Label: information for the user

CALMANTE VITAMINADO pérezgiménez tablets

Acetylsalicylic acid, caffeine and vitamin B1

Read this label carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days

The association of acetylsalicylic acid, caffeine, hydrochloride of thiamine (vitamin B1) is effective in reducing fever and pain.

CALMANTE VITAMINADO is indicated for symptomatic relief of occasional mild or moderate pains, such as headaches, toothaches, menstrual pains, muscle pains (contractures) or back pains (lumbago).

Feverish states.

You should consult a doctor if it worsens or does not improve after 3 days.

Do not take CALMANTE VITAMINADO:

• if you are allergic to acetylsalicylic acid, caffeine, hydrochloride of thiamine, or any of the other components of this medication (listed in section 6).
• if you have or have had a stomach ulcer, duodenal ulcer, or recurring stomach pain.
• if you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and some cases of coughing or wheezing) when taking anti-inflammatory medications, acetylsalicylic acid, other analgesics, as well as the tartrazine dye.
• 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 bleeding disorders that predispose you to internal bleeding.
• if you are being treated with medications to prevent blood clotting (oral anticoagulants).
• if you have a 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 may interact with CALMANTE VITAMINADO and produce undesirable effects (see "Other medications and CALMANTE VITAMINADO").
• if you have hypertension, reduced kidney, heart, or liver function, bleeding disorders, or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or antirheumatic medications.
• if you have a deficiency of glucose-6-phosphate dehydrogenase.
• if you have rhinitis and/or urticaria.
• if you have been recently vaccinated.
• if you are diabetic, as caffeine may elevate blood glucose 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 minors under 16 years old.

Other medications and CALMANTE VITAMINADO

Certain medications may 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, medications used to treat pain and/or muscle inflammation, as it increases the risk of gastrointestinal bleeding.
• Corticosteroids, as it may potentiate the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding.
• Medications for blood clotting (oral anticoagulants) as it increases the risk of bleeding.
• Some medications for high blood pressure.
• Medications for lowering blood sugar levels.
• Ciclosporin, used in transplants.
• Vancomycin, an antibiotic used in some infections.
• Interferon alfa.
• Lithium, used in some psychiatric diseases.
• Metotrexate, used for cancer and rheumatoid arthritis treatment.
• Medications used for gout treatment.
• Antacids.
• Digoxin, used in heart problems.
• Barbiturates, medications used as sedatives for sleep problems and to treat seizures.
• Zidovudine, used in HIV infections treatment.
• Fenitoína and ácido valproico, medications for epilepsy.

The concurrent use of alcohol with acetylsalicylic acid increases the risk of gastrointestinal bleeding.

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

Avoid taking this medication with beverages containing caffeine or other medications containing caffeine or that stimulate the central nervous system, as it may cause insomnia, nervousness, or irritability.

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

This is especially important in the case of:

• Medications used to prevent transplant rejection (ciclosporin and tacrolimus),
• High blood pressure (diuretics and ACE inhibitors)
• Cancer, rheumatoid arthritis (metotrexate)
• 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 clotting) such as Warfarin.
• Medications used for gout treatment (probenecid)

Take CALMANTE VITAMINADO with food, beverages, and alcohol

Take this medication after meals or with some food.

The simultaneous use of this medication with beverages containing caffeine may cause excessive stimulation of the central nervous system, leading to nervousness, irritability, or insomnia.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

CALMANTE VITAMINADO should not be used during the third trimester of pregnancy and throughout lactation.

Driving and operating machinery

No effects have been described.

Use in elderly patients

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

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical result for doping control.

CALMANTE VITAMINADO contains wheat starch

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

Patients with wheat allergy (other than celiac disease) should not take this medication.

Interference with diagnostic tests:

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

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

The recommended dose for adults and individuals 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 shouldconsult their doctor as they must reduce the dose.

CALMANTE VITAMINADO should be administered orally and taken 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 the preparation is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, discontinue this medication.

If pain persists for more than 10 days, or fever for more than 3 days, or worsens or other symptoms appear, discontinue treatment and consult a doctor.

If you estimate that the action 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 Toxicological Information Service, Tel. 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 occasionally diarrhea. They may also cause symptoms of excitement, restlessness, sweating, and insomnia due to caffeine.

If you forgot to take CALMANTE VITAMINADO

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Frequent adverse effects (may affect between 1 and 10 of every 100 patients):

• Stomach ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, stomach discomfort, nausea, vomiting.
• Difficulty breathing, bronchial spasm, rhinitis.
• Urticaria, skin rash, angioedema
• Hypoprothrombinemia (with high doses)

Rare adverse effects(may affect between 1 and 10 of every 1000 patients):

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

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

Treatment should be immediately suspended if the patient notes any episode of hearing loss, ear noises, or dizziness.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

Keep the original packaging perfectly closed.

Do not store at a temperature above 25°C.

Do not use CALMANTE VITAMINATED after the expiration date indicated 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 medicines you no longer need at the designated point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment

Composition of CALMANTE VITAMINADO Pérez Giménez tablets

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

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

Appearance of the product and content of the packaging

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

They are presented in packaging containing 10 and 20 tablets and clinical packaging of 200 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Pharmex Advanced Laboratories, S.L.

Ctra. A-431 Km. 19

14720 Almodóvar del Río (Córdoba)

Spain

Last review date of this leaflet: August 2017

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