TRALODIE 100 mg Hard Capsules, Prolonged Release

Зміст інструкції

1. Tralodie 100 mg Prolonged-Release Hard Capsules
   1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRALODIE
   2. HOW TO TAKE TRALODIE
   3. POSSIBLE SIDE EFFECTS
   4. HOW TO STORE TRALODIE
   5. PACKAGE CONTENTS AND OTHER INFORMATION

Tralodie 100 mg Prolonged-Release Hard Capsules

Tralodie150 mg Prolonged-Release Hard Capsules
Tralodie200 mg Prolonged-Release Hard Capsules
Tramadol hydrochloride
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient contained in Tralodie, is an analgesic belonging to the class of
opioids, 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 pain, ranging from moderate to severe in intensity

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRALODIE

Tralodie can only be taken by adults and adolescents over the age of 12 years.

Do not take Tralodie
if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed
in section 6);
if you are taking monoamine oxidase inhibitors (MAOIs, medicines used for depression) or have taken them in the
last two weeks (see “Other medicines and Tralodie ”).
in case of acute alcohol poisoning, sleeping pills, painkillers or other psychotropic drugs (medicines
that affect mood and emotions);
if you suffer from epilepsy and seizures are not adequately controlled by treatment;
if you suffer from severe liver failure;
as a substitute treatment in case of drug withdrawal.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tralodie
if you think you are suffering from dependence on other painkillers (opioids);
if you suffer from disorders of consciousness (if you feel faint);
if you are in shock (cold sweats may be a symptom)
if you suffer from increased pressure inside the brain (possibly if you have been hit on the head or have a
brain disease);
if you have difficulty breathing;
if you suffer from epilepsy or seizures as the risk of seizures may increase;
if you suffer from kidney or liver disease.
In these cases, consult your doctor before taking the medicine.
Seizures have been reported in patients taking tramadol at the recommended therapeutic dose
recommended. The risk may increase if you exceed the maximum recommended daily dose (400 mg).
Tralodie can cause physical and psychological dependence. With long-term use, the effectiveness of Tralodie
may decrease and higher doses may be necessary (tolerance may develop). In patients with
a history of drug abuse or dependence, treatment with Tralodie should be administered for
short periods and under strict medical supervision.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation in
this enzyme, which may have different effects on them. Some people may not get enough
pain relief, but others may experience serious side effects. If you notice
any of the following side effects, you should stop taking this medicine and consult
your doctor immediately: slowed or shallow breathing, confusion, drowsiness, constricted pupils,
feeling unwell or sick, constipation, loss of appetite.
Tell 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 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 Tralodie
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tralodie should not be taken with monoamine oxidase inhibitors (medicines used for the
treatment of depression).
The analgesic effect of Tralodie may be reduced and its duration of action shortened if you take
medicines that contain:

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

The risk of side effects increases:

• if you take Tralodie together with other medicines that depress the nervous system. This may increase drowsiness or the feeling of impending fainting. In this case, inform your Doctor. These other medicines include tranquillizers, sleeping pills and other painkillers such as morphine and codeine (also used as a medicine to suppress cough) and alcohol.
• If you are taking Tralodie and sedatives such as benzodiazepines or similar. This increases the risk of drowsiness, difficulty breathing (respiratory depression), coma which can be life-threatening. For this reason, concomitant use should only be considered when other treatments are not possible. However, if your doctor prescribes Tralodie in conjunction with sedatives, the dose and duration of treatment must be reduced and decided by your doctor. Tell your doctor if you are taking sedatives, and always follow your doctor's advice closely. It may be helpful to inform relatives and caregivers of the signs and symptoms above. Contact your doctor if these symptoms appear.
• If you are taking certain medicines that can cause seizures (attacks), such as some antipsychotic antidepressants. The risk of having an attack may increase if you take Tralodie at the same time. Your doctor will tell you if Tralodie is suitable for you.
• If you are taking certain antidepressants. Tralodie can interact with these drugs and you may experience symptoms such as: involuntary rhythmic muscle contractions, including the muscles that control eye movement, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C.
• If you take Tralodie together with coumarin anticoagulants (medicines to thin the blood), such as warfarin. The effect of these drugs on bleeding time may be altered and bleeding may occur.

