Sweatosan

SWEATOSAN coated tablets

Important notes (mandatory information)

Sweatosan coated tablets. Active ingredient: sage leaf dry extract. Areas of application: traditional herbal medicinal product for the relief of excessive sweating.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Sweatosan coated tablets for use in adults
Active ingredient: sage leaf dry extract

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package 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, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, talk to your doctor.

What this package leaflet contains

1. WHAT IS SWEATOSAN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SWEATOSAN?
3. HOW TO TAKE SWEATOSAN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SWEATOSAN?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SWEATOSAN AND WHAT IS IT USED FOR?

Sweatosan is a traditional herbal medicinal product for the relief of excessive sweating. The medicinal product is a traditional medicinal product that is registered exclusively on the basis of many years of use for the area of application. The user should consult a doctor or other qualified person in the healthcare profession if the symptoms of the disease persist or if side effects other than those mentioned in the package leaflet occur.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING SWEATOSAN?

Sweatosan must not be taken if you are hypersensitive (allergic) to the active ingredient sage leaf dry extract or any of the other ingredients of Sweatosan.

Warnings and precautions

Special care should be taken when taking Sweatosan if the symptoms worsen or persist for more than 2 weeks. In this case, a doctor should be consulted. In case of persistent heavy sweating, especially at night, a doctor should be consulted because of the possibility of an underlying internal disease.

Children and adolescents

There are no adequate studies on the use of this medicinal product in children and adolescents under 18 years of age, therefore Sweatosan should only be taken by children and adolescents under 18 years of age on medical advice.

Taking Sweatosan 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. No interaction studies have been performed with Sweatosan. Taking sage leaf preparations may affect the action of medicines whose action is achieved via GABA receptors (e.g. barbiturates, benzodiazepines), even though this has not been observed clinically. Therefore, concomitant use with such medicines is not recommended.

Pregnancy and breast-feeding

There are no adequate studies on the use of this medicinal product during pregnancy and breast-feeding. For this reason, Sweatosan should not be taken during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Sweatosan contains glucose, lactose, sucrose (=

saccharose) and sodium

Therefore, please only take Sweatosan after consulting your doctor if you are known to suffer from an intolerance to certain sugars. This medicinal product contains less than 1 mmol (23 mg) sodium per coated tablet, i.e. it is virtually "sodium-free".

3. HOW TO TAKE SWEATOSAN?

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

The recommended dose for adults is

For daytime sweating, take 1 - 2 coated tablets 3 times a day, for nervous night sweats, take 1 - 4 coated tablets in the evening.

Use in children and adolescents

Sweatosan is not recommended for use in children and adolescents under 18 years of age (see section 2. "Children and adolescents").

Method of administration

The coated tablets should be taken whole with a little water after meals.

Duration of use

Medicinal products containing sage preparations should not be taken for more than 2 weeks without medical advice in order to rule out serious diseases as the cause of excessive sweating.

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

If you have taken more Sweatosan than you should

In the event of an intentional or accidental overdose, please inform your doctor or pharmacist immediately so that he/she can decide on the severity and any further measures that may be necessary.

If you forget to take Sweatosan

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

If you stop taking Sweatosan

If you interrupt treatment with Sweatosan or stop taking it prematurely, you must expect that the desired effect will not occur or that the symptoms will recur. Therefore, please consult your doctor if you wish to stop or interrupt treatment.

If you have any further questions about taking 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 frequency information is used to assess 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.

Hypersensitivity reactions, also accompanied by shortness of breath (dyspnoea), may occur. The frequency of occurrence is not known. After taking Sweatosan, allergic skin reactions such as skin redness, itching or rash may occur. The frequency of occurrence is not known. If you notice any side effects, please inform your doctor or pharmacist immediately so that he/she can determine the severity and decide or advise on any further measures that may be necessary.

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 package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE SWEATOSAN?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the container and outer carton.

Storage conditions

Do not store above 25°C. Store in the original package to protect the contents from moisture. Close the container tightly after use.

Note on shelf life after opening

After opening the container, Sweatosan should be used within 7 months.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sweatosan contains

The active ingredient is a dry extract of sage leaves. 1 coated tablet contains 80 mg dry extract of sage leaves (4-7:1), extraction solvent: water. The other ingredients are quinoline yellow aluminium salt (E104); indigo carmine (E132); montan glycol wax; gelatine; povidone K 25; titanium dioxide (E171); magnesium stearate (vegetable); glucose syrup; highly dispersed silicon dioxide; macrogol (35,000); talc; sodium carboxymethyl starch type A; lactose monohydrate; white clay; sucrose (= saccharose); cellulose.

What Sweatosan looks like and contents of the pack

Light blue, round, biconvex, glossy coated tablets. Sweatosan is available in packs of 50, 100 and 200 coated tablets.

Pharmaceutical entrepreneur

Stada Consumer Health Deutschland GmbH
Stadastraße 2 - 18
61118 Bad Vilbel
Telephone: 06101 603-0
Telefax: 06101 603-259
Internet: www.stada.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This package leaflet was last revised in October 2020.

Source: Package leaflet information
Status: 10/2020
Active ingredient: sage leaf dry extract. Areas of application: traditional herbal medicinal product for the relief of excessive sweating.