PANTOPRAZOL CODRAMOL 20 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Pantoprazol Codramol 20 mg Gastro-Resistant Tablets EFG

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

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

Contents of the pack

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

1. What is Pantoprazol Codramol and what is it used for

Pantoprazol Codramol is a selective inhibitor of the "proton pump", a medicine that reduces the amount of acid produced in your stomach. It is used for the treatment of diseases related to stomach and intestine acid.

Pantoprazol Codramol is used for:

Adults and adolescents from 12 years:

• Treatment of symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing) caused by acid reflux from the stomach.
• Long-term treatment and prevention of relapses of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach).

Adults:

Prevention of gastroduodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) in patients at risk who require continued treatment with these types of drugs.

2. What you need to know before you take Pantoprazol Codramol

Do not take Pantoprazol Codramol

• If you are allergic (hypersensitive) to pantoprazole, or to any of the other ingredients of Pantoprazol Codramol (see section 6)
• If you are allergic to medicines that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be cautious when taking Pantoprazol Codramol

• If you have serious liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. In case of an increase in liver enzymes, treatment should be discontinued.

• If you need to take non-steroidal anti-inflammatory drugs (NSAIDs) continuously and take pantoprazole, as there is a higher risk of developing stomach and intestine complications. Any increased risk will be assessed according to your personal risk factors such as age (65 years or older), history of stomach or duodenal ulcers or stomach or intestine bleeding.
• If you have decreased body stores of vitamin B12 or risk factors for it and receive long-term treatment with pantoprazole. Like all medicines that reduce acid, pantoprazole may reduce the absorption of vitamin B12.
• Consult your doctor if you are taking any medicine that contains atazanavir (for HIV infection treatment) at the same time as pantoprazole.

Warnings and precautions

Before taking this medicine, inform your doctor if:

• If you have ever had a skin reaction after treatment with a medicine similar to Pantoprazol Farmalider to reduce stomach acid.

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 discontinue treatment with Pantoprazol Codramol. Remember to mention any other symptoms you may notice, such as joint pain.

• A specific blood test (Chromogranin A) is planned
• If you take pantoprazole for more than three months, you may experience a decrease in magnesium levels in your blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, dizziness, or increased heart rate. If you experience any of these symptoms, inform your doctor immediately. Additionally, low magnesium levels can cause a decrease in potassium and calcium levels in your blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

Inform your doctor immediatelyif you notice any of the following symptoms:

• unintentional weight loss
• repeated vomiting
• difficulty swallowing
• blood in vomit
• pale appearance and feeling of weakness (anemia)
• blood in your stools
• severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need any additional tests to rule out a malignant disease, as pantoprazole may alleviate symptoms of cancer and delay its diagnosis. If, despite treatment, your symptoms persist, complementary tests will be performed.

If you take pantoprazole for a prolonged period (more than one year), your doctor may monitor you regularly. You should inform your doctor of any symptoms and/or new or unexpected events each time you visit your doctor.

Use of other medicines

Pantoprazol Codramol may affect the efficacy of other medicines, so inform your doctor if you are taking:

• Medicines such as ketoconazole, itraconazole, and posaconazole (used to treat fungal infections) or erlotinib (used to treat certain types of cancer), as Pantoprazol Codramol may cause these and other medicines to not work properly.

• Warfarin and phenprocoumon, which affect blood coagulation. You may need additional monitoring.

• Atazanavir (used to treat HIV infection).

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Pregnancy and breastfeeding

There is not enough data on the use of pantoprazole in pregnant women. It has been reported that pantoprazole is excreted in human breast milk. If you are pregnant, think you may be pregnant, or are breastfeeding, you should only use this medicine if your doctor considers that the benefit to you is greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

You should not drive or use machines if you experience side effects such as dizziness or blurred vision.

3. How to take Pantoprazol Codramol

Follow the administration instructions of Pantoprazol Codramol indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take Pantoprazol Codramol?

Take the tablets whole, without chewing or crushing, with a little water, 1 hour before a meal.

Unless your doctor has indicated otherwise, the usual dose is:

Adults and adolescents from 12 years:

To treat symptoms associated with gastroesophageal reflux disease (heartburn, acid regurgitation, pain when swallowing)

The usual dose is one tablet per day.

This dose usually provides relief within 2-4 weeks, and if not, within 4 weeks. Your doctor will indicate how long you should take the medicine. Any recurring symptoms can be controlled as needed, taking one tablet per day.

For long-term treatment and prevention of relapses of reflux esophagitis

The usual dose is one tablet per day. If the disease recurs, your doctor may double the dose, in which case you can take Pantoprazol 40 mg once a day. After healing, you can reduce the dose back to one 20 mg tablet per day.

Adults:

To prevent duodenal and stomach ulcers in patients who require continued treatment with NSAIDs

The usual dose is one tablet per day.

Special patient groups:

• If you have serious liver problems, you should not take more than one 20 mg tablet per day.
• Children under 12 years: The use of these tablets is not recommended in children under 12 years.

If you take more Pantoprazol Codramol than you should

Inform your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. No symptoms of overdose are known.

If you forget to take Pantoprazol Codramol

Do not take a double dose to make up for forgotten doses. Take your next dose as usual.

If you stop taking Pantoprazol Codramol

Do not stop taking these tablets without consulting your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, Pantoprazol Codramol can cause side effects, although not everybody gets them.

The frequency of the possible side effects described below is classified as follows:

• very common (affects more than 1 in 10 people)
• common (affects between 1 and 10 people in 100)
• uncommon (affects between 1 and 10 people in 1,000)
• rare (affects between 1 and 10 people in 10,000)
• very rare (affects less than 1 in 10,000 people)
• frequency not known (cannot be estimated from the available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the emergency department of the nearest hospital:

• Severe allergic reactions (rare): swelling of the tongue and/or throat, difficulty swallowing, rash (urticaria), difficulty breathing, swelling of the face of allergic origin (angioedema/Quincke's edema), intense dizziness with rapid heartbeat and profuse sweating.

• Severe skin reactions (frequency not known): blisters on the skin and rapid deterioration of general conditions, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.

• Other serious conditions (frequency not known): yellowing of the skin and the whites of the eyes (severe liver cell damage, jaundice), or fever, rash, increased kidney size with occasional pain when urinating and pain in the lower back (severe kidney inflammation)

Other side effects are:

• Uncommon(affects between 1 and 10 people in 1,000)

headache; dizziness; diarrhea; feeling of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; skin rash, exanthema, eruption; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances.

• Rare(affects between 1 and 10 people in 10,000)

visual disturbances such as blurred vision; urticaria; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; increased breast size in men.

• Very rare(affects less than 1 in 10,000 people)

disorientation

Frequency not known(cannot be estimated from the available data)

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

If you are taking pantoprazole for more than three months, it is possible that your magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, or increased heart rate. If you experience any of these symptoms, go to the doctor immediately. Low magnesium levels can also cause a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors like pantoprazole, especially for a period of more than one year, you may have a slightly increased risk of hip, wrist, and spine fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (which can increase the risk of osteoporosis).

Side effects identified through blood tests:

• Uncommon(affects between 1 and 10 people in 1,000)

increased liver enzymes

• Rare(affects between 1 and 10 people in 10,000)

increased bilirubin; increased blood fat levels

• Very rare(affects less than 1 in 10,000 people)

reduction in the number of platelets that could cause bleeding or more bruising than usual; reduction in the number of white blood cells that could lead to more frequent infections.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Pantoprazol Codramol

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

Do not use Pantoprazol Codramol after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Pantoprazol Codramol

The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (in the form of sodium sesquihydrate).

The other ingredients (excipients) are:

Core:Mannitol (Pearitol 160C) (E-421), Microcrystalline cellulose (Avicel PH101), Microcrystalline cellulose (Avicel PH102), Pregelatinized corn starch (Starch 1500), Sodium starch glycolate (Explotab), Anhydrous sodium carbonate, Calcium stearate, Purified water (removed during the process).

Coating:

Isolating coating:Hydroxypropyl methylcellulose, Propylene glycol, Titanium dioxide (E171), Yellow iron oxide (E172).

Enteric coating:Methacrylic acid - ethyl acrylate copolymer, Polysorbate 80, Sodium lauryl sulfate, Triethyl citrate, Purified water (removed during the process)

Appearance of the product and contents of the pack

Gastro-resistant tablet of yellowish color, convex and oblong in shape.

Packaging:

Available in blister packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

FARMALIDER S.A.

c/Aragoneses 15

28108 Alcobendas - Madrid

Spain

Manufacturer:

West Pharma – Producções de Especialidades Farmaceuticas, S.A.

Rua João de Deus, nº11, Venda Nova, 2700 Amadora.

Lisbon (Portugal)

or

Atlantic Pharma Produções Farmaceuticas, S.A.

• da Tapada Grande, nº2

Abrumheira

2710-089 Sintra (Portugal)

Date of the last revision of this leaflet:October 2019

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