Prospecto: information for the patient

Zytram BID 75 mg prolonged-release tablets

Tramadol hydrochloride

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Contents of theprospectus

1. What Zytram BID tablets are and for what they are used

2. What you need to know before starting to take Zytram BID tablets

3. How to take Zytram BID tablets

4. Possible adverse effects

5. Storage of Zytram BID tablets

6. Contents of the package and additional information

These tablets have been prescribed by your doctor for the treatment of moderate to severe pain for a period of 12 hours. The tablets contain tramadol as the active ingredient, which is a potent analgesic (pain reliever), belonging to a group of medicines called opioids.

These tablets are only for use in adults and adolescents over 12 years old.

Do not take Zytram BID tablets

• If you are allergic to tramadol or any of the excipients of the other components of this medication (listed in section 6);
• If you have taken excessive alcohol or higher doses than recommended of sleep medications, analgesics, or psychotropic medications (used to treat psychiatric or mental disorders);
• If you are taking monoamine oxidase inhibitors (e.g. tranilcipromina, fenelzina, isocarboxazida, mocoblemida, and linezolid), or if you have taken this type of medication in the last two weeks;
• To treat withdrawal syndrome caused by stopping another potent analgesic.

Warnings and precautions

Consult your doctor or pharmacist before starting to take these tablets if:

• You have or have had a history of addiction to alcohol or drugs;
• You have or have had epilepsy, seizures, tremors, or convulsions;
• You have severe headaches, or are feeling unwell due to a head injury, or have high intracranial pressure (e.g. due to a brain pathology). The tablets may worsen symptoms or mask a head injury;
• You have severe liver or kidney disease;
• You are in shock (suddenly feeling very dizzy, tired, cold, trembling, and pale);
• You have slow and shallow breathing (respiratory depression);
• You are depressed and taking antidepressants, as some may interact with tramadol (see "Other medications and Zytram BID prolonged-release tablets");
• You have constipation.

Respiratory disorders related to sleep

Zytram BID tablets may cause respiratory disorders related to sleep such as central sleep apnea (pause in breathing during sleep) and sleep-related hypoxemia (low oxygen level in blood). These symptoms may include pause in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tolerance, dependence, and addiction

This medication contains tramadol, which is an opioid medication. Repeated use of opioids can make the medication less effective (you become accustomed to it, known as tolerance). Repeated use of Zytram BID tablets can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use.

Dependence or addiction can make you feel like you no longer have control over the amount of medication you take or how often you take it.

The risk of becoming dependent or addicted varies from person to person. You may be at a higher risk of becoming dependent or addicted to Zytram BID if:

- You or a family member has a history of alcohol abuse or dependence.

- You are a smoker.

- You have had problems with your mood (depression, anxiety, or personality disorder) or have received treatment from a psychiatrist for other mental health conditions.

If you notice any of the following signs while taking Zytram BID, it could be a sign that you have become dependent or addicted:

- You need to take the medication for longer than recommended by your doctor.

- You need to take more doses than recommended.

- You are using the medication for reasons other than those prescribed, such as "to calm down" or "to help you sleep".

- You have made repeated and unsuccessful attempts to stop or control the use of the medication.

- You do not feel well when you stop taking the medication and feel better when you take it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to address the best therapeutic strategy for your case, including when it is appropriate to stop taking it and how to do it safely (see section 3, "If you stop taking Zytram BID").

Consult your doctor or pharmacist if you experience any of the following symptoms while taking Zytram BID: extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. This may indicate that you have adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, report them to your doctor, who will decide if you should take a hormonal supplement.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, and this can affect each person differently. In some people, it may not be possible to achieve sufficient pain relief, while others may be more likely to experience severe adverse effects. If you notice any of the following adverse effects, stop taking this medication and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general discomfort, or vomiting, constipation, loss of appetite.

Occasionally, increased sensitivity to pain (hyperalgesia) may occur, which does not respond to an increase in tramadol dose, especially at high doses. It may be necessary to reduce the tramadol dose or switch to an alternative opioid.

There is a weak risk that you may experience a serotonin syndrome that can occur after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult your doctor immediately if you experience any symptoms associated with this severe syndrome (see section 4 "Possible side effects").

Children and adolescents

Use in children with respiratory problems

Tramadol should not be used in children with respiratory problems, as the symptoms of tramadol toxicity may worsen in these children.

Other medications and Zytram BID prolonged-release tablets

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication. If you are taking other medications in combination with these tablets, the effect of these tablets or the other medication may be altered.

The concomitant use of Zytram BID and sedatives, such as benzodiazepines or related medications, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Zytram BID with sedatives, your doctor should limit the dose and duration of concomitant treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations regarding the dose. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Inform your doctor when you experience such symptoms.

