Tramal retard 150

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging is in a foreign language.
Tramal Retard 150 (Tramal SR)
150 mg, prolonged-release tablets
Tramadoli hydrochloridum
Tramal Retard 150 and Tramal SR are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of contents of the leaflet:

1. What Tramal Retard 150 is and what it is used for
2. Important information before taking Tramal Retard 150
3. How to take Tramal Retard 150
4. Possible side effects
5. How to store Tramal Retard 150
6. Contents of the pack and other information

1. What Tramal Retard 150 is and what it is used for

Tramadol – the active substance in Tramal Retard 150 – is an analgesic belonging to the group of opioids acting on the central nervous system. It exerts its analgesic effect by acting on specific nerve cell receptors in the spinal cord and brain.
Tramal Retard 150 is indicated for the treatment of moderate to severe pain.

2. Important information before using Tramal Retard 150

When not to use Tramal Retard 150:

• if the patient is allergic to tramadol or any of the other ingredients of this medicine (listed in section 6);
• in case of acute alcohol intoxication, sedatives, painkillers, or psychotropic medicines (medicines affecting mood and emotions);
• during treatment with medicines from the group of MAO inhibitors (certain antidepressants) and within 14 days after discontinuation of such treatment (see "Tramal Retard 150 and other medicines");
• in patients with epilepsy that is not responding to treatment;
• in the treatment of opioid dependence.

Warnings and precautions
Before starting treatment with Tramal Retard 150, consult a doctor:

• if the patient is dependent on other analgesic substances (opioids);
• in disorders of consciousness (if the patient feels fainting coming on);
• in shock (cold sweats may be a symptom);
• in case of increased intracranial pressure (which may occur after head injury or brain diseases);
• in case of respiratory disorders;
• in patients with increased sensitivity to opioid medicines;
• in patients with epilepsy or increased risk of seizure, as this risk may be further increased;
• in patients with liver or kidney disease;
• if the patient suffers from depression and is taking antidepressants, because some of them may interact with tramadol (see "Tramal Retard 150 and other medicines"). There is a small risk of developing so-called serotonin syndrome when tramadol is taken alone or in combination with certain antidepressants. If the patient experiences any symptoms of this serious condition, medical advice should be sought immediately (see section 4 "Possible side effects").

Respiratory disorders during sleep
Tramal Retard 150 may cause breathing problems during sleep, such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to shortness of breath, 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.
Caution is advised in patients with depressed respiratory centre function, especially when taking other medicines that depress the central nervous system (see "Tramal Retard 150 and other medicines") or when doses higher than recommended are used (see "Use of higher than recommended dose of Tramal Retard 150" in section 3 and section 4), as respiratory depression cannot be ruled out in such cases.
Seizures have been observed in patients taking tramadol at recommended doses. The risk of seizures may be higher if the tramadol dose exceeds the recommended maximum daily dose (400 mg) or if the patient is concurrently taking other medicines that lower the seizure threshold (see section "Tramal Retard 150 and other medicines").
Tramal Retard 150 may cause psychological and physical dependence. Long-term use of Tramal Retard 150 may lead to reduced effectiveness, requiring higher doses (development of tolerance). In patients with a history of drug abuse or dependence, treatment should be short-term and under strict medical supervision.
Excessive fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure may indicate adrenal insufficiency (low cortisol levels). If such symptoms occur, contact a doctor, who will decide whether hormone replacement is necessary.
Consult a doctor if any of the above situations occur during treatment with Tramal Retard 150, even if these warnings relate to conditions from the past.
Tramadol is metabolized in the liver by an enzyme. Some individuals have a genetic variation of this enzyme, which may lead to different effects. In some people, pain relief may be insufficient, while in others, the risk of severe adverse effects may be higher.
Stop taking the medicine and contact a doctor immediately if the patient experiences any of the following adverse effects: slow or shallow breathing, confusion, drowsiness, pinpoint pupils, nausea or vomiting, constipation, or loss of appetite.

Tramal Retard 150 and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Tramal Retard 150 must not be used together with MAO inhibitors (medicines used to treat depression) or within 14 days after stopping such treatment.
The analgesic effect of Tramal Retard 150 may be reduced and its duration shortened when used concomitantly with medicines containing:

• carbamazepine (an antiepileptic medicine),
• pentazocine, nalbuphine, or buprenorphine (analgesics),
• ondansetron (an antiemetic medicine). Consult your doctor regarding the use and dosing of Tramal Retard 150.

The risk of adverse effects increases:

• when Tramal Retard 150 is used together with other analgesics such as morphine and codeine (including as a cough suppressant) or alcohol. Drowsiness or fainting may occur. In such cases, consult a doctor.
• when Tramal Retard 150 is used together with sedatives or sleeping pills (e.g. benzodiazepines), increasing the risk of drowsiness, breathing difficulties (respiratory depression), coma, and potentially life-threatening effects. Therefore, concomitant use should only be considered if no other treatment options are available. However, if a doctor prescribes Tramal Retard 150 together with sedatives, the dose and duration of combined treatment should be minimized. Inform the doctor about all sedative medicines being taken and strictly follow dosing instructions. Informing family members or friends about the above symptoms may be helpful. If such symptoms occur, contact a doctor immediately.
• if the patient is taking other medicines that may cause seizures, such as certain antidepressants or antipsychotics, including: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, antipsychotics, and other medicines that lower the seizure threshold (such as bupropion, mirtazapine, tetrahydrocannabinol). The risk of seizures may increase if Tramal Retard 150 is used together with these medicines. Consult a doctor to determine whether Tramal Retard 150 can be used with these medicines.
• if the patient is taking certain antidepressants, Tramal Retard 150 may interact with them and cause serotonin syndrome (see section 4 "Possible side effects").
• when anticoagulant medicines containing coumarin derivatives (to reduce blood clotting), e.g. warfarin, are used together with Tramal Retard 150. Bleeding may occur due to the effects of these medicines on the coagulation system.

Ketoconazole (an antifungal medicine) and erythromycin (a bacteriostatic antibiotic) may inhibit the metabolism of tramadol and its active metabolite.

Tramal Retard 150 with food, drink, and alcohol
Do not drink alcohol while taking Tramal Retard 150, as the effect of the medicine may be intensified, potentially leading to respiratory depression.
Food does not affect the action of Tramal Retard 150.

Children and adolescents
Use in children with respiratory disorders
Tramadol is not recommended in children with respiratory disorders, as symptoms of tramadol toxicity may be more severe in this group.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
The safety of tramadol use during pregnancy has not been established. Therefore, Tramal Retard 150 should not be used during pregnancy.
Long-term use of tramadol during pregnancy may lead to neonatal withdrawal syndrome.
Breastfeeding
Tramadol is excreted in breast milk. Therefore, Tramal Retard 150 should not be taken more than once during breastfeeding, or if Tramal Retard 150 has been taken more than once, breastfeeding should be discontinued.
Experience with tramadol use in humans does not indicate that tramadol affects fertility in men or women.

Driving and operating machinery
Tramal Retard 150 may cause drowsiness, dizziness, and blurred vision, which may affect reaction speed. Therefore, patients should not drive or operate machinery.

Tramal Retard 150 contains lactose monohydrate
In case of intolerance to certain sugars, consult a doctor before using this medicine. This medicine contains lactose monohydrate.

