Leaflet: information for the user

Voltarén50 mg gastro-resistant tablets

diclofenaco sódico

Read this leaflet carefully before you start taking this medicinebecause 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; 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 isVoltarénand what it is used for

2. What you need to knowbefore starting to take Voltarén

3. How to take Voltarén

4. Possible side effects

5. Storage of Voltarén

6. Contents of the pack and additional information

Sodium diclofenac, the active ingredient ofVoltaren 50 mg belongs to the group of medications known as nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation.

Voltaren 50 mg is used to treat the following conditions:

-Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),

-Extra-articular rheumatism,

• Acute gout attacks,
• M menstrual pains,

-Post-traumatic inflammation.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Voltarén

-if you are allergic to diclofenac sodium or any of the other components of this medication (listed in section 6).

-if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other analgesics (pain medications) similar to it. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (allergic reaction on the skin with itching), acute rhinitis (inflammation of the nasal mucosa), or swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema). If you think you may be allergic, consult your doctor.

-if you have had a previous gastrointestinal hemorrhage or have experienced two or more instances of gastrointestinal perforation while taking a nonsteroidal anti-inflammatory drug.

-if you currently have or have had more than one instance of stomach or duodenal ulcer or hemorrhage.

-if you have active Crohn's disease or ulcerative colitis (diseases that produce diarrhea with or without blood and abdominal pain).

-if you have severe kidney disease.

-if you have severe liver disease.

-if you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or coronary artery bypass surgery.

-if you have or have had peripheral arterial disease (circulation problems).

-if you are in the third trimester of pregnancy.

-if you have bleeding disorders.

Make sure your doctor knows:

-if you smoke

-if you have diabetes

-if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

The adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Voltarén:

-if you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as severe or persistent abdominal pain and/or black stools, even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector.

-if you have any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders, including porphyria hepatica.

-if you are taking blood pressure medications or ciclosporin, as this increases the risk of kidney damage (see section “Other Medications and Voltarén”).

-if you take medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as other nonsteroidal anti-inflammatory drugs, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs) (see section “Other Medications and Voltarén”).

-if you have Crohn's disease or ulcerative colitis, as Voltarén-type medications may worsen these conditions.

-if you have high blood pressure, high cholesterol, or triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor will reevaluate whether you should continue treatment with this medication, especially if you have been taking it for more than 4 weeks.

-if you have liver insufficiency, kidney insufficiency, or blood disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to monitor the function of your liver (transaminase levels), kidneys (creatinine levels), or blood (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide whether to interrupt or change the dose of this medication.

-if you have recently undergone or are about to undergo gastrointestinal surgery, as this medication may sometimes worsen the healing of intestinal wounds after surgery.

Patients with Cardiovascular Problems

Medications like Voltarén may be associated with an increased risk of heart attacks or strokes, especially when used in high doses and for prolonged periods. 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 example, you have high blood pressure, diabetes, high cholesterol, or triglycerides, or are a smoker) and your doctor decides to treat you with this medication, do not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Additionally, this type of medication may cause fluid retention, especially in patients with heart disease and/or high blood pressure.

In general, it is very important to take the lowest effective dose of this medication for the shortest possible period to alleviate pain and/or inflammation and reduce the risk of cardiovascular adverse effects.

If you experience chest pain, shortness of breath, weakness, or difficulty speaking while taking this medication, contact your doctor immediately.

Other Medications and Voltarén

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

Certain medications may interact with Voltarén; in these cases, you may need to change the dose or interrupt treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

-medications containing lithium or selective serotonin reuptake inhibitors (SSRIs) (for treating depression),

-medications containing methotrexate (for treating rheumatoid arthritis and cancer),

-medications containing ciclosporin, tacrolimus (after transplants),

-medications containing trimethoprim (for preventing and treating urinary tract diseases),

-medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),

-medications used to treat diabetes, except for insulin,

-medications for controlling blood pressure (diuretics, beta blockers, and ACE inhibitors),

-medications for preventing blood clots,

-medications containing quinolone or ceftriaxone (for treating infections),

-other medications in the same group as Voltarén (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,

-corticosteroids (medications that reduce inflammation and immune system activity),

-medications containing voriconazole (a medication used to treat fungal infections),

-medications containing phenytoin (a medication used to treat seizures),

-medications containing misoprostol (for treating stomach ulcers),

-medications containing cholestyramine and colestipol to lower cholesterol levels in the blood),

-medications containing pentazocine (for relieving pain),

-antibiotic medications used to treat bacterial infections (rifampicin).

Taking Voltarén with Food, Drinks, and Alcohol

This medication should be taken preferably before meals or on an empty stomach, as it delays the onset of effect.

The consumption of alcoholic beverages with this medication may increase its toxicity.

Children and Adolescents

This medication is not recommended for children and adolescents under 14 years old.

Older Adults

Older adults, especially those who are more fragile or have a low body weight, may be more sensitive to the effects of this medication than the rest of adults. Therefore, it is especially important for older adults to inform their doctor immediately about any adverse effects they experience.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Do not take this medication if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery. Do not take this medication during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible period. If you take it for more than a few days after week 20 of pregnancy, this medication may cause kidney problems in your fetus, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Small amounts of diclofenac may appear in breast milk, so you should not take this medication while breastfeeding.

Fertility

For fertile women, it is essential to consider that medications like Voltarén have been associated with a decrease in the ability to conceive.

Driving and Operating Machines

The influence of diclofenac on the ability to drive and operate machines is negligible or insignificant. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking Voltarén should avoid driving vehicles or operating machinery.

Voltarén Contains Lactose and Sodium

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

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

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

Remember to take your medication.

Use in adults and adolescents over 14 years old

For mild cases, the recommended dose is 2 diclofenac 50 mg tablets per day. Do not exceed 3 tablets (150 mg of diclofenac) per day. The total daily dose should be divided into 2 or 3 fractional doses.

For menstrual cramps, the daily dose, which should be adjusted individually, is 50-200 mg (1 to 4 tablets). An initial dose of 50-100 mg (1 to 2 tablets) will be administered, and if necessary, it will be increased in subsequent menstrual cycles. Treatment should start when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

Take this medication preferably before meals or on an empty stomach (see section “Taking Voltarén with food, drinks, and alcohol”).

Swallow the tablets whole with a glass of water or another liquid, without dividing or chewing them.

If you take more Voltarénthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91.562.04.20.

If you forgot to take Voltarén

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

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

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

Some side effects can be serious.

Stop using this medicine and immediately inform your doctor if you notice:

Abdominal cramps and abdominal pain to palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea observed within 24 hours after the onset of abdominal pain (with unknown frequency, cannot be determined from available data).

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects that have been reported with the use of this medicine are as follows:

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 the Spanish System for the Vigilance of Medicinal Products for Human Use: http://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.

This medication does not require any special storage temperature.

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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy (or any other medication waste collection system). If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Voltarén

- The active ingredient is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.

- The other components (excipients) are anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460), lactose, cornstarch, povidone (E-1201), magnesium stearate (E-470b), sodium carboxymethylcellulose (potato starch), hypromellose (E-464), yellow iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171), dispersed acrylic polymers, polyethylene glycol (E-1521), simethicone, talc (E-553b), and hydrogenated ricin oil.

Appearance of Voltarén and content of the packaging

Enteric-coated tablets, round, biconvex, light brown in color with "CG" on one side and "GT" on the other, in an Al/PVC/PE/PVDC blister, in packs of 40 tablets.

Holder of the authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – España

Responsible for manufacturing

Novartis Farma S.p.A.

Via Provinciale Schito, 131 (Torre Annunziata)

Napoles- Italia

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – España

Novartis Pharma GmbH

Roonstrasse 25 und Obere Turnstrasse 8 - 10

DE-90429 Nuremberg

Alemania

Last review date of this prospectus: 11/2023

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/