Voltaren 100 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Voltarén 100 mg suppositories

Sodium 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, consult 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, because it may 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 Voltarén is and what it is used for
2. What you need to know before using Voltarén
3. How to use Voltarén
4. Possible side effects
5. How to store Voltarén
6. Contents of the pack and other information

1. What Voltarén is and what it is used for

Diclofenac sodium, the active substance in 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 symptomatic treatment of mild to moderate pain associated with:

• rheumatoid arthritis

• ankylosing spondylitis

• osteoarthritis

• renal colic

• acute gout attack

• menstrual pain

• musculoskeletal pain

• post-traumatic inflammation

• soft tissue rheumatism

2. What you need to know before using Voltarén

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

Do not use 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 or to other similar painkillers (analgesics). 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 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 more than one episode of stomach or duodenal ulcer or bleeding.
• if you have active Crohn's disease or ulcerative colitis (conditions causing 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), blockages in blood vessels of the heart or brain, or surgery to remove an obstruction or 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.
• if you have proctitis (inflammation of the rectum causing pain, bleeding, and occasionally mucus or pus) or rectal bleeding.

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 duration.

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 higher when high doses are used or treatment is prolonged, especially in patients with a history of peptic ulcer or in elderly patients. 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), bleeding 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 Voltarén”).
  • if you are taking medicines 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 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 inhibitors (SSRIs).
• if you have Crohn’s disease or ulcerative colitis, as medicines like 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 more than 4 weeks.
• if you have liver impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. These tests will monitor liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This will allow 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, 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 Voltarén or other painkillers.

Patients with cardiovascular problems

Medicines like Voltarén may be associated with an increased risk of heart attack ("myocardial infarction") or stroke, especially when used at high doses or 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.

In addition, this type of medicine may cause fluid retention, particularly 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 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 Voltarén

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with Voltarén; 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),
• corticosteroids (medicines that reduce inflammation and suppress the immune system),
• other medicines in 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 (used to treat stomach ulcers),
• medicines containing cholestyramine and colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain),
• an antibiotic medicine used to treat bacterial infections (rifampicin).

Use of Voltarén with food, drinks and alcohol

Consumption of alcoholic beverages while taking this medicine may increase its toxicity.

Children and adolescents

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

Elderly patients

Elderly patients, especially those who are frail or have low body weight, may be more sensitive to the effects of this medicine. It is therefore especially important that elderly patients inform their doctor immediately if they experience any adverse effects.

Pregnancy, lactation and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Do not take this medicine during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and that of your baby 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 become pregnant, 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 your 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 use this medication if you are breastfeeding.

Fertility

For patients of childbearing age, it should be considered that medications of the type Voltarén 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 while being treated with this medicinal product should avoid driving vehicles or operating machinery.

3. How to use Voltarén

Follow exactly the instructions for use of this medicine as provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

Use in adults

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

For menstrual pain, the daily dose should be individually adjusted to 50–200 mg (1 or 2 suppositories). An initial dose of 50–100 mg (1 suppository) should be given and, if necessary, increased in subsequent menstrual cycles. Treatment should begin at the onset of the first symptom. Depending on symptom severity, treatment will continue for a few days.

Method of administration

Administer rectally. If the suppository is too soft to insert, cool it in the refrigerator for a few minutes or under cold water before removing the wrapper. Do not divide the suppositories, as improper 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20.

If you forget to use Voltarén

Do not use a double dose to make up for missed doses. If you forget to insert a suppository, do so as soon as possible, unless it is almost time for the next dose; then return to your regular dosing schedule. If you miss several doses, consult your doctor.

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 beginning shortly after starting treatment with this medicine, followed by rectal bleeding or diarrhoea with blood, usually observed within 24 hours after onset of abdominal pain (frequency not known, cannot be estimated 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 spots, 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 it is a possible adverse reaction not listed in this leaflet. You may also report them directly via 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. Conservation of Voltarén

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

Do not store above 30°C. Keep in the original packaging.

Do not use this medicine after the expiry date stated on the container 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 medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Voltarén

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

• The other component is a mixture of saturated fatty acid triglycerides.

What Voltarén looks like and contents of the pack

White to yellowish suppositories.

Pack sizes 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

Date of the most recent revision of this leaflet: 10/2023

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