Leaflet: information for the user

Reutenox 20 mg powder for oral suspension

Tenoxicam

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms of illness 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.

1. What is Reutenox and what it is used for

2. What you need to know before starting to take Reutenox

3. How to take Reutenox

4. Possible side effects

5. Storage of Reutenox

6. Contents of the pack and additional information

Tenoxicam is a medication that belongs to the group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs), which acts by reducing inflammation.

Reutenox is indicated for:

• Treatment of painful inflammatory conditions of muscles, joints, tendons, and ligaments.
• Treatment of menstrual pain.

Reutenox has a strong and lasting effect on pain and inflammation or swelling. It does not eliminate the causes of muscle and joint conditions, but it improves symptoms.

It is essential to use the smallest dose that relieves or controls pain and not to take this medicationReutenox 20 mg for longer than necessary to control symptoms.

Do not take Reutenox:

• If you are allergic to tenoxicam or any of the other components of this medication (including those listed in section 6), or to any anti-inflammatory or calming medication.
• If you react with asthma, rhinitis, or skin alterations when taking medications containing salicylates as the active ingredient, or other non-steroidal anti-inflammatory drugs.
• If you have severe renal or hepatic insufficiency.
• If you are allergic to dairy products, as Reutenox contains powdered cow's milk. If you are unsure, consult your doctor.
• If you have had a stomach or duodenal ulcer or hemorrhage or have suffered a perforation of the digestive apparatus.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

• If you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• Inform your doctor

• If you have renal or hepatic dysfunction.
• If you have blood disorders.
• If you have heart diseases or other diseases.
• If you have allergies.
• If you are to be operated on and are taking Reutenox, as your doctor will decide on the treatment.
• If you are taking medications that alter blood coagulation, such as corticosteroids, oral anticoagulants, or antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of these hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Reutenox-type medications may worsen these pathologies.

Cardiovascular Precautions

Medications such as Reutenox may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

Similarly, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Severe skin eruptions that can threaten the patient's life (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been described with the use of Reutenox, initially appearing as red, circular spots with a central blister.

Additional signs that may appear include mouth, throat, nose, genital, and conjunctivitis (swollen and red eyes) lesions.

These life-threatening skin eruptions often accompany flu-like symptoms. The rash may progress to widespread blistering or skin peeling.

The highest risk period for the appearance of severe skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Reutenox, do not use Reutenox again at any time.

If you develop rashes or these skin symptoms, seek immediate medical attention and inform your doctor that you are taking this medication.

Reutenox Interactions with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is very important, as taking multiple medications at the same time may increase or decrease their effect. For example, other medications used to treat muscle or joint pain (salicylates or other non-steroidal anti-inflammatory drugs) may increase the frequency of gastrointestinal side effects (stomach disorders).

Caution should be exercised when taking Reutenox with other medications containing methotrexate as the active ingredient, as severe adverse effects may occur, such as blood disorders, liver or kidney problems, diarrhea, or inflammation and ulceration of the mouth.

The combination of Reutenox and lithium may cause undesirable effects such as tremors, vomiting, skin redness, and fluid retention. However, no clinically relevant interactions have been detected between Reutenox and low-molecular-weight heparin.

You should consult your doctor if you are taking medications containing the following active ingredients: salicylates, other non-steroidal anti-inflammatory drugs, diuretics that conserve potassium (substances that increase urine flow), alpha-adrenergic blockers, hydrochlorothiazide, and inhibitors of the ECA (substances that lower blood pressure), anticoagulants (substances that thin the blood), antidiabetic medications (substances that lower blood sugar levels), or corticosteroids (substances used to treat, for example, allergic reactions such as asthma or skin alterations).

Consult with your doctor if you need more information about this.

Pregnancy, Lactation, and Fertility

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

Pregnancy

Due to the association of administering medications of the type Reutenox with an increased risk of congenital anomalies/abortions, it is not recommended to administer the same during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Reutenox is contraindicated.

Lactation

Reutenox is eliminated through breast milk in small amounts. Your doctor will decide if you can take Reutenox during breastfeeding.

Fertility

For women of childbearing age, it should be noted that medications of the type Reutenox have been associated with a decrease in the ability to conceive.

Driving and Operating Machines

Depending on the individual response to Reutenox, you may be affected in your ability to drive vehicles or operate machinery; therefore, the patient treated with Reutenox should ensure that they retain their reflexes before driving a car or operating machinery.

Reutenox contains aspartame and lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 2.667 g of lactose (corresponding to 1.334 g of glucose and 1.334 g of galactose) per packet.

