HEMOLIV 1000 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Hemoliv 1,000 mg film-coated tablets

Diosmin

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.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your 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 symptoms worsen or do not improve after 1 week.

Contents of the Package Leaflet

1. What Hemoliv is and what it is used for
2. What you need to know before taking Hemoliv
3. How to take Hemoliv
4. Possible side effects
5. Storage of Hemoliv
6. Package Contents and Additional Information

1. What Hemoliv is and what it is used for

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

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 symptoms worsen or do not improve after 1 week of treatment.

2. What you need to know before taking Hemoliv

Do not take Hemoliv

If you are allergic to diosmin, other flavonoids, or any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Hemoliv.

If your symptoms persist for more than 7 days, you should consult your doctor.

Children and Adolescents

Hemoliv is not indicated for children and adolescents (under 18 years of age).

Other Medications and Hemoliv

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

No interactions with food or other medications are known; however, you should never take another medication on your own initiative without your doctor's recommendation.

Pregnancy and Breastfeeding

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.

Pregnancy

As a precautionary measure, it is preferable to avoid using Hemoliv during pregnancy.

Breastfeeding

Breastfeeding is not recommended during treatment due to the lack of data on the excretion of the medication in breast milk.

Driving and Using Machines

No effects on driving ability or machine use have been described with Hemoliv.

Hemoliv contains lactose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Hemoliv contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Hemoliv

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:

The recommended dose is 3 tablets per day for the first four days and 2 tablets per day for the next 3 days. After this, a dose of 1 tablet per day can be maintained. The tablets should be taken with water to facilitate swallowing.

The tablet can be divided into equal doses.

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

If you take more Hemoliv than you should

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

If you forget to take Hemoliv

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

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

4. Possible side effects

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

These side effects include:

• Frequent (may affect up to 1 in 10 patients): gastrointestinal disorders (diarrhea, indigestion, nausea, vomiting).
• Uncommon (may affect up to 1 in 100 patients): colitis.
• Rare (may affect up to 1 in 1,000 patients): nervous system disorders (dizziness, headache, malaise) and skin reactions (rash, pruritus, urticaria).
• Frequency not known (cannot be estimated from available data): 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).

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 Hemoliv

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hemoliv

• The active ingredient is diosmin (1,000 mg per tablet).

• The other ingredients are:

Tablet core: microcrystalline cellulose (E-460), gelatin, sodium carboxymethyl starch (type A) (from potato), talc, and magnesium stearate.

Tablet coating: Opadry OY-L-28900 white (lactose monohydrate, hypromellose, titanium dioxide, macrogol 4000), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Film-coated tablets, biconvex, oblong, scored, salmon-colored, and marked with the code "D1000" on one side.

The tablets are packaged in single-dose PVC-PVDC/Aluminum blisters. Each package contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Package Leaflet: June 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/