Tramadol ABC

Package leaflet: Information for the patient

TRAMADOL ABC 100 mg/ml oral drops, solution

Tramadol
Generic medicine
Please read 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 they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tramadolo ABC is and what it is used for

Tramadolo – the active substance of Tramadolo ABC – is an opioid analgesic (painkiller) that acts on the central nervous system. It reduces pain by acting on specific nerve cells in the spinal cord and brain.
Tramadolo ABC is used to treat moderate to severe pain of various types and causes, as well as pain caused by diagnostic and surgical procedures.

2. What you need to know before taking Tramadolo ABC

Do not take Tramadolo ABC

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6)
• in cases of acute alcohol, sleeping pills, painkillers, or other psychotropic drug intoxication (drugs acting on mood and emotions)
• if you are currently taking or have taken monoamine oxidase inhibitors (MAO inhibitors—some medicines used to treat depression) within the previous 14 days before starting treatment with Tramadolo ABC (see "Other medicines and Tramadolo ABC")
• if you have epilepsy and your seizures are not adequately controlled by therapy
• as a substitute in drug detoxification therapy.

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

• if you think you may misuse other painkillers (opioids)
• if you suffer from disturbances of consciousness (if you feel faint)
• if you are in shock (cold sweats may be a sign)
• if you have increased intracranial pressure (possible after head trauma or brain diseases)
• if you have breathing difficulties
• if you are prone to epilepsy or seizures, as the risk of an attack may increase
• if you have liver or kidney disease
• if you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see "Other medicines and Tramadolo ABC").
• there is a small but existing risk that you may develop the so-called serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol as monotherapy.

Contact your doctor immediately if you experience any of the symptoms associated with this serious syndrome
(see section 4 “Possible side effects”).
Sleep-related breathing disorders
Tramadolo ABC 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 pauses in breathing during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor, who may consider reducing the dose.
Seizures have been reported in patients taking tramadol at recommended doses. The risk may increase when tramadol doses exceed the recommended levels, particularly beyond the daily maximum dose of 400 mg.
Tolerance, physical and psychological dependence
This medicine contains tramadol, a medicine belonging to the opioid class. Repeated use of opioids may lead to reduced effectiveness of the medicine (the patient becomes accustomed to its effects, a phenomenon known as tolerance). Repeated use of Tramadolo ABC may also lead to abuse and physical and psychological dependence, with a consequent risk of potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged use.
In case of physical or psychological dependence, you may feel unable to control the amount of medicine you need or how often you take it.
The risk of developing physical or psychological dependence varies from person to person. The risk of developing dependence on Tramadolo ABC may be higher if:

• you or a family member has a history of alcohol, prescription medicine, or illegal drug abuse or dependence (“addiction”);
• you are a smoker;
• you have had mood disorders (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking Tramadolo ABC, you may have developed physical or psychological dependence:

• You need to take the medicine for a longer period than recommended by your doctor;
• You need to take a higher dose than recommended;
• You use the medicine for reasons other than those for which it was prescribed, for example, to “stay calm” or “help sleep”;
• You have repeatedly tried, but failed, to stop or control the use of the medicine;
• You feel unwell when you stop taking the medicine and feel better when you take it again (“withdrawal effects”).

If you notice any of these signs, consult your doctor to evaluate the most appropriate treatment plan for you, including when and how to safely discontinue treatment (see section 3, If you stop treatment with Tramadolo ABC).
If you have a tendency to misuse medicines or are dependent on medicines, you should take Tramadolo ABC only for short periods and under strict medical supervision.
Tramadol is metabolized in the liver by an enzyme. Some people have variations in this enzyme, which may lead to different effects in them. Some people may not get sufficient pain relief, while others may experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.
Talk to your doctor or pharmacist if you experience any of the following symptoms while taking Tramadolo ABC:

• extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether hormone replacement therapy is needed.

Children and adolescents
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as tramadol toxicity symptoms may be more severe in these children.
Other medicines and Tramadolo ABC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Tramadolo ABC must not be taken with MAO inhibitors (some medicines used for depression).
The intensity and duration of the analgesic effect of Tramadolo ABC may be reduced if you are taking medicines containing

• carbamazepine (for epileptic seizures)
• ondansetron (to prevent nausea). Your doctor will advise you whether and which doses of Tramadolo ABC you should take.

The risk of adverse effects increases if you are taking:

• gabapentin or pregabalin for the treatment of epilepsy or nerve-related pain (neuropathic pain)
• other analgesics such as morphine and codeine (even when taken for cough), and alcohol together with Tramadolo ABC. You may feel drowsy or weak. In such cases, consult your doctor.
• concomitant use of Tramadolo ABC and sedatives or sleeping medicines (e.g., benzodiazepines) increases the risk of sedation, breathing difficulties (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes Tramadolo ABC 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 the dosage recommendations carefully. It may be helpful to inform friends or family members about the signs and symptoms listed above. Contact your doctor if such symptoms occur.
• medicines that may cause seizures (fits), such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tramadolo ABC at the same time. Your doctor will tell you whether Tramadolo ABC is suitable for you.
• certain antidepressants; Tramadolo ABC may interact with these medicines and you may develop serotonin syndrome (see section 4 “Possible side effects”).
• coumarin anticoagulants (medicines that thin the blood), such as warfarin, together with Tramadolo ABC. The effect of these medicines on blood clotting may be affected, leading to bleeding.

Tramadolo ABC with food, drinks, and alcohol
Do not drink alcohol during treatment with Tramadolo ABC, as its effect may be enhanced.
Food intake does not affect the action of Tramadolo ABC.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is limited information on the safety of tramadol in pregnant women. Therefore, if you are pregnant, you should not take Tramadolo ABC oral drops solution. Chronic use during pregnancy may lead to withdrawal symptoms in newborns.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tramadolo ABC more than once during breastfeeding, or alternatively, if you take Tramadolo ABC more than once, you must stop breastfeeding.
Fertility
There is limited data on the effects of Tramadolo ABC on fertility.
Driving and using machines
Tramadolo ABC may cause drowsiness, dizziness, and vision problems (blurred vision). If you feel your ability to react is impaired, do not drive or operate vehicles, machinery, or tools requiring a secure footing.
Tramadolo ABC contains sucrose, sodium, and propylene glycol
This medicine contains a sugar, sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
Tramadolo ABC contains less than 1 mmol (23 mg) of sodium per 50 mg dose (equivalent to 20 drops), i.e., essentially “sodium-free”.
Tramadolo ABC contains up to 125 mg of propylene glycol per dose of 20 drops.

3. How to use Tramadolo ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Before starting treatment and at regular intervals during treatment, your doctor will discuss with you what you can expect from using Tramadolo ABC, when and for how long you should take it, when you should contact your doctor, and when you should stop taking it (see also section 2).
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.
Do not take more than 160 drops per day (for example, 8 doses of 20 drops each) (equivalent to 400 mg of tramadol hydrochloride), unless your doctor has instructed you otherwise. Unless otherwise prescribed by a physician, the usual dose is:
Adults and adolescents over 12 years of age:
20 to 40 drops (equivalent to 50 mg or 100 mg of tramadol hydrochloride) every 4–6 hours.
Use in children over 1 year of age
In children over 1 year of age, the single dose is 4–8 drops per 10 kg of body weight (1–2 mg of tramadol hydrochloride per kg of body weight).
The lowest dose that provides pain relief should be used. Daily doses must not exceed 8 mg of active substance per kg of body weight or 400 mg of active substance, whichever is lower.
Note on dosing of Tramadolo ABC 100 mg/ml oral drops, solution in children over 1 year of age.
Dosage table according to body weight in children over 1 year of age:

Tramadol hydrochloride content in the drops:

Elderly patients
In elderly people (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/dialysis
Patients with severe hepatic and/or renal insufficiency must not take Tramadolo ABC. In case of mild or moderate
insufficiency, your doctor may advise you to increase the interval between doses.

How and when to take Tramadolo ABC
Take Tramadolo ABC with sugar or a small amount of liquid. Food intake does not affect the action
of Tramadolo ABC.

How long to take Tramadolo ABC
Do not take Tramadolo ABC for longer than necessary. If long-term treatment is required, your doctor will
schedule regular, frequent check-ups (and, if necessary, temporary interruptions of therapy) to determine
whether you should continue treatment and at what dose. If you feel that the analgesic effect of Tramadolo ABC
is too strong or too weak, consult your doctor or pharmacist.

If you take more Tramadolo ABC than you should
Taking an extra dose by mistake should not cause adverse effects. You may continue taking the medicine as prescribed.
After ingestion of very high doses, the following may occur: pinpoint pupils, vomiting, severe drop in blood pressure,
rapid heartbeat, collapse, disturbances of consciousness up to coma (deep unconsciousness), epileptic seizures,
and breathing difficulties up to respiratory arrest.
In such cases, call your doctor immediately.

