SOMAC CONTROL 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient SOMAC Control 20 mg Gastro-Resistant Tabletspantoprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.
• You must not use SOMAC Control tablets for more than 4 weeks without consulting your doctor.

Contents of the Package Leaflet:

1. What is SOMAC Control and what is it used for.
2. What you need to know before you start taking SOMAC Control.
3. How to take SOMAC Control
4. Possible side effects
5. Storage of SOMAC Control
6. Contents of the pack and further information

1. What is SOMAC Control and what is it used for

SOMAC Control contains the active ingredient pantoprazole, which blocks the "pump" that produces acid in the stomach. Therefore, this medicine reduces the amount of acid in your stomach.

SOMAC Control is used for the short-term treatment of symptoms of reflux (e.g., heartburn and acid regurgitation) in adults.

Reflux is the backflow of acid from the stomach into the throat (esophagus), which can cause inflammation and pain. This can cause symptoms such as a painful burning sensation in the chest, which can reach the throat (heartburn) and leave a sour taste in the mouth (acid regurgitation).

You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with SOMAC Control, but this does not mean that the medicine provides immediate relief. You may need to take the tablets for 2-3 consecutive days for symptom relief to occur.

You should consult a doctor if your symptoms worsen or do not improve after 2 weeks.

2. What you need to know before you start taking SOMAC Control

Do not take SOMAC Control:

• if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6)
• if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). See "Using SOMAC Control with other medicines".

Warnings and precautions

Consult your doctor or pharmacist before starting to take SOMAC Control:

• if you have received treatment for heartburn or dyspepsia continuously for 4 or more weeks.
• if you are over 55 years old and take daily treatment for dyspepsia without a medical prescription.
• if you are over 55 years old and have new symptoms of reflux or symptoms that have changed recently.

• if you have previously had a gastric ulcer or stomach surgery.
• if you have liver problems or jaundice (yellowing of the skin or eyes).
• if you regularly visit your doctor for severe discomfort or illness.
• if you are going to have an endoscopy or a breath test called the urea test.
• if you have ever had a skin reaction after treatment with a medicine similar to SOMAC Control to reduce stomach acid.
• if you are scheduled to have a specific blood test (Chromogranin A)
• if you are taking HIV protease inhibitors, such as atazanavir, nelfinavir (for HIV infection treatment) at the same time as pantoprazole, consult your doctor in this case.

Do not take this product for more than 4 weeks without consulting your doctor. If reflux symptoms (acid stomach or acid regurgitation) persist for more than 2 weeks, consult your doctor, who will assess the need to take this medicine long-term.

If you take SOMAC Control for longer periods, additional risks may occur, such as:

• reduced absorption of Vitamin B12, and Vitamin B12 deficiency if the patient already has low Vitamin B12 reserves
• fracture of the hip, wrist, or spine, especially if the patient suffers from osteoporosis or is taking corticosteroids (which can increase the risk of osteoporosis).
• decrease in blood magnesium levels (possible symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Additionally, low magnesium levels can cause a decrease in blood potassium and calcium levels. You should consult your doctor if you have been taking this medicine for more than 4 weeks. Your doctor will decide whether to perform periodic blood tests to monitor magnesium levels.

Tell your doctor immediatelybefore or after taking this medicine if you notice any of the following symptoms, which could be signs of a more serious illness:

• Involuntary weight loss (not related to any diet or exercise).
• Vomiting, especially if it is repeated.
• Blood in the vomit, which may appear as dark coffee grounds in the vomit.
• You notice blood in your stools, which may appear black or tarry.
• Difficulty swallowing or pain when swallowing.
• You are pale or feel weak (anemia).
• Chest pain.
• Stomach pain.
• Severe and/or persistent diarrhea, as this medicine has been associated with a slight increase in the occurrence of infectious diarrhea.
• If you experience a skin rash, especially in areas of the skin exposed to the sun, consult your doctor as soon as possible, as it may be necessary to interrupt treatment with SOMAC Control. Remember to mention any other symptoms you may notice, such as joint pain.

Your doctor may decide that it is necessary to perform some tests.

If you are going to have a blood test, inform your doctor that you are taking this medicine.

You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with SOMAC Control, but this does not mean that the medicine provides immediate relief. Do not take it as a preventive measure.

If you have experienced symptoms of dyspepsia or heartburn repeatedly over time, remember to visit your doctor periodically.

Children and adolescents

SOMAC Control must not be used by children and adolescents under 18 years of age due to the lack of safety information in this age group.

Other medicines and SOMAC Control

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially medicines that contain any of the following active ingredients:

• HIV protease inhibitors such as atazanavir, nelfinavir (used to treat HIV infection). Do not use SOMAC Control if you are taking HIV protease inhibitors. See "Do not take SOMAC Control";
• ketoconazole (used to treat fungal infections)
• warfarin and phenprocoumon (used to make blood more liquid and prevent clot formation). You may need to have additional blood tests. methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer). If you are taking methotrexate, your doctor may temporarily stop your treatment with SOMAC Control because pantoprazole can increase methotrexate levels in the blood.

Do not take SOMAC Control with other medicines that limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazol, lansoprazol, or rabeprazol) or an H2 antagonist (e.g., ranitidine, famotidine).

However, if necessary, you can take SOMAC Control with antacids (e.g., magaldrate, alginate acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate, or combinations).

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

If you experience side effects such as dizziness or vision disturbances, do not drive or use machines.

3. How to take SOMAC Control

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Do not exceed the recommended dose of 20 mg of pantoprazole per day.

You should take this medicine for at least 2-3 consecutive days. Stop taking SOMAC Control when you are completely free of symptoms. You may notice relief from acid reflux symptoms and heartburn after a single day of treatment with SOMAC Control, but this does not mean that the medicine provides immediate relief.

If you do not notice relief from symptoms after taking this medicine for 2 consecutive weeks, consult your doctor.

Do not take SOMAC Control tablets for more than 4 weeks without consulting your doctor.

Take the tablet before one of the main meals, at the same time every day. You should swallow the tablet whole with a little water. Do not chew or break the tablet.

If you take more SOMAC Control than you should

Tell your doctor or pharmacist if you have taken a larger dose than recommended. If possible, bring your medicine and this leaflet with you.

If you forget to take SOMAC Control

Do not take a double dose to make up for the forgotten dose. Take the normal dose the next day, at the usual time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediatelyor contact the emergency department of your nearest hospital if you notice any of the following side effects. Stop taking this medicine immediately, but bring this leaflet and/or the tablets with you.

• Severe allergic reactions(rare: may affect up to 1 in 1,000 people): hypersensitivity reactions, also called anaphylactic reactions, anaphylactic shock, and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue, and/or throat, which can cause difficulty swallowing or breathing, hives (urticaria), intense dizziness with very rapid heartbeats and excessive sweating.
• Severe skin reactions(frequency not known: cannot be estimated from the available data): skin rash with swelling, blistering, or peeling of the skin, loss of skin and bleeding around the eyes, nose, mouth, or genitals, and rapid deterioration of your general health, or skin rash after sun exposure.
• Other serious side effects(frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as pain when urinating and pain in the lower back with fever.

Other side effects include:

• Common side effects(may affect up to 1 in 10 people): Benign polyps in the stomach.

• Uncommon side effects(may affect up to 1 in 100 people): Headache; dizziness; diarrhea; nausea, vomiting; bloating and flatulence (gas); constipation; dry mouth; stomach discomfort and pain; hives or skin rash; itching; feeling of weakness, fatigue, or general malaise; sleep disorders; increased liver enzymes in blood tests and fracture of the hip, wrist, or spine.

• Rare side effects:

Distortion or complete loss of taste; vision disorders such as blurred vision; joint pain; muscle pain; weight changes; elevated body temperature; swelling of the limbs; depression; increased bilirubin and fat levels in the blood (detected in blood tests), increased breast size in men; high fever and sudden drop in circulating granulocytes (observed in blood tests).

• Very rare side effects(may affect up to 1 in 10,000 people): Disorientation, decreased platelet count in the blood that can lead to more frequent bleeding or bruising than usual; decreased white blood cell count that can lead to more frequent infections; coexistence of an abnormal reduction in the number of red blood cells, white blood cells, and platelets (observed in blood tests).

Frequency not known

Hallucinations, confusion (especially in patients with a history of these symptoms); decreased sodium levels in the blood; decreased magnesium levels in the blood, skin rash, possibly with joint pain, sensation of tingling, prickling, paresthesia (tingling), burning, or numbness, inflammation of the large intestine that causes persistent watery diarrhea.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of SOMAC Control

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after 'EXP'. The expiry date is the last day of the month indicated.

Store in the original package to protect from moisture.

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. Container Content and Additional Information

Composition of SOMAC Control

• The active ingredient is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
• The other components are:

• Core: Sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, and calcium stearate
• Coating: Hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, ethyl acrylate-methacrylic acid copolymer, sodium lauryl sulfate, polysorbate 80, and triethyl citrate.

• Printing ink: Shellac, red, black, and yellow iron oxide (E172), and concentrated ammonia solution.

Appearance of the Product and Container Content

The gastro-resistant tablets are yellow, oval, biconvex, coated, and printed with "P20" on one side.

SOMAC Control is available in Alu/Alu blisters with or without cardboard reinforcement.

The containers contain 7 or 14 gastro-resistant tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Takeda GmbH

Byk-Gulden-Straße 2, 78467 Konstanz

Germany

Manufacturer:

Takeda GmbH. Manufacturing site located in Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the Last Revision of this Leaflet: {MM/YYYY}

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu/.

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The following lifestyle and dietary recommendations may also help alleviate symptoms of heartburn or acid reflux:

• Avoid large meals
• Eat more slowly
• Stop smoking
• Reduce alcohol and caffeine consumption
• Lose weight (if you are overweight)
• Avoid wearing tight clothing or belts
• Avoid eating during the three hours before bedtime
• Elevate the head of your bed (if you experience symptoms at night)

Reduce the intake of foods that may cause heartburn. This may include: chocolate, pepper, green mint, fried foods, and high-fat foods, acidic foods, spices, citrus fruits and juices, and tomatoes.