VOLTAREN 100 mg SUPPOSITORIES

2. What you need to know before you use Voltarén

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

Do not use 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 or other similar painkillers. Reactions may include asthma (difficulty breathing), chest pain, hives (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 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 bleeding disorders.
• if you have proctitis (inflammation of the rectum that causes pain, bleeding, and occasional mucus or pus) or rectal bleeding (bleeding from the rectum).

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 severe and 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 Voltarén").
• if you are taking medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section "Other medicines and Voltarén").

Tell 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 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 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 to monitor liver function (transaminase levels), kidney function (creatinine levels), or blood (lymphocyte, erythrocyte, and platelet levels). This will allow your doctor to decide whether to interrupt or change the dose of this medication.
• if you have recently undergone or are about to undergo stomach or intestinal surgery before using this medication, as it 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 Voltarén or other painkillers.

Patients with cardiovascular problems

Medicines like 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.

Additionally, 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 use 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 Voltarén

Tell your doctor or pharmacist if you are using, have recently used, or might use another medicine.

Certain medicines may interfere with Voltarén; in these cases, it may be necessary to change the dose or interrupt 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 cyclosporine, tacrolimus (after transplants),
• medicines containing trimethoprim (to prevent and treat urinary tract diseases),
• medicines for treating heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines for controlling blood pressure (diuretics, beta blockers, and ACE inhibitors),
• medicines to prevent blood clots,
• medicines containing quinolone or ceftriaxone (for treating infections),
• corticosteroids (medicines that reduce inflammation and the action of the immune system),
• other medicines of the same group as Voltarén (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• 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 relieving pain),
• the antibiotic medicine rifampicin (used to treat bacterial infections).

Using Voltarén with food, drinks, and alcohol

Consuming alcoholic beverages with this medication may increase its toxicity.

Children and adolescents

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

Elderly patients

Elderly patients, especially those who are frail or have a low body weight, may be more sensitive to the effects of this medication. 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 checks.

Breastfeeding

Consult your doctor or pharmacist before taking any medication.

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

Fertility

For women of childbearing age, it should be noted that medicines like Voltarén 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. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

3. How to use Voltarén

Follow exactly the administration instructions of this medicine given 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 needed, 50 mg tablets will be administered.

In 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 start when the first symptoms appear. Depending on the intensity, it will continue for a few days.

Method of administration

It should be administered rectally. If the suppository is too soft to be inserted, cool it in the refrigerator for a few minutes or with cold water before removing the wrapper. Do not divide the suppositories, as incorrect storage conditions may cause uneven distribution of the active substance. Never swallow 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 Toxicology Information Service. Telephone 91.562.04.20.

If you forget to use Voltarén

Do not use a double dose to make up for forgotten doses. If you forget to insert a suppository, do so as soon as you can, except if it is almost time for the next one; then return to your regular administration schedule. If you forget several doses, consult your doctor.

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 large, generalized red or dark spots, 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 it 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 Voltaren

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30°C. Store in the original packaging.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

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

Appearance of Voltaren and Package Contents

Suppositories are white to yellowish in color.

Packaging of 12 suppositories.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona – Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstraße 25

90429 Nuremberg

Germany

Date of Last Revision of this Prospectus:10/2023

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/