VELYNTRA 44 MG/56 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Velyntra 44 mg/56 mg film-coated tablets

tramadol hydrochloride / celecoxib

Read all of 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Velyntra and what is it used for
2. What you need to know before you take Velyntra
3. How to take Velyntra
4. Possible side effects
5. Storage of Velyntra
6. Contents of the pack and further information

1. What is Velyntra and what is it used for

This medicine contains two active substances: tramadol hydrochloride and celecoxib.

Tramadol is a pain reliever belonging to the group of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells in the brain and spinal cord.

Celecoxib is a pain reliever and anti-inflammatory belonging to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Velyntra is used for the short-term symptomatic treatment of moderate to severe acute somatic pain in adults, such as post-operative pain (e.g., orthopedic and traumatologic surgery, or after dental surgical procedures) or musculoskeletal pain (muscle, ligament, tendon, and joint injuries).

2. What you need to know before you take Velyntra

Do not take Velyntra

• if you are allergic to tramadol hydrochloride, celecoxib, or any of the other ingredients of this medicine (listed in section 6);
• if you have acute intoxication caused by alcohol, sleeping pills, pain relievers, or other psychotropic medicines (medicines that affect mood and emotions);
• if you are also taking monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression) or if you have taken them in the last two weeks before starting treatment with this medicine;
• if you have been diagnosed with epilepsy and your seizures are not adequately controlled with your treatment;
• as a substitute medication for the treatment of withdrawal syndrome;
• if you have had an allergic reaction to any medication in the group called "sulfonamides" (e.g., some antibiotics used to treat infections);
• if you currently have a stomach or intestinal ulcer, or bleeding in your stomach or intestines;
• if you have previously experienced any of the following symptoms after taking acetylsalicylic acid or any other anti-inflammatory and pain reliever (NSAID): asthma, nasal polyps, severe nasal congestion, or allergic reactions such as skin rash with itching, swelling of the face, lips, tongue, or throat, difficulty breathing, or wheezing;
• if you are pregnant. If you can become pregnant during treatment, you should consult your doctor about the use of contraceptive methods;
• if you are breastfeeding;
• if you have severe liver disease;
• if you have severe kidney disease;
• if you have inflammatory bowel disease such as ulcerative colitis or Crohn's disease;
• if you have heart failure, diagnosed ischemic heart disease, or cerebrovascular disease, e.g., you have been diagnosed with a heart attack, stroke, or transient ischemic attack (temporary reduction in blood flow to the brain; also known as "mini-stroke"), angina pectoris, or obstruction of blood vessels to the heart or brain;
• if you have or have had circulation problems (peripheral arterial disease) or if you have undergone surgery on the arteries in your legs.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Velyntra:

• if you think you are addicted to other pain relievers (opioids);
• if you have disorders of consciousness (if you feel like you are going to faint);
• if you have cold sweats, pallor, rapid pulse, rapid breathing, dizziness... (possible symptoms and signs of shock, among others);
• if you have been informed by a healthcare professional that the pressure inside your skull is higher than normal. This can occur after a head injury or when suffering from diseases that affect the brain, such as a brain tumor;
• if you have difficulty breathing;
• if you tend to suffer from epilepsy or have seizures, because the risk of these seizures may increase;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see "Other medicines and Velyntra");
• if you have any liver or kidney disease;
• if you have or have had a stomach or intestinal ulcer or bleeding;
• if you are taking acetylsalicylic acid (even at low doses as a cardiac protector);
• if you are taking antiplatelet therapies (e.g., clopidogrel, dipyridamole);
• if you are receiving medications to reduce blood coagulation (e.g., acenocoumarol, anticoagulants analogous to acenocoumarol or new oral anticoagulants, e.g., apixaban);
• if you are receiving corticosteroid medications (e.g., prednisone);
• if you are taking this medicine at the same time as other non-acetylsalicylic NSAIDs such as ibuprofen or diclofenac. The concomitant use of these medications should be avoided;
• if you are a smoker, have diabetes, high blood pressure, or high cholesterol;
• if your heart, liver, or kidneys do not function properly, your doctor may want to monitor you regularly;
• if you have fluid retention (e.g., swollen feet or ankles);
• if you are dehydrated, for example, due to vomiting, diarrhea, or the use of diuretics (used to treat excess fluid in the body);
• if you have had a severe allergic reaction or a severe skin reaction to any medication;
• if you feel unwell due to an infection or think you have an infection, as taking this medicine may mask fever or other signs of infection and inflammation;
• if you are over 65 years old, your doctor will want to monitor you regularly.

Tell your doctor or pharmacist if you experience any of the following symptoms while taking this medicine:

• Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate that you have adrenal insufficiency (low cortisol levels). If you have these symptoms, contact your doctor, who will decide if you need to take hormonal supplements.

Respiratory disorders related to sleep

This medicine 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, nighttime awakenings due to lack of breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor.

There is a lower risk that you may experience a serotonin syndrome that may appear after taking tramadol in combination with certain antidepressants or tramadol monotherapy. Consult a doctor immediately if you present any of the symptoms linked to this serious syndrome (see section 4 "Possible side effects").

Seizures have been reported mainly when administering high doses of tramadol.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). Repeated use of this medicine can also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may be greater with a higher dose and longer use.

Dependence or addiction can cause a feeling of lack of control over the amount of medicine you need to use or how often you need to use it.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to this medicine may be greater if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have had problems with your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you observe any of the following symptoms while using this medicine, it could be a sign of dependence or addiction:

• You need to use the medicine for a longer period than indicated by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and you feel better once you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do it safely (see section 3, if you stop treatment with Velyntra).

You may also experience withdrawal symptoms when you stop taking this medicine. Your doctor will inform you how long you should take this medicine, when you should stop taking it, and how to do it safely. Inform your doctor if any of these problems occur during treatment with this medicine or if they occurred in the past.

Tramadol is transformed by an enzyme in the liver. Some people have a variation of this enzyme, and this can affect each person differently. In some people, sufficient pain relief may not be achieved, while others are more likely to experience serious side effects. If you notice any of the following side effects, you should stop taking this medicine and consult a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise, or vomiting, constipation, loss of appetite.

Like other NSAIDs (e.g., ibuprofen or diclofenac), celecoxib (a component of this medicine) may increase your blood pressure, so your doctor may perform periodic blood pressure checks.

Some cases of severe liver reactions have been reported with celecoxib, including severe liver inflammation, liver damage, liver failure (some with a fatal outcome or requiring liver transplantation). Most severe liver reactions occurred in the first month of treatment.

Children and adolescents

This medicine has not been studied in children or adolescents. Therefore, its safety and efficacy have not been established, and the medicine should not be used in children or adolescents.

Tramadol is not recommended in children with respiratory problems, as symptoms of tramadol toxicity may worsen in these patients.

Other medicines and Velyntra

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines should not be taken together, and others may require a dose adjustment if taken together.

Do not take this medicine with:

• Monoamine oxidase inhibitors (MAOIs), or 2 weeks before and after taking these medicines. MAOIs are medicines for the treatment of depression.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

• Other pain relievers such as morphine and codeine (also used as a cough medicine), or alcohol.
• Sedatives or sleeping pills (e.g., benzodiazepines).
• Medicines that may cause seizures (attacks), such as certain antidepressants or antipsychotics.
• Antidepressants. Velyntra may interact with these medicines, and you may experience a serotonin syndrome (see section 4 "Possible side effects").
• Anticoagulants (e.g., acenocoumarol, apixaban).
• Dextromethorphan (used to treat cough).
• ACE inhibitors, angiotensin II antagonists, beta-blockers, and diuretics (used to control high blood pressure and heart disorders).
• Fluconazole, ketoconazole, rifampicin, isoniazid, and erythromycin (used to treat fungal and bacterial infections).
• Lithium (used to treat some types of depression).
• Other medicines used to treat depression, sleep disorders, high blood pressure, or irregular heart rhythm (quinidine, paroxetine, fluoxetine, sertraline, amitriptyline).
• Neuroleptics (used to treat some mental disorders).
• Methotrexate (used in rheumatoid arthritis, psoriasis, and leukemia).
• Barbiturates (used to treat epilepsy/convulsions and some sleep disorders).
• Cyclosporine and tacrolimus (used to suppress the immune system, e.g., after transplants).
• Ritonavir (treatment of patients infected with HIV-1 in combination with other medicines).
• Gabapentin or pregabalin to treat epilepsy or pain due to nerve problems (neuropathic pain).

