VOLTAREN 12.5 mg Tablets

Contents of the leaflet

1. Patient Information Leaflet: User Information
2. Voltaren Acti, 12.5 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 and what is it used for
4. Important information before taking Voltaren Acti
   1. When not to take Voltaren Acti
   2. Tell your doctor or pharmacist if you have any of these conditions, as Voltaren Acti should not be taken in such cases.
   3. Warnings and precautions
   4. Before taking the medicine, tell your doctor or pharmacist
   5. Other warnings:
   6. Do not exceed:
   7. Using Voltaren Acti in elderly patients
   8. Children and adolescents
   9. Voltaren Acti and other medicines
   10. Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take.
   11. Using Voltaren Acti with food and drink
   12. Pregnancy, breastfeeding, and fertility
   13. Driving and using machines
   14. Important information about some ingredients of Voltaren Acti
5. How to take Voltaren Acti
   1. Adults and adolescents over 14 years of age
   2. Taking a higher dose of Voltaren Acti than recommended
   3. Missing a dose of Voltaren Acti
6. Possible side effects
   1. Some side effects can be serious
   2. Some rare or very rare side effects can be serious.
   3. Some side effects with unknown frequency can be serious.
   4. If you experience any of the above side effects, contact your doctor immediately.
   5. Other side effects
   6. Common
   7. Uncommon
   8. Rare
   9. If you experience any side effects not listed in this leaflet, stop taking Voltaren Acti and inform your doctor.
   10. Reporting side effects
7. How to store Voltaren Acti
8. Contents of the pack and other information
   1. What Voltaren Acti contains
   2. What Voltaren Acti looks like and contents of the pack
   3. Marketing authorization holder

Patient Information Leaflet: User Information

Voltaren Acti, 12.5 mg, Coated Tablets

Diclofenac Potassium

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 information leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days for pain or 3 days for fever, there is no improvement or you feel worse, consult your doctor.

Table of Contents of the Leaflet

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

Voltaren Acti contains the active substance diclofenac potassium, 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 is used for:

• Muscle pain, rheumatic pain, acute lower back pain (back pain), headache, toothache, painful menstruation.
• It is also used to treat symptoms of flu and colds (pain, fever), sore throat.

Voltaren Acti relieves symptoms of inflammation such as pain and swelling by blocking the synthesis of molecules (prostaglandins) responsible for inflammation, pain, and fever.

Voltaren Acti does not affect the causes of inflammation and fever.

You should consult your doctor if symptoms worsen or do not improve within 5 days for pain or 3 days for fever.

Do not take a higher dose than recommended.

Use the lowest effective dose for the shortest possible time.

2. Important information before taking Voltaren Acti

When not to take Voltaren Acti

• If you are allergic to diclofenacor to any of the other ingredients of this medicine(listed in section 6);
• If you have ever had allergic reactions to pain, inflammation, or fever medications, or if you think you may be allergic to diclofenac, ibuprofen, or acetylsalicylic acid (also used to prevent blood clotting) or any other NSAID. Symptoms of hypersensitivity include asthma attacks, wheezing, facial and lip swelling (angioedema), difficulty breathing, chest pain, runny nose, rash, or any other allergic reactions. If in doubt, consult your doctor or pharmacist;
• If you have had heart or brain blood vessel disease, e.g., after a heart attack, stroke, transient ischemic attack (temporary cerebral ischemia), or blood vessel surgery or angioplasty;
• If you have circulatory disorders(peripheral vascular disease);
• If you have or have had stomach or duodenal ulcers;
• If you have blood in your stool or black stools(symptoms indicating gastrointestinal bleeding);
• If you have severe kidney or liver failure;
• In the last three months of pregnancy.

Tell your doctor or pharmacist if you have any of these conditions, as Voltaren Acti should not be taken in such cases.

Warnings and precautions

Before taking Voltaren Acti, discuss with your doctor or pharmacist:

• If you have had gastrointestinal disorders, such as stomach or duodenal ulcers, gastrointestinal bleeding, or black stools. If you have had stomach problems or heartburn after taking pain or anti-inflammatory medications;
• If you have intestinal disorders;
• If you have recently had or are scheduled to have stomach or intestinal surgery, as Voltaren Acti may sometimes cause delayed wound healing after surgery;
• If you have allergies, wheezing, shortness of breath, or nasal polyps;
• If you have kidney or liver function disordersor if you have swelling of the feet;
• If you are taking other anti-inflammatory or pain medications;
• If you have heart problems;
• If you are at risk of dehydration(due to disease, diarrhea, before or after surgery);
• If you have bleeding disordersor other blood diseases, including rare porphyria.

Before taking the medicine, tell your doctor or pharmacist

• If you smoke;
• If you have diabetes;
• If you have: angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Taking the minimum effective dose for the shortest possible time can reduce the risk of side effects.

Other warnings:

• Taking medicines like Voltaren Actimay 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 them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been rarely reported with the use of NSAIDs. 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 you experience the first symptoms of skin rash, mucosal damage, or other signs of hypersensitivity (see section 4), contact your doctor and stop taking the medicine.

Do not exceed:

• the recommended dose of 6 tablets per day;
• treatment duration: 5 days for pain or 3 days for fever.
• If you experience any signs or symptoms of heart or blood vessel disorders, such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor immediately.
• Voltaren Acti may mask infection symptoms(e.g., headache, elevated body temperature) and make it difficult to diagnose. Inform your doctor that you are taking the medicine.
• Long-term use of pain medications for headaches can lead to worsening of headaches. In such cases, consult your doctor.

Using Voltaren Acti in elderly patients

As with other pain medications, elderly people may respond more strongly to the medicine compared to adults. Follow the instructions in the leaflet, use the lowest effective dose, and report any side effects to your doctor.

