Voltaren Retard 100 mg modified-release tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Voltarén Retard 100 mg modified-release tablets

sodium diclofenac

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Voltarén Retard 100 mg is and what it is used for
2. What you need to know before taking Voltarén Retard 100 mg
3. How to take Voltarén Retard 100 mg
4. Possible adverse effects
5. How to store Voltarén Retard 100 mg
6. Contents of the pack and other information

1. What Voltarén Retard 100 mg is and what it is used for

Sodium diclofenac, the active substance in Voltarén Retard, belongs to a group of medicines known as non-steroidal 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,
• Menstrual pain,
• Post-traumatic inflammation.

2. What you need to know before taking Voltarén Retard 100 mg

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

Do not take Voltarén Retard

• if you are allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid or other similar painkillers (medicines used to treat pain). Reactions may include asthma (difficulty breathing), chest pain, urticaria (skin allergic 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 previously experienced gastrointestinal 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 on more than one occasion a stomach or duodenal ulcer or gastrointestinal bleeding.
• if you have active Crohn’s disease or active ulcerative colitis (conditions causing 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, mini-stroke (TIA), blockages in the blood vessels of the heart or brain, or surgery to remove an obstruction or to perform 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 Retard:

• 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, or even without prior warning symptoms.

This risk is greater when high doses are used or with prolonged treatment 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), haemorrhagic 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 Retard”).

  • 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 medicines, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs) (see section “Other medicines and Voltarén Retard”).

• 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 impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. This allows monitoring of liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, red blood cell, and platelet levels). This helps your doctor decide whether to stop or adjust your dose.

• if you have recently undergone or are about to undergo stomach or intestinal surgery before taking this medicine, as this medicine may sometimes impair wound healing in the intestine after surgery.

• if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking Voltarén Retard or other painkillers.

Patients with cardiovascular problems

Medicines like Voltarén Retard 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 (e.g., 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.

These types of medicines can also 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, in order 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 Retard

Tell 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 Retard; 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, 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 to control blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines used to prevent blood clots,
• medicines containing quinolone 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 (a medicine used to treat fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (used to treat stomach ulcers),
• medicines containing cholestyramine and colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain),
• an antibiotic medicine used to treat bacterial infections (rifampicin).

Taking Voltarén Retard with food, drinks, and alcohol

You may take this medicine with or without food, as food does not affect the action of this medicine.

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

Children and adolescents

The use of this medicine is not recommended in children and adolescents.

Elderly Patients

Elderly patients, especially those who are frail or have low body weight, may be more sensitive to the effects of this medication than other adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any adverse effects they experience.

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 three months of pregnancy, as it may harm the fetus or cause complications 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 beyond the expected duration. You should not take this medicine during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is required during this period or while trying to become pregnant, 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, 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 treatment for more than a few days is needed, 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

For women of childbearing age, it should be noted that medicines of the type Voltarén Retard have been associated with a reduced ability to conceive.

Driving and Use of Machines

The influence of diclofenac on the ability to drive and operate machinery is none or negligible. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while being treated with Voltarén Retard should avoid driving vehicles or operating machinery.

Voltarén Retard contains sucrose and sodium.

This medicine contains sucrose. If your doctor has advised 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; hence, it is essentially "sodium-free".

3. How to take Voltarén Retard 100 mg

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

Remember to take your medicine.

Use in adults

The usual dose for mild cases or long-term treatment is 1 tablet of 100 mg daily.

For menstrual pain, the daily dose, which should be individually adjusted, is 50–200 mg of diclofenac (1 to 2 tablets of Voltarén Retard 100 mg). An initial dose of 50–100 mg of diclofenac (1 tablet of Voltarén Retard 100 mg) should be administered, and if necessary, increased in subsequent menstrual cycles. Treatment should begin at the onset of the first symptom. Depending on symptom severity, treatment may continue for several days. For a 50 mg dose, use of Voltarén 50 mg gastro-resistant tablets is recommended, and for doses of 75 mg and 150 mg, Voltarén Retard 75 mg should be used.

Method of administration

You may take this medicine with or without food (see section “Taking Voltarén Retard with food, drink 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 Voltarén Retard than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the toxicology information service at telephone number 91.562.04.20.

If you forget to take Voltarén Retard

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

If you forget to take a dose, take it as soon as possible, unless it is almost time for your next dose; then return to your usual dosing schedule. If you forget several doses, consult your doctor.

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

If you stop treatment with Voltarén Retard

Your doctor will determine the duration of your treatment with this medicine. Do not discontinue treatment prematurely.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets 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 that begin 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 not known, cannot be estimated from the 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 large red or dark widespread spots, skin swelling, blisters and itching (generalized fixed bullous drug eruption).

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

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 Retard 100 mg

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

Do not store above 30°C. Keep the blister pack in the outer packaging to protect it from moisture.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltarén Retard

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components (excipients) are sucrose, cetyl alcohol, anhydrous colloidal silica (E-551), povidone (E-1201), magnesium stearate (E-470b), hypromellose (E-464), polysorbate 80, titanium dioxide (E-171), red iron oxide (E-172), talc (E-553b), and polyethylene glycol 8000 (E-1521).

Appearance of Voltarén Retard and contents of the pack

Modified-release round tablets, pink in color, marked with "CG" on one side and "CGC" on the other, packed in Al/PVC/PE/PVDC blisters, in packs of 20 tablets.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Manufacturer Responsible for Batch Release

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

Date of the 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/