Tramadol HCl Sandoz

Patient Information Leaflet

Tramadolo HCl Sandoz 100 mg prolonged-release tablets

Generic medicine
Please read this entire leaflet carefully before you start 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including 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 taking 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 Tramadolo HCl Sandoz is and what it is used for

Tramadol, the active substance of Tramadolo HCl Sandoz, is a painkiller (analgesic) belonging to the opioid group, whose pain-relieving effect is due to its influence on specific nerve cells in the spinal cord and brain.
Tramadolo HCl Sandoz is used in the treatment of moderate to severe pain.

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

Do not take Tramadolo HCl Sandoz

• if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6).
• in cases of acute intoxication with alcohol, sleeping medications, painkillers, opioids, or other psychotropic medicines (medicines affecting mood, emotional state, and temperament).
• if you are currently taking, or have taken within the last 14 days, certain medicines called "monoamine oxidase inhibitors" or MAOIs (used to treat depression or Parkinson’s disease) before starting treatment with Tramadolo HCl Sandoz (see section “Other medicines and Tramadolo HCl Sandoz”).
• if you suffer from epilepsy and your seizures are not adequately controlled by treatment.
• as a substitute medication in drug withdrawal therapy.

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

• you believe you are already dependent on other opioid painkillers
• you experience sensitivity reactions to opioids
• you suffer from a disturbance of consciousness (if you feel like fainting)
• you are in shock (a possible symptom is cold sweating)
• you have difficulty breathing
• you suffer from increased intracranial pressure (possibly after brain trauma or brain disease)
• you have liver or kidney problems
• you suffer, or have previously suffered, from epilepsy or seizures (epileptic fits).

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• you suffer from depression and are taking antidepressants, because some of them may interact with tramadol (see “Other medicines and Tramadolo HCl Sandoz”). There is a slight risk that you may develop the so-called serotonin syndrome, which may occur after taking tramadol together with certain antidepressants or tramadol alone. Contact your doctor immediately if you experience any of the symptoms related to this serious syndrome (see section 4 “Possible side effects”).

If any of the above situations apply to you, consult your doctor before starting to take this medicine.
Sleep-related breathing disorders: Tramadolo HCl Sandoz may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, nighttime awakenings due to breathlessness, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing the dose.
Seizures have been reported in patients taking tramadol at the recommended dose. The risk may increase if the maximum daily dose of 400 mg of tramadol hydrochloride is exceeded, or if you are taking concomitant medications that lower the seizure threshold (see "Other medicines and Tramadolo HCl Sandoz").
Tolerance, dependence, and substance abuse
This medicine contains tramadol, which is an opioid substance. Repeated use of opioids may make the medicine less effective (you become accustomed to it, a phenomenon known as drug tolerance). Repeated use of Tramadolo HCl Sandoz may also lead to dependence, abuse, and substance abuse, which may result in potentially fatal overdose. The risk of these adverse effects may increase with higher doses and prolonged duration of use.
In patients with a tendency to drug abuse or who are drug-dependent, treatment with Tramadolo HCl Sandoz should only be carried out for short periods and under strict medical supervision.
Dependence or substance abuse may make you feel that you have lost control over the amount of medicine needed or how often you need to take it.
The risk of developing dependence or substance abuse varies from person to person. You may have a higher risk of becoming dependent on or abusing Tramadolo HCl Sandoz if:

• you or a family member have previously suffered from alcohol, prescription medication, or illegal drug abuse or dependence ("substance abuse").
• you are a smoker.
• you have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Tramadolo HCl Sandoz, it may be a sign of dependence or substance abuse:

• you feel the need to use the medicine for longer than prescribed by your doctor
• you feel the need to use a higher dose than recommended
• you use the medicine for reasons other than those prescribed, for example, “to stay calm” or “to help sleep”
• you have repeatedly tried to stop or control use of this medicine without success
• you feel unwell when stopping treatment with the medicine, and feel better when you resume taking it (“withdrawal effects”).

If you notice any of these symptoms, consult your doctor to discuss the best treatment approach for you, including whether it is appropriate to stop treatment and how to do so safely (see section 3, “If you stop taking Tramadolo HCl Sandoz”).
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Tramadol is metabolized in the liver by an enzyme. Some people have a variation in this enzyme, which may lead to different effects in them. Some people may not achieve sufficient pain relief, while others may experience serious side effects. If you notice any of the following side effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, feeling unwell or malaise, constipation, loss of appetite.
Contact your doctor if you experience any of the following symptoms while using Tramadolo HCl Sandoz:

• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These symptoms may indicate adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide whether you need hormone replacement therapy.