Children and adolescents

Do not use the medicine in children and adolescents under 14 years of age unless your doctor advises otherwise.

Voltaren Acti and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, and about any medicines you plan to take.

It is especially important to inform your doctor about the use of the following medicines:

• Lithium or antidepressant medications(used to treat depression).
• Digoxin(used to treat heart conditions).
• ACE inhibitors or beta-blockers(used to treat high blood pressure or heart failure).
• Methotrexate(used to treat certain cancers or arthritis).
• Diabetes medications, except insulin.
• Diuretics(increasing urine output).
• Blood thinning medications(anticoagulants).
• Other anti-inflammatory or pain medications, such as acetylsalicylic acid or ibuprofen.
• Corticosteroids(used to reduce inflammation on various body surfaces).
• Cyclosporine and tacrolimus(used in patients with transplanted organs).
• Trimethoprim(used to prevent or treat urinary tract infections).
• Quinolone antibiotics(used to treat infections).
• Sulfinpyrazone(used to treat gout) or voriconazole(used to treat fungal infections).
• Phenytoin(used to treat epilepsy).
• Cholestyramine or colestipol(used to regulate cholesterol levels).

Using Voltaren Acti with food and drink

Swallow the tablet whole, preferably during or after a meal, with a glass of water.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before taking Voltaren Acti.

If you are pregnant or think you may be pregnant, tell your doctor and do not take Voltaren Acti. Do not take Voltaren Acti if you are in the last three months of pregnancy, as it may harm your unborn baby or cause problems during delivery. Voltaren Acti may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in you and your baby and prolong labor. During the first 6 months of pregnancy, do not take Voltaren Acti unless your doctor considers it absolutely necessary. If treatment during the first 6 months or while trying to conceive is necessary, use the lowest effective dose for the shortest possible time. Taking Voltaren Acti from the 20th week of pregnancy for more than a few days may cause kidney problems in the unborn baby. This can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding

Do not take Voltaren Actiwhile breastfeeding, as the medicine may harm your baby.

During pregnancy and breastfeeding, consult your doctor or pharmacist before taking any medicine.

Fertility

Like other anti-inflammatory medications, taking diclofenac, the active substance of Voltaren Acti, may make it more difficult to become pregnant. This effect is reversible if you stop taking the medicine; however, if you are planning to become pregnant or are having trouble becoming pregnant, inform your doctor.

Driving and using machines

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

Important information about some ingredients of Voltaren Acti

The medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

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

3. How to take Voltaren Acti

Always take this medicine exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, 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 time.

Adults and adolescents over 14 years of age

The initial dose is 2 tablets. If necessary, you can take 1 or 2 tablets every 4 to 6 hours. Do not take more than 6 tablets in 24 hours.

Swallow the tablet whole with a glass of water.

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

Taking a higher dose of Voltaren Acti than recommended

If you have taken a higher dose than recommended, contact your doctor or pharmacist immediately.

Missing a dose of Voltaren Acti

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Voltaren Acti can cause side effects, although not everybody gets them. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Some side effects can be serious

Some side effects occur infrequently, especially with high doses (150 mg per day) and long-term use.

Infrequent –(occurring in less than 1 in 100 people taking the medicine):

• Palpitations, sudden and crushing chest pain (symptoms of a heart attack),
• 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.

• 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 feeling of tightness in the chest with wheezing or coughing (symptoms indicating asthma);
• Sudden and severe headache, stiffness of the neck, 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 peeling;
• Swelling of the hands, fingers, feet, and ankles;
• Any changes in the appearance or amount of urine, blood in the urine;
• Yellowing of the skin or eyes (symptoms of kidney and/or liver failure);
• Bleeding, bruising, high fever, or prolonged sore throat, frequent infections, extreme paleness, weakness;
• Increased sensitivity of the skin to light.

Some side effects with unknown frequency can be serious.

• Mild painful cramps and tenderness in the abdomen, occurring soon after starting Voltaren Acti, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency unknown - cannot be estimated from available data);
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome;

Taking diclofenac may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is increased with high doses and long-term use.

If you experience any of the above side effects, contact your doctor immediately.

Other side effects

Side effects that may occur are usually mild. Some side effects have been observed with higher doses of diclofenac, the active substance of Voltaren Acti, taken for a long time.

If you experience any of these, contact your doctor or pharmacist.

Common

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

• Abdominal pain, stomach pain, diarrhea, nausea, bloating, indigestion, decreased appetite.
• Headache, dizziness.
• Rash.

Uncommon

(occurring in less than 1 in 100 people taking the medicine):

• Drowsiness.
• Hives.

Rare

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

• Constipation, oral thrush, swelling, redness, and pain of the tongue, taste disturbances, stomach cramps.
• Itching and redness of the skin, hair loss.
• Numbness or tingling of the hands or feet, tremors.
• Blurred vision, ringing in the ears, hearing disturbances.
• Mood changes, difficulty sleeping, feeling disoriented.
• High blood pressure, vasculitis.

If you experience any side effects not listed in this leaflet, stop taking Voltaren Acti and inform your doctor.

If you have taken a higher dose than recommended, inform your doctor, pharmacist, or go to the nearest emergency department. Overdose may require specialized medical care.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring 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.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Voltaren Acti

Keep the medicine out of the sight and reach of children.

Store in a temperature 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 month.

Medicines should 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 silica, lactose monohydrate, corn starch, sodium carboxymethylcellulose, 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 coated tablets

Marketing authorization holder

Haleon Poland Sp. z o.o.

ul. Rzymowskiego 53

02-697 Warsaw

tel. 800 702 849

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

Date of last revision of the leaflet: December 2024