VOLTAREN 50 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Voltaren50 mg Gastro-Resistant Tablets

diclofenac sodium

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

• Keep this leaflet, 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 signs of illness are the same as yours.
• If you get 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 Voltaren and what is it used for
2. What you need to know before you take Voltaren
3. How to take Voltaren
4. Possible side effects
5. Storing Voltaren
6. Contents of the pack and other information

1. What is Voltaren and what is it used for

Diclofenac sodium, the active ingredient in Voltaren 50 mg, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), 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 attacks of gout,
  • Menstrual pain,

• Post-traumatic inflammation.

2. What you need to know before you take Voltaren

It is important that you use the lowest dose that relieves your pain and do not take this medicine for longer than necessary to control your symptoms.

Do not take Voltaren

• if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other analgesics (pain-relieving medicines) similar to Voltaren. Reactions may include asthma (difficulty breathing), chest pain, hives (allergic skin reaction with itching), acute rhinitis (inflammation of the nasal mucosa) or swelling of the face, lips, tongue, throat, and/or limbs (signs of angioedema). If you think you may be allergic, consult your doctor.
• if you have had a stomach or duodenal ulcer or have suffered from more than one episode of stomach or intestinal perforation while taking a non-steroidal anti-inflammatory medicine.
• if you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• if you have active Crohn's disease or ulcerative colitis (diseases that cause diarrhea with or without blood and abdominal pain).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, transient ischaemic attack (TIA), or have had an operation to remove a blockage or perform a coronary bypass.
• if you have problems with blood circulation (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood coagulation disorders.

Make sure your doctor knows before taking diclofenac:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Voltaren:

• if you have had or developed a stomach or duodenal ulcer or bleeding, which may be manifested by severe abdominal pain or black stools, even without prior warning signs.

This risk is higher when using high doses and prolonged treatment in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor may consider prescribing a stomach protective medicine.

• if you have any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure, bleeding disorders, or other blood disorders, including porphyria.
• if you are taking medicines for high blood pressure or ciclosporin, as this may increase the risk of kidney damage (see section “Other medicines and Voltaren”).
• if you are taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medicines that may increase the risk of bleeding, such as other non-steroidal anti-inflammatory medicines, corticosteroids, and selective serotonin reuptake inhibitors (see section “Other medicines and Voltaren”).
• if you have Crohn's disease or ulcerative colitis, as medicines like Voltaren may worsen these conditions.
• if you have high blood pressure, high cholesterol, or high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor should regularly reassess whether you should continue treatment with this medicine, especially if you have been taking it for more than 4 weeks.
• if you have liver or kidney failure, or blood disorders, you will need to have regular blood tests during treatment to monitor liver (transaminase levels) or kidney (creatinine levels) function or blood (lymphocyte, erythrocyte, and platelet levels). This will allow your doctor to decide whether to stop or change the dose of this medicine.
• if you have recently undergone or are about to undergo stomach or intestinal surgery, as this medicine may sometimes worsen the healing of intestinal wounds after surgery.
• if you have ever had a severe skin rash or peeling, blisters, or sores in the mouth after taking Voltaren or other pain-relieving medicines.

Patients with cardiovascular problems

Medicines like Voltaren may be associated with an increased risk of heart attacks (“myocardial infarction”) or strokes, especially when used in high doses and for prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of strokes, or think you may be at risk of having them (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker) and your doctor decides to treat you with this medicine, do not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Additionally, these types of medicines can cause fluid retention, especially in patients with heart disease and/or high blood pressure.

It is very important to take the lowest effective dose of this medicine for the shortest possible time to relieve pain and/or inflammation to reduce the risk of cardiovascular side effects.

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

Other medicines and Voltaren

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interfere with Voltaren; in these cases, it may be necessary to change the dose or stop treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• medicines containing lithium or selective serotonin reuptake inhibitors (for treating certain types of depression),
• medicines containing methotrexate (for treating rheumatoid arthritis and cancer),
• medicines containing ciclosporin, tacrolimus (after transplants),
• medicines containing trimethoprim (for preventing and treating urinary tract diseases),
• medicines for treating heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines for controlling blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines for preventing blood clots,
• medicines containing quinolone or ceftriaxone (for treating infections),
• other medicines of the same group as Voltaren (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• corticosteroids (medicines that reduce inflammation and the action of the immune system),
• medicines containing voriconazole (a medicine used in the treatment of fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (for treating stomach ulcers),
• medicines containing cholestyramine and colestipol for reducing cholesterol levels in the blood),
• medicines containing pentazocine (for relieving pain),
• the antibiotic rifampicin (used to treat bacterial infections).

Taking Voltaren with food, drinks, and alcohol

This medicine should be taken preferably before meals or on an empty stomach, as this delays the onset of action.

Consuming alcoholic beverages with this medicine may increase its toxicity.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 14 years of age.

Elderly patients

Elderly patients, especially those who are frail or have low body weight, may be more sensitive to the effects of this medicine than other adults. It is especially important that elderly patients inform their doctor immediately of any side effects that occur.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take this medicine if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney or heart problems in your baby. It may affect your tendency and your baby's tendency to bleed and may prolong or delay delivery more than expected. You should not take this medicine during the first 6 months of pregnancy unless clearly necessary and as directed 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 time. If you take this medicine for more than a few days from the 20th week of pregnancy, it may cause kidney problems in your baby, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Small amounts of diclofenac may appear in breast milk; therefore, you should not take this medicine if you are breastfeeding.

Fertility

For women of childbearing age, it should be noted that medicines like Voltaren have been associated with a decrease in fertility.

Driving and using machines

Diclofenac's influence on the ability to drive and use machines is negligible. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking Voltaren should avoid driving vehicles or operating machinery.

Voltaren contains lactose and sodium.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

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

3. How to take Voltaren

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in adults and adolescents over 14 years

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

In menstrual pain, the daily dose, which should be individually adjusted, 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 be started when the first symptoms appear. Depending on the intensity, it will be continued for a few days.

Method of administration

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

The tablets should be swallowed whole with a glass of water or other liquid, without dividing or chewing them.

If you take more Voltaren than you should

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

If you forget to take Voltaren

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious.

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

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

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

Severe skin allergic reaction, which can include widespread red or dark patches, skin swelling, blisters, and itching (generalized fixed drug eruption).

Other adverse effects that have been reported with the use of this medicine are the following:

Reporting of Adverse Effects:

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

5. Storage of Voltarén

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage temperature.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy (or any other system for collecting medicinal waste). If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Voltarén Composition

• The active ingredient is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
• The other ingredients (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), acrylic polymer dispersions, polyethylene glycol (E-1521), simethicone, talc (E-553b), and hydrogenated castor oil.

Voltarén Appearanceand Package Contents

Gastro-resistant tablets, round, biconvex, light brown in color with "CG" on one side and "GT" on the other, in Al/PVC/PE/PVDC blisters, in packages of 40 tablets.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito, 131 (Torre Annunziata)

Naples, Italy

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

Novartis Pharma GmbH

Roonstrasse 25 and Obere Turnstrasse 8 - 10

DE-90429 Nuremberg

Germany

Date of Last Revision of this Prospectus:11/2023

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