biomo

BIOMO-lipon 600 mg film-coated tablets

Important notes (mandatory information)

biomo-lipon 600 mg film-coated tablets. Active ingredient: alpha-lipoic acid. Field of application: For paraesthesia in diabetic nerve damage (polyneuropathy).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


Patient information: Information for users
biomo-lipon 600 mg film-coated tablets
For use in adults
Active ingredient: alpha-lipoic acid

Read the entire package leaflet carefully because it contains important information for you. Always take this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist.
- Keep the package leaflet. You may want to read it again later.
- Ask your pharmacist if you need more information or advice.
- If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4.
- If your symptoms worsen or do not improve, you must see a doctor in any case.

What is in this leaflet
1. WHAT ARE BIOMO-LIPON 600 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIOMO-LIPON 600 MG FILM-COATED TABLETS?
3. HOW TO TAKE BIOMO-LIPON 600 MG FILM-COATED TABLETS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE BIOMO-LIPON 600 MG FILM-COATED TABLETS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE BIOMO-LIPON 600 MG FILM-COATED TABLETS AND WHAT ARE THEY USED FOR?

?lpha-lipoic acid, the active ingredient in biomo-lipon 600 mg, is a substance formed in the body's own metabolism in higher organisms, which influences certain metabolic functions of the body. In addition, alpha-lipoic acid has antioxidant properties that protect nerve cells from reactive degradation products.

biomo-lipon 600 mg is used for paraesthesia in diabetic nerve damage (polyneuropathy).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BIOMO-LIPON 600 MG FILM-COATED TABLETS?

biomo-lipon 600 mg must not be taken,
- if you are allergic to alpha-lipoic acid or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before taking biomo-lipon 600 mg.

Children and adolescents
Children and adolescents are excluded from treatment with biomo-lipon 600 mg, as there is insufficient experience for this age group.

Taking biomo-lipon 600 mg together with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. It cannot be ruled out that the simultaneous use of biomo-lipon 600 mg leads to the loss of effect of cisplatin (a cancer drug). Alpha-lipoic acid, the active ingredient in biomo-lipon 600 mg, easily forms chemical compounds with metals (metal chelator) and should therefore not be given at the same time as metal compounds (e.g. iron preparations, magnesium preparations, milk products due to the calcium content), as this can lead to loss of effect. If the entire daily dose of biomo-lipon 600 mg - 30 minutes before breakfast is taken, iron and magnesium preparations can be taken at noon or in the evening. The blood sugar-lowering effect of antidiabetic agents (insulin or other antidiabetic agents taken orally) may be increased. Therefore, especially at the beginning of therapy with biomo-lipon 600 mg, close monitoring of blood sugar levels is indicated. In individual cases, it may be necessary to reduce the insulin dose or the dose of the antidiabetic agent according to the instructions of the attending physician in order to avoid hypoglycaemic symptoms.

Taking biomo-lipon 600 mg together with food, drink and alcohol
Regular alcohol consumption is a significant risk factor for the development and progression of diseases associated with nerve damage and can therefore also impair the success of treatment with biomo-lipon 600 mg. Therefore, patients with diabetic neuropathy (polyneuropathy) are generally advised to avoid alcohol consumption as far as possible. This also applies to therapy-free intervals.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
It is in accordance with the general principles of pharmacotherapy to use medicines during pregnancy and breast-feeding only after careful consideration of the benefits and risks. Pregnant and breast-feeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by a doctor, as there is no experience with this patient group to date. Special studies in animals have shown no evidence of impaired fertility or harmful effects on the foetus.

Breast-feeding
Nothing is known about the possible transfer of alpha-lipoic acid into breast milk.

Driving and using machines
No special precautions are required.

biomo-lipon 600 mg contains lactose.
Therefore, please only take biomo-lipon 600 mg after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE BIOMO-LIPON 600 MG FILM-COATED TABLETS?

