Package Leaflet: Information for the Patient

Tramadol/Paracetamol Sandoz 37.5 mg/325 mg Film-Coated Tablets

Tramadol hydrochloride/paracetamol

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Tramadol/Paracetamol Sandoz and what it is used for

2.What you need to know before you start taking Tramadol/Paracetamol Sandoz

3.How to take Tramadol/Paracetamol Sandoz

4.Possible side effects

5Storage of Tramadol/Paracetamol Sandoz

6.Contents of the pack and additional information

Tramadol/Paracetamol Sandoz is a combination of two analgesics, tramadol and paracetamol, that work together to relieve pain.

Tramadol/Paracetamolis indicated for the symptomatic treatment of moderate to severe pain whenever your doctor believes that the combination of tramadol and paracetamol is necessary.

Tramadol/Paracetamolshould only be used in adults and adolescents over 12 years old.

Do not take Tramadol/Paracetamol Sandoz:

• if you are allergic to tramadol, paracetamol or any of the other ingredients of this medicine (listed in section 6)
• in case of acute alcohol intoxication, if you are taking sleeping pills, potent analgesics or other psychotropic medicines (medicines that can alter mood and emotions)
• if you are taking medicines called monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease), or if you have taken them in the last 14 days before treatment with tramadol/paracetamol
• if you have severe liver disease
• if you have uncontrolled epilepsy

Warnings and precautions

Consult your doctor before starting to take tramadol/paracetamol if you:

• are taking other medicines that contain paracetamol or tramadol
• have liver problems or liver disease or if you notice that your eyes or skin turn yellow. This may be indicative of jaundice or problems with your bile ducts
• have kidney problems
• have severe respiratory difficulties, for example asthma or severe lung problems
• have epilepsy or have already experienced seizures or convulsions
• have recently experienced head trauma, shock or severe headaches associated with vomiting
• are experiencing loss of consciousness of unknown origin (if you feel like you are going to faint)
• are dependent on any other medicine used for pain relief, for example morphine
• are taking other medicines for pain relief that contain buprenorphine, nalbuphine or pentazocine
• are going to be anaesthetized. Inform your doctor or dentist that you are using tramadol/paracetamol
• are experiencing depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Tramadol/Paracetamol Sandoz”)

If any of the above situations apply to you or have occurred in the past while taking tramadol/paracetamol, inform your doctor. He will decide if you should continue taking this medicine

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 side effects. If you notice any of the following side effects, stop taking this medicine and consult your doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general feeling of being unwell or vomiting, constipation, loss of appetite

Inform your doctor or pharmacist if you experience any of the following symptoms while taking tramadol/paracetamol:

• Respiratory disorders related to sleep: tramadol/paracetamol may cause respiratory disorders related to sleep, such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakenings due to lack of breath, difficulty maintaining sleep or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose
• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting or low blood pressure. These may be indicative of adrenal insufficiency (low cortisol levels). If you experience these symptoms, contact your doctor, who will decide if you need to take hormone supplements

Children and adolescents

The use of tramadol/paracetamol is not recommended in children under 12 years of age, as the safety and efficacy have not been established in this age group

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 medicines and Tramadol/Paracetamol Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine

Important:This medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medicine that contains paracetamol or tramadol hydrochloride, so that you do not exceed the maximum daily dose

Do not take tramadol/paracetamol if you are taking monoamine oxidase inhibitors (“MAOIs”) (see “Do not take Tramadol/Paracetamol Sandoz”)

Do not take tramadol/paracetamol with the following medicines:

-carbamazepine (a medicine normally used to treat epilepsy or some types of pain such as trigeminal neuralgia attacks),

-buprenorphine, nalbuphine or pentazocine (opioid analgesics). Pain relief may be reduced

The risk of side effects increases if you are also taking:

-triptans (for migraines) or selective serotonin reuptake inhibitors, “SSRIs” (for depression). If you experience confusion, agitation, fever, sweating, uncoordinated movements of the limbs or eyes, involuntary muscle contractions or diarrhea, you should call your doctor,

-sedatives such as benzodiazepines or related medicines (tranquilizers, sleeping pills). The concomitant use of tramadol/paracetamol and sedatives such as benzodiazepines or related medicines increases the risk of drowsiness, respiratory difficulties (respiratory depression), coma and may be potentially fatal. For this reason, concomitant use should only be considered when other treatment options are not possible. However, if your doctor prescribes this medicine with sedatives, you should limit the dose and duration of concomitant treatment. Inform your doctor of all sedatives you are taking and follow your doctor's dose recommendation strictly. It may be helpful to inform your friends and family about the signs and symptoms mentioned above. Inform your doctor if you experience any of these symptoms

-other pain relievers such as morphine or codeine (also used to treat cough), baclofen (muscle relaxant), blood pressure-lowering medicines or allergy medicines. You may feel drowsy or dizzy. If this occurs, consult your doctor,

-medicines that can cause seizures (attacks) such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take tramadol/paracetamol at the same time. Your doctor will tell you if tramadol/paracetamol is suitable for you,

-certain antidepressants. Tramadol/paracetamol may interact with these medicines and you may experience a serotonin syndrome (see section 4 “possible side effects”)

-warfarin or phenprocoumon (a medicine used to prevent blood clots). The effectiveness of these medicines may be altered and bleeding may occur. You should inform your doctor immediately of any prolonged or unexpected bleeding,

-flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used

The effectiveness oftramadol/paracetamolmay be altered if you are also taking any of the following medicines:

-metoclopramide, domperidone or ondansetron (medicines used to treat nausea and vomiting),

-colestiramine (medicine that reduces cholesterol in the blood).

Your doctor will tell youwhich medicines are safe to take withtramadol/paracetamol

Use of Tramadol/Paracetamol Sandoz with alcohol

Tramadol/Paracetamol Sandoz may make you feel drowsy. Alcohol may make you feel drowsy, so it is recommended not to take alcohol while taking Tramadol/Paracetamol Sandoz

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine

Because this medicine contains tramadol, you should not take this medicine during pregnancy. If you become pregnant during treatment withTramadol/ParacetamolSandoz, consult your doctor before taking more tablets

Tramadol is excreted in breast milk. For this reason, you should not take tramadol/paracetamol more than once during breastfeeding, or, if you take tramadol/paracetamol more than once, you should stop breastfeeding

Driving and operating machinery

Tramadol/Paracetamol Sandoz may make you feel drowsy andthis may affect your ability to drive or use tools and machines safely.

Tramadol/Paracetamol Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You should taketramadol/paracetamolfor the shortest time possible.

The dose should be adjusted to the intensity of the pain and the sensitivity of each patient. Generally, the lowest effective dose that produces analgesia should be selected.

Use in adults and adolescents (12 years and older)

Unless your doctor prescribes something different, the recommended starting dose is 2 tablets.

If necessary, more doses can be taken as recommended by your doctor. The shortest interval between doses should be at least 6 hours.

Do not take more than 8 tablets of Tramadol/Paracetamol Sandoz per day.

Do not taketramadol/paracetamolmore frequently than your doctor has indicated.

If you estimate that the effect of tramadol/paracetamol is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not have adequate pain relief), inform your doctor.

Older patients

In elderly patients (over 75 years), the excretion of tramadol may be delayed. If this happens, your doctor may recommend a prolonged dose interval.

Severe liver or kidney disease (insufficiency)/patients on dialysis

Patients with severe liver and/or kidney insufficiency should not take tramadol/paracetamol. If your insufficiency is mild to moderate, your doctor may recommend a prolonged interval between doses.

Administration form:

The tablets are for oral administration.

Swallow the tablets whole with sufficient liquid. Do not break or chew them.

If you take moreTramadol/Paracetamol Sandozthan you should

Consult your doctor or pharmacist immediately, even if you feel well, as there is a risk of severe liver damage that may only become apparent later.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tramadol/Paracetamol Sandoz

If you forgot to take the tablets, it is likely that the pain will recur. Do not take a double dose to compensate for the missed dose, simply continue taking the tablets as usual.

If you interrupt treatment with Tramadol/Paracetamol Sandoz

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 stop it, which can be done by gradually reducing the dose to reduce the risk of unnecessary adverse effects (withdrawal symptoms) (see section 4. “Possible adverse effects”).

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

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

Some side effects can be serious. Contact your doctor immediately if you experience any of the following:

• Rare cases of skin rash, indicating an allergic reaction, can develop facial swelling, tongue, or throat swelling, difficulty breathing, or decreased blood pressure, and fainting. If this happens, discontinue treatment. Do not take this medicine again,
• Prolonged or unexpected bleeding, due to the use of tramadol/paracetamol with blood-thinning medications (e.g., warfarin, fenprocumon).

