Actovegin tablets

What is Actovegin Forte tablets and what is it used for?

Actovegin Forte is a protein-free extract of calf’s blood. It improves oxygen uptake and utilisation, facilitating the entry of nutrients into the cells. This speeds up blood flow to the brain. As a result, Actovegin promotes more energy flow to the brain and improves your memory.

Actovegin Forte 200 mg coated tablets are used to treat metabolic and circulatory disorders of the brain (such as dementia, brain and skull injuries) and diabetic polyneuropathy (DPN).  Actovegin Forte 200 mg film-coated tablets are used as a follow-up treatment for cerebral circulation disorders after injection and infusion therapy.

How does Actovegin tablets work?

Actovegin is characterised by its multiple mechanisms of action, including direct effects on cellular metabolism – stimulation of oxygen uptake and utilisation, energy metabolism and glucose uptake/utilisation. This is why it is been speculated that Actovegin has performance enhacing properties. As a secondary phenomenon, increased perfusion is observed.

Actovegin’s inositol phospho-oligosaccharides (IFOs) enhance glucose transport to the brain, stimulating the activity of insulin-dependent transport enzymes (e.g. GLUT1), deficiency of which is characteristic, for example, in patients with dementia. IFO is able to cross the blood-brain barrier. In addition, IFOs in Actovegin have been shown to activate pyruvate dehydrogenase, a key enzyme complex in glucose metabolism, and thereby enhance glucose utilisation.

Actovegin has been shown to improve oxygen metabolism indirectly (by increasing the intracellular concentrations of energy donors such as ATP, ADP, phosphocreatine and amino acids such as glutamic acid, aspartic acid and GASS).20

Clinical efficacy and safety of Actovegin tablets

Published data are available on the use of Actovegin in more than 6600 patients. In most clinical trials, the duration of treatment ranged from a few days to several weeks. Data are available for treatment of approximately 400 patients for more than 12 weeks and for treatment of approximately 200 patients for more than 24 weeks.

In total, more than 760 patients with dementia, 120 patients with cerebrovascular insufficiency and 200 patients with organic psychiatric syndromes have been included in randomised placebo-controlled trials. The duration of therapy ranged from 2 to 26 weeks. In most of these studies, Actovegin was first administered as an infusion (2-4 weeks), sometimes followed by up to 20 weeks of oral therapy. In some studies, the product was given orally only. The doses were as follows: once daily i/v 2 g (250 ml) Actovegin 5-7 times a week and 2 Actovegin 200 mg film-coated tablets three times a day.

Actovegin was superior to placebo in most studies. In the masked trials, doctors reported a significant or rapid improvement of 16-27% in the “Clinical Global Impression” or CGI score of Actovegin-treated patients compared with 6-10% in placebo-treated patients. The improvement in the Short Cognitive Test (Syndrom-Kurztest or SKT) score was 2 – 3 times greater with Actovegin compared to placebo. This very well ilustrates why elderly pepople tend to buy Actovegin tablets an duse them regularly.

What you need to know before taking Actovegin Forte tablets ?

Do not use Actovegin Forte in the following cases:

• if you are hypersensitive to deproteinised calf’s blood serum or

any of the other ingredients (listed in section 6) in the medicine.

Warnings and precautions for use

Before taking Actovegin Forte, consult your doctor or pharmacist if:

• You are prone to allergic reactions or allergic reactions when taking Actovegin Forte or similar medicines.

Other medicines and Actovegin Forte

No interactions with other medicines have been observed with Actovegin Forte so far.

Actovegin Forte with diet

No effects observed. Actovegin Forte 200 mg film-coated tablets should be taken before meals

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before taking this medicine. Information on the use of Actovegin Forte during pregnancy and breastfeeding limited. Although no cases of Actovegin Forte have been reported to dateadverse effects on pregnancy or the unborn child/infant, but should be assessedpotential risks, especially to the child. Therefore, during pregnancy and breastfeeding take Actovegin Forte only as directed by your doctor.Consult your doctor or pharmacist before taking any medicine.