Tralodiewith food, drinks and alcohol
Do not drink alcohol when taking Tralodie as the effect of alcohol may be
intensified. Food does not affect the effectiveness of Tralodie .

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There are insufficient data on the safety of tramadol use during
pregnancy in humans. Therefore, you should not take Tralodie during pregnancy.
Chronic use during pregnancy can cause withdrawal syndrome in the newborn.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tralodie more than once
during breastfeeding or, alternatively, if you take Tralodie more than once, you should stop
breastfeeding.

Driving and operating machinery
Tralodie can cause drowsiness, dizziness and blurred vision and can therefore alter your reactions. If you feel
that your reactions are slowed down, you should not drive cars or other vehicles, do not use electrical
appliances or other machinery and do not work without a firm grip!

Tralodiecontains saccharose monostearate.
This medicine contains saccharose monostearate as a source of sucrose. If your doctor has
diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE TRALODIE

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The dosage must be chosen based on the intensity of the pain and your personal sensitivity to pain. In
general, you should take the lowest dose that reduces the pain.
Unless your doctor prescribes otherwise, the usual dose is:
Adults and adolescents starting from 12 years of age
The usual initial dose is one 100 or 200 mg capsule per day.
Take the capsule every day at the same time. For example, if you take a capsule at 8 a.m., take the
next one at 8 a.m. the next day.
Your doctor may prescribe a different and more appropriate dosage, if necessary.
Do not exceed 400 mg of tramadol per day, unless otherwise prescribed by your doctor.
Children
Tralodie is not indicated for children under 12 years of age.
Elderly patients
In elderly people (over 75 years of age) the elimination of tramadol may be delayed. If this is the
case, your doctor may advise you to prolong the time interval between doses.
Patients with severe hepatic or renal insufficiency / dialysis
Patients with severe hepatic and/or renal insufficiency should not take Tralodie. In case of
mild or moderate insufficiency, your doctor may advise you to prolong the time interval between
doses.
How and when to take Tralodie
The capsules of Tralodie are for oral use.
The capsules must be swallowed whole, without chewing. It is possible to carefully open the capsules of
Tralodie to pour their granules onto a spoon. The spoon should then be placed inside
the patient's mouth, who will swallow the granules with a glass of water, being careful to ingest
them all. The granules should not be chewed or crushed.
For how long to take Tralodie
You should not take Tralodie for longer than necessary.
If you need treatment for a longer period, your doctor will check at short and regular intervals
(possibly with interruptions in therapy) whether you should continue to take 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 Tralodiethan you should
If you have accidentally taken high doses, contact your doctor immediately or go to the nearest Emergency
Room. A number of symptoms may occur, including: vomiting (feeling sick), low blood pressure, rapid
heartbeat, collapse, fainting or even coma, seizures and difficulty breathing.

If you forget to take Tralodie
If you have forgotten to take the capsules, the pain may return. Do not take a double dose
to make up for a missed dose. Take the next tablet as usual.
Contact your doctor for advice. They may suggest another pain reliever to take until the time of
taking the next capsule.

If you stop taking Tralodie
You should not suddenly stop taking this medicine, unless your doctor tells you to. If you intend to stop
taking the medicine, talk to your doctor first, especially
if you have been taking it for a long time. Your doctor will advise you when and how to stop it, which may involve
gradually reducing the dose to reduce the likelihood of developing unnecessary side effects
(withdrawal symptoms).
If you stop or discontinue treatment with Tralodie too early, the pain may return. If
you want to stop treatment due to side effects, talk to your doctor.
Generally, no withdrawal effects occur when stopping treatment with Tralodie prolonged-release capsules.
However, in rare cases, subjects who have abruptly stopped therapy with
Tralodie after a period of treatment may not feel well. They may feel agitated, anxious,
nervous or upset. They may be hyperactive, have difficulty sleeping, or have stomach or
intestinal disorders. Very rarely, some subjects may experience panic attacks, hallucinations, unusual sensations such as
itching, tingling, numbness and ringing in the ears (tinnitus). If any of these
symptoms occur after stopping treatment with Tralodie, contact your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Tralodie can cause side effects, although not everybody gets them.
Normally, the frequency of side effects is 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 (the frequency cannot be estimated from the available data)

The most common side effects during treatment with Tralodie are nausea and dizziness, which occur in
more than 1 in 10 patients.
Heart and circulation disorders:

Uncommon: effects on the heartbeat and circulation (palpitations, fast heartbeat, feeling of weakness or collapse). These side effects may
occur, in particular, in patients who are standing or undergoing
physical exertion.

Rare: slowing of the heartbeat, increase in blood pressure.
Nervous system disorders :

Very common: dizziness

Common: headache, drowsiness

Rare: changes in appetite, abnormal sensations (e.g. itching, tingling,
numbness) tremor, difficulty breathing, seizures, involuntary
muscle contractions, uncoordinated movements, temporary loss of consciousness
(syncope).
If you exceed the recommended doses or if you take other medicines at the same time
that depress brain functions, breathing may slow down.
Seizures have occurred mainly after ingestion of
high doses of tramadol or when medicines were taken at the same time
that make you more vulnerable to seizures.
Psychiatric disorders:

Rare: hallucinations, confusion, sleep disturbances, anxiety and nightmares.
Psychological disorders may occur after treatment with Tralodie. Their
intensity and nature can change (depending on the patient's personality and the
duration of treatment). Changes in mood may occur (usually
vivacity, occasionally irritability), changes in activity (usually
inhibition; sporadically increase) and decreased cognitive and sensory ability
(change in the ability of the senses and recognition, which can lead to
incorrect judgements).
Dependence can 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: nausea, stomach discomfort (feeling of pressure in the stomach, bloating),
diarrhea.
Skin disorders:

Common: sweating.

Uncommon: skin reactions (such as itching, hives).
Musculoskeletal disorders:

Rare:muscle weakness.
Liver and biliary disorders:

Very rare:increased levels of liver enzymes.
Urinary disorders:

Rare: difficulty or pain when urinating, production of less urine than normal.
Systemic disorders:

Common: fatigue.

Rare: allergic reactions (e.g. difficulty breathing, wheezing,
sweating of the skin) and shock (sudden circulatory failure). Consult
a doctor immediately if you experience symptoms such as swelling of the
face, tongue and/or throat and/or difficulty swallowing or hives combined with difficulty
breathing.
Withdrawal symptoms may occur at the end of treatment (see
“ If you stop taking Tralodie”).
Metabolism and nutrition disorders

Not known:hypoglycemia (low blood sugar level).
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa.
By reporting side 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 indicated on the packaging. The expiry date refers to the last day of the month.
o This medicine does not require any particular storage conditions.
o Do not dispose of any medicine in 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 Tralodie contains

• The active ingredient 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 ingredients are:
• microcrystalline cellulose
• saccharose 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 package contents
o The hard capsules of Tralodie 100 have a turquoise-colored cap and body and
contain a white granulate
o The hard capsules of Tralodie 150 have a turquoise-colored cap and a white opaque body
and contain a white granulate
o The hard capsules of Tralodie 200 have a turquoise-colored cap and a transparent body
and contain a white granulate
The capsules are packaged in blisters and available in packs of 10, 20, 30, 60 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15 – 20143 Milano
Manufacturer:
SMB Technology S.A.
39 rue du Parc Industriel
B-6900 Marche en Famenne
Belgium

This medicinal product is authorised in the Member States of the European Economic Area with 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.