TRAMADOLO 100 mg Extended-Release Tablet

Зміст інструкції

1. Tramadolo HCl Sandoz 100 mg prolonged-release tablets
   1. What is Tramadolo HCl Sandoz and what is it used for
   2. What you need to know before you take Tramadolo HCl Sandoz
   3. How to take Tramadolo HCl Sandoz
   4. Possible side effects
   5. How to store Tramadolo HCL Sandoz
   6. Contents of the pack and other information

Tramadolo HCl Sandoz 100 mg prolonged-release tablets

Generic medicine
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 pass it on to others even if they have the same symptoms as you, 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 Tramadolo HCl Sandoz is and what it is used for
2 What you need to know before you take Tramadolo HCl Sandoz
3 How to take Tramadolo HCl Sandoz
4 Possible side effects
5 How to store Tramadolo HCl Sandoz
6 Contents of the pack and other information

1. What is Tramadolo HCl Sandoz and what is it used for

Tramadolo, the active ingredient of Tramadolo HCl Sandoz, is a pain reliever (analgesic)
belonging to the group of opioids whose analgesic effect is due to its influence on
specific nerve cells present in the spinal cord and in the brain.
Tramadolo HCl Sandoz is used in the treatment of moderate to severe pain.

2. What you need to know before you take Tramadolo HCl Sandoz

Do not take Tramadolo HCl Sandoz

• if you are allergic to tramadol or to any of the other ingredients of this medicine (listed in section 6).
• in acute intoxication with alcohol, sleeping pills, pain relievers, opioids or other psychotropic medicines (medicines that affect mood, emotional state and temperament)
• if you are also taking certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat depression or Parkinson's disease) or have taken them in the last 14 days before treatment with Tramadolo HCl Sandoz (see section “Other medicines and Tramadolo HCl Sandoz”)
• if you suffer from epilepsy and seizures are not adequately controlled by treatment
• as a substitute drug in detoxification therapy from drugs.

Warnings and precautions
Talk to your doctor before taking Tramadolo HCl Sandoz if

• you believe you are already dependent on other opioid pain relievers
• you experience sensitivity reactions to opioids
• you suffer from a disturbance of consciousness (if you feel like you are going to faint)
• you are in a state of shock (a symptom could be cold sweats)
• you suffer from breathing difficulties
• you suffer from increased pressure in the brain (possible after a head injury or brain illness)
• you suffer from liver or kidney disorders
• you suffer from, or have suffered from, epilepsy or seizures (convulsions). If any of the above situations apply to you, consult your doctor before starting to take this medicine.

Seizures have been reported in patients taking tramadol at the recommended dose.
The risk may be increased if the upper limit of the recommended daily dose of
400 mg of tramadol hydrochloride is exceeded or if you are taking concomitant medicines that lower the
seizure threshold (see "Other medicines and Tramadolo HCl Sandoz").
It should be noted that patients receiving Tramadolo HCl Sandoz may develop psychological and physical dependence. During long-term treatment, the effects of this medicine
may weaken, thus determining the need to resort to a higher
dosage (development of tolerance). For this reason, in patients at risk for the development of
drug dependence, Tramadolo HCl Sandoz must be used for short periods and only under
strict medical supervision.
If you develop any of these disorders during treatment with this medicine, or if you
have suffered from similar problems in the past, tell your doctor.
Tramadol is metabolized in the liver by an enzyme. Some people have a variation
of 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
The use of Tramadolo HCl Sandoz is not recommended in children under 12 years of age.
Use in children with respiratory problems
Tramadol is not recommended in children with respiratory problems, as the
symptoms of tramadol toxicity may be worse in these children.

Elderly
Patients over 75 years of age should be monitored carefully as the elimination of
tramadol may be prolonged (see section 3 "How to take Tramadolo HCl Sandoz").

Other medicines and Tramadolo HCl Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not take Tramadolo HCl Sandoz together with other medicines called “monoamine oxidase inhibitors” or MAOIs (medicines used to treat depression or Parkinson's disease),
or if you have taken them in the last 14 days. The combination may give rise to
a serious and potentially fatal interaction
The analgesic effect of Tramadolo HCl Sandoz may be weakened and/or shortened over time
if you also take medicines containing:

• carbamazepine (used to treat epilepsy)
• pentazocine, nalbuphine or buprenorphine (pain relievers)
• ondansetron (used to treat nausea)

The risk of side effects increases if you take Tramadolo HCl Sandoz at the same time as:

• sedative medicines such as benzodiazepines or related medicines (e.g. tranquilizers, sleeping pills). The concomitant use of Tramadolo HCl Sandoz with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, respiratory depression, coma and can be life-threatening. For this reason, concomitant use should only be considered if other treatment options are not possible. However, if your doctor prescribes Tramadolo HCL Sandoz together with sedative medicines, the dose and duration of treatment must be limited by your doctor. Tell your doctor about all the sedative medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform friends and family that you are aware of the above signs and symptoms. Contact your doctor if you experience these symptoms.
• other sedative medicines, such as antidepressants and other analgesics such as morphine and codeine (even when taken for coughs) and alcohol. You may experience excessive drowsiness or a feeling of fainting
• medicines that can cause seizures (convulsions), such as some antidepressants or antipsychotics. The risk of having a seizure may increase if you take Tramadolo HCl Sandoz at the same time. Your doctor will tell you if Tramadolo HCl Sandoz is suitable for you.
• some antidepressants. Tramadolo HCl Sandoz may 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, exaggerated reflexes, increased muscle tension, body temperature above 38°C.
• medicines that inhibit blood clotting, such as warfarin. The dosage of these medicines may need to be reduced, otherwise there may be an increased risk of potentially serious bleeding.

Tramadolo HCl Sandoz with food and alcohol
Do not drink alcohol during treatment with Tramadolo HCl Sandoz; this may increase
the effects of this medicine.
Food does not affect the effect of Tramadolo HCl Sandoz (see section 3 “How to take
Tramadolo HCl Sandoz).

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
Information on the safety of tramadol in pregnancy is very limited; therefore
you should not take Tramadolo HCl Sandoz if you are pregnant.
Chronic use of Tramadolo HCl Sandoz during pregnancy can lead to withdrawal symptoms
in newborns.

Breastfeeding
Tramadol is excreted in breast milk. For this reason, you should not take Tramadolo HCl
Sandoz more than once during breastfeeding or, alternatively, if you take Tramadolo HCl Sandoz
more than once, you should stop breastfeeding.

Fertility
Based on experience in humans, tramadol hydrochloride does not affect
female or male fertility.

Driving and using machines
This medicine can cause side effects such as dizziness, drowsiness and blurred
vision. If this happens, do not drive vehicles or use tools or machinery and do not
engage in any potentially dangerous activity.

3. How to take Tramadolo HCl Sandoz

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.

• Swallow the prolonged-release tablets whole, with a glass of water.
• Do not break or chew the tablets.
• The tablets can be taken with or without food.

The recommended doses are indicated below. Your doctor may gradually increase or decrease the dosage depending on your response to treatment. The dosage should 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. Important: do not take this medicine for a period of time longer than absolutely necessary.

Adults and children aged 12 years and over

• The recommended initial dose is 100 mg twice a day.
• Take one prolonged-release tablet in the morning and one in the evening. There must be a minimum interval of 8 hours between each dose. As a general rule, do not take a dose higher than the minimum necessary to control the pain. You should not take a dose higher than 400 mg of active ingredient per day, unless there are specific medical reasons.

Use in children under 12 years
This medicine is not recommended in children under 12 years.

Elderly

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

Patients with severe hepatic or renal insufficiency/dialysis

• Patients with severe hepatic and/or renal insufficiency should not take Tramadolo HCl Sandoz. In case of mild or moderate insufficiency, your doctor may advise you to extend the time interval between doses.

If you take more Tramadolo HCl Sandoz than you should
Generally, accidentally taking one extra prolonged-release tablet does not cause negative consequences. Continue to take Tramadolo HCl Sandoz as soon as the pain returns, as usual. If you have taken an excessive dose of the medicine, the following signs may appear: pinpoint pupils, vomiting (nausea), low blood pressure, increased heart rate, collapse, disturbances of consciousness including coma, seizures and difficulty breathing. If you experience any of these symptoms, or if a child accidentally takes this medicine, contact your doctor immediately or go to the nearest hospital emergency room!

If you forget to take Tramadolo HCl Sandoz
Pain may recur. Do not take a double dose to make up for the forgotten dose, but continue to take the medicine as prescribed.