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 symptoms of tramadol toxicity may be worse in these children.
Elderly
Patients over 75 years of age should be closely monitored, as elimination of tramadol may be prolonged (see section 3 "How to take Tramadolo HCl Sandoz").
Other medicines and Tramadolo HCl Sandoz
Inform 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 within the last 14 days. The combination could lead to a serious and potentially fatal interaction.
The pain-relieving effect of Tramadolo HCl Sandoz may be weakened and/or shortened over time if you are also taking medicines containing:

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

Your doctor will inform you whether and which doses of Tramadolo HCl Sandoz you should take.
The risk of side effects increases if you take Tramadolo HCl Sandoz together with:

• sedative medicines such as benzodiazepines or related medicines (e.g., tranquilizers, sleeping pills). Concomitant use of Tramadolo HCl Sandoz with sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered if no other treatment options are possible. However, if your doctor prescribes Tramadolo HCl Sandoz together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor. Inform your doctor about all sedative medicines you are taking and carefully follow the dose recommended by your doctor. It may be helpful to inform friends and family members about the signs and symptoms listed above. Contact your doctor if you experience such symptoms.
• other sedative medicines, such as antidepressants and other analgesics like morphine and codeine (even when taken for cough), and alcohol. You may experience excessive drowsiness or feel faint. FI_TRAMADOLO_HCL_SANDOZ 2601_18
• medicines that may cause seizures (fits), 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 whether Tramadolo HCl Sandoz is suitable for you.
• certain antidepressants. Tramadolo HCl Sandoz may interact with these medicines and you may develop serotonin syndrome (see section 4 “Possible side effects”).
• medicines that inhibit blood clotting, such as warfarin. The dose of these medicines may need to be reduced, otherwise there may be an increased risk of potentially serious bleeding.
• gabapentin or pregabalin used to treat epilepsy or nerve-related pain (neuropathic pain)

Tramadolo HCl Sandoz with food and alcohol
Do not drink alcohol while being treated with Tramadolo HCl Sandoz; this could increase the effects of this medicine.
Food does not affect the action of Tramadolo HCl Sandoz (see section 3 “How to take Tramadolo HCl Sandoz”).
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Information on the safety of tramadol during pregnancy is very limited; therefore, you should not take Tramadolo HCl Sandoz during pregnancy.
Chronic use of Tramadolo HCl Sandoz during pregnancy may 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 must stop breastfeeding.
Fertility
Based on human experience, tramadol hydrochloride does not affect male or female fertility.
Driving and using machines
This medicine may cause side effects such as dizziness, drowsiness, and blurred vision. If this occurs, refrain from driving vehicles and using tools or machinery, and avoid any potentially dangerous activities.

3. How to take Tramadol HCl Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Before starting treatment and regularly during treatment, your doctor will discuss with you what to expect from the use of Tramadol HCl Sandoz, when and for how long it should be used, when to contact the doctor, and when treatment should be stopped (see also section 2).
The recommended doses are indicated below. Your doctor may gradually increase or decrease the dose depending on your response to treatment.
The dose should be adjusted according to the intensity of your pain and your individual sensitivity to pain. Generally, the lowest effective dose that controls your pain should be used. Do not take more than 400 mg of tramadol hydrochloride per day unless your doctor has instructed you otherwise.
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Adults and children aged 12 years and older:

• The recommended initial dose is 100 mg twice daily.
• 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 higher dose than the minimum required to control your pain. Do not exceed a daily dose of 400 mg of active substance unless there are specific medical reasons.

Use in children under 12 years of age:
This medicine is not recommended for children under 12 years of age.
Elderly patients:

• In elderly patients (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

• Tramadol HCl Sandoz must not be used in patients with severe hepatic and/or renal impairment. If you have mild or moderate impairment, your doctor may advise you to increase the interval between doses.

How and when to take Tramadol HCl Sandoz
Tramadol HCl Sandoz prolonged-release tablets are for oral use.
Always swallow the Tramadol HCl Sandoz prolonged-release tablets whole, without dividing or chewing them, with sufficient liquid, preferably in the morning and in the evening. The tablets may be taken with or without food.
How long to take Tramadol HCl Sandoz
Do not take Tramadol HCl Sandoz for longer than necessary.
If long-term treatment is required, your doctor will regularly and frequently review (if necessary with treatment breaks) whether you should continue taking Tramadol HCl Sandoz and at which dose.
If you feel the effect of Tramadol HCl Sandoz is too strong or too weak, speak to your doctor or pharmacist.
If you take more Tramadol HCl Sandoz than you should
Accidentally taking one extra prolonged-release tablet than prescribed will normally not cause harmful effects. Continue taking Tramadol HCl Sandoz as usual when pain returns.
If you take an excessive dose of the medicine, the following signs may occur: pinpoint pupils, vomiting (nausea), drop in blood pressure, increased heart rate, collapse, disturbances of consciousness including coma, seizures, and breathing difficulties. 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 department!
If you forget to take Tramadol HCl Sandoz
You may experience a return of pain. Do not take a double dose to make up for the missed dose, but continue taking the medicine as prescribed.
If you stop taking Tramadol HCl Sandoz
If you stop or discontinue treatment with Tramadol HCl Sandoz too early, your pain is likely to return. If you wish to stop treatment due to side effects, consult your doctor.
Do not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the medicine, especially if you have been taking it for a long time, discuss this with your doctor first. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of developing unnecessary side effects (withdrawal symptoms).
Generally, discontinuation symptoms do not occur when stopping treatment with Tramadol HCl Sandoz.
However, in rare cases, some people who have taken Tramadol HCl Sandoz for a prolonged period may feel unwell when stopping abruptly.
Withdrawal symptoms may include: feeling agitated, anxious, nervous, or weak. You may become hyperactive, have difficulty sleeping, and experience stomach or intestinal disturbances. A small number of people may experience panic attacks, hallucinations, unusual sensations such as itching, tingling, and numbness, and ringing in the ears (tinnitus). Very rarely, additional unusual central nervous system symptoms have been observed, such as confusion, delirium, altered perception of self (depersonalization), altered perception of reality (derealization), and delusions of persecution (paranoia). If any of these symptoms occur after stopping Tramadol HCl Sandoz, consult your doctor.
If you have any further questions about the use of Tramadol HCl Sandoz, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Serious side effects
This medicine may occasionally cause allergic reactions, although these occur 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 (shortness of breath), difficulty swallowing, or hives together 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, inform 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, tiredness
• constipation, dry mouth, vomiting
• sweating (hyperhidrosis)

