DOLINTOL 20 mg HARD GASTRO-RESISTANT CAPSULES

Introduction

Package Leaflet: Information for the User

Dolintol 20 mg Hard Gastro-Resistant Capsules EFG

Omeprazole

Read all of this leaflet carefully before you start taking this medicine.

• 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, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Dolintol and what is it used for

Dolintol contains the active ingredient omeprazole. It belongs to a group of medicines called “proton pump inhibitors”. These medicines work by reducing the amount of acid produced by the stomach.

Dolintol is used to treat the following conditions:

In adults:

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.
• Ulcers in the upper part of the intestine (duodenal ulcer) or in the stomach (gastric ulcer).
• Ulcers infected by a bacterium called Helicobacter pylori. If you have this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.
• Ulcers caused by medicines called NSAIDs (non-steroidal anti-inflammatory drugs). Dolintol can also be used to prevent ulcers if you are taking NSAIDs.
• Excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome).

In children:

Children over 1 year of age and = 10 kg

• “Gastro-oesophageal reflux disease” (GORD). In this condition, acid from the stomach passes into the gullet (the tube that connects the throat to the stomach), causing pain, inflammation and heartburn.

In children, the symptoms of the disease can include return of stomach contents to the mouth (regurgitation), vomiting and insufficient weight gain.

Children over 4 years of age and adolescents

Ulcers infected by a bacterium called Helicobacter pylori. If your child has this condition, your doctor may also prescribe antibiotics to treat the infection and allow the ulcer to heal.

2. What you need to know before taking Dolintol

Do not take Dolintol

• if you are allergic to omeprazole or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to medicines that contain proton pump inhibitors (e.g. pantoprazole, lansoprazole, rabeprazole, esomeprazole).
• if you are taking a medicine that contains nelfinavir (used to treat HIV infection).

Do not take Dolintol if you are in one of these situations. If you are not sure, talk to your doctor or pharmacist before taking Dolintol.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dolintol.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) have been reported with omeprazole. Stop taking Dolintol and contact your doctor immediately if you experience any of these symptoms related to serious skin reactions described in section 4.

Dolintol may mask the symptoms of other diseases. Therefore, if you experience any of the following conditions before starting or during treatment with Dolintol, contact your doctor immediately:

• Unexplained weight loss and difficulty swallowing.
• Stomach pain or indigestion.
• Vomiting food or blood.
• Black stools (faeces stained with blood).
• Severe or persistent diarrhoea, as omeprazole has been associated with a slight increase in infectious diarrhoea.
• Severe liver problems.
• If you have ever had a skin reaction after treatment with a medicine similar to Dolintol to reduce stomach acid.

• You are scheduled to have a specific blood test (Chromogranin A).

If you take Dolintol for a long period (more than 1 year) your doctor will probably schedule regular check-ups. You should inform your doctor of any new or unusual symptoms or circumstances whenever you visit your doctor.

Taking a proton pump inhibitor like Dolintol, especially for a period of more than one year, may slightly increase the risk of fracture of the hip, wrist or spine. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

If you get a rash on your skin, especially in areas exposed to the sun, you should contact your doctor as soon as possible, as it may be necessary to interrupt treatment with Dolintol. Remember to mention any other symptoms you may notice, such as joint pain.

When taking omeprazole, kidney inflammation can occur. The signs and symptoms may include decreased urine output or blood in the urine and/or hypersensitivity reactions such as fever, rash and joint stiffness. You should inform your doctor of these signs.

This medicine may affect the way your body absorbs vitamin B12, especially if you need to take it for a long time. Contact your doctor if you notice any of the following symptoms, which could indicate low levels of vitamin B12:

• Extreme tiredness or lack of energy
• Numbness
• Pain in the tongue or red tongue, mouth ulcers
• Muscle weakness
• Altered vision
• Memory problems, confusion, depression

Children

Some children with chronic diseases may require long-term treatment, although it is not recommended. Do not give this medicine to children under 1 year of age or weighing less than 10 kg.

Other medicines and Dolintol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription. This is because Dolintol can affect the way some medicines work and some medicines can affect Dolintol.

Do not take Dolintol if you are taking a medicine that contains 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 (used to treat fungal infections)
• Digoxin (used to treat heart problems)
• Diazepam (used to treat anxiety, relax muscles or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when you start or stop treatment with Dolintol
• Medicines used to prevent blood clots, such as warfarin or other vitamin K antagonists. Your doctor will need to monitor you when you start or stop treatment with Dolintol
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (in cases of organ transplantation)
• St. John's Wort (Hypericum perforatum) (used to treat mild depression)
• Cilostazol (used to treat intermittent claudication)
• Saquinavir (used to treat HIV infection)
• Clopidogrel (used to prevent blood clots (thrombi))
• Erlotinib (used to treat cancer)
• Methotrexate (chemotherapy medicine used in high doses to treat cancer) - if you are taking a high dose of methotrexate, your doctor will need to temporarily stop treatment with Dolintol.

If your doctor has also prescribed the antibiotics amoxicillin and clarithromycin for you to treat ulcers caused by Helicobacter pyloriinfection, it is very important that you inform your doctor of any other medicines you are taking.

Taking Dolintol with food and drinks

See section 3.

Pregnancy, breastfeeding and fertility

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

Omeprazole passes into breast milk but it is unlikely to affect the baby when used in therapeutic doses.

Your doctor will decide whether you can take Dolintol if you are breastfeeding.

Driving and using machines

Dolintol is unlikely to affect your ability to drive or use tools or machines.

Side effects such as dizziness and visual disturbances (see section 4) may occur. If this happens, patients should not drive or use machines.

Important information about some of the ingredients of Dolintol

This medicine contains lactose and sucrose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 23 mg of sodium (1mmol) per capsule; this is essentially “sodium-free”.

3. How to take Dolintol

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

Your doctor will tell you how many capsules to take and for how long. This will depend on your condition and age. The usual doses are indicated below.

Adults:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation:

• If your doctor confirms that you have mild oesophageal damage, the recommended dose is 20 mg once daily for 4-8 weeks. Your doctor may prescribe a dose of 40 mg for another 8 weeks if the oesophagus has not yet healed.
• The recommended dose once the oesophagus has healed is 10 mg once daily.
• If you do not have oesophageal damage, the recommended dose is 10 mg once daily.

Treatment of duodenal ulcers:

• The recommended dose is 20 mg once daily for 2 weeks. Your doctor may prescribe the same dose for another 2 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 4 weeks.

Treatment of gastric ulcers:

• The recommended dose is 20 mg once daily for 4 weeks. Your doctor may prescribe the same dose for another 4 weeks if the ulcer has not yet healed.
• If the ulcer does not heal completely, the dose may be increased to 40 mg once daily for 8 weeks.

Preventionof recurrence of stomach and duodenal ulcers:

• The recommended dose is 10 mg or 20 mg once daily. Your doctor may increase the dose to 40 mg once daily.

Treatment of stomach and duodenal ulcers caused by NSAIDs

(non-steroidal anti-inflammatory drugs):

• The recommended dose is 20 mg once daily for 4-8 weeks.

Prevention of stomach and duodenal ulcersduring NSAID therapy:

• The recommended dose is 20 mg once daily

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of recurrence:

• The recommended dose is 20 mg of Dolintol twice daily for one week.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin.

Treatment of excess acid in the stomach caused by a tumour in the pancreas (Zollinger-Ellison syndrome):

• The recommended dose is 60 mg daily.
• Your doctor will adjust the dose according to your needs and decide how long you need to take the medicine.

Use in children and adolescents:

Treatment of symptoms of GORD, such as heartburn and acid regurgitation

• Children over 1 year of age who weigh more than 10 kg can take Dolintol. The dose for children is based on body weight and your doctor will decide the correct dose.

Treatment of ulcers caused by Helicobacter pylori infectionand prevention of recurrence:

• Children over 4 years of age can take Dolintol. The dose for children is based on body weight and your doctor will decide the correct dose.
• Your doctor will also prescribe two antibiotics, amoxicillin and clarithromycin, for your child.

How to take this medicine

• It is recommended to take the capsules in the morning.
• You can take your capsules with food or on an empty stomach.
• Swallow the capsules whole with half a glass of water. Do not chew or crush the capsules, as they contain coated granules that prevent the medicine from being broken down by the acid in the stomach. It is important not to damage the granules.

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

• If you or your child have problems swallowing the capsules:
• Open the capsules and swallow the contents directly with half a glass of water or pour the contents into a glass of still water, acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
• Always shake the mixture well before drinking it (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To make sure you have taken all the medicine, fill the glass with water, rinse it well and drink the water. The solid parts contain the medicine; do not chew or crush them.