These tablets should not be used in combination with a monoamine oxidase inhibitor (MAOI), or if you have taken this type of medication in the last 2 weeks (see section 2. "Do not take Zytram BID tablets").

The risk of side effects increases:

• If you are taking medications that can cause seizures, such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take Zytram BID tablets at the same time. Your doctor will inform you if Zytram BID tablets are suitable for you.
• If you are taking certain antidepressants. Zytram BID tablets may interact with these medications and you may experience a serotonin syndrome (see section 4 "Possible side effects").

Inform your doctor or pharmacist if you are taking:

• Sleep medications (tranquilizers, hypnotics, or sedatives);
• Carbamazepine to treat seizures, tremors, convulsions, and some types of pain;
• Depression medications;
• Medications to treat psychiatric or mental disorders;
• Ritonavir to treat HIV;
• Digoxin to treat heart failure or arrhythmias;
• Other potent analgesics (buprenorphine, nalbuphine, and pentazocine);
• Certain morphine-like medications, such as to treat cough or to treat withdrawal syndrome;
• Barbiturates to treat seizures or to sleep;
• Benzodiazepines, to treat anxiety or to sleep;
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain);
• Certain medications to prevent blood clotting or to dilute blood (anticoagulant coumarins, such as warfarin);
• Ondansetron, to treat nausea or general discomfort.

Taking Zytram BID tablets with alcohol

Consult your doctor or pharmacist if you ingest or intend to ingest alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take this medication if you are pregnant. Depending on the dose and duration of tramadol treatment, the newborn may experience slow and shallow breathing (respiratory depression) or withdrawal symptoms.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, do not take Zytram BID more than once during breastfeeding, or if you take Zytram BID more than once, stop breastfeeding.

Babies born to mothers who have used Zytram BID prolonged-release tablets during pregnancy may experience withdrawal symptoms, including loud crying, irritability, agitation (trembling), feeding difficulties, and sweating.

Driving and operating machinery

These tablets may cause a range of side effects, such as drowsiness, blurred vision, and dizziness, which may affect your ability to drive or operate machinery (see section 4 for a complete list of side effects). These effects are more noticeable when you start treatment with the tablets, or when your dose is increased. If you are affected, do not drive or operate machinery.

Zytram BID tablets contain lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for these tablets as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist. Before starting treatment and regularly during treatment, your doctor will discuss with you what you can expect from the use of Zytram BID, when and for how long you should take it, when to contact your doctor and when to discontinue it (see also section 2).

The dose should be adjusted to the intensity of the pain and your individual sensitivity. Normally, the lowest possible dose that produces pain relief should be used.

Adults and adolescents over 12 years

The usual initial dose is one 75 mg tablet twice a day. However, your doctor will prescribe the required dose to treat the pain you are experiencing. Do not exceed the dose recommended by your doctor. If you find that you still feel pain while taking the tablets, consult your doctor. Generally, you should not take more than 400 mg per day.

Swallow the tablets with water.Do not crush, dissolve or chew them.

Zytram BID tablets are designed to provide adequate treatment for 12 hours when taken whole. If the tablet is broken, crushed, dissolved or chewed, the full 12-hour dose may be absorbed rapidly by your body, which can be hazardous and cause serious problems such as a fatal overdose.

You should take the tablets every 12 hours. For example, if you have taken a tablet at 8 am, you should take the next tablet at 8 pm.

Older patients

In older patients (over 75 years), the elimination of tramadol may be slow. If this is your case, your doctor may recommend reducing the dose.

Patients with liver or kidney disease/patients on dialysis

If you have a serious liver or kidney disease, treatment with Zytram BID tablets is not recommended. If you have mild or moderate liver or kidney disease, your doctor may recommend reducing the dose.

Children under 12 years

The safety of Zytram BID in children between 1 and 12 years of age has not been demonstrated.

If you take more Zytram BID tablets than you should or someone takes your tablets by accident

Contact your doctor or the nearest hospital immediately. People who have taken an overdose may experience excessive sleepiness, feel very unwell or very dizzy. They may suffer from seizures, tremors or convulsions. They may also have breathing difficulties that can lead to loss of consciousness or even death and may require emergency hospital treatment. In case of requiring medical attention, make sure to bring this leaflet and the rest of the tablets with you.

In case of overdose or accidental ingestion, consult the Toxicological Information Service (Tel. 91.562.04.20), indicating the product and the amount ingested.

If you forget to take Zytram BID tablets

If you remember within the next 6 hours from when you should have taken the tablet, take the missed tablet immediately. Then take the next tablet at the usual time. If more than 6 hours have passed, it is best to consult your doctor.