If you forget to take Tramadolo ABC
If you forget to take the oral solution, your pain may return. Do not take a double dose to make up for the missed dose;
simply continue taking the medicine as before.

If you stop taking Tramadolo ABC
If you stop or discontinue treatment too early, your pain may return. If you wish to stop treatment due to
unwanted effects, consult your doctor.
Do not stop taking this medicine abruptly unless instructed by your doctor. If you intend to stop taking the medicine,
especially after long-term use, discuss it with your doctor first. Your doctor will advise you when and how to stop,
possibly by gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).
Generally, discontinuation of Tramadolo ABC does not cause withdrawal effects.
However, in rare cases, some individuals who have taken Tramadolo ABC for a prolonged period may feel unwell
when stopping abruptly.
They may:

• feel restless, anxious, nervous, or weak
• be hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances
• experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, and ringing in the ears (tinnitus)
• experience other rare central nervous system (CNS) symptoms such as confusion, delusion, changes in perception of self (depersonalization), changes in perception of reality (derealization), and feelings of persecution (paranoia).

If you experience any of these symptoms after stopping treatment with Tramadolo ABC, consult your doctor.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact a doctor immediately if you experience symptoms of an allergic reaction such as:

• swelling of the face, tongue and/or throat
• difficulty swallowing
• hives
• difficulty breathing.

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

• nausea
• dizziness

Common (may affect up to 1 in 10 people)

• headache, drowsiness
• vomiting, constipation, dry mouth
• sweating (hyperhidrosis)
• fatigue

Uncommon (may affect up to 1 in 100 people)

• effects on the heart and blood circulation (palpitations, rapid heartbeat, feeling of faintness or collapse). These side effects may occur particularly in patients in an upright position or undergoing physical exertion
• urge to vomit (nausea), stomach discomfort (feeling of pressure in the stomach, bloating), diarrhoea
• skin reactions (itching, rashes)

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

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slow heartbeat
• increase in blood pressure
• abnormal sensations (e.g. tingling, itching, numbness), tremor, slow breathing, epileptic seizures, muscle spasms, uncoordinated movements, temporary loss of consciousness (syncope), speech disorders
• epileptic seizures have occurred mainly with high doses of tramadol or when tramadol was taken together with other medicines that may cause seizures
• changes in appetite
• hallucinations, confusion, sleep disturbances, anxiety, nightmares
• psychological symptoms may occur after treatment with Tramadolo ABC, varying in nature and intensity depending on the patient's personality and duration of therapy. These may present as changes in mood (mainly elevated mood, in some cases irritable mood), changes in activity (usually decreased or suppressed, sometimes increased), and reduced cognitive and sensory perception (changes in senses and emotional recognition ability, which may lead to impaired judgment)
• drug dependence. When treatment is abruptly discontinued, withdrawal symptoms may occur (see “If you stop taking Tramadolo ABC”).
• vision problems, excessive dilation of the pupils (mydriasis), constriction of the pupils (miosis)
• slow breathing, shortness of breath (dyspnoea). If recommended doses are exceeded, or if other medicines that reduce brain function are taken simultaneously, breathing may become slower
• worsening of asthma; however, it has not been established whether this could have been caused by tramadol
• muscle weakness
• difficulty or pain when urinating, reduced urine output (dysuria)

Very rare (may affect up to 1 in 10,000 people)

• increased liver enzyme levels

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

• decrease in blood sugar levels
• hiccups
• serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects 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 “What you need to know before taking Tramadolo ABC”).

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 Tramadolo ABC

Keep this medicine out of the sight and reach of children.
Store this medicine in a safe and secure place where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
The expiry date refers to the last day of that 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. Package contents and other information

What Tramadolo ABC contains
The active substance is tramadol hydrochloride. Each ml of solution contains 100 mg of tramadol hydrochloride (one drop contains 2.5 mg of tramadol).
The other components are: sucrose, propylene glycol, glycerol, sodium cyclamate, sodium saccharin, potassium sorbate, macrogol glycerol hydroxystearate, mint flavor, anise flavor, purified water.

Description of the appearance of Tramadolo ABC and packaging contents
Carton pack containing a 10 ml bottle.

Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (TO)