Uncommon: may affect up to 1 in 100 people

• increased heart rate, stronger than normal or irregular heartbeat, collapse or marked drop in blood pressure upon standing, causing dizziness, lightheadedness or fainting. These side effects may particularly occur in patients who are standing up or under physical exertion.
• nausea, sensation of pressure in the stomach, stomach bloating, diarrhoea
• itching, skin rash and raised red itchy skin rash (urticaria).

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

• allergic reactions (e.g. difficulty breathing, shortness of breath, skin swelling) and shock (circulatory failure)
• slowed heart rate
• increased blood pressure
• changes in appetite
• abnormal sensations (e.g. itching), tingling or numbness in hands and feet
• tremor
• seizures; mainly reported after use of high doses of tramadol or when tramadol has been taken concomitantly with other medicines that may induce seizures
• sleep disturbances, nightmares
• hallucinations, confusion, delirium, anxiety
• psychiatric disorders may occur after treatment with Tramadol HCl Sandoz. Their severity and nature may vary (depending on the patient's personality and duration of therapy). These may manifest as mood changes (mostly elevated mood, in some cases irritable mood), changes in activity (usually suppression, sometimes increase) and reduced cognitive and sensory perception (changes in senses and recognition ability, which may lead to impaired judgment).
• slow breathing, shortness of breath (dyspnoea). If recommended doses are exceeded, or if other medicines that depress brain function are taken concomitantly, breathing may slow down.
• worsening of asthma has been reported; however, it has not been established whether this was caused by tramadol
• blurred vision
• pupil constriction (miosis)
• pupil dilation (mydriasis)
• muscle weakness
• dependence. When treatment is stopped, withdrawal symptoms may occur (see section 3 “If you stop taking Tramadol HCl Sandoz”)
• involuntary muscle contractions
• loss of coordination
• temporary loss of consciousness (syncope)
• problems speaking
• difficulty or pain when urinating, reduced urine output compared to 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 from the available data)

• Serotonin syndrome, which may present as changes in mental status (e.g. agitation, hallucinations, coma) and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you should know before taking Tramadol HCl Sandoz”).
• Low blood sugar levels
• hiccups

When treatment is abruptly discontinued, signs of drug withdrawal syndrome may occur (see “If you stop taking Tramadol HCl Sandoz”).
Reporting of side effects
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If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via 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.
Store this medicine in a safe and secure place, inaccessible to other people.
Taking this medicine by other people for whom it has not been prescribed may cause serious harm and be fatal.
Do not use this medicine after the expiry date, which is stated on the blister and carton after the wording
"Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
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. Pack contents and other information

What Tramadolo HCl Sandoz contains
The active substance is tramadol hydrochloride. Each prolonged-release tablet contains 100 mg of
tramadol hydrochloride.
The other components are: dibasic calcium phosphate dihydrate (E 341), colloidal anhydrous silica (E 551),
hydroxypropylcellulose (E 463), magnesium stearate (E 470b).
Description of the appearance of Tramadolo HCl Sandoz and pack contents
Tramadolo HCl Sandoz 100 mg prolonged-release tablets are white, opaque, round, biconvex tablets.
Packs contain 10, 20, 30, 50, 60, 100 or 100x1 (unit dose) tablets in PVC/aluminium blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milano
Italy
Responsible manufacturer for batch release
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben - Germany
This medicinal product is authorised in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Italy: Tramadolo HCl Sandoz
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Netherlands: Tramadol HCl Sandoz retard 100, tabletten met verlengde afgifte 100 mg
United Kingdom: Larapam 100mg SR Tablets
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