Voltaren acti forte

Package leaflet: Information for the patient

Voltaren Acti Forte, 25 mg, coated tablets
Diclofenacum kalicum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet so that 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 5 days of treatment for pain or after 3 days for fever, consult your doctor.

Table of contents

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

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

Voltaren Acti Forte contains, as the active substance, diclofenac potassium, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works as a painkiller and anti-inflammatory agent and also reduces fever.
Voltaren Acti Forte 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 (generalized aches, fever), and sore throat.

Voltaren Acti 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 Acti Forte does not affect the underlying causes of inflammation or fever.

2. Important information before using Voltaren Acti Forte

When not to use Voltaren Acti 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 and lip swelling (angioedema), difficulty breathing, 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 currently has or has previously had circulatory disorders (peripheral vascular disease);

• if the patient currently has or has previously had peptic ulcer of the stomach and/or duodenum;

• if the patient has blood in the stool or black stool (symptoms indicating gastrointestinal bleeding);

• if the patient has severe kidney or liver failure;

• in women during the third trimester of pregnancy.

Patients should inform their doctor or pharmacist if any of the above conditions are present, as Voltaren Acti Forte should not be used in such cases.
Warnings and precautions
Before starting to use Voltaren Acti Forte, consult a 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;
• 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 is scheduled for stomach or gastrointestinal surgery, as Voltaren Acti Forte 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 has swelling of the feet;
• the patient is taking other anti-inflammatory or pain-relieving medicines;
• the patient has current or past heart disorders;
• 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 disorders, including rare hepatic porphyria;
• the patient has ever experienced severe skin rash, skin peeling, blistering, and/or oral ulcers after taking Voltaren Acti Forte or other pain-relieving medicines.

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

• the patient smokes;
• the patient has diabetes;
• the patient suffers from angina, 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 Acti Forte 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 may be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported with NSAIDs. The highest risk occurs early in treatment, usually within the first month of use. Contact a doctor and discontinue the medicine immediately if the first signs of skin rash, mucosal damage, or other hypersensitivity symptoms occur (see section 4).
• If at any time during treatment with Voltaren Acti 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 Acti Forte may mask symptoms of infection (e.g. headache, fever) and make correct diagnosis more difficult. Inform your doctor about using this medicine.
• Long-term use of painkillers for headache may worsen the condition. In such cases, consult a doctor.

Use of Voltaren Acti Forte 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 a doctor.
Children and adolescents
Voltaren Acti Forte is not recommended for use in children and adolescents under 14 years of age.
Voltaren Acti Forte and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
It is particularly 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 high blood pressure or heart failure);
• methotrexate (a medicine used to treat certain cancers or rheumatoid arthritis);
• oral medicines for diabetes;
• diuretics (medicines that increase urine output);
• medicines that reduce blood clotting (anticoagulants and antiplatelet agents);
• other systemic anti-inflammatory or pain-relieving medicines, 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 Acti Forte with food and drink
Swallow the tablet whole, preferably during or after a meal, with water.
Pregnancy, breastfeeding, and fertility
Pregnancy
Consult a doctor or pharmacist before using Voltaren Acti Forte.
If pregnant or suspecting pregnancy, inform your doctor and do not use Voltaren Acti Forte. Do not take Voltaren Acti Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Voltaren Acti 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 Acti 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 when trying to conceive is required, use the lowest possible dose for the shortest possible time. Voltaren Acti Forte 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 a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is needed, your doctor may recommend additional monitoring.
Breastfeeding
Do not use Voltaren Acti Forte during breastfeeding, as it may harm the infant.
During pregnancy and breastfeeding, consult a doctor or pharmacist before taking any medicine.
Fertility
As with other anti-inflammatory medicines, use of diclofenac, the active substance in Voltaren Acti Forte, may impair fertility. This effect is reversible upon 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 Forte usually does not affect the ability to drive or operate machinery. However, as with other NSAIDs, some patients may experience visual disturbances or dizziness after taking Voltaren Acti Forte. If such side effects occur, do not drive or operate machinery.
This medicine contains sucrose
If the patient has been previously diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Voltaren Acti Forte

This medicine should always be taken exactly as described in this patient information leaflet, or as directed by your doctor or pharmacist. If you are 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 1 tablet. If necessary, 1 tablet may be taken every 4 to 6 hours.
Do not take more than 3 tablets in 24 hours.
Swallow the tablet whole with a glass of water.

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

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

If you forget to take Voltaren Acti Forte
If you miss a dose, take it as soon as you remember. If it is almost time for your 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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet,
consult a doctor or pharmacist.
Some adverse reactions may be serious.
Some adverse reactions occur uncommonly, especially when high doses (150 mg per day) are used
and for prolonged periods.
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 feet or legs (symptoms of heart failure).

Some adverse reactions occurring rarely or very rarely 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, 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 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 and severe headache, neck stiffness, difficulty speaking;
• seizures;
• redness of the skin with blisters, skin peeling, purple skin changes, blisters on 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 (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 adverse reactions with unknown frequency may be serious.

• Mild, painful abdominal cramps and tenderness occurring shortly after starting treatment with Voltaren Acti Forte, 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 extensive red and/or dark patches, 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 adverse reactions occur, stop taking Voltaren Acti Forte immediately and contact a doctor without delay.

Other adverse reactions
Adverse reactions that may occur are usually mild. Some adverse reactions have been observed after using higher doses of diclofenac, the active substance in Voltaren Acti Forte, when used long-term. If any of these occur, consult a doctor or pharmacist.

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

• drowsiness;
• urticaria.

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

• constipation, herpetic stomatitis, swelling, redness and pain of the tongue, taste disturbances, upper abdominal cramps;
• 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, feeling of disorientation;
• hypertension, vasculitis.

Frequency unknown (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 (erythema multiforme). The affected skin areas may also have a darker colour, which may persist after healing. Upon re-exposure to the medicine, erythema multiforme usually reappears in the same locations.

If adverse reactions not listed in this leaflet occur, discontinue use of Voltaren Acti Forte and inform a doctor.
If more medicine is taken than recommended, inform a doctor, pharmacist or go to the nearest emergency department. Poisoning may require specialized medical care.

Reporting adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Voltaren Acti Forte

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.
Do not store above 30°C.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Voltaren Acti Forte contains
The active substance is diclofenac potassium.
One coated tablet contains 25 mg of diclofenac potassium.
Other ingredients are:
tablet core: calcium hydrogen phosphate, maize starch, sodium carboxymethyl starch, colloidal anhydrous silica, povidone, magnesium stearate.
coating: sucrose, talc, povidone, macrogol 8000, microcrystalline cellulose, colouring agent Dispersed Red 16158 Anstead: iron oxide (E 172), titanium dioxide (E 171).
What Voltaren Acti Forte looks like and contents of the pack
10 or 20 coated tablets in a cardboard box.
PVC/PE/PVDC/Aluminium blister contains 10 coated tablets.
Marketing Authorisation Holder
Haleon Poland Sp. z o.o.
Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849
Manufacturer
Doppel Farmaceutical S.r.l
Via Volturno 48,
20089 Quinto de' Stampi - Rozzano,
Milan
Italy
Importer:
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany