Pantoprazole antacid Sandoz Filmtabl 20 mg 14 pcs

What Pantoprazole Antacid Sandoz is and what it is used for

The active ingredient in Pantoprazole Sandoz, pantoprazole, belongs to the class of proton pump inhibitors. It blocks the enzyme responsible for releasing acid in the stomach (the proton pump).

Pantoprazole Antacid Sandoz is used in adults for the short-term treatment of symptoms of burning in the stomach and acid regurgitation, which are caused by stomach acid flowing back up into the esophagus.

When should Pantoprazole Antacid Sandoz not be taken?

Pantoprazole Antacid Sandoz must not be used if there is a known hypersensitivity to the active substance pantoprazole, other proton pump inhibitors or any of the excipients of Pantoprazole antacid Sandoz.

Pantoprazole Antacid Sandoz must not be taken by children and adolescents. Pantoprazole antacid Sandoz should only be taken during pregnancy and breastfeeding after consulting a doctor.

When is caution required when taking Pantoprazole Antacid Sandoz?

Please inform your doctor immediately in the following situations:

• unintentional, unexplained weight loss,
• unexplained looking pale and feeling weak (anaemia),
• if you have blood in your stool or if your stool is black in colour,
• difficulty swallowing,
• repeated vomiting,
• bloody vomit,
• Stomach pain,
• severe and/or persistent diarrhea,
• development of a rash, especially in areas of the skin exposed to the sun, as this may require you to stop your treatment with Pantoprazole Sandoz. Don't forget to mention other ailments like joint pain.

Please talk to your doctor before taking Pantoprazole Antacid Sandoz in the following situations:

• if you have had a stomach ulcer or an operation on the gastrointestinal tract,
• if you have been taking a medicine for heartburn or acid regurgitation continuously for 4 weeks or more,
• if you have jaundice or liver problems,
• if you have another concomitant serious illness,
• if you are about to have an endoscopic examination (e.g. gastroscopy or breath test),
• you are older than 55 years and treat digestive disorders with non-prescription medicines on a daily basis,
• you are older than 55 years and have new or recently changed symptoms,
• if you have ever experienced skin reactions as a result of treatment with a medicine similar to Pantoprazole Sandoz, which also reduces stomach acid.

Pantoprazole Antacid Sandoz can affect the way other medicines work. Therefore, tell your doctor, pharmacist or druggist if you are taking other medicines, such as:

• antifungal medicines,
• erlotinib to treat certain types of cancer,
• methotrexate for cancer,
• Medicines to thin your blood or medicines for HIV infection (e.g. atazanavir, ritonavir).

Concomitant use of these medicines should be avoided.

Do not take Pantoprazole Sandoz with other medicines that reduce the amount of acid in the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (eg ranitidine).

However, if necessary, you may take Pantoprazole Sandoz with antacids (eg magaldrate, alginic acid, sodium bicarbonate, aluminum hydroxide, magnesium carbonate or combinations thereof).

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

If you take Pantoprazole antacid Sandoz for more than 3 months it is possible that the levels of magnesium in your blood may fall. Low magnesium levels are manifested by fatigue, involuntary muscle tension, confusion, cramps, dizziness and increased heart rate. If you experience any of these side effects, please tell your doctor immediately. Low magnesium levels can also lead to a decrease in blood potassium and calcium levels. Your doctor may do regular blood tests to monitor your magnesium levels.

Taking proton pump inhibitors like Pantoprazole Sandoz, especially for more than a year, may slightly increase your risk of fractures in your hip, wrist or spine. Tell your doctor if you have osteoporosis or are taking corticosteroids (these medicines can increase the risk of osteoporosis).

Before starting treatment, tell your doctor, pharmacist or druggist if you are having specific blood tests (chromogranin A).

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, ie essentially 'sodium-free'.

This medicine contains the dye cochineal red A (E124) and may cause allergic reactions.

Tell your doctor, pharmacist or druggist if you

• suffer from other diseases
• have allergies or
• take other medicines (including those you bought yourself!) or use them externally.

Can Pantoprazole antacid Sandoz be taken during pregnancy or while breastfeeding?

If you are pregnant or want to become pregnant, or if you are breastfeeding, you must not take Pantoprazole antacid Sandoz without consulting your doctor.

How do you use Pantoprazole Antacid Sandoz?

Always take Pantoprazole antacid Sandoz as described here. Ask your doctor, pharmacist or druggist if you are not sure.

The adult dosage is one gastro-resistant film-coated tablet per day.

The film-coated tablets may need to be taken for 2-3 consecutive days to improve symptoms. Stop taking the tablets when you are completely free of symptoms.

If there is no improvement in symptoms within 2 weeks of continuous treatment, you should consult your doctor.

Without consulting a doctor, the treatment should not last longer than 4 weeks.

Pantoprazole antacid Sandoz gastro-resistant film-coated tablets should be swallowed whole and whole with some water 1 hour before a meal.

If you have taken more than the recommended dose of 1 film-coated tablet per day, tell your doctor, pharmacist or druggist. The symptoms of an overdose are not known.

If you forget to take a film-coated tablet, you must not double the dose. Instead, take the next dose at the usual time.

Follow the dosage given in the package leaflet or prescribed by your doctor. If you think the medicine is too weak or too strong, talk to your doctor, pharmacist or druggist.

What side effects can Pantoprazole Antacid Sandoz have?

Common (affects 1 to 10 users in 100)

Benign growths of the gastric mucosa.

Uncommon (affects 1 to 10 users in 1000)

Difficulty sleeping, headache, dizziness, diarrhea, nausea and vomiting, gas and bloating, constipation, dry mouth, abdominal pain and discomfort, rash, reddening of the skin, itching, feeling weak, tired or generally unwell.

Rare (affects 1 to 10 users in 10,000)

Immediate-type hypersensitivity reactions (dizziness, increased heart rate, sweating), weight changes, depressive moods and worsening of pre-existing depression, taste disorders, visual disturbances and blurred vision, hives (severely itchy skin rash, hives), joint and muscle pain, enlargement of the male breasts, increased body temperature and swelling of the arms and legs due to fluid retention (oedema).

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

Disorientation and aggravation of pre-existing disorientation, particularly in predisposed individuals.

Isolated cases

Delusions and confusion in predisposed individuals. If these symptoms already exist, they can be made worse by Pantoprazole antacid Sandoz. Decreased levels of certain minerals in the blood, rash, possibly associated with pain in the joints.

Inflammation of the colon causing persistent watery diarrhea.

Side effects found in blood tests are:

• Raised liver function tests have occasionally been reported.
• Rarely, an increase in bilirubin and blood lipid levels occurred.
• Very rarely, there have been reports of a decrease in the number of blood platelets, which may lead to increased bleeding or bruising, and a decrease in the number of white blood cells, which may cause more infections.

If you experience the following side effects, you should immediately stop taking Pantoprazole Sandoz and contact your doctor immediately:

• Severe allergic reactions: swelling of the tongue or throat, difficulty swallowing, hives, difficulty breathing, allergic swelling of the face and throat (Quincke's edema, angioedema), severe drowsiness with rapid heartbeat and profuse sweating.
• Serious skin changes such as blistering and rapid deterioration of your general condition, skin damage (including minor bleeding) of the eyes, nose, mouth and lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme) and sensitivity to light.
• Other serious conditions: yellowing of the skin or eyes (severe damage to liver cells, jaundice), fever, skin rash and enlarged kidneys sometimes accompanied by pain when urinating and pain in the lower back (severe inflammation of the kidneys).

If you notice side effects, contact your doctor, pharmacist or druggist. This also applies in particular to side effects that are not listed in this leaflet.

What should also be noted?

The medicinal product may only be used up to the date marked “EXP” on the package.

Storage Notice

Store in the original packaging, at room temperature (15-25°C) and out of the reach of children.

Your doctor, pharmacist or druggist can provide you with further information. These people have the detailed information for specialists.

What does Pantoprazole Antacid Sandoz contain?

Active Ingredients

1 film-coated tablet Pantoprazole antacid Sandoz contains 20 mg pantoprazole as pantoprazole sodium sesquihydrate.

Excipients

Core:

Sodium carbonate, microcrystalline cellulose, crospovidone, hydroxypropyl cellulose, highly disperse silicon dioxide, calcium stearate.

Intermediate coating:

Hypromellose, titanium dioxide, macrogol 400, quinoline yellow (E104), iron oxide yellow, cochineal red A (E124).

Enteric coating:

Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion polysorbate 80, sodium laurilsulfate), triethyl citrate.yellow iron oxide (E 172)

Registration Number

61372 (Swissmedic)

Where can you get Pantoprazole Antacid Sandoz? What packs are available?

In pharmacies and drugstores, without medical prescription.

Packs of 7 and 14 gastro-resistant film-coated tablets.

Marketing Authorization Holder

Sandoz Pharmaceuticals AG, Risch; Domicile: Red Cross