DOLOTREN 46.5 mg dispersible tablets

2. What you need to know before you take Dolotren

It is important that you use the smallest dose of Dolotren that relieves or controls your pain and you should not take this medicine for longer than necessary to control your symptoms.

Do not take Dolotren

• if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other similar painkillers. Reactions can include asthma (difficulty breathing), hives (allergic reaction on the skin with itching), acute rhinitis (inflammation of the nasal mucosa) or swelling of the face. If you think you may be allergic, consult your doctor.
• if you have had a stomach or duodenal hemorrhage, or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medicine.
• if you currently have or have had more than once: a stomach or duodenal ulcer or hemorrhage.
• if you have active Crohn's disease or ulcerative colitis (diseases that produce diarrhea with or without blood and abdominal pain).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA) or blockages in the blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass.
• if you have had problems with blood circulation (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood coagulation disorders.

Make sure your doctor knows before taking diclofenac:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Dolotren

• if you have had or developed an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by severe or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medicine.

• if you have any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders, including hepatic porphyria.

• if you are taking other anti-inflammatory medicines, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see the section "Other medicines and Dolotren").

• if you are taking medicines for blood pressure or cyclosporine, as this increases the risk of kidney damage (see the section "Other medicines and Dolotren").

• Some people SHOULD NOT use Dolotren. Consult your doctor if you think you may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other ingredient of Dolotren. (These are listed at the end of the leaflet). The signs of a hypersensitivity reaction are swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash, or any other allergic reaction.

• If you have ever had a severe skin rash or peeling of the skin, blisters, or sores in the mouth after taking Dolotren or other painkillers.

Tell your doctor

• if you are taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

• if you have Crohn's disease or ulcerative colitis, as medicines like Dolotren may worsen these conditions.

• if you have high blood pressure, high cholesterol, or high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor should regularly reassess whether you should continue treatment with Dolotren, especially if you have been treated for more than 4 weeks.

• if you have liver or kidney failure, or blood disorders, you will need to have frequent blood tests during your treatment. This will allow your doctor to monitor the functioning of your liver (transaminase levels) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels). With this, your doctor can decide to interrupt or change the dose of Dolotren.

• if you have recently undergone or are going to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Medicines like Dolotren may be associated with an increased risk of heart attacks (myocardial infarction) or strokes, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of strokes, or think you may be at risk of having them (for example, you have high blood pressure, diabetes, high cholesterol, or triglycerides, or are a smoker) and your doctor decides to treat you with this medicine, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Also, this type of medicine may cause fluid retention, especially in patients with heart disease and/or high blood pressure (hypertension).

In general, it is very important to take the lowest effective dose of Dolotren for the shortest possible time that relieves pain and/or inflammation to reduce the risk of cardiovascular side effects.

If you experience chest pain, shortness of breath, weakness, or difficulty speaking while taking this medicine, contact your doctor immediately.

Children and Adolescents

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

Use in Elderly Patients

Elderly patients may be more sensitive to the effects of this medicine than other adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any side effects.

Other Medicines and Dolotren

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Certain medicines may interfere with Dolotren, and in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• medicines containing lithium or selective serotonin reuptake inhibitors (for treating some types of depression),
• medicines containing methotrexate (for treating cancer and rheumatoid arthritis),
• medicines containing cyclosporine, tacrolimus (after transplants),
• medicines containing trimethoprim (for preventing and treating urinary tract diseases),
• medicines for treating heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines for controlling blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines for preventing blood clots,
• medicines containing quinolone or ceftriaxone (for treating infections),
• other medicines of the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• corticosteroids (medicines that reduce inflammation and the action of the immune system),
• medicines containing voriconazole (a medicine used in the treatment of fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (for treating stomach ulcers),
• medicines containing cholestyramine and colestipol (for reducing cholesterol levels in the blood),
• medicines containing pentazocine (for relieving pain).

Taking Dolotren with Food and Alcohol

This medicine should be taken preferably before meals or on an empty stomach, as food reduces absorption.

Consuming alcoholic beverages with Dolotren may increase its toxicity.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Because the administration of medicines like Dolotren has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to take this medicine during the first and second trimester of pregnancy unless it is strictly necessary and as indicated by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

From the 20th week of pregnancy, Dolotren may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

In the third trimester, the administration of Dolotren is contraindicated as it may harm your fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and delay or prolong delivery more than expected.

Breastfeeding

Small amounts of Dolotren may appear in breast milk, so you should not take this medicine if you are breastfeeding.

Fertility

For women of childbearing age, it should be noted that medicines like Dolotren have been associated with a decrease in fertility.

Driving and Using Machines

The influence of diclofenac on the ability to drive and use machines is negligible or minimal. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while taking Dolotren should avoid driving vehicles or operating machinery.

Dolotren 46.5 mg Dispersible Tablets contain sodium (from potato starch carboxymethylamide, sodium stearyl fumarate, and sodium saccharin)

This medicine contains less than 23 mg of sodium (1 mmol) per dispersible tablet; this is, essentially "sodium-free"

3. How to Take Dolotren

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in Adults and Children over 14 years

In milder cases, 2 Dolotren tablets per day are usually sufficient. Do not exceed the dose of 3 tablets (150 mg of diclofenac) per day. The total daily dose should be divided into 2 or 3 divided doses.

Method of Administration

This medicine should be taken preferably before meals or on an empty stomach (see the section "Taking Dolotren with Food and Beverages").

The tablets should be dissolved in a glass of water. Put one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remains in the glass, add more water and repeat the process.

If you take more Dolotren than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Dolotren

Do not take a double dose to make up for forgotten doses.

If you forget a dose, take it as soon as you can, unless it is almost time for the next dose; then return to your regular dosing schedule. If you forget several doses, consult your doctor.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious.

Stop using Dolotren and inform your doctor immediately if you experience any of the following serious adverse effects; you may need urgent medical treatment:

• Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain (frequency not known, cannot be determined from available data).
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Severe allergic skin reaction, which can include large, generalized red or dark spots, skin swelling, blisters, and itching (generalized fixed drug eruption).

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dolotren

Keep this medicine out of sight and reach of children.

Store the blister pack in the outer packaging to protect it from moisture.

Do not use Dolotren after the expiration date indicated on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Dolotren Composition

• The active ingredient is diclofenac. Each tablet contains 46.5 mg of diclofenac (equivalent to 50 mg of diclofenac sodium).

• The other ingredients (excipients) are: microcrystalline cellulose, corn starch, sodium starch glycolate, crospovidone, orange flavor, polyethylene glycol 6000, sodium stearyl fumarate, sodium saccharin, anhydrous colloidal silica.

Product Appearance and Package Contents

Each package contains 40 dispersible tablets, white in color.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

O

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of Last Revision of this Prospectus:July 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/