Leaflet: information for the user

Diosmina Kern Pharma 500 mg film-coated tablets

Purified and micronized flavonoid fraction

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

Follow exactly the administration instructions contained in this leaflet or those indicated 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 doctor or pharmacist.
• If you experience any 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 condition worsens or does not improve after 1 or 2 weeks, depending on the indication.

Storage of the container and additional information

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

Diosmina Kern Pharma is indicated, in adults, for the relief of symptoms related to mild lower limb venous insufficiency, such as pain, heaviness, tension, tingling, and itching in legs with varicose veins 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.

Consult a doctor if symptoms worsen or do not improve after 2 weeks of treatment in case of venous insufficiency, or after 1 week of treatment in case of hemorrhoids.

Do not take Diosmina 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 Diosmina Kern Pharma.

Do not use for an extended period without medical supervision.

Children and adolescents

Diosmina Kern Pharma is not intended for use in children and adolescents (under 18 years old).

Use of Diosmina Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take other medications, including those obtained 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.

Use of Diosmina 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

No information is available on whether the medication passes into breast milk, so its use is not recommended during breastfeeding.

Driving and operating machinery

No effects of diosmina on driving and operating machinery have been described.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.orthose indicated by your doctor or pharmacist.

Adults

Varicose Veins:

The recommended dose for 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, consult your doctor.

On doctor's orders, treatment can be continued with the same daily dose (2 tablets per day) for 2 to 3 months.

Hemorrhoids:

The recommended dose is:

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

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

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

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

Use in children and adolescents

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

If you take more Diosmina Kern Pharma than you should

No cases of overdose with diosmina have been described.

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

If you forgot to take Diosmina Kern Pharma

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

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

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

Like all medications, Diosmina Kern Pharma may produce adverse effects, although not all people will experience them.

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

Very frequent: May affect more than 1 in 10 people

Frequent: May affect up to 1 in 10 people

Infrequent: 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

Frequent: Gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).

Infrequent: Colitis

Rare: Nervous system disorders (dizziness, headache, discomfort) and skin reactions (skin rash, pruritus, urticaria).

Unknown frequency: Abdominal pain, isolated edema of the face, lips, and eyelids (swelling). Exceptionally, angioedema (rapid swelling of tissues such as the face, lips, mouth, tongue, or throat that may cause difficulty breathing).

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

Reporting Adverse Effects

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

This product does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diosmina Kern Pharma

• The active principle is the purified and micronized flavonoid fraction (500 mg per tablet), containing Diosmina (450 mg) and other flavonoids expressed in Hesperidina (50 mg).

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

Appearance of the product and content of the packaging

Diosmina Kern Pharma are orange-colored, oval-shaped, and scored tablets on one side. The tablets are presented in blister-type packaging in cases with 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus 72

08228 Terrassa (Barcelona)

Last review date of this leaflet:December 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/