CALMANTE VITAMINADO PEREZGIMENEZ TABLETS

2. What you need to know before taking CALMANTE VITAMINADO

Do not take CALMANTE VITAMINADO:

• if you are allergic to acetylsalicylic acid, caffeine, or thiamine hydrochloride or to any of the other components of this medication (listed in section 6).
• if you have or have had stomach ulcers, duodenal ulcers, or recurring stomach problems.
• if you have experienced allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and some cases of coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, or other analgesics, as well as the dye tartrazine.
• if you have or have had asthma with or without nasal polyps, rhinitis, or urticaria after taking acetylsalicylic acid.
• if you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.
• if you are being treated with medications to prevent blood coagulation (oral anticoagulants).
• if you have severe kidney and/or liver disease (renal and/or hepatic insufficiency).
• if you are under 16 years old, as the use of acetylsalicylic acid has been linked to Reye's syndrome, a rare but serious disease. Additionally, this preparation contains caffeine and should not be administered to children.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take CALMANTE VITAMINADO.

• if you have recently undergone surgery, including dental surgery.
• if you are scheduled to undergo surgery, including dental surgery, in the next seven days.
• if you are taking anti-inflammatory medications or other types of medications, as certain medications can interact with CALMANTE VITAMINADO and produce unwanted effects (see "Other medications and CALMANTE VITAMINADO").
• if you have high blood pressure, reduced kidney, heart, or liver function, blood coagulation disorders, or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or anti-rheumatic medications.
• if you have a glucose-6-phosphate dehydrogenase deficiency.
• if you have rhinitis and/or urticaria.
• if you have been recently vaccinated.
• if you are diabetic, as caffeine can raise blood sugar levels.
• if you have previously experienced hypersensitivity reactions to other medications used in asthmatic patients, such as aminophylline or theophylline.

Children and adolescents

This medication should not be administered to children under 16 years old.

Other medications and CALMANTE VITAMINADO

Certain medications can interact with CALMANTE VITAMINADO, so they should not be used without consulting a doctor. This is especially important in the case of:

• Analgesics and non-steroidal anti-inflammatory medications, which can increase the risk of gastrointestinal bleeding.
• Corticosteroids, which can increase the risk of gastrointestinal bleeding.
• Diuretics.
• Certain antidepressants, such as selective serotonin reuptake inhibitors, which can increase the risk of bleeding.
• Medications for blood coagulation (oral anticoagulants), which can increase the risk of bleeding.
• Certain medications for controlling high blood pressure.
• Medications for lowering blood sugar levels.
• Cyclosporine, used in transplants.
• Vancomycin, an antibiotic used in certain infections.
• Interferon alpha.
• Lithium, used in certain psychiatric disorders.
• Methotrexate, used in the treatment of cancer and rheumatoid arthritis.
• Medications used to treat gout.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat convulsions.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medications for epilepsy.

Taking CALMANTE VITAMINADO with alcohol can increase the risk of gastrointestinal bleeding.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

You should avoid taking this medication with beverages that contain caffeine or other medications that contain caffeine or stimulate the central nervous system, as insomnia, nervousness, or irritability may occur.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• Medications used to prevent transplant rejection (cyclosporine and tacrolimus),
• High blood pressure medications (diuretics and ACE inhibitors),
• Cancer and rheumatoid arthritis medications (methotrexate),
• Other analgesics or non-steroidal anti-inflammatory medications (medications used to treat pain and/or muscle inflammation),
• Anticoagulants (medications used to "thin" the blood and prevent clot formation) such as warfarin.
• Medications used to treat gout (probenecid).

Taking CALMANTE VITAMINADO with food, beverages, and alcohol

Take this medication after meals or with some food.

Taking this medication simultaneously with beverages that contain caffeine can cause excessive stimulation of the central nervous system, leading to nervousness, irritability, or insomnia.

Pregnancy and breastfeeding

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.

CALMANTE VITAMINADO should not be used during the third trimester of pregnancy or during breastfeeding.

Driving and using machines

No effects have been described.

Use in elderly patients

Elderly patients should not take this medication without consulting their doctor, as they are more likely to experience adverse effects.

Use in athletes

Athletes are informed that this medication contains a component that can produce a positive result in doping tests.

CALMANTE VITAMINADO contains wheat starch

This medication contains wheat starch, which is equivalent to more than 20 ppm of gluten, and should be taken into account by patients with celiac disease.

Patients with a wheat allergy (distinct from celiac disease) should not take this medication.

Interference with diagnostic tests:

If you are going to undergo any diagnostic tests (including blood or urine tests), inform your doctor that you are taking this medication, as it may alter the results.

3. How to take CALMANTE VITAMINADO

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

The recommended dose for adults and children over 16 years old is one tablet every 4-6 hours, if necessary. In no case should more than 8 tablets be taken in 24 hours (1 day).

Patients with liver or kidney problems should consult their doctor, as they may need to reduce the dose.

CALMANTE VITAMINADO should be taken orally and after meals or with some food. It is recommended to remove the tablet from the packaging immediately before administration.

Always use the lowest effective dose.

The administration of this preparation is subject to the appearance of painful or febrile symptoms. As these symptoms disappear, this medication should be discontinued.

If the pain persists for more than 10 days, or the fever for more than 3 days, or worsens, or other symptoms appear, treatment should be discontinued and a doctor consulted.

If you think the effect of CALMANTE VITAMINADO is too strong or too weak, inform your doctor or pharmacist.

If you take more CALMANTE VITAMINADO than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

The main symptoms are: headache, dizziness, ringing in the ears, blurred vision, drowsiness, nausea, vomiting, and occasional diarrhea. Caffeine can also cause symptoms of excitement, restlessness, sweating, and insomnia.

If you forget to take CALMANTE VITAMINADO

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Due to its effect on platelet aggregation, acetylsalicylic acid can increase the risk of bleeding.

Common side effects (may affect 1 to 10 in every 100 patients):

• Stomach ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, stomach upset, nausea, vomiting.
• Difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

Uncommon side effects (may affect 1 to 10 in every 1000 patients):

• Reye's syndrome in children under 16 years old with febrile processes, flu, or chickenpox (see "What you need to know before taking CALMANTE VITAMINADO").
• Liver problems, especially in patients with juvenile arthritis.

In long-term treatments and with high doses, the following may appear: dizziness, ringing in the ears, hearing loss, sweating, headache, confusion, and kidney problems.

Treatment should be discontinued immediately if the patient experiences any episode of hearing loss, ringing in the ears, or dizziness.

In patients who have experienced allergic reactions to acetylsalicylic acid and other non-steroidal anti-inflammatory medications, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these medications.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Medication Monitoring System for Human Use: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of CALMANTE VITAMINADO

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

Keep the original packaging perfectly closed.

Do not store above 25°C.

Do not use CALMANTE VITAMINADO after the expiration date indicated on the packaging after EXP.: The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of CALMANTE VITAMINADO pérez giménez tablets

Each tablet contains 500 mg of acetylsalicylic acid, 50 mg of caffeine, and 2 mg of thiamine hydrochloride (vitamin B1).

The other components (excipients) are: wheat starch, magnesium stearate, and talc.

Appearance of the product and package contents

CALMANTE VITAMINADO are white, round tablets with the anagram C/V on both sides.

They are available in packages containing 10 and 20 tablets and clinical packages of 200 tablets.

Only certain package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Date of the last revision of this leaflet: August 2017

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