Voltaren Express Forte

Leaflet accompanying the packaging: patient information

Voltaren Express Forte, 25 mg, soft capsules

Diclofenac potassium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days for pain or 3 days for fever there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Voltaren Express Forte and what is it used for
• 2. Important information before taking Voltaren Express Forte
• 3. How to take Voltaren Express Forte
• 4. Possible side effects
• 5. How to store Voltaren Express Forte
• 6. Contents of the packaging and other information

1. What is Voltaren Express Forte and what is it used for

Voltaren Express Forte contains the active substance diclofenac potassium, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). It acts as a pain reliever and anti-inflammatory, and also reduces fever.

Voltaren Express Forte is used:

• for muscle pain, rheumatic pain, acute lower back pain (back pain), headache, toothache, painful menstruation;
• to treat symptoms of flu and colds (generalized pain, fever), sore throat.

Voltaren Express Forte relieves symptoms of inflammation such as pain and swelling by blocking the synthesis of molecules responsible for inflammation, pain, and fever, called prostaglandins.

Voltaren Express Forte does not affect the causes of inflammation and fever.

The medicine in the form of soft capsules acts faster than in the form of tablets.

In case of doubts about the action of Voltaren Express Forte, a doctor or pharmacist should be consulted.

2. Important information before taking Voltaren Express Forte

When not to take Voltaren Express Forte:

• if the patient is allergic to diclofenacor to any of the other ingredients of this medicine(listed in section 6);
• if the patient has ever had allergic reactions to pain, inflammation, or fever medications,or if the patient thinks they may be allergic to diclofenac, ibuprofen, or acetylsalicylic acid (a medicine also used to reduce blood clotting) or any other NSAID. Symptoms of hypersensitivity include asthma attacks, wheezing, facial and lip swelling (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reactions. In case of doubts, a doctor or pharmacist should be consulted;
• if the patient has been diagnosed with heart disease and (or) cerebrovascular disease, such as after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or occlusion of cardiac or cerebral blood vessels, or after a procedure to clear or bypass blocked blood vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease);
• if the patient has or has had stomach or duodenal ulcers;
• if the patient has had or has gastrointestinal bleedingmanifested by the presence of blood in the stool or black stool, or perforation (perforation) of the digestive tract;
• if the patient has severe kidney or liver failure;
• in women in the third trimester of pregnancy.

The doctor or pharmacist should be informed about the occurrence of these conditions, as Voltaren Express Forte should not be taken in such cases.

Warnings and precautions

Before starting to take Voltaren Express Forte, the patient should discuss it with their doctor or pharmacist if:

• the patient has had gastrointestinal disorders in the past, such as stomach or duodenal ulcers, gastrointestinal bleeding, or black stools;
• the patient has had stomach problems or heartburn after taking pain or anti-inflammatory medications;
• the patient has intestinal disorders;
• the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as Voltaren Express Forte may sometimes cause impaired wound healing in the intestines after surgery;
• the patient has allergies, wheezing, shortness of breath, and nasal polyps;
• the patient has kidney or liver function disorders, as well as swelling of the feet;
• the patient is taking other anti-inflammatory or pain medications;
• the patient has or has had heart problems;
• the patient is at risk of dehydration(due to e.g., diarrhea, other illness, as well as before or after surgery);
• the patient has bleeding or blood disorders, including rare porphyria.

Before taking the medicine, the doctor or pharmacist should be informed:

• •if the patient smokes;
• •if the patient has diabetes;
• •if the patient has angina pectoris, thrombosis, high blood pressure, high cholesterol, or high triglycerides.

The occurrence of side effects can be limited by taking the medicine in the smallest effective dose and for no longer than necessary.

Other warnings

• Taking medicines like Voltaren Express Forte may be associated with a slight increase in the risk of heart attack or stroke.
• The smallest effective dose of the medicine should be taken for the shortest possible time.
• Severe skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported in association with the use of NSAIDs. The greatest risk of these severe reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine. If the first symptoms of a skin rash, mucosal damage, or other symptoms of hypersensitivity occur (see section 4), the doctor should be contacted and the medicine should be discontinued.
• If at any time during the use of Voltaren Express Forte, signals or symptoms of cardiovascular or cerebrovascular disorders occur, such as chest pain, shortness of breath, weakness, or slurred speech, the doctor should be contacted immediately.
• Voltaren Express Forte may mask infection symptoms(e.g., headache, elevated body temperature) and make it difficult to diagnose. The doctor should be informed about the use of the medicine.
• Long-term use of pain medications for headache may cause its worsening. In such a case, the doctor should be contacted.