The effect and duration of pain relief of the treatment may be reduced if you take medicines that contain:

• Carbamazepine (for epileptic seizures).
• Ondansetron (to prevent nausea).

This medicine can be taken with low doses of acetylsalicylic acid (75 mg daily or less). Ask your doctor for advice before taking both medicines together.

Taking Velyntra with food and alcohol

This medicine can be taken with or without food. Do not drink alcohol during treatment with this medicine, as it may increase side effects, especially those affecting the nervous system and digestive system. For instructions on how to take this medicine, see section 3.

Pregnancy, breastfeeding, and fertility

The use of this medicine is contraindicated during pregnancy and breastfeeding.

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

Tramadol (a component of this medicine) is excreted in breast milk.

Celecoxib (a component of this medicine) may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or if you are having difficulty becoming pregnant.

Driving and using machines

This medicine may cause drowsiness, dizziness, and blurred vision, and therefore may affect your ability to drive and use machines. If you are affected, do not drive cars or any other type of vehicle, or use machines or electric tools until the symptoms disappear.

Velyntra contains mannitol and sodium

It may produce a mild laxative effect.

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

3. How to take Velyntra

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

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Velyntra, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2).

For short-term use only.

Adults

The recommended dose is 2 tablets (corresponding to 88 mg of tramadol hydrochloride and 112 mg of celecoxib) every 12 hours.

Do not take more than 4 tablets (176 mg tramadol hydrochloride/224 mg celecoxib) in 24 hours. Your doctor will indicate how long you should follow the treatment.

Some patients may experience insufficient pain relief as the time for the next dose approaches. Talk to your doctor if the treatment does not control your pain.

Use in children and adolescents

The use of this medication is not recommended in children and adolescents.

Elderly patients

No dose adjustment is required in elderly patients.

Patients with severe liver or kidney disease (insufficiency)/patients on dialysis

If you have severe liver or kidney disease, you should not take this medication. If your insufficiency is mild or moderate, your doctor will decide if you can take this medication.

Method of administration

The tablets are administered orally.

You should swallow the tablets whole, with a sufficient amount of water. Do not divide, crush, or chew the tablets.

The tablets can be taken at any time of day, with or without food. However, try to take each dose at the same time every day.

If you take more Velyntra than you should

If you have taken an extra dose by mistake, it is unlikely to have negative effects. You should take the next dose as prescribed.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the emergency department of your nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20. Please bring the medication packaging or this leaflet with you.

The symptoms of overdose of this medication are:

• pupil contraction;
• vomiting;
• decrease in blood pressure;
• increase in heart rate;
• collapse;
• decrease in level of consciousness to coma (deep unconsciousness);
• epileptic seizures;
• difficulty breathing that can lead to respiratory arrest. In this case, call a doctor or go to the nearest emergency department immediately!

Your doctor will treat the symptoms of overdose of this medication.

If you forget to take Velyntra

If you forget to take a dose of this medication, it is likely that the pain will return. Take the dose as soon as you remember, and then take the next doses at the same time as you were supposed to, as prescribed. Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Velyntra

Pain is usually self-limiting and requires treatment for a few days or weeks. If you interrupt or finish treatment with this medication too early, it is likely that the pain will return. If you want to interrupt treatment due to undesirable effects, consult your doctor.

Sudden interruption of treatment with this medication can cause worsening of symptoms (see Section 3 "How to take Velyntra").

Generally, no subsequent adverse effects are expected after suspension of treatment with this medication.

However, in rare cases, patients who have been taking tramadol for some time may feel discomfort if they stop taking it suddenly. They may feel agitation, anxiety, nervousness, or tremors, confusion, hyperactivity, difficulty sleeping, and stomach or intestinal disorders. Rarely, people may suffer from panic attacks, hallucinations, delirium, paranoia, or feel a loss of identity.

They may experience unusual perceptions such as itching, tingling, and numbness, ringing in the ears (tinnitus). Very rarely, other unusual symptoms have been observed, such as confusion, delirium, feeling of being detached from oneself (depersonalization), change in perception of reality (derealization), and delusions of persecution (paranoia). Please consult your doctor if you experience any of these effects after stopping this medication.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Possible side effects are listed below according to their likelihood of occurrence.

