Voltaren express

Patient Information Leaflet: Information for the Patient

Voltaren Express, 12.5 mg, soft capsules
Diclofenacum kalicum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If, after 5 days for pain or 3 days for fever, there is no improvement or if your condition worsens, you should contact your doctor.

Table of Contents

1. What Voltaren Express is and what it is 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 package and other information

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

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

• for muscle pain, rheumatic pain, acute lower back pain (backache), headache, toothache, and painful menstruation;
• for the treatment of symptoms of flu and cold (pain, fever), and sore throat.

Voltaren Express relieves inflammatory symptoms such as pain and swelling by blocking the synthesis of molecules responsible for inflammation, pain, and fever, known as prostaglandins.
Voltaren Express does not affect the underlying causes of inflammation or fever.
The soft capsule formulation of this medicine acts faster than the tablet form.
If you have any doubts regarding the action of Voltaren Express, please consult your doctor or pharmacist.

2. Important information before using Voltaren Express

When not to use Voltaren Express:

• if the patient is allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever experienced allergic reactions to medicines used to treat pain, inflammation or fever, or if the patient suspects they may be allergic to diclofenac, ibuprofen, or acetylsalicylic acid (a medicine also used to reduce blood clotting) or any other medicine in the NSAID group. Symptoms of hypersensitivity include asthma attacks, wheezing, facial or lip swelling (angioedema), breathing difficulties, chest pain, runny nose, rash, or any other allergic-type reactions. If in doubt, consult a doctor or pharmacist;
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after a heart attack, stroke, mini-stroke (transient ischaemic attack), or arterial blockage in the heart or brain, or following a procedure to unblock or bypass blocked blood vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease);
• if the patient has or has had peptic ulcer disease of the stomach and/or duodenum;
• if the patient has had or currently has gastrointestinal bleeding, manifested by blood in the stool or black stools, or gastrointestinal perforation (a hole in the digestive tract);
• if the patient has severe kidney or liver failure;
• in women during the third trimester of pregnancy.

Inform your doctor or pharmacist if any of the above conditions apply, as Voltaren Express should not be used in such cases.
Warnings and precautions
Before starting to use Voltaren Express, discuss with your doctor or pharmacist if:

• the patient has previously experienced gastrointestinal disorders, such as peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, or black stools;
• the patient has experienced stomach discomfort or heartburn after taking pain-relieving or anti-inflammatory medicines;
• the patient has intestinal disorders;
• the patient has recently undergone or is scheduled for stomach or gastrointestinal surgery, as Voltaren Express may sometimes impair wound healing in the intestines after surgery;
• the patient has allergies, wheezing, shortness of breath, or nasal polyps;
• the patient has impaired kidney or liver function or swelling of the feet;
• the patient is taking other anti-inflammatory or pain-relieving medicines;
• the patient has or has had heart problems in the past;
• the patient is at risk of dehydration (due to, for example, diarrhoea, another illness, or before or after surgical procedures);
• the patient has bleeding disorders or other blood diseases, including rare hepatic porphyria;
• the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Voltaren Express or other pain-relieving medicines.

Before taking the medicine, inform your doctor or pharmacist:

• if the patient smokes;
• if the patient has diabetes;
• if the patient has angina pectoris, blood clots, hypertension, high cholesterol, or high triglyceride levels.

The risk of adverse effects can be minimized by using the medicine at the lowest effective dose and for the shortest duration necessary.
Other warnings

• Taking medicines such as Voltaren Express may be associated with a small increased risk of heart attack or stroke.
• Use the lowest effective dose for the shortest possible time.
• Severe skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported with NSAIDs. The highest risk of these severe reactions occurs early in treatment, usually within the first month of use. Contact a doctor and discontinue use immediately if the first signs of skin rash, mucosal lesions, or other hypersensitivity symptoms occur (see section 4).
• If at any time during treatment with Voltaren Express symptoms suggestive of heart or blood vessel problems occur, such as chest pain, shortness of breath, weakness, or slurred speech, seek immediate medical attention.
• Voltaren Express may mask symptoms of infection (e.g. headache, elevated body temperature), making diagnosis more difficult. Inform your doctor about using this medicine.
• Prolonged use of pain-relieving medicines for headache may worsen the condition. In such cases, consult a doctor.

