Normosan

Leaflet attached to the packaging: patient information

NORMOSAN

22.02-29.79 mg of anthraquinone derivatives calculated as glucofrangulin A/1.4 g,
herbal infusion

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as advised by
the doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, the pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Normosan and what is it used for
• 2. Important information before taking Normosan
• 3. How to take Normosan
• 4. Possible side effects
• 5. How to store Normosan
• 6. Package contents and other information

1. What is Normosan and what is it used for

The infusion of the mixture is used as a herbal medicinal product intended for short-term use in occasional constipation.

2. Important information before taking Normosan

When not to take Normosan

• if the patient is allergic to rhubarb, senna, menthol, or plants of the Apiaceae family (formerly Umbelliferae) (anise, caraway, celery, coriander, dill), or to common wormwood or birch;
• if the patient has intestinal obstruction and narrowing, atony (stagnation) of the intestines, appendicitis, inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration with water and electrolyte deficiency;
• in pregnancy and during breastfeeding;
• in children under 12 years of age.

Warnings and precautions

Before starting to take Normosan, the patient should discuss it with their doctor or pharmacist.

• Prolonged use of laxatives should be avoided. Taking the medicine for more than 7 days may lead to intestinal function disorders and dependence.
• If there is a daily need to take laxatives, the patient should consult their doctor about the cause of constipation.
• This medicine should only be used when constipation does not improve despite dietary changes and the use of stool softeners.
• Patient taking cardiac glycosides, antiarrhythmic drugs, QT-prolonging drugs, diuretics, adrenocorticosteroids, or products containing licorice root should consult their doctor before starting to take Normosan.
• The medicine should not be used in patients with fecal impaction, undiagnosed, acute, or persistent gastrointestinal symptoms, such as abdominal pain, nausea, and vomiting, unless the doctor advises otherwise.
• In patients with renal function disorders, taking the medicine may cause electrolyte balance disorders (hypokalemia - decreased potassium ion concentration in circulating blood, caused by excessive potassium loss in urine or through the gastrointestinal tract).
• The medicine is not recommended for patients with a deficiency or lack of gastric acid, liver disease, gallstones, bile duct inflammation, and other bile duct diseases.
• Patient with gastroesophageal reflux (heartburn) should avoid taking the medicine due to the possibility of worsening heartburn. Patients with gallstones and other bile duct diseases should exercise particular caution when using peppermint leaf preparations.
• In the case of using rhubarb bark and senna leaf in patients with fecal incontinence, clothing or personal hygiene products should be changed more frequently to limit skin contact with feces. If symptoms worsen during treatment, the patient should consult their doctor or pharmacist.

Children

Not to be used in children under 12 years of age.

Normosan and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Prolonged use of the medicine may cause excessive potassium loss (hypokalemia) and enhance the effect of cardiac glycosides and interact with antiarrhythmic drugs. Concurrent use with diuretics, adrenocorticosteroids, and products containing licorice root may increase potassium loss.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Use in pregnant and breastfeeding women is contraindicated.
There is no data on the effect on fertility.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.

3. How to take Normosan

This medicine should always be taken exactly as described in the patient leaflet or as advised by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The maximum daily dose of hydroxyanthracene glycosides is 30 mg. This is equivalent to 1.4 g of the product, which corresponds to ¾ of a measuring spoon.
The appropriate individual dose is the lowest dose necessary to achieve a soft stool.
Adolescents over 12 years of age, adults, elderly patients
Single dose:
1.4 g of herbal infusion (equivalent to ¾ of a measuring spoon (½ + ¼ of a measuring spoon)) pour 1 glass of cold water, boil under a lid, set aside. After about 15 minutes, strain. The prepared infusion should be drunk in the evening, after eating (from ⅔ to the whole prepared infusion). Always drink freshly prepared infusion. The laxative effect occurs on average after 8-12 hours.
Duration of use
The medicine should not be used for more than 1 week. Usually, it is enough to take the medicine 2-3 times a week.
Method of administration
Oral administration.
If symptoms persist during treatment, the patient should consult their doctor or pharmacist.

Using a higher dose of Normosan than recommended

The main symptoms of overdose or abuse are severe abdominal pain and heavy diarrhea causing fluid and electrolyte loss. If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor. The doctor will prescribe the appropriate treatment (supportive treatment with intensive hydration, monitoring of electrolyte levels, especially potassium). This is especially important in elderly patients.
Prolonged use of high doses of anthranoid-containing medicines may lead to the development of toxic hepatitis.

Missing a dose of Normosan

A double dose should not be taken to make up for a missed dose.

Stopping Normosan treatment

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Normosan can cause side effects, although not everybody gets them.
Allergic reactions may occur: itching, hives, local or generalized rash. Rhubarb bark and senna leaf may cause abdominal pain and cramps, as well as watery stools, especially in patients with irritable bowel syndrome. These symptoms are often the result of overdose and, in such cases, the dose should be reduced.
In patients with gastroesophageal reflux, the condition may worsen, and heartburn may increase.
Prolonged use of the medicine may cause reversible pigmentation changes in the colon mucosa (pseudomelanosis coli).
Prolonged use may lead to water and electrolyte balance disorders and may result in the development of proteinuria and hematuria.
During treatment, the urine color may change to yellow or reddish-brown (depending on the urine pH), but this symptom has no clinical significance.
The frequency of side effects is unknown (cannot be determined based on available data).

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Normosan

Store in closed packaging, at a temperature not exceeding 25°C. Protect from light, moisture, and foreign odors.
The medicine should be stored 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 the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Normosan contains

100 g of the mixture contains:
Rhamnus frangulaL. (Frangula alnusMiller) , cortex(rhubarb bark)
16.4-23.6 g
Cassia sennaL. (C. acutifoliaDelile), known as Alexandrian or Tinnevelly senna, or Cassia
angustifoliaVahl, known as Tinnevelly senna, foliolum(senna leaf)
7.9-14.3 g
Carum carviL., fructus(caraway fruit)
35 g
Sambucus nigraL., fructus(elderberry fruit)
10.1-23.7 g
Mentha x piperitaL. , folium(peppermint leaf)
17 g
1.4 g of herbal infusion (equivalent to ¾ of a measuring spoon (½+¼ of a measuring spoon)), contains
22.02-29.79 mg of anthraquinone derivatives calculated as glucofrangulin A.

What Normosan looks like and what the package contains

A bag made of polypropylene film with a measuring spoon attached in a cardboard box covered with foil.
Package contents: 100 g.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

Herbapol-Lublin S.A.,
Diamentowa 25, 20-471 Lublin

Date of the last update of the leaflet: