MEDYN

MEDYN forte capsules

Important notes (mandatory information)

Medyn forte capsules 0.5 mg/ 25 mg/ 2.5 mg, hard capsules. Field of application: Proven, combined deficiency of vitamin B6, B12 and folic acid, which cannot be remedied by nutrition.

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


Patient information: Information for the user
Medyn forte capsules 0.5 mg/ 25 mg/ 2.5 mg, hard capsules
Active ingredients: Cyanocobalamin/ pyridoxine hydrochloride/ folic acid

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, Medyn forte capsules must be used as directed in order to achieve the best possible treatment results.
. Keep the package leaflet. You may want to read it again later.
. Ask your pharmacist if you need more information or advice.
. If your symptoms worsen or do not improve, you must see a doctor in any case.
. If any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT ARE MEDYN FORTE CAPSULES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MEDYN FORTE CAPSULES?
3. HOW TO TAKE MEDYN FORTE CAPSULES?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MEDYN FORTE CAPSULES BE STORED?
6. FURTHER INFORMATION

1. WHAT ARE MEDYN FORTE CAPSULES AND WHAT ARE THEY USED FOR?

Medyn forte capsules are a vitamin preparation.

Field of application
Proven, combined deficiency of vitamin B6, B12 and folic acid, which cannot be remedied by nutrition.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING MEDYN FORTE CAPSULES?

Medyn forte capsules must not be taken
- if you are hypersensitive (allergic) to the active ingredients or any of the other ingredients of Medyn forte capsules.
- in case of megaloblastic anemia due to an isolated vitamin B12 deficiency (e.g. due to a lack of intrinsic factor) or in case of isolated folic acid deficiency.

Special care should be taken when taking Medyn forte capsules

In case of long-term intake of daily doses of more than 50 mg vitamin B6 as well as in case of short-term intake of doses in the gram range, tingling and numbness in hands and feet (signs of a peripheral sensory neuropathy or paraesthesia) have been observed. If you experience tingling and numbness, contact your doctor. He will check the amount of medication you are taking and, if necessary, discontinue the medication.

When taking Medyn forte capsules with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines. Therapeutic doses of pyridoxine hydrochloride can weaken the effect of L-dopa. There are interactions with INH, D-penicillamine, cycloserine and hydralazine. The enteral absorption of folic acid is reduced when taken together with primidone, diphenylhydantoin, phenobarbital, carbamazepine, valproate, sulfasalazine, hormonal contraceptives and folic acid antagonists such as methotrexate, trimethoprim, pyrimethamine and triamterene.

When taking Medyn forte capsules with food and drink
No interactions with food and beverages are known to date.

Pregnancy and breast-feeding
During pregnancy and breast-feeding, the daily vitamin requirement should be ensured by a balanced diet. This medicine (due to its active ingredient content) is only intended for the treatment of a vitamin deficiency and should therefore only be used after careful consideration of the benefits and risks by the doctor. Systematic studies on the use of Medyn forte capsules during pregnancy are not available. Vitamin B6 and B12 pass into breast milk.

Driving and operating machinery

No special precautions are required.

3. HOW TO TAKE MEDYN FORTE CAPSULES?

Always take Medyn forte capsules exactly as described in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is

Take one hard capsule daily.
The duration of use is not limited.
Please talk to your doctor or pharmacist if you have the impression that the effect of Medyn forte capsules is too strong or too weak.

If you have taken more Medyn forte capsules than you should
Please contact your doctor who will inform you about further measures.

If you forget to take Medyn forte capsules
Do not take a double dose if you have forgotten to take the previous dose.

If you stop taking Medyn forte capsules
Untreated vitamin deficiency can lead to clinical sequelae.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Medyn forte capsules can have side effects, although not everybody gets them.

The following categories are used as a basis 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.

Possible side effects

Vitamin B6: No side effects are known in the specified dose range for the prevention and treatment of vitamin B6 deficiency. Daily doses of more than 50 mg can cause a peripheral sensory neuropathy (nerve disease with tingling and numbness) (see warnings).
Folic acid: Folic acid can occasionally cause gastrointestinal disorders (stomach/intestinal disorders), sleep disorders, agitation and depression when taken in high doses.
Vitamin B12: Acne, eczematous or urticarial drug reactions (hives) and anaphylactic or anaphylactoid reactions (hypersensitivity reactions) have been reported very rarely.
In the extremely rare case of an allergic shock, the emergency measures necessary in this case must be taken. In other cases of mild intolerances, it is sufficient to discontinue Medyn forte capsules. Please inform your doctor or pharmacist if any of the side effects listed here affect you significantly or if you notice any side effects not listed in this leaflet.

5. HOW SHOULD MEDYN FORTE CAPSULES BE STORED?

Keep medicines out of the reach of children.
Do not use the medicine after the expiry date which is stated on the blister and carton after "Use by". The expiry date refers to the last day of the month.

Storage conditions

Do not store above 30 ºC.
Store in the outer carton to protect the contents from light and moisture.

The medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you no longer need it. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Medyn forte capsules contain

The active ingredients are

1 hard capsule contains

Cyanocobalamin (vitamin B12) 0.5 mg
Pyridoxine hydrochloride (vitamin B6) 25 mg
Folic acid 2.5 mg

The other ingredients are

Maltodextrin; citric acid monohydrate; sodium citrate 2 H20; microcrystalline cellulose; highly dispersed silicon dioxide; magnesium stearate (Ph. Eur.); titanium dioxide; iron(III)oxide; sodium dodecyl sulfate; purified water; gelatin.

What Medyn forte capsules look like and contents of the pack

Capsules (colours: yellow/ivory)
Blister pack with 30 and 90 hard capsules.

Pharmaceutical entrepreneur and manufacturer
MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
D-58638 Iserlohn
Phone: 02371/937-0
Fax: 02371/937-329
www.medice.de
e-mail: info@medice.de

This leaflet was last revised in August 2011.

Source: Information from the package leaflet
Status: 08/2015
Field of application: Proven, combined deficiency of vitamin B6, B12 and folic acid, which cannot be remedied by nutrition.