Sopral Omeprazole 20 mg (14 tablets)

Adults

For the treatment of GERD symptoms such as burning behind the sternum and return of stomach acid:

If your doctor has found that your esophagus is slightly affected, the usual dose is 20 mg once a day for 4-8 weeks. If the esophagus is not cured within this time, your doctor may recommend that you continue treatment with 40 mg
for another 8 weeks.
After recovery of the esophagus, the usual dose is 10 mg once a day.
If the disease occurs without damage to the esophagus, the usual dose is 10 mg once a day.

For the treatment of duodenal ulcers

The usual dose is 20 mg once a day for 2 weeks. If the ulcer has not healed within this time, your doctor may recommend that you continue treatment with the same dose for another 2 weeks.
If the ulcer is not completely cured, the dose can be increased to 40 mg once a day for 4 weeks.

For the treatment of gastric ulcers

The usual dose is 20 mg once a day for 4 weeks. If the ulcer has not healed within this time, your doctor may recommend that you continue treatment with the same dose for another 4 weeks.
If the ulcer is not completely cured, the dose can be increased to 40 mg once a day for 8 weeks.
To prevent the recurrence of duodenal and gastric ulcers:
The usual dose is 10 mg and 20 mg once a day, respectively. Your doctor may increase the dose to 40 mg once a day.

For the treatment of duodenal and gastric ulcers associated with the use of NSAIDs

The usual dose is 20 mg once a day for 4-8 weeks.
To prevent the development of duodenal and gastric ulcers associated with the use of NSAIDs:
The usual dose is 20 mg once a day.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:
The usual dose is 20 mg once daily for 1 week.
In addition to treatment with Sopral, your doctor will prescribe 2 of the following antibiotics: amoxicillin, clarithromycin and metronidazole.

In case of too much acid in the stomach due to the presence of a formation in the pancreas – Zollinger-Ellison syndrome:
The usual dose is 60 mg once a day.
Your doctor will adjust the dosage according to your needs and will decide how long to take Sopral

Children

For the treatment of GERD symptoms such as burning behind the sternum and return of stomach acid:

Sopral can be taken by children over 1 year of age and weighing more than 10 kg. Your doctor will decide on the exact dose for your child depending on his weight.
For the treatment of ulcers caused by Helicobacter pylori infection and to prevent their recurrence:
Sopral can be taken by children over 4 years of age.
Your doctor will decide on the exact dose for your child depending on his weight.
In addition to treatment with Sopral, your doctor will prescribe your child 2 of the following antibiotics: amoxicillin, clarithromycin.

How to take this medicine

It is recommended to take Sopral capsules in the morning.
You can take Sopral after a meal or on an empty stomach.

Always stir the solution before drinking (the solution is not clear). Drink the solution immediately or within 30 minutes of preparation.
To make sure you have taken the full amount of medicine, rinse the glass well with half a glass of water, which is also drunk. The solids contain the medicine – do not chew or crush them!

Like all medicines, Sopral can cause side effects, although not everybody gets them. If you notice any of the following rare but serious side effects, stop taking Sopral immediately and contact a doctor immediately:

Sudden wheezing, swelling of the lips, tongue and throat or body, rash, loss of consciousness or difficulty swallowing (severe allergic reaction);
Reddening of the skin with blisters or scaling. Blisters and bleeding from the lips, eyes, mouth, nose and genitals are also possible. This may be “Stevens-Johnson syndrome” or “toxic epidermal necrolysis”;

Yellowing of the skin, darkening of the urine and fatigue, which may be symptoms of liver problems.

Unwanted reactions

Common side effects

• Headache;
• Effects on the stomach and intestines: diarrhea, stomach pain, constipation, flatulence (flatulence);
• Nausea or vomiting.

Uncommon side effects

• Swelling of the legs and ankles;
• Sleep disorders (insomnia);
• Dizziness, tingling, tingling sensation, drowsiness;
• Dizziness (vertigo);
• Changes in blood liver tests;
• Skin rash, bullous rash (hives) and itchy skin;
• General malaise and lack of energy.

Rare side effects

• Decrease in the number of white blood cells or platelets. This can cause weakness, bruising or increase the risk of infections;
• Allergic reactions, sometimes very severe, including swelling of the lips, tongue and throat, fever, wheezing;
• Low levels of sodium in the blood. This can cause weakness, vomiting and cramps;
  Anxiety, confusion or depression;
• Change of taste;
• Visual disturbances such as blurred vision;
• Sudden wheezing or difficulty breathing (bronchospasm);
• Dry mouth;
• Inflammation of the mucous membranes of the mouth;
• An infection called “candidiasis”, which is caused by a fungus and can affect the gut;
• Liver problems, including jaundice – yellowing of the skin, dark urine and fatigue;
• Hair loss (alopecia);
• Skin rashes from sun exposure;
• Joint pain (arthralgia) or muscle pain (myalgia);
• Severe kidney problems (interstitial nephritis);
• Increased sweating.

Very rare side effects

• Changes in the blood picture, including agranulocytosis (lack of white blood cells);
• Aggression;
• Seeing, feeling or hearing things that do not exist (hallucinations);
• Serious liver problems leading to liver failure and brain damage;
• Sudden appearance of a rash or blisters and flaking of the skin. This may be associated with fever and joint pain (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• Muscle weakness;
• Breast augmentation in men;
• Hypomagnesaemia.

Sopral can in very rare cases affect white blood cells, leading to immune deficiency. If you have an infection with symptoms such as fever and a very bad general condition or a fever with symptoms of a local infection, such as pain in the neck, throat or mouth, or difficulty urinating, you should consult your doctor as soon as possible. to exclude agranulocytosis (reduced number and absence of white blood cells).

It is important to tell your doctor that you are using Sopral at this time.

Don’t worry about this list of possible side effects. You may not develop any of them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

SOPRAL capsules 20 mg * 14 SOPHARMA

Package leaflet: Patient information

Sopral 20 mg gastro-resistant hard capsules

Omeprazole

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

Keep this leaflet. You may have to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Don’t pass it on to other people. It can harm them, even if their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sopral is and what it is used for

2. What you need to know before you take Copral

3. How to take Sopral

4. Possible side effects

5. How to store Sopral

6. Contents of the pack and other information

1. What Sopral is and what it is used for

Sopral gastro-resistant hard capsules contain the active substance omeprazole. It belongs to a group of medicines called ‘proton pump inhibitors’ that reduce the secretion of stomach acids.

Sopral is used to treat the following conditions:

Gastroesophageal reflux disease (GERD) – a state of return to the esophagus of gastric acid, accompanied by pain, inflammation and burning behind the sternum;

Ulcers in the upper part of the small intestine (duodenal ulcers) or stomach; Ulcers that are due to infection with a bacterium called Helicobacter pylori. In this disease, your doctor may also prescribe antibiotics to cure the infection and make the ulcer heal.

Ulcers that develop with medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). If you are taking medications of this group, Sopral can also be used to prevent the development of ulcers.

Secretion of too much acid in the stomach due to a formation in the posterior gland (pancreas) – Zollinger-Ellison syndrome.

Children:

Children over 1 year of age and weighing > 10kg

Gastroesophageal reflux disease (return to the esophagus of stomach acid). In children, symptoms of this condition may include the return of stomach contents to the mouth, nausea, and delayed weight gain. Children over 4 years and adolescents

Ulcers that are due to infection with a bacterium called Helicobacter rolls. Your doctor may also prescribe antibiotics to treat an infection’What
you need to know before you take Sopral

Do not take Sopral

– if you are allergic (hypersensitive) to omeprasis or any of the other ingredients of this medicine (listed in section 6);

– if you are allergic to other medicines in the group “proton pump inhibitors”;

– if you are taking a medicine containing nelfinavir (to treat HIV infection).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sopral.

Sopral can mask the symptoms of other stomach diseases. Therefore, if any of the following occur to you before you start taking Sopral or while taking it, consult your doctor right away:

– if you lose a lot of weight for no apparent reason or have trouble swallowing;

– if you have stomach pain or indigestion;

– if you start vomiting food or blood;

– if you have black stools (blood in your stool);

– if you develop severe or prolonged diarrhoea, as omeprazole is associated with a slightly increased risk of infectious diarrhoea;

– if you have had stomach disease or gastrointestinal surgery in the past;

– if you have severe liver disease.

Taking proton pump inhibitors (such as Sopral), especially for more than one year, may slightly increase the risk of hip, wrist, or spine fractures. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which may increase your risk of osteoporosis).

– if you have ever had a skin reaction after taking a medicine similar to Sopral that reduces acidity in your stomach. If you experience a skin rash, especially in areas exposed to sunlight, tell your doctor straight away. Discontinuation of Sopral may be necessary. Be sure to describe any other symptoms you’ve noticed, such as joint pain.

– if you need to have a specific blood test (chromogranin A).

With prolonged intake of Sopral (over 1 year), your doctor will regularly monitor your condition. At each examination, tell your doctor about any new and unusual symptom or circumstance.

Other medicines and Sopral

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is necessary because Sopral can change the action of certain drugs or, conversely, they can alter its effects.

Do not take Sopral if you are taking a medicine containing nelfinavir (used to treat HIV infection).

Tell your doctor or pharmacist if you are taking any of the following medicines:

Ketoconazole, itraconazole, posaconazole or voriconazole (to treat infections caused by fungi);

Digoxin (for the treatment of heart failure);

Diazepam (to treat anxiety, relax the muscles or epilepsy) Phenytoin (used for epilepsy) – if you are taking phenytoin, your mild] monitors you when you start or stop taking Sopral;

medicines used for bleeding disorders, such as warfarin or other vitamin K antagonists – your doctor may need to monitor you when starting or stopping treatment with Sopral;

Rifampicin (for the treatment of tuberculosis);

Atazanavir (to treat HIV infection)

Tacrolimus (in organ transplantation);

St. John’s wort (Hypericum perforatum) (tea or medicines containing this plant are used to treat mild depression);

Cilostazol (for the treatment of periodic limping); Saquinavir (for the treatment of HTV infection);

Clogavdogrel (a medicine to prevent blood clots (thrombi)); Methotrexate, erlotinib (in the treatment of oncological diseases); Clarithromycin (to treat infections caused by bacteria).

If your doctor has prescribed you to take the antibiotics amoxicillin and clarithromycin (to treat Helicobacter pylori infection) at the same time as Sopraal, be sure to tell him or her about any other medicines you are taking.

Sopral with food and drink

You can take the capsules both after meals and on an empty stomach. Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

It is not known whether Sopral passes into breast milk. Therefore, you should not take Sopral if you are breast-feeding.

Driving and using machines

Sopral is unlikely to affect your ability to drive or use tools and machines. Dizziness and visual disturbances may occur (see section 4). If you have such complaints, you should not drive or use machines.

Sopral contains sucrose as an excipient. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Sopral.

3. How to take Sopral

Always take Sopral exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Mature

To treat symptoms of GERD such as burning behind the sternum and returning heartburn:

– If your doctor has determined that your esophagus is slightly affected, the usual dose is 20 mg once a day for 4-8 weeks. If the esophagus is not cured within this period of time, your doctor may recommend that you continue treatment at a dose of 40 mg for another 8 weeks.

– After the esophagus is restored, the usual dosage is 10 mg once a day.

– If the disease proceeds without damage to the esophagus, the usual dosage is 10 mg once a day.

For the treatment of duodenal ulcers:

– The usual dosage is 20 mg once daily for 2 weeks.

– If the ulcer has not healed within this period of time, your doctor may recommend that you continue treatment with the same dose for another 2 weeks.

– If the ulcer is not completely cured, the dosage can be increased to 40 mg once a day for 4 weeks.

For the treatment of stomach ulcers:

– The usual dosage is 20 mg once daily for 4 weeks.

– If the ulcer has not healed within this period of time, your doctor may recommend that you continue treatment with the same dose for another 4 weeks.

– If the ulcer is not completely cured, the dosage can be increased to 40 mg once a day for 8 weeks.

To prevent the re-development of duodenal and stomach ulcers:

– The usual dosage is 10 mg and 20 mg once daily, respectively. Your doctor may increase the dosage to 40 mg once a day.

For the treatment of duodenal and stomach ulcers associated with the use of NSAIDs:

– The usual dosage is 20 mg once a day for 4-8 weeks.

To prevent the development of duodenal and stomach ulcers associated with the use of NSAIDs:

– The usual dosage is 20 mg once a day.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

– The usual dosage is 20 mg once daily for 1 week.

– In addition to treatment with Sopral, your doctor will prescribe 2 of the following antibiotics: amoxicillin, clarithromycin and metronidazole.

When excreting too much acid in the stomach due to the presence of a formation in the pancreas – Zollinger-EUison syndrome:

– The usual dosage is 60 mg once a day.

– Your doctor will specify the dosage according to your needs and decide how long to take Sopral.

Use in children:

To treat symptoms of GERD such as burning behind the sternum and returning heartburn:

– Sopral can be taken by children over 1 year of age and weighing more than 10 kg. Your doctor will decide the correct dose for your child depending on their weight.

To treat ulcers caused by Helicobacter pylori infection and to prevent their recurrence:

– Sopral can accept children older than 4 years. Your doctor will decide the correct dose for your child depending on their weight.

– In addition to treatment with Sopral, your doctor will prescribe your child to take 2 of the following antibiotics: amoxicillin, clarithromycin.

Use in liver disease

If you have liver disease, the maximum daily dose should not exceed 20 mg.

How to take this medicine

– It is recommended to take Sopral capsules in the morning.

– You can take Sopral after a meal or on an empty stomach.

– Swallow the capsule whole with half a glass of water. Do not chew or grind the capsule contents. The capsules contain coated granules that prevent stomach acids from occurring. It is important that the integrity of the granules is not broken. These microbeads contain the active substance omeprazole and have a coating that protects them from degradation during their passage through the stomach. The granules release the active substance into the intestine, where it is absorbed and manifests its action.

What to do if you or your child have difficulty swallowing the capsules

– Open the capsule and directly swallow its contents with half a glass of water or pour the contents of the capsule into half a glass of water (non-carbonated), some sour fruit juice (e.g. apple, orange or pineapple) or applesauce.

– Always stir the solution before drinking it (the solution is not clear). Drink the solution immediately or within 30 minutes of preparation.

– To make sure that you have drunk the entire amount of medicine, rinse well the glass with half a glass of water, which is also drunk. The drug is contained in the solid particles – do not chew or crush them!

Your doctor will tell you how many capsules to take and for how long. It depends on your condition and age.

If you take more Sopral than you should

If you take more than your doctor’s prescribed dose, contact your doctor or pharmacist straight away.

If you forget to take Sopral

If you miss a dose, take it as soon as possible. If it’s almost time for your next dose, skip the forgotten dose. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

If you notice any of the following serious side effects, stop taking Sopral and contact a doctor immediately:

They occur rarely (in I up to 10 in 10,000 patients)

– Sudden wheezing, swelling of the lips, tongue and throat or body, rash, loss of consciousness or difficulty swallowing (severe allergic reaction);

– Yellowing of the skin, darkening of urine and fatigue, which can be symptoms of liver problems.

They are very rare (less than 1 in 10,000 patients)

– Redness of the skin with blisters or flaking. Blisters and bleeding from the lips, eyes, mouth, nose and genitals are also possible. This can be Stevens-Johnson syndrome or toxic epidermal necrolysis.

Other side effects may occur with a frequency that is defined as follows:

Frequent

-Headache

– Effects on the stomach and intestines: diarrhea, stomach pain, benign polyps in the stomach, constipation, flatulence (flatulence);

– Nausea or vomiting.

Uncommon

– Swelling of the legs and ankles;

– Sleep disorders (insomnia);

– Dizziness, tingling, a feeling of “tingling”, drowsiness;

– Vertigo (vertigo);

– Changes in blood liver tests;

– Skin rash and inflammation, bullous rash (hives) and itchy skin;

– General malaise and lack of energy;

– Fractures of the femur, wrist, spine.

Rare

– Decrease in the number of white blood cells or platelets. This can cause weakness, bruising, or increase the risk of infections.

– Low levels of sodium in the blood. This can cause weakness, vomiting and cramps. Anxiety, confusion or depression;

– Change of taste;

– Visual disturbances such as blurred vision;

– Sudden onset of wheezing or difficulty breathing (bronchospasm);

– Dry mouth;

– Inflammation of the mucous membrane of the mouth;

– An infection called “candidiasis”, which is caused by fungi and can affect the intestines;

– Hair loss (alopecia);

– Skin rashes when exposed to the sun;

– Joint pain (arthralgia) or muscle pain (myalgia);

– Severe kidney problems (interstitial nephritis);

– Increased sweating.

Very rare

– Changes in blood counts, including agranulocytosis (lack of white blood cells); Aggressiveness;

Seeing, feeling, or hearing things that don’t exist (hallucinations)

– Serious liver problems leading to liver failure and brain damage;

– Muscle weakness;

– Breast enlargement in men;

– Hypomagnesiaemia.

– Sopral can in very rare cases affect white blood cells, leading to immunodeficiency. If you have an infection with symptoms such as fever and severe general condition or fever with symptoms of local infection, such as neck, throat or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible to rule out agranulocytosis (reduced number and lack of white blood cells). It is important to tell the doctor that you are using Sopral at this time.

Not known

– Rash, probably accompanied by joint pain.

If you take omeprazole for more than three months, your blood magnesium levels may drop. Low levels of magnesium are observed (manifested) as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, increased heart rate . If you know any of these symptoms, please tell your doctor may perform immediately. A low level of magnesium can lead to a decrease in the levels of potassium or calcium in the blood. Your doctor regular blood tests to monitor your magnesium level.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sopral

Keep out of the reach of children.

Do not use Sopral after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Store in the original package. Store below 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment,

6. Contents of the pack and other information

What Sopral contains

– The active substance is omeprazole. Each gastro-resistant solid cylindrical gelatin capsule contains 20 mg omeprazole.

– The other ingredients are:

• capsule contents: sucrose, corn starch, sodium laurilsulfate, anhydrous disodium phosphate, mannitol, hydroxyproshtmethylcellulose, macrogol 6000, talc, polysorbate 80, titanium dioxide, methacrylic acid – ethylacrylate;
• capsule shell: indigo carmine (E132), titanium dioxide (E171), gelatin.

What Sopral looks like and contents of the pack

Hard cylindrical gelatin capsules with a light blue transparent body and a blue opaque cap,

Capsular contents: spherical, uniform and without visible defects granules, with almost white to cream color. 7 gastro-resistant hard capsules in a blister of PVC / aluminum foil; 4 blisters per cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria