DIOSMIN KERN PHARMA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Diosmin Kern Pharma 500 mg film-coated tablets

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

• You should consult a doctor if your condition worsens or does not improve after 1 or 2 weeks, depending on the indication.

Contents of the Package Leaflet:

1. What is Diosmin Kern Pharma and what is it used for
2. What you need to know before taking Diosmin Kern Pharma
3. How to take Diosmin Kern Pharma
4. Possible side effects
5. Storage of Diosmin Kern Pharma
6. Package contents and additional information

1. What is Diosmin Kern Pharma and what is it used for

Diosmin Kern Pharma is a venotonic medication: it increases the tone of the veins and the resistance of the capillaries (small blood vessels).

Diosmin Kern Pharma is indicated, in adults, for the relief of symptoms related to mild venous insufficiency of the lower limbs, such as pain, feeling of heaviness, tightness, tingling, and itching in legs with varices or swollen legs.

It is indicated for the relief of symptoms related to hemorrhoids, such as pain or inflammation in the anal area in adults.

You should consult a doctor if your condition worsens or does not improve after 2 weeks of treatment in case of venous insufficiency, or after 1 week of treatment in case of hemorrhoids.

2. What you need to know before taking Diosmin Kern Pharma

Do not take Diosmin Kern Pharma

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diosmin Kern Pharma.

Do not use for prolonged periods without medical supervision.

Children and adolescents

Diosmin Kern Pharma is not intended for use in children and adolescents (under 18 years of age).

Using Diosmin Kern Pharma with other medications

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

No interactions with food or other medications are known. In any case, never take another medication on your own initiative without your doctor's recommendation.

Using Diosmin Kern Pharma with food, beverages, and alcohol

No interactions of this medication with food, beverages, or alcohol are known.

Pregnancy, breastfeeding, and fertility

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

No harmful effects have been reported in humans. However, caution should be exercised when using diosmin during pregnancy, weighing the potential benefits of this medication during pregnancy.

It is not known whether the medication passes into breast milk, so its use is not recommended during breastfeeding.

Driving and using machines

No effects of diosmin on the ability to drive and use machines have been reported.

3. How to take Diosmin Kern Pharma

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults

Venous insufficiency:

The recommended dose in adults is 2 tablets per day, divided into two doses, one tablet at midday and another at night, with meals.

Relief of symptoms usually occurs within the first 2 weeks of treatment. If you do not feel relief after 2 weeks or symptoms worsen, you should consult your doctor.

On medical indication, treatment can be continued with the same daily dose (2 tablets per day) for up to 2 to 3 months.

Hemorrhoids:

The recommended dose is:

For the first 4 days: 2 tablets, 3 times a day.

For the next 3 days: 2 tablets, 2 times a day.

After this, treatment can be continued with a dose of 2 tablets per day.

If symptoms do not improve or worsen within the first week of treatment, you should consult your doctor.

Use in children and adolescents

The safety and efficacy of diosmin in children and adolescents have not been established.

If you take more Diosmin Kern Pharma than you should

No cases of overdose with diosmin have been reported.

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

If you forget to take Diosmin Kern Pharma

It is important to take this medication every day. However, if you forget to take one or more doses of Diosmin Kern Pharma, take another as soon as you remember and then continue with the prescribed treatment.

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

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

4. Possible side effects

Like all medications, Diosmin Kern Pharma can cause side effects, although not everyone will experience them.

The frequencies of side effects have been listed below according to the following definitions:

Very common: May affect more than 1 in 10 people

Common: May affect up to 1 in 10 people

Uncommon: May affect up to 1 in 100 people

Rare: May affect up to 1 in 1,000 people

Very rare: May affect up to 1 in 10,000 people

Common: gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).

Uncommon: colitis

Rare: disorders of the nervous system (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).

Frequency not known: abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, Quincke's edema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that can cause difficulty breathing).

These side effects have been reported without the need to interrupt treatment.

Reporting side effects

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

5. Storage of Diosmin Kern Pharma

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box 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 SIGRE point in the 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.

6. Package contents and additional information

Composition of Diosmin Kern Pharma

• The active ingredient is diosmin (500 mg per tablet).

• The other components are: microcrystalline cellulose (E460i), gelatin, sodium glycolate starch (potato starch), talc (E553b), magnesium stearate, sodium lauryl sulfate, and orange opadry (hydroxypropyl methylcellulose (E464), glycerol, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), polyethylene glycol 6000, magnesium stearate).

Appearance of the product and package contents

Diosmin Kern Pharma are orange, oblong, and scored film-coated tablets. The tablets are presented in blister packs in boxes of 30 or 60 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this package leaflet:December 2022.

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.es/