Voltaren 50 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voltarén 50 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Voltaren is and what it is used for

Diclofenac sodium, the active ingredient in Voltaren 50 mg, belongs to a group of medicines known as non-steroidal 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,
  • Menstrual pain,

• Post-traumatic inflammation.

2. What you need to know before taking Voltarén

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

Do not take Voltarén

• if you are allergic to sodium diclofenac 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 to other similar painkillers (analgesics). Reactions may include asthma (difficulty breathing), chest pain, hives (skin rash 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 previously experienced stomach or duodenal bleeding or have had two or more episodes of gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug (NSAID).
• if you currently have or have had two or more episodes of stomach or duodenal ulcer or bleeding.
• if you currently suffer from active Crohn’s disease or active ulcerative colitis (conditions causing diarrhoea 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, mini-stroke (TIA), blockages in blood vessels of the heart or brain, or surgery to remove blockages or coronary bypass.
• if you have or have had circulatory problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood clotting disorders.

Before taking diclofenac, 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

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Voltarén:

• if you have had or develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms.

This risk is higher when high doses are used and treatment is prolonged, especially in patients with a history of peptic ulcer or in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• if you suffer from any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure (hypertension), bleeding disorders or other blood disorders including hepatic porphyria.
• if you are taking medicines for high blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and Voltarén”).
• 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 mention the use of other medicines that could increase the risk of such bleeding, such as other anti-inflammatory drugs, corticosteroids, and selective serotonin reuptake inhibitor (SSRI) antidepressants (see section “Other medicines and Voltarén”).
• if you have Crohn’s disease or ulcerative colitis, as medicines like Voltarén may worsen these conditions.
• if you have high blood pressure, high cholesterol or triglyceride levels, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with this medicine, especially if treatment lasts longer than 4 weeks.
• if you have liver failure, kidney failure or blood disorders, you will need frequent blood tests during treatment. These tests will monitor liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, red blood cell, and platelet levels). This allows your doctor to decide whether to stop or adjust your dose.
• if you have recently undergone or are about to undergo stomach or intestinal surgery, as this medicine may sometimes impair intestinal wound healing after surgery.
• if you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking Voltarén or other painkillers.

Patients with cardiovascular problems

Medicines like Voltarén may be associated with an increased risk of heart attack ("myocardial infarction") or stroke, especially when used at high doses or for prolonged periods. Do not exceed the recommended dose or duration of treatment.

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

Also, these types of medicines may cause fluid retention, especially in patients with heart disease and/or high blood pressure (hypertension).

In general, it is very important to take the lowest effective dose of this medicine for the shortest possible time needed to relieve your pain and/or inflammation, to reduce the risk of cardiovascular adverse effects.

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

Other medicines and Voltarén

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

Certain medicines may interact with Voltarén; in such cases, it may be necessary to adjust 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 serotonin reuptake inhibitors (used to treat certain types of depression),
• medicines containing methotrexate (used to treat rheumatoid arthritis and cancer),
• medicines containing cyclosporine or tacrolimus (used after organ transplants),
• medicines containing trimethoprim (used to prevent and treat urinary tract infections),
• medicines used to treat heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines used to control blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines used to prevent blood clots,
• medicines containing quinolones or ceftriaxone (used to treat infections),
• other medicines in the same group as Voltarén (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• corticosteroids (medicines that reduce inflammation and suppress the immune system),
• medicines containing voriconazole (used to treat fungal infections),
• medicines containing phenytoin (used to treat epileptic seizures),
• medicines containing misoprostol (used to treat stomach ulcers),
• medicines containing colestyramine or colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain),
• an antibiotic used to treat bacterial infections (rifampicin).

Taking Voltarén with food, drinks and alcohol

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

Consuming alcoholic beverages while using this medicine may increase its toxicity.

Children and adolescents

This medicine is not recommended for 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. Therefore, it is especially important that elderly patients report any adverse effects to their doctor immediately.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take this medicine during 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 unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour 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 treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, this medicine may cause kidney problems in your unborn baby, leading 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 longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

Female patients of childbearing age should be aware that medicines like Voltarén have been associated with reduced fertility.

Driving and using machines

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

Voltarén contains lactose and sodium.

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

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

3. How to take Voltarén

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in adults and adolescents over 14 years of age

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

For 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) should be administered, and if necessary, increased during subsequent menstrual cycles. Treatment should begin at the onset of the first symptoms and continued for several days, depending on symptom severity.

Method of administration

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

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

If you take more Voltarén than you should

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

If you forget to take voltarén

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

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

4. Possible adverse effects

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

Some adverse effects may be serious.

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

Mild abdominal cramps and abdominal tenderness beginning shortly after starting treatment with this medicine, followed by rectal bleeding or diarrhoea with blood, usually observed within 24 hours after the onset of abdominal pain (frequency unknown, cannot be determined from available data).

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

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

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

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Voltarén

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

This medicine does not require any special storage temperature.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy (or any other medicine waste collection system). If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltarén

• The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.
• The other components (excipients) are anhydrous colloidal silica (E-551), microcrystalline cellulose (E-460), lactose, maize starch, povidone (E-1201), magnesium stearate (E-470b), sodium carboxymethyl starch (potato starch), hypromellose (E-464), yellow iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171), dispersed acrylic polyesters, polyethylene glycol (E-1521), simethicone, talc (E-553b) and hydrogenated castor oil.

Appearance of Voltarén and contents of the pack

Gastro-resistant tablets, round, biconvex, light brown in colour, marked “CG” on one side and “GT” on the other, in Al/PVC/PE/PVDC blisters, in packs of 40 tablets.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Manufacturer Responsible

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 und Obere Turnstrasse 8 - 10

DE-90429 Nuremberg

Germany

Date of most recent review of this leaflet: 11/2023

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