Patient Information Leaflet

NORMOSAN fix
22.02-29.79 mg of anthraquinone derivatives, expressed as glucofrangulin A per sachet,
herbal tea in tea bags
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a physician or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If symptoms do not improve or if you feel worse, consult your doctor.

Table of Contents

What Normosan fix is and what it is used for
Important information before taking Normosan fix
How to take Normosan fix
Possible side effects
How to store Normosan fix
Contents of the pack and other information

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

The herbal infusion is used as a herbal medicinal product with laxative properties, 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, fennel, menthol, or plants from the Apiaceae family (formerly Umbelliferae) (anise, caraway, celery, coriander, and parsley), birch, or common tarragon;
if the patient has intestinal obstruction or narrowing, intestinal atony (stasis), appendicitis, inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration with deficiency of water and electrolytes;
during pregnancy and breastfeeding;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Normosan fix, consult a doctor or pharmacist.

Avoid prolonged use of laxatives. Using the medicine for more than 7 days may lead to intestinal dysfunction and development of dependence.
If laxatives are needed daily, consult a doctor to determine the cause of constipation.
This medicine should only be used when constipation persists despite dietary changes and use of stool-softening agents.
Patients taking cardiac glycosides, antiarrhythmic drugs, QT-prolonging drugs, diuretics, adrenocorticosteroids, or products containing liquorice root should consult a doctor before starting treatment with this medicine.
This medicine should not be used in patients suffering from fecal impaction, or undiagnosed acute or persistent gastrointestinal disorders such as abdominal pain, nausea, and vomiting, unless otherwise directed by a doctor.
In patients with impaired kidney function, use of the medicine may cause electrolyte imbalance.
Use of the medicine is not recommended in patients with deficiency or absence of gastric hydrochloric acid, liver disease, gallstones, cholangitis, or other biliary tract diseases.
Patients with gastroesophageal reflux (heartburn) should avoid using the medicine due to the risk of worsening symptoms. Patients with gallstones or other biliary tract disorders should exercise particular caution when using products containing peppermint leaves.
When using senna bark and fennel leaf in patients with fecal incontinence, clothing and personal hygiene products should be changed more frequently to minimize skin contact with feces. If symptoms worsen during treatment, consult a doctor or pharmacist.

Children
Do not use in children under 12 years of age.
Normosan fix and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Prolonged use of the medicine may lead to excessive loss of potassium ions (hypokalemia), which may enhance the effect of cardiac glycosides and interact with antiarrhythmic drugs. Concurrent use with diuretics, adrenocorticosteroids, and products containing liquorice root may increase potassium loss.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Use in pregnant women and women who are breastfeeding is contraindicated.
There is lack of data regarding effects on fertility.
Driving and operating machinery
No studies have been conducted on the effects of the medicine on the ability to drive vehicles or operate machinery.

3. How to take Normosan fix

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The maximum daily dose of hydroxyanthracene glycosides is 30 mg. This corresponds to 1 sachet of the medicine.
The appropriate individual dose is the lowest dose necessary to achieve soft bowel movements.

Adolescents over 12 years of age, adults, elderly patients
Single dose:
Pour 1 sachet into a glass of boiling water (approximately 250 ml) and let it steep, covered, for about 15 minutes.
Before going to bed, drink from ⅔ to the entire amount of the prepared infusion at once. Always drink freshly prepared infusion. The laxative effect usually occurs after 8–12 hours.

Duration of use
Do not use the medicine for longer than 1 week. Usually, it is sufficient to take this medicine 2 to 3 times per week.

Method of administration
Oral use.

If symptoms persist during treatment, consult your doctor or pharmacist.

Taking more Normosan fix than recommended
The main symptoms of overdose or abuse are severe abdominal pain and serious diarrhoea causing fluid and electrolyte loss. If you have taken more than the recommended dose, seek immediate medical advice from a doctor. The doctor will recommend appropriate treatment (supportive treatment with intensive rehydration, monitoring of electrolyte levels, especially potassium). This is particularly important in elderly patients.
Long-term use of high doses of medicines containing anthranoids may lead to toxic hepatitis.

Missing a dose of Normosan fix
Do not take a double dose to make up for a missed dose.

Stopping Normosan fix
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Hypersensitivity reactions may occur, such as itching, urticaria, localised or generalised rash.
The bark of buckthorn and the leaf of senna may cause abdominal pain and cramps as well as watery diarrhoea, particularly in patients with irritable bowel syndrome. These symptoms are often due to overdose, and in such cases the dose should be reduced.
When used in patients with gastro-oesophageal reflux, the condition may worsen and heartburn may intensify.
Prolonged use of the medicine may cause reversible pigmentation changes in the mucosa of the large intestine (pseudomelanosis coli).
Prolonged use may lead to disturbances in water and electrolyte balance and may result in proteinuria and haematuria.
During treatment, urine may change colour to yellow or red-brown (depending on urine pH), however this effect has no significant clinical relevance.
The frequency of adverse effects is unknown (cannot be estimated based on available data).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Normosan fix
Keep in tightly closed containers, at a temperature not exceeding 25°C. Protect from light, moisture and exposure to foreign odours.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Normosan fix contains
Each sachet contains: 0.230-0.330 g Rhamnus frangula L. (Frangula alnus Miller), cortex (buckthorn bark), 0.110-0.200 g Cassia senna L. (C. acutifolia Delile) or Cassia angustifolia Vahl, foliolum (senna leaf), 0.490 g Carum carvi L., fructus (caraway fruit), 0.142-0.332 g Sambucus nigra L., fructus (black elderberry fruit), 0.238 g 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 contents of the pack
Filter paper sachets made of heat-sealable non-woven fabric, packed in a foil-coated cardboard box.
Pack contents: 20 or 40 sachets of 1.4 g each.

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

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