Dolo-Voltaren 46.5 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dolo-Voltarén 46.5 mg dispersible tablets

Diclofenac

Read the entire leaflet carefully before you start taking this medicine.

• 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolo-Voltarén is and what it is used for

Diclofenac sodium, the active ingredient in Dolo-Voltarén, belongs to a group of medicines known as non-steroidal anti-inflammatory drugs, used to treat pain and inflammation. This medicine is used for the short-term treatment of acute inflammatory and painful conditions following trauma or surgery.

2. What you need to know before taking Dolo-Voltarén

It is important to use the smallest 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 Dolo-Voltarén

• 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 (aspirin) or to other similar painkillers (analgesics). 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 limbs (signs of angioedema). If you think you may be allergic, consult your doctor.
• if you have previously had a stomach or duodenal bleed, or have experienced 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 have 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 the blood vessels of the heart or brain, or surgery to remove an obstruction or to perform a coronary bypass.
• if you have or have had problems with blood circulation (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 time.

Warnings and precautions

• 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, with prolonged treatment, in patients with a history of peptic ulcer, and in the elderly. In such 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 (hypertension), haemorrhagic disorders or other blood disorders including hepatic porphyria.

• if you are taking other anti-inflammatory medicines, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of gastrointestinal ulcer and/or bleeding (see section “Other medicines and Dolo-Voltarén”).

• if you are taking medicines for high blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and Dolo-Voltarén”).

Tell your doctor before taking Dolo-Voltarén

• if you are simultaneously 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 corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• if you have Crohn’s disease or ulcerative colitis, as medicines like Dolo-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. These will monitor liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet counts). 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 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 Dolo-Voltarén or other painkillers.

Patients with cardiovascular problems

Medicines such as Dolo-Voltarén may be associated with an increased risk of heart attack ("myocardial infarction") or stroke, especially when used at high doses and 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, if you have 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, particularly 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 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 Dolo-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 this medicine; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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 conditions (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 immune system activity),
• 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),
• antibiotic medicine used to treat bacterial infections (rifampicin).

Taking Dolo-Voltarén with food, drinks, and alcohol

This medicine should preferably be taken before meals or on an empty stomach, as food reduces its absorption.

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

Children and adolescents

This medicine is not recommended for use 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 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

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Do not take this medicine during the last 3 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 also affect your own 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 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is required during this period or while trying to conceive, the lowest possible dose should be used 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 the fetus, which could 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 longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Fertility

For patients of childbearing age, it should be considered that medications of the diclofenac type 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 during treatment with this medication should avoid driving vehicles or operating machinery.

Dolo-Voltarén contains sodium

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

3. How to take Dolo-Voltarén

Follow exactly the administration instructions for 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 milder cases, 2 tablets a day are usually sufficient. 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.

Method of administration

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

The tablets must be dissolved in a glass of water. Place one tablet into a glass of water and stir. Once dissolved, drink the liquid. If any residue remains in the glass, add more water and repeat the process.

If you take more Dolo-Voltarén than you should:

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

If you forget to take Dolo-Voltarén

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

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 to palpation 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 not known, cannot be determined 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 widespread red or dark 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 they are possible adverse reactions 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 Dolo-Voltarén

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

Do not store above 25°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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolo-Voltarén

• The active substance is diclofenac. Each tablet contains 46.5 mg of diclofenac in free acid form, equivalent to 50 mg of sodium diclofenac.
• The other components are microcrystalline cellulose (E-460), sodium carboxymethyl starch (potato starch), sodium carmellose (E-469), colloidal siliconic acid (E-551), hydrogenated castor oil, talc (E-533b).

Appearance of Dolo-Voltarén and contents of the pack
Dispersible, triangular biconvex white tablets marked with "V" on one side and "CG" on the other, 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

Novartis Pharma GmbH
Roonstrasse 25, Gostenhof
Nuremberg, Bavaria, 90429
Germany

or

Novartis Farmaceutica, S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona – Spain

Spain

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

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