CalmanTE Vitaminado PerezGimenez tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CALMANTE VITAMINADO pérezgiménez tablets

Acetylsalicylic acid, caffeine and vitamin B1

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

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

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

Contents of this leaflet

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

1. What CALMANTE VITAMINADO is and what it is used for

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

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

Febrile conditions.

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

2. What you need to know before starting to take 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 medicine (listed in section 6).
• if you have or have had gastric, duodenal ulcers, or recurrent gastric discomfort.
• if you have experienced asthma-type allergic reactions (difficulty breathing, suffocation, bronchospasms, and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, other analgesics, or 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 blood coagulation disorders that predispose you to internal bleeding.
• if you are being treated with medications to prevent blood clotting (oral anticoagulants).
• if you have severe kidney and/or liver disease (renal and/or hepatic insufficiency).
• if you are under 16 years of age, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious condition. In addition, 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, within the next seven days.
• if you are taking anti-inflammatory drugs or other medications, as certain medicines may interact with CALMANTE VITAMINADO and cause undesirable effects (see “Other medicines and CALMANTE VITAMINADO”).
• if you have hypertension, or impaired kidney, heart, or liver function, or have blood coagulation disorders, or are being treated with anticoagulants.
• if you are allergic to other anti-inflammatory or antirheumatic drugs.
• if you have glucose-6-phosphate dehydrogenase deficiency.
• if you have rhinitis and/or urticaria.
• if you have recently been vaccinated.
• if you are diabetic, as caffeine may increase 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 medicine must not be given to children or adolescents under 16 years of age.

Other medicines and CALMANTE VITAMINADO

Certain medicines may interact with CALMANTE VITAMINADO and therefore should not be used without consulting your doctor. This is especially important in the case of:

• Analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to treat pain and/or muscle inflammation, as they increase the risk of gastrointestinal bleeding.
• Corticosteroids, as they may enhance the risk of gastrointestinal bleeding.
• Diuretics.
• Some antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), as they increase the risk of bleeding.
• Medications for blood clotting (oral anticoagulants), as they increase the risk of bleeding.
• Some medications for controlling high blood pressure.
• Medications to lower blood sugar levels.
• Cyclosporine, used in transplant patients.
• Vancomycin, an antibiotic used for certain infections.
• Interferon alfa.
• Lithium, used in certain psychiatric conditions.
• Methotrexate, used in the treatment of cancer and rheumatoid arthritis.
• Medications used to treat gout.
• Antacids.
• Digoxin, used for heart problems.
• Barbiturates, medications used as sedatives for sleep disorders and to treat seizures.
• Zidovudine, used in the treatment of HIV infections.
• Phenytoin and valproic acid, medications used for epilepsy.

Taking alcohol together with acetylsalicylic acid increases the risk of gastrointestinal bleeding.

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

You should avoid taking this medicine with beverages containing caffeine or with other caffeine-containing medicines or substances that stimulate the central nervous system, as this may cause insomnia, nervousness, or irritability.

Inform your doctor or pharmacist if you are currently using or have recently used other medicines, including over-the-counter products, homeopathic remedies, herbal medicines, 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 (cyclosporine and tacrolimus).
• High blood pressure (diuretics and ACE inhibitors).
• Cancer, rheumatoid arthritis (methotrexate).
• Other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
• Anticoagulants (medicines used to "thin" the blood and prevent clots), such as warfarin.
• Medications used to treat gout (probenecid).

Taking CALMANTE VITAMINADO with food, drinks, and alcohol

Take this medicine after meals or with food.

Concomitant use of this medicine with beverages containing caffeine may cause excessive stimulation of the central nervous system, resulting in nervousness, irritability, or insomnia.

Pregnancy and breastfeeding

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.

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

Driving and use of machines

No effects have been reported.

Use in elderly patients

Elderly individuals should not take this medicine without consulting their doctor, as they are more prone to experience adverse effects.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping control tests.

CALMANTE VITAMINADO contains wheat starch

This medicine contains wheat starch, equivalent to more than 20 ppm of gluten, which should be considered by patients with celiac disease.

Patients with wheat allergy (other than celiac disease) must not take this medicine.

Interference with diagnostic tests:

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

3. How to take CALMANTE VITAMINADO

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

The recommended dose for adults and patients over 16 years of age is one tablet every 4–6 hours, if necessary. Under no circumstances 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 must be administered orally and taken after meals or with food. It is recommended to remove the tablet from the packaging immediately before administration.

Always use the lowest effective dose.

The administration of this medicine depends on the presence of pain or fever symptoms. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 10 days, fever for more than 3 days, or if symptoms worsen or new symptoms appear, treatment must be stopped and a doctor should be 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, Tel. 91 562 04 20, indicating the medicine and the amount ingested.

The main symptoms are: headache, dizziness, tinnitus, blurred vision, drowsiness, nausea, vomiting, and occasionally diarrhea. Symptoms such as excitement, restlessness, sweating, and insomnia may also occur due to caffeine.

If you forget to take CALMANTE VITAMINADO

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

4. Possible adverse effects

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

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

Common adverse effects (may affect between 1 and 10 out of 100 patients):

• Gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
• Difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients):

• Reye's syndrome in patients under 16 years of age with febrile conditions, influenza or varicella (see “What you need to know before taking CALMANTE VITAMINADO”).
• Liver problems, especially in patients with juvenile arthritis.

With long-term treatment and high doses, dizziness, tinnitus, deafness, sweating, headache, confusion, and kidney problems may occur.

Treatment must be stopped immediately if the patient experiences any episode of deafness, tinnitus, or dizziness.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CALMANTE VITAMINADO

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

Keep the original container tightly closed.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other 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 medicinal product and contents of the pack

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

They are available in packs containing 10 and 20 tablets, and hospital packs of 200 tablets.

Only certain pack 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 most recent revision of this leaflet: August 2017

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"