TRADONAL 50 mg Hard Capsules With Prolonged Release

Зміст інструкції

1. Tradonal SR 50 mg prolonged-release hard capsules, SR 100 mg prolonged-release hard capsules, SR 150 mg prolonged-release hard capsules, SR 200 mg prolonged-release hard capsules
   1. What is Tradonal SR and what is it used for
   2. What you need to know before taking Tradonal SR
   3. How to take Tradonal SR
   4. Possible side effects
   5. How to store Tradonal SR
   6. Contents of the pack and other information
2. Tradonal SR 150 mg hard capsules with prolonged release are dark green in colour and

Tradonal SR 50 mg prolonged-release hard capsules, SR 100 mg prolonged-release hard capsules, SR 150 mg prolonged-release hard capsules, SR 200 mg prolonged-release hard capsules

Tramadol hydrochloride

Read this leaflet carefully before you start 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 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 Tradonal SR is and what it is used for
• 2. What you need to know before you take Tradonal SR
• 3. How to take Tradonal SR
• 4. Possible side effects
• 5. How to store Tradonal SR
• 6. Contents of the pack and other information

1. What is Tradonal SR and what is it used for

Tradonal SR belongs to a class of medicines called analgesics, commonly known as
pain relievers. The active ingredient, tramadol hydrochloride, interrupts the sending of
pain messages to your brain and also acts at the brain level to prevent pain messages from being
felt. This means that Tradonal SR does not prevent pain from occurring, but prevents
you from feeling the pain anyway.
Tradonal SR is used to relieve moderate to severe pain (for example, pain after
surgery, or after an injury).

2. What you need to know before taking Tradonal SR

Do not take Tradonal SR:

• if you are allergic to tramadol hydrochloride or any of the other ingredients of this medicine (listed in section 6), as skin rash, swelling of the face or difficulty breathing may occur;
• if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) for treating depression (see section 2, “Other medicines and Tradonal SR”);
• if you have epilepsy that is not controlled by any treatment;
• if you have drunk enough alcohol to feel dizzy or intoxicated;
• if you have taken a dose higher than prescribed of your sleeping tablets, antipsychotics, antidepressants (antipsychotics and antidepressants are medicines that affect mood and emotions) or other painkillers, which may slow down your breathing and your reactions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tradonal SR, if:

• you have had an allergic reaction to any medicine similar to morphine;
• you have been taking Tradonal SR or any other medicine containing tramadol for a long period;
• you are dependent on morphine;
• you have serious problems with your liver or kidneys;
• you have recently had a head injury or have a particularly severe headache that causes you to vomit;
• you have ever had seizures (fits) or if you suffer from epilepsy;
• you suffer from asthma or breathing difficulties;
• you are going to have surgery with general anesthesia;
• you suffer from depression and are taking antidepressants, as some of them may interact with tramadol (see section 2, “Other medicines and Tradonal SR”).

Breathing-related sleep disorders
Tradonal SR can cause breathing-related sleep disorders such as sleep apnea (pauses
in breathing during sleep) and sleep-related hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing during sleep, nighttime awakenings due to
labored breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or
another person observes these symptoms, contact your doctor, who may consider a dose reduction.
Talk to your doctor if you notice any of the following symptoms while taking Tradonal SR:
Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure.
These symptoms may be indicative of adrenal insufficiency (low levels of cortisol). If
you experience these symptoms, contact your doctor, who will decide if you need hormone replacement therapy.
There is a rare possibility that Tradonal SR may cause seizures (fits). The risk increases if
doses higher than the maximum daily doses are taken and if you are also taking antidepressants or
antipsychotics.
If you are prone to addiction or drug abuse, you should only take Tradonal SR for short
periods. Tell your doctor because your doctor may want to monitor your pain control more
carefully.
You should not take this medicine to treat withdrawal symptoms if you are dependent on drugs.
There is a slight risk that you may develop so-called serotonin syndrome, which may
occur after taking tramadol together with certain antidepressants or tramadol in
monotherapy. Consult your doctor immediately if you experience any of the symptoms associated with
this serious syndrome (see section 4, “Possible side effects”).
Tramadol is broken down 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.

Children and adolescents:
Tradonal SR should not be given to children under 12 years of age.
Use in children with breathing problems
Tramadol is not recommended in children with breathing problems, as the symptoms of tramadol toxicity may be worse in these children.

Other medicines and Tradonal SR
Tell your doctor or pharmacist or dentist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
Do not take Tradonal SR at the same time as medicines called monoamine oxidase inhibitors (moclobemide or phenelzine for depression, selegiline for Parkinson's disease) or within 14
days of taking them.
The pain-relieving effect of Tradonal SR may be weakened and/or shortened if you are also taking medicines
containing:

• carbamazepine (used to treat epilepsy)
• buprenorphine, nalbuphine or pentazocine (painkillers)
• ondansetron (prevents nausea)

The doctor will tell you if you should take Tradonal SR and at what dosage.
The risk of side effects increases if you are taking medicines that can cause
seizures (fits), such as some antidepressants or antipsychotics. The risk of having a fit may
increase if you take Tradonal SR at the same time. Your doctor will tell you if Tradonal SR modified-release capsules
are suitable for you.
The risk of side effects increases if you are taking certain antidepressants. Tradonal SR may
interact with these drugs and you may experience serotonin syndrome (see section 4,
“Possible side effects”).
Medicines that act on the nervous system such as hypnotics, sedatives, sleeping pills and
painkillers, may make you feel more drowsy or weak when taken with Tradonal SR.
Anticoagulant medicines to thin the blood, such as warfarin. The effectiveness of these medicines may
be altered if you are also taking Tradonal SR.
Tell your doctor if you are taking these medicines.
The concomitant use of Tradonal SR and sedatives such as benzodiazepines or medicines related to them increases the risk of drowsiness, difficulty breathing (respiratory depression), coma
and may be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Tradonal SR together with sedatives, the dose and duration of
concomitant treatment must be limited by the doctor.
Tell your doctor about all the sedatives you are taking and carefully follow
the doctor's dosage recommendations. It may be helpful to let friends or family members pay
attention to the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

Tradonal SR with food, drinks and alcohol
Tradonal SR should be taken with some water, with or without food. Avoid drinking alcohol while taking
this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine. Contact
your doctor if you become pregnant during treatment.
Pregnancy
Tradonal SR should not be used during pregnancy or breastfeeding, as the safety profile of this medicine in pregnancy is not yet known. Contact your doctor if you become pregnant during
treatment.
Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tradonal SR more than
once during breastfeeding, otherwise, if you take Tradonal SR more than once, you should stop
breastfeeding.

Driving and operating machinery
Tradonal SR can cause drowsiness and this effect may be enhanced by alcohol, antihistamines and
other central nervous system antidepressants. If patients are affected, they should be
warned not to drive or operate machinery.

Tradonal SRcontains sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Tradonal SR

Take this medicine following the instructions of your doctor exactly. 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.
Generally, you should take the lowest dose that reduces the pain.
Swallow the capsules whole with water, without chewing.
If you have difficulty swallowing, you can open the capsules. You must open the capsules very carefully, pulling
and rotating each end over a spoon, so that the granules remain in the spoon. Do not
chew. Swallow all the granules with a little water.

Dosage for adults and adolescents over 12 years of age:
The usual initial dose is 50-100 mg twice a day, in the morning and in the evening. Your doctor may
increase your dose to 150-200 mg twice a day, as needed. Usually you should
take Tradonal SR every 12 hours, at the same time, in the morning and in the evening.
The maximum doseis 400 mg per day.

Use in children:
Tradonal SR should not be given to children under 12 years of age.

Use in elderly patients:
In elderly people (over 75 years of age) the elimination of tramadol may be delayed. If
this is your case, your doctor may advise you to extend the time interval between doses.

Use in patients with severe kidney problems (insufficiency) and/or patients on dialysis:
Patients with severe hepatic and/or renal insufficiency should not take Tradonal SR. In case of
mild or moderate insufficiency, your doctor may advise you to extend the time interval between
doses.

If you take more Tradonal SR than you should
If you accidentally take more capsules than prescribed, inform your doctor or
pharmacist immediately and, if necessary, contact the nearest emergency room. Remember to bring the
package and any remaining medicine with you.

If you forget to take Tradonal SR
Do not take a double dose to make up for a missed dose.

If you stop taking Tradonal SR
You should not suddenly stop taking this medicine unless your doctor
prescribes it. 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).
People who have been taking Tradonal SR for some time may feel unwell if the
treatment is stopped abruptly. You may feel restless, anxious, nervous, or
shaken. You may be hyperactive, have difficulty falling asleep, and have stomach or
intestinal problems. If you experience any of these symptoms after stopping Tradonal SR, consult
your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tradonal SR can cause side effects, although not everybody gets them.
The most serious side effects that may occur include allergic reaction (difficulty
breathing, wheezing and swelling of the face or throat), anaphylactic reaction (a severe allergic
reaction resulting in difficulty breathing, changes in heart rate, weakness, collapse or
loss of consciousness due to a drop in blood pressure) or convulsions (seizures). If any of
these symptoms occur, stop taking Tradonal SR immediately and contact
your doctor.

Very common (may affect more than 1 in 10 people)

• Dizziness
• Vomiting and nausea (feeling unwell)

Common (may affect up to 1 in 10 people)

• Headache
• Numbness, drowsiness (fatigue)
• Constipation, dry mouth
• Sweating

Uncommon (may affect up to 1 in 100 people)

• Rapid heartbeat, palpitations, sudden drops in blood pressure. These adverse events may occur especially with intravenous administration and in physically stressed patients
• Itching, rash
• Nausea, feeling of bloating or fullness

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

• Changes in appetite
• Psychiatric effects including: mood changes, behaviour and perception of activities, hallucinations, confusion, restlessness, sleep disturbances and nightmares
• Convulsions (seizures)
• Feeling of tingling and tremor
• Slow heartbeat, increased blood pressure
• Muscle weakness
• Difficulty or inability to urinate
• Blurred vision

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

• Flushing
• Vertigo (a sensation of spinning or dizziness)
• Asthma and difficulty breathing
• Increased liver enzymes

Not known: frequency cannot be estimated from the available data

• Decreased blood sugar levels
• Low blood sodium levels which can cause fatigue and confusion, muscle cramps, convulsions and coma
• Hiccups
• Serotonin syndrome, which can manifest as changes in mental status (for example agitation, hallucinations, coma) and other effects, such as fever, increased heart rate, unstable blood pressure, involuntary contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (for example nausea, vomiting, diarrhea) (see section 2, “What you need to know before you use Tradonal SR”).

The withdrawal syndromeincludes: agitation, anxiety, nervousness, difficulty sleeping,
restlessness, tremor and gastrointestinal disorders (see section 3, “How to take Tradonal SR”).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through 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 Tradonal SR

Do not store at a temperature above 25°C
Store in the original packaging, to protect the medicine from humidity.
Keep out of sight and reach of children.
Do not use Tradonal SR after the expiry date which is reported on the package. The expiry date
refers to the last day of that month.

• Do not dispose of medicines down the drain or in household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tradonal SR contains:
The active ingredient is tramadol hydrochloride.
Tradonal SR 50 mg 100 mg 150 mg 200 mg prolonged-release hard capsules contains 50 mg 100
mg 150 mg 200 mg of tramadol hydrochloride.
The other ingredients of the capsule contents are: sugar spheres (sucrose and corn starch),
anhydrous colloidal silica, ethylcellulose, shellac, talc.
The capsules contain: gelatin, titanium dioxide (E171), yellow iron oxide (E172) [ for the dosage

of 50, 150 and 200 mg], indigotine (E132) [ for the 50 and 150 mg dosage].
The printing ink contains: shellac, black iron oxide (E172), propylene glycol, ammonium
hydroxide.

Description of the appearance of Tradonal SR prolonged-release hard capsules and contents of the
pack:
Prolonged-release hard capsules.

Tradonal SR 50 mg prolonged-release hard capsulesare dark green in color and marked
with T50SR.

Tradonal SR 100 mg prolonged-release hard capsulesare white in color and marked
with T100SR.

Tradonal SR 150 mg hard capsules with prolonged release are dark green in colour and

marked with T150SR.

Tradonal SR 200 mg hard capsules with prolonged releaseare yellow in colour and marked with

T200SR.
This medicinal product is in the form of a hard capsule with prolonged release. The capsules release
the active substance over a period of time.
All capsules are packaged in a PVC/PVDC/aluminium blister pack of 10 capsules. Each
pack contains 1, 2, 3, 5, 6 or 10 blister packs, meaning that each pack contains 10, 20, 30,
50, 60 or 100 capsules per pack. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Viatris Healthcare limited – Damastwon Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
Temmler Pharma GmbH, Temmlerstrasse 2, D-35039 Marburg, Germany

This medicinal product is authorised in the Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) under the following denominations:
Belgium Tradonal Retard 50/100/150/200 mg, prolonged-release capsules
Tradonal Retard 50/100/150/200 mg, capsules with prolonged release, hard
Tradonal Retard 50/100/150/200 mg, hard capsules, sustained release
Denmark Gemadol Retard
France Zamudol LP 50/100/150/200 mg, prolonged-release capsule
Germany Travex retard 50/100/150/200 mg hard capsules, sustained release
Italy Tradonal SR 50/100/150/200 mg 30/60 hard capsules with prolonged release
Luxembourg Tradonal Retard 50/100/150/200 mg, prolonged-release capsules
Tradonal Retard 50/100/150/200 mg, capsules with prolonged release, hard
Tradonal Retard 50/100/150/200 mg, hard capsules, sustained release
Netherlands Tramadol HCl Retard Mylan 50/100/150/200 mg, hard capsules with
prolonged release
Portugal Travex hard capsule with prolonged release
Spain Tradonal retard 50/100/150/200 mg hard capsules with prolonged release
Sweden Gemadol 50/100/150/200 mg depot capsule hard
United Kingdom
(Northern Ireland)
Zamadol SR 50/100/150/200 mg prolonged-release hard capsules