Using Voltaren Express Forte in the elderly

As with other pain medications, elderly people may react more strongly to the action of the medicine compared to adults. The recommendations contained in the leaflet should be followed, the smallest effective doses should be taken, and all side effects occurring during treatment should be reported to the doctor.

Children and adolescents

The use of the medicine is not recommended in children and adolescents under the age of 14.

Voltaren Express Forte and other medicines

The doctor or pharmacist should be told about all medicines currently being taken by the patient or recently taken, as well as any medicines the patient plans to take.

It is especially important to inform the doctor or pharmacist about the use of the following medicines:

• lithium or antidepressant medicines(medicines used to treat depression);
• digoxin(a medicine used to treat heart conditions);
• ACE inhibitors or beta-blockers(medicines used to treat high blood pressure or heart failure);
• methotrexate(a medicine used to treat certain cancers or arthritis);
• oral diabetes medications;
• diuretics(medicines that increase urine production);
• medicines that reduce blood clotting(anticoagulant and antiplatelet medicines);
• other systemic anti-inflammatory or pain medications, such as acetylsalicylic acid or ibuprofen;
• systemic corticosteroids(medicines used to treat inflammation);
• cyclosporine or tacrolimus(medicines used in organ transplant patients);
• trimethoprim(a medicine used to prevent or treat urinary tract infections);
• quinolone antibacterials(medicines used to treat infections);
• sulfinpyrazone(a medicine used to treat gout) or voriconazole(a medicine used to treat fungal infections);
• phenytoin(a medicine used to treat epilepsy);
• colestipol or cholestyramine(medicines used to lower cholesterol levels).

Using Voltaren Express Forte with food and drink

The capsule should be swallowed whole, preferably during or after a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

Pregnancy

Before taking Voltaren Express Forte, a doctor or pharmacist should be consulted.

In case of pregnancy or suspected pregnancy, the doctor should be informed and the medicine should not be taken.

Voltaren Express Forte should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Voltaren Express Forte may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and the child and cause delayed or prolonged delivery. During the first six months of pregnancy, Voltaren Express Forte should not be taken unless the doctor considers it absolutely necessary. If treatment during the first six months or while trying to conceive is necessary, the smallest effective dose of the medicine should be taken for the shortest possible time. Voltaren Express Forte taken from the 20th week of pregnancy for a period longer than a few days may cause kidney problems in the unborn child, which may lead to oligohydramnios (low amniotic fluid level around the baby) or narrowing of the ductus arteriosus (a blood vessel in the baby's heart). If treatment for a longer period than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding

Voltaren Express Forte should not be takenin breastfeeding women, as the medicine may have a harmful effect on the infant.

During pregnancy and breastfeeding, before taking any medicine, a doctor or pharmacist should be consulted.

Fertility

As with other anti-inflammatory medications, taking diclofenac, the active substance of Voltaren Express Forte, may make it difficult to conceive. This is reversible if the medicine is stopped, but if the patient plans to conceive or has difficulty conceiving, they should inform their doctor.

Driving and operating machinery

Usually, Voltaren Express Forte does not affect the ability to drive vehicles and operate machinery. However, as with other nonsteroidal anti-inflammatory drugs, after taking Voltaren Express Forte, some people may experience vision disturbances or dizziness. If such side effects occur, the patient should not drive vehicles or operate machinery.

Voltaren Express Forte contains sorbitol

Voltaren Express Forte contains 19 mg of sorbitol in each soft capsule.

3. How to take Voltaren Express Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

In case of doubts, a doctor or pharmacist should be consulted.

The patient should not take a higher dose than recommended. It is important to take the smallest effective dose of the medicine for the shortest possible time.

Adults and adolescents over 14 years old

Initially, 1 capsule. The dose can be repeated after 4-6 hours. No more than 3 capsules should be taken in 24 hours.

The capsule should be swallowed whole with a glass of water.

Voltaren Express Forte should not be taken without consulting a doctor for more than 5 days for pain or longer than 3 days for fever. If symptoms worsen or do not improve, a doctor or pharmacist should be contacted.

Taking a higher dose of Voltaren Express Forte than recommended

In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be contacted immediately.

Missing a dose of Voltaren Express Forte

In case of missing a dose, it should be taken as soon as the patient remembers. If there is not much time left before the next dose, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

4. Possible side effects

Like all medicines, Voltaren Express Forte can cause side effects, although not everybody gets them.

