®VOLTFAST

 Voltfast®

What Voltfast is and what it is used for

This medicine is used on prescription from a doctor.

Voltfast contains the potassium salt of diclofenac, a non-steroidal active substance, and has significant pain-relieving and anti-inflammatory properties.

Taking Voltfast can relieve symptoms of inflammation such as pain and swelling by blocking the synthesis of the molecules (prostaglandins) responsible for inflammation, pain and fever. However, it cannot treat the causes.

It takes effect within about 30 minutes.

Voltfast is used on prescription from your doctor for the short-term treatment (maximum 3 days) of acute illnesses when it is particularly important that the medicine takes effect quickly, such as in the following cases: painful inflammation following injuries (e.g. strains and sprains), inflammation and pain following dental or orthopaedic surgery, gynaecological pain and inflammation, migraine attacks with or without aura, back and neck pain, soft-tissue rheumatism and as an additional treatment for various acute infections, particularly of the ear, nose and throat.

Voltfast should not be used to reduce fever only.

If you have heart disease or have significant risk factors for heart disease, your doctor will regularly re-assess whether you should continue treatment with Voltfast, particularly if your treatment lasts more than 4 weeks.

Do not take Voltfast

Do not use Voltfast if you are allergic to any of the ingredients or have experienced difficulty breathing or allergy-like skin reactions such as swelling of the face, lips, tongue, throat and/or extremities (signs of angioedema) after taking acetylsalicylic acid or other medicines used to treat pain or inflammation (non-steroidal anti-inflammatory drugs), are in the last 3 months of pregnancy, have an active ulcer of the stomach and/or small intestine (duodenal ulcer), gastrointestinal bleeding or perforation or symptoms such as bloody or black stool, chronic intestinal inflammation (Crohn's disease, ulcerative colitis), liver or kidney failure, severe heart failure or to treat pain following coronary bypass surgery on the heart (or use of a heart-lung machine).

 Voltfast must not be used by children under 14 years of age.

If any of the above applies to you, tell your doctor and do not take Voltfast. Your doctor will decide whether this medicine is suitable for you.

If you think you may be allergic, ask your doctor for advice.

Warnings and precautions

Mucosal ulcers, bleeding (rare) or (in isolated cases) perforation (rupture of the stomach or intestine) may occur in the upper gastrointestinal tract during treatment with Voltfast. These complications may occur at any time during treatment, even without warning symptoms.

To reduce this risk, your doctor will prescribe the lowest effective dose for the shortest possible treatment period. Consult your doctor if you have stomach pain and think that it may have something to do with taking this medicine.

Caution is required if you have a heart or blood vessel disease (cardiovascular disease, including uncontrolled high blood pressure, heart failure, ischaemic heart disease or peripheral arterial disease) as treatment with Voltfast is usually not recommended.

Caution is required if you have recently had surgery on your stomach/intestine or if you are soon due to have such surgery.

If you have a cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally high levels of fat in your blood (cholesterol, triglycerides), diabetes or if you smoke and your doctor decides to prescribe you Voltfast, you must not increase the dose above 100 mg per day if you are treated for longer than 4 weeks. It is generally important to use the lowest dose of Voltfast that relieves your pain and/or swelling and to use it for the shortest time possible to keep your risk of cardiovascular side effects as low as possible.

Certain painkillers called COX-2 inhibitors have been shown to increase the risk of heart attack and stroke when given at high dosages and/or during long-term treatment. It is not known if this increased risk also applies to Voltfast. If you have ever had a heart attack, stroke or venous thrombosis (blood clot in a vein) or if you have risk factors such as high blood pressure, diabetes, high levels of fat in your blood or if you smoke, your doctor will decide if you can use Voltfast. If any of the above applies to you, tell your doctor.

Taking Voltfast may affect the function of your kidneys, which may cause an increase in blood pressure and/or a build-up of fluid (oedema). Tell your doctor if you have heart disease or kidney disease, if you are taking medicine for high blood pressure (e.g. diuretics ("water pills"), ACE inhibitors), or if you experience an increase in fluid loss (e.g. through heavy sweating).

In very rare cases anti-inflammatory medicines (including Voltfast) may cause severe skin reactions (e.g. rash). Stop treatment with Voltfast immediately at the first signs of any skin reaction and tell your doctor. This medicine may affect your reactions and your ability to drive or use tools or machines.

If you experience dizziness, visual disturbances or other central nervous system disorders in particular, do not drive or use machines and consult your doctor immediately.

Furthermore, particular caution is required if you are taking Voltfast at the same time as other anti-inflammatory medicines (such as acetylsalicylic acid, corticosteroids), "blood thinners" (anticoagulants) or selective serotonin reuptake inhibitors (SSRIs; medicines used to treat depression), if you have asthma, hay fever (seasonal allergic rhinitis), liver or kidney problems, blood clotting disorders or other problems with the blood, including a rare liver problem known as porphyria.

If any of the above applies to you, tell your doctor before you take Voltfast.

If you experience any signs or symptoms of problems with your heart or blood vessels such as chest pain, shortness of breath, weakness or slurring of speech while using Voltfast, contact your doctor immediately.

Tell your doctor or pharmacist if you:

have any other illnesses,

have any allergies or

are taking or externally applying any other medicines (including

non-prescription medicines),

particularly if you are taking the following medicines: lithium or selective serotonin reuptake inhibitors (SSRIs; used to treat depression), digoxin (for heart problems), diuretics (to increase urination), ACE inhibitors or beta blockers (for high blood pressure and heart problems), other anti-inflammatory medicines such as acetylsalicylic acid or ibuprofen, corticosteroids, medicines used to prevent blood clots (anticoagulants), medicines (e.g. metformin) used to treat diabetes (except insulin), methotrexate (used to treat arthritis and cancer), ciclosporin or tacrolimus (used in organ transplantation), trimethoprim (used to treat urinary tract infections), quinolone antibiotics (medicines used to treat infections) or voriconazole (a medicine used to treat fungal infections), phenytoin (a medicine used to treat epileptic seizures), rifampicin (an antibiotic used to treat bacterial infections).

Voltfast may reduce the signs of an infection (e.g. headache, high body temperature) and therefore make it more difficult to detect and appropriately treat the infection.

As with other anti-inflammatory medicines, in very rare cases patients treated with Voltfast may experience severe allergic reactions (e.g. rash). Therefore, tell your doctor immediately if you experience such a reaction.

Caution is required in elderly patients, particularly those who are frail or with a low body weight. They may also be more sensitive to the effects of Voltfast. Therefore, as a precaution, they should use the lowest effective dose.

This medicine contains 50 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare hereditary disorder that leads to the accumulation of phenylalanine, because the body cannot sufficiently metabolise it.

This medicinal product contains less than 1 mmol (23 mg) of sodium per sachet, making it practically sodium-free.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or plan to become pregnant, you should only take Voltfast if this has been discussed with your doctor. Do not take Voltfast in the last 3 months of pregnancy.

Breast-feeding

Voltfast should not be taken during breast-feeding unless your doctor has expressly allowed you to do so.

How to use Voltfast

Dosage and administration will be decided by your doctor based on the severity of your illness. Follow your doctor's instructions carefully.

Do not exceed the recommended daily dose and treatment period prescribed by your doctor.

If you use Voltfast for longer than a few weeks, you should consult your doctor for regular check-ups to ensure that you are not experiencing any unnoticed side effects.

Adults: 100-150 mg per day. For milder cases and children over 14 years of age 50-100 mg per day is usually sufficient.

 The daily dose should always be divided into 1-2 separate doses. Do not exceed the maximum daily dose of 150 mg.

For period pain start treatment with a single dose of 50-100 mg as soon as you experience the first symptoms. If required, continue treatment for a few days with up to 50 mg three times daily.

For migraine attacks start by taking one 50 mg Voltfast sachet at the first signs of a migraine attack. If pain relief is not sufficient approximately 2 hours after taking the first dose, you may take the contents of another 50 mg sachet. If necessary, you may take additional 50 mg doses at intervals of 6-8 hours, but you must not exceed the maximum dose of 150 mg (three 50 mg sachets) within 24 hours.

Dissolve the contents of a sachet by stirring into a glass of (non-carbonated) water, then drink. The solution may remain slightly cloudy, but this does not impact the effectiveness of this medicine. The solution should preferably be taken before meals.

Do not change the prescribed dosage yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor or pharmacist.

Possible side effects

The following side effects may occur when taking Voltfast:

Common (affects 1 to 10 in 100 users)

Common: Headache, light-headedness, dizziness, nausea, vomiting, diarrhoea, stomach problems, abdominal pain, flatulence, decreased appetite, rash, fluid build-up, swelling, increased blood pressure, change in liver function (e.g. increased liver enzyme concentration in the blood).

Uncommon (affects 1 to 10 in 1,000 users)

Uncommon (occur particularly when taking a high daily dose (150 mg) over a longer period): sudden chest pain with a sensation of tightness/heaviness (sign of a heart attack); difficulty breathing, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure).

Rare (affects 1 to 10 in 10,000 users)

Rare: Hypersensitivity reactions (allergic reactions) with swelling in the face, mouth, limbs (may include decreased blood pressure and shock), asthma, drowsiness, inflammation and ulcers of the gastrointestinal tract, vomiting blood, bloody diarrhoea, liver function problems, liver inflammation, jaundice (very rare: liver failure), hives. Unknown frequency: sudden chest pain and allergic reactions (signs of Kounis syndrome).

Very rare (affects fewer than 1 in 10,000 users)

Very rare: Changes in blood count, unusual bleeding, bruising, mental health problems (including sleeplessness, irritability), discomfort, memory problems, convulsions, anxiety, tremor, abnormal sense of taste, visual disturbance*, visual impairment, noises in the ear(s), reduced hearing, stiff neck, inflammation of the blood vessels/lungs/large intestine, constipation, pancreas inflammation, inflammation of the mucous membranes of the mouth, tongue inflammation, eczema, itching, inflamed, red skin, hair loss, bleeding skin, acute kidney problems, blood in the urine.

*Visual disturbance: If you experience symptoms of a visual disturbance during treatment with Voltfast, contact your doctor. An eye examination may be considered to rule out other causes.

Tell your doctor if you experience any of these side effects.

If you notice any side effects which are not described here, tell your doctor or pharmacist.

Further information

Do not use after the expiry date (= EXP) printed on the pack.

Storage instructions

Keep out of the reach of children.

Protect from moisture and do not store above 25°C.

Additional information

Your doctor or pharmacist will be able to give you more information.

They have access to the full prescribing information.

What Voltfast contains

Active substances

1 sachet contains 50 mg diclofenac potassium

hele

Other ingredients

1 sachet contains 50 mg of aspartame (E951), saccharin sodium,

mannitol, mint and anise flavouring agent, potassium hydrogen carbonate, glyceryl dibehenate

Information might differ in some countries

Availability/pack sizes

Available only in pharmacies with a doctor's prescription.

50 mg sachet: 3x10.

50 mg sachet: 3x3

50 mg sachet: 3x1

Not all pack sizes are marketed