Additionally, if any of the following side effects worsen, contact your doctor or pharmacist:

Very common:can affect more than 1 in 10 people:

-Nausea,

-Dizziness, drowsiness.

Common:can affect up to 1 in 10 people

-Vomiting, digestive problems (constipation, flatulence, diarrhea), stomach pain, dry mouth,

-Itching, sweating,

-Headache, agitation,

-Confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria - feeling high).

Uncommon:can affect up to 1 in 100 people

-Increased heart rate or blood pressure, heart rhythm or frequency disorders,

-Difficulty or pain urinating,

-Skin reactions (e.g., skin rashes, urticaria),

-Tickling, numbness, or tingling in the extremities, ear noises, involuntary muscle spasms,

-Depression, nightmares, hallucinations (hearing, seeing, or perceiving something that is not real),memory loss,

-Difficulty swallowing,Blood in the stool,

-Chills, hot flashes, chest pain,

-Difficulty breathing,

-Increased liver enzymes (transaminases), loss of certain proteins in the urine (albumin).

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

-Seizures,Difficulty performing coordinated movements,

-Adiction, delirium,

-Blurred vision, pupil constriction (miosis), excessive pupil dilation (mydriasis),

-Speech disorders,

-Transient loss of consciousness (syncope).

Frequency not known:cannot be estimated from available data

-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 Tramadol/Paracetamol Sandoz).

-Decreased blood sugar level,

-Hypo.

In addition, the following recognized side effects have been reported by people who have taken medications containing only tramadol or only paracetamol. However, if you experience any of these symptoms while taking tramadol/paracetamol, you should inform your doctor:

-Dizziness when getting up after lying down or sitting,Low heart rate,Fainting,

-Changes in appetite,

-Muscle weakness,Slower or weaker breathing,

-Mood changes,Changes in activity (usually decreasing, occasionally increasing),Changes in perception,

-Worsening of existing asthma,

-Nasal bleeding or bleeding gums, which can result from a low platelet count,

-Severe reduction in the number of white blood cells, making infections more likely to have signs of fever and sore throat (agranulocytosis).

Using a medicine like tramadol can create dependence, making it difficult to stop taking it. People who have been taking tramadol for some time may feel unwell when they stop treatment abruptly. They may feel agitated, anxious, nervous, or shaky. They may be hyperactive, have difficulty sleeping, and experience digestive and intestinal problems. Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, and numbness, and ear noises (tinnitus). If you experience any of these symptoms after stopping treatment with tramadol/paracetamol, consult your doctor.

The use of tramadol/paracetamol with anticoagulants (e.g., fenprocumon, warfarin) may increase the risk of bleeding. You should inform your doctor immediately about any prolonged or unexpected bleeding.

Rare cases of severe skin reactions have been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:https://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.

Do not use this medication after the expiration date that appears on the carton packaging, blister pack, or container after CAD. The expiration date is the last day of the month indicated.

After the first opening of the container, this medication can be administered for 50 days if it is stored between 15°C – 30°C.

This medication does not require special storage conditions.

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

Composition of Tramadol/Paracetamol Sandoz

• The active principles are tramadol hydrochloride and paracetamol.

Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components are:

Core of the tablet: copolymer of macrogol polyvinyl alcohol, pregelatinized cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (Type A) from potato, hipoelosa, magnesium stearate.

Film coating:polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Appearance of the product and contents of the package

Tramadol/Paracetamol Sandoz film-coated tablets are of orange color, capsule-shaped, engraved with T37.5 on one face and A325 on the other face.

Tramadol/Paracetamol Sandoz is presented in carton boxes with blisters of 2, 10, 15, 20, 30, 40, 60, 80, and 90 tablets and bottles with 10 and 100 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

Teva Pharma, S.L.U.

C/ C, n 4 Industrial Estate Malpica (Zaragoza) – 50016

Spain

or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526Ljubljana

Slovenia

or

Pliva Hrvatska D.O.O.

Prilaz Baruna Filipovica 25 (ZAGREB) – 10000

Croatia

This medicine is authorized in Member States with the following names:

Republic of Czech:Tutus 37.5 mg/325 mg

Portugal:Tramadol + Paracetamol Sandoz

Last review date of this leaflet:July 2022

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es