If any side effects occur, including any not listed in this leaflet, a doctor or pharmacist should be consulted.

Some side effects can be serious

Some side effects occur not very often, especially when taking high doses (150 mg per day) and for a long time.

Uncommon –(occurring in less than 1 in 100 people taking the medicine):

• palpitations, sudden and crushing chest pain (symptoms of a heart attack, also known as a myocardial infarction);
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (symptoms of heart failure).

Some side effects, including rare or very rare ones, can be serious.

In case of observing any of the following side effects, the medicine should be discontinued and a doctor should be contacted immediately:

• severe stomach pain, blood in the stool, black stools, bloody vomiting, bloody diarrhea;
• allergic reactions involving difficulty breathing or swallowing, facial, lip, tongue, or throat swelling, often with accompanying skin rash, anaphylaxis;
• sudden breathing difficulties and a feeling of pressure in the chest with wheezing or coughing (symptoms indicating asthma);
• sudden breathing difficulties and a feeling of heaviness in the chest with wheezing or coughing (symptoms indicating pneumonia);
• sudden and severe headache, neck stiffness, difficulty speaking;
• seizures;
• skin redness with blisters, skin peeling, purple skin changes, blisters on the mucous membrane in the mouth or around the eyes, skin inflammation with peeling;
• swelling of the hands, palms, feet, and legs;
• any changes in the appearance or amount of urine, blood in the urine;
• jaundice (symptoms of liver damage and/or liver failure), increased liver enzyme levels;
• bleeding, bruising, high fever, or prolonged sore throat, frequent infections, extreme pallor, weakness;
• increased skin sensitivity to sunlight.

Some side effects with unknown frequency may be serious.

• Mild, painful abdominal cramps and tenderness, occurring soon after starting to take Voltaren Express Forte, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - frequency cannot be estimated from available data).
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Taking medicines like diclofenac may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke. The risk is increased when taking high doses for a long time.

In case of observing any of the above side effects, the use of Voltaren Express Forte should be discontinued and a doctor should be contacted immediately.

Other side effects

Side effects that may occur are usually mild. Some side effects have been observed after taking higher doses of diclofenac, the active substance of Voltaren Express Forte, for a long time. In case of observing them, a doctor or pharmacist should be contacted.

Common

(occurring in less than 1 in 10 people taking the medicine):

• stomach pain, diarrhea, nausea, bloating, vomiting, indigestion, decreased appetite;
• increased liver enzyme activity;
• headache, dizziness;
• rash.

Rare

(occurring in less than 1 in 1000 people taking the medicine):

• drowsiness;
• hives.

Very rare

(occurring in less than 1 in 10,000 people taking the medicine):

• constipation, oral thrush, swelling, redness, and pain of the tongue, taste disorders, abdominal cramps;
• tingling or numbness of the hands or feet, tremors;
• itching and redness of the skin, hair loss;
• blurred vision, double vision, ringing in the ears, hearing disorders;
• mood changes, difficulty sleeping, feeling disoriented;
• high blood pressure, vasculitis.

In case of observing side effects not listed in this leaflet, the use of Voltaren Express Forte should be discontinued and a doctor should be informed.

In case of taking a higher dose of the medicine than recommended, a doctor, pharmacist, or the nearest emergency department should be contacted. Poisoning may require specialized medical care.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, a doctor, pharmacist, or nurse should be informed.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Voltaren Express Forte

The medicine should be stored out of sight and reach of children.

Do not store above 30°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Voltaren Express Forte contains

• The active substance of the medicine is diclofenac potassium. One capsule contains 25 mg of diclofenac potassium.
• Other ingredients are: macrogol 600, glycerol 85%, purified water. Capsule ingredients: gelatin, glycerol 85%, Anidrisorb 85/70, 85% solution, quinoline yellow 70% (E 104), medium-chain triglycerides.

What Voltaren Express Forte looks like and contents of the pack

10 or 20 soft capsules.

Marketing authorization holder

Haleon Poland Sp. z o.o.

ul. Rzymowskiego 53

02-697 Warsaw

tel. 800 702 849

Manufacturer

Catalent Germany Eberbach GmbH

Gammelsbacher Strasse 2

D-69412 Eberbach/Baden Germany

Importer

Haleon Germany GmbH

Barthstrasse 4

80339 Munich

Germany

Date of last revision of the leaflet: