Label: information for the user

Voltarén 100 mg suppositories

Diclofenaco sódico

Read this label carefully before starting to take this medication.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Voltarén and what is it used for

2. What you need to know before starting to use Voltarén

3. How to use Voltarén

4. Possible adverse effects

5. Storage of Voltarén

6. Contents of the package and additional information

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

This medication is used for the symptomatic treatment of mild to moderate pain associated with:

• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis

• Renal colic
• Acute gout attack
• M menstrual cramps
• Musculoskeletal pain

• Post-traumatic inflammation

-Soft tissue rheumatism

It is essential to use the smallest effective dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Do not use 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 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 stomach or duodenal hemorrhage, or have experienced 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 stomach or duodenal ulcers.
• 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 circulation problems (peripheral arterial disease)
• if you are in the third trimester of pregnancy.
• if you have blood clotting disorders.
• if you have proctitis (inflammation of the rectum that causes pain, bleeding, and occasionally mucus or pus) or rectal hemorrhage (bleeding through the rectum).

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, or 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 ulcers and/or gastrointestinal bleeding (see section “Other medications and Voltarén”).

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

Inform your doctor

-if you are taking medications that alter blood clotting 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.

-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 blood 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 a surgical procedure on the stomach or intestine before using this medication, as it may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Medications like Voltarén 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.

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 use the lowest effective dose of this medication for the shortest possible time to relieve 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

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

Certain medications may interact with Voltarén; 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 lithiumor selective serotonin reuptake inhibitors (for treating certain types of depression),
• medications containing methotrexate (for treating rheumatoid arthritis and cancer),
• medications containing ciclosporin, tacrolimus(for after transplants),
• medications containing trimethoprim (for preventing and treating urinary tract diseases),
• medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medications used to treat diabetes, except for insulin,
• medications for controlling blood pressure(diuretics, beta blockers, and ACE inhibitors),
• medications for preventing blood clots,
• medications containing quinolone or ceftriaxone (for treating infections),
• corticosteroids (medicationsthat reduce inflammation and the action of the immune system),
• other medications in the same group as Voltarén (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• medications containing voriconazole (a medication used in the treatment of fungal infections),
• medications containing phenytoin (a medication used to treat seizures),
• medications containing misoprostol (for treating stomach ulcers),
• medications containing cholestyramine and colestipol (for lowering cholesterol levels in the blood),
• medications containing pentazocine (for relieving pain),
• antibiotic medication used to treat bacterial infections (rifampicin).

Use of Voltarén with food, drinks, and alcohol

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

Children and adolescents

This medication is not recommended for use in 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. 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 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

Consult your doctor or pharmacist before using any medication.

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

Fertility

For women of childbearing age, it is essential to consider that medications like Voltarén 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.

Follow exactly the administration instructions for this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication.

Use in adults

The recommended dose is 1 suppository once a day, at bedtime. If higher doses are necessary, 50 mg tablets will be administered.

For menstrual cramps, the daily dose, which should be adjusted individually, is 50-200 mg (1 or 2 suppositories). An initial dose of 50-100 mg (1 suppository) 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.

Administration form

It should be administered rectally. If the suppository is too soft to be inserted, refrigerate it for a few minutes or soak it in cold water before removing the wrapper. Do not divide the suppositories, as incorrect storage conditions may cause uneven distribution of the active substance. Never ingest the suppositories.

If you use more Voltarén than 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 use Voltarén

Do not use a double dose to compensate for the missed doses.If you forget to apply a suppository, apply it as soon as possible, except if it is almost time for the next one; then return to the usual administration schedule. If you forget several doses, consult your doctor.

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 unknown frequency, cannot be determined from available data).

Chest pain, which can be a sign of a potentially serious 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 Pharmacovigilance of Medicines 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 above30°C. Store in the original packaging.

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

Composition ofVoltarén

• The active ingredient is diclofenac sodium. Each suppository contains 100 mg of diclofenac sodium.

• The other components are a mixture of saturated fatty acid triglycerides.

Appearance of Voltarén and content of the container

White to yellowish suppositories.

Containers of 12 suppositories.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Responsible for Manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Date of the last review of this leaflet:10/2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/