Tralodie

PATIENT LEAFLET: INFORMATION FOR THE USER

Tralodie 100 mg Prolonged-release hard capsules, 150 mg Prolonged-release hard capsules, 200 mg Prolonged-release hard capsules

Tramadol hydrochloride
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 may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. WHAT TRALODIE IS AND WHAT IT IS USED FOR
Tramadol, the active substance in Tralodie, is an analgesic belonging to the opioid class, which acts on the central nervous system. It relieves pain by acting on specific nerve cells in the spinal cord and brain.
Tralodie is used to relieve moderate to severe pain.

2. WHAT YOU NEED TO KNOW BEFORE TAKING TRALODIE

Tralodie may only be taken by adults and children over 12 years of age.
Do not take Tralodie

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking monoamine oxidase inhibitor (MAOI) medications (used to treat depression) or have taken them within the last two weeks (see “Other medicines and Tralodie”);
• in case of acute alcohol, sedative, analgesic, or other psychotropic drug poisoning (medicines that affect mood and emotions);
• if you suffer from epilepsy and seizures are not adequately controlled by treatment;
• if you have severe liver impairment;
• as a substitute treatment for drug withdrawal.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tralodie

• if you think you may be dependent on other painkillers (opioids);
• if you have disorders affecting consciousness (such as feeling faint);
• if you are in shock (cold sweats may be a symptom);
• if you have increased pressure inside the brain (possibly after head injury or brain disease);
• if you have breathing difficulties;
• if you have epilepsy or seizures, as the risk of seizures may increase;
• if you have kidney or liver disease.

In these cases, consult your doctor before taking this medicine.
Seizures have been observed in patients taking tramadol at the recommended therapeutic dose. The risk may increase if the maximum daily dose (400 mg) is exceeded.
Tralodie may cause physical and psychological dependence. With long-term use, the effectiveness of Tralodie may decrease, requiring higher doses (tolerance may develop). In patients with a history of drug abuse or dependence, treatment with Tralodie should be limited to short durations and under strict medical supervision.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation of 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 adverse 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.
Inform your doctor if any of these problems occur during treatment with Tralodie or if they have occurred in the past.

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

Other medicines and Tralodie
Tell your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Tralodie must not be taken together with monoamine oxidase inhibitor (MAOI) medicines (used to treat depression).
The analgesic effect of Tralodie may be reduced and its duration of action shortened if you are taking medicines containing:

• carbamazepine (used for epilepsy);
• pentazocine, nalbuphine, or buprenorphine (analgesics);
• ondansetron (used to prevent nausea). Your doctor will advise you whether to take Tralodie and what dosage to use.

The risk of side effects increases:

• if you take Tralodie together with other medicines that depress the central nervous system. This may increase drowsiness or the feeling of fainting. In this case, inform your doctor. Such medicines include tranquilizers, sleeping pills, and other analgesics such as morphine and codeine (also used as a cough suppressant), as well as alcohol.
• if you are taking Tralodie together with sedative medicines such as benzodiazepines or similar substances. This increases the risk of drowsiness, breathing difficulties (respiratory depression), and coma, which may be life-threatening. Because of this, concomitant use should only be considered when other treatments are not possible. However, if your doctor prescribes Tralodie together with sedative medicines, the dose and duration of treatment must be reduced and determined by your doctor. Inform your doctor if you are taking sedative medicines, and always follow your doctor’s advice closely. It may be helpful to inform family members or caregivers about the signs and symptoms listed above. Contact your doctor if these symptoms occur.
• 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 Tralodie at the same time. Your doctor will advise you whether Tralodie is suitable for you.
• if you are taking certain antidepressants. Tralodie may interact with these medicines, causing symptoms such as involuntary rhythmic muscle contractions, including those controlling eye movements, agitation, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38°C.
• if you are taking Tralodie together with coumarin anticoagulants (medicines to thin the blood), such as warfarin. The effect of these medicines on bleeding time may be altered, potentially leading to bleeding.

Tralodie with food, drinks, and alcohol
Do not consume alcoholic beverages while taking Tralodie, as the effects of alcohol may be enhanced. Food does not affect the efficacy of Tralodie.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data in humans regarding the safety of tramadol use during pregnancy. Therefore, you should not take Tralodie during pregnancy.
Chronic use during pregnancy may result in withdrawal syndrome in the newborn.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tralodie more than once while breastfeeding, or alternatively, if you take Tralodie more than once, you must stop breastfeeding.

