Voltaren express forte

Package leaflet: Information for the patient

Voltaren Express Forte, 25 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, so you can read it again if necessary.
• 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 there is no improvement after 5 days of treatment for pain or after 3 days for fever, or if you feel worse, consult your doctor.

Table of contents

1. What Voltaren Express Forte is and what it is 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 pack and other information

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

Voltaren Express Forte 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 Forte is used:

• for muscle pain, rheumatic pain, acute lumbosacral pain (back pain), headache, toothache, and painful menstruation;
• for the symptomatic treatment of flu and cold (generalized aches, fever), and sore throat.

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

2. Information before using Voltaren Express Forte

When not to use Voltaren Express Forte:

• 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 being allergic to diclofenac, ibuprofen or acetylsalicylic acid (a medicine also used to reduce blood clotting) or any other medicine from 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 myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after 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 or has previously had gastrointestinal bleeding, manifested by blood in the stool or black-coloured stools, or gastrointestinal perforation (a hole in the digestive tract);
• if the patient has severe renal or hepatic insufficiency;
• in women during the third trimester of pregnancy.

Inform your doctor or pharmacist if any of these conditions apply, as Voltaren Express Forte should not be used in such cases.
Warnings and precautions
Before using Voltaren Express Forte, consult your doctor or pharmacist if:

• the patient has previously experienced gastrointestinal disorders, such as gastric and/or duodenal ulcer, gastrointestinal bleeding or black-coloured stools;
• the patient has experienced stomach problems or heartburn after taking painkillers or anti-inflammatory medicines;
• the patient has intestinal disorders;
• the patient has recently undergone or has planned surgery of the stomach or gastrointestinal tract, as Voltaren Express Forte may sometimes impair intestinal wound healing after surgery;
• the patient has allergies, wheezing, shortness of breath or nasal polyps;
• the patient has impaired kidney or liver function, and if swelling of the feet occurs;
• the patient is taking other anti-inflammatory or analgesic 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 or oral ulcers after taking Voltaren Express Forte 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 suffers from angina, blood clots, hypertension, high cholesterol or high triglyceride levels.

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

• Taking medicines such as Voltaren Express Forte may be associated with a small increased risk of heart attack or stroke.
• The lowest effective dose should be used 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 in association with NSAID therapy. The highest risk of these severe reactions occurs at the beginning of treatment, in most cases during the first month of use. Contact a doctor and discontinue the medicine immediately if the first signs of skin rash, mucosal lesions or other hypersensitivity symptoms appear (see section 4).
• If at any time during treatment with Voltaren Express Forte 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 Forte may mask symptoms of infection (e.g. headache, elevated body temperature), making diagnosis more difficult. Inform your doctor about using this medicine.
• Long-term use of painkillers for headache may worsen the headache. In such cases, consult a doctor.

Use of Voltaren Express Forte in elderly patients
As with other painkillers, elderly patients may be more sensitive to the effects of the medicine than 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 Forte is not recommended in children and adolescents under 14 years of age.
Voltaren Express Forte and other medicines
Tell your doctor or pharmacist 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 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);
• medicines that reduce blood clotting (anticoagulants and antiplatelet agents);
• other medicines with systemic anti-inflammatory or analgesic effects, such as acetylsalicylic acid or ibuprofen;
• systemic corticosteroids (medicines used to treat 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 Forte with food and drink
Swallow the capsule whole, preferably during or after a meal, with water.
Pregnancy, breastfeeding and fertility
Pregnancy
Consult a doctor or pharmacist before using Voltaren Express Forte.
If pregnant or suspecting pregnancy, inform your doctor and do not use Voltaren Express Forte. Do not take Voltaren Express Forte during 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 both mother and child and may delay or prolong labour. Do not use Voltaren Express Forte during the first six months of pregnancy unless your 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 Forte taken from week 20 of pregnancy for longer than a few days may cause kidney problems in the unborn child, which may lead to oligohydramnios (low amniotic fluid levels) 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
Do not use Voltaren Express Forte during breastfeeding, as it may have harmful effects on the infant.
During pregnancy and breastfeeding, consult your doctor or pharmacist before taking any medicine.
Fertility
As with other anti-inflammatory medicines, use of diclofenac, the active substance in Voltaren Express Forte, may impair fertility. This effect is reversible upon discontinuation of the medicine; however, if the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Voltaren Express Forte usually does not affect the ability to drive or operate machinery. However, as with other NSAIDs, some people may experience visual disturbances or dizziness after taking Voltaren Express Forte. If such adverse effects occur, do not drive or operate machinery.
Voltaren Express Forte contains sorbitol
Voltaren Express Forte contains 19 mg of sorbitol in each soft capsule.

3. How to use Voltaren Express Forte

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
Initially, take 1 capsule. The dose may be repeated after 4 to 6 hours. Do not take more than 3 capsules in 24 hours.

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

Do not use Voltaren Express Forte for more than 5 days for pain relief or more than 3 days for fever relief without consulting a doctor. If symptoms worsen or do not improve, consult a doctor or pharmacist.

Taking more medicine than recommended – Voltaren Express Forte
If you take more medicine than recommended, seek immediate advice from a doctor or pharmacist.

If you forget to take Voltaren Express Forte
If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any adverse reactions 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 not very frequently, especially when high doses (150 mg per day) are used for a prolonged period.
Not very common – (occurring in no more than 1 in 100 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).

Occasionally, rarely or very rarely occurring side effects may be serious.
If any of the following adverse reactions occur, stop taking the medicine and contact a doctor immediately:

• severe stomach pain, blood in stool, black tarry stools, vomiting blood, 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 and feeling of chest tightness 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;
• seizures;
• 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 the 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 sunlight.

Some adverse reactions with unknown frequency may be serious.

• Mild, painful abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren Express Forte, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – frequency cannot be estimated based on 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 higher when high doses are used for a long time.
If any of the above adverse reactions occur, stop taking Voltaren Express Forte immediately and contact a 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 Forte, used long-term. If any of these occur, consult a doctor or pharmacist.
Common
(occurring in no more than 1 in 10 people taking the medicine):

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

Rare
(occurring in no more than 1 in 1,000 people taking the medicine):

• drowsiness;
• urticaria.

Very rare
(occurring in no more than 1 in 10,000 people taking the medicine):

• constipation, aphthous stomatitis, swelling, redness and pain 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, tinnitus, hearing disturbances;
• mood changes, difficulty falling asleep, feeling of disorientation;
• hypertension, vasculitis.

Frequency unknown (cannot be estimated based on available data)

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

If any adverse reactions not listed in this leaflet occur, discontinue use of Voltaren Express Forte and inform a doctor.
If a larger dose than recommended has been taken, inform a doctor, pharmacist or go to the nearest emergency department. Poisoning may require specialized medical care.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting of adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Voltaren Express Forte

Keep this medicine 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 package. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Voltaren Express Forte contains

• The active substance is diclofenac potassium. One capsule contains 25 mg of diclofenac potassium.
• Other ingredients are: macrogol 600, glycerol 85%, purified water. Capsule shell composition: 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 Authorisation Holder
Haleon Poland Sp. z o.o.
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