Ulgastran

Package Leaflet: Information for the Patient

ULGASTRAN, 1 g/5 ml, Oral Suspension

Sucralfate

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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Ulgastran and what is it used for

Sucralfate, the active substance of Ulgastran, forms a gel in the acidic environment of the stomach, which adheres to the surface of the ulcer, creating a protective barrier over the ulcer, reducing the patient's discomfort associated with irritation of the ulcer surface by hydrochloric acid and allowing it to heal.

Ulgastran is used to treat the following diseases and conditions:

Gastric and duodenal ulcer disease.

2. Important information before taking Ulgastran

When not to take Ulgastran:

Warnings and precautions

If you have kidney failure, the medicine can only be used if absolutely necessary and for a short period. In this case, the concentration of aluminum and phosphates in the blood should be regularly checked.
Antacids should be taken 30 minutes before or after taking Ulgastran.
Other aluminum-containing medicines should not be taken at the same time, due to the risk of aluminum toxicity.
Bezoars (masses of undigested food material) have been reported to occur after sucralfate administration in patients with impaired gastric emptying due to surgery, medication, or diseases that reduce gastric motility.

Children and adolescents under 14 years of age

Ulgastran is not recommended for children and adolescents under 14 years of age due to the lack of data on safety and efficacy.
Consult a doctor even if the above warnings apply to past situations.

Ulgastran and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Ulgastran may reduce the effectiveness of the following medicines:

• certain antibiotics (e.g., ciprofloxacin, doxycycline);
• antifungal medicines (e.g., ketoconazole, fluconazole);
• medicines that reduce stomach acid production (ranitidine, cimetidine, famotidine);
• oral anticoagulants (blood thinners), coumarin derivatives;
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen, ketoprofen, diclofenac, naproxen);
• phosphates;
• digoxin preparations, mainly used in heart failure;
• the antiepileptic medicine phenytoin;
• theophylline preparations.

Antacids reduce the effectiveness of Ulgastran.
Ulgastran releases aluminum ions, which can be absorbed into the blood and interact with other medicines, such as:

• certain antiviral medicines;
• medicines used mainly to treat high blood pressure, coronary artery disease, and heart failure, known as angiotensin-converting enzyme inhibitors (e.g., benazepril, enalapril, fosinopril, lisinopril, ramipril, quinapril), as well as beta-blockers (e.g., acebutolol, atenolol, betaxolol, metoprolol, nadolol, pindolol, propranolol, timolol, sotalol);
• antidiabetic medicines;
• medicines used to treat diseases resulting from excessive immune system activity against the body's own cells or after transplants (immunosuppressive medicines);
• certain medicines used mainly in psychiatric disorders (e.g., benzodiazepines - diazepam, lorazepam, temazepam, oxazepam);
• oral steroid anti-inflammatory medicines;
• iron preparations. It is recommended to maintain a 2-hour interval between the time of Ulgastran administration and

other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Ulgastran should not be taken during pregnancy.
Women who are breastfeeding should not take Ulgastran.

Driving and using machines

Ulgastran does not affect the ability to drive or operate machines.
Ulgastran contains sorbitol.
The medicine contains 85.9 mg of sorbitol in 5 ml.
Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should consult your doctor before taking the medicine or giving it to your child.

Ulgastran contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

The medicine may cause allergic reactions (possible late reactions).

Ulgastran contains sodium.

The medicine contains less than 1 mmol (23 mg) of sodium in 40 ml, which means the medicine is considered "sodium-free".

3. How to take Ulgastran

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
1 g (1 teaspoon) 4 times a day (every 6 hours), 0.5-1 hour before each meal and before bedtime.
Ulgastran is taken orally. The medicine should be swallowed with a large amount of water. Treatment should be continued for 4 to 6 weeks. The maximum daily dose is 8 g (8 teaspoons).
Shake before use.

Use in children and adolescents

Ulgastran is not recommended for children and adolescents under 14 years of age due to the lack of data on safety and efficacy.
If you feel that the effect of Ulgastran is too strong or too weak, consult your doctor.

Taking a higher dose of Ulgastran than recommended

If you have taken more than the recommended dose, consult your doctor immediately. Show the doctor the package with the suspension.

Missing a dose of Ulgastran

If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. In this case, do not take the missed dose.
Do not take a double dose to make up for the missed dose.

Stopping Ulgastran treatment

Treatment of the disease for which Ulgastran is used is long-term. Do not stop treatment without consulting your doctor, even if you feel better.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ulgastran can cause side effects, although not everybody gets them.
Ulgastran is generally well-tolerated. Side effects, if they occur, are usually mild and transient.
Common side effects (occurring in 1 in 10 people):

• constipation.

Uncommon side effects (occurring in 1 in 100 people):

• dry mouth,
• discomfort in the abdominal cavity,
• bloating,
• nausea,
• skin changes (rash),
• dizziness and headaches,
• allergic reactions, such as: hives, itching, swelling of the face
• decreased phosphate levels in the blood.

Rare side effects (occurring in 1 in 1000 people):

• diarrhea,
• vomiting,
• indigestion,
• excessive sleepiness or insomnia,
• rhinitis,
• pharyngitis,
• kidney or liver damage,
• bezoars.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ulgastran

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging after:
“EXP”. The expiry date refers to the last day of the month stated.
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 Ulgastran contains

The active substance is sucralfate.
The other ingredients are: hypromellose, simethicone emulsion 30%, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, sorbitol, sodium saccharin, citric acid, vanillin, lemon oil, purified water.

What Ulgastran looks like and contents of the pack

Ulgastran is a white oral suspension with a lemon-vanilla odor. The suspension may sediment slightly, but after shaking the bottle, it returns to a uniform state.
The pack contains 250 ml of suspension in an orange glass bottle.

Marketing Authorization Holder and Manufacturer

GEDEON RICHTER POLSKA Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
tel.: (22) 755 50 81
To obtain more detailed information about the medicine, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22) 755 96 48
[email protected]
Fax: +48 (22) 755 96 24

Date of last revision of the leaflet:

((logo of the marketing authorization holder))