Stop using this medication and inform your doctor immediately if you experience:

• Symptoms of an allergic reaction such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing and rash along with wheezing or difficulty breathing.
• Heart problems such as chest pain.
• Severe stomach pain or any sign of bleeding in the stomach or intestines, such as dark urine or stool stained with blood, or blood in vomit.
• Any injury inside the mouth or on the mucous membranes, or skin reaction such as rash, blisters, or peeling of the skin.
• Liver failure [symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes)].

The most common side effects during treatment with this medication are drowsiness, dizziness, fatigue, nausea, and vomiting, which occur in more than 1 in 10 patients (very common). The adverse effects reported for tramadol and celecoxib as individual products taken alone, and either after short-term or long-term administration, are listed below:

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

• Feeling of discomfort (nausea).
• Dizziness.
• Increased blood pressure, including worsening of existing high blood pressure (hypertension).

Common (may affect up to 1 in 10 people)

• Discomfort (vomiting).
• Constipation.
• Dry mouth.
• Headache.
• Sweating (hyperhidrosis).
• Drowsiness.
• Fatigue.
• Heart attack.
• Fluid retention with swelling of ankles, legs, and/or hands.
• Urinary tract infections.
• Difficulty breathing, sinusitis (inflammation, infection of the paranasal sinuses, obstruction, or pain of the paranasal sinuses), stuffy nose, or runny nose, sore throat, cough, cold, flu-like symptoms.
• Difficulty sleeping.
• Stomach pain, diarrhea, indigestion, gas.
• Rash, itching.
• Muscle stiffness.
• Difficulty swallowing.
• Joint pain.
• Allergic reactions (e.g., difficulty breathing, wheezing, or shortness of breath), worsening of existing allergies.
• Accidental injury.

Uncommon (may affect up to 1 in 100 people)

• Desire to vomit (retching).
• Gastrointestinal irritation (feeling of pressure in the stomach, bloating).
• Effects on cardiovascular regulation, including perception of heartbeat (palpitations), rapid heartbeat (tachycardia), feeling of dizziness or collapse when standing up (postural hypotension), when there is not enough blood circulation because the heart is not working properly (cardiovascular collapse). These adverse effects may occur particularly in patients who are incorporated or who make physical effort.
• Skin reactions, including rash (urticaria).
• Stroke.
• Abnormalities in blood tests related to the liver.
• Abnormalities in blood tests related to the kidneys.
• Anemia (changes in red blood cells that can cause fatigue and shortness of breath).
• Anxiety, depression, fatigue, feeling of tingling.
• High potassium levels in blood test results [can cause nausea (feeling of discomfort), fatigue, muscle weakness, or palpitations].
• Blurred or altered vision, ringing in the ears, mouth pain and ulcers, difficulty hearing.
• Belching, stomach or intestinal inflammation (including worsening of stomach or intestinal inflammation).
• Leg cramps.
• Eye inflammation.
• Difficulty breathing.
• Discoloration of the skin (bruises).
• Chest pain (generalized pain not related to the heart).
• Facial swelling.

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

• Changes in appetite.
• Slow heartbeat (bradycardia).
• Increased blood pressure.
• Seizures. These are more likely to occur:
• • after taking a high dose of tramadol (a component of this medication); or
  • after taking medications that cause seizures or increase the possibility of seizures along with Velyntra. For example, antidepressant or antipsychotic medications (see "Other medications and Velyntra").
• Muscle twitches.
• Tremors.
• Psychological problems may appear after treatment with tramadol. Their intensity and nature may vary depending on:
• • your personality;
  • the duration of treatment with Velyntra.

These problems include:

• • mood changes - usually elevated mood (euphoria), occasionally irritability (dysphoria);
  • changes in activity (usually less active, occasionally more active);
  • changes in the ability to think and perceive things clearly (your cognitive and sensory ability) such as:
  • • decision-making (behavior when making decisions);
    • lack of awareness or understanding (altered perception);
    • seeing or hearing things that are not real (hallucinations);
    • confusion;
    • sleep disturbance;
    • delirium;
    • nightmares.
• Muscle weakness.
• Excessive pupil contraction (miosis).
• Difficulty or pain when urinating, less urine than normal (dysuria).
• Uncoordinated movements.
• Transient loss of consciousness (syncope).
• Severe allergic reactions (swelling of the face, lips, mouth, tongue, or throat, or difficulty swallowing, including potentially fatal anaphylactic shock).
• Ulcers (bleeding) in the stomach, throat, or intestines; or rupture of the intestine (can cause stomach pain, fever, nausea, vomiting, intestinal obstruction), dark or black stools, inflammation of the pancreas (can lead to stomach pain), inflammation of the throat (esophagus), inflammation of the intestine or colon.
• Low sodium levels in the blood (a disease known as hyponatremia).
• Decrease in the number of white blood cells or platelets in the blood (which increases the risk of bleeding and bruising).
• Difficulty in muscular coordination of movements.
• Feeling of confusion, alterations in taste.
• Increased sensitivity to light.
• Hair loss.
• Hallucinations.
• Eye bleeding.
• Acute reaction that can lead to lung inflammation.
• Irregular heartbeat.
• Redness of the skin.
• Blood clots in the blood vessels of the lungs. Symptoms may include sudden difficulty breathing, sharp pain when breathing, or collapse.
• Severe liver inflammation (hepatitis). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching, or chills.
• Sudden kidney failure.
• Menstrual disorders.

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

• Severe skin disorders such as Stevens-Johnson syndrome, exfoliative dermatitis, and toxic epidermal necrolysis (can cause rash, blistering, or peeling of the skin) and generalized acute exanthematous pustulosis (symptoms include redness of the skin with swollen areas and numerous small pustules).
• A late allergic reaction with possible symptoms such as rash, swelling of the face, fever, swollen lymph nodes, and abnormalities in clinical test results [e.g., liver, blood cells (eosinophilia, a type of increase in blood cell count)].
• Bleeding in the brain that causes death.
• Meningitis (inflammation of the membrane surrounding the brain and spinal cord).
• Liver failure, liver damage, and severe liver inflammation (fulminant hepatitis) (sometimes with fatal outcome or requiring liver transplant). Symptoms may include nausea (feeling of discomfort), diarrhea, jaundice (yellowing of the skin and eyes), dark urine, pale stools, ease of bleeding, itching, or chills.
• Liver problems (such as cholestasis and cholestatic hepatitis, which may be accompanied by symptoms such as pale stools, nausea, and yellowing of the skin or eyes).
• Kidney inflammation and other kidney problems (such as nephrotic syndrome and minimal change disease, which may be accompanied by symptoms such as fluid retention (edema), foamy urine, fatigue, and loss of appetite).
• Worsening of epilepsy (possibility of more frequent and/or severe seizures).
• Obstruction of an artery or vein in the eye that leads to partial or complete loss of vision.
• Inflammation of blood vessels (can cause fever, pain, purple spots on the skin).
• Pain, inflammation, and muscle weakness.
• Alteration of the sense of smell.
• Loss of taste.
• Decrease in the number of red, white, and platelet blood cells (can cause fatigue, ease of bruising, frequent nosebleeds, and increased risk of infections).

Not known (frequency cannot be estimated from available data)

• Excessive dilation of the pupils (mydriasis).
• Speech disorders.
• Decrease in blood sugar levels (hypoglycemia).
• Decrease in female fertility, which is usually reversible if the medication is discontinued.
• Dependence and addiction.
• Hiccup.
• 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see section 2 "What you need to know before you start taking Velyntra").

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Velyntra

Keep this medication out of sight and reach of children.

Store this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal to people who have not been prescribed it.

Do not use this medication after the expiration date shown on the box or blister after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Velyntra

• The active ingredient is a co-crystal of tramadol hydrochloride and celecoxib. Each tablet contains 44 mg of tramadol hydrochloride and 56 mg of celecoxib.
• Other components are:
• • Core of the tablet: sodium lauryl sulfate, crospovidone, mannitol (E-421), sodium stearyl fumarate, talc, microcrystalline cellulose, and copovidone.
  • Film coating: Opadry white II 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), polyethylene glycol, and talc).

Appearance of Velyntra and package contents

White to off-white film-coated tablets, elongated, with the inscription "100" on one side and "CTC" on the other. Approximate size: 16.2 mm (length) x 5.4 mm (width).

Available in Alu/Alu blisters. Package size: 30 film-coated tablets.

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona (Spain)

Manufacturer

Towa Pharmaceutical Europe S.L.

c/ de Sant Marti, 75-97

08107 Martorelles (Spain)

Recipharm Leganés S.L.U.

Calle Severo Ochoa 13

28914 Leganés, Madrid (Spain)

Date of last revision of this leaflet:April 2024.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)