Pantoloc Control

Pantoprazole.

The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with "P20" on one side.
The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Excipients/Inactive Ingredients: Core: sodium carbonate (anhydrous), mannitol (E421), crospovidone, povidone K90, calcium stearate.
Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauryl sulfate, polysorbate 80, triethyl citrate.
Printing ink: shellac, red, black and yellow iron oxide (E172), and ammonia solution, concentrated.

PANTOLOC Control contains the active substance pantoprazole, which blocks the 'pump' that produces stomach acid. Hence it reduces the amount of acid in the stomach.
PANTOLOC Control is used for relief of heartburn symptoms associated with acid reflux in patients 18 years old or above.
Reflux is the backflow of acid from the stomach into the gullet ("foodpipe"), which may become inflamed and painful. This may cause symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Relief from acid reflux and heartburn symptoms may be experienced after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief. It may be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms.
Patients must be advised if the patient does not feel better or feel worse after 2 weeks.

This medicine should always be taken exactly as described in this monograph or as prescribed.
The recommended dose is one tablet a day. The recommended dose of 20 mg pantoprazole daily should not be exceeded.
This medicine should be taken for at least 2-3 consecutive days. PANTOLOC Control should be stopped when completely symptom-free. Relief from acid reflux and heartburn symptoms may be experienced after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief.
Patients must be advised if there is no symptom relief after taking this medicine for 2 weeks continuously. PANTOLOC Control tablets should not be taken for more than 4 weeks unless prescribed.
The tablet should be taken before a meal, at the same time every day. The tablet should be swallowed whole with some water. The tablet should not be chewed or broken.
Forgotten intake of PANTOLOC Control: A double dose should not be taken to make up for the forgotten dose. The next, normal dose should be taken the next day, at the usual time.

Patients must be advised if more than the recommended dose has been taken.

PANTOLOC Control should not be taken by: Patients who are allergic to pantoprazole, or to any of the other ingredients of this medicine (listed in Description); Patients who are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection). See Interactions.

Before taking PANTOLOC Control, caution should be exercised by: Patients who have been treated for heartburn or indigestion continuously for 4 or more weeks; Patients who are over 55 years old and taking non-prescription indigestion treatment on a daily basis; Patients who are over 55 years old with any new or recently changed reflux symptoms: Patients who have previously had a gastric ulcer or stomach surgery; Patients who have liver problems or jaundice (yellowing of skin or eyes); Patients who regularly see the doctor for serious complaints or conditions; Patients who are due to have an endoscopy or a breath test called a C-urea test; Patients who have ever had a skin reaction after treatment with a medicine similar to PANTOLOC Control that reduces stomach acid; Patients who are due to have a specific blood test (Chromogranin A); Patients taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection) at the same time as pantoprazole. Patients must be specifically advised.
This product should not be used for longer than 4 weeks unless prescribed. If the reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, patients must be advised about the need for long-term intake of this medicine.
Taking PANTOLOC Control for longer periods may cause additional risks, such as: reduced absorption of Vitamin B12, and Vitamin B12 deficiency in patients who already have low body stores of Vitamin B12; fracture of the hip, wrist or spine, especially in patients who already have osteoporosis (reduced bone density) or at risk of getting osteoporosis (for example, patients taking steroids); falling magnesium levels in the blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate). Low levels of magnesium can also lead to a reduction in potassium or calcium levels in the blood. Patients must be advised if this product is being used for more than 4 weeks. Regular blood tests may be performed to monitor the levels of magnesium.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia requires magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PANTOLOC Control. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Patients should seek medical attention immediately in case of any of the following symptoms, which could be a sign of another, more serious, disease: an unintentional loss of weight (not related to a diet or an exercise programme); vomiting (particularly if repeated); vomiting blood (this may appear as dark coffee grounds in the vomit); blood in the stools which may be black or tarry in appearance; difficulty in swallowing or pain when swallowing; looking pale and feeling weak (anaemia); chest pain; stomach pain; severe and/or persistent diarrhoea (because this medicine has been associated with a small increase in infectious diarrhoea); presence of a rash on the skin especially in areas exposed to the sun. Patients must be advised to inform the doctor as soon as possible, as there may be a need to stop the treatment with PANTOLOC Control. Patients must also be advised to mention any other ill-effects like pain in the joints.
Some tests may need to be performed.
Patients must be advised to inform the doctor that this medicine is being taken if the patient is due to have a blood test.
Relief from acid reflux and heartburn symptoms may be experienced after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief. This should not be taken as a preventive measure.
Patients must be advised to have regular checkups if they have been suffering from repetitive heartburn or indigestion symptoms for some time.
The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or acid-related symptoms: Avoid large meals; Eat slowly; Stop smoking; Reduce alcohol and caffeine consumption; Reduce weight (if overweight); Avoid tight-fitting clothing or belts; Avoid eating less than three hours before bedtime; Elevate bedhead (if the patient suffers from nocturnal symptoms); Reduce intake of food that can cause heartburn. These might include: Chocolate, peppermint, spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Driving and using machines: PANTOLOC Control may cause side effects like dizziness or disturbed vision. Patients must be advised not to drive or use machines.
Use in Children: PANTOLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.

This medicine should not be taken if the patient is pregnant or while breastfeeding.
Patients must be advised if: pregnant or breast-feeding, may be pregnant or planning to have a baby, before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients should seek medical attention immediately in case of any of the following serious side effects. This medicine should be stopped straight away. Patients must be informed to bring the leaflet and/or the tablets.
Serious allergic reactions (frequency rare: may affect up to 1 in 1,000 people): hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
Serious skin reactions (frequency not known: frequency cannot be estimated from the available data): rash with swelling, blistering or peeling of the skin, losing skin and bleeding around eyes, nose, mouth or genitals and rapid deterioration of general health, or rash particularly in areas of skin exposed to the sun. Joint pain or flu-like symptoms, a fever, swollen glands (e.g. in the armpit) and blood tests may show changes in certain white blood cells or liver enzymes.
Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or fever, rash, and enlarged kidneys sometimes with painful urination, and lower back pain (serious inflammation of the kidneys), possibly leading to kidney failure.
Other side effects include: Common side effects (may affect up to 1 in 10 people): benign polyps in the stomach.
Uncommon side effects (may affect up to 1 in 100 people): headache; dizziness; diarrhoea; feeling sick, vomiting; bloating and flatulence (wind); constipation; dry mouth; bellyache and discomfort; skin rash or hives; itching; feeling weak, exhausted or generally unwell; sleep disorders; increase in liver enzymes in a blood test; fracture in the hip, wrist or spine.
Rare side effects (may affect up to 1 in 1,000 people): distortion or complete lack of the sense of taste; disturbances in vision such as blurred vision; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in circulating granular white blood cells (seen in blood tests).
Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause bleeding or bruising more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).
Not known frequency cannot be estimated from the available data: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium, magnesium, calcium or potassium in blood (see Contraindications), rash, possibly with pain in the joints; feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhea.
Reporting of side effects: Patients must be advised in case of any side effects. This includes any possible side effects not listed in this monograph. Reporting side effects can help provide more information on the safety of this medicine.

Caution must be exercised in patients using, have recently used or might use any other medicines. PANTOLOC Control may stop certain other medicines from working properly. Especially medicines containing one of the following active substances.
HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV infection). PANTOLOC Control should not be used with HIV protease inhibitors. See Contraindications.
Ketoconazole (used for fungal infections).
Warfarin and phenprocoumon (used to thin blood and prevent clots). Further blood tests may be needed.
Methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer).
PANTOLOC Control treatment may be temporarily stopped if the patient is taking methotrexate because pantoprazole can increase levels of methotrexate in the blood.
PANTOLOC Control should not be taken with other medicines which limit the amount of acid produced in the stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
However, PANTOLOC Control may be taken with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.

Store in the original package in order to protect from moisture.

Antacids, Antireflux Agents & Antiulcerants

A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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