Package Insert: Information for the User

Diclofenaco Alter 50 mg Gastric-Resistant Tablets EFG

Diclofenac Sodium

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

Diclofenaco sodium, the active ingredient of this medication, belongs to the group of medications known as nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation.

This medication is used to treat the following conditions:

-Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),

-Extra-articular rheumatism,

• Acute gout attacks,
• M menstrual pains,
• Post-traumatic inflammation.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using Diclofenaco Alter, as Diclofenaco Alter may sometimes worsen the healing of intestinal wounds after surgery.

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

Do not take Diclofenaco Alter

• 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 it. Reactions may include asthma (difficulty breathing), chest pain, urticaria (allergic reaction on the skin 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 previous stomach or duodenal bleeding or have suffered, on two or more occasions, a perforation of the digestive system while taking a nonsteroidal anti-inflammatory drug.
• if you currently have or have had more than one occasion of stomach or duodenal ulcer or bleeding.
• if you suffer from 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 cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the heart or brain blood vessels, or a procedure to remove an obstruction or bypass the coronary artery.
• if you have or have had circulation problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have bleeding disorders.

Make sure before taking diclofenac that 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 adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Be especially careful with Diclofenaco Alter

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

This risk is higher when using high doses and prolonged treatments 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 protector medication.

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

-if you are taking other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as it increases the risk of stomach ulcers and/or gastrointestinal bleeding (see "Taking other medications" section).

• if you are taking blood pressure medications or ciclosporin, as it increases the risk of kidney damage (see "Taking other medications" section).

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 like 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.

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

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

-if you have liver insufficiency, kidney insufficiency, or bleeding disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to control the functioning 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 the dose of this medication.

Patients with cardiovascular problems

Medications like diclofenac can 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 can 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 this medication for the shortest possible time to alleviate 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.

Taking other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Certain medications may interact with this medication; in these cases, you may need to change the dose or interrupt treatment with one of them.

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

• medications containing lithium or selective serotonin reuptake inhibitors (for treating certain types of depression),
• medications containing methotrexate (for treating rheumatoid arthritis and cancer),
• medications containing ciclosporin, tacrolimus (after transplants),
• medications containing trimethoprim (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 blood pressure (diuretics, beta blockers, and ACE inhibitors),
• medications for preventing blood clots,
• medications containing quinolone or ceftriaxone (for treating infections),
• other medications in the same group as diclofenac (nonsteroidal 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 to lower cholesterol levels in the blood),
• medications containing pentazocine (for relieving pain).

Taking Diclofenaco Alter with food and drinks

This medication should be taken preferably before meals or on an empty stomach, as it delays the onset of effect.

The consumption of alcoholic beverages with this medication may increase its toxicity.

Use in children and adolescents

This medication is not recommended for use in 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 rest of adults. Therefore, it is especially important for elderly patients to inform their doctor immediately about any adverse effects they experience.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

Due to the association of diclofenac-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. In these cases, the dose and duration will be limited to the minimum possible.

Do not take Diclofenaco Alter if you are in 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 fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Do not take Diclofenaco Alter during the first 6 months of pregnancy unless it is clearly 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, Diclofenaco Alter may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional monitoring.

During the third trimester, administration of this medication is contraindicated.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Fertility

For fertile women, it should be noted that diclofenac-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 this medication should avoid driving vehicles or operating machinery.

This medication contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Use in adults and children over 14 years old

In mild cases, 2 tablets of this medication per day are usually sufficient. Do not exceed a dose of 3 tablets (150 mg of diclofenaco) per day. The total daily dose should be divided into 2 or 3 fractional doses.

The daily dose for menstrual cramps, which should be adjusted individually, is 50-200 mg (1 to 4 tablets). An initial dose of 50-100 mg (1 to 2 tablets) will be administered, and if necessary, it will be increased in subsequent menstrual cycles. Treatment should begin when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

Take this medication preferably before meals or with an empty stomach (see section “Taking Diclofenaco Alter with food and drinks”).

The tablets should be swallowed whole with a glass of water or another liquid, without dividing or chewing them.

If you take more Diclofenaco Alter 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 ingested.

If you forgot to take Diclofenaco Alter

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

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

The side effects reported with the use of this medicine are as follows:

Some side effects can be severe.

Inform your doctor immediately if you experience any of the following side effects:

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome

Stop taking Diclofenaco Alter and consult your doctor immediately if you notice:

Side effectswith unknown frequency, (cannot be determined from the available data).

• Mild abdominal cramps and abdominal pain to palpation that begins shortly after starting treatment with Diclofenaco Alter, followed by rectal bleeding or bloody diarrhea observed normally within 24 hours after the onset of abdominal pain.

Reporting of side effects:

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

Keep out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging 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 the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Diclofenaco Alter

The active ingredient is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.

The other components are: Core: sodium carboxymethyl starch (type A) (from potato), lactose monohydrate, povidone 30, microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E-470b), and cornstarch. Coating: hypromellose, macrogol, titanium dioxide (E-171), talc (E-553b), red iron oxide (E-172), yellow iron oxide (E-172), methacrylic acid L30D, and triacetin.

Appearance of the product and contents of the packaging

Diclofenaco Alter is presented in the form of gastro-resistant tablets, lenticular in shape, and brown-orange in color.

Each package contains 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

(Spain)

Last review date of this leaflet: March 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/