Dolotren 46.5 mg dispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dolotren 46.5 mg dispersible tablets

diclofenac

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolotren is and what it is used for

The active substance in Dolotren is diclofenac 46.5 mg (equivalent to 50 mg of sodium diclofenac). Diclofenac belongs to a group of medicines known as non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

This medicine is used for short-term treatment of acute inflammatory and painful conditions following trauma or surgery.

2. What you need to know before taking 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 to 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 (analgesics). Reactions may include asthma (difficulty breathing), urticaria (skin allergic reaction with itching), acute rhinitis (inflammation of the nasal mucosa), or facial swelling. If you think you may be allergic, consult your doctor.
• if you have previously had stomach or duodenal bleeding, or experienced a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug.
• if you currently have or have had on more than one occasion: a stomach or duodenal ulcer or gastrointestinal bleeding.
• if you suffer from active Crohn's disease or active ulcerative colitis (conditions causing diarrhoea 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), blockages in blood vessels of the heart or brain, or undergone surgery to remove an obstruction or coronary bypass.
• if you have or have had circulation problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood coagulation disorders.

Before taking diclofenac, make sure your doctor knows:

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

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Warnings and precautions

Consult your doctor or pharmacist before starting Dolotren

• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

• if you suffer from 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 gastrointestinal ulceration and/or bleeding (see section “Other medicines and Dolotren”).

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

• some people MUST NOT use Dolotren. Consult your doctor if you think you may be allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of Dolotren (listed at the end of the leaflet). Signs of hypersensitivity reactions include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.

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

Inform your doctor

• if you are taking medicines that affect blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

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

• if you have high blood pressure, elevated cholesterol or triglyceride levels, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with Dolotren, especially if treatment lasts more than 4 weeks.

• if you have liver impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. These tests monitor liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This allows your doctor to decide whether to stop or adjust your Dolotren dose.

• if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes impair wound healing in the intestine after surgery.

Patients with cardiovascular problems

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

If you have heart problems, a history of stroke, or think you may be at risk (for example, 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 treatment lasts longer than 4 weeks.

Also, these medicines may cause fluid retention, particularly 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 needed to relieve pain and/or inflammation, to reduce the risk of cardiovascular adverse effects.

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

Children and adolescents

This medicine is not recommended for use 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 younger adults. Therefore, it is especially important that elderly patients report any adverse effects to their doctor immediately.

Other medicines and Dolotren

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

Certain medicines may interact with Dolotren, and in such cases it may be necessary to adjust the dose or stop 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 serotonin reuptake inhibitors (used to treat certain types of depression),
  • medicines containing methotrexate (used to treat cancer and rheumatoid arthritis),
  • medicines containing cyclosporine, tacrolimus (used after organ transplants),
  • medicines containing trimethoprim (used to prevent and treat urinary tract infections),
  • medicines used to treat heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
  • medicines used to treat diabetes, except insulin,
  • medicines used to control blood pressure (diuretics, beta-blockers, and ACE inhibitors),
  • medicines used to prevent blood clots,
  • medicines containing quinolone or ceftriaxone (used to treat infections),
  • other medicines in the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
  • corticosteroids (medicines that reduce inflammation and suppress immune system activity),
  • medicines containing voriconazole (used to treat fungal infections),
  • medicines containing phenytoin (used to treat epileptic seizures),
  • medicines containing misoprostol (used to treat stomach ulcers),
  • medicines containing colestyramine and colestipol (used to lower blood cholesterol levels),
  • medicines containing pentazocine (used to relieve pain).

Taking Dolotren with food and alcohol

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

Consuming alcoholic beverages together 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Dolotren during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labour more than expected.

You should not take Dolotren during the first 6 months of pregnancy unless clearly necessary and specifically instructed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time.

From week 20 of pregnancy, Dolotren may cause kidney problems in your unborn baby if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) 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

Small amounts of diclofenac may appear in breast milk; therefore, 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 reduced fertility.

Driving and using machines

The effect of diclofenac on the ability to drive and use machines is none or negligible. 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 sodium carboxymethylstarch, 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 instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults and children over 14 years of age

In milder cases, 2 tablets of Dolotren per day are usually sufficient. Do not exceed a 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 preferably be taken before meals or on an empty stomach (see section "Taking Dolotren with food and drink").

The tablets must be dissolved in a glass of water. Place one tablet into a glass of water and stir. Once dissolved, drink the liquid. If any residue 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 at telephone number: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to take Dolotren

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody experiences them.

Some adverse effects may be serious.

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

• Mild abdominal cramps and abdominal pain on palpation starting shortly after beginning treatment with this medicine, followed by rectal bleeding or diarrhoea with blood, usually observed within 24 hours after the onset of abdominal pain (frequency not known, cannot be estimated from available data).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Severe skin allergic reaction, which may include widespread red or dark patches, skin swelling, blisters and itching (generalized fixed bullous drug eruption).

Reporting of adverse reactions:

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Dolotren

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

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

Do not use Dolotren after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolotren 46.5 mg dispersible tablets

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

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

Appearance of the product and contents of the pack

Each pack contains 40 white dispersible tablets.

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

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Date of the most recent review of this leaflet: November 2025

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