20 mg enteric-tablet is
pantoprazole
What Pantoprazole Sandoz is and what it is used for
Pantoprazole Sandoz contains the active substance pantoprazole. Pantoprazole is a “selective proton pump inhibitor” that reduces the amount of acid formed in your stomach. It is used to treat acid-related diseases of the stomach and intestines.
Pantoprazole Sandoz is used to treating adults and children over 12 years of age for:
- treatment of symptoms (eg heartburn, acid reflux, pain when swallowing) in connection with a disease of the esophagus caused by reflux of acid from the stomach.
- long-term treatment and preventive treatment of reflux esophagitis (esophageal inflammation accompanied by acid reflux).
Pantoprazole Sandoz is used to treating adults for:
- preventive treatment of duodenal and gastric ulcers caused by non-steroidal anti-inflammatory drugs (so-called NSAIDs, eg ibuprofen ) in patients at risk who need this type of drug continuously.
Pantoprazole contained in Pantoprazole Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Pantoprazole Sandoz
Do not take Pantoprazole Sandoz
- if you are allergic to pantoprazole or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to other medicines that contain proton pump inhibitors
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Pantoprazole Sandoz:
- if you have severe liver problems. Tell your doctor if you have ever had problems with your liver. Your doctor will then check your liver enzymes more often, especially if you are taking Pantoprazole Sandoz as a long-term treatment. If liver enzymes increase, treatment should be discontinued.
- if you need to take so-called NSAIDs (for example for inflammation and pain) regularly and receive Pantoprazole Sandoz because you have an increased risk of stomach or intestinal complications. Any increased risk will be investigated concerning your personal risk factors such as your age (over 65 years), previous ulcers in the stomach or duodenum, or bleeding in the stomach or intestines.
- if you have a reduced ability to store vitamin B12 in your body or risk factors for reduced vitamin B12 and receive pantoprazole as a long-term treatment. As with any acid-lowering drug, pantoprazole may lead to reduced absorption of vitamin B12.
- If you are taking an HIV protease inhibitor such as atazanavir (for the treatment of HIV infection ) while taking pantoprazole, you should talk to your doctor for special advice.
- Use of a proton pump inhibitor such as pantoprazole, especially if you use it for more than a year, may increase the risk of a hip, wrist, or vertebral fracture (bone fracture). Tell your doctor if you have osteoporosis or if you are taking medicines called corticosteroids as they may increase the risk of osteoporosis.
- if you use Pantoprazole Sandoz for more than three months, your magnesium levels may drop. Low levels of magnesium can manifest as fatigue, involuntary muscle contractions, confusion, cramps, dizziness, and rapid heartbeat. If you get any of these symptoms, contact your doctor immediately. Low magnesium levels can also lead to a decrease in potassium or calcium levels in the blood. Your doctor may take regular blood tests to monitor your magnesium levels.
- if you are going to have a specific blood test (chromogranin A).
- if you have ever had a skin reaction after treatment with medicine like Pantoprazole Sandoz that reduces stomach acid.
If you get a rash, especially in areas exposed to the sun, tell your doctor as soon as possible as you may need to stop taking Pantoprazole Sandoz. Also remember to mention any other side effects, such as joint pain.
Contact your doctor immediately before or after taking this medicine if you notice any of the following symptoms which may be a sign of another, more serious condition:
- unjustified weight loss
- vomiting, especially if it happens repeatedly
- bloody vomiting, can look like coffee grounds in the vomit
- bloody stools that look black or tar-like
- difficulty swallowing or pain when swallowing
- you look pale and feel weak (which may be due to anemia )
- chest pain
- abdominal pain
- severe and/or persistent diarrhea, when a link has been found between this medicine and a small increase in infectious diarrhea
Your doctor may decide that you need to undergo some tests to rule out serious illness as pantoprazole may also relieve the symptoms of cancer and could delay such a diagnosis. If your symptoms persist despite your treatment, further examinations should be considered.
If you are taking Pantoprazole Sandoz as a long-term treatment (longer than 1 year), your doctor will probably call you for regular check-ups. You should tell your doctor about new and unusual symptoms and illnesses when you have contact with the doctor.
Children and young people
Pantoprazole Sandoz is not recommended for use in children below 12 years of age, as there is not enough experience for use in this age group.
Other medicines and Pantoprazole Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
This is because Pantoprazole Sandoz can affect the way other medicines work, so tell your doctor if you are taking
- medicines such as ketoconazole, itraconazole, and posaconazole (for the treatment of fungal infections) or erlotinib (for the treatment of certain cancers) as Pantoprazole Sandoz may cause these and other medicines to not work properly.
- warfarin and phenprocoumon which affect the thickness of the blood. You may need additional controls.
- drugs for the treatment of HIV infection such as atazanavir.
- methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) – if you are taking methotrexate, your doctor may temporarily stop your treatment with Pantoprazole Sandoz, as pantoprazole may increase methotrexate levels in your blood.
- fluvoxamine (used to treat depression and other mental illnesses) – if you are taking fluvoxamine, your doctor may reduce your dose.
- rifampicin (used to treat infections ).
- St. John’s wort ( Hypericum perforatum ) (for the treatment of mild depression).
Pregnancy and breastfeeding
There are no adequate data on the use of pantoprazole in pregnant women. Excretion in breast milk has been reported.
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.
You should only use this medicine if your doctor thinks that the benefits to you outweigh the risks to the fetus or baby.
Driving and using machines
Pantoprazole Sandoz has no or negligible effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
If you experience side effects such as dizziness and visual disturbances, do not drive or use machines.
Pantoprazole Sandoz contains dye and sodium
This medicine contains the azo dye nycockin (E 124), which may cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) sodium per enteric tablet, ie essentially ‘sodium-free’.
How to take Pantoprazole Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How to take this medicine
Take the medicine one hour before a meal without chewing or crushing the tablet. Swallow the tablet whole with a little water.
The recommended dose is:
Adults and adolescents over 12 years:
- For the treatment of symptoms (eg heartburn, acid reflux, and pain when swallowing) in connection with esophageal problems caused by reflux of acid from the stomach:
The usual dose is one tablet daily. This dose usually provides relief within 2-4 weeks – sometimes a further maximum of 4 weeks of treatment is needed. Your doctor will tell you how long to take the medicine. Thereafter, recurrent symptoms can be controlled by taking one tablet daily as needed.
- For long-term treatment and to prevent recurrence of reflux esophagitis :
The usual dose is one tablet a day. If the disease returns, your doctor may double the dose and you can then use Pantoprazole Sandoz 40 mg tablets instead, one tablet daily. After healing, you can reduce the dose one to one tablet of 20 mg per day.
Adults:
- To prevent duodenal and gastric ulcers in patients who need to take NSAIDs regularly:
The usual dose is one tablet a day.
Hepatic impairment
If you have severe liver problems, do not take more than one 20 mg tablet per day.
Use for children and adolescents
These tablets are not recommended for children under 12 years.
If you take more Pantoprazole Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
There are no known symptoms of overdose.
If you forget to take Pantoprazole Sandoz
Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.
If you stop taking Pantoprazole Sandoz
Do not stop taking these tablets without first talking to a doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse .
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following side effects, stop taking the tablets and tell your doctor immediately or contact the emergency department at the nearest hospital:
- Severe allergic reaction ( rare: may affect up to 1 in 1,000 people): swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (Quincke’s edema/angioedema), severe dizziness with very rapid heartbeat and heavy sweating.
- Severe skin reactions ( reported: occurs in an unknown number of users): you may notice one or more of the following symptoms: blistering of the skin and rapid deterioration of your general condition, superficial sores (with light bleeding) in the eyes, nose, mouth/lips or genitals, or rashes, especially on skin areas exposed to the sun. You may also experience joint pain or flu-like symptoms, fever, swollen glands (eg in the armpits), and blood tests may show changes in certain white blood cells or liver enzymes ( Stevens-Johnson syndrome, Lyell’s syndrome, erythema multiforme, subacute cutaneous lupus erythematosus, drug reaction with eosinophilia and systemic symptoms (DRESS), photosensitivity).