Driving and using machines
Tralodie may cause drowsiness, dizziness, and blurred vision, and may therefore impair your reaction ability. If you feel your reactions are slowed, do not drive or operate vehicles, do not use electrical appliances or machinery, and avoid working without secure footing!

Tralodie contains monostearate of sucrose.
This medicine contains monostearate of sucrose as a source of sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.

3. HOW TO TAKE TRALODIE

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dose should be determined based on the intensity of pain and your individual sensitivity to pain. Generally, the lowest effective dose that relieves pain should be used.
Unless otherwise prescribed by your doctor, the usual dose is:

Adults and adolescents from 12 years of age
The usual initial dose is one capsule of 100 mg or 200 mg per day.
Take the capsule at the same time each day. For example, if you take a capsule at 8 a.m., take the next capsule at 8 a.m. the following day.
Your doctor may prescribe a different and more appropriate dose if necessary.
Do not exceed 400 mg of tramadol per day, unless otherwise directed by your doctor.

Children
Tralodie is not indicated for children under 12 years of age.

Elderly patients
In elderly individuals (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 impairment / dialysis
Patients with severe hepatic and/or renal impairment should not take Tralodie. In cases of mild or moderate impairment, your doctor may recommend prolonging the interval between doses.

How and when to take Tralodie
Tralodie capsules are for oral use.
The capsules must be swallowed whole, without chewing. It is possible to carefully open Tralodie capsules and pour the granules onto a spoon. The spoon should then be placed inside the patient's mouth, and the granules should be swallowed with a glass of water, taking care to ingest all of them. The granules must not be chewed or crushed.

How long to take Tralodie
Do not take Tralodie for longer than necessary.
If long-term treatment is required, your doctor will regularly and frequently review (possibly with treatment interruptions) whether you should continue taking Tralodie and at what dose.
If you feel that the effects of Tralodie are too strong or too weak, consult your doctor or pharmacist.

If you take more Tralodie than you should
If you have accidentally taken a high dose, contact your doctor immediately or go to the nearest Emergency Department. A range of symptoms may occur, including: vomiting (feeling unwell), low blood pressure, rapid heartbeat, collapse, fainting, or even coma, seizures, and breathing difficulties.

If you forget to take Tralodie
If you forget to take your capsules, your pain may return. Do not take a double dose to make up for a missed dose. Take the next capsule as usual.
Contact your doctor for advice. They may recommend taking another painkiller in the meantime until the next scheduled dose.

If you stop taking Tralodie
Do not stop taking this medicine abruptly, unless instructed by your doctor. If you wish to discontinue treatment, 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 stop or discontinue Tralodie treatment too early, your pain may return. If you wish to stop treatment due to side effects, discuss this with your doctor.

Generally, discontinuation of prolonged-release Tralodie capsules does not lead to withdrawal effects. However, in rare cases, individuals who have abruptly stopped Tralodie treatment after a period of use may feel unwell. They may experience restlessness, anxiety, nervousness, or agitation. They may become hyperactive, have difficulty sleeping, or experience stomach or intestinal disturbances. Very rarely, some individuals may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, numbness, or ringing in the ears (tinnitus). If any of these symptoms occur after stopping Tralodie, contact your doctor.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Tralodie may cause adverse effects, although not everyone experiences them.
The frequency of adverse effects is normally classified as follows:

• Very common (may affect more than 1 in 10 people)
• Common (may affect up to 1 in 10 people)
• Uncommon (may affect up to 1 in 100 people)
• Rare (may affect up to 1 in 1,000 people)
• Very rare (may affect up to 1 in 10,000 people)
• Not known (frequency cannot be estimated from the available data)

The most common adverse effects during treatment with Tralodie are nausea and dizziness, occurring in more than 1 patient in 10.

Cardiac and circulatory disorders:
Uncommon: effects on heart rate and circulation (palpitations, rapid heartbeat, feeling of weakness or collapse). These adverse effects may occur particularly in patients who are standing or undergoing physical exertion.
Rare: slowing of the heartbeat, increased blood pressure.

Nervous system disorders:
Very common: dizziness
Common: headache, drowsiness
Rare: changes in appetite, abnormal sensations (e.g. itching, tingling, numbness), tremor, breathing difficulties, epileptic seizures, involuntary muscle contractions, uncoordinated movements, temporary loss of consciousness (syncope).

If doses higher than recommended are taken, or if other medicines that depress brain function are taken simultaneously, breathing may slow down.
Epileptic seizures have mainly occurred following ingestion of high doses of tramadol or when other medicines that increase susceptibility to seizures have been taken concomitantly.

Psychiatric disorders:
Rare: hallucinations, confusion, sleep disturbances, anxiety, and nightmares.
Psychological disturbances may occur after treatment with Tralodie. Their intensity and nature may vary (depending on the patient's personality and duration of treatment). Mood changes (typically increased liveliness, occasionally irritability), changes in activity (typically inhibition; occasionally increased activity), and reduced cognitive and sensory capacity (changes in sensory perception and recognition, which may lead to incorrect judgments) may occur.
Dependence may occur.

Eye disorders:
Rare: blurred vision.

Respiratory disorders:
Rare: shortness of breath (dyspnea).
Cases of worsening asthma have been reported, although it has not been established whether they were caused by tramadol.

Gastrointestinal disorders:
Very common: nausea.
Common: vomiting, constipation, dry mouth.
Uncommon: vomiting urges, stomach discomfort (feeling of pressure in the stomach, bloating), diarrhoea.

Skin disorders:
Common: sweating.
Uncommon: skin reactions (such as itching, urticaria).

Musculoskeletal disorders:
Rare: muscle weakness.

Hepatobiliary disorders:
Very rare: increased liver enzyme values.

Urinary disorders:
Rare: difficulty or pain in urinating, reduced urine output.

General disorders:
Common: fatigue.
Rare: allergic reactions (e.g. breathing difficulties, laboured breathing, skin sweating) and shock (sudden circulatory failure). Consult a doctor immediately if symptoms such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria associated with breathing difficulties occur.

Withdrawal symptoms may occur at the end of treatment (see "If you stop taking Tralodie").

Metabolism and nutrition disorders
Not known: hypoglycaemia (low blood sugar levels).

If any of these adverse effects worsens, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRALODIE

o Keep out of the sight and reach of children
o Do not use Tralodie capsules after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
o This medicinal product does not require any special storage conditions.
o Do not dispose of any medicine 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 PACKAGE AND OTHER INFORMATION

What Tralodie contains

• The active substance is tramadol hydrochloride. Each Tralodie 100 capsule contains 100 mg of tramadol hydrochloride. Each Tralodie 150 capsule contains 150 mg of tramadol hydrochloride. Each Tralodie 200 capsule contains 200 mg of tramadol hydrochloride.
• The other components are:
  • microcrystalline cellulose
  • sucrose monostearate
  • hypromellose
  • talc
  • polysorbate 80
  • polyethylene acrylate
  • simethicone
  • magnesium stearate
  • gelatin
  • titanium dioxide (E 171)
  • indigo carmine (E 132)

Description of the appearance of Tralodie and contents of the pack

• Tralodie 100 hard capsules have a turquoise cap and turquoise body and contain a white granule
• Tralodie 150 hard capsules have a turquoise cap and an opaque white body and contain a white granule
• Tralodie 200 hard capsules have a turquoise cap and a transparent body and contain a white granule

The capsules are packaged in blisters and supplied in pack sizes of 10, 20, 30, and 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milan, Italy

Manufacturer:
SMB Technology S.A.
39 rue du Parc Industriel
B-6900 Marche en Famenne
Belgium

This medicinal product is authorized in the European Economic Area countries under the following names:
Finland TRAMIUM 100-150-200 mg
Belgium TRAMIUM 100-150-200 mg
Luxembourg TRAMIUM 100-150-200 mg
Germany T-LONG 100-150-200 mg
Spain DOLODOL 100-150-200 mg
Portugal TRAM-U-RON OD 100-150-200 mg
France MONOCRIXO 100-150-200 mg
Italy TRALODIE 100-150-200 mg
Denmark DOLOL RETARD UNO 100-150-200 mg
Slovenia TRAMACUR 100-150-200 mg

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco).