Biomo-lipon 600mg, 100 tablets

active ingredients

• 600 mg DL-α-lipoic acid

- Paraesthesia in diabetic neuropathy

ingredients

• hypromellose
• Carboxymethyl Starch, Sodium Type A
• Silica, colloidal
• Corn starch, pregelatinized
• cellulose, microcrystalline
• ferric oxide
• Magnesium stearate (vegetable)
• lactose-1 water
• Macrogol 6000
• titanium dioxide
• talc

Indication :

• Thioctic acid (alpha-lipoic acid) is a substance formed in higher organisms in the body's own metabolism, which influences certain metabolic processes in the body. In addition, thioctic acid has (antioxidative) properties that protect the nerve cell from reactive breakdown products.

• The drug is used in

  • Paraesthesia with diabetic nerve damage (polyneuropathy).

Dosage :

• Always take this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• The recommended dose is:

  • 1 film-coated tablet of thioctic acid (equivalent to 600 mg thioctic acid) as a single dose about 30 minutes before the first meal.

• duration of use

  • Since diabetic nerve damage is a chronic disease, you may need to take thioctic acid on a long-term basis.

  • Your doctor will decide in individual cases.

  • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

• If you take more than you should

  • Overdose may cause nausea, vomiting and headaches.

  • In individual cases, severe, e.g. T. life-threatening symptoms of poisoning observed (such as generalized seizures, derailment of the acid-base balance with lactic acidosis, severe blood clotting disorders).

  • Therefore, if a significant overdose is suspected (e.g. more than 10 tablets of 600 mg in adults and more than 50 mg/kg body weight in children), immediate hospitalization and the initiation of measures according to the general treatment principles for cases of poisoning are required.

• If you forget to take a dose

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

• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

way :

• The film-coated tablets should be swallowed whole and with sufficient liquid on an empty stomach. Simultaneously ingesting food can impede the passage of thioctic acid into the bloodstream. It is therefore particularly important in patients who also have a prolonged gastric emptying time that the dose is taken half an hour before a meal/breakfast.

Side effects :

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

• Very rare (affects less than 1 user in 10,000):

  • Gastrointestinal symptoms such as nausea, vomiting, stomach and intestinal pain and diarrhea

  • taste disorders

  • Allergic reactions such as skin rash, hives (urticaria) and itching

  • Due to improved glucose utilization, the blood sugar level can drop. Symptoms like hypoglycaemia with dizziness, sweating, headaches and visual disturbances were described.

• countermeasures

  • If you notice the side effects mentioned above, thioctic acid should not be taken again. Notify your doctor so he can decide on the severity and any further action that may be needed.

  • At the first sign of a hypersensitivity reaction, the drug should be discontinued and a doctor contacted immediately.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to side effects that are not specified.

Interactions :

• Taking together with other medicines

  • Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. It cannot be ruled out that the simultaneous use of thioctic acid leads to a loss of effectiveness of cisplatin (a cancer drug).

  • Thioctic acid 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) for fundamental reasons, as this can lead to a loss of effectiveness. If the entire daily dose of thioctic acid is taken 30 minutes before breakfast, iron and magnesium supplements can be taken at noon or in the evening.

  • The blood sugar-lowering effect of insulin or oral antidiabetics can be increased. Close blood sugar monitoring is therefore indicated, particularly in the initial stages of therapy with thioctic acid. In individual cases, it may be necessary to reduce the insulin dose or the dose of the oral antidiabetic in accordance with the instructions of the attending physician in order to avoid symptoms of hypoglycaemia.

• Take with food, drink and alcohol

  • The regular consumption of alcohol represents a significant risk factor for the development and progression (progression) of neuropathic diseases and can thus also impair the success of treatment with thioctic acid. Therefore, patients with diabetic polyneuropathy are generally recommended to avoid the consumption of alcohol as far as possible. This also applies to therapy-free intervals.

Contraindications :

• The medicine should not be taken

  • if you are allergic to thioctic acid or any of the other ingredients.

Pregnancy and lactation :

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

• It is in accordance with the general principles of pharmacotherapy to use drugs during pregnancy and breastfeeding only after carefully weighing the benefits and risks.

• Pregnant and breastfeeding women should only undergo treatment with alpha-lipoic acid after careful recommendation and monitoring by their doctor, as there is no experience with this group of patients to date. Special studies on animals have not produced any indications of fertility disorders or teratogenic effects.

• Nothing is known about a possible transfer of alpha-lipoic acid into breast milk.

Patient Notes :

• Warnings and Precautions

  • Please talk to your doctor, pharmacist or nurse before taking this medicine.

  • children and young people

    • Children and adolescents should be excluded from treatment as there is no clinical experience in this age group.

• Driving and using machines:

  • There are no special precautions required.

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine with liquid (e.g. 1 glass of water).

Duration of use?
The duration of use depends on the type of symptoms and/or the course of the disease. In principle, the duration of use is not limited in time, so the drug can be used for a longer period of time.

overdose?
An overdose can cause nausea, vomiting, seizures and severe blood clotting disorders. If you suspect an overdose, contact a doctor immediately.

Forgot to take?
Continue taking it as normal (i.e. not double the amount) at the next prescribed time.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

What speaks against an application?

- Hypersensitivity to the ingredients

Which age group should be considered?
- Children and adolescents under 18 years of age: The medicine must not be used.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

What adverse effects may occur?

Only side effects that have only occurred in exceptional cases so far are described for the drug.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

The medicinal product must be stored   in the dark (eg in the outer carton)
  protected from heat .
What should you consider?
- The ability to react can also be impaired when used as intended, especially in higher doses or in combination with alcohol. Be particularly careful when driving or using machines (including household ones) that could injure you.
- Beware of intolerance to lactose. If you have to follow a diabetic diet, you should consider the sugar content.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

How does the ingredient of the medicine work?

The active ingredient protects the nerves of the arms and especially the legs from the damaging effects of diabetes. Two mechanisms come into play for this: On the one hand, the substance ensures that the blood supply to the nerves is not impeded by breakdown products that are produced when the sugar content in the blood is too high. In order to achieve this, the active ingredient reduces the formation of these products. On the other hand, it intercepts nerve-damaging substances that arise due to an insufficient blood supply and the associated oxygen supply.

What is included in medicines?
 

Manufacturer: biomo pharma GmbH