VOLTAREN 25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Voltaren Acti Forte, 25 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Voltaren Acti Forte and what is it used for
4. Important information before taking Voltaren Acti Forte
   1. When not to take Voltaren Acti Forte
   2. The doctor or pharmacist should be informed about the presence of these diseases, as in such cases, Voltaren Acti Forte should not be taken.
   3. Warnings and precautions
   4. Before taking the medicine, the doctor or pharmacist should be informed
   5. Other warnings:
   6. Using Voltaren Acti Forte in elderly patients
   7. Children and adolescents
   8. Voltaren Acti Forte and other medicines
   9. The doctor or pharmacist should be told about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
   10. Using Voltaren Acti Forte with food and drink
   11. Pregnancy, breastfeeding, and fertility
   12. Driving and using machines
   13. The medicine contains sugar
   14. The medicine contains sodium
5. How to take Voltaren Acti Forte
   1. Adults and adolescents over 14 years of age
   2. Taking a higher dose of Voltaren Acti Forte than recommended
   3. Missing a dose of Voltaren Acti Forte
6. Possible side effects
   1. Some side effects can be serious.
   2. Some rare or very rare side effects can be serious.
   3. If any of the following side effects are observed, the patient should stop taking the medicine and immediately contact their doctor:
   4. Some side effects with unknown frequency can be serious.
   5. If any of the above side effects are observed, the patient should stop taking Voltaren Acti Forte and immediately contact their doctor
   6. Other side effects
   7. Common
   8. Rare
   9. Very rare
   10. If any side effects not listed in this leaflet occur, the patient should stop taking Voltaren Acti Forte and inform their doctor.
   11. Reporting side effects
7. How to store Voltaren Acti Forte
8. Contents of the pack and other information
   1. What Voltaren Acti Forte contains
   2. What Voltaren Acti Forte looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Importer:
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: patient information

Voltaren Acti Forte, 25 mg, coated tablets

Potassium diclofenac

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days for pain or 3 days for fever there is no improvement or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

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

Voltaren Acti Forte contains the active substance potassium diclofenac, which belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs). It acts as a pain reliever and anti-inflammatory, and also reduces fever.
Voltaren Acti Forte is used:

• for muscle pain, rheumatic pain, acute lower back pain (back pain), headache, toothache, painful menstruation;
• to treat symptoms of flu and colds (generalized pain, fever), sore throat.

Voltaren Acti Forte relieves symptoms of inflammation, such as pain and swelling, by blocking the synthesis of molecules responsible for inflammation, pain, and fever, called prostaglandins.
Voltaren Acti Forte does not affect the causes of inflammation and fever.

2. Important information before taking Voltaren Acti Forte

When not to take Voltaren Acti Forte

• if the patient is allergic to diclofenacor to any of the other ingredients of this medicine(listed in section 6);
• if the patient has ever had allergic reactions to pain, inflammation, or fever medications,or if the patient thinks they may be allergic to diclofenac, ibuprofen, or acetylsalicylic acid (a medicine also used to reduce blood clotting) or any other NSAID. Hypersensitivity symptoms include asthma attacks, wheezing, facial and lip swelling (angioedema), difficulty

breathing, chest pain, runny nose, rash, or any other allergic reactions. In case of doubt, consult a doctor or pharmacist;

• if the patient has been diagnosed with heart disease and (or) cerebrovascular disease, such as after a heart attack, stroke, mini-stroke (transient cerebral ischemia), or thrombosis of the heart or brain, or after a procedure to clear or bypass blocked vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease);
• if the patient has or has had stomach or duodenal ulcers;
• 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 in the third trimester of pregnancy.

The doctor or pharmacist should be informed about the presence of these diseases, as in such cases, Voltaren Acti Forte should not be taken.

Warnings and precautions

Before starting to take Voltaren Acti Forte, the patient should discuss it with their doctor or pharmacist if:

• the patient has a history of gastrointestinal disorders,such as stomach or duodenal ulcers, gastrointestinal bleeding, or black stools;
• the patient has experienced stomach problems or heartburn after taking pain or anti-inflammatory medications;
• the patient has intestinal disorders;
• the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as Voltaren Acti Forte may sometimes cause impaired wound healing in the gut after surgery;
• the patient has allergies, wheezing, shortness of breath, or nasal polyps;
• the patient has kidney or liver function disordersor swelling of the feet;
• the patient is taking other anti-inflammatory or pain medications;
• the patient has or has had heart problems;
• the patient is at risk of dehydration(due to e.g., diarrhea, other illness, as well as before or after surgery);
• the patient has bleeding disordersor other blood diseases, including rare porphyria.

Before taking the medicine, the doctor or pharmacist should be informed

• if the patient smokes
• if the patient has diabetes
• if the patient has angina, thrombosis, high blood pressure, high cholesterol, or high triglycerides.

The occurrence of side effects can be reduced by using the medicine in the smallest effective dose and for no longer than necessary.

Other warnings:

• Taking medicines like Voltaren Acti Fortemay be associated with a small increased risk of heart attack or stroke.
• The smallest effective dose of the medicine should be used for the shortest possible time.
• Severe skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported

in association with the use of nonsteroidal anti-inflammatory drugs. The greatest risk of these severe reactions occurs at the beginning of treatment, in most cases within the first month of taking the medicine. If symptoms of a skin rash, mucosal damage, or other hypersensitivity reactions occur (see section 4), the patient should contact their doctor and stop taking the medicine.

• If at any time during treatment with Voltaren Acti Forte, symptoms of heart or blood vessel disorders occur, such as chest pain, shortness of breath, weakness, or slurred speech, the patient should immediately contact their doctor.
• Voltaren Acti Forte may mask symptoms of infection(e.g., headache, elevated body temperature) and make its proper diagnosis difficult. The doctor should be informed about the use of the medicine.
• Long-term use of painkillers for headache may cause its worsening. In such a case, the patient should contact their doctor.

Using Voltaren Acti Forte in elderly patients

As with other painkillers, elderly people may react more strongly to the action of the medicine compared to adults. The recommendations in the leaflet should be followed, the smallest effective dose should be used, and all side effects that occur during treatment should be reported to the doctor.

Children and adolescents

The use of the medicine is not recommended in children and adolescents under 14 years of age.

Voltaren Acti Forte and other medicines

The doctor or pharmacist should be told 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 the doctor or pharmacist about the use of the following medicines:

• lithium or antidepressant medicines(medicines used to treat depression);
• digoxin(a medicine used to treat heart diseases);
• ACE inhibitors or beta-blockers(medicines used to treat high blood pressure or heart failure);
• methotrexate(a medicine used to treat certain cancers or arthritis);
• oral diabetes medications;
• diuretics(medicines that increase urine production);
• medicines that reduce blood clotting(anticoagulant and antiplatelet medicines);
• other systemic anti-inflammatory or pain medications, such as acetylsalicylic acid or ibuprofen;
• systemic corticosteroids(medicines used to treat inflammation);
• cyclosporine and tacrolimus(medicines used in organ transplant patients);
• trimethoprim(a medicine used to prevent or treat urinary tract infections);
• quinolone antibacterials(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);
• cholestyramine or colestipol(medicines used to lower cholesterol levels).

Using Voltaren Acti Forte with food and drink

The tablet should be swallowed whole, preferably during a meal or after a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

Pregnancy
Before taking Voltaren Acti Forte, the patient should consult a doctor or pharmacist.
In case of pregnancy or suspected pregnancy, the patient should inform their doctor and not take Voltaren Acti Forte. The medicine should not be taken if the patient is in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Voltaren Acti Forte may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor. During the first six months of pregnancy, Voltaren Acti Forte should not be taken unless the doctor considers it absolutely necessary. If treatment during the first six months of pregnancy or while trying to conceive is necessary, the smallest effective dose should be used for the shortest possible time. Voltaren Acti Forte taken from the 20th week of pregnancy, for a period longer than a few days, may cause kidney problems in the unborn baby, which may lead to oligohydramnios (low amniotic fluid level around the baby) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment for a longer period than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Voltaren Acti Forte should not be takenin breastfeeding women, as the medicine may have a harmful effect on the baby.
During pregnancy and breastfeeding, before taking any medicine, the patient should consult a doctor or pharmacist.
Fertility
As with other anti-inflammatory medicines, taking diclofenac, the active substance of Voltaren Acti Forte, may make it more difficult to become pregnant. This effect is reversible if the medicine is stopped, but if the patient is planning a pregnancy or is having trouble becoming pregnant, they should inform their doctor.

Driving and using machines

Usually, Voltaren Acti Forte does not affect the ability to drive or use machines. As with other nonsteroidal anti-inflammatory drugs, after taking Voltaren Acti Forte, some people may experience vision disturbances or dizziness. If such side effects occur, the patient should not drive or operate machines.

The medicine contains sugar

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Voltaren Acti Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Do not take a higher dose than recommended. It is important to take the smallest effective dose of the medicine for the shortest possible time.

Adults and adolescents over 14 years of age

The initial dose is 1 tablet. If necessary, 1 tablet can be taken every 4 to 6 hours.
Do not take more than 3 tablets in 24 hours.
The tablet should be swallowed whole, with a glass of water.
Do not take Voltaren Acti Forte 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, the patient should contact their doctor or pharmacist.

Taking a higher dose of Voltaren Acti Forte than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist.

Missing a dose of Voltaren Acti Forte

If a dose is missed, the patient should take it as soon as they remember. If it is almost time for the next dose, the patient should 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, Voltaren Acti Forte can cause side effects, although not everybody gets them.
If any side effects occur, including any not listed in this leaflet, the patient should consult their doctor or pharmacist.

Some side effects can be serious.

Some side effects occur not very often, especially when taking high doses (150 mg per day) and for a long time.
Uncommon –(occur in less than 1 in 100 people taking the medicine):

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

Some rare or very rare side effects can be serious.

If any of the following side effects are observed, the patient should stop taking the medicine and immediately contact their doctor:

• severe stomach pain, blood in the stool, black stools, bloody vomiting, bloody diarrhea;
• allergic reactions including difficulty breathing or swallowing, swelling of the face, lips, tongue, or throat, often with a skin rash; anaphylaxis;
• sudden difficulty breathing and a feeling of tightness in the chest with wheezing or coughing (symptoms indicating asthma);
• sudden difficulty breathing and a feeling of heaviness in the chest with wheezing or coughing (symptoms indicating pneumonia);
• sudden severe headache, stiffness of the neck, difficulty speaking;
• seizures;
• redness of the skin with blisters, peeling of the skin, purple spots on the skin, blisters on the mucous membranes in the mouth or eyes, skin inflammation with peeling;
• swelling of the hands, feet, and ankles;
• any changes in the appearance or amount of urine, blood in the urine;
• yellowing of the skin or eyes (symptoms of liver damage and (or) liver failure), increased liver enzymes;
• bleeding, bruising, high fever, or prolonged sore throat, frequent infections, extreme pallor, weakness;
• increased sensitivity of the skin to light.

Some side effects with unknown frequency can be serious.

• Mild, painful cramps, and tenderness of the abdomen, occurring soon after starting to take Voltaren Acti Forte, followed by rectal bleeding or bloody diarrhea, usually within 24 hours 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.

Taking medicines like diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is increased when taking high doses for a long time.

If any of the above side effects are observed, the patient should stop taking Voltaren Acti Forte and immediately contact their doctor

Other side effects

Side effects that may occur are usually mild. Some side effects have been observed after taking higher doses of diclofenac, the active substance of Voltaren Acti Forte, for a long time. If they are observed, the patient should contact their doctor or pharmacist.

Common

(occur in less than 1 in 10 people taking the medicine):

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

Rare

(occur in less than 1 in 1000 people taking the medicine):

• drowsiness;
• hives.

Very rare

(occur in less than 1 in 10,000 people taking the medicine):

• constipation, oral thrush, swelling, redness, and pain of the tongue, taste disorders, hair loss;
• itching and redness of the skin, hair loss;
• tingling or numbness of the hands or feet, tremors;
• blurred vision, double vision, ringing in the ears, hearing disorders;
• mood changes, difficulty sleeping, feeling disoriented;
• high blood pressure, vasculitis.

If any side effects not listed in this leaflet occur, the patient should stop taking Voltaren Acti Forte and inform their doctor.

In case of taking a higher dose of the medicine than recommended, the patient should inform their doctor, pharmacist, or go to the nearest emergency department. Overdose may require specialized medical care.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Voltaren Acti Forte

The medicine should be stored 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 month.
Do not store above 30°C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Voltaren Acti Forte contains

The active substance of the medicine is potassium diclofenac.
One coated tablet contains 25 mg of potassium diclofenac.
The other ingredients are:
tablet core: calcium phosphate, corn starch, sodium carboxymethylcellulose, silicon dioxide, povidone, magnesium stearate.
tablet coating: sugar, talc, povidone, macrogol 8000, microcrystalline cellulose, colorant 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.
A PVC/PE/PVDC/Aluminum blister pack contains 10 coated tablets.

Marketing authorization holder

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
phone: 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

Date of last revision of the leaflet: