Bellapan

Package leaflet: Information for the user

BELLAPAN
0.25 mg, tablets
Alkaloids, tropane
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

1. What Bellapan is and what it is 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 Bellapan is and what it is used for

Bellapan contains the active substance tropane alkaloids (the main alkaloid being atropine).
Atropine has various effects on the body, including:

• Reducing the tone of smooth muscles in the gastrointestinal tract, biliary ducts, ureters, and urinary bladder,
• Inhibiting secretion of sweat, tear, salivary, and mucus glands,
• Slight bronchodilation,
• Increasing heart rate and dilating skin blood vessels, causing facial flushing,
• Dilating pupils, paralyzing accommodation of the eye (blurred vision), and increasing intraocular pressure,
• Depending on the dose, may cause motor agitation, anxiety, or depression.

Indications:

• Spasms in the gastrointestinal tract (gastric or intestinal colic),
• Biliary tract spasms,
• Urinary tract spasms,
• 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 urinary tract obstruction,
• If you have conditions causing gastrointestinal obstruction (e.g. pyloric stenosis),
• If you have tachycardia (rapid heartbeat),
• If you have circulatory failure,
• If you have ulcerative colitis,
• If you are pregnant or breastfeeding.

Warnings and precautions

In men with benign prostatic hyperplasia, symptoms related to urination may worsen, such as: strong urge to urinate, lower abdominal pain, or a feeling of incomplete bladder emptying. If such symptoms occur, the patient should discontinue the medicine and contact a doctor.

Children

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

Bellapan with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

Medicines that enhance the effects of atropine:

• Amantadine (an antiviral drug used in the treatment of influenza),
• Quinidine (a drug used to normalize abnormal heart rhythm),
• Some antihistamines (antiallergic drugs used in the treatment of, among others, allergies),
• Some drugs used in the treatment of Parkinson's disease (e.g. levodopa),
• Phenothiazine derivatives (drugs used in the treatment of psychiatric disorders, mainly schizophrenia),
• Antidepressants (tricyclic antidepressants and MAO inhibitors),
• Meperidine (an analgesic),
• Neuroleptics (drugs used in the treatment of psychiatric disorders, mainly schizophrenia and other psychoses).

Atropine may increase the absorption of certain orally administered drugs, such as:

• Metoclopramide (an antiemetic),
• Cholinesterase inhibitors (drugs used in the treatment of Alzheimer's disease),
• Parasympathomimetics (drugs used in the treatment of, among others, glaucoma).

Atropine may delay the absorption of certain orally administered drugs, such as:

• Atenolol (a drug used in the treatment of hypertension, ischemic heart disease, and cardiac rhythm disorders),
• Digoxin (a cardiac glycoside used in the treatment of heart failure and cardiac rhythm disorders),
• Thiazide diuretics (drugs that increase urine production),
• Cimetidine (a drug used in the treatment of peptic ulcer disease of the stomach and duodenum).

Pregnancy, breastfeeding, and fertility

Bellapan may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the potential risk to the fetus.
Bellapan should not be used during breastfeeding, as the drug passes into breast milk.

Driving and operating machinery

Bellapan may cause visual disturbances; therefore, driving and operating machinery should be avoided during treatment.

Bellapan contains monohydrate lactose. One tablet contains 64 mg of monohydrate lactose. If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.

3. How to take Bellapan

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Use in adults and adolescents over 12 years of age
1 to 2 tablets 2 to 3 times daily.
The medicine should be taken orally, with water.
Bellapan may be taken regardless of meals.
Taking more Bellapan than recommended
If more Bellapan has been taken than recommended, consult a doctor immediately.
The following symptoms of overdose may occur:

• reduced salivation and sweating,
• double vision, dilated pupils, eye sensitivity to light (photophobia),
• skin redness, rash,
• excessively elevated body temperature, headache,
• rapid heartbeat (tachycardia), palpitations (irregular, fast heartbeat),
• motor agitation,
• disorientation regarding time, place, situation or self (disorientation),
• loss of balance, unsteady gait (ataxia),
• hallucinations (perception of non-existent objects or persons),
• speech disturbances,
• delirium,
• seizures, coma.

Missing a dose of Bellapan
If a dose of Bellapan is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose.
Stopping Bellapan
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The following adverse effects may occur:

• dryness of mucous membranes and skin,
• skin redness,
• constipation,
• visual disturbances, such as blurred vision (eye accommodation disorder),
• pupil dilation,
• increased intraocular pressure,
• excitation or depression (depending on the dose),
• visual hallucinations (perceiving objects or people that are not there).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, please inform your doctor, pharmacist, or nurse. Adverse effects
can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide 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 packaging, at a temperature below 25°C.
Do not use after the expiry date stated on the packaging. The expiry date refers to the last day of the stated 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 is a complex of tropane alkaloids.
Each tablet contains: 0.25 mg of tropane alkaloids calculated as atropine sulfate.
The other ingredients are: monohydrate lactose, potato starch, dextrin, talc, magnesium stearate.

What Bellapan looks like and contents of the pack
Bellapan is in the form of white, round, slightly convex on both sides tablets.
Available pack: 20 tablets in a container within a cardboard box.

Marketing Authorisation Holder and Manufacturer
Farmapol Pharmaceutical Company Sp. z o.o.
ul. Święty Wojciech 29
61-749 Poznań
tel.: + 48 61 852 63 53 e-mail: [email protected]
For further information, please contact the Marketing Authorisation Holder.

Information for blind and partially sighted people: the leaflet content is available via a free telephone number: 0800 706 848.