Dolintol 20 mg hard gastro-resistant capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Dolintol 20 mg gastro-resistant hard capsules EFG

Omeprazole

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Dolintol is and what it is used for

Dolintol contains the active substance 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, stomach acid passes into the oesophagus (the tube connecting 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 help the ulcer heal.
• Ulcers caused by medicines known as NSAIDs (non-steroidal anti-inflammatory drugs). Dolintol can also be used to prevent ulcers from forming if you are taking NSAIDs.
• Excess stomach acid 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, stomach acid passes into the oesophagus (the tube connecting the throat to the stomach), causing pain, inflammation, and heartburn.

In children, symptoms of the disease may include regurgitation of stomach contents into the mouth, vomiting, and poor weight gain.

Children over 4 years of age and adolescents

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

2. What you need to know before taking Dolintol

Do not take Dolintol

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

Do not take Dolintol if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Dolintol.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Dolintol.

Serious skin reactions have been reported with omeprazole treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). 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 symptoms of other conditions. Therefore, if you experience any of the following conditions before starting or during treatment with Dolintol, consult your doctor immediately:

• You lose weight significantly without reason and have difficulty swallowing.

• You have stomach pain or indigestion.

• You start vomiting food or vomiting blood.

• Your bowel movements are black (blood-stained stools).

• You have severe or persistent diarrhea, as omeprazole has been associated with a slight increase in infectious diarrhea.

• You have severe liver problems.

• You have ever had a skin reaction after treatment with a medicine similar to Dolintol used 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 likely perform periodic check-ups. You should report any new or unusual symptoms or circumstances during each visit to your doctor.

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

If you develop a skin rash, especially in areas of skin exposed to sunlight, consult your doctor as soon as possible, as treatment with Dolintol may need to be discontinued. Remember to mention any other symptoms you may notice, such as joint pain.

Kidney inflammation may occur while taking omeprazole. Signs and symptoms may include reduced urine volume or blood in the urine and/or hypersensitivity reactions such as fever, skin rash, and joint stiffness. You should report these signs to your treating doctor.

This medicine may affect how 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 vitamin B12 levels:

• Extreme tiredness or lack of energy
• Tingling
• Tongue pain or red tongue, mouth ulcers
• Muscle weakness
• Vision changes
• Memory problems, confusion, depression

Children

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

Other medicines and Dolintol

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription. This is because Dolintol may affect how some medicines work, and some medicines may affect Dolintol.

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

Inform 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, to relax muscles, or in epilepsy)
• Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to monitor you when starting or stopping 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 starting or stopping treatment with Dolintol
• Rifampicin (used to treat tuberculosis)
• Atazanavir (used to treat HIV infection)
• Tacrolimus (used in 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 (a 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 prescribed you the antibiotics amoxicillin and clarithromycin, in addition to Dolintol, to treat ulcers caused by Helicobacter pylori infection, it is very important that you inform them about any other medicines you are taking.

Taking Dolintol with food and drink

See section 3.

Pregnancy, breastfeeding, and fertility

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

Omeprazole passes into breast milk, but is unlikely to affect the infant when therapeutic doses are used.

Your doctor will decide whether you can take Dolintol while breastfeeding.

Driving and using machines

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

Adverse effects such as dizziness and visual disturbances may occur (see section 4). If they do occur, 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 informed you of an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Dolintol

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult 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 your age. The usual doses are indicated below.

Adults:

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

• If your doctor confirms you have mild damage to the esophagus, 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 esophagus has not yet healed.
• The recommended dose after healing of the esophagus is 10 mg once daily.
• If you do not have esophageal damage, the recommended dose is 10 mg once daily.

Treatment of ulcers in the upper intestine (duodenal ulcer):

• 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 stomach ulcers (gastric ulcer):

• 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.

Prevention of 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 ulcers during NSAID treatment:

• The recommended dose is 20 mg once daily.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

• The recommended dose is 20 mg of Dolintol twice daily for one week.
• Your doctor will also instruct you to take two of the following antibiotics: amoxicillin, clarithromycin, and metronidazole.

Treatment of excess stomach acid caused by a pancreatic tumor (Zollinger-Ellison syndrome):

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

Use in children and adolescents:

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

• Children over one year of age weighing more than 10 kg may take Dolintol. The dose for children is based on body weight, and the doctor will determine the correct dose.

Treatment of ulcers caused by Helicobacter pylori infection and prevention of their recurrence:

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

How to take this medicine

• It is recommended to take the capsules in the morning.
• You may 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 breaking down due to stomach acid. It is important not to damage the granules.

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

• Open the capsule 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 juice), or apple sauce.
• Always shake the mixture well just before drinking (the mixture will not be clear). Then drink the mixture immediately or within 30 minutes.
• To ensure you have taken all the medicine, refill the glass halfway with water, swirl it well, and drink the water. The solid particles contain the medicine; do not chew or crush them.

If you take more Dolintol than you should

If you have taken more Dolintol than prescribed by your doctor, consult your doctor or pharmacist immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating 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 treatment with Dolintol without first talking to your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience 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 side effects, stop taking omeprazole and consult your doctor immediately:

• Sudden wheezing, swelling of the lips, tongue, throat or body, skin rash, fainting or difficulty swallowing (severe allergic reaction) (rare).
• Reddening of the skin with blistering or peeling. Severe blisters and bleeding in the lips, eyes, mouth, nose, and genitals may also occur.

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

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

Other adverse effects include:

Frequent adverse effects (may affect up to 1 in 10 people)

• Headache.
• Stomach or intestinal problems: diarrhoea, 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.
• Sensation of spinning (vertigo).
• Abnormalities in blood tests used to monitor liver function.
• Skin rash, hives, and itching.
• General feeling of being unwell 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 may cause weakness or bruising and increase the likelihood of developing infections.
• Low sodium levels in the blood. This may cause weakness, vomiting, and cramps.
• Restlessness, confusion, or depression.
• Taste disturbances.
• Vision problems, such as blurred vision.
• Sudden feeling of shortness of breath (bronchospasm).
• Dry mouth.
• Inflammation inside the mouth.
• Fungal infection called “candidiasis” that may affect the intestine.
• Hair loss (alopecia).
• Skin rash upon exposure to sunlight.
• Joint pain (arthralgia) or muscle pain (myalgia).
• Serious kidney problems (interstitial nephritis).
• Increased sweating.

Very rare adverse effects (may affect up to 1 in 10,000 people)

• Blood count abnormalities, such as agranulocytosis (lack of white blood cells).
• Aggression.
• Seeing, feeling, or hearing things that are not real (hallucinations).
• Severe liver problems leading to liver failure and brain inflammation.
• Erythema multiforme. Muscle weakness.
• Enlargement of the breasts in males.

Frequency not known (cannot be estimated from available data)

• Inflammation in the intestine (causing diarrhoea).

• If you are being treated with omeprazole for more than three months, your blood magnesium levels may decrease. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, or increased heart rate. If you experience any of these symptoms, contact your doctor immediately. Low magnesium levels may also lead to reduced levels of potassium or calcium 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 may affect white blood cells and cause immunodeficiency. If you develop an infection with symptoms such as fever with a severely deteriorated general condition, or fever with signs of local infection such as neck, throat, or mouth pain, or difficulty urinating, you should consult your doctor as soon as possible for a blood test to rule out a deficiency in white blood cells (agranulocytosis). It is important that you provide information about the medicines you are taking at that time.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolintol

• Keep out of the sight and reach of children.

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

• Store below 30°C.

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

• Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolintol

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

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

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

Appearance of the product and contents of the pack

Dolintol 20 mg is available as hard gelatin capsules with green body and cap, containing enteric-coated pellets.

Pack sizes:

Packs containing 14, 28 or 56 capsules and a hospital pack containing 500 capsules.

Only some pack 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 most recent review of this leaflet: March 2025

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