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Zytram BID tablets

You should not stop taking this medication suddenly unless your doctor tells you to. If you want to stop taking your medication, talk to your doctor first, especially if you have been taking it for a long time. Your doctor will inform you when and how to discontinue it, which can be done by gradually reducing the dose to reduce the likelihood of unnecessary side effects (withdrawal symptoms). If you stop taking these tablets suddenly, you may experience withdrawal symptoms such as agitation, anxiety, nervousness, difficulty falling asleep, unusual hyperactivity, tremors or gastrointestinal disturbances, e.g. stomach upset.

If you have any other questions about the use of these tablets, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

All medicines can cause allergic reactions, even though severe allergic reactions are rare. Contact your doctor immediately if you suddenly experience shortness of breath, difficulty breathing, swelling of the eyelids, face, or lips, or a particular itching sensation, especially if it affects the entire body.

The most severe side effect is one in which slower or weaker breathing than usual is observed (respiratory depression).

Like what happens with all powerful analgesics, there is a risk of addiction or dependence on these tablets.

Very common:can affect more than 1 in 10 patients

• Dizziness (usually this effect subsides within a few days, but your doctor may prescribe a medication for dizziness if it continues to be a problem)
• Vertigo

Common:can affect up to 1 in 10 patients

• Drowsiness (it is more common when you start taking the tablets or when your dose is increased, but it usually subsides within a few days)

• Dry mouth
• Sweating
• Vomiting (with a sensation of dizziness)

Uncommon:can affect up to 1 in 100 patients

• Headache
• Tachycardia, palpitations, or severe heart problems
• Sensation of "fainting" particularly when standing up, low blood pressure (hypotension)
• Constipation
• Abdominal pain or discomfort
• Rash, hives (urticaria), or itching

Rare:can affect up to 1 in 1,000 patients

• Tickling or numbness
• Blurred vision
• Hallucinations
• Nightmares
• Changes in mood, feeling of discomfort and displeasure, or extreme feeling of happiness
• Changes in activity level
• Confusion
• Problems with recognition, changes in thought, memory, and behavior
• Seizures, tremors, or convulsions
• High blood pressure (hypertension)
• Lack of breath, difficulty breathing, or shortness of breath
• Worsening of asthma
• Loss of appetite
• Diarrhea
• Pain or difficulty urinating
• Muscle weakness
• Skin redness
• Bradycardia
• Fainting

Very rare:can affect up to 1 in 10,000 patients

• Symptoms of withdrawal when stopping the tablets, such as agitation, anxiety, nervousness, hyperactivity, tremors, difficulty falling asleep, stomach discomfort
• Worsening in liver function tests (seen in blood tests)

Frequency not known:the frequency cannot be estimated from the available data

• Decreased blood sugar levels
• Unusual feeling of weakness
• Symptoms of withdrawal in babies born to mothers who have used tramadol during pregnancy (see section 2 "Pregnancy, breastfeeding, and fertility")
• Hiccup
• Need to take higher doses of the tablets to achieve the same level of pain relief (tolerance).
• Increased sensitivity to pain.
• Serotonin syndrome, which can manifest as changes in mental state (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, diarrhea) (see section 2 "What you need to know before taking Zytram BID prolonged-release tablets")

In some cases, the tablet matrix may be observed in the stool, which does not affect the efficacy of the tablets.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store this medication in a safe place, where other people cannot access it. It may cause serious harm and be fatal to individuals who have not been prescribed it.

Do not take these tablets after the expiration date that appears on the blister pack and the box. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Zytram BID tablets

The active ingredient is hydrochloride of tramadol. Each tablet contains 75 mg of hydrochloride of tramadol.

The other components are:

• Hydrogenated vegetable oil
• Talc
• Magnesium stearate
• Lactose monohydrate
• Macrogol
• Hypromellose (E464)
• Titanium dioxide (E171)
• Iron oxide (E172)
• Indigo carmine (E132)

Appearance of the product and content of the packaging

This medication is presented in the form of gray-colored, round tablets, marked with “TBD” on one face and the dose (75) on the other face, with an approximate diameter of 7 mm.

Each box contains 7, 14, 28, 30, 56 or 60 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mundipharma Pharmaceuticals S.L.

Bahía de Pollensa, 11

28042 Madrid

Spain

Responsible for manufacturing

Mundipharma DC B.V.

Leusderend 16

3832 RC Leusden

Netherlands

or

ZAMBON SWITZERLAND LTD

Via Industria, 13 (Cadempino)

CH-6814 – Switzerland

Date of the last review of this leaflet:May 2024

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/