If you take more Dolintol than you should

If you have taken more Dolintol than your doctor prescribed, talk to your doctor or pharmacist immediately. You can also contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Dolintol

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Dolintol

Do not stop taking Dolintol without talking to your doctor or pharmacist first.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you notice any of the following rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) but serious adverse effects, stop taking omeprazole and consult your doctor immediately:

• Sudden whistling when breathing (sudden wheezing), swelling of the lips, tongue, and throat or body, skin rash, fainting, or difficulty swallowing (severe allergic reaction) (rare).
• Redness of the skin with blistering or peeling. Intense blisters and bleeding may also appear on the lips, eyes, mouth, nose, and genitals.

This could be "Stevens-Johnson syndrome" or "toxic epidermal necrolysis" (very rare).

• Widespread rash, high body temperature, and inflammation of the lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) (rare).
• A red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis) (rare).
• Yellowing of the skin, dark urine, and fatigue, which can be symptoms of liver problems.

Other adverse effects are:

Common Adverse Effects (may affect up to 1 in 10 people)

• Headache.
• Effects on the stomach or intestine: diarrhea, stomach pain, constipation, and gas (flatulence).
• Nausea or vomiting.
• Benign polyps in the stomach.

Uncommon Adverse Effects (may affect up to 1 in 100 people)

• Swelling of the feet and ankles.
• Sleep disorders (insomnia).
• Dizziness, tingling sensation, drowsiness.
• Feeling that everything is spinning (vertigo).
• Abnormal liver function tests.
• Skin rash, hives, and itching.
• General feeling of discomfort and lack of energy.

Rare Adverse Effects (may affect up to 1 in 1,000 people)

• Blood problems, such as decreased white blood cells or platelets. This can cause weakness or bruising and increase the risk of infections.
• Low sodium levels in the blood. This can cause weakness, vomiting, and cramps.
• Agitation, confusion, or depression.
• Taste disturbances.
• Visual problems, such as blurred vision.
• Sudden difficulty breathing (bronchospasm).
• Dry mouth.
• Inflammation of the mouth.
• A fungal infection called "candidiasis" that can affect the intestine.
• Hair loss (alopecia).
• Skin rash when exposed to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Severe kidney problems (interstitial nephritis).
• Increased sweating.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people)

• Abnormal blood counts, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Severe liver problems that can cause liver failure and brain inflammation.
• Erythema multiforme. Muscle weakness.
• Enlargement of the breasts in men.

Frequency Not Known (cannot be estimated from available data)

• Inflammation of the intestine (causing diarrhea)
• If you are taking omeprazole for more than three months, your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, consult your doctor immediately. Low magnesium levels can also lead to reduced potassium or calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor your magnesium levels.

• Skin rash, possibly with joint pain.

In very rare cases, omeprazole can affect the white blood cells and cause immunodeficiency. If you have an infection with symptoms such as fever with a severely deteriorated 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 perform a blood test and rule out a lack of white blood cells (agranulocytosis). It is essential that you provide information about the medication you are taking at that time.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dolintol

• Keep out of sight and reach of children.

• Do not use Dolintol after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

• Store below 30°C.

• Keep this blister pack in the original packaging to protect it from moisture.

• Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Dolintol

• The active ingredient is omeprazole. Dolintol contains 20 mg of omeprazole.

• The other ingredients are: sugar spheres (sucrose and cornstarch), anhydrous lactose, hypromellose, sodium lauryl sulfate, hydroxypropylcellulose, disodium phosphate dihydrate, hypromellose phthalate, and diethyl phthalate.

The gelatin capsule is composed of: gelatin, indigo carmine (E-132), and quinoline yellow (E-104).

Appearance of the Product and Package Contents

Dolintol 20 mg is presented in the form of hard gelatin capsules with a green body and cap containing enteric-coated pellets.

Package sizes:

Packages containing 14, 28, or 56 capsules, and a clinical package with 500 capsules.

Only some package sizes may be marketed.

Marketing Authorization Holder

ABABOR PHARMACEUTICALS, S.L.

C/Chile 4 – Edificio 1 – 28290 LAS ROZAS (Madrid)

Spain

Manufacturer:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

Date of the Last Revision of this Prospectus: March 2025

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/