Driving and operating machinery

No or slightly affects the ability to drive and use machines.This medicine contains phenylalanine. May be harmful to patients with phenylketonuria.This medicine contains up to 68 mg of sodium per tablet. To be observed in patients on a sodium controlled diet.This medicine contains up to 13 mg of potassium per tablet. To be observed in patients with renal insufficiency or on a controlled potassium diet.

Excipients with known effects

Sucrose.This medicine contains 52.3 mg of sucrose per tablet. It should not be used in patients with a rare congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.

How to take Actovegin Forte tablets ?

Always take this medicine exactly as described in this leaflet or as your doctor has told you. If you are unsure, ask your doctor or pharmacist. Unless otherwise prescribed by your doctor, the recommended dose is 1 to 2 tablets three times a day.

Do not take more than 2 tablets three times a day (six tablets in total).

For diabetic polyneuropathy (DPN), take 3 tablets (600 mg) 3 times a day (1800 mg). The recommended duration of therapy is at least 4-5 months. Swallow the tablet whole (do not chew) with a little liquid before eating.

Duration of use

Actovegin Forte is usually taken for 4-6 weeks. You may have recently been treated with .Actovegin for injection or infusion and your doctor has prescribed Actovegin Forte to continue treatment.

Use in children

There are currently no data on use in children, so use in this patient group is not recommended. Consult a doctor.

If you take Actovegin Forte more than prescribed

To date, no cases of overdose have been reported.

If you forget to take Actovegin Forte

Do not take a double dose to replace a forgotten dose. Continue taking as the doctor said.

If you stop taking Actovegin Forte

Do not stop taking Actovegin Forte without consulting your doctor. He/she will tell how long to take the medicine to achieve a successful treatment outcome. If you have any questions about taking this medicine, ask your doctor or pharmacist.

Possible side effects of Actovegin tablets

Like all medicines, Actovegin Forte can cause side effects, although not everyone gets them some rare side effects are possible.The most serious side effects of Actovegin Forte are allergic reactions (including drug-induced fever and signs of shock). These side effects are rare and specifically for patients prone to allergic reactions. If you experience allergic reaction, stop taking Actovegin Forte and consult your doctor. In rare cases (less than 1 in 1000 but more than 1 in 10000 patients) allergic reactions (see above), urticaria (skin rash with ulceration), skin redness (with burning sensation), dizziness. Complaints of stomach discomfort may occur after higher doses.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist or nurse. This also applies to possible side effects not mentioned in this leaflet. You can also report side effects directly to the State Medicines Agency

 How to store Actovegin Forte

Keep out of the sight and reach of children. Store at temperatures up to 25 °C. Store in original packaging to protect from light. Shelf life after first opening: 100 days. Do not use Actovegin Forte after the expiry date stated on the box. Medication must not be disposed of with household waste or down the drain. Ask your pharmacist about disposing of unwanted medicines. These measures will help protect the environment.

Contents of Actovegin packaging and other information

What does Actovegin Forte contain

– The active substance is dried deproteinised calf’s blood serum. Each tablet contains 200 mg deproteinised calf’s blood serum (dry matter). Actovegin’s active ingredient, dried deproteinised calf’s blood serum, contains sodium, potassium and  phenylalanine. Other ingredients are: povidone K90, microcrystalline cellulose, magnesium stearate, talc (in the tablet core); diethyl phthalate, hypromellose phthalate, sucrose, gum arabic , quinoline yellow  (E104), povidone K30, macrogol 6000, talc, titanium dioxide (E171), mountain glycol wax (tablet coating).

Actovegin Forte Appearance and Packaging

Actovegin Forte coated tablets are yellow, glossy, round tablets with a coating. Each pack contains 50 tablets in a brown glass bottle with a screw-top aluminium cap.

Holder of the registration certificate:

Takeda Austria GmbH
St.Peter Strasse 25
A-4020 Linz
Austria