Tegens

Package leaflet: Information for the user

Tegens 80 mg hard capsules

Anthocyanoside complex of bilberry
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you notice a worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Tegens is and what it is used for
2. What you need to know before taking Tegens
3. How to take Tegens
4. Possible side effects
5. How to store Tegens
6. Contents of the pack and other information

1. What Tegens is and what it is used for

Tegens is a medicinal product based on bioflavonoids extracted from blueberry that has a protective effect on capillaries and veins (vasoprotective).
Tegens is used to treat symptoms due to venous insufficiency (impaired return of blood to the heart) and conditions of capillary fragility (tendency of capillaries to rupture or dilate).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Tegens

Do not take Tegens

• if you are allergic to the anthocyanoside complex of bilberry or to any of the other components of this medicinal product (listed in section 6);

Warnings and precautions
Consult your doctor or pharmacist before taking Tegens if:
you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

Children and adolescents
This product is intended for use by adults only.

Other medicines and Tegens
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other substances have ever been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicinal product.
The safety of this medicinal product during pregnancy has not been established; therefore, it is advisable not to administer this product during pregnancy.
During breastfeeding, Tegens should only be used after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.

Driving and using machines
No adverse effects on the ability to drive or operate machinery are known.

Tegens contains lactose
This medicinal product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicinal product.

3. How to take Tegens

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 2 - 4 capsules per day.

Warning: Do not exceed the recommended doses without medical advice.
Tegens can be taken at any time of the day, regardless of meals.
It is advisable to take this medicine in the morning and in the evening, with intervals of 6-8 hours.
Consult your doctor if symptoms occur repeatedly or if you have noticed any recent changes in their characteristics.
Warning: Use only for short-term treatment.
Method of administration
Swallow the capsules with a little water.
If you take more Tegens than you should
Cases of overdose are not known.
Nevertheless, in the event of accidental ingestion or overdose of Tegens, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rarely, cases of gastrointestinal disorders such as heartburn, nausea and gastric heaviness, and skin erythema (redness of the skin) have been reported.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the website www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tegens

Keep this medicine out of the sight and reach of children.
Store below 30°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Tegens contains

• The active substance is: anthocyanoside complex of bilberry containing 36% anthocyanosides (Myrtocyan). Each capsule contains 80 mg of anthocyanoside complex of bilberry standardized to 36% anthocyanosides.
• The other components are: mannitol, lactose, methylcellulose, citric acid, precipitated silica, magnesium stearate; capsule shell excipient: gelatin.

Description of the appearance of Tegens and package contents
Oral capsules 80 mg; pack contents: 20 capsules.
Marketing Authorization Holder
VEMEDIA MANUFACTURING B.V.
Verrijn Stuartweg 60, 1112 - AX DIEMEN (THE NETHERLANDS).
Manufacturer
sanofi-aventis S.A. – Riells i Viabrea facility (Spain)
Package leaflet: information for the user

Tegens 160 mg hard capsules

Bilberry anthocyanoside complex
Please read this leaflet carefully before taking this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Tegens is and what it is used for
2. What you need to know before taking Tegens
3. How to take Tegens
4. Possible side effects
5. How to store Tegens
6. Package contents and other information

1. What Tegens is and what it is used for

Tegens is a medicinal product based on bioflavonoids extracted from blueberry that has a protective effect on capillaries and veins (vasoprotective).
Tegens is used for the treatment of symptoms due to venous insufficiency (impaired return of blood to the heart) and conditions of capillary fragility (tendency of capillaries to rupture or dilate).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you should know before taking Tegens

Do not take Tegens

• if you are allergic to the anthocyanoside complex of bilberry or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Consult your doctor or pharmacist before taking Tegens if you are pregnant or
if you are breastfeeding (see “Pregnancy and breastfeeding”).
Consult your doctor if you do not feel better or if you feel worse after a short period of
treatment.
Children and adolescents
This product is intended for use by adults only.
Other medicines and Tegens
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other substances have ever been reported.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The safety of this medicine during pregnancy has not been established; therefore, administration during pregnancy should be avoided.
During breastfeeding, Tegens should only be used after consulting your doctor and carefully evaluating, together with him, the risk/benefit ratio in your individual case.
Driving and using machines
No adverse effects on the ability to drive or operate machinery are known.
Tegens contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tegens

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 1–2 capsules per day. Warning: Do not exceed the recommended dose without medical advice.
Tegens can be taken at any time of the day, regardless of meals.
It is advisable to take this medicine in the morning and in the evening, with intervals of 12–24 hours.
Consult your doctor if the condition recurs or if you have noticed any recent changes in its characteristics.
Warning: Use only for short-term treatment.
Method of administration
The capsules should be swallowed with a glass of water.
If you take more Tegens than you should
There are no known cases of overdose.
However, in the event of accidental ingestion or intake of an excessive dose of Tegens, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Rarely, cases of gastrointestinal disorders such as heartburn, nausea, and gastric heaviness, as well as skin erythema (redness of the skin), have been reported.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tegens

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tegens contains

• The active substance is 36% anthocyanoside complex of bilberry (Myrtocyan). Each capsule contains 160 mg of 36% anthocyanoside complex of bilberry.
• The other components are: mannitol, lactose, methylcellulose, citric acid, precipitated silica, magnesium stearate; capsule shell: gelatin.

Description of the appearance of Tegens and package contents
Oral capsules of 160 mg; pack sizes of 20 capsules.
Marketing Authorization Holder
VEMEDIA MANUFACTURING B.V.
Verrijn Stuartweg 60, 1112 - AX DIEMEN (THE NETHERLANDS).
Manufacturer
sanofi-aventis S.A. – Riells i Viabrea facility (Spain)
Package leaflet: information for the user

Tegens 80 mg granules for oral solution

Anthocyanoside complex from bilberry
Please read this leaflet carefully before taking this medicine, as it
contains important information for you.
Always take this medicine exactly as described in this leaflet or as your
doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Tegens is and what it is used for
2. What you need to know before taking Tegens
3. How to take Tegens
4. Possible side effects
5. How to store Tegens
6. Contents of the pack and other information

1. What Tegens is and what it is used for

Tegens is a medicinal product based on bioflavonoids extracted from blueberry that has a protective effect on capillaries and veins (vasoprotective).
Tegens is used to treat symptoms due to venous insufficiency (difficulty in blood returning to the heart); conditions of capillary fragility (tendency of capillaries to break or dilate).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Tegens

Do not take Tegens

• if you are allergic to the anthocyanosidic complex of bilberry or to any of the other components of this medicinal product (listed in section 6);

Warnings and precautions
Consult your doctor or pharmacist before taking Tegens if you are pregnant or if you are breastfeeding (see "Pregnancy and breastfeeding").
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.
Children and adolescents
This product is intended for adults only.
Other medicines and Tegens
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other substances have ever been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The safety of this medicine during pregnancy has not been established; therefore, administration during pregnancy is not recommended.
During breastfeeding, Tegens should only be used after consulting your doctor and carefully evaluating the risk/benefit ratio in your individual case.
Driving and using machines
No adverse effects on the ability to drive or operate machinery are known.
Tegens contains lactose
This medicinal product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Tegens

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 2–4 sachets per day
Warning: Do not exceed the recommended doses without medical advice.
Tegens can be taken at any time of the day, regardless of meals.
It is advisable to take this medicine in the morning and in the evening, with intervals of 6–8 hours.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.
Warning: Use only for short-term treatment.
Method of administration
The granulate can be taken undissolved or dissolved in a small amount of water; it is recommended for patients with swallowing difficulties and in conditions of gastric mucosa irritability due to gastritic or ulcerative processes.
If you take more Tegens than you should
Cases of overdose are not known.
However, in case of accidental ingestion/overdose of Tegens, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Rarely, cases of gastrointestinal disorders such as heartburn, nausea, and gastric heaviness, as well as skin erythema (redness of the skin) have been reported.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tegens

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tegens contains

• The active substance is 36% anthocyanoside blueberry complex (Myrtocyan). Each sachet contains 80 mg of 36% anthocyanoside blueberry complex.
• The other ingredients are: mannitol, lactose, methylcellulose, citric acid, blueberry flavour, ammonium glycyrrhizinate.

