CARVOMIN ORAL SOLUTION DROPS

Introduction

Patient Information Leaflet

Carvomin oral drops in solution.

Extract of a mixture of angelica root, blessed thistle, and peppermint leaves.

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

This medication can be obtained without a prescription. Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the leaflet:

1. What Carvomin oral drops in solution are and what they are used for
2. What you need to know before taking Carvomin oral drops in solution
3. How to take Carvomin oral drops in solution
4. Possible side effects
5. Storage of Carvomin oral drops in solution
6. Package contents and additional information

1. What Carvomin oral drops in solution are and what they are used for

Carvomin oral drops in solution are a traditional herbal medicinal product to facilitate heavy digestions in adults.

This medication is a traditional herbal medicinal product for use in a specific indication or indications, based solely on long-standing use.

The patient should consult a doctor or a qualified healthcare professional if symptoms persist during the use of the medication or if adverse reactions not mentioned in the leaflet occur.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Carvomin oral drops in solution

Do not take Carvomin oral drops in solution

• if you are allergic to angelica root, blessed thistle, or other asteraceae, peppermint leaves, menthol, or any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding
• do not administer to children under 12 years of age
• if you have an irritable stomach due to excessive gastric juice secretion and acute gastritis.
• if you have or have had liver disease or are taking medications that include liver damage as a side effect in the leaflet. In case of doubt, consult your doctor or pharmacist.

Warnings and precautions:

Consult your doctor or pharmacist if symptoms persist or if the expected results are not achieved despite treatment.

Be particularly cautious:

• if you have bile duct stones or other bile duct disease, you should consult your doctor before taking this medication.
• if you have gastroesophageal reflux. You should not use medications with peppermint leaves as they may increase stomach acidity.
• if you notice that your skin or eyes are yellowish, your urine is dark, your stools are discolored, or you have pain in the upper abdomen, stop treatment with Carvomin immediately and consult your doctor. These may be symptoms of liver damage.

The furocoumarins contained in angelica root can cause increased skin sensitivity to light, and in combination with UV rays, can cause dermatitis. For this reason, it is advisable to avoid prolonged exposure to sunlight and ultraviolet light during treatment with Carvomin oral drops in solution.

Children and adolescents under 18 years of age

Administration of this medication is not indicated for children under 12 years of age. There are insufficient studies on the administration of this medication to adolescents between 12 and 18 years of age.

Due to the alcohol content, Carvomin oral drops in solution should not be administered to children and adolescents under 18 years of age.

If your symptoms do not improve within 7 days or worsen, consult your doctor so that they can rule out other serious diseases.

Taking Carvomin oral drops in solution with other medications:

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

No studies have been conducted on the interactions of Carvomin oral drops in solution with other medications. No interactions with other medications are known to date.

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.

Carvomin oral drops in solution should not be taken during pregnancy and breastfeeding.

Administration should be carefully evaluated in women of childbearing age who do not use contraceptive methods, as they may be unknowingly pregnant.

Driving and using machines

Carvomin contains ethanol (alcohol). It does not appear that the recommended doses of the medication will alter the ability to drive or operate machinery. However, it may decrease reaction capacity, so it is not recommended to drive vehicles or operate machinery that requires special attention until it is verified that the ability to perform these tasks is not affected.

Important information about some of the components of Carvomin:

This medication contains 58% ethanol (alcohol), which corresponds to an amount of 0.99 g (maximum 50 drops or 2 ml) per dose, equivalent to 15.9 ml of beer or 6.64 ml of wine.

This medication is harmful to people with alcoholism.

The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

This medication may decrease or increase the effect of other medications.

3. How to take Carvomin oral drops in solution

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: Take 45-50 drops (approx. 2 ml) 1-3 times a day with a little liquid, preferably before meals. If necessary, it can also be taken after meals.

Use in children and adolescents.

Carvomin oral drops in solution are contraindicated in children under 12 years of age (see section "Warnings and precautions").

Administration is not recommended for adolescents between 12 and 18 years of age due to insufficient studies.

If symptoms persist after 7 days of treatment, consult your doctor.

If you take more Carvomin oral drops in solution than you should

To date, no intoxications have been reported. However, the alcohol content present in the product should be considered.

If you have taken more drops than you should, consult your doctor or pharmacist immediately or the Toxicology Information Service (telephone: 91 562 04 20). If the amount ingested is significant, go to the doctor without delay or to the emergency department of the nearest hospital and bring this leaflet with you.

If you forget to take Carvomin oral drops in solution

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

If you have forgotten to take Carvomin, the next dose will be taken as described in the instructions in this leaflet or according to the dose indicated by your doctor.

If you interrupt treatment with Carvomin oral drops in solution

Treatment can be interrupted or suspended prematurely.

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

4. Possible side effects

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

The frequency of side effects is based on the following categories: Very common (may affect up to 1 in 10 patients), Common (may affect up to 1 in 100 patients), Uncommon (may affect up to 1 in 1,000 patients), Rare (may affect up to 1 in 10,000 patients), Very rare (may affect up to 1 in 100,000 patients), Not known (frequency cannot be estimated from available data)

The following side effects have been observed:

Unknown frequency(cannot be estimated from available data):

• In case of prolonged exposure to sunlight or UV rays, skin inflammation similar to sunburn may occur (see section 2 "Warnings and precautions").
• Allergic reactions may occur.
• Liver damage (increased liver values, drug-related jaundice, hepatitis, and liver failure) has been reported; if you notice symptoms such as yellowing of the skin or eyes, dark urine, discolored stools, you should stop treatment with Carvomin immediately and consult your doctor.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use

Website: www.notificaRAM.es.

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

5. Storage of Carvomin oral drops in solution

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

Do not use the medication after the expiration date shown on the label and packaging after the abbreviation CAD. 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 Sigre collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

No special storage conditions are required.

Indication regarding the duration after opening the package:

Once the package is opened, the duration is 6 months.

6. Package contents and additional information

Composition of Carvomin oral drops in solution

Active ingredients: extract of a mixture of angelica root, blessed thistle, and peppermint leaves.

1 ml of extract (as liquid extract) (1:4.7-5.3) contains 92.75 mg of a mixture (1:3.3:3.3) of Angelica archangelicaL (angelica root), Cnicus benedictus(blessed thistle, whole plant) and Mentha piperita(peppermint leaves). Extraction solvent: ethanol 60% (V/V).

1 ml = approx. 23 drops.

Other excipients are:

The medication contains 58% (V/V) ethanol.

Appearance of the product and package contents:

Brown-green solution marketed in amber glass bottles with a dropper and screw cap of 20 ml, 50 ml, and 100 ml.

Marketing authorization holder and manufacturer

Holder:

Aristo Pharma Iberia S.L.

c/ Solana, 26

28850 – Torrejón de Ardoz, Madrid

Spain

Manufacturer:

Pharma Werningerode GmbH

Dombergsweg 35

38855 Werningerode

Date of the last revision of this leaflet:October 2021

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/