Helar 22,5 mg hard capsules

Package leaflet: information for the user 

Helar 22.5 mg hard capsules

Silymarin

Read the whole leaflet carefully before you start taking this medicinal product because it contains important information for you. Always take this medicine exactly as described in this leaflet or as directed by your doctor or a pharmacist.

• Keep this leaflet; you may need to read it again.
• If you have any further questions, consult a pharmacist.
• If you experience any side effects (even if it is not listed in this leaflet), consult your doctor or pharmacist. (see chapter 4)
• If your condition did not improve within 3 months or has worsened, contact your doctor.

What is in this leaflet?

1. What is HELAR and what it is used for

2. What do you need to know before you use HELAR

3. How to use HELAR

4. Possible side effects

5. How to store HELAR

6. Content of the package and other information.

1. What is HELAR and what it is used for

HELAR’s active substance is silymarin – an active substance of plant origin extracted from the seeds of milk thistle (Silybum marianum). Silymarin has a protective effect on the liver. Studies have shown that silymarin has a strong antioxidant action and controls the level of glutathione inside the cell, neutralises free radicals, stops the access of harmful substances to liver cells, promotes liver renewal and inhibits the accumulation of collagen fibres in the liver. These disorders occur in the case of cirrhosis of the liver.

HELAR hard capsules, as an additional measure, are used for the treatment of adult liver toxicity. This medicinal product can also be used together with other medication for the treatment of chronic hepatitis and cirrhosis of the liver.

2. What do you need to know before you use HELAR

Do not use HELAR:

– If you are allergic to silymarin or any excipient of this medicinal product (they are listed in chapter 6).

 

Warnings and precautions

Consult your doctor or a pharmacist before taking HELAR. If you have diabetes, low levels of glucose or take medicinal products, food supplements or other products that influence levels of glucose, HELAR might reduce glucose levels.

If your condition did not improve or has worsened, consult your doctor.

Use in children and adolescents

Use of HELAR is not recommended for children and adolescents under 18 years of age.

Other medicinal products and HELAR 

If you take or recently took other medicinal products or you are not sure about that, inform a doctor or a pharmacist.

There is no evidence that HELAR interacts with other medicinal products.

HELAR use with food and beverages

HELAR can be taken during a meal and on an empty stomach.

Pregnancy and breastfeeding

If you are (possibly) pregnant, breastfeeding or wish to become pregnant, consult your doctor or a pharmacist before taking this medicinal product.

Animal studies do not indicate direct or indirect harmful effect with respect to pregnancy, embryo or foetus development, or parturition. There are no studies on pregnant or breastfeeding women so it is not recommended to take this medicinal product during these periods.

Driving and using machines

HELAR does not influence the ability to drive and use machines.

HELAR contains lactose monohydrate.

If the doctor told you that you are allergic to some carbohydrates, consult your doctor before you start taking this medicinal product.

3. How to use HELAR

Always take this medicinal product exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

You need to take 3 or 4 hard capsules of 22.5 mg 3 times a day.

It is recommended to use this medicinal product for more than 3 months.

No dose adjustment in elderly patients with impaired renal function is needed.

If you take more HELAR than you should

In the event of an accidental overdose, consult your doctor or the nearest hospital emergency department.

 

If you forget to take HELAR

If you forget to take a dose at the usual time, take it as soon as you remember. If it is almost time to take another dose, skip the forgotten one and continue using the medication normally. Do not use a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicinal product, consult your doctor or a pharmacist.

4. Possible side effects

This medicinal product, like all of them, can cause side effects, although, not everybody experiences them.

HELAR can cause the following side effects.

The frequency of a side effect is unknown (cannot be estimated from the available data)

Headache, dizziness, epigastrium (epigastric region) pain, diarrhoea, itchiness and hives.

Reporting side effects

If you experience side effects, including the effect not indicated in this leaflet, tell your doctor or a pharmacist. You can also report a side effect directly, via the form on www.vvkt.lt website, by mail to the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania, Žirmūnų str. 139A, LT 09120 Vilnius, phone: 8 800 73568, fax: 8 800 20131 or via email: NepageidaujamaR@vvkt.lt. By reporting a side effect, you can help us get more information about the safety of this medicinal product.

 

5. How to store HELAR

Keep out of the reach and sight of children.

Do not store above 25 ^oC.

Do not use this medicinal product after the expiry date stated on the carton and blister pack. This medicinal product is suitable for use until the last day of the indicated month.

Medicinal products should not be disposed to drainage or with household waste. Ask a pharmacist how to dispose of unnecessary medicinal products. These measures will help protect the environment.

6. Content of the package and other information

HELAR composition

– The active substance is silymarin. Each hard capsule contains 34.6–75 mg of Silybum marianum (L.) Gaertn., fructus (milk thistle fruit) refined and standardised dry extract (24-27:1) that corresponds to 22.5 mg of silymarin, based on silibinin.

Extraction solvent: acetone : water (95:5). 

or

Each hard capsule contains 34.6–75 mg of Silybum marianum (L.) Gaertn., fructus (milk thistle fruit) refined and standardised dry extract (36-44:1) that corresponds to 22.5 mg of silymarin based on silibinin.

Extraction solvent: ethyl acetate.

– Excipients. The capsule contains microcrystalline cellulose, lactose monohydrate, talc, magnesium stearate, anhydrous colloidal silicon dioxide. The coating of the tablet contains gelatine, red iron oxide (E172), titanium dioxide (E171).

HELAR appearance and amount in the package

HELAR hard capsules are chestnut brown, filled with light yellow powder.

HELAR is packed in blister packs of 20 capsules. Blister packs are packed in cartons of 40, 60, 80, 100, 120, 140, 160, 180 or 200 capsules.

Not all package sizes might be available.

Registrant and producer

UAB Aconitum

Inovaciju str. 4

Biruliskes village

Kaunas district municipality

Lithuania

Phone: +370 37 328008

Fax: +370 37 338487

Email: info@aconitum.lt

 

If you want more information on this medicinal product, contact the registrant.

 

This package leaflet was last reviewed: 2015-06-18

 

Detailed information on this medicinal product is provided on the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania website https://www.vvkt.lt/.