Use of Voltaren Express in elderly patients
As with other pain-relieving medicines, elderly individuals may be more sensitive to the effects of the medicine compared to younger adults. Follow the instructions in the leaflet, use the lowest effective doses, and report any adverse effects to your doctor.
Children and adolescents
Use of Voltaren Express is not recommended in children and adolescents under 14 years of age.
Voltaren Express and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
It is especially important to inform your doctor or pharmacist if the patient is taking any of the following medicines:

• lithium or antidepressants (medicines used to treat depression);
• digoxin (a medicine used to treat heart conditions);
• ACE inhibitors or beta-blockers (medicines used to treat hypertension or heart failure);
• methotrexate (a medicine used to treat certain cancers or rheumatoid arthritis);
• oral antidiabetic medicines;
• diuretics (medicines that increase urine output);
• anticoagulant or antiplatelet medicines (medicines that prevent blood clotting);
• other systemic anti-inflammatory or pain-relieving medicines, such as acetylsalicylic acid or ibuprofen;
• systemic corticosteroids (medicines used to reduce inflammation);
• cyclosporine and tacrolimus (medicines used in organ transplant recipients);
• trimethoprim (a medicine used to prevent and treat urinary tract infections);
• quinolone antibiotics (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).

Taking Voltaren Express with food and drink
Swallow the capsule whole, preferably during or after a meal, with water.
Pregnancy, breastfeeding and fertility
Pregnancy
Before using Voltaren Express, consult a doctor or pharmacist.
If pregnant or suspecting pregnancy, inform your doctor and do not use Voltaren Express. Do not take Voltaren Express during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Voltaren Express may cause kidney and heart problems in the unborn child. It may increase the tendency to bleed in both the mother and the child and may delay or prolong labour. Voltaren Express should not be used during the first six months of pregnancy unless a doctor considers it absolutely necessary. If treatment during the first six months of pregnancy or while trying to conceive is required, use the lowest possible dose for the shortest possible time. Voltaren Express taken from the 20th week of pregnancy for longer than a few days may cause kidney problems in the unborn child, potentially leading to oligohydramnios (low amniotic fluid levels) or narrowing of the 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
Do not use Voltaren Express during breastfeeding, as it may have harmful effects on the infant.
During pregnancy and breastfeeding, consult a doctor or pharmacist before using any medicine.
Fertility
Like other anti-inflammatory medicines, use of diclofenac, the active substance in Voltaren Express, may impair fertility. This effect is reversible upon discontinuation of the medicine; however, if the patient is planning pregnancy or experiencing difficulty conceiving, they should inform their doctor.
Driving and operating machinery
Generally, Voltaren Express does not affect the ability to drive or operate machinery. However, as with other non-steroidal anti-inflammatory drugs, some individuals may experience visual disturbances or dizziness after taking Voltaren Express. If such adverse effects occur, do not drive or operate machinery.
Voltaren Express contains sorbitol
Voltaren Express contains 10.86 mg of sorbitol in each soft capsule.

3. How to use Voltaren Express

This medicine should always be taken exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not take more than the recommended dose. It is important to take the lowest effective dose for the shortest possible duration.
Adults and adolescents over 14 years of age
The initial dose is 2 capsules. If necessary, 1 or 2 capsules may be taken every 4 to 6 hours. Do not take more than 6 capsules in any 24-hour period.
The capsule should be swallowed whole with a glass of water.
Do not use Voltaren Express for more than 5 days for pain relief or more than 3 days for fever relief without consulting a doctor. If symptoms worsen or persist, consult a doctor.
Taking more Voltaren Express than recommended
If more medicine has been taken than recommended, seek immediate advice from a doctor or pharmacist.
Missed dose of Voltaren Express
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any side effects occur, including any possible side effects not listed in this leaflet, consult a doctor or pharmacist.
Some side effects may be serious
Some side effects occur infrequently, especially when high doses (150 mg per day) are used and for prolonged periods.
Uncommon – (may occur in 1 to 10 out of 1,000 people taking the medicine):

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

Some side effects occur rarely or very rarely and may be severe.
If any of the following side effects occur, stop taking the medicine immediately and contact your doctor without delay:

• severe stomach pain, blood in stool, tarry stools, bloody vomiting, bloody diarrhoea;
• allergic reactions including difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, often accompanied by skin rash, collapse;
• 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 gasping or coughing (symptoms indicating pneumonia);
• sudden, severe headache, neck stiffness, difficulty speaking;
• convulsions;
• redness of the skin with blisters, peeling of the skin, purple skin changes, blisters on the mucous membranes in the mouth or around the eyes, skin inflammation with skin peeling;
• swelling of hands, palms, feet and ankles;
• any changes in appearance or amount of urine, blood in urine;
• yellowing of the skin or eyes (symptoms of liver damage and/or liver failure), increased liver enzymes;
• bleeding, bruising, high fever or persistent sore throat, frequent infections, extreme paleness, weakness;
• increased sensitivity of the skin to light.

Some side effects of unknown frequency may be serious.

• Mild, painful abdominal cramps and tenderness occurring shortly after starting Voltaren Express treatment, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – frequency cannot be estimated from available data);
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;
• Severe allergic skin reaction, which may present as widespread red and/or dark spots, skin swelling, blisters and itching (generalized bullous fixed drug eruption).

Taking medicines such as diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is increased when high doses are used for prolonged periods.
If any of the above side effects occur, stop taking Voltaren Express immediately and contact your doctor without delay.
Other side effects
Side effects that may occur are usually mild. Some side effects have been observed after administration of higher doses of diclofenac, the active substance in Voltaren Express, used long-term. If any of these occur, consult your doctor or pharmacist.
Common
(occur no more frequently than in 1 out of 10 people taking the medicine):

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

Rare
(occur no more frequently than in 1 out of 1,000 people taking the medicine):

• drowsiness;
• urticaria.

Very rare
(occur no more frequently than in 1 out of 10,000 people taking the medicine):

• constipation, oral mucosal inflammation (stomatitis), swelling, redness and tenderness of the tongue, taste disturbances, upper abdominal cramps;
• tingling or numbness of hands or feet, tremor;
• itching and redness of the skin, hair loss;
• blurred vision, double vision, ringing in the ears (tinnitus), hearing disturbances;
• mood changes, difficulty falling asleep, feeling of disorientation;
• hypertension, vasculitis.

Frequency not known (cannot be estimated from available data)

• allergic skin reaction, which may present as round or oval redness and swelling of the skin, blisters and itching (fixed drug eruption). In affected areas, the skin may also appear darker, which may persist after healing. Upon re-administration of the medicine, fixed drug eruption usually reappears in the same locations.

If any side effects not listed in this leaflet occur, stop taking Voltaren Express and inform your doctor.
If more medicine is taken than recommended, inform your doctor, pharmacist or go to the nearest emergency department. Poisoning may require specialized medical care.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 helps provide more information on the safety of the medicine.

5. How to store Voltaren Express

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps 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 is diclofenac potassium. One soft capsule contains 12.5 mg of potassium diclofenac.
• The other ingredients are: macrogol 600, glycerol 85%, purified water. Capsule shell composition: gelatine, 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.
An opaque, white blister made of PVC/PVdC/Aluminium foil containing 10 soft capsules.
A transparent blister made of PVC/PVdC/Aluminium foil containing 10 soft capsules.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
Rzymowskiego Street 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