This medication contains 30 mg of aspartame in each packet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions forReutenox as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Reutenox should be administered at the same time every day, preferably during or immediately after meals. The contents of the packets will dissolve in cold water immediately before taking.

For the treatment of rheumatic diseases, muscle and joint pain, a dose of 1 packet (20 mg) per day is sufficient. However, your doctor may prescribe a different dose.

For the treatment of menstrual pain, 1 or 2 packets per day are recommended, depending on the intensity of the pain.

In any case, the daily dose will not exceed 2 packets, corresponding to 40 mg of tenoxicam.

Reutenox provides relief shortly after starting treatment, and this relief may increase over time. In prolonged treatments, your doctor may prescribe lower daily doses to maintain the same effect.

Patients of advanced age

Your doctor will decide on the dose, which will generally be lower than that prescribed for other adult patients. While taking Reutenox, your doctor will ask you to attend a consultation to check that the dose is correct for you and to determine if any adverse effects occur. This is especially important if you are an elderly person. Risks are more likely with high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If the patient has liver, kidney, heart, blood, or stomach problems, your doctor will decide whether it is appropriate to administerReutenox at lower doses or if the patient should not take it. Follow your doctor's instructions carefully.

Do not change the dose prescribed by your doctor. If you consider that the medication's effect is too weak or too strong, you must consult your doctor.

Do not interrupt treatment on your own, as your doctor is the one who should decide on the treatment duration. If your doctor considers it necessary, treatment withReutenox may be restarted later.

Reutenox is prescribed individually by your doctor for each patient, and under no circumstances should you give it to a third party.

Treatment withReutenox may be completed with other measures, such as hot or cold baths, exercises, or massages. These additional treatments will be indicated individually for each patient by your doctor.

If you need more information aboutReutenox, you can ask your doctor or pharmacist.

If you take more Reutenox than you should

If you or another person has taken an overdose ofReutenox, you should go immediately to your doctor, pharmacist, nearest hospital, or consult the Toxicological Information Service. Phone: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Reutenox

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

If you forget to take a dose, as soon as you remember, take the dose and continue with the usual treatment.

Like all medications,Reutenox may cause side effects, although not everyone will experience them.

Reutenox is well tolerated by most patients.

The most common side effects are loss of appetite and dry mouth. Sometimes fatigue, sleep disturbances, itching, skin redness, dizziness, and headaches may occur. Generally, these side effects are temporary and rarely is it necessary to interrupt treatment.

Gastrointestinal:

The most frequent side effects that occur with medications likeReutenox are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Very rare (may affect up to 1 in 10,000 people): pancreatitis (inflammation of the pancreas).

Cardiovascular:

Medications likeReutenox, especially, may be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or stroke.

Dermatological:

In very rare cases, skin eruptions may appear that can threaten the patient's life (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

Hepatic:

Medications likeReutenox may be associated with liver disorders that cause yellowing of the skin and eyes, sometimes with elevated fever or swelling and sensitivity in the upper abdomen.

If any of the following reactions occur: Yellowing of the skin or eyes, discontinue treatment and IMMEDIATELY report to your doctor.

In exceptional cases, swelling in the ankles, skin redness, increased sensitivity to sunlight, blue marks, visual disturbances, vomiting with blood, intense stomach pain, facial swelling, asthma, or flu-like symptoms, vasculitis, hepatitis may occur.

Unknown frequency (cannot be estimated from available data):

• Changes in vision
• Confusion, hallucinations (hearing or seeing things that do not exist in reality)
• Paresthesia (abnormal sensations such as tingling, pins and needles, or numbness, especially in the hands and feet), drowsiness

If you experience any of these symptoms, you must consult your doctor immediately, who will decide whether to discontinue treatment withReutenox.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this prospectus, report to your doctor or pharmacist.

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even ifit is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medications for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store in the original packaging.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Reutenox

• The active principle is tenoxicam.
• The other components are aspartame (E-951), skimmed milk powder (contains lactose) and ethylvanillin.

Appearance of the product and content of the container

Reutenox 20 mg granulated for oral suspension is presented in the form of granulated for oral administration in sachets, with each container containing 20 single-dose sachets.

Other presentations:

Reutenox 20 mg coated tablets: coated tablets (scored), conditioned in blister packs. Container of 20 and 500 tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Rubió, S.A.

C/Industria, 29 – Pol. Ind. Comte de Sert,

08755 Castellbisbal (Barcelona)

SPAIN

Last review date of the text:June 2021.

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