Diosmina Kern Pharma 500 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diosmina Kern Pharma 500 mg film-coated tablets

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

Follow exactly the instructions for administration contained in this leaflet or those provided by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your doctor or pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

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

Contents of the package leaflet:

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

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

Diosmina Kern Pharma is a venotonic medication: it increases venous tone and capillary resistance (small blood vessels).

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

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

You should consult a doctor if symptoms worsen or do not improve after 2 weeks of treatment in the case of venous insufficiency, or after 1 week of treatment in the case of haemorrhoids.

2. What you need to know before starting to take Diosmina Kern Pharma

Do not take Diosmina Kern Pharma

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Diosmina Kern Pharma.

Do not use for prolonged periods without medical supervision.

Children and adolescents

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

Taking Diosmina Kern Pharma with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

No interactions with food or other medicines are known. However, you should never take another medicine on your own initiative without your doctor having recommended it.

Taking Diosmina Kern Pharma with food, drinks and alcohol

No interactions of this medicine with food, drinks or alcohol are known.

Pregnancy, breastfeeding and fertility

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

There are no reported harmful effects in humans. However, caution should be exercised when using diosmin during pregnancy, with careful assessment of the potential benefit of this medicine.

It is not known whether the medicine passes into breast milk; therefore, its use during breastfeeding is not recommended.

Driving and using machines

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

3. How to take Diosmina Kern Pharma

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults

Venous insufficiency:

The recommended dose for adults is 2 tablets daily, divided into two doses: one tablet at midday and one in the evening, taken with meals.

Symptom relief usually occurs within the first 2 weeks of treatment. If you do not experience relief within 2 weeks or if symptoms worsen, you should consult your doctor.

As directed by your physician, treatment may continue with the same daily dose (2 tablets daily) 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 following 3 days: 2 tablets, 2 times a day.

After this, treatment may continue with a dose of 2 tablets daily.

If symptoms do not improve or worsen during 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 Diosmina Kern Pharma than you should

Cases of overdose with diosmin have not 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 at telephone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Diosmina Kern Pharma

It is important to take this medicine every day. However, if you forget to take one or more doses of Diosmina Kern Pharma, take the next dose 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Diosmina Kern Pharma can produce adverse effects, although not everyone will experience them.

The frequencies of adverse effects are 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: nervous system disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diosmina Kern Pharma

This medicine does not require special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diosmina Kern Pharma

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

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

Appearance of the medicine and pack contents

Diosmina Kern Pharma are orange-colored, oblong tablets, scored on one side. The tablets are presented in blister packs contained in cartons with 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 most recent revision of this leaflet: December 2022.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.es/