Controloc Control 20mg 14 Tablets

CONTROLOC Control 20mg 14 tablets

WHAT IS CONTROLOC CONTROL AND WHAT IS IT USED FOR?

CONTROLOC Control contains the active substance pantoprazole, which blocks the "pump" which produce hydrochloric acid in the stomach. In this way, the product reduces the acidity in your stomach.

CONTROLOC Control is used for short-term treatment of symptoms of gastric reflux, such as heartburn, acid regurgitation in adults. Reflux is the backflow of acidic stomach contents into the esophagus, which can cause inflammation or pain. This can lead to symptoms such as feelings of heartburn, reaching throat (heartburn) and a sour taste in the mouth (acid regurgitation).

You may experience relief from symptoms of acid reflux and heartburn after just one day of treatment with CONTROLOC 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 symptoms.

2. BEFORE YOU TAKE CONTROLOC Control:

Do not take CONTROLOC Control:

if you are allergic (hypersensitive to pantoprazole, soya or any of the other ingredients of CONTROLOC Control (listed in section 6. WHAT IS CONTROLOC Control);

if you are taking a medicine containing atazanavir (for the treatment of HIV-infection);

if you are under 18 years of age;

if you are pregnant or breast-feeding.

Take special care with CONTROLOC Control

Tell your doctor:

if you have been treated continuously for heartburn or indigestion for 4 weeks or more;

if you are aged over 55 and taking medicine for indigestion without a prescription daily;

if you are over 55 years and have emerging or recently changed symptoms;

if you have had stomach surgery or have had gastric ulcers;

if you have liver problems or jaundice (yellowing of the skin or eyes);

if you regularly see your doctor for serious complaints or illnesses;

if you need to have an endoscopy or breath study called a C-urea test.

Tell your doctor immediately if before or after taking this medicine, you notice any of the following symptoms which may indicate other, more serious diseases:

Adverse loss of body weight (not related to diet or exercise);

Vomiting, particularly if repeated;

Vomiting blood; It may look like coffee grounds in your vomit;

If you notice blood in your stools, which can appear black or tarry in appearance;

Difficulty or pain when swallowing;

You look pale and feel weak (anemia);

Chest pain;

Tummy ache;

Severe and / or persistent diarrhea, because CONTROLOC Control is associated with a small increase in infectious diarrhea.

Perhaps your doctor will decide that you need additional research.

If you need to conduct blood tests tell your doctor that you are taking this medicine.

You may experience relief from symptoms of acid reflux and heartburn after just one day of treatment with CONTROLOC Control, but this medicine is not meant to bring immediate relief.

You should not take CONTROLOC Control as a prophylactic treatment.

If you have had recurring symptoms of heartburn or indigestion, do not forget to regularly visit your doctor.

Taking other medicines

CONTROLOC Control may stop certain other medicines from working properly. Tell your doctor or pharmacist if you are taking other medicines containing any of the following:

ketoconazole (used to treat fungal infections);

warfarin and phenprocoumon (used to thin the blood and prevent clots). Maybe you need further research;

atazanavir (used for the treatment of HIV-infection). You should not take CONTROLOC Control if you are taking atazanavir.

Do not take CONTROLOC Control with other medicines which limit the production of hydrochloric acid in your stomach, like other proton pump inhibitors (omeprazole, lansoprazole, or rabeprazole) or H2 blockers (ranitidine, famotidine).

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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This also applies to herbal and homeopathic products.

Intake of CONTROLOC Control with food and drinks

The tablets should be swallowed whole with some liquid before a meal.

Pregnancy and lactation

Do not take CONTROLOC Control if you are pregnant, you think you may be pregnant or are breastfeeding.

Ask your doctor or pharmacist before taking any medicine.

Driving and operating machines

If you experience side effects like dizziness or disturbed vision, you should not drive or operate machinery.

3. HOW TO TAKE CONTROLOC Control?

Always take CONTROLOC Control exactly as described in this leaflet. If you're not sure about something, ask your doctor or pharmacist.

Take 1 tablet daily. Do not exceed the recommended dose of 20 mg pantoprazole daily.

You should take this medicine for at least 2-3 consecutive days. Stop taking CONTROLOC Control when your symptoms subside completely. You may experience relief from symptoms of acid reflux and heartburn after just one day of treatment with CONTROLOC Control, but this medicine is not meant to bring immediate relief.

