DOLO-VOLTAREN 46.5 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Dolo-Voltarén 46.5 mg Dispersible Tablets

Diclofenac

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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 Package Leaflet

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

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

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

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

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

Do not take Dolo-Voltarén

• 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 similar painkillers. Reactions may include asthma (difficulty breathing), chest pain, hives (allergic reaction on the skin 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 bleeding or have suffered from two or more episodes of perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• if you currently have or have had more than one episode of stomach or duodenal ulcers 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, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass.
• if you have had 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

• if you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, even without prior warning symptoms.

This risk is higher when high doses and prolonged treatments are used in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• if you have 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 other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see section "Other medicines and Dolo-Voltarén").
• if you are taking medications for blood pressure or cyclosporin, 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 taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• if you have Crohn's disease or ulcerative colitis, as medications like Dolo-Voltarén may worsen these conditions.
• if you have high blood pressure, high cholesterol or triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with this medication, 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 frequent blood tests during treatment. This will allow your doctor to monitor the functioning of your liver (transaminase levels) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels), and decide whether to interrupt or change the dose of this medication.
• if you have recently undergone or are going to undergo stomach or intestinal surgery before taking this medication, as this medication may sometimes worsen the healing of intestinal wounds after surgery.
• if you have ever had a severe skin rash or skin peeling, blisters, or sores in the mouth after taking Dolo-Voltarén or other painkillers.

Patients with Cardiovascular Problems

Medicines like Dolo-Voltarén may be associated with an increased risk of heart attacks ("myocardial infarction") or strokes, especially when used in high doses and for prolonged treatments. 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 of having them (for example, you have high blood pressure, diabetes, high cholesterol or triglycerides, or are a smoker), and your doctor decides to treat you with this medication, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks. Also, this type of medication 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 medication for the shortest possible time that relieves your 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 medication, contact your doctor immediately.

Other Medicines and Dolo-Voltarén

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

Certain medicines may interfere with this medicine; 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 serotonin reuptake inhibitors (for treating certain types of depression),
• medicines containing methotrexate (for treating rheumatoid arthritis and cancer),
• medicines containing cyclosporin, tacrolimus (after transplants),
• medicines containing trimethoprim (to prevent and treat urinary tract diseases),
• medicines for heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines to control blood pressure (diuretics, beta blockers, and ACE inhibitors),
• medicines to prevent blood clots,
• medicines containing quinolone or ceftriaxone (for treating infections),
• other medicines of the same group as Voltarén (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 to treat fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (for treating stomach ulcers),
• medicines containing cholestyramine and colestipol to decrease blood cholesterol levels),
• medicines containing pentazocine (for pain relief),
• antibiotic medicine used to treat bacterial infections (rifampicin).

Taking Dolo-Voltarén with Food, Drinks, and Alcohol

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

Consuming alcoholic beverages with the use of this medication may increase its toxicity.

Children and Adolescents

The use of this medication 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 medication than other adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any side effects that occur.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

Consult your doctor or pharmacist before taking any medication.

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 labor more than expected. You should not take this medication during the first 6 months of pregnancy unless it is 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 it for more than a few days from the 20th week of pregnancy, this medication may cause kidney problems in your fetus, 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

Consult your doctor or pharmacist before taking any medication.

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

Fertility

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

Driving and Using Machines

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

Dolo-Voltarén contains Sodium

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

3. How to Take Dolo-Voltarén

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in Adults and Adolescents over 14 years

In milder cases, 2 tablets a day are usually sufficient. 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.

Method of Administration

Take this medicine preferably before meals or on an empty stomach (see section "Taking Dolo-Voltarén with Food, Drinks, and Alcohol").

The tablets should be dissolved in a glass of water. Put one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any 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 Toxicology Information Service. Telephone 91.562.04.20.

If you forget to take Dolo-Voltarén

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

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 inform your doctor immediately 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 Dolo-Voltarén

Keep this medicine out of 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. 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

Composition of Dolo-Voltarén

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

Appearance of Dolo-Voltarén and Package ContentsDispersible tablets, triangular and biconvex, white in color with "V" on one side and "CG" on the other, in Al/PVC/PE/PVDC blisters, in packages 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

Date of Last Revision of this Prospectus:

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/