3. How to use Tramal Retard 150

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
The physician will adjust the dose according to the intensity of pain and the individual patient's response to treatment.
This will be the lowest dose effectively relieving pain. Do not use more than 400 mg of tramadol hydrochloride per day,
except in situations where the physician advises otherwise.
The following are available on the market: Tramal Retard 100, Tramal Retard 150, and Tramal Retard 200.
Unless otherwise advised by the physician, the usual dosing is as follows:
Adults and adolescents over 12 years of age:
One tablet of Tramal Retard 100 twice daily (equivalent to 200 mg tramadol hydrochloride), preferably in the morning and evening.
or
One tablet of Tramal Retard 150 twice daily (equivalent to 300 mg tramadol hydrochloride), preferably in the morning and evening.
or
One tablet of Tramal Retard 200 twice daily (equivalent to 400 mg tramadol hydrochloride), preferably in the morning and evening.
If necessary, the physician may prescribe a different, more individualized dosing regimen for Tramal Retard.
If required, the dose may be increased to 150 mg or 200 mg twice daily (equivalent to 300 mg to 400 mg tramadol hydrochloride per day).
Children:
Tramal Retard 150 must not be used in children under 12 years of age.
Elderly patients:
In patients over 75 years of age, tramadol elimination may be delayed. In these patients, the physician may recommend extending the time interval between doses.
Patients with renal impairment, undergoing dialysis, or with hepatic impairment:
Tramal Retard must not be taken in cases of severe hepatic and/or renal impairment. In cases of mild or moderate impairment, the physician may recommend extending the dosing intervals.
Method of administration:
Tramal Retard 150 should be taken orally.
The tablet must always be swallowed whole with a small amount of liquid; do not divide or chew the tablet. It may be taken regardless of meals.
Duration of treatment:
Tramal Retard 150 should not be used longer than absolutely necessary. In cases where long-term treatment is required due to the type and severity of the condition, the physician will regularly monitor the patient's condition (possibly interrupting treatment for a period if necessary) to determine whether, and at what dose, treatment with Tramal Retard 150 should continue.
If you feel that the effect of Tramal Retard 150 is too strong or too weak, consult your doctor or pharmacist.
Use of a higher than recommended dose of Tramal Retard 150
After taking doses higher than recommended, the following may occur: pinpoint pupils (as small as a pinhead), vomiting, drop in arterial blood pressure, rapid heartbeat, collapse, disturbances of consciousness up to coma (a state of deep unconsciousness), seizures, respiratory depression up to respiratory arrest.
In such cases, seek immediate medical attention!
Missed dose of Tramal Retard 150
If you forget to take the medicine at the appropriate time, pain symptoms may return.
Do not take a double dose to make up for a missed dose.
Resume your regular dosing schedule.
Discontinuation of Tramal Retard 150
If treatment with Tramal Retard 150 is suddenly stopped or prematurely discontinued, pain symptoms are likely to return.
If the patient wishes to discontinue treatment due to adverse effects, they should inform the physician.
Do not abruptly stop taking this medicine without medical advice. If the patient wishes to discontinue the medicine, this should be discussed with the physician, especially if the medicine has been taken long-term.
The physician will advise when and how to discontinue the medicine; this may involve gradually reducing the dose to minimize the likelihood of adverse effects (withdrawal symptoms).
Generally, no serious post-treatment symptoms are observed after discontinuation of Tramal Retard 150. However, in rare cases, after abrupt discontinuation of Tramal Retard 150 following prolonged use, the patient may feel unwell. Symptoms may include agitation, anxiety, restlessness, tremors, excessive motor activity, difficulty falling asleep, and gastrointestinal or intestinal disturbances.
Very rarely, panic attacks, hallucinations, abnormal sensations such as itching, tingling, numbness, and tinnitus may occur.
Other rare central nervous system disturbances, such as confusion, delusions, altered perception of self (depersonalization), altered perception of reality (derealization), and persecutory delusions (paranoia) have occurred very rarely.
If any of the above symptoms occur after discontinuation of the medicine, consult a physician immediately.
If you have any further doubts regarding 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 will experience them.
You should consult a doctor immediately if symptoms of allergic reactions occur, such as:
swelling of the face, tongue and (or) throat and (or) difficulty swallowing or
urticaria combined with breathing difficulties, low blood pressure, weakness, fainting
due to life-threatening anaphylactic shock. Allergic reactions are rare

• occurring in 1 to 10 out of 10,000 patients. The most common adverse reactions reported more frequently than dizziness during treatment with Tramal Retard 150 were nausea and dizziness.