Description of the appearance of Tegens and package contents
Oral solution granulate sachets of 80 mg; pack contents: 20 sachets.
Marketing Authorization Holder
VEMEDIA MANUFACTURING B.V.
Verrijn Stuartweg 60, 1112 - AX DIEMEN (THE NETHERLANDS).
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – IT-24041 Brembate BG (Italy)
Patient Information Leaflet

Tegens 160 mg granules for oral solution

Anthocyanoside complex from bilberry
Please read this entire leaflet carefully before taking this medicine because
it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement, or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

13. What Tegens is and what it is used for
14. What you need to know before taking Tegens
15. How to take Tegens
16. Possible side effects
17. How to store Tegens
18. Contents of the packaging and other information

1. What Tegens is and what it is used for

Tegens is a medicinal product based on bioflavonoids extracted from blueberry that has a protective effect on capillaries and veins (vasoprotective). Tegens is used for the treatment of symptoms due to venous insufficiency (impaired return of blood to the heart); capillary fragility conditions (tendency of capillaries to rupture or dilate).
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Tegens

Do not take Tegens

• if you are allergic to the anthocyanoside complex of bilberry or to any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions
Consult your doctor or pharmacist before taking Tegens if you are pregnant or
if you are breastfeeding (see "Pregnancy and breastfeeding").
Consult your doctor if you do not feel better or if you feel worse after a short period of
treatment.
Children and adolescents
This product is intended for use by adults only.
Other medicines and Tegens
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other substances have ever been reported.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The safety of this medicine during pregnancy has not been established; therefore, administration of this product during pregnancy is not recommended.
During breastfeeding, Tegens should only be used after consulting your doctor and evaluating with him the risk/benefit ratio in your specific case.
Driving and using machines
No negative effects on the ability to drive or operate machinery are known.
Tegens contains monohydrate lactose
This medicine contains monohydrate lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Tegens

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose: 1–2 sachets per day. Warning: Do not exceed the recommended doses without medical advice.
Tegens can be taken at any time of the day, regardless of meals.
It is advisable to take this medicine in the morning and in the evening, with intervals of 12–24 hours.
Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.
Warning: Use only for short-term treatment.
Method of administration
The granules can be taken as they are or dissolved in a small amount of water; this is recommended for patients with swallowing difficulties and in conditions of gastric mucosa irritation due to gastric-ulcerative processes.
If you take more Tegens than you should
There are no known cases of overdose.
However, in the event of accidental ingestion or intake of an excessive dose of Tegens, inform your doctor immediately or go to the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets
them.
Rarely, cases of gastrointestinal disorders such as heartburn, nausea and gastric
heaviness, and skin erythema (skin redness) have been reported.
Following the instructions in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via the national reporting
system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Tegens

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Tegens contains

• The active substance is anthocyanoside complex of bilberry, containing 36% anthocyanosides (Myrtocyan). Each sachet contains 160 mg of anthocyanoside complex of bilberry standardized to 36% anthocyanosides.
• The other ingredients are: mannitol, lactose monohydrate, methylcellulose, anhydrous citric acid, bilberry flavour, ammonium glycyrrhizinate.

Description of the appearance of Tegens and contents of the pack
Sachets of oral granules for solution 160 mg; pack contents: 20 sachets.
Marketing Authorization Holder
VEMEDIA MANUFACTURING B.V.
Verrijn Stuartweg 60, 1112 - AX DIEMEN (THE NETHERLANDS).
Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. – IT- 24041 Brembate BG
or
A. Nattermann & Cie GmbH – DE-50829 Cologne (Germany)