Pantoloc Control

Pantoprazole.

The active substance is pantoprazole. Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Excipients/Inactive Ingredients: Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril 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 of 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).
The patient may experience relief from acid reflux and heartburn symptoms 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.
The patient must talk to a doctor if he/she does not feel better or feel worse after 2 weeks.

Always take this medicine exactly as follows or as the doctor or pharmacist have told. Check with the doctor or pharmacist if not sure.
The recommended dose is one tablet a day. Do not exceed this recommended dose of 20 mg pantoprazole daily.
The patient should take this medicine for at least 2-3 consecutive days. Stop taking PANTOLOC Control when completely symptom-free. The patient may experience relief from acid reflux and heartburn symptoms after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief.
If the patient has no symptom-relief after taking this medicine for 2 weeks continuously, consult the doctor. Do not take PANTOLOC Control tablets for more than 4 weeks without consulting the doctor.
Take the tablet before a meal, at the same time every day. The patient should swallow the tablet whole with some water. Do not chew or break the tablet.
If the patient forgets to take PANTOLOC Control: Do not take a double dose to make up for the forgotten dose. Take the next, normal dose, the next day, at the usual time.
For further questions on the use of this medicine, ask the doctor or pharmacist.

Tell the doctor or pharmacist if the patient has taken more than the recommended dose. If possible, the patient should bring the medicine and the leaflet.

Do not take PANTOLOC Control: if the patient is allergic to pantoprazole, or to any of the other ingredients of this medicine (listed in Description); if the patient is taking a medicine containing atazanavir HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection). See Interactions.

Talk to the doctor before taking PANTOLOC Control: If the patient has been treated for heartburn or indigestion continuously for 4 or more weeks; if the patients is over 55 years old and taking non-prescription indigestion treatment on a daily basis; if the patient is over 55 years old with any new or recently changed reflux symptoms; if the patient has previously had a gastric ulcer or stomach surgery; if the patient has liver problems or jaundice (yellowing of skin or eyes); if the patient regularly sees the doctor for serious complaints or conditions; if the patient is due to have an endoscopy or a breath test called a C-urea test; if the patient has ever had a skin reaction after treatment with a medicine similar to PANTOLOC Control that reduces stomach acid; if the patient is due to have a specific blood test (Chromogranin A); If the patient is taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection) at the same time as pantoprazole, ask the doctor for specific advice.
Do not take this product for longer than 4 weeks without consulting the doctor. If the reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult the doctor who will decide about the need for long-term intake of this medicinal product.
If the patient takes Pantoloc Control for longer periods, this may cause additional risks, such as: reduced absorption of Vitamin B12, and Vitamin B12 deficiency if already having low body stores of Vitamin B12; fracture of the hip, wrist or spine, especially if already suffering from osteoporosis or taking corticosteroids (which can increase the risk of osteoporosis); 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. Talk to the doctor if the patient has been using this product for more than 4 weeks.
The doctor may decide to perform regular blood tests 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 required 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.
Tell the doctor immediately, before or after taking this medicine, if the patient notices 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; if the patient gets a rash on the skin, especially in areas exposed to the sun, tell the doctor as soon as possible, as there may be a need to stop the treatment with PANTOLOC Control.
Remember to also mention any other ill effects like pain in the joints.
The doctor may decide that the patient needs some tests.
If the patient is due to have a blood test, tell the doctor that he/she is taking this medicine.
The patient may experience relief from acid reflux and heartburn symptoms after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief.
The patient should not take it as a preventive measure.
If the patient has been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see the doctor regularly.
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: If the patient experiences side effects like dizziness or disturbed vision, he/she should not 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.

The patient should not take this medicine if pregnant or while-breastfeeding.
If the patient is pregnant or breast-feeding, may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell the doctor immediately or contact the casualty department at the nearest hospital, if the patient gets any of the following serious side effects. Stop taking this medicine straight away, but the patient should bring the leaflet and/or the tablets.
Serious allergic reactions (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 the patient's general health, or rash when exposed to the sun.
Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver damage), or kidney problems such as painful urination and lower back pain with fever.
Other side effects include: Common (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: 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 the patient to bleed or bruise 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).
Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed. By reporting side effects, the patient can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if the patient is 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). The patient must not use PANTOLOC Control if taking HIV protease inhibitors. See Contraindications; ketoconazole (used for fungal infections); warfarin and phenprocoumon (used to thin blood and prevent clots). The patient may need further blood tests; methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if the patient is taking methotrexate, the doctor may temporarily stop the PANTOLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Do not take PANTOLOC Control 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, the patient may take PANTOLOC Control 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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