Normosan fix

Package Leaflet: Information for the Patient

NORMOSAN fix

22.02-29.79 mg of anthraquinone derivatives calculated as glucofrangulin A per sachet,

herbal infusion in sachets

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Normosan fix and what is it used for

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

2. Important information before taking Normosan fix

When not to take Normosan fix

• if the patient is allergic to senna, senes, menthol, or plants of the Apiaceae family (formerly Umbelliferae) (anise, caraway, celery, coriander, and dill), birch, or common wormwood;
• 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 fix, the doctor or pharmacist should be consulted.

• Prolonged use of laxatives should be avoided. Taking the medicine for more than 7 days may lead to intestinal function disorders and dependence.
• In case of daily need for laxatives, the cause of constipation should be consulted with a doctor.
• This medicine should only be used when constipation does not improve despite dietary changes and the use of stool softeners.
• Patients taking cardiac glycosides, antiarrhythmic drugs, drugs that prolong the QT interval, diuretics, adrenocorticosteroids, or products containing licorice root should consult a doctor before starting to take the medicine.
• 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 otherwise directed by a doctor.
• In patients with renal function disorders, taking the medicine may cause electrolyte balance disorders.
• The use of the medicine is not recommended in patients with a deficiency or lack of gastric acid, liver disease, gallstones, bile duct inflammation, and other bile duct diseases.
• Patients 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 case of using senna 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, a doctor or pharmacist should be consulted.

Children

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

Normosan fix and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any planned to be taken.
Prolonged use of the medicine may cause excessive potassium loss (hypokalemia) and lead to increased effects of cardiac glycosides and interactions 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 she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
The use of the medicine in pregnant and breastfeeding women is contraindicated.
There are 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 fix

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubts, a doctor or pharmacist should be consulted.
The maximum daily dose of hydroxyanthracene glycosides is 30 mg. This is equivalent to 1 sachet of the medicine.
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 sachet should be poured with 1 cup of boiling water (about 250 ml) and infused under a cover for about 15 minutes.
Before going to bed, ⅔ to the whole of the prepared infusion should be taken at once. The infusion should always be taken freshly prepared. The laxative effect occurs on average after 8-12 hours.
Duration of use
The medicine should not be taken for more than 1 week. Usually, it is enough to take the medicine 2-3 times a week.
Method of administration
Oral use.
If symptoms persist during treatment, a doctor or pharmacist should be consulted.

Taking a higher dose of Normosan fix than recommended

The main symptoms of overdose or abuse are severe abdominal pain and severe diarrhea leading to fluid and electrolyte loss. In case of taking a higher dose of the medicine than recommended, a doctor should be consulted immediately. The doctor will recommend 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 fix

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

Stopping Normosan fix treatment

In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Normosan fix can cause side effects, although not everybody gets them.
Allergic reactions may occur: itching, hives, local or generalized rash. Senna 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, urine color may change to yellow or reddish-brown (depending on 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 not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 fix

Store in closed containers, at a temperature not exceeding 25°C. Protect from light, moisture, and the influence of foreign odors.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Normosan fix contains

Each sachet contains: 0.230-0.330 g of Rhamnus frangula L. (Frangula alnus Miller) cortex (senna bark), 0.110-0.200 g of Cassia senna L. (C. acutifolia Delile) or Cassia angustifolia Vahl, foliolum (senna leaf), 0.490 g of Carum carvi L., fructus (caraway fruit), 0.142-0.332 g of Sambucus nigra L., fructus (elderberry fruit), 0.238 g of Mentha x piperita L., folium (peppermint leaf).
Each 1.4 g sachet contains 22.02-29.79 mg of anthraquinone derivatives calculated as glucofrangulin A.

What Normosan fix looks like and what the package contains

Sachets of thermosealing filter fabric in a cardboard box coated with foil.
Package contents: 20 or 40 sachets of 1.4 g each.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański

Manufacturer

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

Date of the last update of the package leaflet: