating;
• headache, tremors;
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria).

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

• increased pulse rate or blood pressure, disturbances in heart rate or rhythm;
• difficulty or pain during urination;
• skin reactions (e.g. rash, urticaria);
• tingling, numbness or pins and needles sensation in the limbs, ringing in the ears, involuntary muscle contractions;
• depression, nightmares, hallucinations (hearing, seeing or experiencing things that are not real), memory loss;
• difficulty swallowing, blood in the stools;
• chills, chest pain;
• breathing difficulties.

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

• seizures, uncoordinated movements;
• dependence;
• blurred vision;
• constriction of the pupil (miosis);
• dilation of the pupil (mydriasis);
• transient loss of consciousness (syncope), speech disorders;
• delirium.

Frequency not known:

• reduction in blood sugar levels.

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

• feeling faint when standing up from a lying or sitting position, slowed heart rate, fainting, changes in appetite, muscle weakness, shorter or weaker breathing, mood changes, changes in activity, altered perception, worsening of pre-existing asthma;
• in rare cases, allergic symptoms such as skin rash indicating an allergic reaction, which may develop together with sudden swelling of the face and neck, breathing difficulties, or drop in blood pressure and fainting. If this happens to you, stop treatment and consult your doctor immediately. Do not take the medicine again.
• Very rare cases of severe skin reactions;
• frequency not known: hiccups.

People taking a medicine containing tramadol may develop dependence and experience difficulty stopping the medicine. People taking a medicine containing tramadol may feel unwell when stopping treatment abruptly and may experience restlessness, nervousness or agitation. They may also develop a pathological urge to move, difficulty sleeping and gastrointestinal disorders. Very rarely, panic attacks, hallucinations, and unusual sensations such as itching, tingling, numbness and ringing in the ears (tinnitus) may occur. If you experience any of these symptoms after stopping treatment with EBYNDO, consult your doctor.

In isolated cases, abnormalities in blood test results have been observed, for example, low platelet count which may cause bleeding from the nose or gums. Concomitant use of EBYNDO with medicines used to thin the blood (e.g. warfarin, phenprocoumon) may increase the risk of bleeding. Inform your doctor if you experience prolonged or unexpected bleeding.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EBYNDO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What EBYNDO contains
The active substances are tramadol hydrochloride and paracetamol.
One film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.
One film-coated tablet contains 75 mg of tramadol hydrochloride and 650 mg of paracetamol.
Excipients: powdered cellulose, pregelatinized corn starch, sodium carboxymethylamido (type A), corn starch, magnesium stearate, hypromellose, titanium dioxide, talc, triethyl citrate.

Description of the appearance of EBYNDO and pack contents
EBYNDO 37.5 mg/325 mg film-coated tablets are film-coated tablets of white to off-white colour.
EBYNDO 75 mg/650 mg film-coated tablets are film-coated tablets of white to off-white colour with a score line.
EBYNDO 37.5 mg/325 mg film-coated tablets are available in PVC/aluminum blisters in packs containing 10, 16, 20, 30, 40 and 60 film-coated tablets.
EBYNDO 75 mg/650 mg film-coated tablets are available in PVC/aluminum blisters in packs containing 20, 30, 50 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Italfarmaco S.p.A.
Viale Fulvio Testi 330 - 20126 Milan, Italy

Manufacturers
Laboratorios Medicamentos Internacionales S.A. Medinsa
C/ Solana No. 26
28850 Torrejón de Ardoz
Madrid, Spain

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Ebyndo
Italy: Ebyndo