Package Leaflet: Information for the User

Voltarén Retard 75 mg Modified Release Tablets

Diclofenac Sodium

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What is Voltarén Retard 75 mg and what is it used for

2. What you need to know before you take Voltarén Retard 75 mg

3. How to take Voltarén Retard 75 mg

4. Possible side effects

5. Storage of Voltarén Retard 75 mg

6. Contents of the pack and additional information

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

Voltarén Retard 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 Retard

• 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 or other analgesics (pain medications) similar to this. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (allergic skin reaction 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 suffered two or more instances of a perforated digestive tract while taking a nonsteroidal anti-inflammatory drug.
• if you currently have or have had more than one instance of a stomach or duodenal ulcer.
• if you suffer from 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 a surgical procedure to remove an obstruction or perform a coronary bypass.
• if you have peripheral arterial disease (problems with blood circulation).
• if you are in the third trimester of pregnancy.
• if you have bleeding disorders.

Make sure your doctor knows before taking diclofenac that:

• 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 Retard:

-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, 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 suffer from 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 "Other medications and Voltarén Retard").

• 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 "Other medications and Voltarén Retard").

• 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 bleeding disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to control the functioning 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 surgical intervention on the stomach or intestine before taking this medication, as this medication may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Medications like Voltarén Retard 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 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 time to alleviate 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 medication, contact your doctor immediately.

Other medications and Voltarén Retard

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 Retard; 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 depression
• medications containing methotrexate for rheumatoid arthritis and cancer
• medications containing ciclosporin, tacrolimus (after transplants)
• medications containing trimethoprim for urinary tract diseases
• medications for heart problems (digoxin, calcium channel blockers like verapamil or isradipine)
• medications used to treat diabetes, except insulin
• medications to control blood pressure (diuretics, beta blockers, and ACE inhibitors)
• medications to prevent blood clots
• medications containing quinolone or ceftriaxone for infections
• other medications in the same group as Voltarén (nonsteroidal anti-inflammatory drugs) like 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 stomach ulcers)
• medications containing cholestyramine and colestipol to lower cholesterol levels in the blood
• medications containing pentazocine (for pain relief)
• antibiotic medications used to treat bacterial infections (rifampicin)

Taking Voltarén Retard with food, drinks, and alcohol

You can take this medication with or without food, as food does not affect the effect of this medication.

Consuming alcoholic beverages with this medication may increase its toxicity.

Children and adolescents

This medication is not recommended for children and adolescents.

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 general adult population. 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, think you may be pregnant, or plan to become 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 more than expected. 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 time. 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 cause low amniotic fluid levels surrounding the baby (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 women of childbearing age, it is essential to consider that medications like Voltarén Retard have been associated with a decrease in the ability to conceive.

Driving and operating machinery

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

Voltarén Retard contains saccharose and sodium.

This medication contains saccharose, and if your doctor has indicated that you have an intolerance to certain sugars, 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. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in adults

The usual dose in mild cases or for prolonged treatments is 1 tablet of 75 mg per day. Do not exceed a dose of 2 tablets (150 mg of diclofenac) per day, divided into two doses.

In menstrual cramps, the daily dose, which should be adjusted individually, is 50-200 mg of diclofenac (1 to 2 tablets of Voltarén Retard 75 mg). A starting dose of 50-100 mg of diclofenac (1 tablet of Voltarén Retard 75 mg) will be administered, and if necessary, it will be increased in subsequent menstrual cycles. Treatment should begin when the first symptom appears. Depending on its intensity, it will be continued for a few days. For a dose of 50 mg, the use of Voltarén 50 mg gastro-resistant tablets is recommended, and for doses of 100 and 200 mg, Voltaren Retard 100 mg tablets are recommended.

Administration form

This medication can be taken with or without food (see section “Taking Voltarén Retard with food, drinks, and alcohol”).

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

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:

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

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

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

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 Pharmacovigilance 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.

Maintain this medicationout of the sight and reach of children.

Do not store at a temperature above30°C. Store the blister pack in the outer packaging to protect it from moisture.

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.Deposit the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Voltarén Retard

• The active ingredient is diclofenac sodium. Each tablet contains 75 mg of diclofenac sodium.
• The other components (excipients) are sucrose, cetyl alcohol, anhydrous colloidal silica (E-551), povidone (E-1201), magnesium stearate (E-470b), hypromellose (E-464), polisorbate 80, titanium dioxide (E-171), iron oxide red (E-172), talc (E-553b), and polyethylene glycol 8000 (E-1521).

Appearance of Voltarén Retard and content of the packaging

Modified-release triangular, biconvex tablets, pink in color with "ID" on one side and "CG" on the other, in an Al/PVC/PE/PVDC blister, in packs of 40 tablets.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Responsible for manufacturing

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

DE-90429 Nuremberg

Germany

Last review date of this leaflet:11/2023

The 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/