Bellapan

Package Leaflet: Information for the User

BELLAPAN

0.25 mg, tablets

Tropane alkaloids

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse,
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What is Bellapan and what is it used for

Bellapan contains the active substance tropane alkaloids (the main alkaloid is atropine).
Atropine has a number of effects on the body, including:

• reducing the tension of smooth muscles in the digestive tract, bile ducts, ureters, and bladder,
• inhibiting the secretion of sweat, tear, salivary, and mucous glands,
• slightly dilating the bronchi,
• causing an increase in heart rate and dilation of skin blood vessels, resulting in flushing of the skin,
• dilating the pupils, paralyzing eye accommodation (reducing visual acuity), and increasing intraocular pressure,
• depending on the dose, it may cause a state of motor excitement, anxiety, or depression.

Indications:

• spasms in the digestive tract (gastric or intestinal colic),
• spasm of the bile ducts,
• spasm of the urinary tract,
• the need to reduce saliva and bronchial secretion.

2. Important information before taking Bellapan

When not to take Bellapan

• if you are allergic (hypersensitive) to atropine or any of the other ingredients of this medicine (listed in section 6),
• if you have glaucoma,
• if you have bronchial asthma,
• if you have conditions causing obstruction of the urinary tract,
• if you have conditions causing obstruction of the digestive tract (such as pyloric stenosis),
• if you have tachycardia (rapid heart rate),
• if you have circulatory failure,
• if you have ulcerative colitis,
• if you are pregnant or breastfeeding,

Warnings and precautions

In men with prostate enlargement, symptoms related to urination, such as strong pressure on the bladder, abdominal pain, and a feeling of incomplete emptying of the bladder, may worsen. If such symptoms occur, the patient should discontinue the medicine and consult a doctor.

Children

Bellapan should not be used in children under 12 years of age.

Bellapan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Medicines that enhance the effect of atropine:

• amantadine (an antiviral medicine used to treat influenza),
• quinidine (a medicine used to regulate abnormal heart rhythm),
• certain antihistamines (medicines used to treat allergies),
• certain medicines used to treat Parkinson's disease (e.g., levodopa),
• phenothiazine derivatives (medicines used to treat mental disorders, mainly schizophrenia),
• medicines used to treat depression (tricyclic antidepressants and MAO inhibitors),
• meperidine (a pain reliever),
• neuroleptics (medicines used to treat mental disorders, mainly schizophrenia and other psychoses). Atropine may cause increased absorption of certain orally administered medicines, such as:
• metoclopramide (a medicine with anti-emetic effect),
• cholinesterase inhibitors (medicines used to treat Alzheimer's disease),
• parasympathomimetics (medicines used to treat, among other things, glaucoma). Atropine may cause slowed absorption of certain orally administered medicines, such as:
• atenolol (a medicine used to treat hypertension, coronary heart disease, and heart rhythm disorders),
• digoxin (a cardiac glycoside used to treat heart failure and heart rhythm disorders),
• thiazide diuretics (medicines that increase urine production),
• cimetidine (a medicine used to treat gastric and duodenal ulcers).

Pregnancy, breastfeeding, and fertility

Bellapan may be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
Bellapan should not be used during breastfeeding, as the medicine passes into breast milk.

Driving and using machines

Bellapan may cause visual disturbances, so you should not drive or operate machinery while taking it.
Bellapan contains lactose monohydrate. One tablet contains 64 mg of lactose monohydrate. If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take Bellapan

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Use in adults and adolescents over 12 years of age

1 to 2 tablets 2 to 3 times a day.
Take the medicine orally, with water.
Bellapan can be taken with or without food.

Overdose of Bellapan

If you have taken more than the recommended dose, contact your doctor immediately.
The following overdose symptoms may occur:

• reduced saliva and sweat secretion,
• double vision, dilated pupils, increased sensitivity to light (photophobia),
• flushing of the skin, rash,
• excessive increase in body temperature, headache,
• rapid heart rate (tachycardia), irregular heartbeat (arrhythmia),
• motor excitement,
• disorientation (confusion about time, place, situation, or own identity),
• balance disorders, unsteady gait (ataxia),
• hallucinations (perception of non-existent objects or people),
• speech disorders,
• delirium,
• seizures, coma.

Missed dose of Bellapan

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.

Stopping treatment with Bellapan

If you have any further questions about taking the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bellapan can cause side effects, although not everybody gets them.
The following side effects may occur:

• dryness of mucous membranes and skin,
• flushing of the skin,
• constipation,
• visual disturbances, such as blurred vision (accommodation disorder),
• dilated pupils,
• increased intraocular pressure,
• excitement or depression (depending on the dose),
• visual hallucinations (perception of non-existent objects or people).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +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 to gather more information on the safety of this medicine.

5. How to store Bellapan

Keep out of the sight and reach of children.
Store in the original package, at a temperature below 25°C.
Do not use after the expiry date stated on the package. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bellapan contains

The active substance of the medicine is a complex of tropane alkaloids.
One tablet contains: 0.25 mg of tropane alkaloids, calculated as atropine sulfate.
The other ingredients are: lactose monohydrate, potato starch, dextrin, talc, magnesium stearate.

What Bellapan looks like and contents of the pack

Bellapan is a white, round, slightly convex tablet.
Packaging: 20 tablets in a container in a cardboard box.

Marketing authorization holder and manufacturer

Przedsiębiorstwo Farmaceutyczne Farmapol Sp. z o.o.
ul. Święty Wojciech 29
61-749 Poznań
tel.: + 48 61 852 63 53 e-mail: info@farmapol.pl
To obtain more detailed information, contact the marketing authorization holder's representative.
Information for the blind and visually impaired:the leaflet content is available at the free phone number: 0800 706 848.
Date of last revision of the leaflet:06/2021