Voltaren acti

Voltaren Acti, 12.5 mg, film-coated tablets
Diclofenacum kalicum
Please read the entire package leaflet carefully before using this 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
your doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions 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 your condition worsens, consult your doctor.

Table of contents of the leaflet

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

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

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

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

Voltaren Acti relieves inflammatory symptoms such as pain and swelling by inhibiting the production of molecules responsible for inflammation, pain, and fever, known as prostaglandins.
Voltaren Acti does not affect the underlying causes of inflammation or fever.

2. Information before using Voltaren Acti

When not to use Voltaren Acti

• 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), difficulty breathing, chest pain, nasal discharge, 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 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 ulceration of the stomach and (or) duodenum;
• if the patient has blood in the stool or black-coloured stools (symptoms indicating gastrointestinal bleeding);
• 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 Acti should not be used in such cases.
Warnings and precautions
Before starting treatment with Voltaren Acti, discuss the following with your doctor or pharmacist:

• if the patient has previously experienced gastrointestinal disorders, such as: peptic ulcer of the stomach and (or) duodenum, gastrointestinal bleeding, or black stools;
• if gastrointestinal disturbances or heartburn occurred after taking painkillers or anti-inflammatory medicines;
• if the patient has intestinal disorders;
• if the patient has recently undergone or is scheduled for surgery on the stomach or gastrointestinal tract, as Voltaren Acti may sometimes impair intestinal wound healing after surgery;
• if the patient has allergies, wheezing, shortness of breath or nasal polyps;
• if the patient has kidney or liver function disorders or if swelling of the feet occurs;
• if the patient is taking other systemic anti-inflammatory or systemic pain-relieving medicines;
• if the patient has heart problems;
• if the patient is at risk of dehydration (due to, for example, diarrhoea, another illness, or before or after surgical procedures);
• if the patient has bleeding disorders or other blood disorders, including rare hepatic porphyria;
• if the patient has ever experienced a severe skin rash, skin peeling, blistering or (and) oral mucosal ulcers after taking Voltaren Acti or other pain-relieving medicines.

Before taking the medicine, inform your doctor or pharmacist if:

• the patient smokes;
• the patient has diabetes;
• the patient has angina pectoris, blood clots, hypertension, elevated cholesterol or elevated 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 Acti may be associated with a small increased risk of heart attack or stroke.
• Use the lowest effective dose for the shortest possible duration.
• 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 occurs early in treatment, most often within the first month of treatment. Contact your doctor and discontinue the medicine at the first signs of skin rash, mucosal lesions or other symptoms of hypersensitivity (see section 4).
• If at any time during treatment with Voltaren Acti 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 Acti may mask symptoms of infection (e.g. headache, elevated body temperature) and may interfere with correct diagnosis. Inform your doctor about using this medicine.
• Prolonged use of pain-relieving medicines for headache may worsen the condition. In such cases, consult your doctor.

Use of Voltaren Acti in elderly patients
As with other pain-relieving medicines, elderly patients 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 this medicine is not recommended in children and adolescents under 14 years of age.
Voltaren Acti 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 particularly important to inform your doctor about the use of the following medicines:

• Lithium or serotonin reuptake inhibitors (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 rheumatoid arthritis);
• Oral medicines used to treat diabetes;
• Diuretics (medicines that increase urine output);
• Medicines used to prevent blood clotting (anticoagulants);
• Other medicines with systemic anti-inflammatory or systemic pain-relieving effects, such as: acetylsalicylic acid or ibuprofen;
• Corticosteroids (medicines used to reduce inflammation on various body surfaces);
• 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 and cholestyramine (medicines used to reduce cholesterol levels).

Taking Voltaren Acti with food and drink
Swallow the tablet whole, preferably during or after a meal, with water.
Pregnancy, breastfeeding and fertility
Pregnancy
Before using Voltaren Acti, consult your doctor or pharmacist.
If pregnant or suspecting pregnancy, inform your doctor and do not use Voltaren Acti. Do not take Voltaren Acti if you are in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications.
Voltaren Acti 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. Voltaren Acti should not be used during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If treatment during the first 6 months or while trying to conceive is required, use the lowest possible dose for the shortest possible time. Voltaren Acti 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 Acti during breastfeeding, as the medicine may harm 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 Acti, may impair fertility. This effect is reversible after stopping the medicine; however, if the patient is planning pregnancy or experiencing difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Voltaren Acti usually does not affect the ability to drive or operate machinery. However, as with other non-steroidal anti-inflammatory drugs, some people may experience visual disturbances or dizziness after taking Voltaren Acti.
If such adverse effects occur, do not drive or operate machinery.
Voltaren Acti contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Voltaren Acti contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Voltaren Acti

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Do not take a higher dose than recommended. 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 tablets. If necessary, 1 or 2 tablets may be taken every 4 to 6 hours. Do not take more than 6 tablets in any 24-hour period.
Swallow the tablet whole with a glass of water.

Do not use Voltaren Acti for more than 5 days for pain or more than 3 days for fever without consulting a doctor. If symptoms worsen or do not improve, contact your doctor or pharmacist.

Taking more Voltaren Acti than recommended
If you take more medicine than recommended, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Voltaren Acti
If you miss a dose, take it as soon as you remember. However, 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 missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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. If any of the following side effects occur, stop taking the medicine
and contact a doctor immediately:

Uncommon (occur 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 the feet or legs (symptoms of heart failure).

These effects usually occur when high doses of the medicine (above 150 mg per day) are used for a long time.

Rare (occur in no more than 1 in 1,000 people taking the medicine) or very rare (occur in no more than 1 in 10,000 people taking the medicine):

• Severe stomach pain, blood in stool, 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 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;
• Seizures;
• Redness of the skin with blisters, skin peeling, purple skin changes, blisters on the mucous membranes in the mouth or eyes, skin inflammation with skin peeling;
• Swelling of hands, palms, feet and legs;
• Any changes in appearance or amount of urine, blood in urine;
• Yellowing of the skin or eyes accompanied by increased liver enzyme activity (symptoms of liver function disorders/liver failure);
• Bleeding, bruising, high fever or persistent sore throat, frequent infections, extreme paleness, weakness;
• Increased sensitivity of the skin to light.

Frequency not known (frequency cannot be estimated from the available data):

• Mild abdominal cramps and tenderness occurring shortly after starting Voltaren Acti, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset 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;
• 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 of the medicine are used for a long time.

If any of the above side effects occur, stop taking Voltaren Acti and contact a doctor immediately.

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 Acti, used long-term. If any of these are observed, contact a doctor or pharmacist.

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

• Abdominal pain, diarrhoea, nausea, bloating, vomiting, indigestion, loss of appetite.
• Increased liver enzyme activity.
• Headache, dizziness.
• Rash.

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

• Drowsiness.
• Urticaria.

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

• Constipation, oral herpes, swelling, redness and tenderness of the tongue, taste disturbances, cramps in the upper abdomen.
• Itching and redness of the skin, hair loss.
• Tingling or numbness of hands or feet, tremor.
• Blurred vision, double vision, ringing in the ears, hearing disturbances.
• Mood changes, difficulty falling asleep, disorientation.
• Hypertension, vasculitis.

Frequency not known (cannot be estimated from the available data):

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

If side effects not listed in this leaflet occur, stop using Voltaren Acti and consult a doctor.

If more medicine is taken than recommended, inform a doctor, pharmacist or go to the nearest emergency department. Poisoning may require specialist medical care.

Reporting of side effects

If any adverse reactions occur, including any adverse effects 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
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, additional information on the safety of the medicine can be collected.

5. How to store Voltaren Acti

Keep this medicine out of sight and reach of children.
Store below 25°C.
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. This will help protect the environment.

6. Contents of the pack and other information

What Voltaren Acti contains
The active substance is diclofenac potassium. One coated tablet contains 12.5 mg of diclofenac potassium.
The other ingredients are:
Tablet core: colloidal silicon dioxide, monohydrate lactose, corn starch, sodium carboxymethyl starch, povidone, microcrystalline cellulose, magnesium stearate;
Tablet coating: hypromellose, microcrystalline cellulose, stearic acid, titanium dioxide (E 171).

What Voltaren Acti looks like and contents of the pack
10 or 20 white, capsule-shaped coated tablets.
Transparent or opaque PVC/PCTFE/PVC – Aluminium or OPA/ALUMINIUM/PVC – Aluminium blisters containing 10 coated tablets.
The pack contains 1 or 2 blisters.

Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
Tel. 22 576 96 00

Manufacturer:
GSK Consumer Healthcare GmbH & Co. KG
Barthstraße 4
80339 Munich
Germany
Delpharm l’Aigle
Zone Industrielle N01
Route de Crulai
61300 L’AIGLE
France