Voltaren Express

Leaflet attached to the packaging: patient information

Voltaren Express, 12.5 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 their doctor.

Table of contents of the leaflet

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

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

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

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

Voltaren Express relieves symptoms of inflammation such as pain and swelling by blocking the production of molecules responsible for inflammation, pain, and fever, called prostaglandins.
Voltaren Express 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, a doctor or pharmacist should be consulted.

2. Important information before taking Voltaren Express

When not to take Voltaren Express:

• 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 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, mini-stroke (transient cerebral ischemia), or blockage of heart or brain blood vessels, or after a procedure to clear or bypass blocked blood vessels;
• if the patient has or has had circulation disorders (peripheral vascular disease);
• if the patient has or has had stomach or duodenal ulcers;
• if the patient has had or has gastrointestinal bleedingor perforationof 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 should not be taken in such cases.

Warnings and precautions

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

• the patient has had gastrointestinal disorderssuch 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 may sometimes cause delayed wound healing in the intestines after surgery;
• the patient has allergies, wheezing, shortness of breath, or nasal polyps;
• the patient has kidney or liver function disordersand in case of foot swelling;
• 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 disordersor other blood diseases, 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, blood clots, high blood pressure, high cholesterol, or high triglycerides.

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

Other warnings

• Taking medicines like Voltaren Express may be associated with a small increased risk of heart attack or stroke.
• The smallest effective dose 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 signs of hypersensitivity occur, the patient should contact their doctor and stop taking the medicine (see section 4).
• If at any time during treatment with Voltaren Express, signals or symptoms of heart or blood vessel disorders occur, such as chest pain, shortness of breath, weakness, or slurred speech, the patient should immediately contact their doctor.
• Voltaren Express may mask the symptoms of infection(e.g., headache, elevated body temperature) and make it difficult to diagnose. The doctor should be informed about taking the medicine.
• Long-term use of painkillers for headache may cause it to worsen. In such a case, the patient should contact their doctor.

Using Voltaren Express 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 in the leaflet should be followed, the smallest effective dose should be taken, and all side effects that occur during treatment should be reported to the doctor.

Children and adolescents

The use of Voltaren Express is not recommended in children and adolescents under 14 years of age.

Voltaren Express and other medicines

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

It is especially important to inform the doctor or pharmacist about taking 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 prevent blood clotting(anticoagulant and antiplatelet medicines),
• other systemic anti-inflammatory or pain medications, such as acetylsalicylic acid or ibuprofen;
• systemic corticosteroids(medicines used to reduce inflammation);
• cyclosporine and tacrolimus(medicines used in patients with transplanted organs);
• 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 colestyramine(medicines used to lower cholesterol levels).

Using Voltaren Express 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, the patient should consult their doctor or pharmacist.
If pregnant or suspected to be pregnant, the patient should inform their doctor and not take Voltaren Express. The patient should not take Voltaren Express if they are in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Voltaren Express may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the patient and the baby and prolong or delay delivery. During the first six months of pregnancy, Voltaren Express 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 should be taken for the shortest possible time. Voltaren Express taken from the 20th week of pregnancy for a period longer than a few days may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby or narrowing of the blood vessel (ductus arteriosus) 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 should not be takenin breastfeeding women, as the medicine may harm the baby.
During pregnancy and breastfeeding, before taking any medicine, the patient should consult their doctor or pharmacist.
Fertility
As with other anti-inflammatory medicines, taking diclofenac, the active substance of Voltaren Express, may make it more difficult to become pregnant. This is reversible if the medicine is stopped, but if the patient is planning a pregnancy or is having problems becoming pregnant, they should inform their doctor.

Driving and using machines

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

Voltaren Express contains sorbitol

Voltaren Express contains 10.86 mg of sorbitol in each soft capsule.

3. How to take Voltaren Express

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, the patient should consult their doctor or pharmacist.
Do 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 of age

The initial dose is 2 capsules. If necessary, 1 or 2 capsules can be taken every 4 to 6 hours. Do not take more than 6 capsules in 24 hours.
The capsule should be swallowed whole with a glass of water.
Do not take Voltaren Express 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, the patient should contact their doctor.

Taking a higher dose of Voltaren Express than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Voltaren Express

If a dose is missed, the patient should take it as soon as they remember. If it is almost time for the next dose, the patient should take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Voltaren Express can cause side effects, although not everybody gets them. If any side effects occur, including any not listed in this leaflet, the patient should consult their doctor or pharmacist.

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 –(may occur in 1 to 10 out of 1000 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 rare or very rare side effects can be serious.

If any of the following side effects are observed, the patient should stop taking the medicine and immediately contact their doctor:

• severe stomach pain, blood in the stool, black stools, bloody vomiting, bloody diarrhea;
• allergic reactions including difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, often with a skin rash, and anaphylaxis;
• sudden difficulty breathing, feeling of tightness in the chest with wheezing or coughing (symptoms indicating asthma);
• sudden difficulty breathing and feeling of heaviness in the chest with wheezing or coughing (symptoms indicating pneumonia);
• sudden and severe headache, stiffness of the neck, difficulty speaking:
• seizures;
• redness of the skin with blisters, peeling of the skin, purple spots on the skin, blisters on the mucous membranes in the mouth or eyes, skin inflammation with peeling;
• swelling of the hands, palms, feet, and ankles;
• any changes in the appearance or amount of urine, blood in the urine;
• yellowing of the skin or eyes (symptoms of liver damage and (or) liver failure), increased liver enzymes;
• bleeding, bruising, high fever, or prolonged sore throat, frequent infections, extreme pallor, weakness;
• increased sensitivity of the skin to light.

Some side effects with unknown frequency may be serious.

• Mild, painful cramps, and tenderness of the abdomen, occurring soon after starting to take Voltaren Express, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known - frequency cannot be estimated from the 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 small increased risk of heart attack (myocardial infarction) or stroke. The risk is increased when taking high doses for a long time.

If any of the above side effects are observed, the patient should stop taking Voltaren Express and immediately contact their doctor.

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, for a long time. If they are observed, the patient should contact their doctor or pharmacist.

Common

(occur in no more than 1 in 10 people taking the medicine):

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

Uncommon

(occur in no more than 1 in 1000 people taking the medicine):

• drowsiness;
• hives.

Very rare

(occur in no more 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.

If any side effects not listed in this leaflet occur, the patient should stop taking Voltaren Express and inform their doctor.

If a higher dose of the medicine than recommended is taken, the patient should inform their doctor, pharmacist, or go to the nearest emergency department. Overdose may require specialized medical care.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Voltaren Express

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.
Opaque blisters

• Do not store above 25°C.

Transparent blisters

• Do not store above 25°C.
• Store in the original packaging to protect from light.

6. Contents of the pack and other information

What Voltaren Express contains

• The active substance of the medicine is diclofenac potassium. One soft capsule contains 12.5 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 looks like and contents of the pack

10, 20, 30, or 40 soft capsules in a cardboard box.
A non-transparent, white blister pack of PVC/PVdC/Aluminum foil contains 10 soft capsules.
A transparent blister pack of PVC/PVdC/Aluminum foil contains 10 soft capsules.

Marketing authorization holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: 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: