Tramadol and paracetamol Aristo

Package leaflet: Information for the patient

Tramadolo e Paracetamolo Aristo, 37.5 mg/325 mg film-coated tablets, 75 mg/650 mg film-coated tablets

Tramadol hydrochloride and paracetamol
Generic medicine
Please read this leaflet carefully before taking this medicine, as 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, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What TRAMADOLO E PARACETAMOLO ARISTO is and what it is used for

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

2. What you need to know before taking TRAMADOLO AND PARACETAMOL ARISTO

Do not take TRAMADOLO AND PARACETAMOL ARISTO:
if you are allergic to tramadol hydrochloride, paracetamol, or any of the other
components 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 that affect 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 Tramadol and Paracetamol Aristo. 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 your current medication.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tramadol and Paracetamol Aristo:
if you are taking other medicines containing paracetamol or tramadol;
if you have liver problems or a 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 medicines for pain containing buprenorphine,
nalbuphine, or pentazocine;
if you think you might receive an anaesthetic (inform your doctor or dentist that you are taking Tramadol and Paracetamol Aristo).

Children
Treatment should be avoided in children under 12 years of age.

Other medicines and Tramadol and Paracetamol Aristo
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 together with Tramadol and Paracetamol Aristo.

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 the two active ingredients.

Do not take Tramadol and Paracetamol Aristo with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Tramadol and Paracetamol Aristo”).

Concomitant use of Tramadol and Paracetamol Aristo with the following medicines should be avoided, as their effects 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 movements of limbs or eyes, uncontrollable muscle spasms, or diarrhoea, contact your doctor immediately.

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 feel like fainting, consult your doctor.

medicines that may provoke seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tramadolo and Paracetamol Aristo at the same time. Your doctor will advise whether Tramadolo and Paracetamol Aristo is suitable for you.

Antidepressants: Tramadolo and Paracetamol Aristo may interact with these medicines and you may experience symptoms such as: involuntary, rhythmic muscle contractions, including muscles controlling eye movement, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, 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 Tramadolo and Paracetamol Aristo 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 should be reported immediately to your doctor.

The effectiveness of Tramadolo and Paracetamol Aristo may be altered if you are also taking any of the following medicines:
metoclopramide, domperidone, or ondansetron (medicines used to treat nausea, vomiting, or feeling unwell);
cholestyramine (a medicine used to reduce cholesterol in the blood);
ketoconazole or erythromycin (medicines used to fight infections).

Concomitant use of Tramadolo and Paracetamol Aristo with 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 available.

However, if your doctor prescribes Tramadolo and Paracetamol Aristo 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 follow your doctor’s dosage recommendations carefully. 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 together with Tramadolo and Paracetamol Aristo.

Tramadol and Paracetamol Aristo with alcohol
Do not drink alcohol during treatment with Tramadol and Paracetamol Aristo, as you may experience drowsiness.

Pregnancy and breastfeeding
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 Tramadol and Paracetamol Aristo during pregnancy.
Consult your doctor if you discover you are pregnant while being treated with Tramadol and Paracetamol Aristo, and before taking any further tablets.

Breastfeeding
Tramadol passes into breast milk. For this reason, do not take Tramadol and Paracetamol Aristo more than once during breastfeeding, or alternatively, if you plan to take Tramadol and Paracetamol Aristo more than once, you must stop breastfeeding.

Driving and using machines
If you feel drowsy while taking Tramadol and Paracetamol Aristo, do not drive or operate tools or machinery.

3. How to take Tramadol and Paracetamol Aristo

Take this medicine exactly as prescribed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The duration of treatment with Tramadol and Paracetamol Aristo should be as short as possible. The
dosage should be adjusted according to the intensity of pain and your individual sensitivity to
pain. Generally, the lowest effective dose that relieves pain should be used.
Use in children under 12 years of age should be avoided.
Use in children and adolescents over 12 years of age:
The recommended initial 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. If
necessary, additional doses may be taken as directed by the doctor.
The minimum interval between doses must be at least 6 hours.
Do not take more than 8 tablets per day (or 4 tablets for the higher dosage strength).
Your doctor may recommend increasing the interval between doses if:
you are over 75 years old;
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 recommend prolonging the interval between doses.
Patients with severe hepatic or renal insufficiency / patients undergoing dialysis
Tramadol and Paracetamol Aristo must not be taken by patients with severe hepatic and/or renal
insufficiency. In cases of mild or moderate insufficiency, your doctor may recommend prolonging 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 with strength 75 mg/650 mg may be divided into two equal doses.
If you feel that the effect of Tramadol and Paracetamol Aristo is too strong (e.g. you experience
severe drowsiness or breathing difficulties) or too weak (the pain is not sufficiently relieved),
contact your doctor.
Do not take Tramadol and Paracetamol Aristo for longer than necessary.
If you take more Tramadol and Paracetamol Aristo than you should
If you have taken an excessive dose of this medicine, contact a doctor immediately, even if you feel
well, because there is a risk of delayed severe liver damage.
If you forget to take Tramadol and Paracetamol Aristo
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 prescribed.
If you stop taking Tramadol and Paracetamol Aristo
Generally, stopping treatment with Tramadol and Paracetamol Aristo does not cause withdrawal
effects.
Rarely, people who use a medicine containing tramadol may develop dependence and experience
difficulty discontinuing the medicine. If you have taken Tramadol and Paracetamol Aristo for a
prolonged period and wish to stop, contact your doctor, as your body may have developed
dependence on Tramadol and Paracetamol Aristo.
If you experience any of these symptoms after stopping treatment with Tramadol and Paracetamol
Aristo, 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 everyone gets them.

Very common side effects (may occur in more than 1 out of 10 people):

• Nausea
• Dizziness, drowsiness

Common side effects (may occur in up to 1 out of 10 people):

• Vomiting (feeling unwell), digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• Itching, sweating
• Headache, tremors
• Confusion, sleep disturbances, mood changes (anxiety, nervousness, euphoria)

Uncommon side effects (may occur in up to 1 out of 100 people):

• Increased pulse rate or blood pressure, disturbances in heart rate or rhythm
• Difficulty or pain when passing urine
• Skin reactions (e.g. rash, itching)
• Tingling, numbness, or pins and needles sensation in limbs, ringing in the ears (tinnitus), involuntary muscle contractions
• Depression, nightmares, hallucinations (hearing, seeing, or experiencing things that do not exist in reality), memory loss
• Difficulty swallowing, blood in faeces
• Chills, hot flushes, chest pain
• Breathing difficulties

Rare side effects (may occur in up to 1 out of 1,000 people):

• Seizures, uncoordinated movements
• Dependence
• Blurred vision
• Temporary loss of consciousness (syncope)

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, shortness of breath or weak 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 may occur, and may develop with sudden swelling of the face and neck, breathing difficulties, or drop in blood pressure and fainting. If this happens to you, stop treatment immediately and consult your doctor without delay. Do not take the medicine again.

Rarely, people taking a medicine containing tramadol may develop dependence and experience difficulty stopping the medicine. Rarely, people taking a medicine containing tramadol may feel unwell when stopping treatment abruptly, experiencing agitation, nervousness, or restlessness. They may also develop an uncontrollable urge to move, difficulty sleeping, and gastrointestinal disorders.

Very rarely, panic attacks, hallucinations, or 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 Tramadolo e Paracetamolo Aristo, 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 Tramadolo e Paracetamolo Aristo 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 effect, 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 the website
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 Tramadolo e Paracetamolo Aristo

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

6. Package contents and other information

What Tramadolo e Paracetamolo Aristo 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 carboxymethylamidone (type A), corn starch, magnesium stearate, hypromellose, titanium dioxide, talc, triethyl citrate.

Description of the appearance of Tramadolo e Paracetamolo Aristo and package contents
Tramadolo e Paracetamolo Aristo 37.5 mg/325 mg film-coated tablets are film-coated tablets, white to almost white in colour.
Tramadolo e Paracetamolo Aristo 75 mg/650 mg film-coated tablets are film-coated tablets, white to almost white in colour, with a score line.
The tablets are available in PVC/aluminium blisters in pack sizes of 20, 30, 50 and 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Laboratorios Medicamentos Internacionales S.A. Medinsa
C/Solana 26
28850 Torrejón de Ardoz – Madrid
Spain

Following trade names:
Germany: Tramadol / Paracetamol Aristo 37.5 mg / 325 mg Filmtabletten
Germany: Tramadol / Paracetamol Aristo 75 mg / 650 mg Filmtabletten
Italy: Tramadolo e Paracetamolo Aristo 37.5 mg / 325 mg compresse rivestite con film
Italy: Tramadolo e Paracetamolo Aristo 75 mg / 650 mg compresse rivestite con film
Portugal: Tramadol + Paracetamol Aristo 37.5 mg / 325 mg comprimidos revestidos por película
Portugal: Tramadol + Paracetamol Aristo 75 mg / 650 mg comprimidos revestidos por película
Spain: Tramadol / Paracetamol Aristo 37.5 mg / 325 mg comprimidos recubiertos con película EFG
Spain: Tramadol / Paracetamol Aristo 75 mg / 650 mg comprimidos recubiertos con película EFG