Very common (occurs more frequently than dizziness,
in 1 out of 10 people): nausea.
Common headache, drowsiness,
(occurs in 1 to 10 out of 100 people): vomiting, constipation, dryness of the oral mucosa,
excessive sweating,
fatigue.
Uncommon (occurs in 1 to 10 out of 1,000 people): cardiac and circulatory system disorders (palpitations,
rapid heartbeat, feeling of weakness due to reduced
arterial blood pressure in patients changing body position
from lying down to standing, and collapse). Such adverse
reactions may occur especially when intravenous formulations of tramadol are administered, and
in patients after physical exertion.
Vomiting reflex, gastrointestinal irritation (feeling of pressure
in the stomach, bloating), diarrhea,
skin reactions (e.g. itching, rash, urticaria).
Rare (occurs in 1 to 10 out of 10,000 people): slow heartbeat,
increased arterial pressure,
changes in appetite,
slow breathing, "shortness of breath" (dyspnea).
Exacerbation of bronchial asthma has been reported during tramadol treatment, although a causal
relationship between these events has not been established. In case of ingestion of doses
significantly higher than recommended, and simultaneous use of other medicines that depress central nervous system function (e.g. sedatives, sleep-inducing medicines, other analgesics, alcohol),
respiratory depression may occur.
Abnormal sensation of stimuli (e.g. itching, tingling,
numbness), tremors, seizures, muscle spasms,
incoordinated movements, fainting, speech disorders;
Seizures occur mainly after administration of high
doses of tramadol and when other medicines that may provoke seizures are used concomitantly;
Hallucinations, confusion, sleep disorders, delirium, restlessness and
nightmares. Psychiatric disorders may occur after administration of Tramal Retard 150. Their severity and type may vary (depending on the patient's personality and duration of
treatment). These may include mood disorders (usually
excitement, sometimes irritability), changes in activity
(typically decreased, sometimes increased), and
reduced sensory and cognitive perception (changes in sensations and
cognition which may lead to incorrect assessment of
situations);
The medicine may cause dependence.
If treatment is abruptly discontinued, withdrawal symptoms may occur (see "Discontinuation of Tramal Retard 150 treatment");
Pupil constriction (miosis), blurred vision, excessive
pupil dilation (mydriasis),
muscle weakness;
difficulty or pain during urination, reduced urine volume (urinary retention);
allergic reactions (e.g. difficulty breathing, wheezing, skin swelling) and shock (sudden circulatory failure);
Very rare (occurs less frequently than increased liver enzyme activity:
in less than 1 out of 10,000 people):
Unknown frequency (cannot be estimated from available data): very low blood sugar concentration, hiccups, serotonin syndrome,
the symptoms of which may include changes in mental status (e.g.
agitation, hallucinations, coma), as well as other symptoms such as
fever, rapid heart rate, unstable blood pressure,
involuntary muscle contractions, muscle rigidity, lack of coordination, and (or) gastrointestinal symptoms (e.g. nausea,
vomiting, diarrhea) (see section 2 Important information before using Tramal Retard 150).

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions
not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions
can be reported directly to the Department of Monitoring 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tramal Retard 150

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 the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Tramal Retard 150 contains

• The active substance is tramadol hydrochloride. One prolonged-release tablet of Tramal Retard 150 contains 150 mg of tramadol hydrochloride (Tramadoli hydrochloridum).
• Other components of the medicine are:
  Tablet core: hypromellose 100,000 mPas, colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose.
  Coating: hypromellose 6 mPas, lactose monohydrate, macrogol 6000, propylene glycol, talc, titanium dioxide (E 171), iron oxide red (E 172), quinoline yellow lake (E 104).

What Tramal Retard 150 looks like and contents of the pack
The tablets are pale orange, round, with "T2" embossed on one side and the manufacturer's logo  on the other side.
Packs contain 10, 30 or 50 tablets in blisters of 10 tablets in a cardboard box.
For more detailed information, contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
VIANEX S.A.
Tatoiou Str., 18th km Athens-Lamia National Road
146 71, Nea Erythrea, Greece
Manufacturer:
Grunenthal GmbH
Zieglerstrasse 6
52078 Aachen
Germany
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Greece, country of export: 54733/27-06-2014
22044/15/06-03-2017
Parallel Import Authorisation Number: 415/22