- Other serious conditions ( reported: occurs in an unknown number of users): yellowing of the skin or whites of the eyes (severe damage to liver cells, jaundice) or fever, rash, and enlarged kidneys sometimes with pain associated with urinary incontinence and lower back pain ( severe nephritis). This can lead to kidney failure.
Other side effects are:
- Common (may affect up to 1 in 10 people)Benign polyps are in the stomach.
- Uncommon (may affect up to 1 in 100 people): headache, dizziness, diarrhea, nausea, vomiting, bloating and flatulence, constipation, dry mouth, abdominal pain and discomfort, rash, hives, rash, itching, feeling of weakness, lethargy or general malaise, difficulty sleeping, hip, wrist or vertebral fracture (bone fracture).
- Rare (may affect up to 1 in 1,000 people): change or total loss of sense of taste, visual disturbances such as blurred vision, hives, joint pain, muscle aches, weight changes, increased body temperature, high fever, swelling of arms and legs (peripheral edema ), allergic reactions, depression, enlarged breasts in men
- Very rare (may affect up to 1 in 10,000 people):disorientation
- Has been reported (occurs in an unknown number of users): hallucinations, confusion (especially in patients who have previously had such symptoms), amount of sodium, magnesium , calcium, or potassium (see section 2), feeling of numbness, tingling, burning sensation or loss of sensation, rash, possibly with joint pain. Inflammation of the colon, causes persistent watery diarrhea.
Side effects identified by blood tests:
- Uncommon (may affect up to 1 in 100 people): an increase in liver enzymes
- Rare (may affect up to 1 in 1,000 people): an increase in bilirubin, higher levels of blood fats, high fever associated with a sharp decrease in granular white blood cells.
- Very rare (may affect up to 1 in 10,000 people): a reduction in the number of platelets which can lead to you bleeding more or more easily getting bruises, a reduction in the number of white blood cells which can lead to more infections, while an abnormal reduction in the number of red and white blood cells and platelets.
How to store Pantoprazole Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton, or tablet jar after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Pantoprazole Sandoz HDPE tablet jar: Use no later than 6 months after opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is pantoprazole. An enteric tablet contains 20 mg pantoprazole (as sodium sesquihydrate)
- The other ingredients are
Tablet core:
calcium stearate, microcrystalline cellulose, crospovidone (type A), hydroxypropylcellulose (type EXF), anhydrous sodium carbonate, anhydrous colloidal silica.
Tablet coating:
hypromellose, yellow iron oxide (E 172), macrogol 400, methacrylic acid – ethyl acrylate copolymer (1: 1), polysorbate 80, nycockin (E 124), quinoline yellow (E 104), sodium lauryl sulfate, titanium dioxide (E 171), triethyl citrate.
What the medicine looks like and the contents of the pack
Pantoprazole Sandoz 20 mg entero-tablet is yellow and oval (coated with a special layer), approximately 8.9 x 4.6 mm, and is available in:
Blister pack of 7, 10, 14, 15, 20, 28, 30, 50, 56, 56×1, 60, 84, 90, 98, 100, 100×1, 140, 168 tablets
Jar of 14, 28, 56, 98, 100, 250, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S
Edvard Thomsens Vej 14
2300 Copenhagen S
Denmark
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany
or
LEK Spolka Akcyjna,
Ul. Domaniewska 50 c,
02-672 Warsaw,
Poland
or
Lek Pharmaceuticals dd,
Verovškova 57,
1526 Ljubljana,
Slovenia
or
Lek Pharmaceuticals dd,
Trimline 2 D, 9220 Lendava,
Slovenia
or
Sandoz SRL,
Page Livezeni nr. 7 A,
540472 Targu-Mures,
Romania