Package Leaflet: Information for the User

Hemoliv 1.000 mg Film-Coated Tablets

Diosmin

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine 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 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 you get worse or do not improve after 1 week.

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

It is indicated for the relief of symptoms related tohemorrhoids such aspain orinflammation in the anal areain adults.

Consult a doctor if symptoms worsen or do not improve after 1 week of treatment.

Do not take Hemoliv

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hemoliv.

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

Children and adolescents

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

Other medications and Hemoliv

Inform your doctor or pharmacist if you are taking, have taken recently, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

As a precaution, it is preferable to avoid the use of Hemoliv during pregnancy.

Breastfeeding

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

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described with Hemoliv.

Hemoliv contains lactose.

If your doctor has indicated 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; that is, it is essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those 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 may be maintained.Tablets should be taken with water to facilitate swallowing.

Tablets can be divided into equal doses.

If symptoms do not improve or worsen in the first week of treatment, you must 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Hemoliv

It is essential to take this medication every day.However, if you forgot 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 compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

These adverse effects include:

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es/.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears 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 drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hemoliv

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

• The other components are:

Tablet core: microcrystalline cellulose (E-460), gelatin, sodium carboxymethylcellulose (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 content of the packaging

Coated tablets with a film, 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.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: June 2021

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.gob.es/