Leaflet: information for the user

Dolotren 46.5 mg dispersible tablets

diclofenac

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient in Dolotren 46.5 mg dispersible tablets is diclofenac (equivalent to 50 mg of diclofenac sodium).

Dolotren belongs to a group of medicines called non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

Dolotren is used as a short-term treatment for acute inflammatory and painful post-traumatic and postoperative conditions.

It is essential to use the smallest effective dose of Dolotren that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Dolotren

• if you are allergic (hypersensitive) to diclofenac or any of the other components of this medication (including those listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other analgesics (pain medications) similar to Dolotren. Allergic reactions may include asthma (difficulty breathing), urticaria (skin rash 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 had a stomach or duodenal hemorrhage in the past, or have experienced a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• if you currently have or have had more than one episode of stomach or duodenal ulcers or hemorrhage.
• if you have active Crohn's disease or ulcerative colitis (diseases that cause diarrhea with or without blood and abdominal pain).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or have undergone surgery to remove an obstruction or perform a coronary bypass.
• if you have peripheral arterial disease (problems with blood circulation).
• if you are in the third trimester of pregnancy.
• if you have bleeding disorders.

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.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Warnings and precautions

Consult your doctor or pharmacist before starting Dolotren treatment.

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

This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor may consider associating a stomach protector.

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

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

• if you are taking medications for high blood pressure or ciclosporin, as this increases the risk of kidney damage (see the section "Other medications 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 NSAID, or to any of the other components of Dolotren. (These are listed at the end of the prospectus). The signs of a hypersensitivity reaction are facial and lip swelling (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.

Inform your doctor

• if you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants, or antiplatelet agents of the type acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

• if you have Crohn's disease or ulcerative colitis, as Dolotren-type medications may worsen these conditions.

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

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

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

Patients with cardiovascular problems

Dolotren-type medications may be associated with an increased risk of heart attacks or strokes, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

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

Additionally, this type of medication may cause fluid retention, especially in patients with heart disease and/or high blood pressure.

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

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

Children and adolescents

This medication is not recommended for children and adolescents under 14 years old.

Use in elderly patients

Elderly patients may be more sensitive to the effects of this medication than the general adult population. Therefore, it is especially important for elderly patients to inform their doctor immediately about any adverse effects.

Other medications and Dolotren

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Certain medications may interact with Dolotren, in which case it may be necessary to change the dose or interrupt treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

-medications containing lithium or selective serotonin reuptake inhibitors (SSRIs) for treating depression,

• medications containingmethotrexate (for treating cancer and rheumatoid arthritis),
• medications containingciclosporin, tacrolimus (after transplants),
• medications containingtrimetoprim (for preventing and treating urinary tract diseases),
• medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medications used to treat diabetes, except for insulin,
• medications for controlling high blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medications forpreventing blood clots,
• medications containing quinolone or ceftriaxone (for treating infections),
• other medications in the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• corticosteroids(medications that reduce inflammation and the action of the immune system),
• medications containing voriconazole (a medication used in the treatment of fungal infections),
• medications containing phenytoin (a medication used to treat seizures),
• medications containing misoprostol (for treating stomach ulcers),
• medications containing cholestyramine and colestipol (for lowering cholesterol levels in the blood),
• medications containing pentazocine (for relieving pain).

Taking Dolotren with food and alcohol

This medication 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Due to the association of Dolotren-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time.

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

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 tendency and that of your baby to bleed and delay or prolong delivery.

Breastfeeding

Small amounts of Dolotren may appear in breast milk, so you should not take this medication while breastfeeding.

Fertility

For fertile women, it is essential to consider that Dolotren-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery

The influence of diclofenac on the ability to drive and operate machinery is negligible or insignificant. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, 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 carboxymethylcellulose sodium from potato, sodium stearate fumarate, and sodium saccharin)

This medication contains less than 23 mg of sodium (1 mmol) per dispersible tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults and children over 14 years old

In mild 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 fractional doses.

Administration form

This medication should be taken preferably before meals or on an empty stomach (see section “Taking Dolotren with food and drinks”).

The tablets should be dissolved in a glass of water. Place one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remaining particles 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 Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Dolotren

Do not take a double dose to compensate for the missed doses.

If you forget a dose, take it as soon as you can, except if it is almost time for the next one; then return to the usual administration schedule. If you forget several doses, consult your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects can be serious.

Stop using Dolotren and immediately inform your doctor if you experience any of the following side effects:

• Abdominal cramps and abdominal pain to palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea observed within 24 hours after the onset of abdominal pain (frequency unknown, cannot be determined from available data).
• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse reactions:

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

Keep this medication 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 expiration date indicated on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Dolotren

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

• The other components (excipients) are: microcrystalline cellulose, cornstarch, sodium carboxymethylstarch, crospovidone, orange flavor, polyethylene glycol 6000, sodium stearoylfumarate, sodium saccharin, anhydrous colloidal silica.

Appearance of the product and content of the packaging

Each package contains 40 dispersible tablets, white in color.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2023

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/