Leaflet: information for the user

Dolo-Voltarén 46.5 mg dispersible tablets

Diclofenac

Read this 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. 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. This includes any possible side effects not listed in this leaflet.See section 4.

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

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

3. How to take Dolo-Voltarén

4. Possible side effects

5. Storage of Dolo-Voltarén

6. Contents of the pack and additional information

Sodium diclofenac, the active ingredient ofDolo-Voltarén belongs to a group of medications called nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation. This medication is used as a short-term treatment for acute inflammatory and painful post-traumatic and postoperative conditions.

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 Dolo-Voltarén

• 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 (aspirin) or other analgesics (pain medications) similar to it. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (allergic reaction on the skin 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 from two or more instances of a perforated digestive tract while taking a nonsteroidal anti-inflammatory medication.
• if you currently have or have had more than one instance of a stomach or duodenal ulcer.
• if you have 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 or have had peripheral arterial disease (circulation problems).
• if you are in the third trimester of pregnancy.
• if you have bleeding disorders.

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

The adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Warnings and precautions

-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 treatment 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 medication.

• if you have 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 other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as it increases the risk of stomach ulcers and/or gastrointestinal bleeding (see section “Other medications and Dolo-Voltarén”).

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

Inform your doctor

-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 inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

-if you have Crohn's disease or ulcerative colitis, as Dolo-Voltarén-type medications may worsen these conditions.

-if you have high blood pressure, high cholesterol, high 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 undergo 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 a surgical procedure on the stomach or intestine before taking this medication, as it may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Dolo-Voltarén-type medications 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 period to alleviate pain and/or inflammation and 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 Dolo-Voltarén

Inform your doctor or pharmacist if you are using, have used recently, or may need to use another medication.

Certain medications may interact with this medication; 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 infections
• medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine)
• medications used to treat diabetes, except for insulin
• medications for high 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) such as 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 colestiramine and colestipol to lower cholesterol levels
• medications containing pentazocine for pain relief
• antibiotic medications used to treat bacterial infections (rifampicin)

Taking Dolo-Voltarén with food, drinks, and alcohol

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

The consumption of alcoholic beverages with this medication may increase its toxicity.

Children and adolescents

This medication is not recommended for children and adolescents under 14 years old.

Older adults

Older adults, especially the more fragile or underweight, may be more sensitive to the effects of this medication than the rest of adults. Therefore, it is especially important for older adults to inform their doctor immediately about any adverse effects they experience.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using 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 and your baby's tendency 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 period. 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

Consult your doctor or pharmacist before using any medication.

Small amounts of diclofenac may appear in breast milk, so you should not take this medication while breastfeeding.

Fertility

For fertile women, it is essential to consider that diclofenac-type medications 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 this medication should avoid driving vehicles or operating machinery.

Dolo-Voltarén contains sodium

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. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in adults and adolescents over 14 years old

In mild cases, 2 tablets per day are usually sufficient. Do not exceed a dose of 3 tablets (150 mg of diclofenac) per day. The total daily dose should be divided into 2 or 3 fractional doses.

Administration Form

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

The tablets must be dissolved in a glass of water. Place one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remaining particles in the glass, add more water and repeat the process.

If you take more Dolo-Voltarénthan you should:

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

If you forgot to takeDolo-Voltarén

Do not take a double dose to compensate for the missed doses.

Like all medicines,this medicinecan 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 unknown frequency, 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 as follows:

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 Vigilance 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.

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

Do not store at a temperature above25°C.

Storethe blisterin 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 Dolo-Voltarén

-The active ingredient is diclofenac. Each tablet contains 46.5 mg of diclofenac, in the form of the free acid, corresponding to 50 mg of diclofenac sodium.

-The other components are microcrystalline cellulose (E-460), sodium carboxymethyl starch (potato starch), sodium carmellose (E-469), colloidal silicon dioxide (E-551), hydrogenated ricin oil, talc (E-533b).

Appearance ofDolo-Voltarénand content of the packagingDispersible tablets, triangular biconvex of white color with “V” on one side and “CG” on the other, in Al/PVC/PE/PVDC blister, in packs of 20 tablets.

Holder of the marketing authorization

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona - Spain

Responsible for manufacturing

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 the last review 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/