Ulcamed

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Ulcamed, 120 mg coated tablets

bismuth oxide

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ulcamed and what is it used for

Symptoms from the upper part of the digestive tract may be caused by inflammation of the stomach and duodenum (the first part of the small intestine). Ulcamed treats ulcers and inflammation of the mucous membranes by creating a protective layer (a kind of patch) and helps to stop further irritation caused by hydrochloric acid in the stomach. It also has antibacterial properties against Helicobacter pylori, bacteria that can cause inflammation of the mucous membranes and ulcers.
In order to cure ulcers, it is necessary to completely eliminate (eradicate) the bacteria. Ulcamed helps to eliminate or reduce inflammation caused by these bacteria. Your doctor may prescribe Ulcamed in combination with other medicines to help eliminate Helicobacter pyloribacteria.

2. Important information before taking Ulcamed

When not to take Ulcamed

• if you are allergic to bismuth oxide or any of the other ingredients of this medicine (listed in section 6),
• if you have severe kidney disease (severe renal insufficiency).

Warnings and precautions

Before taking Ulcamed, discuss it with your doctor or pharmacist.
Do not take other medicines containing bismuth while taking Ulcamed.
Long-term use of bismuth-containing medicines is not recommended. Your doctor will prescribe Ulcamed for no longer than 2 months.

Children and adolescents

Ulcamed is not indicated for use in children and adolescents.

Ulcamed and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take other acid-reducing agents half an hour before or after taking Ulcamed, as they may affect the action of this medicine.
Ulcamed may reduce the effectiveness of antibiotics from the tetracycline group taken at the same time.

Ulcamed with food and drink

Do not eat or drink for half an hour before or after taking Ulcamed. Milk, fruits, and fruit juices may have an adverse effect on the action of the medicine.

Pregnancy, breastfeeding, and fertility

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.
Do not take Ulcamed during pregnancy or breastfeeding, unless it is absolutely necessary.

Driving and using machines

It is unlikely that Ulcamed will affect your ability to drive or use machines.

Ulcamed contains potassium

This medicine contains 1.19 mmol (or 46.58 mg) of potassium per tablet. This should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take Ulcamed

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults is 4 tablets, which can be taken according to the treatment schedule:

• 1 tablet four times a day on an empty stomach (half an hour before main meals and before bedtime) or
• 2 tablets twice a day on an empty stomach, half an hour before breakfast and half an hour before dinner or bedtime.

Ulcamed tablets should be swallowed whole with a sufficient amount of water.
Do not eat or drink for half an hour before or after taking the tablet. If you miss a meal, take the tablet anyway.

Duration of treatment

In the treatment of stomach or duodenal ulcers, the duration of one treatment cycle is from 4 to 8 weeks.
To eradicate H. pylori, the choice of combined treatment and duration (7 to 14 days) should take into account the patient's tolerance to the medicine, national, regional, and local data on bacterial resistance, and therapeutic guidelines.
The maximum duration of one treatment cycle is 2 months. Do not take Ulcamed or other bismuth-containing preparations for longer than this period. Do not take bismuth-containing preparations for the next 2 months after completing treatment with Ulcamed.

Taking a higher dose of Ulcamed than recommended

Do not worry if you have taken an extra one or two tablets. However, if you have taken a significantly larger amount of tablets at the same time or in a short period, consult your doctor immediately. Your doctor will take appropriate preventive measures to avoid bismuth absorption. Additionally, your doctor will monitor your kidney function for several weeks.

Missing a dose of Ulcamed

Do not take a double dose to make up for a missed dose.
If you miss a dose, take the missed dose as soon as possible before the next dose. If it is already time for the next dose, skip the missed dose,

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Ulcamed, a potentially life-threatening allergic reactionmay occur.
Symptoms of an allergy are sudden wheezing, swelling of the lips, tongue, and throat, difficulty swallowing, rash, and even fainting.
If you experience any of these symptoms, stop taking Ulcamed and immediatelycontact your doctor.These are serious side effects, but they are very rare (may affect up to 1 in 10,000 people).
Other side effects include:
Very common(may affect more than 1 in 10 people):

• Darkening of the stool (feces). This should not worry you and will disappear soon after stopping treatment.

Uncommon(may affect up to 1 in 100 people):

• Nausea, vomiting, constipation, diarrhea;
• Rash, hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. 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, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ulcamed

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
There are no special storage temperature requirements for this medicine.
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 packaging and other information

What Ulcamed contains

• The active substance is bismuth oxide. Each coated tablet contains 120 mg of bismuth oxide (as bismuth potassium ammonium citrate).
• The other ingredients are: corn starch, povidone K30, potassium polyacrylate, macrogol 6000, magnesium stearate in the tablet core, and polyvinyl alcohol, macrogol 4000, talc, titanium dioxide (E 171) in the tablet coating. See section 2 "Ulcamed contains potassium".

What Ulcamed looks like and contents of the pack

White to almost white, round (10 mm in diameter) coated tablets, slightly biconvex with beveled edges. Scoring is acceptable on the surface of the tablets.
Cartons containing 28, 30, 40, 42, 45, 56, or 60 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:24.12.2024