Always take this medicine exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

Unless otherwise prescribed, the daily dose is 1 film-coated tablet biomo-lipon 600 mg (corresponding to 600 mg alpha-lipoic acid), which should be taken as a single dose about 30 minutes before the first meal. Always take biomo-lipon 600 mg exactly as described in this leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The breaking notch is only used to divide the film-coated tablet if you have difficulty swallowing it whole.

Method of administration
biomo-lipon 600 mg film-coated tablets should be taken unchewed and with sufficient liquid on an empty stomach. The simultaneous intake of food can hinder the passage of alpha-lipoic acid into the bloodstream. Therefore, it is particularly important for patients who also have a prolonged gastric emptying time to take the medicine half an hour before the meal/breakfast.

Duration of use
As diabetic neuropathy is a chronic disease, you may need to take biomo-lipon 600 mg permanently. In individual cases, your doctor will decide.

If you have taken more biomo-lipon 600 mg than you should
Overdosage may cause nausea, vomiting and headache. In individual cases, severe, sometimes life-threatening poisoning symptoms have been observed when taking more than 10 g of alpha-lipoic acid, especially when combined with heavy alcohol consumption (such as generalised seizures, acid-base imbalance with lactic acidosis, severe blood clotting disorders). Therefore, if there is a suspicion of a significant overdose or accidental ingestion with biomo-lipon 600 mg (e.g. more than 10 tablets of 600 mg in adults and more than 50 mg/kg body weight in children), immediate hospitalisation and initiation of measures according to the general principles of treatment of poisoning cases are required.

If you forget to take biomo-lipon 600 mg
Do not take twice the amount if you have forgotten to take the previous dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following categories are used for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Gastrointestinal disorders
Very rare: nausea, vomiting, gastrointestinal pain and diarrhoea.

Hypersensitivity reactions
Very rare: allergic reactions such as rash, hives (urticaria) and itching.

Nervous system disorders
Very rare: change or disturbance of taste perception.

General disorders and administration site conditions
Very rare: Due to improved glucose utilisation, blood sugar levels may drop. Symptoms such as dizziness, sweating, headache and visual disturbances have been described.

Special notes

If you observe the above side effects, biomo-lipon 600 mg should not be taken again. Inform your doctor so that he/she can decide on the severity and any further measures that may be necessary. At the first signs of a hypersensitivity reaction, the medicine must be discontinued and a doctor must be contacted immediately.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the
Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: http://www.bfarm.de

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BIOMO-LIPON 600 MG FILM-COATED TABLETS?

Keep this medicine out of the reach of children.
Do not store above 25° C!
Store in the original package to protect the contents from light.
Do not use this medicine after the expiry date which is stated on the blister pack and carton. The expiry date refers to the last day of the month indicated.
Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What biomo-lipon 600 mg contains
- The active ingredient is: alpha-lipoic acid.

- The other ingredients are

Lactose monohydrate (Ph.Eur.), povidone K25, microcrystalline cellulose, cellulose powder, highly dispersed silicon dioxide (Ph.Eur.), silicon dioxide hydrate, sodium carboxymethyl starch (type A) (Ph.Eur.), stearic acid, magnesium stearate (Ph.Eur.), hypromellose, talc, macrogol 6000, titanium dioxide (E171), iron oxide hydrate (E 172).

What biomo-lipon 600 mg looks like and contents of the pack

biomo-lipon 600 mg are ochre-yellow, olive-shaped film-coated tablets with a breaking notch on both sides.
biomo-lipon 600 mg is available in packs of 30 film-coated tablets, 60 film-coated tablets and 100 film-coated tablets.
Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer
biomo pharma GmbH
Josef-Dietzgen-Str. 3
53773 Hennef
Tel. 02242/8740-0
Fax: 02242/8740-499
E-Mail: biomo@biomopharma.de

This leaflet was last revised in January 2015.

Source: Information from the package leaflet
Status: 09/2015
Active ingredient: alpha-lipoic acid. Field of application: For paraesthesia in diabetic nerve damage (polyneuropathy).