If you do not notice relief of your symptoms after taking the drug for two consecutive weeks, consult your doctor.

Do not take CONTROLOC Control more than four weeks without consulting your doctor.

Take the tablet before a meal, at the same time each day. You should swallow the tablet whole with some water. Do not chew or crush the tablet.

Children and adolescents

CONTROLOC Control should not be used by children and adolescents under 18 years of age.

If you take more than the recommended amount of CONTROLOC Control:

Tell your doctor or pharmacist immediately. If possible, take your medicine and this leaflet with you. There are no known symptoms of an overdose.

If you forget to take CONTROLOC Control

Do not take a double dose to make up for the missed dose. Take your next normal dose the next day at the usual time.

If you have further questions about the adoption of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, CONTROLOC Control can cause side effects, although not everybody gets them.

Tell your doctor immediately or contact the emergency department of the nearest hospital if you experience any of the following serious side effects. Stop taking the drug immediately and take this leaflet and / or the tablets with you.

Serious allergic reactions (rare): Hypersensitivity reactions, so-called anaphylactic reactions, anaphylactic shock and angioedema. Typical symptoms are: swelling of the face, lips, tongue and / or throat that may cause difficulty in swallowing and breathing, urticaria (nettle rash), severe dizziness with very fast heartbeat and heavy sweating;

Serious skin reactions (frequency not known): rashes, blisters and peeling of the skin, loss of skin and bleeding around the eyes, nose, mouth or genitals and rapid deterioration of the general condition or rashes when exposed to sunlight;

Other serious reactions (frequency not known): yellowing of the skin and eyes (due to severe liver), or kidney problems such as painful urination or low back pain with fever.

Side effects may occur with certain frequencies, which are defined as follows:

very common: affects more than 1 user in 10;

often affects 1 to 10 users in 100;

uncommon: affects 1 to 10 users in 1000;

rare: affects 1 to 10 users in 10,000;

very rare: affects less than 1 user in 10 000;

unknown: frequency can not be estimated from the available data.

Uncommon side effects:

headache; fatigue; diarrhea; nausea, vomiting; bloating and release of large amounts of gases; constipation; dry mouth; colic and discomfort; skin rash or hives; itching; feeling weak, feelings of fatigue or malaise; sleep disturbances; increase in liver enzymes in blood tests.

Rare side effects:

Distortion or complete lack of taste; visual disturbances such as blurred vision; joint pain; muscle pain; changes in body weight; fever; swelling of the extremities; allergic reactions; depression; increased bilirubin and fat levels in blood (seen in blood tests), breast enlargement in males; high fever and a sharp drop in the number of granulocytes in the blood (white blood cells) (seen in blood tests).

Very rare side effects:

disorientation; reducing the number of platelets which can cause bleeding and bruising, more than normal; decrease in white blood cells which can lead to more frequent infections; simultaneously abnormal reduction in the number of red and white blood cells, and platelets (see in blood tests).

Not known:

hallucinations, convulsions (especially in patients with a history of these symptoms); increased level of sodium in the blood, lowering the level of magnesium in the blood.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE CONTROLOC Control

Keep out of reach of children.

Do not use CONTROLOC Control after the expiry date stated on the box and blister. The expiry date refers to the last day of that month.

Store in the original container to protect from moisture.

Medicines should not be disposed of in wastewater or as household waste. Ask your pharmacist how to dispose of medicines you no longer require. These measures will help protect the environment.

6. FURTHER INFORMATION

What CONTROLOC Control contains:

The active substance is pantoprazole. Each tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).

Other ingredients are:

Core: sodium carbonate, mannitol (E421), crospovidone, povidone K90, calcium stearate.

Coating: hypromellose, povidone K25, titanium dioxide (E 171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer (1: 1), sodium lauryl sulfate, polysorbate 80, triethyl citrate.

Printing ink: shellac, red iron oxide (E172), black iron oxide (E172), yellow iron oxide (E172) and concentrated ammonia solution.

What CONTROLOC Control looks like and contents of the pack:

The gastro-resistant tablets are yellow, oval, convex, film-coated tablets imprinted with "P20" in brown ink on one side.

CONTROLOC Control is available in Alu / Alu blisters with or without reinforcement.

The pack contains 7 or 14 gastro-resistant tablets.

Not all pack sizes may be marketed.