If you stop taking Tramadolo HCl Sandoz
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 decreasing the dose to reduce the likelihood of developing unnecessary side effects (withdrawal symptoms). Withdrawal symptoms may include: you may feel agitated, anxious, nervous or weak. You may be hyperactive, have difficulty sleeping, and have stomach or intestinal disorders. Very few people may experience panic attacks, hallucinations, unusual perceptions such as itching, tingling and numbness, and ringing in the ears (tinnitus). Very rarely, further unusual symptoms of the central nervous system have been observed, such as confusion, delusions, changes in the perception of one's own personality (depersonalization), and changes in the perception of reality (derealization) and paranoid delusions. If any of these symptoms occur after stopping Tramadolo HCl Sandoz, consult your doctor. If you have any further questions about the use of Tramadolo HCl Sandoz, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
This medicine can occasionally cause allergic reactions, although these manifest in a severe form only rarely (may affect up to 1 in 1,000 people). If you experience any of the following symptoms of a severe allergic reaction, stop taking this medicine and inform your doctor immediately:

• sudden wheezing (difficulty breathing), difficulty swallowing or hives with difficulty breathing or dizziness
• swelling of the face, tongue and/or throat.

Other possible side effects
If any of the following side effects occur, tell your doctor:

Very common:may affect more than 1 in 10 people

• feeling unwell (nausea)
• dizziness

Common:may affect up to 1 in 10 people

• headache
• drowsiness, fatigue
• constipation, dry mouth, vomiting
• sweating

Uncommon:may affect up to 1 in 100 people

• fast heartbeat, more intense than normal or irregular, collapse or marked drop in blood pressure when getting up, causing dizziness, lightheadedness or fainting These side effects may occur particularly in patients who are standing or under physical exertion
• nausea, feeling of pressure in the stomach, stomach bloating, diarrhea
• itching, skin rash and raised, red, itchy rash (urticaria).

Rare:may affect up to 1 in 1,000 people

• slowing of the heartbeat
• increased blood pressure
• changes in appetite
• tingling or numbness of hands and feet
• tremor
• seizures; occurred mainly after the use of high doses of tramadol or when tramadol was taken simultaneously with other drugs that can induce convulsions
• sleep disorders, nightmares
• hallucinations, confusion, delirium, anxiety
• mental illnesses may appear after treatment with Tramadol HCl Sandoz. Their intensity and nature can vary (according to the patient's personality and the duration of therapy). These can manifest as a change of mood (mostly good mood, in some cases irritated mood), changes in activity (usually suppression, sometimes increase) and decreased cognitive and sensory perception (changes in the senses and the ability to recognize, which can lead to errors in judgment).
• slow breathing, shortness of breath (dyspnea) If you exceed the recommended doses, or if you take other drugs that depress brain function at the same time, breathing may slow down
• worsening of asthma has been reported, however it has not been established whether it was caused by tramadol
• blurred vision
• constriction of the pupil (miosis)
• dilation of the pupils (mydriasis)
• muscle weakness
• dependence.. Withdrawal symptoms may occur when treatment is stopped (see section 3 “If you stop taking Tramadol HCl Sandoz”)
• withdrawal (see section 3 “If you stop taking Tramadol HCl Sandoz”)
• involuntary muscle contractions
• loss of coordination
• temporary loss of consciousness (syncope)
• problems with speech
• difficulty or pain when urinating, less urine output than usual

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

• blood tests showing changes in liver function

Not known(frequency cannot be estimated based on available data)

• Low blood sugar levels Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 Tramadolo HCL Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and the packaging after
the wording “EXP”. The expiry date refers to the last day of that month.
Do not store Tramadolo HCl Sandoz at a temperature above 25°C.
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. Contents of the pack and other information

What Tramadolo HCl Sandoz contains
The active ingredient is tramadol hydrochloride. Each prolonged-release tablet contains
100 mg of tramadol hydrochloride.
The excipients are: dibasic calcium phosphate dihydrate (E341), anhydrous colloidal silica (E551),
hydroxypropylcellulose (E463), magnesium stearate (E470b).

Description of the appearance of Tramadolo HCl Sandoz and contents of the pack
Tramadolo HCl Sandoz 100 mg prolonged-release tablets: round and biconvex tablets
of white-ivory color.
The packs contain PVC/Aluminum blisters with 10, 20, 30, 50, 60, 100 or 100x1 (single
dose) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
L.go U.Boccioni 1
21040 Origgio (VA)

Manufacturer responsible for batch release
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben - Germany

This medicinal product is authorised in the member states of the EEA under the following
names:
Germany: Tramadol Sandoz 100 mg Retardtabletten
Italy: Tramadolo HCl Sandoz
Netherlands: Tramadol HCl Sandoz retard 100, tabletten met verlengde afgifte 100 mg
United Kingdom: Larapam 100mg SR Tablets